Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pancreatitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: She was then admitted to the hospital for pancreatitis; She received the Pfizer Covid-19 Vaccine on 25Feb2021 and her second dose on 12Mar2021; She received the Pfizer Covid-19 Vaccine on 25Feb2021 and her second dose on 12Mar2021; Clotting in systems/ Clotting in the liver and heart duct; All kinds of inflammation; She had gallstones or whatever; fogginess/has a foggy brain; sluggish; nap-y/wants to sleep all the time; Cough; lost taste and smell; lost taste and smell; 102 fever; aches and pains like a bad flu; aches and pains like a bad flu; she feels really tired/ she still has fatigue and like it is complete exhaustion; Chills; Nausea; Diarrhoea; She feels very slow; 1st dose 25th feb2021,second dose 12 march 2021; She contacted COVID-19 virus while in the hospital from her roommate; inflated in her belly; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program COVAX US Support. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6206), via an unspecified route of administration, administered in left upper arm on 12Mar2021 at 11:30 as dose 2, single dose for COVID-19 immunization (at the age of 53-year-old). Medical history included Wegener's disease from 2019 and ongoing, immunocompromised and she has a rare autoimmune disease from an unknown date and unknown if ongoing. Concomitant medication(s) included rituximab abbs (RITUXIMAB ABBS) taken for Wegener's disease from Nov2019 to Jan2021. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: E69264) via unspecified route of administration, administered in left upper arm on 25Feb2021 at 11:30, as single dose for COVID-19 immunization. It was reported that on 12Mar2021 the patient received second dose of vaccine and on an unspecified date in Mar2021, the patient was admitted to the hospital for pancreatitis (hospitalization) and she contacted covid-19 virus while in the hospital from her roommate and experienced clotting in systems/clotting in the liver and heart duct, all kinds of inflammation, she had gallstones or whatever, fogginess/has a foggy brain, sluggish, nap-y/wants to sleep all the time, cough, lost taste and smell, 102 fever, aches and pains like a bad flu, she feels really tired/she still has fatigue and like it is complete exhaustion, chills, nausea, diarrhoea, she feels very slow and on an unspecified date in 2021 had inflated in her belly and reported that the patient received the first dose of vaccine on 25Feb2021 and her second dose on 12Mar2021. The reporter stated that four days after receiving her second dose of vaccine she was admitted to the hospital for pancreatitis where she contacted COVID-19 virus while in the hospital from her roommate and after that she came home from the hospital, she also tested positive for Covid which was a little soon to be fully vaccinated. Six to seven days into the second vaccine she was placed with a roommate. She added that she was negative, but it was festering in her and the hospital separated them immediately. She got home 8 days later and developed a cough and went to urgent care and was like, come on man. She also stated that it was 15Mar2021 or 16Mar2021, maybe 15Mar2021 and the 16Mar2021 she was admitted to the hospital. She was admitted for 8 days because of the pancreatitis and further stated that maybe it was 13 or 14, she does not know, she has Covid fog. She added that she came home and then went to urgent care on 15Mar2021. She stated that she needs to get on a trial, she was screwed, and she needs help. She was on Ritxumab which was a medication that counteracts the vaccine, and the FDA knows this and mentioned that it is on the list of some medications that are immunocompromising and does not work with the vaccine. Caller stated her rheumatologist has been trying to get her into trials. She further added that the Covid-19 rapid was negative, and the PCR was positive, and she did not have additional dates or details. The next day, she had a cough before the PCR test came back. She lost her taste and smell, she had 102 fever, no taste or smell, aches and pains like a bad flu. She stated that she took Mucinex which she takes when she gets a cough. It got rid of the cough, fever, aches, pains, and chills. The no taste, the no smell, and everything else. The diarrhea, the nausea, and all that other nonsense she had. She was sure she had protection from the vaccine. She had pancreatitis, a lot of clotting in systems and added that then she got pancreatitis again and they thought it was her gallbladder. She was not sure; they did more testing before this because she had a lot of clotting in systems. They did not know why, if it was from the vaccine doing wacky nonsense or clotting in her heart and all this other stuff. She stated that before surgery, her gallbladder was causing pancreatitis and they wanted future testing before her liver ruptured and all that crap. She was diagnosed with pancreatitis again before she could get all of the other tests done. Caller does not know specific dates of events. Three weeks after Covid, or maybe two weeks after Covid, it resolved itself maybe in Mar or end of Apr and May. Four weeks after or maybe 3 weeks after Covid, everything resolved. Nothing was wrong with her liver, and they took her gallbladder out. She also stated that all of the clotting was due to an infection and whatever, it was resolved itself. Clotting in the liver and heart duct. All kinds of inflammation were gone, and she was able to have surgery on her gallbladder and they took it out as she had gallstones or whatever. It was Jun whatever and she was still inflated in her belly. Caller states call handler does not need to know about that and provides no additional details. She also stated that after second vaccination she had fogginess, sluggish, and nappy and that after Covid, she just has a foggy brain thing whatever they call that the fogginess where you cannot remember things or form sentences. She feels very slow. A little big sluggish and like nap-y, like she was not a nap person, but she feels really tired. She stated she was just shutting off her phone alarm. She added that she still has fatigue and like it is complete exhaustion and she just wants to sleep all the time. Patient also mentioned that she had not taken Ritxumab from 3 months prior to being vaccinated and she had taken it in Jan, and she was supposed to take it every 6 months. It was a chemotherapy drug, but she took it in Jan, and nobody told her, and nobody knew that you should not take it at a certain time before getting vaccinated and nobody knows this, there were no alerts and it was nobody's fault, it was too soon, and no other information was known. Infusion centre people put her in a chair for 6 hours and stick the thing in her arm for the drip. She has to have every 6 months for at least three years. Caller states she has Wegener's disease since 2019, which was what this was for. The reporter was nervous with all of the clotting they thought it was clotting and it was from the infection and pancreatitis and nothing related to the vaccine. While she went for her second pancreatitis when she did that she got tested for antibodies and here was she now had Covid. She goes for her second round of Rituximab in July and they will run the test for B cells because that is the marker. Antibody B marker for any kind of resilience for Covid. Caller does not provide additional details. She also stated that she did not know what to take and stated if she takes Mucinex d as soon as she gets a cough or Advil cold and sinus or sinus and allergy if she gets stuffed up or itchy eyes and that is all she ever takes. The product complaint team provided the conclusion as 'The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed'. On Mar2021, the patient underwent lab tests and procedures which included antibody test which result showed tested negative for antibodies, culture performed which was positive and body temperature was 102 Fahrenheit and on 15Mar2021 the COVID-19 rapid showed negative and PCR test was positive. The event pancreatitis was considered serious (hospitalization) and for other events it was not specified. The outcome was unknown for the events of Inappropriate schedule of product administration, Off label use Feeling abnormal, Sluggishness, Somnolence, Cough, Depressed mood and patient was not recovered from the events of fatigue and abdominal discomfort and outcome of events pancreatitis, drug ineffective and covid-19 Coagulopathy, Inflammation, Cholelithiasis, Taste loss, Anosmia, Pyrexia, Pain, Influenza like illness, chills, nausea, Diarrheas was recovered in 2021.   Information on Lot/Batch number was available. Additional information has been requested.