Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Full blood count, Gynaecological examination, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient reported for self). A 63-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 06.30 (age at vaccination 63 years) as dose 2, single for COVID-19 immunisation. The patient medical history included Surgeries and operations, Penicillin allergy (Has a penicillin allergy, critical, that will put her in the hospital or kill her), Latex allergy (Is also allergic to Latex and found that out after a surgery), anaphylactic shock , start date: 2016 (ended up in the hospital 5 times in a week in 2016, with something she ate at a restaurant),wisdom teeth pulled (she had upper respiratory difficulties after having some wisdom teeth pulled), Allergy, Compromised immune status, Genetic/chromosomal abnormality, Endocrine abnormality, Diabetes, Obesity start date: 23Aug2019, ate at a restaurant in the past where she ended up in the hospital, start date: 2016 , Non alcoholic fatty liver disease (Illness/AE:Non alcoholic fatty liver disease), Cough start date: 16Feb2021, Dermatitis start date: 03Mar2020, Cervicalgia start date: 29Oct2019, Pressure sore, small l buttox stage 1 start date: 29Oct2019, Breast pain, Bilateral start date: 04Oct2018, Vitamin D deficiency start date: 05Aug2017, Deconditioning start date: 28Sep2016, Dyspnea on exertion start date: 28Apr2016, Obstructive sleep apnea start date: 27Apr2016, Abnormal glucose nec start date: 24Dec2009, Gerd start date: 23Dec2008, Rhinitis allergic  start date: 26Jun2015 ,Urinary frequency start date: 14Sep2009, Arthritis, generalized start date: 06Jan2014, Personal history of cervical dysplasia start date: 18Apr2013, R shoulder surgery start date: 20Jan2012 Breast red surgery start date: 20Jan2012 , C spine surgery start date: 07Jan2011, C spine surgery x2 for disc dz , chronic pain start date: 10Oct2003, Cholecystectomy start date: 10Oct2003,Total hysterectomy- cis has one ovary start date: 10Oct2003, Stress incontinence start date: 06Jan2014,  Dyspareunia start date: 06Jan2014, Vaginitis , Atrophic start date: 18Apr2013, Cervicalgia-chronic , Variable start date: 10Oct2003 , Insomnia start date: 24Nov2004 , Anaphylactic reaction shellfish, persistent hoarseness start date: 06Apr2016, Anaphylactic reaction- shellfish, persistent hoarseness Cough start date: 06Apr2016, Disorder, Lipoid metabolism nos start date: 20Jan2012, Flu vaccine need plantar fasclltis, Bilateral start date: 28Sep2016 , Meralgia paresthetica of left side start date: 28Sep2016 , Dysphonia start date: 18Apr2016 , Elevated blood pressure start date: 23Feb2019 , Otitis externa , Chronic, start date: 13Feb2019 , Chest pain, start date: 13Feb2019, Elevated lft start date: 16Nov2020, Cough chronic start date: 19Aug2020 . Family history included: Type 2 diabetes start date: 16Nov2020 (Illness/AE: Type 2 diabetes). The patient's concomitant medications were not reported. The patients drug history included: Ampicillin this was when she was younger and had a really bad reaction. Was too sick and they gave Ampicillin and she ended up in the hospital in a coma and came out of it quickly), Codeine, reaction(s)allergy , Bactrim, reaction(s): hives (Can't take Bactrim, it was given for what they thought she had was MRSA several years ago and she took it for 9-10 days and went into full body hives and ended up in the ER), Doxycycline hyclate, reaction(s): allergy (it as critical), Dilaudid, reaction(s): upper respiratory difficulties (Can not take Dilaudid she had upper respiratory difficulties after having some wisdom teeth pulled), Aspirin, reaction itching( Has had Aspirin, and if taken more than a baby Aspirin, it makes her itch), Mortin, reaction(s): adverse reaction. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 06Apr2021 as dose 1, single for COVID-19 immunisation and experienced itching and did break out with bumps and they were in different spots of her body, blisters and they have lingered and left some red spots, weight gain. The patient took Flu shot (FLU VACCINE VII) and arm was red it took quite a few months to disappear (this was about 3 years ago). The patient also previously took Shingles vaccine (SHINGRIX), Pneumococcal vaccine. The patient's concomitant medications were not reported. On an unspecified date in Apr 2021 the patient experienced having extreme chills/like ice cold body; could not get warm, feeling cold, she is still getting the bumps, fever/ her temperature