Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Mastitis/recurring subclinical mastitis; She got the vaccine when her daughter was 2 weeks old; She got the vaccine when her daughter was 2 weeks old; after first dose she got blebs; arm was sore; she felt crappy and it went a went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28 year-old female patient received BNT162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28May2021 10:00 (Lot number: EW0191, Expiration Date: 30Sep2021) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: She occasionally gets migraines.; "allergic to cats" (unspecified if ongoing); "mildly allergic to berries" (unspecified if ongoing), notes: Verbatim: mildly allergic to berries; "allergic to penicillin" (unspecified if ongoing); "headache" (unspecified if ongoing), notes: She gets a headache with a certain type of antibiotic. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] taken for pregnancy (ongoing); VITAMIN D [COLECALCIFEROL] taken for pregnancy (ongoing). Past drug history included: Benadryl for vomiting, notes: stated she only took an occasional Benadryl to help with vomiting during first trimester; Tylenol, start date: 17May2021, notes: she took 500mg Tylenol maybe once in the morning and then she went into active labor by two, and daughter was born at like eight pm. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28May2021, outcome "unknown" and all described as "She got the vaccine when her daughter was 2 weeks old"; BLISTER (non-serious) with onset 2021, outcome "unknown", described as "after first dose she got blebs"; MASTITIS (non-serious) with onset Jun2021, outcome "unknown", described as "Mastitis/recurring subclinical mastitis"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was sore"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "she felt crappy and it went a went away". Additional information: The report was unrelated to a study or programme. There were no family medical history relevant to adverse events. Additional Information for concomitant Products prenatal vitamin was that it started before pregancy, it was just normal prenatal vitamins, and that of vitamin D was that it started before pregnancy, needs 6400 IUs while lactating. The patient didn't smoke, drink alcohol or use illicit drugs during this pregnancy. This was the first pregnancy. There were no treatment for infertility. There were no problems before, during or after delivery. There were no additional vaccines administered on same date of the Pfizer suspect. Time when the first vaccination given was reported as around 10 am. She had a lot of inflammation with breastfeeding, mentions she didn't have mastitis until after the vaccine, just a few days after first dose she got blebs. Dates for Mastitis was reported as from Jun2021. Her daughter was born in the middle of May and the beginning of Jun is when she started getting lactational blebs and mastitis. She got the vaccine when her daughter was 2 weeks old, then started getting the blebs and mastitis. She had all the typical things everyone has, like her arm was sore, she felt crappy and it went a went away. The patient clarified both doses given as intramuscular injections into right upper arm and also stated the blebs and mastitis started on right side.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200269210 Maternal/ Baby case;Regulatory Authority same reporter/ product/ patient, different dose and similar events