Received Jul 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | UNK | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
the child was diagnosed with an abscess on his lower eyelid; the mother received Boostrix, RSV vaccine, Flu vaccine and Moderna COVID-19 vaccine in pregnancy/ child was diagnosed with an abscess on his lower eyelid; This serious retrospective pregnancy case was reported by a other health professional via registry (registry ID 186982) and described the occurrence of abscess of eyelid in a male infant exposed to DTPa (Reduced antigen) (Boostrix) solution for injection in utero. The mother received the product for prophylaxis. The parent's medical history included anemia (since 2010), asthma (since 1992), hypothyroidism (since 2016), ear infection (started on 16-FEB-2025 and ended on 28-FEB-2025), fever (pneumonia, sinus infection, food poisoning started on 27-FEB-2025 and ended on 28-FEB-2025), food poisoning (started on 21-FEB-2025 and ended on 24-FEB-2025), gravid (4), parity (2), pneumonia, respiratory infection (pneumonia, started on 01-FEB-2025 and ended on 28-FEB-2025), sinus infection (started on 01-MAY-2025 and ended on 10-MAY-2025), sinus infection (started on 16-FEB-2025 and ended on 28-FEB-2025), spontaneous abortion (1), albuterol (inhaled 2 puffs one day total on 22-FEB-2025, stopped albuterol due to heart racing on 28-FEB-2025), augmentin (took 1 oral pill 2 per day on 21-FEB-2025 and stopped on 23-FEB-2025), augmentin (took 2 oral pills for 2 days total on 01-MAY-2025 for sinus infection/ear infection and stopped on 10-MAY-2025), ganirelix acetate (received 0.25 mg once a day subcutaneously for fertility on 16-JAN-2025 and stopped on 21-JAN-2025), gonal-f (received 225 IU once a day subcutaneously for fertility on 12-JAN-2025 and stopped on 21-JAN-2025), hcg (received 100000 unit once a day subcutaneously for fertility on 21-JAN-2025 and stopped on 21-JAN-2025), iron (45 mg orally twice a week, started on 15-MAR-2025 and stopped on 18-OCT-2025), levothyroxine sodium (125 mcg orally once a day, started on 09-JAN-2025 and stopped on 18-OCT-2025), menopur injection (225 IU used subcutaneously for fertility once a day, started on 12-JAN-2025 and stopped on 21-JAN-2025), prenatal vitamin (Prenatal vitamin nos, orally 2 pills once a day started on 01-JUL-2024 and stopped on 18-OCT-2025), qvar (QVAR HFA inhaler, inhaled 2 puffs for 3.5 days in total, started on 22-FEB-2025 and stopped on 28-FEB-2025), testosterone gel (used as topical-face, scalp/ skin for fertility once a day, started on 27-DEC-2024 and stopped on 17-JAN-2025), vitamin b 12 (1 mcg subcutaneously 2 per month started on 09-JAN-2025 and stooped on 18-OCT-2025) and vitamin d 3 (50 mcg orally once a day started on 09-JAN-2025). On an unknown date, the mother received Boostrix (intramuscular), RSV vaccine (intramuscular), Flu vaccine (intramuscular) and Moderna COVID-19 vaccine (intramuscular). The infant was diagnosed with abscess of eyelid (Verbatim: the child was diagnosed with an abscess on his lower eyelid) (serious criteria hospitalization). On an unknown date, the infant experienced fetal exposure during pregnancy (Verbatim: the mother received Boostrix, RSV vaccine, Flu vaccine and Moderna COVID-19 vaccine in pregnancy/ child was diagnosed with an abscess on his lower eyelid). The infant was treated with antibiotics. The outcome of the abscess of eyelid was not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the abscess of eyelid to be related to Boostrix, RSV vaccine and Flu vaccine. The company considered the abscess of eyelid to be unrelated to Boostrix, RSV vaccine and Flu vaccine. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (RSV vaccine): Trimester unknown Pregnancy Exposure (Flu vaccine): Trimester unknown Pregnancy Exposure (Moderna COVID-19 vaccine): Trimester unknown Last Menstrual Period Date: 09-JAN-2025 Estimated Delivery/Due date: 16-OCT-2025 Pregnancy Details (Neonate 1): Actual Delivery Date: XX-OCT-2025 Gestation Time at Delivery: 40 weeks and 2 days Delivery Type: vaginal Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3572 grams (7lbs 14oz) Apgar Scores: 9 and 9 Delivery Notes: She delivered a liveborn infant, gestational age at delivery was 40.29, sex was male, birth length was 51.99 cm, birth head circumference was 34 cm, apgars 1 min/ 5 min was 9/ 9 See case US2026AMR083346 for details regarding the mother case. Additional Information: GSK Receipt Date: 23-JUN-2026 This was a spontaneous event report. The mother of the patient mentioned she enrolled prospectively in the OTIS study with pregnancy exposed to Boostrix. The date of conception was reported as 23-JAN-2025. The mother of the patient received historical drug TEA orally 1 serving once a day started on 09-JAN-2025 and stopped on 18-OCT-2025. She also received concomitant product TUMS (NEW FORM 1975) orally 2 pills 5 per week for heartburn started on 26-JUN-2025 and stopped on 18-OCT-2025. On 04-AUG-2025, the mother received Boostrix, on 02-SEP-2025, the mother received RSV vaccine, on 18-SEP-2025, the mother received Flu vaccine and on 09-SEP-2025, the mother received Moderna COVID-19 vaccine. On 17-NOV-2025 the child (patient) was diagnosed with an abscess on his lower eyelid. On 20-NOV-2025 he was admitted to hospital for intravenous antibiotics to treat the abscess. He was discharged to home on 22-NOV-2025. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Abscess of eyelid, after vaccination with Boostrix, RSV vaccine, Flu vaccine, in a 4-week-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (mother had multiple intercurrent illnesses during pregnancy, multiple concomitant medications and multiple vaccine exposure during pregnancy).