Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Malaise, Oral disorder
Clinical narrative: feeling unwell; tiredness; developed a cough; Cough got worse since she got some bumps in her mouth; bumps that appeared on her head and in her mouth; Little bit of shortness of breath and that could have been from the cough and the wheezing; Little bit of shortness of breath and that could have been from the cough and the wheezing; This is a spontaneous report from a contactable consumer. This consumer(daughter) reported on behalf of a female patient(mother) that:   Identification of the case safety report:  Identification of the country of the primary: (Country) Identification of the country where the reaction/event occurred: (Country) Serious: No Patient characteristics Sex: Female  Reaction(s)/Event(s) MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE    Drug(s) Information Characterization of drug role: 1(Suspect) Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE    Identification of the country where the drug was obtained:(Country)   Country of authorization/application: (Country)  Active Substance Information Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE    Narrative case summary and further information: Case Narrative: Originating AE Request: REQ-# Attachments: 1  Reporter Subtype: Patient PQC Present: No  AE Present: Yes PQC Details:  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Consumer calling on behalf of her mother who received her first dose of Pfizer-Biontech Covid19 vaccine 26Jan2021, and is supposed to receive her second dose, tomorrow 16Feb2021.  Caller wants to know if her mother should defer the dose if she's feeling unwell? the vaccination site was specific about 3 week interval.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Consumer calling on behalf of her mother who received her first dose of Pfizer-Biontech Covid19 vaccine 26Jan2021, and is supposed to receive her second dose, tomorrow 16Feb2021. Caller is reporting that her mother experienced tiredness, developed a cough, and is most concerned about bumps that appeared on her head and in her mouth. These symptoms were treated by her HCP with prednisone, an antibiotic, and an inhaler.  Are these reported AEs?  Is it safe for her to receive the second dose as scheduled?  Follow-up(15Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer(daughter) reported on behalf of a patient(mother) that:  Reaction(s)/Event(s) Reaction/event as reported by primary source: Cough   Reaction/event in MedDRA terminology (LLT): Cough    Reaction/event MedDRA term (PT): Cough     Reaction(s)/Event(s) Reaction/event as reported by primary source: Had bumps in her head   Reaction(s)/Event(s) Reaction/event as reported by primary source: Cough got worse since she got some bumps in her mouth   Reaction(s)/Event(s) Reaction/event as reported by primary source: Little bit of shortness of breath and that could have been from the cough and the wheezing    Drug(s) Information Characterization of drug role: (Suspect) Proprietary medicinal product name: COVID 19 vaccine    Batch/lot number: Unknown  Action(s) taken with drug: Unknown  Narrative case summary and further information: Case narrative:  Selected Report Type: Initial Is the patient also the reporter? No Reporter type: Consumer or other non health professional Reporter telephone: (number provided)  Primary / Prescribing Healthcare Professional Info HCP postal address: (Country) Dates for Cough: (From: Unspecified To: Unspecified) Dates for Had bumps in her head: (From: Unspecified To: Unspecified) Dates for Cough got worse since she got some bumps in her mouth: (From: Unspecified To: Unspecified) Dates for Little bit of shortness of breath and that could have been from the cough and the wheezing: (From: Unspecified To: Unspecified)  Is COVID-19 Vaccine a Pfizer product? Yes COVID-19 Vaccine manufacturer: Unspecified Dates for COVID-19 Vaccine: (Start: Unspecified Stop: Unspecified) NDC number of COVID-19 Vaccine: Unknown UPC number of COVID-19 Vaccine: Unknown Reason for no lot number: of COVID-19 Vaccine: Other: Reporter stated, "I do not have that on me." Expiry Date of COVID-19 Vaccine: Unknown  Additional Context: Reporter stated, "I had taken my mother (patient), this is really a call regarding my mom but we have not been able to  get into touch with anybody nor has anybody been helpful. So, my mom got the Covid vaccine, Pfizer one, on 16Feb (not clarified). After she got the shot, she developed a cough. She had bumps in her head and the cough got worse since she got some bumps in her mouth, little bit of shortness of breath and that could have been from the cough and the wheezing."  Reporter further stated, "They put in the app and they told us that if you have side effects from the vaccine then you can contact. So, I am reaching out today because now a second shot is supposed to be coming up on Tuesday and I do not know that I am willing for her to get that shot but we have not talked to a healthcare professional about it. We talked to her doctor but he is like I do not know if it is related to the shot, maybe it is just allergies, so he gave her Prednisone (treatment), he also gave her antibiotics and then inhaler (treatment) So, I wanted to hear from somebody from Pfizer, their thought on what they think has happened. Did she have a reaction and may be something else was going on at the same time but I do not know that I am feeling comfortable having (sentence incomplete), she just came off the medicine (further clarification unknown) and she is not even a hundred percent well yet and her vaccine is tomorrow." Reporter was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department   LOT#: Reporter stated, "I do not have that on me." Reporter further stated, "It was given on 16Feb in (facility name and city provided)." In response to further probing, reporter stated, "I want to talk to the medical professional first right now because her vaccine is tomorrow. So, I really want to get this done first." Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call.  Information about batch/lot number has been requested.  Follow-up (12May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected