Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Neuralgia, Oral discomfort, Peptic ulcer
Clinical narrative: Vagus nerve cut for peptic ulcer disease; she has lost strength in her arms; Suspected torn rotator cuff; her blood pressure was over 230; burning moved into her hand, up her left arm, her right arm; burning moved into her chest; nerve pain, which remained in her arms; needed help to do activities around the house; Burning in her mouth; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PEPTIC ULCER (Vagus nerve cut for peptic ulcer disease) and HYPERTENSION (her blood pressure was over 230) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Vagotomy on 16-Sep-2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ORAL DISCOMFORT (Burning in her mouth) and NAUSEA (nausea). In April 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (needed help to do activities around the house). On 20-Apr-2021, the patient experienced BURNING SENSATION (burning moved into her hand, up her left arm, her right arm), CHEST PAIN (burning moved into her chest) and NEURALGIA (nerve pain, which remained in her arms). On 28-Jun-2021, the patient experienced HYPERTENSION (her blood pressure was over 230) (seriousness criterion medically significant). On 13-Jul-2021, the patient experienced ROTATOR CUFF SYNDROME (Suspected torn rotator cuff). On 13-Aug-2021, the patient experienced MUSCULAR WEAKNESS (she has lost strength in her arms). On an unknown date, the patient experienced PEPTIC ULCER (Vagus nerve cut for peptic ulcer disease) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; NITROGLYCERIN on 28-Jun-2021 for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) on 28-Jun-2021 for Nausea, at an unspecified dose and frequency; Surgery (Vagus nerve cut for peptic ulcer disease) for Peptic ulcer and Physical therapy (Occupational therapy) for Muscular weakness. On 01-Apr-2021, ORAL DISCOMFORT (Burning in her mouth) had resolved. On 28-Jun-2021, NAUSEA (nausea) had resolved. At the time of the report, PEPTIC ULCER (Vagus nerve cut for peptic ulcer disease), HYPERTENSION (her blood pressure was over 230), BURNING SENSATION (burning moved into her hand, up her left arm, her right arm), CHEST PAIN (burning moved into her chest), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (needed help to do activities around the house), MUSCULAR WEAKNESS (she has lost strength in her arms), NEURALGIA (nerve pain, which remained in her arms) and ROTATOR CUFF SYNDROME (Suspected torn rotator cuff) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, Blood pressure measurement: 230 (abnormal) Over 230.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information also include occupational therapy that same day and had been going for 5 weeks ,heat and  massage.  It was reported that the patient has lost strength in her arms as she could only hold a 2 pound weight with her left arm and a 5 pound weight with her right arm.  Company Comment: This case concerns a 76-year-old, female subject, who experienced the unexpected event/s of PEPTIC ULCER and HYPERTENSION. The event peptic ulcer occurred prior in an unknown date after vaccination, and hypertension occurred four months after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as there's no information available about the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. It is unclear if PEPTIC ULCER event happened before vaccination or not, hence it is kept as event until requested further information arrival.; Sender's Comments: This case concerns a 76-year-old, female subject, who experienced the unexpected event/s of PEPTIC ULCER and HYPERTENSION. The event peptic ulcer occurred prior in an unknown date after vaccination, and hypertension occurred four months after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as there's no information available about the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. It is unclear if PEPTIC ULCER event happened before vaccination or not, hence it is kept as event until requested further information arrival.