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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a case series, 4 women [ages not stated] were described, who developed pain, discomfort, redness or seroma following COVID-19-Vaccine-Pfizer-BioNTech, Ad26.COV2-S or AZD-1222 vaccine [dosages, routes or duration of treatments to reactions onsets not stated].
Patient 1: The woman had undergone a cosmetic breast augmentation 5 years prior and presented with discomfort and pain resembling symptoms of bilateral capsular fibrosis two days after receiving the COVID-19-Vaccine-Pfizer-BioNTech vaccine [Pfizer/Biontec vaccine]. She received unspecified local treatment with non-steroidal anti-inflammatory drugs and cryotherapy with resolution of all symptoms.
Patient 2: The woman, who had a bilateral breast augmentation with implants 17 months prior, presented with redness and pain bilaterally 2 days after receiving the COVID-19-Vaccine-Pfizer-BioNTech vaccine. She received unspecified conservative treatment with spontaneous resolution of all symptoms.
Patient 3: The woman presented with onset of excruciating pain in her right breast where she had an expander placement in preparation of a later implant based reconstruction after receiving the Ad26.COV2-S [Johnson and Johnson's Janssen vaccine] three days prior. Four weeks prior to the presentation, she had her last expander filling. She received unspecified conservative treatment with resolution of pain.
Patient 4: The woman presented with signs of a fulminant infection and sudden exaggerating pain in her right breast after implant reconstruction eight weeks prior. One day prior to the presentation, she had received the AZD-1222 [AstraZeneca vaccine]. She received unspecified antibiotic treatment. However, her symptoms worsened. An ultrasound showed seroma which was not present in earlier post-operative scans. Puncture showed pus in the implant pocket. Therefore, the implant was removed and a thorough washout was performed. She underwent an immediate reconstruction with a free transverse myocutaneous gracilis flap from the contralateral thigh. Her post-operative course was uncomplicated. After few days, she was discharged from the hospital.
Reference
- Weitgasser L, et al. Potential immune response to breast implants after immunization with COVID-19 vaccines. Breast 59: 76-78, Oct 2021. Available from: URL: http://www.elsevier-international.com/journals/brst/ [DOI] [PMC free article] [PubMed]