Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Nausea, Off label use
Clinical narrative: her throat - soreness and hoarseness. Today it is really bad and she can't swallow; sore throat; hard time swallowing; indigestion; she started having hives all over; joint pain; Nausea; small headache; hives were a quarter size that were itching; 3rd booster dose; 3rd booster dose; soreness; Sore Arm; chills; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient (mother):   A 65-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 03Oct2021 13:30 as a dose 3 (booster), single for COVID-19 immunization. The patient medical history included blood pressure high and hypothyroidism. The concomitant medication of the patient was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unspecified route of administration, on 09Jan2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via unspecified route of administration, on 29Jan2021 as single dose for COVID-19 immunization. The patient not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Oct2021 the patient experienced soreness, sore arm and chills. On 04Oct2021 the patient experienced quarter size hives that were itching; now itching stopped and hives were the size of half the palm. On 04Oct2021 and 05Oct2021 the patient experienced small and slight headache. On 05Oct2021 the patient experienced nausea, joint pain, muscle pain, terrible indigestion and patient started having hives all over. On 06Oct2021 the patient experienced throat soreness and difficulty swallowing, patient can only drink liquids. On an unspecified date the patient had her throat was soreness and hoarseness. Today it was really bad and she can't swallow. Patient received the treatment of tylenol for headache and aching, Pepcid, Benadryl, Zyrtec, Epi Pen for the reported events. Reported stated that doctor was saying that patient body was reacting to the vaccine. Reporter stated that doctor doesn't want to give patient the prednisone yet because it was going to interfere with the immune response. Reporter stated that the doctor gave patient an Epi Pen. Outcome of the reported events was recovered for soreness and sore arm on 04Oct2021, chills and indigestion on an unspecified date in 2021. The outcome of the event was not recovered for sore throat, hard time swallowing, hives were a quarter size and now are the size of palm. It's huge. The outcome was unknown for the reported events of small headache, she started having hives all over, joint pain, muscle pain, slight headache, throat was soreness and hoarseness. Today it was really bad and she can't swallow and nausea.; Sender's Comments: Based on the plausible temporal relation, the association between the events of myalgia, headache, chills, dyspepsia, urticaria, arthralgia, oropharyngeal pain, dysphagia, pruritus, dysphonia, pain in arm and nausea and the suspect product of BNT162B2 cannot be completely ruled out. 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.