Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Myalgia, Nausea, Pain in extremity
Clinical narrative: Dehydration; Severe uncontrolled nausea and vomiting, getting dangerous; Severe uncontrolled nausea and vomiting, getting dangerous; Dizziness; Soreness, the muscles pain in the upper extremities; Soreness, the muscles pain in the upper extremities; This is a spontaneous report from a contactable physician (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: reported as EL-32, either 3249 or 3219 could not tell), via intramuscular route in left arm on an unspecified date (at the age of 73-year-old) as single dose for COVID-19 immunization. Medical history included breast cancer from 2004 and intramuscular inoculation was on the opposite side and had blood pressure that was little controlled (from an unknown date and unknown if ongoing). Concomitant medications included hydrochlorothiazide (low dose) taken for high blood pressure; anastrozole (ARIMIDEX) taken for breast cancer. The patient previously received first dose of BNT162B2 via intramuscular route in left arm as single dose for COVID-19 immunization. The patient experienced severe uncontrolled nausea and vomiting, getting dangerous, dehydration, dizziness, soreness, the muscles pain in the upper extremities on an unspecified date. Reporter stated that she was a grateful recipient of both Pfizer vaccine doses and realized while filing her paperwork that she had after the second dose, side effects that were actually not listed, could be dangerous to somebody who is not a Physician. The reporter stated that, after the first dose, she had no problem, no nothing and with second dose no acute problem either, went to work all day. The next, during the night she developed nausea and very severe uncontrolled nausea and vomiting for two days. She was unable to keep anything down it was severe' (not clarified) and had dehydration. Even she was a physician, it was getting dangerous and eventually was able to take small pieces of water and ice chips and she went and got IV fluid. Reporter stated that if she was not wrong this uncontrollable nausea and vomiting went on for 48 hours. So, that when she looked at Pfizer list of side effect, she didn't notice that, so she wanted Pfizer to be aware. Right, out of her sense of responsibility, since treatment care' (not clarified) nausea was listed, vomiting, dehydration and she was taking fluid was not listed. Reporter stated that, nausea, vomiting, dehydration, dizziness' (not clarified) all of that is now listed, she wanted to notify that some, never thought like, as she said she was very, like pain' (not clarified) (incomplete sentence). It was reported that the route of administration was intramuscular in left arm both the times and basic pain sore, and she meant all above its side effects, soreness, the muscles pain in the upper extremities all of that happens but that was listed already, so that was not why she called. Reporter stated no laboratory tests were done and her second inoculation was on 09Feb and eventually recovered it did not, had small, was totally fine and was working full time centrum' (not clarified). And she just realized while filing paperwork and the normal thing was dehydration and all. While reporting on the treatment received for the events, she stated she didn't have any of the usual thing one has in case one has nausea, vomiting, so had chicken soup. No investigation assessments were done. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events dehydration, nausea, vomiting and the suspect drug.  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.