Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Pain, Product use issue
Clinical narrative: I had a pneumonia shot, I guess it was within 4 week on left arm; I had a pneumonia shot, I guess it was within 4 week on left arm; Adverse reaction since I got the Booster shot and I have been sick; Motion sickness; I saw a white spot before my face, I did not get dizzy but I got extremely nauseated; I saw a white spot before my face, I did not get dizzy but I got extremely nauseated; My muscle in my right arm after my shot hurt really bad and I had to lay down; Headache; Really bad body ache; Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2022 at 11:20 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 17Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: AFib. Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset Apr2022, outcome "unknown", described as "Adverse reaction since I got the Booster shot and I have been sick"; HEADACHE (non-serious) with onset Apr2022, outcome "not recovered"; VISUAL IMPAIRMENT (non-serious) with onset Apr2022, outcome "unknown", NAUSEA (non-serious) with onset Apr2022, outcome "not recovered" and all described as "I saw a white spot before my face, I did not get dizzy but I got extremely nauseated"; DECREASED APPETITE (non-serious) with onset Apr2022, outcome "not recovered", described as "Loss of appetite"; MOTION SICKNESS (non-serious) with onset Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset Apr2022, outcome "not recovered", described as "My muscle in my right arm after my shot hurt really bad and I had to lay down"; PAIN (non-serious) with onset Apr2022, outcome "not recovered", described as "Really bad body ache"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Apr2022, outcome "unknown" and all described as "I had a pneumonia shot, I guess it was within 4 week on left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, motion sickness, visual impairment, nausea, myalgia, headache, pain, decreased appetite.  Additional Information: Is report related to a study or programme? No. Drug(s) Information: Characterization of drug role: 1 (suspect), Medicinal Product Name as Reported by the Primary Source: Unspecified Pneumonia shot, Batch/lot number: Unknown. Is COVID-19 Vaccine a Pfizer product? Yes, COVID-19 Vaccine manufacturer: unspecified, NDC number of COVID-19 Vaccine: Unknown, UPC number of COVID-19 Vaccine: Unknown, Expiry Date of COVID-19 Vaccine: Unknown. Is Unspecified Pneumonia shot a Pfizer product? Unspecified, Unspecified Pneumonia shot manufacturer: unspecified, NDC number of Unspecified Pneumonia shot: Unknown, UPC number of Unspecified Pneumonia shot: Unknown, Reason for no lot number: of Unspecified Pneumonia shot: Other: LOT, Unspecified shot hence could not be probed, Expiry Date of Unspecified Pneumonia shot: Unknown, Other Products: Yes. The adverse reaction since I got the second Booster of Pfizer (COVID-19 Vaccine) on Thursday the 21st and I have been sick with it ever since, so I had adverse reaction. When probed for any Laboratory test, consumer stated, More than 2 weeks ago the lab test, blood work was done like a month and a half ago that was on 31Mar. When probed for any treatment for the event, consumer stated, The only thing I have taken Tylenol and I did take for motion sickness (event captured conservatively) pill like an over the counter. When probed for any Prior vaccination within 4 weeks, consumer stated, "Yes I had a pneumonia shot (unspecified pneumonia shot), I guess it was within 4 week on 17Apr and that was on the other arm (left arm). I had no reaction with that other than the muscle on that arm, I got the shot and it (left arm) swelled for a couple of days." Consumer further stated, "Well within the first three minutes of getting the shot I saw a white spot before my face I did not get dizzy but I got extremely nauseated then my muscle in my right arm right after my shot hurt really bad and I had to lay down for 20 minutes in the office and when I got home I got very nauseated and I had slight headache, the nausea, the body ache really bad the very next day and I have them still nausea, headache, body ache and like little loss of appetite. I still have that it is been 4 days though. I have it twice before ever got the (Pfizer COVID-19) vaccinate first time."  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.