Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Skin discolouration, Vaccination site pain, Visual impairment, Weight
Clinical narrative: passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again.  Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore.  At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall.  She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs.  States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine.  States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction.  Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer.  States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early.  She adds that she is lucky she did not break an arm, leg. or bone.  States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore:  States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that.  If she touched it, she noticed, but it didn't hurt her from doing anything.  With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week.  She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so.  It was the same way, tender the first day and then at 4 am was when it got really bad.  That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her.  States she was fine yesterday 15Mar2021.  She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead.  States that her body temperature initially was variable starting on 26Feb2021.  She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021.  States this occurred 4 am after both first and second injection.  Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there.  The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008.  Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning.  Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine.  She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew.  They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it.  Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink.  She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics.  She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off.  She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth.  Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened.  She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming.  She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping.  The nurse got ahold of her husband in his office.  She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site.  She states it is the injection site and will not be the arm.  States that it is like the flu shot.  States she does not want to file a report regarding her husband because it was injection site soreness and went away.  Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history.  States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to.  No follow-up attempts possible. No further information expected.