Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | RA |
burning; Nauseous; tingling; had something wrong with my eyes/ eyes were like moving around/ eyes is going circles or go cross eyes; sick to my stomach; had a strange like I felt sensitivity in my hands all night long/ could not touch my hands, it is like the skin was sensitive; headache/ terrible headache that is possibly the worst headache I have ever had in my life, just weird headache; pain in my hands that weird pain; cannot remember things; Cannot concentrate; This is a spontaneous report received from a Nurse. A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Jan2025 as dose number unknown, single), in right arm for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac arrhythmia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FLECAINIDE; ARMOUR THYROID. Vaccination history included: Rsv vaccine, for immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Jan2025, outcome "unknown", described as "Cannot concentrate"; MEMORY IMPAIRMENT (non-serious) with onset Jan2025, outcome "unknown", described as "cannot remember things"; PAIN IN EXTREMITY (non-serious) with onset Jan2025, outcome "unknown", described as "pain in my hands that weird pain"; HYPERAESTHESIA (non-serious) with onset 27Jan2025, outcome "unknown", described as "had a strange like I felt sensitivity in my hands all night long/ could not touch my hands, it is like the skin was sensitive"; HEADACHE (non-serious) with onset 27Jan2025, outcome "unknown", described as "headache/ terrible headache that is possibly the worst headache I have ever had in my life, just weird headache"; NAUSEA (non-serious) with onset 28Jan2025, outcome "recovering", described as "Nauseous"; BURNING SENSATION (non-serious) with onset 28Jan2025, outcome "unknown", described as "burning"; OCULAR DISCOMFORT (non-serious) with onset 28Jan2025, outcome "unknown", described as "had something wrong with my eyes/ eyes were like moving around/ eyes is going circles or go cross eyes"; ABDOMINAL DISCOMFORT (non-serious) with onset 28Jan2025, outcome "unknown", described as "sick to my stomach"; PARAESTHESIA (non-serious) with onset 28Jan2025, outcome "unknown", described as "tingling". Therapeutic measures were taken as a result of headache, pain in extremity. Additional information: The patient had the Pfizer, Moderna shot this week on the 27th and she had horrible side effects. She was a medical professional. So, she know there were nothing she could do. However, she was having, comes with her head. The first day at night, She had a strange like she felt sensitivity in her hands all night long. She could not touch her hands, it was like the skin was sensitive then and a headache, she had this weird headache. So, when she got up the next morning and she knew because she was kind of sensitive to anything. So, but I had RSV this year and she was worried what was going to happen if she get COVID? She was in her 70s and she was worried. The next day the 28th, when she got up in the morning. she had a terrible headache that was possibly the worst headache she had ever had in her life, just weird headache. It was like burning and tingling and it seems like poking at me and then her eyes, I had something wrong with her eyes. Her eyes were like moving around, like there was a name for it, what was the name of that? Anyways, your eyes was going circles or go cross eyes and what else and she was sick to her stomach, not really bad sick because she did not really get sick to her stomach but she felt she was nauseous and then today, I am feeling better. However, her head is a mess. I cannot concentrate. I cannot remember things like if she did a task, she could not remember if she finished it, where she left it, that kind of thing like she was doing laundry and then she walked away to get something and then when she came back she could not remember what she was doing. The worst part was she have to drive and she almost had a horrible accident, they had this the one lane with the truck but they did not really have enough signs up for and the guy in front of her was blocking her view and he got into the left hand lane around that truck that has a arrow on it which she did not see at all and I normally would see it but obviously I cannot concentrate and she wanted they to know she just saw her life go before her, making it around that big neck truck and then she slowed down, she did not speed, she was retired. So, it was very scary. So, she was calling you to tell you this adverse reaction that she had is abnormal. she know it falls into the categories of the reactions to this new drug, she know it does, she read up on it. Unfortunately, she did not read up before I took the shot. So, she probably would have asked for another shot because she took Pfizer the last." When probed for the name of the shot, consumer stated, "I took Moderna. That said Pfizer Moderna, COVID (It was further not clarified if took both Pfizer and Moderna Covid-19 vaccine. Hence, both captured as suspect). That was right, she forget that Pfizer had many vaccines. I work for pharmaceutical company. It was Moderna, the new 2024. She did not put any of the name on her slip because they do not have to do that anymore." When clarified if Pfizer COVID-19 Vaccine, consumer stated, "Yes, I just said that to you, it was COVID this year. Yes." She was Nurse, retired. Weight: Consumer stated, "Her weight is 147 that is what clothes on. However, because that is what they do here to make everybody look fat. So, her real weight is 130. It weighs maybe with shoes, pants, top, sweater, jacket. So, I weigh 130, I know I weigh 130 because I weigh herself on the scale so, that is her normal weight." Country of Incidence . If vaccination card handy for product details (LOT#, expiration date, NDC# and UPC#): Consumer stated, "No, they do not log anymore. I did bring a card, they do not do it anymore. They do not have to by our state law." Vaccination facility name: Consumer stated, "It is a COVID vaccination, Moderna and I got it at Pharmacy." Vaccination facility type: Pharmacy. Other medical conditions and concomitant medications: Consumer stated, "I am taking meds for cardiac arrythmias. I do not have a heart condition. It is not considered a heart condition and then I take a Thyroid pill, I am hypothyroid." Lab work: Consumer stated, "No, I have her blood will be done next week. I am due I think next Friday and then, I have an appointment the next day but that is what her endocrinologist. I do not get it tested to regular doctor so." When probed if any same date vaccination with Pfizer COVID-19 vaccine, consumer stated, "I did actually in a different arm. I took the Flu vaccine. I cannot name it, I have no idea (Hence, suspect captured as Unspecified Flu Vaccine). It is this year's flu. They do not write those things down and I am not really interested, I just take whatever they are giving. I do not thing there is a specific one that you can ask for, it is what the pharmacy." If vaccination card handy for product details (LOT#, expiration date, NDC# and UPC#): Consumer stated, "They do not require that card anymore and I asked her to write it down for me. So, obviously I have not liked the fact that the doctor's office does not do it anymore but and I go to the cleanest pharmacy in her area and that is why I go to the pharmacy because they have a little vaccination area with brand new chairs and a blood pressure machine and the thermometer, disposable thermometer. They have got all that stuff there, that is why I went. The other ones are pharmacy is disgusting and the other one pharmacy is disgusting too and there is a whole bunchy of people around the area and you have no privacy. This is a nice pharmacy, that is everything to me as a nurse. That is why I want to go." When probed if any four weeks prior vaccination with Pfizer COVID-19 vaccine, consumer stated, "No." Treatment: Consumer stated, "Well, I took her daily medications before I went and I think I might have taken. No, I did not take anything that day. she did not need to take anything but the next day I took Tylenol for the pain in her hands that weird pain and for the headache." Anatomical location of vaccination: Consumer stated, "It is a left arm." Reassurance: Consumer stated, "No, she did not have. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Cardiac arrhythmia; Hypothyroidism
METOPROLOL; FLECAINIDE; ARMOUR THYROID