Age: 79.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain, Pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: swelled up and itching/when she got up on Monday, the area on her arm at the injection side was raised like it was swollen a little bit more; swelled up and itching; pain and stuff; breaking out with bumps around the injection site/then noticed a few little pink bumps just small ones; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer (patient) reported that.  A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 12:25 as (At the age of 79-years) dose 1, single for covid-19 immunisation; paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication; calamine, zinc oxide (CALADRYL [CALAMINE;ZINC OXIDE]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for swelling, pruritus. The patient medical history was not reported. Concomitant medication(s) included diazepam 2mg (caller states this is a high dose of the Diazepam) taken for an unspecified indication from 1975 and ongoing; butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced pain and stuff, breaking out with bumps around the injection site/then noticed a few little pink bumps just small ones, and swelled up and itching on 07Feb2021, patient experienced swelled up and itching/when she got up on monday, the area on her arm at the injection side was raised like it was swollen a little bit more on 08Feb2021. It was reported that Patient got the Pfizer injection COVID19 Vaccine last Saturday, 06Feb2021. On Sunday she had pain and stuff. On Sunday night she started breaking out with bumps around the injection site. It is swelled up and itching. She was asking Is that normal. She just wants to know why it still swollen and itches. It doesn't have that in the pamphlet. She has read it. She has been using Caladryl and that helps a little, but the itching comes back. She is not scratching it. Today it is swollen. It is pink. Later reporter reports that This was her first dose. She has called several times, but it says more than 7 people ahead of you. She sat for 30 to 45 minutes and had things to do. She will have to call USMI back, because she has to go take her cat to the vet. If someone is going to get something different it will be her. She is the biggest, odd ball her doctor has seen in his entire life. What the doctor could give to anyone else he couldn't give it to her. Her mom was the same way, but caller is worse than her mom was. Caller can't take medication, not even pain medication. She can't even take Tylenol. She suffers through any pain. Description of Product Complaint: Caller reporting adverse event with COVID19 Vaccine. On Sunday night she started breaking out with bumps around the injection site. It is swelled up and itching. She has been using Caladryl and that helps a little, but the itching comes back. She is not scratching it. Caller can't take medication, not even pain medication. She can't even take Tylenol. She suffers through any pain. Caller declined to proceed with report. Upon Follow-up Caller states she got the Pfizer Covid shot and went in to have it last Saturday 06Feb2021 and her arm started itching where she had the vaccine injected in her left arm. Caller states she was fine after being administered the Covid vaccine and then she got up in the mid-afternoon on Sunday and her arm started itching; states she then noticed a few little pink bumps just small ones on Sunday; states when she got up on Monday, the area on her arm at the injection side was raised like it was swollen a little bit more, but it did not itch continuously, and it had started out itching all the time. Caller states she did not scratch because she knows better than to do that but the area near the injection site looked like it had pink bumps around the injection site where they put the vaccine in; states that area near the injection site is swollen now and itches off and on but for a couple of days, it itched all the time. Caller states she is just wondering if this is one of the side effects of the Covid Vaccine or if she may be allergic to something in the medication of the Covid Vaccine. Caller states she used Calodril that is like calomine lotion and the Calodril helped a little bit, and she uses it for a short period of time, and it helped the itching; states when she starts itching again she just uses the Calodril again. Caller states she does not have the lot, expiry date or UPC or NDC number for the Calodril as it is not handy and not with her at this time at all, but she thinks the expiry date is Sep2021. Caller states this is her initial report, and she was told to call the number for USMI and was hoping she would not have to hold for very long, but she forgot to look and see the option to select for #3 for USMI. Caller states she happens to be over age 75 and is actually 79 years old. Caller states the itching is ongoing and less at this time she thinks because it comes and goes; states the raised area that looks swollen near the injection site is still ongoing and she can feel the bumps, and this is ongoing, and she feels about the same. Caller states the indication for the Covid vaccine is that she does not want to get the coronavirus because she is 79 years old and the chances of her surviving the coronavirus are really small; states she has other medical problems, so she does not need to get coronavirus. Caller states she did not get the itching, swelling and bumps near the injection side until she got the Pfizer Covid shot; states she has other medical problems and is on medications for it but does not know whether this is relevant; states the medications she takes are prescribed by her HCP and she has taken them for a long time, and they have never given her a side effect and she has been taking them for years. Caller states she used to have to spell this and she was never able to pronounce it and it used to be called valium but is now called butalbital-acetaminophen and caffeine; states she has taken it for a long time and the dosage is 50mg/355mg/40mg and it is in a white bottle; caller states she has to get the tape off of the bottle, aware not to remove the label; states the label has her name, Rx number and states Revised 416 cib703098, lot 20249986A expiry date Sep2022 and does not locate the NDC number; states she is currently taking it and has taken it for a long time. Caller states she is scheduled for her 2nd dose of Covid vaccine on 27Feb2021 at 12:25pm. Description of complaint: Caller states she got the Pfizer Covid shot and went in to have it last Saturday 06Feb2021 and her arm started itching where she had the vaccine injected in her left arm. Caller states she used Calodril that is like calomine lotion and the Calodril helped a little bit, and she uses it for a short period of time, and it helped the itching; states when she starts itching again, she just uses the Calodril again. Caller states she does not have the lot, expiry date or UPC or NDC number for the Calodril as it is not handy and not with her at this time at all, but she thinks the expiry date is Sep2021. Caller states she used to have to spell this and she was never able to pronounce it and it used to be called valium but is now called butalbital-acetaminophen and caffeine; states she has taken it for a long time and the dosage is 50mg/355mg/40mg and it is in a white bottle; caller states she has to get the tape off of the bottle, aware not to remove the label; states the label has her name, Rx number and states Revised 416 cib703098, lot 20249986A expiry date Sep2022 and does not locate the NDC number; states she is currently taking it and has taken it for a long time. The outcome of event breaking out with bumps around the injection site/then noticed a few little pink bumps just small ones was not recovered. The action taken in response to the event for bnt162b2 was not applicable, for paracetamol was unknown, for calamine, zinc oxide was unknown.  Follow-up attempts completed. No further information expected.