VAERS 2660736
GLAXOSMITHKLINE BIOLOGICALS · ROTAVIRUS (ROTARIX) · Charge nl2rk
- Staat
- MA
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 25.07.2023
- Impfdatum
- 19.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / LL
Symptomtext
Oral Suspension intramuscularly; left leg thigh area is red; Warm to the touch; lump that has grown since the injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number nl2rk, expiry date 18-FEB-2025) for prophylaxis. Concurrent medical conditions included injection site lump. On 19-JUL-2023, the patient received Rotarix lyophilized formulation (intramuscular, left thigh). In JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced injection site erythema (Verbatim: left leg thigh area is red), injection site warmth (Verbatim: Warm to the touch) and condition aggravated (Verbatim: lump that has grown since the injection). On 19-JUL-2023, the patient experienced inappropriate route of vaccination (Verbatim: Oral Suspension intramuscularly). The outcome of the injection site erythema, injection site warmth, condition aggravated and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device. It was unknown if the company considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter was the mother of the patient. The reporter reported that the patient received Rotarix oral suspension in her left thigh by intramuscular route which led to, inappropriate route of vaccination. The reporter stated that her left thigh area was red, warm to the touch and there was a lump that had grown since the injection was administered. The reporter did consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Condition aggravated
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Injection site lump
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -