Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inflammation, Loss of personal independence in daily activities, Movement disorder
Clinical narrative: Pain has diminished; my neck pain; muscle pain in the upper back; muscles were damaged/muscles continue to be bad; she wakes up with her back muscles exhausted; she hasn't been able to work and she's been at home/ unable to do anything; It is like a rock; feel like she was worse than an old lady / she is desperate; been like this for 3 weeks, in bed; woke up with my sheets soaked in sweat; back is like swollen; can not do movements with my arms; heart has a lot of palpitations; extreme fatigue/very exhausted/came back very very tired/fatigues when she drives/fatigues when she goes down the stairs/fatigues when she talks a lot; fever up to 103F¨; bile vomiting; Chills; whole body was shaking like a Parkinson person; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE INJURY (muscles were damaged/muscles continue to be bad), FATIGUE (extreme fatigue/very exhausted/came back very very tired/fatigues when she drives/fatigues when she goes down the stairs/fatigues when she talks a lot), TREMOR (whole body was shaking like a Parkinson person), PAIN (Pain has diminished) and HYPERHIDROSIS (woke up with my sheets soaked in sweat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced TREMOR (whole body was shaking like a Parkinson person), VOMITING (bile vomiting), CHILLS (Chills) and PYREXIA (fever up to 103F¨). On 14-May-2021, the patient experienced FATIGUE (extreme fatigue/very exhausted/came back very very tired/fatigues when she drives/fatigues when she goes down the stairs/fatigues when she talks a lot), HYPERHIDROSIS (woke up with my sheets soaked in sweat), SWELLING (back is like swollen), MOVEMENT DISORDER (can not do movements with my arms) and PALPITATIONS (heart has a lot of palpitations). 14-May-2021, the patient experienced BEDRIDDEN (been like this for 3 weeks, in bed). On 09-Jun-2021, the patient experienced FEELING ABNORMAL (feel like she was worse than an old lady / she is desperate). On an unknown date, the patient experienced MUSCLE INJURY (muscles were damaged/muscles continue to be bad), PAIN (Pain has diminished), INFLAMMATION (nflammation on her back), MUSCLE FATIGUE (she wakes up with her back muscles exhausted), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she hasn't been able to work and she's been at home/ unable to do anything), INDURATION (It is like a rock), NECK PAIN (my neck pain) and BACK PAIN (muscle pain in the upper back). The patient was treated with IBUPROFEN at an unspecified dose and frequency and NAPROXEN for Inflammation and Back pain, at a dose of 500 mg twice a day. On 13-May-2021, TREMOR (whole body was shaking like a Parkinson person), VOMITING (bile vomiting), CHILLS (Chills) and PYREXIA (fever up to 103F¨) had resolved. At the time of the report, MUSCLE INJURY (muscles were damaged/muscles continue to be bad) and FATIGUE (extreme fatigue/very exhausted/came back very very tired/fatigues when she drives/fatigues when she goes down the stairs/fatigues when she talks a lot) had not resolved and PAIN (Pain has diminished), HYPERHIDROSIS (woke up with my sheets soaked in sweat), SWELLING (back is like swollen), MOVEMENT DISORDER (can not do movements with my arms), PALPITATIONS (heart has a lot of palpitations), FEELING ABNORMAL (feel like she was worse than an old lady / she is desperate), BEDRIDDEN (been like this for 3 weeks, in bed), INFLAMMATION (nflammation on her back), MUSCLE FATIGUE (she wakes up with her back muscles exhausted), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she hasn't been able to work and she's been at home/ unable to do anything), INDURATION (It is like a rock), NECK PAIN (my neck pain) and BACK PAIN (muscle pain in the upper back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 103 (High) 103F. On an unknown date, Blood test: 430 (High) blood test value (does not know which exactly) that the most elevated that it can be is 200 and she has it in 430.. On an unknown date, Oxygen saturation: 73 (Low) oxygen went down to 73 and was sent to the hospital..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Muscle relaxant was given from her Doctor, but patient only took one dose because it gave her palpitations. Patient stated that she's still in treatment, she hasn't been able to work and she's been at home. Her muscles continue to be bad; she says from a scale to 1 to 10 to feel better she's 4, her pain has diminished. Patient stated that her back muscles were exhausted and with fatigue.   This case was linked to MOD-2021-214682, MOD-2021-264250.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received; events updated and information added to narrative. On 11-Aug-2021: Follow up received on 11-Aug-2021 :Significant follow up-Events added with unknown outcome