Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Blood pressure measurement, Body temperature, Erythema
Clinical narrative: that her arms feels weepy, it is red, and she has a lot of pain/She says her right arm is red and lumpy; that her arms feels weepy, it is red, and she has a lot of pain; feel pain in her back, her stomach; feel pain in her back, her stomach/stomach is hurting; she noticed a funny weird odor coming from her privates and rectum; she noticed a funny weird odor coming from her privates and rectum/she also developed an odor which she never had before; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 67 years, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 07Apr2022 as dose number unknown, 50 ug single (Lot number: VL10PK), in right arm for herpes zoster. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "for her stomach" (unspecified if ongoing); "she got a little brace on her left arm for arthritis in her shoulder bone" (unspecified if ongoing), notes: she got a little brace on her left arm for arthritis in her shoulder bone. Concomitant medication(s) included: METOPROLOL SUCCINATE oral taken for hypertension; OMEPRAZOLE oral taken for abdominal discomfort; LISINOPRIL oral taken for hypertension; AMLODIPINE BESYLATE oral taken for hypertension; ISOSORBIDE DINITRATE oral taken for hypertension. Vaccination history included: BNT162b2 (first dose, 24Feb2021, it was Pfizer EL9262; Expiry date: May2021), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (second dose; LOT: EN6199; Expiry date: Jun2021), administration date: 17Mar2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (third dose or first booster of Pfizer COVID-19 vaccine was given 25Sep2021 of Pfizer LOT: E3592, which she says she can't make it out, it is, either an F or a T, clarified to LOT: FE3592.), administration date: 25Sep2021, when the patient was 66-year-old, for COVID-19 immunization; Shingrix (had a dose of this before in 2019), administration date: 2019, for Shingles vaccine, reaction(s): "No adverse event". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2022, outcome "unknown", described as "that her arms feels weepy, it is red, and she has a lot of pain"; ERYTHEMA (non-serious) with onset 07Apr2022, outcome "unknown", described as "that her arms feels weepy, it is red, and she has a lot of pain/She says her right arm is red and lumpy"; BACK PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "feel pain in her back, her stomach"; ABDOMINAL PAIN UPPER (non-serious) with onset Apr2022, outcome "unknown", described as "feel pain in her back, her stomach/stomach is hurting"; VAGINAL ODOUR (non-serious) with onset Apr2022, outcome "unknown", described as "she noticed a funny weird odor coming from her privates and rectum"; SKIN ODOUR ABNORMAL (non-serious) with onset Apr2022, outcome "unknown", described as "she noticed a funny weird odor coming from her privates and rectum/she also developed an odor which she never had before". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, pain in extremity.  Additional Information: The caller is a consumer. She indicates that yesterday she received both the pfizer covid 19 vaccine (gray cap, 2nd booster, 4 doses so far in total) and the Shingrix vaccine (Shingles Vaccination). She received both vaccines in the same arm. She indicates that her arms feels weepy, it is red, and she has a lot of pain. she also mentioned that after getting the vaccine she started to feel pain in her back, her stomach, and she noticed a funny weird odor coming from her privates and rectum. she wiped and she smelled very bad. she wants to know if these are side effects of the 2nd booster. Other Medical Conditions: Caller says she has fibromyalgia, maybe that is why she is hurting so. No further details provided about her fibromyalgia. Concomitant medications: Caller says she had taken her medications before going to get her shots, which were not new medications, she takes them every day in the morning and evening. She says she took them before she went pharmacy, which was around 09:30. She says she took her Metoprolol Succinate 25mg, she took that and took her Omeprazole for her stomach which is 40mg, and she took her Lisinopril tablet which is 40mg, and she took her blood pressure Amlodipine besylate 5mg tablets, that's what she took before she went. Caller says for her Lisinopril she was taking 40mg once a day, then the day before yesterday her blood pressure was 189/90 something and her doctor increased it but she didn't increase it so she took only 40mg yesterday instead of taking the 80mg a day. Caller clarifies that when she went to the doctor's office the day before yesterday and they increased her medication to 80mg, so her dose was increased to two instead of one tablets a day. Additional information on concomitant drugs: Caller says she has been on Metoprolol succinate for a long time, a couple years, probably started it two years ago; Dosage text: 25mg once a day in the morning by mouth; Omeprazole: Caller says this is like Prilosec, it is the generic for that, which she has been on it forever but she doesn't know when she started, been on it for like four years, Dosage text: 40mg once a day by mouth; Lisinopril: Caller says that she started taking Lisinopril about two years ago. Dosage text: 40mg once a day by mouth; Amlodipine besylate: Caller says she started taking it