Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lymph node pain, Pain in extremity
Clinical narrative: she has developed an anaphylactic reaction to Miralax since her Covid vaccine injections; following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; macrogol 3350 (MIRALAX), (Batch/Lot number: unknown); carbohydrates nos, electrolytes nos, vitamins nos (GATORADE ENERGY DRINK), (Batch/Lot number: unknown); magnesium sulfate, potassium chloride, sodium sulfate (SUTAB), (Batch/Lot number: unknown). The patient's relevant medical history included: "colonoscopy" (unspecified if ongoing), notes: She used Miralax prior to her last colonoscopy with no issues. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore", "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore", "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "she has developed an anaphylactic reaction to Miralax since her Covid vaccine injections"; PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore". The event "she has developed an anaphylactic reaction to miralax since her covid vaccine injections" required emergency room visit. The action taken for macrogol 3350, carbohydrates nos, electrolytes nos, vitamins nos and magnesium sulfate, potassium chloride, sodium sulfate was unknown.  Clinical course: Patient reported that she has developed an anaphylactic reaction to Miralax since her Covid vaccine injections Patient reports she was prepping for a colonoscopy and 15 minutes after the Miralax and Gatorade she had the anaphylactic reaction. The colonoscopy was canceled then re-scheduled a month later. She tried SuTab tablets, same thing happened but stronger reaction. She ended up in the ER. She's very nervous to get the booster. The only thing that she's done differently from the last colonoscopy was the vaccine. She used Miralax prior to her last colonoscopy with no issues. She also reported that following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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.