Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Oropharyngeal discomfort, Paraesthesia, Product administration interrupted
Clinical narrative: paraesthesia; Body wide intense itchiness; tickle in throat; Hives in flushes over arms,trunk,face and upper legs; some sensation of tightening; increased mucous production; several weeks late on 2nd dose; closed up 2nd dose appointments for all the health care providers without notice; dry itchy eyes; dry itchy eyes; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs) and THROAT TIGHTNESS (some sensation of tightening) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CETIRIZINE for an unknown indication.    Concurrent medical conditions included Paraesthesia generalised (Without known cause which flares during some viral infections or intense heat/ UV exposure. It is usually at a low fuzzy feeling but intensifies to pin-pricks when viral sickness.) since 2010.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and CETIRIZINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs), THROAT TIGHTNESS (some sensation of tightening), SECRETION DISCHARGE (increased mucous production), EYE PRURITUS (dry itchy eyes), DRY EYE (dry itchy eyes), PRODUCT ADMINISTRATION INTERRUPTED (several weeks late on 2nd dose) and PRODUCT AVAILABILITY ISSUE (closed up 2nd dose appointments for all the health care providers without notice). At the time of the report, PARAESTHESIA (paraesthesia), PRURITUS (Body wide intense itchiness), OROPHARYNGEAL DISCOMFORT (tickle in throat), URTICARIA (Hives in flushes over arms,trunk,face and upper legs), THROAT TIGHTNESS (some sensation of tightening) and SECRETION DISCHARGE (increased mucous production) outcome was unknown and EYE PRURITUS (dry itchy eyes), DRY EYE (dry itchy eyes), PRODUCT ADMINISTRATION INTERRUPTED (several weeks late on 2nd dose) and PRODUCT AVAILABILITY ISSUE (closed up 2nd dose appointments for all the health care providers without notice) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was provided Action taken with mRNA-1273 in response to the event was not applicable. Patient took cetirizine prior to vaccination with standby epinephrine. A second dose of cetirizine was taken at onset.   This case was linked to MOD-2021-004774 (Patient Link).