Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I felt weak; soreness and pain in my left upper arm where i received vaccine; I had terrible joint pain; had extreme fatigue; Body aches/felt like every muscle in their body hurts/I had terrible muscle pain; Typical gastro issue like nausea/; Chills; Stomach upset/My stomach felt off; Back hurts; Neck hurts; Back of her leg hurts; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset/My stomach felt off), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts) and ASTHENIA (I felt weak) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 031L20A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (She is a survival of three open heart surgery. 2001,2002 and 2011) and Heart valvular prosthesis user. Concurrent medical conditions included Ehlers-Danlos syndrome since January 2012, Dysautonomia in July 2010 and Raynaud's syndrome. Concomitant products included WARFARIN SODIUM (JANTOVEN) from October 2011 to an unknown date for Heart valve replacement, FLUDROCORTISONE from July 2010 to an unknown date for Low BP and Dysautonomia, VITAMIN D [VITAMIN D NOS], PARACETAMOL (TYLENOL [PARACETAMOL]), LIOTHYRONINE and PROBIOTICS NOS for an unknown indication, LEVOTHYROXINE.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset/My stomach felt off), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts/I had terrible muscle pain), NAUSEA (Typical gastro issue like nausea/) and CHILLS (Chills). On an unknown date, the patient experienced ASTHENIA (I felt weak), VACCINATION SITE PAIN (soreness and pain in my left upper arm where i received vaccine), ARTHRALGIA (I had terrible joint pain) and FATIGUE (had extreme fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset/My stomach felt off), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), ASTHENIA (I felt weak), MYALGIA (Body aches/felt like every muscle in their body hurts/I had terrible muscle pain), NAUSEA (Typical gastro issue like nausea/), CHILLS (Chills) and FATIGUE (had extreme fatigue) had resolved and VACCINATION SITE PAIN (soreness and pain in my left upper arm where i received vaccine) and ARTHRALGIA (I had terrible joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated after the 2nd dose within 4 hours, they started having side effects; these side effects were body aches, chills, stomach upset, their back hurts, the back of their leg hurts and felt like every muscle in their body hurts, neck hurts and typical gastro issue like Reportedly, the patient waited for 6 hours before using Tylenol 650 mg and heat. The patient reported that the symptoms were all gone within a day and a-half and the patient was back to their normal lifestyle.   The patient also reported that they were a survivor of three open heart surgery and had artificial heart valve.   The patient used Heat and Tylenol to alleviate the events.   This case was linked to MOD-2021-395769, MOD-2021-395919.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Followup received on 03 Dec 2021 includes HCP added, patient demographic details added, allergic condition added, medical history added, concomitants added, additional events added, treatment drug added.