Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Body temperature increased, Erythema, Injection site erythema, Injection site induration
Clinical narrative: Initial information regarding this unsolicited courtesy case from a physician via a consumer via Pfizer was received and transmitted to Sanofi on 29-Nov-2018. This case involves a 67 years old female patient (79.38 kg) who experienced feels nauseous, feeling unwell, injection site is hard, red, the size of a softball, temperature up to 101 degrees Fahrenheit, her armpits are sore, ribs sore, her lymph nodes are inflamed/she feels like her lymph nodes are involved, line of red from the injection site to her armpit, up over her breast and lethargic, while she received vaccines PREVENAR 13 and INFLUENZA VACCINE. The patient's past medical history included pneumonia last year, and was diagnosed with breast cancer five years ago and also underwent surgeries. The patient's past medical treatment included ALEVE about four years ago when she was visiting her son and experienced anaphylactic shock. The patient took TYLENOL because of that. The patient's past vaccination(s) included PNEUMOCOCCAL 13 VALENT VACCINE after she developed a condition of pneumonia and also administered TETANUS VACCINE when she was 59 years old that was included in her medical records. She used to suffer sick and her arms swells up and her throat closed up after receiving the tetanus shot. The patient's past family history was not provided. However, family history related to occurrence of this AE has been found nil. On 12-Nov-2018, the patient received a dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in the left arm. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the right arm. On 12-Nov-2018, the patient developed a non-serious feels nauseous, feeling unwell, injection site is hard, red, the size of a softball, following the administration of INFLUENZA VACCINE and same-day following the administration of PREVENAR 13. On 13-Nov-2018, the patient developed a non-serious temperature up to 101 degrees Fahrenheit, ribs sore, her lymph nodes are inflamed/she feels like her lymph nodes are involved following the administration of INFLUENZA VACCINE and 1 day following the administration of PREVENAR 13. On 14-Nov-2018, the patient developed a non-serious line of red from the injection site to her armpit, up over her breast following the administration of INFLUENZA VACCINE and 2 days following the administration of PREVENAR 13. On an unknown date, the patient developed a non-serious lethargic following the administration of INFLUENZA VACCINE and following the administration of PREVENAR 13. No lab data reported. Final diagnosis was injection site is hard, red, the size of a softball, feeling unwell, feels nauseous, her lymph nodes are inflamed/she feels like her lymph nodes are involved, ribs sore, her armpits are sore, temperature up to 101 degrees Fahrenheit, line of red from the injection site to her armpit, up over her breast and lethargic. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering/Resolving for feels nauseous, as Recovered/Resolved on 14-Nov-2018 for temperature up to 101 degrees Fahrenheit, as Recovering/Resolving for feeling unwell, as Not Recovered/Not Resolved on an unknown date for her armpits are sore, as Not Recovered/Not Resolved on an unknown date for her lymph nodes are inflamed/she feels like her lymph nodes are involved, as Not Recovered/Not Resolved on an unknown date for injection site is hard, red, the size of a softball, as Not Recovered/Not Resolved on an unknown date for ribs sore, as Unknown for lethargic and as Not Recovered/Not Resolved on an unknown date for line of red from the injection site to her armpit, up over her breast.