Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
Rash; Had the swelling at injection site; pain/soreness; Chills; Fever; High blood pressure/One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81/It got to 166/78/Got as high as 175/89; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 26Sep2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol being up a little" (unspecified if ongoing); "white coat syndrome" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for hypertension; COZAAR taken for hypertension (ongoing); LIPITOR taken for blood cholesterol increased, start date: Apr2025. Past drug history included: Amoxicillin, reaction(s): "Allergy:rash". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2025, outcome "not recovered", described as "High blood pressure/One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81/It got to 166/78/Got as high as 175/89"; CHILLS (non-serious) with onset 27Sep2025, outcome "recovered" (27Sep2025); PYREXIA (non-serious) with onset 27Sep2025, outcome "recovered" (27Sep2025), described as "Fever"; VACCINATION SITE SWELLING (non-serious) with onset 27Sep2025, outcome "unknown", described as "Had the swelling at injection site"; PAIN (non-serious) with onset 27Sep2025, outcome "unknown", described as "pain/soreness"; RASH (non-serious) with onset 28Sep2025, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, rash. Additional information: Is over 65, knows they had her reading consent forms for the shot. Had flu shot at same time, was not going to get them together but, had to stand in line, about an hour. They gave her both shots in left arm. Had normal swelling a little bit, normal problems with it. Then, had fever of 100.3. Had chills the following day. Then, had rash on left arm, which went aways after a while. Also, her blood pressure, her systolic blood pressure has been way higher than normal. Does not know if that was part of the combination of the 2. Clarified, caller had both Covid shot and flu shot at same time. Always got flu shot separately, now with the 2, does not know what each has done. Not sure if anyone has reported increased blood pressure with this. Has appointment with doctor Wednesday, on telephone, and physical coaming at end of month. No matter what she is taking, is taking Losartan, also takes Metoprolol, that do not seem to be helping. It got her a little bit nervous, wondered if something because, they did mention, conditions can put her at risk for heart failure and coronary artery disease and high blood pressure. Would think the symptoms would have stopped or lessened. Chills, Fever: The chills started, maybe around 3PM then, after that, the fever came, then, the rash. Chills lasted, maybe about an hour, fever probably lasted maybe 45 minutes. Rash: Rash came the day after that, Sunday, 28Sep2025. Rash is mostly gone now. Put some cream on it, seemed to dissipate, seems to be ok now, as far as she can see. Treatment: For fever and chills, took aspirin and, thinks she did take dose Nyquil. Concomitant Products/Medical Conditions: Does have high blood pressure, taking Losartan and another drug called Metoprolol. Clarified, the blood pressure medications, the Losartan and Metoprolol, did not help. Did not really seem to help because, one day, one evening out of whole week and a half, this happened. It got to 166/78. High blood pressure: One time, blood pressure went down to 124/72, when on her blood pressure medication. Has been pretty much in that that range, maybe 124 one day, has been pretty manageable, to have normal blood pressure. Has no idea why this is happening. Is a little concerned how long this will continue. Knows blood pressure can be dangerous. Worries about blood pressure being higher. The day before the shot, the blood pressure was up a little but. Has white coat syndrome to start with, always nervous before the shot. Takes blood pressure every day. The day before the shot, which was 26Sep2025, blood pressure was 104/70, pulse 72. The day of the shot, blood pressure was 154/70, pulse 82, then went down to 142/73 then down, to 129/76. Got as high as 175/89, pulse 94, this morning, 8AM. This afternoon, around noon, was 163/79, pulse down to 72. The diastolic numbers seems to be ok but, systolic seems to be pushing the envelope. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as no. AE does not required to visit Emergency Room or Physician's Office. just called advice nurse, set up appointment for phone conversation Wednesday. Patient Medical History. Did the patient previously receive the Pfizer suspect vaccine? not provided. Are you allergic to any previous vaccination, medications, food or other products? Does have allergy to amoxicillin and another one. When clarifying specific reaction to amoxicillin, caller states, she had rash from neck down, after taking it for about 4 days. Would say it was maybe 15 years ago, maybe longer May just be basic, like she has allergy problem or, whatever. Never had this happen before, with shots. Had the swelling at injection site or, had a little fever and chills but, not where blood pressure has gone up so high, it kind of scares