Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | FC3182 | OT |
I was breastfeeding at the time; asthma/wheezing; extreme stuffiness in her nose; she was having trouble breathing in the middle of the night; Vomiting; Had green slimy diarrhea; She quit gaining weight; She would wake up in the middle of the night with high pitched scream; She developed these weird red patchy rashes; This is a spontaneous report received from a Nurse, Program ID. A 3-month-old female patient was exposed to BNT162b2 (BNT162B2), transmammary, administration details for the mother: not provided, on 03Sep2021 as dose number unknown, single (Lot number: FC3182) for covid-19 immunisation. The patient's and the mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING BREAST FEEDING (hospitalization), outcome "unknown", described as "I was breastfeeding at the time"; CHILDHOOD ASTHMA (hospitalization), outcome "unknown", described as "asthma/wheezing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "extreme stuffiness in her nose"; DYSPNOEA (non-serious), outcome "unknown", described as "she was having trouble breathing in the middle of the night"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "Vomiting"; INFANTILE DIARRHOEA (non-serious), outcome "unknown", described as "Had green slimy diarrhea"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "She quit gaining weight"; SCREAMING (non-serious), outcome "unknown", described as "She would wake up in the middle of the night with high pitched scream"; RASH (non-serious), outcome "unknown", described as "She developed these weird red patchy rashes". The patient was hospitalized for childhood asthma (start date: May2022). The patient underwent the following laboratory tests and procedures: Body height: 98 percentile; Weight: 8 lbs. Therapeutic measures were taken as a result of childhood asthma. Therapeutic measures were not taken as a result of nasal congestion. Clinical course: the patient's mother was breastfeeding at the time and told by patient's (daughter) doctor that it would be okay but the mother was pretty concerned about that as well and the mother believe the patient having the adverse reaction from the breastfeeding from the milk as well but the pharmacist told mother that it would be safe for 15 minutes he read in the study etc. The mother ended up taking this and the mother stayed in the store for 15 minutes like them they told her to. The mother ended up taking this (Pfizer COVID-19 Vaccine). The patient started problems the night of mother's shot, she was 16 pounds at that time, she was, she had just doubled her weight, she was born at 8 pounds but could not tell how long she was. She was then like 98 percentile for length so. The patient started out with like extreme stuffiness in her nose like when she was breathing and the mother asked her husband like do you think that she was having a history making problem for this and he thought the mother was being crazy after time but it all makes sense now. She had not been sick, they had been isolated for a year so within that evening of the patient getting it, the mother got it late afternoon. The patient was having trouble breathing in the middle of the night, was like being off, stuffed up and then it progressed from there. The patient did not get anything for the stuffiness but she started vomiting after that, for several months. She had green slimy diarrhea for several months, she quit gaining weight and she developed asthma within a month. Once she was diagnosed with asthma for the following month, she was wheezing pretty bad and she was put on breathing treatments (Unspecified medication) and steroid (Clarified as Prednisolone) and then she had a problem with asthma after that, several times. She was hospitalized "the next year in May". So, right around when she was year old, she was in the hospital, needed oxygen, breathing treatments and steroid. The steroid she was given each time was Prednisolone, the Orapred. Just to finish up the patient, she did follow with pulmonology now because she had been diagnosed asthma which she had never had an issue before mother breastfeeds and no one in her family had asthma, no asthma, nothing. The mother just thought of something else that happened to the patient. She never had done this before, neither had any of mother's other kids but right after she breastfed, right after the mother got the shot, she would wake up in the middle of the night with high pitched scream. You are going to think this was weird. The patient could not talk, so it's hard to say but that's just what we knew. The patient did not get eczema after the shot but she developed these weird red patchy rashes all the time, out of no where, when she was probably from the time she started breastfeeding after the mother got the shot (Pfizer COVID-19 Vaccine) "two year old". Amendment: This follow-up report is being submitted to amend previously reported information: event term "asthma" was updated to "infantile asthma".; Sender's Comments: As there is limited information in the case provided, the causal association between the event childhood asthma and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101381462 maternal case;
Test Name: Body Height; Result Unstructured Data: Test Result:98 percentile; Test Name: Weight; Result Unstructured Data: Test Result:8 lbs