Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaphylactic reaction, Chest X-ray, Muscle spasms, Nausea
Clinical narrative: Anaphylaxis; epigastric pain; nausea; Extreme cramping of her neck and shoulder; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Asthma, Drug allergy (hypersensitive to sulfur drugs) and Drug allergy (hypersensitive to codeine).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (epigastric pain), NAUSEA (nausea) and MUSCLE SPASMS (Extreme cramping of her neck and shoulder). The patient was treated with EPINEPHRINE (intramuscular) for Anaphylaxis, at a dose of 0.3 mg in left lateral thigh; DIPHENHYDRAMINE (intravenous) for Anaphylaxis, at a dose of 50 mg; FAMOTIDINE (intravenous) for Anaphylaxis, at a dose of 20 mg; METHYLPREDNISOLONE (intravenous) for Anaphylaxis, at a dose of 125 mg; NORMAL SALINE (intravenous) for Anaphylaxis, at a dose of 1 Litre bolus; ALBUTEROL;IPRATROPIUM for Anaphylaxis, at a dose of 9 ml; ONDANSETRON for Nausea and Epigastric pain, at a dose of 4 mg; METHOCARBAMOL for Anaphylaxis, at a dose of 1 gram and LORAZEPAM for Anaphylaxis, at a dose of 0.25 UNK. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) and MUSCLE SPASMS (Extreme cramping of her neck and shoulder) had resolved and ABDOMINAL PAIN UPPER (epigastric pain) and NAUSEA (nausea) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) chest radiograph demonstrated no acute findings, and all laboratory evaluation were within normal limits.. On an unknown date, Oxygen saturation: 92% 92% on room air. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis), ABDOMINAL PAIN UPPER (epigastric pain), NAUSEA (nausea) and MUSCLE SPASMS (Extreme cramping of her neck and shoulder) to be possibly related.    Patient presented with flushing of her skin, then abnormal throat sensation, which progressed to bilateral wheezing. She was immediately brought to the ED.  On initial assessment, patient was in respiratory distress, with diffuse wheezing bilaterally. Patient also endorsed she felt like her throat was "closing up" and was noted to have flushing of the skin and swelling of her face.  Non-rebreather mask was placed for oxygen supplementation.  With some medications patient's overall status improved after approximately 5 minutes. She then began to complain of epigastric pain and nausea and given Ondansetron, at which time the patient began to endorse extreme cramping of her neck and shoulder muscles. On examination, the patient's neck was held in a flexed position and patient's eyes remained shut.  After approximately 15 min, all symptoms had resolved, and the patient was feeling much better.  Patient is hypersensitive to sulfur drugs and codeine.  Concomitant product use was not provided by the reporter.  This literature-non-study case concerns a 45-year-old female patient, with medical history of asthma and hypersensitive to sulfur drugs and codeine, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred 10 minutes after the administration of the first dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of asthma and hypersensitive to sulfur drugs and codeine, remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Followup received by Safety on 11-Nov-2021 included an Email contains new information includes new events and concomitants and relevant medical history and lab data.; Sender's Comments: This literature-non-study case concerns a 45-year-old female patient, with medical history of asthma and hypersensitive to sulfur drugs and codeine, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred 10 minutes after the administration of the first dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of asthma and hypersensitive to sulfur drugs and codeine, remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.