Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | 043221A | — |
vomiting with blood; coughing up with large blood clots; pain in back like the lung area; chest pain; light to dark green stools; abdominal pain; shortness of breath; headache; nausea; weak; diarrhea; stools smell like adhesive band aids; vomiting; This spontaneous report received from a patient concerned a 56 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: 043221A) 0.5 millilitre(s), frequency not reported, administered on 07-Apr-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced vomiting with blood, coughing up with large blood clots, pain in back like the lung area, chest pain, light to dark green stools, abdominal pain, shortness of breath, headache, nausea, weak, diarrhea, stools smell like adhesive band aids, and vomiting. (dose series 1) The patient started having light to dark green stools, abdominal pain, chest pain, shortness of breath, headache, vomiting with blood, nausea, vomiting, coughing up with large blood clots, and pain in her back like the lung area. The patient went to the facility, where they had her go there to get a vaccine and throat culture swab to see if she had Covid. Those came back negative. The patient began having the side effects in June-2021 and they continued until December-2021. The patient's body is still weak, she still has diarrhea, and her stools smell like adhesive band aids. The patient has a severe allergy to adhesive bandages. The patient read that the things in the Johnson and Johnson Covid vaccine said liquid adhesive and chlorophyll were in the Johnson and Johnson Covid vaccine. The patient provided the lot number as 043221A and stated that she thinks it is 221A at the end (043221A). The patient stated that there is not an expiration date written down. It says that she received the vaccine at the pharmacy. On an unspecified date, laboratory data included: throat swab (NR: not provided) covid negative. The action taken with janssen covid-19 vaccine was not applicable. The outcome of vomiting with blood, coughing up with large blood clots, pain in back like the lung area, chest pain, light to dark green stools, abdominal pain, shortness of breath, headache, nausea, weak, diarrhea, stools smell like adhesive band aids and vomiting was not reported. This report was associated with product quality complaints: Product Complaint 90000352871; 90000352871; 90000352871. Investigation Results: This case does not contain product quality issue and the narrative does not describe and/or provide any indication of a product quality issue. Hence, this record will be sent for void in PQMS.. This report was serious (other medically important condition).; Sender's Comments: V0-haematemesis, hemoptysis . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Test Name: THROAT SWAB; Result Unstructured Data: covid negative