Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache, Throat irritation, Vaccination site erythema, Vaccination site swelling, Weight
Clinical narrative: feeling under the weather/not feeling too good; I'm still feeling lightheaded; body ache; headache; arm swelling; red rash/there was this lump, it was real red like a rash; she had flu-like symptoms; chills; congestion in the nasal; fatigue/she was tired; diarrhea; throat was scratchy getting itchy; ear drum on the right side having pain; all symptoms of cold; injection site swelling and redness; injection site swelling and redness; tightness in the head; there was a burning effect that went into the nostril, her nose running, something in it; felt like she is going to fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 5 (booster), single (Lot number: GL1990) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "back surgery", start date: Jul2022 (unspecified if ongoing); "spinal surgery", start date: 24Sep2022 (unspecified if ongoing), notes: she had a disc that was ruptured, it was Spinal pressure, the accident happened 16Jun2021, but the Surgery was 24Sep2022, the second surgery on 26Sep2022; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "Cold" (unspecified if ongoing); "prosthetic knee" (unspecified if ongoing), notes: she also usually takes Tylenol because she has a prosthetic knee; "heart" (unspecified if ongoing), notes: Entresto it's for the heart; "arthritis" (unspecified if ongoing); "accident", start date: 16Jun2021 (unspecified if ongoing), notes: this accident with 2 guys, the guy ran in the back, spun her around, she thought she just walked away but she had a bruise, bang on the elbow and knee. Concomitant medication(s) included: CORICIDIN [CHLORPHENAMINE MALEATE;PARACETAMOL] taken for nasopharyngitis; ENTRESTO taken for cardiac disorder; TYLENOL taken for knee arthroplasty, arthritis; NYQUIL taken for hypertension. Vaccination history included: BNT162b2 (First Dose: Pfizer Covid vaccine Monovalent Date 11Mar2021, Lot EN6208.), administration date: 11Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Second Dose: Pfizer Covid vaccine Monovalent Date 08Apr2021, Lot EWA53. Lot number is documented as provided by the caller.), administration date: 08Apr2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Third Dose: Pfizer Covid vaccine Monovalent Date 02Dec2021, Lot 330308D.), administration date: 02Dec2021, when the patient was 70-year-old, for Covid-19 immunization; BNT162b2 (Fourth Dose: Pfizer Covid vaccine Monovalent date 07Apr2022, Lot FJAA43. Lot number documented as provided by the caller.), administration date: 07Apr2022, when the patient was 70-year-old, for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling under the weather/not feeling too good"; DIZZINESS (non-serious), outcome "unknown", described as "I'm still feeling lightheaded"; PAIN (non-serious), outcome "unknown", described as "body ache"; HEADACHE (non-serious), outcome "unknown"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelling"; RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "red rash/there was this lump, it was real red like a rash"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she had flu-like symptoms"; CHILLS (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion in the nasal"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/she was tired"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; THROAT IRRITATION (non-serious), outcome "unknown", described as "throat was scratchy getting itchy"; EAR PAIN (non-serious), outcome "unknown", described as "ear drum on the right side having pain"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "all symptoms of cold"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "injection site swelling and redness"; TENSION HEADACHE (non-serious), outcome "unknown", described as "tightness in the head"; RHINORRHOEA (non-serious), outcome "not recovered", described as "there was a burning effect that went into the nostril, her nose running, something in it"; FALL (non-serious), outcome "unknown", described as "felt like she is going to fall". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, influenza like illness, throat irritation, vaccination site swelling, vaccination site erythema, rhinorrhoea.   Additional information : A 71 y/o patient who has high blood pressure, and spinal surgery and got the third booster shot last 06Mar2023, mentioned that she is feeling under the weather. She said that on the first two-dose, everything was okay but the last one she took made her sick, she had flu-like symptoms, her arms were swollen for 4 days, had chills, headache, congestion in the nasal, and body aches. She added that her pharmacist advised her that there was something else added to it and to call us to let us instead to know about it but she wants to find out if what she experienced is normal. - Submitted AE form as the caller mentioned she had been under the weather after the third booster shot.Caller is the Patient. She is reporting side effects after the covid 19  vaccine Bivalent booster. She is feeling under the weather, light headedness, body aches, all symptoms of cold and flu, with injection site swelling and redness. Between the previous dose and this dose she had to go through spinal surgery. She is having headaches.Caller confirmed information provided by the transferring agent stating that everything is correct. She adds that she knows that she chose Pfizer as this 3rd booster but it's got her down. She knows that just the last covid vaccine she got was different, the pharmacist did indicate this to her.She was thinking she was going to be alright, it took her a little time even for the very first one, for some off reason the office and God directed her to get the vaccine. She doesn't take flu shots, she has only taken pneumonia shots, she doesn't get sick, very seldom she gets sick, if she feels anything like a scratchy throat or runny nose she usually take that Blood pressure cold medicine Coricidin, she will take a couple of those and feel fine. She has grand kids and one had sneezed coughed, another one sneezing