her. Does not help that, she tries to go to sleep at night, tries to calm herself down that it will go down but, it is not going down, that is why she is calling. Hopefully this information will help someone, and help her too. Caller was thinking that taking the combination of the two vaccines together can probably have an interaction and could possibly cause issues too. Caller said that she did check with the other vaccine, the flu vaccine, and they did mention that there are some people who had blood pressure problems, so she thinks that the possibility of having the two vaccines together probably caused an interaction. Caller said that she does have an appointment with her HCP tomorrow and a physical coming up on the 28th, so she'll let them know what's going on. Caller said that the vaccines were given in her same arm, the left arm, and on Saturday she had a rash, and she also had (carcinoma) pain and swelling. She even had a fever of 100.3 and chills. The side effects kind of went away, but the rash came back a little bit that day. It wasn't terrible, but it was there. Today, caller said that she's still experiencing a little bit of soreness. She was thinking that after 2 weeks it would be okay. Caller also said that she is over 65 years old, and her blood pressure is higher than normal. The diastolic is okay, but the systolic is elevated, and she is on medication (losartan). Caller is wondering if anyone else is reporting increased blood pressure. Caller is aware that it is not listed in the side effects since she received a pamphlet about it after receiving the vaccine. Caller said that the blood pressure increase started the day after the shot, and her normal BP is around 119/73. She kept a record of her blood pressure monitoring and it is as follows: in the morning it was 154/70, then the next morning it was 142/73, then it went down to 136/78 and it's been fluctuating. One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81. She said it's been bouncing around, and she just wants to know if other people have similar issues with it. Caller is mainly concerned about her blood pressure and she wants to know if other people experienced it too.
Medical History/Concurrent Conditions: Blood pressure high; Cholesterol blood increased; White coat syndrome
METOPROLOL; COZAAR; LIPITOR
Test Name: blood pressure; Result Unstructured Data: Test Result:higher than normal; Comments: her systolic blood pressure has been way higher than normal; Test Name: blood pressure; Result Unstructured Data: Test Result:166/78; Comments: Did not really seem to help because, one day, one evening out of whole week and a half, this happened.; Test Name: blood pressure; Result Unstructured Data: Test Result:124/72; Comments: One time, blood pressure went down; Test Name: blood pressure; Result Unstructured Data: Test Result:124; Comments: Has been pretty much in that that range, maybe 124 one day, has been pretty manageable, to have normal blood pressure.; Test Name: blood pressure; Result Unstructured Data: Test Result:129/76; Test Name: blood pressure; Result Unstructured Data: Test Result:119/73; Comments: her normal BP; Test Name: blood pressure; Result Unstructured Data: Test Result:136/78; Comments: then it went down to 136/78 and it's been fluctuating; Test Name: blood pressure; Result Unstructured Data: Test Result:160/78; Comments: One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81; Test Name: blood pressure; Result Unstructured Data: Test Result:134/74; Comments: One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81; Test Name: blood pressure; Result Unstructured Data: Test Result:158/81; Comments: One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81; Test Name: blood pressure; Result Unstructured Data: Test Result:161/75; Comments: One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81; Test Name: blood pressure; Result Unstructured Data: Test Result:151/81; Comments: One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81; Test Date: 20250925; Test Name: blood pressure; Result Unstructured Data: Test Result:104/70; Comments: The day before the shot, the blood pressure was up a little but. Has white coat syndrome to start with, always nervous before the shot.; Test Date: 20250926; Test Name: blood pressure; Result Unstructured Data: Test Result:154/70; Test Date: 20250927; Test Name: blood pressure; Result Unstructured Data: Test Result:142/73; Test Date: 20251006; Test Name: blood pressure; Result Unstructured Data: Test Result:175/89; Comments: this morning, 8AM; Test Date: 20251006; Test Name: blood pressure; Result Unstructured Data: Test Result:163/79; Comments: This afternoon, around noon; Test Date: 20250927; Test Name: fever; Result Unstructured Data: Test Result:100.3; Test Date: 20250925; Test Name: pulse; Result Unstructured Data: Test Result:72; Test Date: 20250926; Test Name: pulse; Result Unstructured Data: Test Result:82; Test Date: 20251006; Test Name: pulse; Result Unstructured Data: Test Result:94; Comments: this morning, 8AM; Test Date: 20251006; Test Name: pulse; Result Unstructured Data: Test Result:72; Comments: This afternoon, around noon