continued to go up and was at 102.9/ she took her temperature again and it was 103.4 or 103.6, she was so exhausted, her head was hurting, contamination or the tip of the needle could have been contaminated, myalgia. The events having extreme chills/like ice cold body, could not get warm, feeling cold, she is still getting the bumps, fever/ her temperature continued to go up and was at 102.9/ she took her temperature again and it was 103.4 or 103.6, she was so exhausted, her head was hurting and contamination or the tip of the needle could have been contaminated were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test: (19Aug2020) unknown results, blood cholesterol: (24Aug2021) 196, (135-200), blood culture positive: (05Mar2021) unknown result(Positive blood culture), blood test: (Apr2021) she had staph in her bloodstream, (Apr2021) she didn't have staph in her bloodstream, (30Apr2021) normal, blood thyroid stimulating hormone increased: (24Aug2021) elevated tsh, blood triglycerides: (24Aug2021) 123(10-150), body mass index: (10Oct2003) 40-44.9 adult(40-44.9 adult), body temperature increased: (Apr2021) 102.6 increased, (Apr2021) 102.9 increased, (Apr2021) 104 increased, electrocardiogram: (Apr2021) abnormal, full blood count (30Apr2021) normal, gynaecological examination: (21Jul2015) unknown result, (04Oct2018) unknown results; high density lipoprotein: (24Aug2021) 49.0 (40-60), influenza virus test: (unspecified date) negative, low density lipoprotein: (24Aug2021) 122, (66-100), (13Feb2019) 115 (0-100), mammogram: (15Dec2020) unknown results, metabolic function test: (30Apr2021) normal, nucleic acid test: (30Apr2021) negative, physical examination: (06Apr2016) unknown results, sars-cov-2 test: (Apr2021) she did not have the covid virus; urine analysis: (30Apr2021) normal, x-ray: (Apr2021) unknown. The outcome of patient experienced having extreme chills/like ice cold body; could not get warm, feeling cold, she is still getting the bumps, she was so exhausted, her head was hurting was not recovered. The outcome of fever/ her temperature continued to go up and was at 102.9/ she took her temperature again and it was 103.4 or 103.6 was recovered. The outcome of the events myalgia and contamination or the tip of the needle could have been contaminated was unknown. Therapeutic measures were taken for all events except myalgia and fever/ her temperature continued to go up and was at 102.9/ she took her temperature again and it was 103.4 or 103.6. The patient stated, within 24 hours she started having extreme chills, meaning like ice cold body, and she could not get warm. Her husband heated up something and put something on her feet to stop the chills and her feeling cold. She was really concerned because here it was 4 months down the road and she was still getting the bumps and thought this could be a reaction. By 3pm in the afternoon she still had the freezing and so she took 2 Extra Strength Tylenol (later clarified as Extra Strength Acetaminophen) because she knew that this was a sign of a probable fever. She checked her temperature and it was 102.6 and so she might have been running a fever previously and didn't realize it or not observed it because of being this cold. Finally got to sleep a few minutes and got up and was still ice cold and within another 4 hours she took 2 more of the Extra Strength Tylenol because her temperature continued to go up and was at 102.9.  So, her taking the first dose of it didn't help and the temperature continued to rise. Hours later, assuming from 3pm-7pm or so, she took another 2 Extra Strength Tylenol and she went to bed and had gotten warm because of what her husband had put something on her feet and added more blankets. She was still cold up to her feet with chills. 4 hours later around 11pm she took her temperature again and it was 103.4 or 103.6 and she took the Tylenol again about every 4 hours. Then at that time she was thinking she shouldn't be taking so much Tylenol, but she was so exhausted and her head was hurting, had headaches and was aching. She laid back down and went to the bathroom and then went back to bed. Clarified she had Tylenol, the Extra Strength Acetaminophen 500mg (500 caplets). Provided Lot number of 9ME3014A and expiry of Sep 2021. On Friday at 4am she got up and went to pee and her temperature was 104 and she called the hospital and was told to come in. Got to the hospital and they immediately took her in and hooked her up to an IV, but not sure what was in the IV. Then