Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hyperventilation, Oropharyngeal pain, Pain in extremity, Pulmonary oedema
Clinical narrative: allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.