Age: 66.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19-2, VARZOS
Symptoms: Ear discomfort, Ear infection, Ear pain, Feeling abnormal, Headache
Clinical narrative: Blood sugar has also been off the scale/ diabetic / that normally she is in the low - mid 100's but now she has been in the mid 300's.; Coughing (constantly); Extremely ill, has been really sick; Eyes are watering; Earache; Ear infection; Swollen lymph nodes; Wheezing; Ears are stopped up; Woke up feeling really bad, does not feel good; Horrible headache/ head hurts, can not think straight; Having trouble seeing; Chills; Blood sugar has also been off the scale/All of symptoms are worsening; Trouble remembering things, she guesses that is due her age; This case was reported by a consumer via other manufacturer and described the occurrence of diabetes in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   Previously administered products included Covid Vaccine (Her first dose was given to her on 24th February 2021), Covid Vaccine (Her second dose was given to her on 17th March 2021.) and Covid Vaccine (The third dose of the Covid Vaccine was received by the patient on 06th April 2022.). Concurrent medical conditions included mitral regurgitation (Patient had woke up one day and her heartbeat did not sound right. She had went to cardiologist, did not know exact year, they had ran some tests. It's been at least 5 years), diabetes (Diagnosed with diabetes after her second child. In 1979, they had a health thing done at her work where they had told her that she was pre-diabetic. First pregnancy 1984-1985 gestational diabetes took some insulin during pregnancy, but not after. In 1992 with her second son, the diabetes came back, and she had to remain on insulin; the patient stated that she was in her mid-30s at that time), hypothyroidism (Hypothyroidism runs in her family, she has been taking medication for this condition for around 20 years), cholesterol and spondylarthritis. Concomitant products included pravastatin, levothyroxine, ibuprofen, cannabidiol (Cbd Gummies), oxybutynin, acetylsalicylic acid (Aspirin), iron (Iron Tablet), cyanocobalamin (Vitamin B12) and colecalciferol (Vitamin D3).   On 27th September 2022, the patient received the 1st dose of Shingrix 50 ug and COVID-19 VACCINE PFIZER. On an unknown date, several days after receiving Shingrix, the patient experienced diabetes (serious criteria medically significant), cough, illness, watering eyes, ear pain, ear infection, swollen lymph nodes, wheezing, ear feels clogged, feeling bad, headache, visual impairment, chills, condition aggravated and memory disturbance. On an unknown date, the outcome of the diabetes, cough, illness, watering eyes, ear pain, ear infection, swollen lymph nodes, wheezing, ear feels clogged, headache, visual impairment, chills, condition aggravated and memory disturbance were unknown and the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the diabetes, cough, illness, watering eyes, ear pain, ear infection, swollen lymph nodes, wheezing, ear feels clogged, feeling bad, headache, visual impairment, chills, condition aggravated and memory disturbance to be related to Shingrix.     Additional Information: Receipt Date: 11-OCT-2022 Reporter's comments: The patient self-reported this case. The reporter was calling about the Pfizer Product Covid Omicron Booster, the fourth Covid Vaccine that she had received on left arm and also had received her first dose of the Shingrix vaccine on right arm. The reporter stated that she had been really sick since she had got the vaccine. She did not know if she got a tainted vaccine, or the wrong vaccine. She stated that up until now she had no side effects with the vaccines, however with this vaccine she had gone to the emergency Room twice. She stated that she had been coughing, eyes watering, earache, ear infection, swollen lymph nodes, wheezing, had no temperature though, she had been coughing constantly. She also stated that she had went to the urgent care and they had tested her, and she did not have neither Covid nor the Flu. She stated that they also had sent off a swab for a PCR test to find any other things that she might be infected with. The reporter stated that she probably would not have the results with her until at the time of reporting. She stated that her ears were also sopped up. She had been trying to get through to her primary care for about 2 weeks, but she could not get through. The reporter stated that they did not knew about her situation. She stated that all of her symptoms began a couple of days later after the vaccine. She stated that she woke up feeling really bad and it all had been going on since then. She had never had a high temperature though; her temperature had remained normal. She also stated that she really did not feel good. She was diabetic, and her blood sugar had also been off the scale, that normally she was in the low - mid 100's but now she had been in the mid 300's and also had a horrible headache. The reporter