the doctor came and said what she experienced was pretty rare and this has happened to the doctor also. By this point, caller stated she just wanted to get better. Was told she should call Pfizer and in the meantime this wonderful and lovely vaccine had gotten her into debt financially. Stated she had an xray at 4am and an EKG, and blood was drawn. They were all expedited and while they did this she continued to have headaches and they had got worse. As she sat up right before they were going to release her she was told they could order Motrin for her, which she declined, since she had an adverse reaction to it, the red pill Motrin. Was told then they could order Morphine instead and she thought going from Motrin to Morphine was much. She did not get either and left. Unable to provide any product details (NDC, Lot, or expiry) for the red pill Motrin or Morphine. On her paperwork she had the EKG, xray, blood work, Covid testing and she did not have the Covid virus and she was not sick previously before they contributed her sickness and visit to ER as reaction from the Covid vaccine. Further stated that, she got the second Covid vaccine on Wednesday about 6:30 and did the stay at the hospital (site) for 30 minutes for observation because she has had adverse reactions to medicines before in past. Has also went into anaphylactic shock in past and so they wanted to observe her so she did not go into a stressful state immediately, but in less in 24 hours was when she started having the chills and things with the second dose. Doctors usually prescribed stuff thinking it would help and they do not, and she had broken out and had other problems. States there may be others that she may have had adverse events to, but unable to provide any other product names, NDC, Lot or expiry. No further details provided. Just had some bloodwork done yesterday, but the results are not back yet. Did have blood work done at the hospital about the 30Apr2021 or 31Apr2021. They called her and she told them her temperature was doing better and thought they were checking on her. They had taken 2 vials of blood from her then and did 2 tests, one was okay and the other showed she had staph in her bloodstream. They proceeded to tell her that maybe the nurse didn't wear gloves when giving her the vaccine, but she did. Caller asked if latex could be the reason because he is allergic and was told maybe there was some contamination or the tip of the needle could have been contaminated. Knew she had to take precautions because of her latex allergy and she had her husband with her both times she got the shot and he had both shots and was fine. Nurse stated maybe someone touched the needle wrong or didn't cap the needle and she does not know if it was capped or not. Nurse had to speak with the doctor and caller was told this was normal, which she didn't understand why the nurse didn't speak with the doctor before calling her. This call was either on Saturday or Sunday. Caller hung up and called her doctor and explained what was told to her and it was recommended for blood work to be redone. She went to Hospital that Monday and got new bloodwork done and it came back and she didn't have staph in her bloodstream because if she did she probably would have been sicker. No further details provided. The patient underwent lab tests and procedures which included Blood work (blood test): she had staph in her bloodstream, blood test: she didn't have staph in her bloodstream, Temperature (body temperature) increased: 102.6, body temperature increased: 102.9, body temperature increased: 104, electrocardiogram: abnormal, COVID-19 Test (SARS-CoV-2 test): she did not have the covid virus, x-ray: unknown on an unspecified date in Apr2021. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered at the time of this report; other events was unknown. Follow-up attempts are completed. No further information is expected. Follow-up(17Sep2021): New follow-up spontaneous report from a contactable consumer and a contactable consumer on behalf of Physician. This consumer reported in response to HCP letter sent. Updated information: Ongoing check box checked as No for Historical vaccine. Reporter added, At Risk classification removed, Patient details updated (patient age), Relevant medical history added, Lab data added, biological product updated, product details updated, New event added (Myalgia) and additional information added. Follow-up attempts were completed. No further information was expected.