Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Pruritus, Skin disorder
Clinical narrative: up all night; Itching; has small bumps; some areas of redness; This is a spontaneous report from a contactable consumer. A 96-year-old female patient (Reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (they hope the mother doesn't contract COVID). Medical history included stomach issues, blood pressure, cholesterol. Concomitant medication(s) included loperamide hydrochloride (LOMOTIL) taken for stomach issues. The patient experienced itching with, has small bumps, some areas of redness; all (non-serious) on 09Feb2021 and up all night (non-serious) on 10Feb2021. Therapeutic measures were taken as a result of itching (pruritus). Additional Information for Concomitant Products Lomotil, cholesterol and one for blood pressure: Reporter declined to provide any further information for medications such as when her mother began taking these medications, the dosages, or further information related to the medications. Reporter was calling for her mother. Her mother had her initial shot on the 8th, 08Feb2021, and she got up the next morning and was complaining of itching and had some areas of redness and bumps that went around the nape of her neck. She has small bumps around her neck, under her chin, on her chest area going down mid-line- from her chin- and then down under her breast. It itches and she didn't have that before. Clarified with caller that the shot being discussed is the Pfizer COVID vaccine. Reporter said areas of itching and bumps are still there today, she wanted to wait a little bit to see how it was going to be, but her mother still has it. Her mother does have a sensitivity to medications. You know, a lot of oral medications she can't really tolerate, it bothers her stomach. She's not really allergic to anything in particular- caller asked her mother, "are you mom, no." She just wanted to clarify that information. Her mother does have a sensitive stomach, but the COVID vaccine shouldn't have anything to do with the stomach. No further details provided on the oral medications that the mother is unable to tolerate that bother her stomach. Two days ago, the caller's mother had the COVID vaccine on the 08Feb2021 and she woke up that evening. While she was going to bed she noticed she was itching. When she got up in the morning she said she was up itching all night. The reporter says, so we will say 09Feb2021 is when this all started. Reporter makes a comment that her mother is a little thing. The reporter says her mother is about 4'5" 4'6" and her mother says she is 4'9" and the reporter says well she wants to say she is 4'9". On 08Feb2021 the patient had the COVID vaccine and then she had the itching behind her ears, on her neck, across her chest, and under her breasts. Clarified the date the itching began an 09Feb2021. The patient put something on that eliminated some of the bumps and every now and then the itching and scratching will feel like she's bleeding, but she is not bleeding anywhere. The bumps are still there. They are still red, the bumps are not red, they are an irritation. Conflicting information obtained in regard to bumps, unable to clarify or obtain further details due to the reporter not wanting to complete the safety report. Some areas of redness: Reporter says it is not really red, it is more off an off-color, pinkish. Reporter states that she can tell there's an irritation on the patient's skin from itching. Up all night: The patient was up last night 10Feb2021 when she went to bed. Reporter mentioned that her mother doesn't always relay information correctly. Company agent is unable to clarify if the inability to relay information correctly began prior to receiving the COVID vaccine or after due to the reporter not wanting to complete the safety report. The patient was up all night itching the last two nights. She feels the itching and gets some relief from an ointment she is using. Reporter is not sure of the name of the ointment off hand, but the patient was provided the ointment it is from the doctor. Unable to probe for NDC, lot number, or expiry date of ointment that only provided some relief to her mother as reporter did not wish to complete the safety report. Probed for NDC, expiry date, and dosage and reporter says this information is not on the vaccination card. Caller says the lot number is an "E" and she can't make up the next letter before 9262, it's either EL or E1 and it is separated from 9262, there is a space between them. Lot number is either: EL9262 or E19262 based on information provided from the reporter. Reporter says the mother takes medications everyday. She takes ones for her blood pressure, cholesterol, and Lomotil medication for her stomach issues. Reporter asks how much longer this is going to take and what further questions will be asked. She doesn't think the rest of the report is necessary she just wanted to report that her mother had the rash and the itching. Unable to clarify information regarding said rash with the reporter as being related to the redness and bumps mentioned previously in the report or if this rash is a different event that was experienced. Medical Conditions: Unable to obtain further information due to reporter not wanting to complete the rest of the safety report. Investigations: When informing the reporter that one question that will be asked for this report is if any testing has been done to what her mother experienced, the reporter says no. Unable to clarify if this means no testing has been completed or no to the reporter not wanting to answer the question at this time since she did not want to complete the safety report. Informed caller that an additional form is part of the safety report, caller declined to complete the safety report so unable to obtain further information and confirm given information to fill out the vaccine supplemental form. Reporter calling on behalf of the side effects experienced from her mother after the COVID vaccine. For all events, outcome was not recovered, except for event up all night, outcome was unknown.  Information about Batch/Lot number has been requested.