Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product use issue, Pruritus, Scratch, Vaccination site pain
Clinical narrative: that area started driving her up a wall. States it was itchy and crawly/ she would scratch until it bled; that area started driving her up a wall. States it was itchy and crawly/ she would scratch until it bled; her A1C was 10.2; injection site pain; was losing her cognition and doesn't feel like herself; was losing her cognition and doesn't feel like herself; third one on 10Sep2021; Headache; the pain will get worse as the day goes on; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Lot number: EW0173, Expiration Date: 30Nov2021) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis" (unspecified if ongoing), notes: Bronchitis, Caller states that she gets this condition once a year; "Asthma" (ongoing), notes: Asthma, Caller states that she was diagnosed with this condition when she was 58 years old.; "Breast cancer", start date: Dec2007 (unspecified if ongoing), notes: Breast cancer; "Fibromyalgia", stop date: 1999, notes: Fibromyalgia; "Pneumonia" (unspecified if ongoing), notes: Pneumonia, Caller states that she had pneumonia when she was diagnosed with asthma at 58 years old.; "Type 2 Diabetes" (unspecified if ongoing), notes: Type 2 Diabetes; "Right ankle fusion surgery" (unspecified if ongoing), notes: Right ankle fusion surgery; "sulfa drugs" (unspecified if ongoing), notes: Drug Allergies Caller states she is allergic to: sulfa drugs; "lymph nodes removed from her left" (unspecified if ongoing), notes: She had lymph nodes removed from her left arm and that area was always numb.; "allergic to all antibiotics" (unspecified if ongoing), notes: allergic to all antibiotics. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; METOPROLOL; FENOFIBRATE; LISINOPRIL; LORATADINE; CLONAZEPAM; LEVODOPA-CARBIDOPA taken for restless legs syndrome; ZINC taken for supplementation therapy; FOLATE taken for supplementation therapy; FOLIC ACID taken for supplementation therapy; VITAMIN D3 taken for supplementation therapy; MAGNESIUM taken for supplementation therapy; CITRACAL + D3 taken for supplementation therapy. Past drug history included: Levaquin, reaction(s): "Allergy: Levaquin", notes: Drug Allergies Caller states she is allergic to: Levaquin; Amoxicillin, reaction(s): "Allergy: amoxicillin", notes: Drug Allergies Caller states she is allergic to amoxicillin; Doxycycline for hives, reaction(s): "Allergy: doxycycline", notes: Drug Allergies Caller states she is allergic to doxycycline, States that she took it and broke out in the worst hives; Azithromycin, reaction(s): "Allergy: azithromycin", notes: Drug Allergies Caller states she is allergic to: azithromycin; Augmentin, reaction(s): "Allergy: Augmentin", notes: Drug Allergies Caller states she is allergic to: Augmentin; Clindamycin, reaction(s): "Allergy:clindamycin", notes: Drug Allergies Caller states she is allergic to: clindamycin; Statins, reaction(s): "Allergy: statins", notes: Drug Allergies Caller states she is allergic to: statins; Actos, reaction(s): "Allergy: actos", notes: Drug Allergies Caller states she is allergic to: actos.; Erythromycin for felt like her throat was starting to close up and she was itching, reaction(s): "Allergic to Erythromycin", notes: felt like her throat was starting to close up and she was itching, Allergic to Erythromycin. Vaccination history included: BNT162b2 (Dose 1, Lot Number: Unknown, is covered by the sticker from the second dose; Administered in the caller's right arm.), administration date: 27Jan2021, when the patient was 78-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Lot Number: EN6201; Administered in the caller's right arm.), administration date: 17Feb2021, when the patient was 78-year-old, for Covid-19 Immunization, reaction(s): "injection site pain". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovering"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "the pain will get worse as the day goes on"; PRODUCT USE ISSUE (non-serious) with onset 10Sep2021, outcome "unknown", described as "third one on 10Sep2021"; PRURITUS (non-serious), SCRATCH (non-serious), outcome "unknown" and all described as "that area started driving her up a wall. States it was itchy and crawly/ she would scratch until it bled"; GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious), outcome "unknown", described as "her A1C was 10.2"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain"; COGNITIVE DISORDER (non-serious), outcome "not recovered", FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "was losing her cognition and doesn't feel like herself". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pruritus, scratch, glycosylated haemoglobin increased.  Additional information: Caller stated that she was currently 80 years old and had three doses of the vaccine. First one on 27Jan2021, second one on 17Feb2021, and the third one on 10Sep2021. Caller stated that she was due for another booster and was told she could get it this Friday at the place where she got her last booster. Caller stated that she was not prone to headaches. Stated that if she ever did get a headache it would be a sinus headache in the forehead area. Stated she wasn't expecting any side effects from the vaccines, has a lot of faith, and was grateful for the vaccines. Stated she doesn't listen to all the negative. Caller stated that approximately the time she got the booster dose of the vaccine she started having headaches that are weird. Stated they kind of feel like if you took a mans big hand and put it on the back of your head, just above your neck, that's the location of the headache. States it has remained consistent since then. Caller says she was debating on the second booster. She wants to go got withheld to see her grandkids. Stated she was wondering if this was a side effect? Caller states that her hair was long and she wears a lightweight headband; even that feels swollen, like she can press the pain with her hands. States that the pain will get worse as