and nose running with allergy with pollen, the kids do have allergies, she went to school with them, so having the kids, and going into the classroom at school with them got her caught up with something, she then went into (name withheld)to pick up her medication and got the Booster.Caller is probed when the effects after the Bivalent Booster began, She recalls that the very first day, when she dropped the kids off, she came in that morning and by 10-10:30AM she got her booster and left, she recalls that she forgot to take her medicine in the morning, for high Blood pressure, the Entresto it's for the heart, she also usually takes Tylenol because she has a prosthetic knee, and the Tylenol in the morning is for arthritis.That morning, she came, the lady gave her the booster, she was told she was not bleeding, and they put a bandage on her and went to rub the arm. She took the bandaged arm and rubbed the arm down with alcohol because she always does that after needles, then that evening 10ish, she was kneeling on her elbow, it was propped up, on the elbow she felt such a pain, and she was reminding herself that she got the needle, but when she rubbed it, she felt the Lump, she went to the bathroom and rolled up her pajama shirt and there was this lump, it was real red like a rash, she then rubbed alcohol around it.She then noticed her head later on that same night, like there was tightness in the head like a headache, she waived it off and laid down, and chalked it up busy with little kids. The next day she was taking them to school driving and she felt lightness in the head, like she was seeing little specs, she shook that off after, sat in the classroom till 11AM lunch time and left came home, there was one medication at the pharmacy that was not ready, and so she had to go back to (name withheld), her cardiology doctor sent a new prescription. She was hoping to see the pharmacist that gave her the injection but it wasn't the same pharmacist.She went to the young lady pharmacist and she was telling her she looked out of it, she told the pharmacist that she feels out of it, she came in yesterday and got the booster and now she feels strange, she pulled up her shirt and showed the pharmacist and that's when another lady standing there besides her said she had the same thing happen with her 3rd booster, it swollen up on her and took 4 days go down , she told her it would go away.In the mean time she experienced fatigue, she was tired but didn't want to sleep, because she didn't want to miss picking up the kids, she felt like she was going to have diarrhea, her throat was scratchy getting itchy, she picked up a germ because it was scratchy, there was a burning effect that went into the nostril, her nose running, something in it. She kept using saline, saline flushing out her nose, she noticed the ear drum on the right side having pain, pain or something she would blow her nose it would go pop, she had dizziness, this was all the next day on 07Mar2023, felt like she worked out or something.She made green tea while talking to this call handler and felt like she is going to fall.She had back surgery, in Sept they cut in the stomach, because she had this accident with 2 guys, the guy ran in the back, spun her around, she thought she just walked away but she had a bruise, bang on the elbow and knee. Her elbow was losing strength, it was the nerve, she had a disc that was ruptured, it was Spinal pressure, the accident happened 16Jun2021, but the Surgery was 24Sep2022 that was the first surgery, the second surgery on 26Sep2022, they couldn't do both in one day because of long hours, they had to go in back and put the trinkets in the back with 2 screws.The Primary Care they have all her information. If they call the doctor and just say her name they can pull up everything on her even with the other specialist like her cardiologist.Caller does not have the Lot number of the lady in the pharmacy that said she had the same thing, she was (ethnicity withheld), she was waiting for her medication, she was at the other cash register while she was explaining it to the pharmacist, she guessed the lady was trying to make her feel secured and that it was nothing to worry about, she had same type of swelling. She looked quite young. She was concerned experiencing all of this signs in her body, she wants to make sure that there is nothing to be concerned about like she will die, or will end up in a hospital, she has gotten this far because she believes in a high power, it didn't bring her this far for nothing, it's a strange medication that was injected in the body and not knowing what effect it caused. The USMI agent couldnt tell her if she should be concerned, she doesn't want to go to sleep and not wake up, she has an appointment coming up in Apr2023, but they called her to change it because in Apr2023 her doctor will not be there, so she doesn't know what do, if she goes to the the doctor then it is the hospital, that where she usually go, that's where she had her surgery, and they have good doctors. She will have to go the emergency Room. Caller asks whats the name of the new stuff that she received.Caller declined transfer to USMI stating that they already spoke to her about it and gave her the right writing, she asked how to spell it,  so now she will know what to say, if she has to go to the doctor. She is trying to treat it like a light flu or cold, making some tea, bought ginger, she's had No fever at all, also flu allergy medication, like the high blood pressure cold medicine she buys, she has  to buy that type medication because its okay with her blood pressure, she now had Nyquil and bought new Nyquil for high blood pressure, since she has been been talking her throat doesn't feel scratchy, but she still has this burning from nostril down the throat in the back, she feels dizzy and will have chicken noodle soup. She is hungry.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110486 same patient/drug, different dose number/event;US-PFIZER INC-202300110487 same reporter/drug, similar event, different patient;US-PFIZER INC-202300111271 same patient, diferent dose/event;