Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ongoing burning sensation in her throat; neck pain; left shoulder pain/lot of shoulder pain; fatigue/ very tired; throat was red/Throat definitely red; my left arm hurt me quite, that's where I got the injection; Both earaches bringing in the ear; sore throat; glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling.; left arm hurt; With my ears I can hardly hear you asking me the last question; her vocal cords were swollen; Confused; I am still not feeling well; I feel awful; Frustration/Frustrated; she had fluid in her ear; increase in acid reflux; bilateral earache; ringing in her ear; back of her neck was swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 58-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 10May2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. (Reason for no lot number: of COVID-19 vaccine: Other: Consumer stated, EW O or 0 probably it's a 0, EW0168). Medical history included hypertension (Verbatim: high blood pressure), hypothyroidism, PE blood clot and DVC blood clot, hydronephrosis of left kidney, TMJ disorder. Concomitant medications included rivaroxaban (XARELTO) 10 mg daily taken for PE blood clot and DVC blood clot., start and stop date were not reported; levothyroxine sodium (SYNTHYROID) 37 and half mg taken for hypothyroidism (Under active Thyroid), start and stop date were not reported; Ongoing metoprolol 75 milligrams a day (50mg one in the morning and half in the evening 25 mg in evening) taken for High blood pressure, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Family medical history relevant to A.E: Consumer stated, No. On 12May2021, patient experienced burning sensation in her throat, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, left arm hurt where the patient got the injection, both earaches bringing in the ear, sore throat, throat was red, swelling glands kind of feeling. On an unknown date in 2021, the patient experienced her vocal cords were swollen, bilateral earache, ringing in her ear, back of her neck was swollen, increase in acid reflux, she had fluid in her ear, confused, still not feeling well, feel awful, frustration, glands are starts swelling now/ there is swelling gland. The patient stated that she was getting all kind of conflicting opinions from the doctors that she has seen but always was curious as to whether, what she was dealing was a common side effect after having receive the first vaccine because she held off having the second vaccine because patient was not just feeling well since the first one and  don't know what timeline is to get the second one. Patient stated that she  thought there is a weekend it would be pretty much gone because I have a lot of friends as such she know it will go after two day well I went into the next week and I was still experiencing all of these things  and so she now waited into the next week. Patient stated "I didn't have an appointment so I went to a sister you know of my PCP and saw one of their doctors then they said, all well we dont think its vaccine may be you have allergy take Zyrtec (Treatment), So I took Zyrtec and I took that for the entire week and then it was going into the next week and I still was not feeling well". Patient saw another Doctor and that doctor said, he checked her glands he said your glands are starts swelling. Patient was in the second week and ENT doctor "he said, well, your throat definitely red  and so he like, go home and gargle with water but anyways then I saw two other doctors. I saw ENT. I had week because ENT people had long schedule that going to wait your turn so I had waited out. All ENT they looked into my throat they didnt see anything, terrible going on they looked into my ears and said, your ears are clear and then I reached out again another week with that like, I am now like six weeks into this".  Patient underwent lab tests which included antibody test: reactive on 14Jun2021. Therapeutic measures were taken by the patient as a result of her vocal cords were swollen included Zyrtec and took medication for 9-10 days but it didnt help so I quit and one time the patient mentioned. Patient stated, The Ibuprofen, I took was 200mg each tablet. Patient took two mortin tablets 200mg each from over the counter and one dose of Tylenol 500mg for pain. Patient stated that "ibuprofen I only took one dose for that one time I took that on 15th that was the first time I took Motrin since the vaccine I don't usually take Motrin because I am not suppose to take it. I had blood, I had blood clot, PE blood clot and DVT blood clot. So, I dont take Motrin very often." Patient queried whether its okay to get the vaccine you know, past the time line, "because I am at 6 weeks now". Consumer stated she was at 6 weeks now and  just didnt know what she should, still getting the second dose or not, because she didnt know if she was out of that window time where it's safe to get it. When informed about the Medical Information Department, consumer stated, With my ears I can hardly hear you asking me the last question. Consumer hung up the call. So no further probing including pharmacy details and treatment details could be done. Hence limited information available over the call. The outcome of the events, ongoing burning sensation in her throat, , neck pain, left shoulder pain, fatigue/ very tired, left arm hurt, bilateral earache, ringing in her ear, back of her neck was swollen, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, my left arm hurt me quite, that's where I got the injection, Both earaches bringing in the ear had not recovered. The outcome of the events, her vocal cords were swollen, increase in acid reflux,  throat was red/Throat definitely red, she had fluid in her ear, sore throat, glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling, Confused, I am still not feeling well, I feel awful, Frustration/Frustrated, left arm hurt, With my ears I can hardly hear you asking me the last question were unknown.  Information on Lot/Batch number was available. Additional information has been requested.