Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oxygen saturation, Paraesthesia oral, Pulmonary function test, Pyrexia, SARS-CoV-2 test
Clinical narrative: ringing in the ears; fever; her tongue and both top and bottom lips and was prickly again; her forehead was a red raised rash on her neck, upper chest like last time/the soles of the feet were bright red; her tongue and both top and bottom lips and was prickly again; Had tingling in her tongue and left upper and left lower lip and hates that feeling on her tongue of tightness in the throat again; in an hour after the vaccine had started the tingling.; she had a little cough all night; Patient had left scapular pain.; This is a spontaneous report from a contactable nurse (reported for herself). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732/Batch number was not reproted), dose 2 via an unspecified route of administration on 29Mar2021 at 09:45 (at the age of 65-years-old) as dose 2, single for covid-19 immunisation, medrol (METHYLPREDNISOLONE) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at short-term increase of the Medrol, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 mg, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 10Mar2021, at 6 mg, via an unspecified route of administration from 11Mar2021 (Batch/Lot number was not reported) to 13Mar2021, at 8 mg, via an unspecified route of administration from 14Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 6 mg, route of administration, start and stop date, batch/lot number and dose were not reported for systemic lupus erythematosus. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing, asthma exercise induced from an unknown date and unknown if ongoing (diagnosed with asthma initially exercised induced and now it is seasonal), asthma from an unknown date and unknown if ongoing (diagnosed with asthma initially exercised induced and now it is seasonal), paraesthesia from an unknown date and unknown if ongoing (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing and body height decreased from an unknown date and unknown if ongoing. Concomitant medication(s) included salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199/Batch number was not reproted), dose 1 via an unspecified route of administration on 07Mar2021at 09:40 (at the age of 65-years-old) as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced ringing in the ears, fever, her tongue and both top and bottom lips and was prickly again, her forehead was a red raised rash on her neck, upper chest like last time/the soles of the feet were bright red, her tongue and both top and bottom lips and was prickly again, had tingling in her tongue and left upper and left lower lip and hates that feeling on her tongue of tightness in the throat again; in an hour after the vaccine had started the tingling, she had a little cough all night, patient had left scapular pain. The patient underwent lab tests and procedures which included blood creatinine: 1.28 (Abnormal), blood thyroid stimulating hormone: was in the usual range, blood urea: 22.3 (Abnormal), glomerular filtration rate: 42 ml/min (states normal is over 60 and she usually runs 70 something; GSR abnormal), laryngoscopy: unknown result on 25Mar2021, urine analysis: creatine of 8.5 (the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg), blood creatinine: 0.97, blood urea: 19.5, full blood count: lymphs and monos (CBC had her lymphs and monos down and she would expect having this response to the vaccine), glomerular filtration rate: 58 ml/min (was up to 58mL/min which is still abnormal), urine analysis: all fine (58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein) on 26Mar2021, oxygen saturation: fine, pulmonary function test: clear on an unspecified date in Mar2021 and sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of events included treatment with pediatric Benadryl and Tylenol. The outcome of the events was unknown.  Description of Product Complaint: Description of complaint: Vaccine Supplemental Form completed in additional context. Caller states she got the Pfizer COVID Vaccine on 07Mar2021 with lot EN6199 on a little sticker on her patient card and states there are no expiry dates or NDC numbers on her card and she has to get in the sunlight to read the card; the 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 with lot ER8732. Caller states it is hard to read the print on the sticker of her patient card. States she has no lot number, expiry date or NDC for the Medrol as it is in a prescription bottle; states she got a flight or fight response and was increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine; states she had to increase the Medrol dose from 6mg and popped it up to 8mg. Asked do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. States the Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; states she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday, states the lot is Y23B with expiry date Dec2021 and she does not locate the NDC but sees GTIN, S/N number and the product has a label on it that may cover the NDC. During the first post vaccination episode, her temperature ran 97.6 normal and went days where the temperature was 96.5 to 97 and that is significant because she should be having a fever if there is increased activity and this also happened again yesterday after the 2nd dose of the vaccine.  No follow up attempts are possible. No further information is expected.