the day goes on. HCP Information: Caller stated that she was not happy with her primary care provider at the moment. Stated that the provider was only there 4 days a week in the morning, and the caller was not a morning person. Caller stated that the doctor she had before retired and moved to withheld. Caller stated that she has about 9 antibiotics she was allergic to and she gets bronchitis once a year. Caller stated that her primary care provider called in a prescription for her for Erythromycin, caller stated that was one of the ones she was allergic to. Caller stated that she took 2 of them, 12 hours apart and felt like her throat was starting to close up and she was itching so she didn't take anymore. Caller does not know the NDC, Lot Number, or Expiry Date for that Erythromycin. Caller stated that she called the nurse and they switched it to Doxycycline. Caller stated that was also on her allergy list. Stated that she took it and broke out in the worst hives. Stated her friends husband had to drive around to find her Benadryl. Caller stated that she was so itchy, she scratched her arm until it bled. Stated that her doctor said that since the caller was allergic to all antibiotics she just needed to go to the emergency room. Caller stated she did not do that, she just treated herself by breathing in steam from a pan of water on the stove and using her asthma inhalers. Caller does not know the NDC, Lot Number, or Expiry date for the Doxycycline. Caller stated that the doctor also had her on Montelukast and Glipizide. Stated that during the time with her issues with the antibiotics and the bronchitis her A1C was 10.2. Caller stated that her A1C had never been that high. Caller says that it may have been due to stress. Stated that her whole family was on the west coast and she was alone. Caller says that she was in the process of looking for a new doctor. Event Details: Headache: Caller stated that with the headache she doesn't know if she should rock the boat by getting the second booster on this Friday. Asks if she possibly had COVID sometime and did not know? Or could the headaches be from the vaccine? Caller says the headaches are strange and she doesn't understand why she can press it and it will hurt, almost like inflammation. Caller stated that her headaches have felt a little better. She feels the doctor had her on too much medicine. Caller stated that she cannot pinpoint when the headaches started exactly because she has had so much going on. A1C was 10.2: Caller stated she cannot pinpoint the dates for this either. Stated it was around the time that her house almost burnt down in Oct2021 or Nov2021. Caller stated that she turned on the furnace in her home and half of her electricity would go out. Stated that when her A1C went to 10.2 her doctor wanted to take her off Metformin. Caller stated that she had been on Metformin since 2000 and was taking three a day. Caller says that the doctor wanted to put the caller on Januvia. The caller refused to take, and never consumed the Januvia after reading about it. Caller stated that she was delivered from fibromyalgia after having it for 11 years and did not want to risk it. Caller stated that the doctor then prescribed Glipizide. The caller stated that she has been allergic to sulfa drugs since she was a child, doesn't know why or what happens, that was just what she has always been told. Caller states that she took the Glipizide and then was driving and felt like she was going to pass out and had to pull off the road because she was swimmy headed. Caller stated that by swimmy headed she means disoriented and dizzy. Caller stated that the pharmacist told her there was very little sulfa in Glipizide and to talk to her doctor. Caller stated that her doctor told her to continue to take it. Caller stated that she was still taking Glipizide twice a day with Metformin and she just kept getting worse. The caller was also taking Montelukast. Caller told one of her friends that she felt like she was losing her cognition and doesn't feel like herself. Caller stated it was all around the same time as the booster. She didn't know if it was the vaccine or the pills, or just her being old. Caller stated that she finished the 90 day supply of Glipizide then took it for 20 more days and it was still making her swimmy headed. Caller stated that she was in the kitchen making bacon and had to sit down because she almost passed out. It was then she decided to stop taking it. Stated she stopped taking Glipizide on 30Mar2022. Stated that her A1C in Feb was back down to 7.2. NDC, Lot Number, Expiry Date for Glipizide are unknown by the caller. Caller also stated that sometime in Apr2022 she took herself off of Montelukast. Stated after reading about it, she doesn't know why she started taking it in the first place. Stated she feels so much better since being off of it. Stated that about 4-5 days later she felt like her cognition was coming back, she feels so much better after being off of Glipizide and Montelukast. NDC, Lot Number, Expiry Date for Montelukast are unknown by the caller. Caller stated that she had all her shots in her right arm. Stated she had breast cancer in Dec2007. She had lymph nodes removed from her left arm and that area was always numb. Stated that after the booster, that area started driving her up a wall. Stated it was itchy and crawly, especially at night and she would scratch until it bled. Caller stated that she has some stuff called Real Time Max Pain Relief analgesic lotion that helps. Caller says she read the information from the vaccine and it says it can cause swollen lymph nodes, lymphadenopathy. Caller stated she wonders if that was related to this for her? Caller mentions that she also had injection site pain. History and Investigations: Caller stated that she was allergic to several drugs. Asks if Levaquin and Cipro are the same drug. Caller stated that she was a technophobe. Says that she has 2 yards and has been mowing them herself.  No follow-up attempts are possible. No further information is expected.