Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin burning sensation, Sleep disorder, Swelling, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), URTICARIA (broke out into hives over entire body), PRURITUS (itchy skin), SKIN BURNING SENSATION (sometimes it burns) and FORMICATION (sometimes feels like skin is crawling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 17-Nov-2020 and Covid-19 in December 2020. Previously administered products included for COVID-19: Mucinex and Tylenol. Past adverse reactions to the above products included No adverse event with Mucinex and Tylenol. On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced URTICARIA (broke out into hives over entire body), PRURITUS (itchy skin), SKIN BURNING SENSATION (sometimes it burns), FORMICATION (sometimes feels like skin is crawling), ABDOMINAL PAIN UPPER (stomach pain), CHEST PAIN (chest pain, not all the time), DYSPEPSIA (like heart burn, indigestion), OROPHARYNGEAL DISCOMFORT (feels like something is lodged in throat), PARAESTHESIA (tingling), BURNING SENSATION (burning sensation), PERIPHERAL SWELLING (swelling of hands and wrists), JOINT SWELLING (Swelling of hands and wrist), VISION BLURRED (vision is blurred), APHTHOUS ULCER (canker sores in mouth), PAIN IN EXTREMITY (aching, throbbing in arms and legs), MUSCLE SPASMS (constant muscle spasms all over), LIP SWELLING (swelling of lips), SWELLING (swelling of nose, swelling of chin), PARAESTHESIA (sometimes pins and needles in lips), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confusion), SLEEP DISORDER (broken sleep), ANXIETY (feelings of being anxious) and RESTLESSNESS (unrested). On 31-Dec-2021, the patient experienced HEADACHE (headache). On 05-Jan-2022, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Throbbing in her arms and legs) and URTICARIA CHRONIC (diagnosed with idiopathic/chronic urticaria). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), URTICARIA CHRONIC (diagnosed with idiopathic/chronic urticaria) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and URTICARIA (broke out into hives over entire body), PRURITUS (itchy skin), SKIN BURNING SENSATION (sometimes it burns), FORMICATION (sometimes feels like skin is crawling), ABDOMINAL PAIN UPPER (stomach pain), CHEST PAIN (chest pain, not all the time), DYSPEPSIA (like heart burn, indigestion), OROPHARYNGEAL DISCOMFORT (feels like something is lodged in throat), PARAESTHESIA (tingling), BURNING SENSATION (burning sensation), PERIPHERAL SWELLING (swelling of hands and wrists), JOINT SWELLING (Swelling of hands and wrist), VISION BLURRED (vision is blurred), APHTHOUS ULCER (canker sores in mouth), PAIN IN EXTREMITY (aching, throbbing in arms and legs), PAIN (Throbbing in her arms and legs), MUSCLE SPASMS (constant muscle spasms all over), LIP SWELLING (swelling of lips), SWELLING (swelling of nose, swelling of chin), PARAESTHESIA (sometimes pins and needles in lips), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confusion), SLEEP DISORDER (broken sleep), ANXIETY (feelings of being anxious), RESTLESSNESS (unrested), COVID-19 (tested positive for COVID) and HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Biopsy skin: idiopathic/chronic urticaria (abnormal) idiopathic/chronic urticaria. On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, SARS-CoV-2 test: positive positive. The patient had multiple blood works and diagnostic tests performed, which had been normal. No concomitant medication received by the patient. Treatment medication reported includes antihistamines. The patient had 5 ER visits and had seen her primary doctor for this issue 8-10 times. The patient had seen a Rheumatologist, Hematologist, Dermatologist, Allergist, and Cardiologist for the symptoms had been experiencing. It was reported around 15-Aug-2021, breaking out into hives all over her body, skin was very itchy sometimes her skin felt like burning and at other times felt like it was crawling. The patient was experiencing headaches, stomach pain, tingling, and burning sensation and swelling of her hands and wrists, vision was blurred. The patient  had canker sores in her mouth there was aching and throbbing in her arms and legs. In addition, patient experienced muscle spasms all over her body which constantly there, had swelling of her lips, nose, and chin. The patient also had a pins and needles sensation in her lips, had brain fog, confusion, and broken sleep with feelings of anxiousness and restlessness. The patient experienced chest pain it felt like heartburn or indigestion type of pain. It felt like there was something lodged in her throat when got these chest pains. This case concerns a 45-year-old female patient with relevant medical history of COVID-19, who experienced the unexpected non-serious adverse event of special interest COVID-19 and other non-serious events. The event occurred approximately 8 months after receiving the second dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2022-450476 (Patient Link). Sender's Comments: This case concerns a 45-year-old female patient with relevant medical history of COVID-19, who experienced the unexpected non-serious adverse event of special interest COVID-19 and other non-serious events. The event occurred approximately 8 months after receiving the second dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.