Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Irritability, Lymphadenopathy, Malaise
Clinical narrative: her arm began to ache (within 15minutes); started to feel bad, not feel too good; achy, aches began by the 3rd-5th day/severe pain; stomach was upset/stomach-ache; irritable; She felt foggy, felt like brain fog; she did not feel too good/she did not feel good at all; groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling; Condition agrravated; headache/coming down with something; lots of joint pain; things felt weird/felt very drained; fever for the next 3 days/pretty high fever 2 weeks (over 100F); This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache) and IRRITABILITY (irritable) in a 42-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.     The patient's past medical history included Meningitis in 2014 and Traumatic brain injury. Concurrent medical conditions included Pain, Attention deficit hyperactivity disorder, Osteophyte formation, Neck pain and Joint pain (at baseline). Concomitant products included OMEPRAZOLE, LISDEXAMFETAMINE MESILATE (VYVANSE), BUPROPION, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, TRAMADOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache), IRRITABILITY (irritable), FEELING ABNORMAL (She felt foggy, felt like brain fog), MALAISE (she did not feel too good/she did not feel good at all), LYMPHADENOPATHY (groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling), HEADACHE (headache/coming down with something), ARTHRALGIA (lots of joint pain), FATIGUE (things felt weird/felt very drained) and PYREXIA (fever for the next 3 days/pretty high fever 2 weeks (over 100F)). 21-Jan-2021, the patient experienced CONDITION AGGRAVATED (Condition agrravated). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm began to ache (within 15minutes)), FEELING ABNORMAL (started to feel bad, not feel too good), PAIN (achy, aches began by the 3rd-5th day/severe pain), ABDOMINAL PAIN UPPER (stomach was upset/stomach-ache), IRRITABILITY (irritable), FEELING ABNORMAL (She felt foggy, felt like brain fog), MALAISE (she did not feel too good/she did not feel good at all), LYMPHADENOPATHY (groin nodes (all on right side) swelled like a golf ball/lymph nodes started swelling all on the right side/supraclavicular nodes lymph swelling/axillary nodes swelling), CONDITION AGGRAVATED (Condition agrravated), HEADACHE (headache/coming down with something), ARTHRALGIA (lots of joint pain), FATIGUE (things felt weird/felt very drained) and PYREXIA (fever for the next 3 days/pretty high fever 2 weeks (over 100F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 99 (High) 99 F. On an unknown date, Body temperature: 103 (High) 103 F, 102.2 (High) 102.2F and 101 (High) high. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had medical history of bone spurs in her back, neck and joint pain at baseline and she has neurological memory issues. patient had reported her lumbar puncture was negative and labs came back normal.  Company comment: This case concerns a 42 year old female with a history of pain, bone spurs in back, neck and joint pain, meningitis, neurologic memory loss and traumatic brain injury who experienced the non-serious unlisted events of Pain in extremity, Abdominal pain upper, Feeling abnormal and non-serious listed events of Fatigue, Arthralgia, Headache and Pyrexia. The events began the day of Moderna COVID-19 vaccine and for days after with occasional relapse over the next couple of months. Re-challenge is positive for pain, pyrexia and fatigue as these occurred with the first dose also. The medical history of pain, bone spurs, neck and joint pain, meningitis and traumatic brain remain confounders as these could contribute to the events. Benefit-risk relationship of Modera COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-326770 (Patient Link).; Sender's Comments: This case concerns a 42 year old female with a history of pain, bone spurs in back, neck and joint pain, meningitis, neurologic memory loss and traumatic brain injury who experienced the non-serious unlisted events of Pain in extremity, Abdominal pain upper, Feeling abnormal and non-serious listed events of Fatigue, Arthralgia, Headache and Pyrexia. The events began the day of Moderna COVID-19 vaccine and for days after with occasional relapse over the next couple of months. Re-challenge is positive for pain, pyrexia and fatigue as these occurred with the first dose also. The medical history of pain, bone spurs, neck and joint pain, meningitis and traumatic brain remain confounders as these could contribute to the events. Benefit-risk relationship of Modera COVID-19 vaccine is not affected by this report.