Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Erythema, Rash, Urticaria
Clinical narrative: patient now had dots coming from her neck; Rash; dots coming from her neck, all over her chest, breast and shoulders; Patient was really red anyway/already red on her chest; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer(patient) reported for herself that:  A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3181, NDC number and Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 17Aug2021 18:00 (at the age of 48-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included chronic obstructive pulmonary disease COPD, asthma and type 2 diabetes mellitus all from an unknown date and unknown if ongoing. The patient was not provided Family Medical History Relevant to adverse events. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for chronic obstructive pulmonary disease, start and stop date were not reported. And insulin glargine (BASAGLAR KWIKPEN), trazodone (TRAZODONE), metformin (METFORMIN), saxagliptin (ONGLYZA [SAXAGLIPTIN]) and beclometasone dipropionate (QVAR)-for all taken for an unspecified indication, start and stop date were not reported. The patient previously took tiotropium bromide. And Spiriva Resp L Mat, Lot number: 806575C. she was out of Spiriva Resp L Mat, 2.5mcg/actuation, she has not had this for 2-3 months. History: patient make the comment she took insulin shots in her stomach. She confirmed she has not started any new medications within the last 2 weeks prior to developing the rash. She has COPD and has 2 inhalers. she stated she was out of one so she was using her rescue inhaler which was Albuterol. The inhaler she was out of was Spiriva Resp L Mat, 2.5mcg/actuation. Lot: 806575C, she states she hasn't had this for 2-3 months and she has been using her rescue inhaler. The patient clarified her doctor actually changed it because the Spiriva inhaler was $600 which she doesn't have. She was given the QVAR inhaler. When probed for product information, the caller makes the comment its very small. She sees PP3745 after it says LOT/EXP then she sees Nov2021 and Lot: AFS63A. The patient stated she also takes insulin, which she ran out of that. She uses the 10 Basaglar Pen which was new for her. She states she was supposed to take 60mg where she worked up 1mg each day until she made it to 60. She made it to 60mg three days ago but she used the last 10 units. She confirms she has no more. She is supposed to be taking 60mg a day. She called in on the 13th and was told the lady hadn't even put in her prescription. She must have not checked her messages. When she bought the Basaglar she was given the first box and paid 391.44. The next month in withheld, she will get it for $50. No further details provided regarding this statement. She seen the following on the packaging for Basaglar: 100units/mL 5x3mL prefilled pen. NDC: # Control number: D344910A, Expiry date: Dec2022. She mentioned she also seen on the bottom, a GTIN number and SN. She took Trazadone 100mg as a sleeping pill when she needed it at night-time. Also, at night-time, she takes a insulin shot and one Onglyza 5mg pill. She is also on Metformin 1000mg, twice a day (once in the morning and once in the evening). She confirmed she has been on these medications for a while, 4 months now. Prior Vaccinations, patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The adverse events was not following prior vaccinations. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): this was the patient's first dose. There was not any additional Vaccines Administered on Same Date of the Pfizer Suspect. On 19 Aug20212021 20:30, the patient experienced rash; dots coming from her neck, all over her chest, breast and shoulders. On 19 Aug20212021 the patient experienced patient was really red anyway/already red on her chest and on 20Aug2021 patient now had dots coming from her neck. It was reported that, patient was called regards to the Pfizer COVID shot, FC3181. The patient stated she had a rash on her body. She got the COVID shot at 18:00 on Tuesday night and she noticed the rash yesterday. She stated she was really red anyway- she is blond with really fair skin, so she was already red on her chest, but she now has dots coming from her neck, all over her chest, breast and shoulders. She did not know if its anywhere else, stating its hard for her to see. The patient stated her doctor said to listen to what Pfizer had to say. She wanted to know if she has quarantine and if so, how long. She wanted to be safe. Patient verified this was her first dose of the COVID vaccine. The next dose was scheduled on her birthday 07Sep2021. She clarified she noticed the rash yesterday, 19Aug2021, but the rash probably developed the night before. She was always red on her neck and she has skin tags on her neck, but she started looking closer in the mirror and noticed the dots all over. When probed for the outcome of this rash, the patient stated it was more red. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: increase (she just checks her blood sugar at home). The patient did not require visit to emergency room. Physician Office: Not yet. She had called because she appointment with her doctor's office in regards to insurance/financial stuff. She called her doctor's office to ask if they still wanted her to come in and she was directed to call Pfizer first to see what they say. She clarifies she was instructed by the financial person at her doctor's office, not a provider/physician, as a doctor isn't there to answer calls like that. The outcome of event patient now had dots coming from her neck was reported as unknown, while outcome of other events was reported as not recovered at the time of last observation.  The product complaint was reported. Description of Product Complaint:  Description of complaint: The patient mentioned she has COPD and has 2 inhalers, she states she is out of one so she is using her rescue inhaler which is Albuterol. The inhaler she was out of was Spiriva Resp L Mat, 2.5mcg/actuation (product name captured as provided by the caller). She makes the comment the writing gets smaller and smaller. Lot: 806575C, she states she hasn't had this for 2-3 months and she has been using her rescue inhaler. The caller clarifies her doctor actually changed it because the Spiriva inhaler was $600 which she doesn't have. She was given the QVAR inhaler. When probed for product information, the caller makes the comment its very small. She sees PP3745 after it says LOT/EXP then she sees Nov 2021 and Lot: AFS63A. When she bought the Basaglar she was given the first box and paid 391.44. The next month in Mexico, she will get it for $50. No further details provided regarding this statement. She seen the following on the packaging for Basaglar: 100units/mL 5x3mL prefilled pen, Control number: D344910A, Expiry date: Dec2022. She mentioned she also seed on the bottom, a GTIN number and SN. No further details were provided or obtained.  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.