probably about two years ago for her blood pressure. Dosage text: 5mg once a day in the morning by mouth; Isosorbide Dinitrate: Caller says she thinks her heart doctor put her on it almost three years ago. Dosage text: 10mg, one in the morning and one in the evening by mouth. caller who yesterday went to (Name withheld) pharmacy and got her second booster dose of Pfizer COVID-19 vaccine and also a shingles shot in her right arm. Agent reports caller said that it is all weepy and it's all red and in a lot of pain. Agent reports caller says she took Advil last night and it didn't help her. Agent reports caller says she also developed an odor which she never had before. Agent says caller wants to confirm if this is a side effect for Pfizer COVID-19 vaccine second booster. Caller clarifies that yesterday was her second booster or fourth dose of the Pfizer COVID-19 vaccine and along with that she got her shingles shot, which later was clarified to Shingrix. Pfizer COVID-19 vaccine: Caller says she got her first dose 24Feb2021, it was Pfizer EL9262 with EXP: May2021. She says NDC was not provided on her handwritten vaccine card for this dose. She says her second dose of Pfizer COVID-19 vaccine was 17Mar2021 of LOT: EN6199, EXP: Jun2021 and was also given at same location. She says NDC was not provided. Caller says her third dose or first booster of Pfizer COVID-19 vaccine was given 25Sep2021 of Pfizer LOT: E3592, which she says she can't make it out, it is either an F or a T, clarified to LOT: FE3592. She says the NDC/EXP are not provided for her third dose which was given at  (Name withheld) store number  (Number withheld) . She says she got her Pfizer COVID-19 fourth dose or second booster yesterday, which on the prescription it says it was for 12 plus and gray cap. She provides LOT: FJ4991 or 4091, and clarifies that LOT is handwritten and after the four it has a 9 or a 0 which is connected to the other nine after that. EXP: Unknown, not provided on handwritten vaccine card. Caller provides NDC: 59267-1025-01 from the paperwork  (Name withheld) gave her for the Pfizer COVID- 19 vaccine. Shingrix: Caller says that the only information she has on this shot she got yesterday is that it was a shingles single dose VL10PK with NDC: 58160-0823-11, refrigerated. She says she thinks she had a dose of this before in 2019, and they told her she doesn't need another one again that this second one should last. She says she thinks had the first one in 2019, and she was ok when had it, but this one seems to make her sick, though she doesn't know which it would be, the shingles or COVID-19 vaccine. Caller says she doesn't have NDC/LOT/EXP to provide for her previous dose of the Shingrix vaccine. AE: Caller says her stomach is hurting. She says her vaccine doses were done in her right arm because she got a little brace on her left arm for arthritis in her shoulder bone or something like. She says they said she could do both shots in her right arm. She says her right arm is red and lumpy, she put ice on it yesterday. She says they said she could rub it, and she put an ice pack on it because it was hard and had pain inside, so she just stopped. She says she had a temperature of 99.3 degrees Fahrenheit this morning when she checked it. She says the pain is still there so she looked in the mirror and her arm was red. She says she didn't look at it last night, she put the ice pack on it and it was lumpy and hard in both areas where he gave her the shots. She says that it is just a hot long red line kind of like one and a half inches down, and across it is three inches long on her right arm. Advil Liqui-Gels AE/PC: Caller says she took Advil yesterday to see if that would help after she tried to put ice on it. She clarifies it was Advil gel caps that are green, 200mg, and she took one Advil Liqui-Gels and it didn't help her. Advil Liqui-Gels UPC: Unknown, caller says the barcode is not on the bottle, LOT: R94350, EXP: Jul2024, PAA 083151. AE Treatment: Caller says she has just been rubbing it to make the medicine circulate, she thought maybe must in one place that didn't go all way thru. She says when he gave her the Pfizer shot he did it real slow and didn't punch it in to make sure the medication goes thru, he injected it real, real slow, not fast like other shot where they stuck you and that is it. She says this one for both shots he did real, real slow. She says she walked home yesterday and it was hurting then, the pharmacy was just right down the street about a half mile or so, and her arm was hurting bad. She says she got home and laid down and got up and put an ice pack on it, then after that thought she would go ahead and take Advil since the ice pack was too hard, it was in the freezer and when she put on her arm it was hurting real bad, it couldn't touch. The patient reported a product complain. Description of Product Complaint: Description of complaint: Advil Liqui-Gels: Caller says she took Advil yesterday to see if that would help after she tried to put ice on it. She clarifies it was Advil gel caps that are green, 200mg, and she took one Advil Liqui-Gels and it didn't help her. Advil Liqui-Gels UPC: Unknown, caller says the barcode is not on the bottle, LOT: R94350, EXP: Jul2024, PAA 083151. Product strength and count size dispensed: 200mg, 20 gel caps   No follow-up attempts are possible. No further information is expected.