Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Did not feel great,feeling unwell; On fluid restriction to 2 liters per day, due to fluid retention; Fluid build up in the abdomen; Cough; coughing a lot more; Feeling more congested; Phlegm; Gagging; Everything tastes bitter; Dry mouth; extreme dry mouth issues that her inner cheek is sticking to her teeth; Long Covid [coronavirus disease]; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP. A 71-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil (TYVASO DPI [TREPROSTINIL]), first regimen since 13Sep2022, second regimen at 48 ug 4x/day, third regimen at 16 ug 4x/day and fourth regimen (ongoing) at 48 ug 4x/day, all resp inhalation for pulmonary arterial hypertension; influenza vaccine (INFLUENZA VACCINE), in 2025 as dose number unknown, single for influenza immunisation. The patient's relevant medical history included: "Current Condition Pulmonary arterial hypertension" (unspecified if ongoing); "Two-Piece Adhesive Barriers" (unspecified if ongoing); "Beef Containing Products" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; OXYBUTYNIN CHLORIDE ER; CLARITIN [LORATADINE]; FIORICET; POTASSIUM CHLORIDE; PEPCID [FAMOTIDINE]; VITAMIN D3; K TAB; MAGNESIUM; ASPIRIN EC; GABAPENTIN; TADALAFIL; TYLENOL; ESTRADIOL; PREDNISONE; OXYGEN; SPIRONOLACTONE; BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]; SODIUM CHLORIDE; AMBRISENTAN; LORATADINE; TORSEMIDE. Past drug history included: Dilaudid, reaction(s): "Drug allergy"; Morphine sulfate, reaction(s): "Drug allergy"; Erythromycin, reaction(s): "Drug hypersensitivity"; Lidocaine hcl, reaction(s): "Drug hypersensitivity"; Simvastatin, reaction(s): "Drug hypersensitivity"; Ciprofloxacin hcl, reaction(s): "Drug hypersensitivity"; Chlorhexidine gluconate, reaction(s): "Drug hypersensitivity". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Did not feel great,feeling unwell"; FLUID RETENTION (non-serious), outcome "unknown", described as "On fluid restriction to 2 liters per day, due to fluid retention"; INTRA-ABDOMINAL FLUID COLLECTION (non-serious), outcome "unknown", described as "Fluid build up in the abdomen"; COUGH (non-serious), outcome "unknown", described as "Cough; coughing a lot more"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "Feeling more congested"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Phlegm"; RETCHING (non-serious), outcome "unknown", described as "Gagging"; DYSGEUSIA (non-serious), outcome "unknown", described as "Everything tastes bitter"; DRY MOUTH (non-serious), outcome "unknown", described as "Dry mouth; extreme dry mouth issues that her inner cheek is sticking to her teeth"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid [coronavirus disease]". The action taken for treprostinil was dosage not changed. Additional information: This 71-year-old, female patient began therapy with Tyvaso DPI (treprostinil inhalation powder), delivered by Tyvaso dry powder inhaler, on 13Sep2022 for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 16 ug and the current dose was reported as 16 ug, four times a day (QID) via inhalation (IH) route. The patient was having dry mouth and a little cough with Tyvaso DPI treatments. In the last year [from 2024], she had tooth issues (tooth disorder) and was not sure if it was due to Tyvaso DPI. Upon follow-up information on 21Oct2025 and 23Oct2025 Pfizer covid-19 vaccine was no longer considered as concomitant medication and updated as co-suspect medication. Additional suspect medication included influenza vaccine [unspecified]. The patient reported having a dry mouth (previously reported) and feeling thirsty. She could not use products containing xylitol and eating smarties candy helps with her dry mouth. She was on a fluid restriction of 2 liters per day due to fluid retention. If she did not take the diuretics [unspecified], she would gain 4 pounds in fluid (oedema). She had been on Tyvaso DPI 16 ug QID for years but had wonky blood work (blood test abnormal), and things were going downhill (condition aggravated). During the last physician appointment, the prescribing physician advised that her lungs were not as good as they needed to be (lung disorder) and that she would need to start increasing the Tyvaso DPI dose to a new goal of 64 ug QID if tolerated. She had previously increased to 48 ug QID some years ago but could not tolerate it (drug tolerance decreased), so the dose had been decreased to 16 ug QID. On an unreported date in 2025, she had received both the flu and Pfizer covid-19 vaccine shots a few days prior but did not feel great (malaise) afterwards and went to sleep when she got home. She stated that she had been feeling a little better since then. Co-suspect medication (Pfizer covid-19 vaccine EC) was updated to Comirnaty. Upon follow-up on 02Dec2025 additional concentration of 48 ug and additional dosage regimen of 48 ug, QID were added to Tyvaso DPI. It was reported that the patient was having fluid retention previously reported) while on Tyvaso DPI, with a lot of fluid build-up in the abdomen (intra-abdominal fluid collection) and coughing a lot more (previously reported), with higher Tyvaso DPI dose. She was feeling more congested (respiratory tract congestion) and was having more phlegm (productive cough). Action taken with Tyvaso DPI was not reported for the events of respiratory tract congestion, productive cough and intra-abdominal fluid collection. At the time of reporting, the outcome of respiratory tract congestion, cough, productive cough and intra-abdominal fluid collection was unknown. Upon follow-up information was received on 22Dec2025, additional information was received on 24Dec2025 with Day 0, 22Dec2025 as a query response, the patient was having coughing (previously reported) and sometimes gagging (retching) during and after Tyvaso DPI treatment. Furthermore, everything tastes bitter (dysgeusia) so her doctor thought she might have long covid (post-acute COVID-19 syndrome). The patient also had extreme dry mouth issues that her inner cheek was sticking to her teeth (previously reported). Action taken with Tyvaso DPI was not reported for the events of retching, dysgeusia and post-acute COVID-19 syndrome. At the time of reporting, the outcome of dry mouth, retching, dysgeusia and post-acute COVID-19 syndrome was unknown. Upon follow-up on 08Jan2026, as a query response from the physician. The patient's demographic (initials) was updated. Action taken with Tyvaso DPI was dose not changed due to the events of malaise, lung disorder, thirst, fluid retention, oedema, blood test abnormal, condition aggravated, respiratory tract congestion, productive cough, intra-abdominal fluid collection, retching, dysgeusia and post-acute COVID-19 syndrome. At the time of reporting, the outcome of lung disorder, thirst, fluid retention, oedema, blood test abnormal, condition aggravated, drug tolerance decreased, respiratory tract congestion, productive cough, intra-abdominal fluid collection, retching, dysgeusia and post-acute COVID-19 syndrome was not resolved. Batch/lot number is not provided, and it cannot be obtained.
Tooth disorder
Medical History/Concurrent Conditions: Allergic contact dermatitis; Food allergy; Pulmonary arterial hypertension
VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; OXYBUTYNIN CHLORIDE ER; CLARITIN [LORATADINE]; FIORICET; POTASSIUM CHLORIDE; PEPCID [FAMOTIDINE]; VITAMIN D3; K TAB; MAGNESIUM; ASPIRIN EC; GABAPENTIN; TADALAFIL; TYLENOL; ESTRADIOL; PREDNISONE; OX