Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | OT |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
feeling sort of bad for a week or two; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789418 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2024 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown (booster), single intramuscular for covid-19 prophylaxis. The patient's relevant medical history included: "Osteopenia" (ongoing); "Selective IgG immunodeficiency", start date: 2014 (unspecified if ongoing); "Asthma", start date: 2021 (ongoing); "Sleep apnea", start date: 2020 (ongoing); "Allergy to gold" (unspecified if ongoing); "Contrast media allergy" (ongoing), notes: Iodinated contrast; "Adhesive tape allergy" (ongoing), notes: glue on tape; "Allergy to silk" (ongoing), notes: silk suture; "allergic to EKG leads" (unspecified if ongoing); "IgG deficiency", start date: 2014 (ongoing); "Allergy to metals" (ongoing). Concomitant medication(s) included: RALOXIFENE HYDROCHLORIDE taken for osteopenia, start date: 2022 (ongoing); FLUTICASONE FUROATE taken for asthma, start date: 2021. Past drug history included: Tymlos, reaction(s): "Drug allergy", notes: Ongoing: Yes; Limbrel, reaction(s): "Drug allergy", notes: Ongoing: Yes; Ampicillin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes; Amoxicillin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes; Erythromycin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes. Vaccination history included: Pfizer biontech covid-19 vaccine (DOSE NUMBER UNKNWON, SINGLE (previously received multiple Pfizer doses).). The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling sort of bad for a week or two". Additional information: This spontaneous case was reported by a consumer and describes the occurrence of feeling abnormal (feeling sort of bad for a week or two) in a patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for Drug use for unknown indication: Tymlos, Limbrel, Ampicillin, Amoxicillin continued in additional info section. and Erythromycin; for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (previously received multiple Pfizer doses). Past adverse reactions to the above products included No adverse effect with Amoxicillin, Ampicillin, Erythromycin, Limbrel, Pfizer BioNTech COVID-19 vaccine and Tymlos. Concurrent medical conditions included Osteopenia, Selective IgG immunodeficiency since 2014, Asthma since 2021, Sleep apnea since 2020, Allergy to gold, Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Ampicillin), Allergy to antibiotic (Erythromycin), Drug allergy (Limbrell), Contrast media allergy (Iodinated contrast), Adhesive tape allergy (glue on tape), Allergy to silk (silk suture) and Drug allergy (Tymlos). Concomitant products included Fluticasone Furoate (Arnuity ellipta) from 2021 to an unknown date for Asthma, Raloxifene hydrochloride (Raloxifene) from 2022 to an unknown date for Osteopenia. In 2024, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling sort of bad for a week or two). At the time of the report, FEELING ABNORMAL (feeling sort of bad for a week or two) had resolved. It was reported that the patient was allergic to EKG leads. Patient had previously received multiple Pfizer doses, a Moderna booster, and another Pfizer booster last year. Patient had felt sort of bad for a week or two after previous COVID-19 vaccinations but clarified it was nothing unusual. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. This case was linked to MOD-2025-789628 (Patient Link). Most recent follow-up information incorporated above includes: On 24Sep2025: Significant follow-up information received contains reporter address, patient demographics, medical history, concomitant medicines added, and narrative updated. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : MOD-2025-789628 Patient Link;
Adhesive tape allergy (glue on tape); Allergy to metals; Allergy to silk (silk suture); Asthma; Contrast media allergy (Iodinated contrast); IgG deficiency; Osteopenia; Sleep apnea
Medical History/Concurrent Conditions: Allergy; Allergy to gold; Selective IgG immunodeficiency
RALOXIFENE HYDROCHLORIDE; FLUTICASONE FUROATE