Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Feeling cold, Headache, Inappropriate schedule of product administration
Clinical narrative: horrible headache; Charlie horse symptoms; trouble swallowing; chest pain; tightness; incredible pain; Inappropriate scheduling of vaccine; fever 103.6 F; tired/felt extremely tired; did not feel like eating.; started  feeling cold; chattering teeth/body chills/shivering; felt sickness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started  feeling cold), CHILLS (chattering teeth/body chills/shivering) and MALAISE (felt sickness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started  feeling cold), CHILLS (chattering teeth/body chills/shivering), MALAISE (felt sickness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduling of vaccine) and PYREXIA (fever 103.6 F). On an unknown date, the patient experienced HEADACHE (horrible headache), MUSCLE SPASMS (Charlie horse symptoms), DYSPHAGIA (trouble swallowing), CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness) and MYALGIA (incredible pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 09-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduling of vaccine) had resolved. At the time of the report, FATIGUE (tired/felt extremely tired), DECREASED APPETITE (did not feel like eating.), FEELING COLD (started  feeling cold), CHILLS (chattering teeth/body chills/shivering), MALAISE (felt sickness), HEADACHE (horrible headache), MUSCLE SPASMS (Charlie horse symptoms), DYSPHAGIA (trouble swallowing), CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness), MYALGIA (incredible pain) and PYREXIA (fever 103.6 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.6 (High) 103.6 F.         No concomitant medication were provided. Patient doctor did order test for Lupus and Rheumatoid arthritis, and put him on the 10 lb. weight limit at his work in case he has damaged muscles since patient had incredible pain in his both arms, right flank, shoulder blades and left hip. Patient also referred to Physical therapist twice a week which is helping him a little bit.  Company Comment: This case concerns a 59-year-old male patient with no relevant medical history reported  who experienced non-serious expected events of fatigue, chills. pyrexia, headache, myalgia and non-serious unexpected events of dysphagia, appetite decreased, chest discomfort, malaise, chest pain and feeling cold.  The events occurred within 24 hours after the second dose of Spikevax. Rechallenge was not applicable since the events occurred after the second dose. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-325251 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no relevant medical history reported  who experienced non-serious expected events of fatigue, chills. pyrexia, headache, myalgia and non-serious unexpected events of dysphagia, appetite decreased, chest discomfort, malaise, chest pain and feeling cold.  The events occurred within 24 hours after the second dose of Spikevax. Rechallenge was not applicable since the events occurred after the second dose. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.