stated that all of her symptoms were worsening. She had gone to the urgent care on 2nd October 2022, and they had put her on a Z Pack. She stated that the Z-Pack did not do anything. She had gone back to the urgent care on 6th October 2022 and they prescribed her two things that she was scared to take. She stated that she had read the side effects of them, and the side effects were scary. She stated that one of them said something about affecting the heart. She stated that she had mitral valve regurgitation, she wanted to call her doctor before she takes these two medications. She stated that they did not give her a vaccination card. She stated that they probably had put it online, she was going to check. She stated that for this Covid Omicron Booster that she had received on 27th September 2022, her online record stated it was the Pfizer Bivalent 12 plus MDZ Injection. She stated that it was listed with an Rx number, no NDC, Lot Number, or expiry date was mentioned. They told her that it was okay to receive the Shingrix and the Covid Omicron Booster on the same day. She stated that her online record for this vaccine stated, Shingrix, 50 mcg injection, it had a RX number and Prescriber information and that was all. She stated that she had already thrown the packaging for Z-Pack medication away. She stated that the two medication she was prescribed but had not taken it yet were also listed on her online profile were Benzonatate 200 mg capsules Doxycycline Hyclate 100 mg capsules. She stated that she had not taken either of them yet. She wanted to talk to her doctor first before she starts them. She stated that she got the medications from urgent care, and she did not trust Urgent Care. She stated that at the Urgent Care they kept asking her what she wanted to take. The reporter stated that she said it was like a vending machine instead of a clinic. She stated that they also offered to prescribe the reporter steroids, but she said no because she was diabetic and did not want to take them. She wanted to speak with her doctor prior to starting these medications today. She mentioned that her eyes were watering, and she was having trouble seeing what she was looking for. She also stated to add chills to her symptoms. She stated that she also had issue with the person who administered issue her Covid Omicron Booster Vaccine. She stated that she had issues with his sanitary protocols. She stated that the man was unmasked and ungloved while preparing the vaccine. Then when he did put gloves on, he dug around in the trash with them, and then handled stuff on the counter. The reporter had asked him what he was doing, and he told her that masks and gloves were not necessary. She stated that she had trouble remembering things, she guesses that was due to her age. When listing off her medication she stated that she could not remembered one pill, stated it was white and shaped like an egg; she thought that it was for blood pressure. She had been diagnosed recently with spinal arthritis and she had been using CBD gummies for that pain since nothing else works. She mentioned that she took brand Levothyroxine at one time but then found out she was allergic to it. She did not have the Manufacturer, NDC, Lot Number, or Expiry Date for the brand Levothyroxine that she was allergic to. She stated this was 20 years ago and her pharmacy might have that information; but she did not. She stated that none of these medications she listed were new for her, she had been taking them all for a while. She stated that she takes more supplements than she did medications. She stated that she had received vaccine in her right arm. She stated that the typical soreness of vaccines, states she did not even have that seriously because she used alcohol and ice packs on her arm as soon as she went home, and it had never gotten past the first. She did not specify with which vaccines she had experienced soreness. She stated that she had her Shingrix vaccine scheduled to be done somewhere else, but the day she went for the booster at they told her that she could do both. She stated that she was concerned about whether or not she had got a bad vaccine, because she was extremely ill. She stated she was going to contact the Center for Disease Control and prevention (CDC), but she had so many phones number she did not know whom to call; or if she should just call where she had the vaccine done. She stated that if the man who had gave her the vaccine did anything nefarious, he would not write it down. She stated that he might have been offended by her questioning his technique. She also stated that her head hurts and she could not even think straight.  Additional supportive information: It was unknown if the reporter considered the diabetes, spondylarthritis, cough, illness, watering eyes, ear pain, ear infection, swollen lymph nodes, wheezing, ear feels clogged, feeling bad, headache, visual impairment, chills, condition aggravated and memory disturbance to be related to COVID-19 VACCINE PFIZER.