Age: 50.0
Sex: F
Vaccine: FLUX, HPVX, PPV, TTOX, VARZOS
Symptoms: Illness, Influenza like illness, Malaise, Seasonal allergy, Smear cervix
Clinical narrative: Feeling unwell; had been sick; Flu like symptoms/influenza like illness; Seasonal allergy; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE for prophylaxis, INFLUENZA VACCINE for prophylaxis, TETANUS VACCINE for prophylaxis and treprostinil sodium (Remodulin) for pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension. Concomitant products included sulfamethoxazole + trimethoprim (Bactrim), furosemide, ondansetron hydrochloride, sulfamethoxazole + trimethoprim (Trimethoprim And Sulfamethoxazole), spironolactone, oxygen, ambrisentan, sildenafil, fluconazole, paracetamol (Tylenol), mycophenolate mofetil and pantoprazole sodium.   On 14-SEP-2023, the patient received Shingles vaccine, HPV vaccine, PNEUMOCOCCAL VACCINE, INFLUENZA VACCINE and TETANUS VACCINE. On 16-FEB-2023, the patient started Remodulin (subcutaneous) .06 ug. In SEP-2023, less than a week after receiving Shingles vaccine and HPV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms/influenza like illness) and seasonal allergy (Verbatim: Seasonal allergy). On 17-SEP-2023, the patient experienced feeling unwell (Verbatim: Feeling unwell) and sickness (Verbatim: had been sick). The action taken with Remodulin was unknown. The outcome of the feeling unwell, influenza-like symptoms and seasonal allergy were unknown and the outcome of the sickness was not reported.   The reporter considered the feeling unwell to be possibly related to Shingles vaccine and HPV vaccine. It was unknown if the reporter considered the sickness, influenza-like symptoms and seasonal allergy to be related to Shingles vaccine and HPV vaccine.     The company considered the feeling unwell to be possibly related to Shingles vaccine and HPV vaccine. It was unknown if the company considered the sickness, influenza-like symptoms and seasonal allergy to be related to Shingles vaccine and HPV vaccine.   Additional Information: GSK Receipt Date: 13-OCT-2023 This case was reported from a consumer from a patient support program via pharmacy. It was reported that patient began therapy with Remodulin (treprostinil sodium, concentration 5.0 mg/ml) delivered via Remunity (SP filled) pump on 16 Feb 2023 for primary pulmonary arterial hypertension. The current dose was reported as 0.060 µg/kg (Remunity pharmacy filled with 3 ml/cassette; rate 32 mcl/hour), continuous via subcutaneous (SQ) route. Concomitant medications included Proair (salbutamol sulfate) and Benadryl. On 17 Sep 2023 (last three days), 7 months 2 days after initiating SQ Remodulin, the patient was not feeling well/ had been sick after getting shots on 14 Sep 2023 for pneumonia, flu, tetanus, shingles and papilloma (malaise). Further, a papanicolaou (PAP) smear was done. The patient's Remunity cassette number was not provided. Action taken with SQ Remodulin was not reported for the event of malaise. At the time of reporting, the outcome of malaise was unknown. The reporter did not provide causality for the event of malaise. The reporter's causality for the event of malaise with pneumococcal vaccine, flu vaccie, shingles vaccine, HPV vaccine, and tetanus vaccine was considered to be possibly related. On an unreported date in Sep 2023 (last week), the patient had flu symptoms due to the flu shot (influenza like illness). On an unreported date in 2023, she was having issues with seasonal allergies (seasonal allergy). Action taken with SQ Remodulin was not reported for the events of influenza like illness and seasonal allergy. At the time of reporting, the outcome of influenza like illness and seasonal allergy was unknown. The reporter did not provide causality for the events of influenza like illness and seasonal allergy. The reporter's causality for the event of influenza like illness with flu vaccine was considered to be possibly related.