Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Presyncope, Rash macular, SARS-CoV-2 test, Tremor
Clinical narrative: Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.