Age: 66.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19-2, VARZOS
Symptoms: Disturbance in attention, Ear congestion, Ear infection, Ear pain, Headache
Clinical narrative: patient received Bivalent COVID-19 Vaccine and SHINGRIX on the same date; Really sick since she got the vaccine/extremely ill; Coughing; eyes watering; earache; ear infection; swollen lymph nodes; Wheezing; ears are also stuffed up; feeling really bad/really does not feel good; blood sugar has also been off the scale; horrible headache/head hurts; Chills; had trouble remembering things; cannot think straight; Caller states that all of her symptoms are worsening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 27Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for varicella immunisation. The patient's relevant medical history included: "Diabetic", start date: 1992 (ongoing), notes: Diagnosed after her second child in her mid 30s. She had to remain on insulin; "gestational diabetes" (unspecified if ongoing), notes: First pregnancy 1984-1985 gestational diabetes took some insulin during pregnancy, but not after.; "Mitral valve regurgitation" (ongoing), notes: heartbeat didn't sound right. Went to cardiologist, they ran tests. It's been at least 5 years.; "Pregnancy" (unspecified if ongoing), notes: First pregnancy 1984-1985. In 1992 with her second son.; "Spinal arthritis" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Helps keep fluid off" (unspecified if ongoing). The patient's family history included: "Hypothyroidism" (ongoing), notes: Runs in her family, has been taking medication for this condition for around 20 years. Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal; LEVOTHYROXINE taken for hypothyroidism; IBUPROFEN taken for arthritis; CBD COMPLEX taken for arthritis; OXYBUTYNIN taken for pollakiuria; ASPIRIN [ACETYLSALICYLIC ACID]; IRON; B12 [CYANOCOBALAMIN]; D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: 24Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: unknown), administration date: 17Mar2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), administration date: 06Apr2022, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown", described as "Caller states that all of her symptoms are worsening"; CHILLS (non-serious) with onset 2022, outcome "unknown"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "Coughing"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Really sick since she got the vaccine/extremely ill"; WHEEZING (non-serious) with onset 2022, outcome "unknown"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "blood sugar has also been off the scale"; DISTURBANCE IN ATTENTION (non-serious) with onset 2022, outcome "unknown", described as "cannot think straight"; EAR INFECTION (non-serious) with onset 2022, outcome "unknown"; EAR PAIN (non-serious) with onset 2022, outcome "unknown", described as "earache"; EAR CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "ears are also stuffed up"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "unknown", described as "eyes watering"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "feeling really bad/really does not feel good"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "unknown", described as "had trouble remembering things"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "horrible headache/head hurts"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "swollen lymph nodes"; PRODUCT USE ISSUE (non-serious) with onset 27Sep2022, outcome "unknown", described as "patient received Bivalent COVID-19 Vaccine and SHINGRIX on the same date". The events "really sick since she got the vaccine/extremely ill", "coughing", "eyes watering", "earache", "ear infection", "swollen lymph nodes", "wheezing", "ears are also stuffed up", "feeling really bad/really does not feel good", "blood sugar has also been off the scale", "horrible headache/head hurts", "chills", "had trouble remembering things", "cannot think straight" and "caller states that all of her symptoms are worsening" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ear infection.  Additional information: Caller stated that she was calling about the Pfizer Product: Covid Omicron Booster, the fourth Covid Vaccine that she received on 27Sep2022. Caller stated that she had been really sick since she got the vaccine.  She doesn't know if she got a tainted vaccine, or the wrong vaccine.  Up until now she had no side effects with the vaccines.  With this vaccine she has gone to the Emergency Room twice. Caller states she had been coughing, eyes watering, earache, ear infection, swollen lymph nodes, wheezing, states that she has had no temperature though; she has been coughing constantly. Caller stated that she went to Urgent Care yesterday and they tested her, and she does not have Covid or the Flu. Caller stated that they also sent off a swab for a PCR test to find any other things she might be infected with. Caller states that she probably won't have the results until tomorrow.  Caller stated that her ears were also stuffed up. Caller stated that she had been trying to get through to her primary care for about 2 weeks, but she cannot get through.  States they don't know about her situation. Caller stated that all of her symptoms began a couple of days later after the vaccine. She woke up feeling really bad and it all has been going on since then. She never had a high temperature though; her temperature has remained normal. She really does not feel good. Caller states that she was diabetic, and her blood sugar had also been off the scale; that normally she is in the low - mid 100's but now she has been in the mid 300's.  States she also has had a horrible headache. Caller stated that all of her symptoms are worsening. She went to the Urgent Care on 02Oct2022, Sunday; and they put her on a Z-Pack. Caller stated that the Z-Pack did not do anything. She went back to the Urgent Care yesterday and they prescribed her two things that she was scared to take. The medications prescribed by the Urgent Care yesterday, but not consumed by the caller yet were Benzonatate 200mg capsules and Doxycycline Hyclate 100mg capsules. Stated that she read the side effects on them, and the side effects were scary. One of them said something about affecting the heart. Caller stated that she had mitral valve regurgitation, she wanted to call her doctor before she takes these two medications. Caller stated that she got the medications from Urgent Care, and she doesn't trust Urgent Care. Caller stated that at the Urgent Care they kept asking her what she wanted to take. Caller stated that she said it was like a vending machine instead of a clinic.  They also offered to prescribe the caller steroids, but she said no because she was diabetic and did not want to take them. Caller wanted to speak with her doctor prior to starting these medications today. Caller mentioned that her eyes were watering, and she was having trouble seeing what she is looking for.  Caller also stated to add chills to her symptoms. Caller stated that she also had issue with the person who administered her Covid Omicron Booster Vaccine. She had issues with his sanitary protocols. Caller said 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 caller asked him what he was doing, and he told her that masks and gloves were not necessary. Caller stated that she reported him. Caller stated that she had trouble remembering things, she guesses that is due to her age. When listing off her medication, caller stated that she cannot remember one pill, stated it was white and shaped like an egg; caller thinks it was for blood pressure. She had been diagnosed recently with spinal arthritis and she has been using CBD gummies for that pain since nothing else works. Caller mentioned that she took brand Levothyroxine at one time but then found out she was allergic to it.  Caller does not have the Manufacturer, NDC, Lot Number, or Expiry Date for the brand Levothyroxine that she was allergic to.  Caller stated this was 20 years ago, her pharmacy might have that information; but the caller does not. Caller stated that none of these medications she listed are new for her, she has been taking them a while.  She takes more supplements than she does medications, thankfully. Prior Vaccinations, patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No adverse events following prior vaccinations. Caller stated the typical soreness of vaccines which she didn't even have that seriously because she uses alcohol and ice packs on her arm as soon as she gets home, and it never gets past the first. Caller did not specify which vaccines she experienced soreness with. Caller stated that she had her Shingrix vaccine scheduled to be done somewhere else, but the day she went for the booster at a pharmacy they told her they could do both. Caller stated that she was concerned about whether or not she got a bad vaccine because she was extremely ill. She was going to contact the CDC, but she had so many phones number she didn't know who to call; or if she should just call where she had the vaccine done. Caller stated that if the man who gave her the vaccine did anything nefarious, he wouldn't write it down. He may have been offended by her questioning his technique.  Caller stated that her head hurts she cannot even think straight.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.