Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypersensitivity, Hypoaesthesia oral, Off label use, Paraesthesia oral
Clinical narrative: Allergic reaction; Throat tightening; Inability to swallow; Numbness and tingling in her tongue, lips, and gums; Numbness and tingling in her tongue, lips, and gums; She was about 2 months postpartum when she received her vaccine and breastfeeding; She was about 2 months postpartum when she received her vaccine and breastfeeding; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable nurse (patient). This nurse (patient) reported information for both mother and baby. This is the maternal report.  A 38-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FA7485), via an unspecified route of administration, administered in the left deltoid on 04Aug2021 9:00 (at the age of 38 years old) as dose 1, single for COVID-19 immunization. Medical history included anaphylaxis, allergy to soy, postpartum blood loss and postpartum anemia, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received TDAP vaccine on an unspecified date in 2021 (reported as Feb2021 or Mar2021) for immunization (while she was still pregnant). The patient experienced allergic reaction, throat tightening, inability to swallow, numbness and tingling in her tongue, lips, and gums on 04Aug2021. It was also reported that on 04Aug2021, she was about 2 months postpartum when she received her vaccine and breastfeeding. It was reported that the patient experienced an allergic reaction within minutes of receiving the vaccine. She experienced throat tightening, inability to swallow, and numbness and tingling in her tongue, lips, and gums. She was advised not to get the second dose, however, her employer said that the reason is not valid. She is wondering if after documenting she is asking if she can get medical exemption. Her reaction occurred within minutes of receiving the first dose, within her observation window. When querying seriousness, she stated she would classify it as severe. She has had anaphylaxis in the past but has never reacted to anything other than soy, a food allergy. Within moments after the vaccine, the sensation of her throat closing was why she would be classifying the seriousness as severe. She explained that throat tightening and the inability to swallow were the first symptoms noticed and then within 30 minutes her tongue, lips, and gums were tingling and numb and she could not feel anything. As for treatment, she was able to take Benadryl and carries an Epi pen but PA was assessing her and said not to use the epi pen and she should have used the epi pen. Swallowing was abnormal for at least 24 hours and it was not until the next day that her swallowing felt normal again. She has no surgical history or any real medical history to provide. She was about 2 months postpartum when she received her vaccine and breastfeeding. She was diagnosed with postpartum anemia when her daughter was born on 26May2021 due to postpartum blood loss. She did follow up with allergy doctor and PCP but on a different day. She spoke to the doctor in employee health for medical exemption and that doctor spoke to her old family doctor and they came to the decision that she should get the second dose which she cannot believe. She knows as a nurse if she is introduced to the same antigen that her allergic symptoms are going to be worse. She does not want to go through this again especially while breastfeeding. The outcome of the event inability to swallow was recovered on an unspecified date in Aug2021 while the outcome of all other events was unknown.; Sender's Comments: As per information provided in case, the causal association between the event hypersensitivity, throat tightness, dysphagia, paraesthesia oral, hypoesthesia oral and the suspect drug BNT162B2 cannot be excluded. 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-202101245144 baby case