Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Expired product administered, Influenza, Malaise, Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 57-year-old female patient who received Influenza vaccine Quadrivalent (2018-2019 season) for prophylaxis. Co-suspect products included VENTOLIN HFA inhaler (batch number 7ZP5073, expiry date 31st January 2019) for seasonal asthma. Previously administered products included VENTOLIN HFA with an associated reaction of chest discomfort (tachycardia, tingling in hands, increased blood pressure and dizziness). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, the patient started VENTOLIN HFA 1 dosage form(s) as needed. On 4th April 2019, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season and VENTOLIN HFA, the patient experienced asthma aggravated, dyspnea exacerbated, chest tightness, tachycardia, tingling of extremity and increased blood pressure. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, condition aggravated, dizziness, sickness and expired drug used. On an unknown date, the outcome of the vaccination failure, condition aggravated, dizziness and expired drug used were unknown and the outcome of the influenza was not recovered/not resolved and the outcome of the asthma aggravated, dyspnea exacerbated, chest tightness, tachycardia, tingling of extremity, increased blood pressure and sickness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza, condition aggravated, dizziness and sickness to be related to Influenza vaccine Quadrivalent 2018-2019 season. The reporter considered the asthma aggravated, dyspnea exacerbated, chest tightness, tachycardia, tingling of extremity and increased blood pressure to be related to Influenza vaccine Quadrivalent 2018-2019 season and VENTOLIN HFA. It was unknown if the reporter considered the influenza, condition aggravated, dizziness and sickness to be related to VENTOLIN HFA. Additional details were provided as follow: The patient had the flu vaccine but still got the flu. The patient did not know the brand name or dosing of the flu vaccine that the patient received. The patient still got the flu and with that the patient got asthma issues. The patient took VENTOLIN for seasonal asthma and usually during the winter months. The patient had been sick for three weeks. The patient had not been using the VENTOLIN but last Thursday (4th April 2019) the patient had some breathing difficulties but it was not too bad. The patient could had gone on without inhaling. However, The patient decided to use the VENTOLIN. The patient primed the product to make sure that it was spraying. The VENTOLIN was already expired in January 2019, which led to expired drug used. When the patient inhaled the product the patient noticed that her breathing worsened increasingly, tightness in her chest, dizzy, not breathing, tachycardia, increase in blood pressure (160 per 95), asthma got worse, tingling in hands. The patient went to emergency room. The patient had breathing treatment and was relieved right after that. The patient reported that at some point in the past, the patient used that same inhaler when the patient needed it and the patient had a similar reaction. However, in the past it was not as severe. The reporter felt that VENTOLIN caused her problems. However, her physician did not think so. The case was considered as suspected vaccination failure as exact time to onset was not provided at the time of reporting. The reporter consented to follow up. This case was considered as medication error associated with adverse event.