Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injection site induration, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain and a car accident three years ago, in July 2011. On 12-JUL-2014, the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in the office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, lightheadedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", lightheadedness that was "on and off', nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Follow up information was received from the physician. The physician reported that the patient had also experienced headaches and numbness and tingling (location unspecified) in July 2014. The outcome of the events was unknown. Follow up information was received from a physician and stated the patient was now experiencing numbness and tingling her hands and face in August 2014. The outcome of the events was not recovered. Follow up information has been received from the physician reporting that the patient was vaccinated at private Doctor's Office with Private Funds. Patient's demographics have been updated. It is also reported that the GARDASIL was administered in the morning (AM). There was no illness at the time of vaccination. On 12-JUL-2014, i.e., on the day of vaccination, patient experienced lightheaded for 5 mins, laid supine for 15 mins and then felt OK. She slept in the car on her way back home and has been lightheaded since then and is also experiencing nausea, pressure in ears, forehead, dizzy, weak, fatigue, shortness of breath, intermittent gasping 7/26. She was sent back home from work and was referred to Emergency Room (ER). Also patient has history of local reaction, known tender (slight) at site of injection, back pain and gastroparesis improvement. The adverse events of lightheadedness, nausea, pressure in ears, forehead, dizzy, weak, fatigue, shortness of breath and intermittent gasping on 26-JUL-2014 required emergency room/doctor visit and resulted in persistent or significant incapacity (also reported that it didn't lead to any disability or incapacity). There was no treatment given for these events. The discharge diagnosis was reported as dyspnea. On 21-JUL-2014, neutrophils was found to be 61%, lymphocytes was 28%, monocytes was 9%, eosinophils and basophils were 1% each, Anion Gap was 9 mmol/L, LDL calculated QN was 115 mg/dL and mono AB QL was negative. As of 30-JUL-2014, these events are not recovered yet. Physician also stated that she received a follow up AE correspondence MARRS 1407USA008933 and queried what does it mean by consent to inform, and if it's a patient's consent. Also, physician asked if the GARDASIL Lot J010395 exp 29-APR-2016 check has been requested. Physician requested that no further information is there to report and hence requested not to send any further MARRS letters. No further information provided. Additional information is not expected.