Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Rash; Itch all over my body - second dose; Hard time breathing through mask - second dose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 21Apr2021 12:15 as single dose for covid-19 immunization. Medical history included Broke femur of right leg from 09Nov2020 to 09Nov2020 (he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), Surgery to repair broken right femur from 12Nov2020 to 12Nov2020, ongoing COPD (Chronic obstructive pulmonary disease) (Chronic COPD, he was diagnosed with chronic COPD at least 13 or 14 years ago), ongoing Asthma, on-going bronchitis, he's been in either a walker or a wheelchair (he is still not fully recovered), hospitalized for the broken femur on 09Nov2020 (reported that he was hospitalized for the broken femur from 09Nov2020 until 15Nov2020 or 16Nov2020), rehabilitation from unknown date to 14Dec2020 (reported that he had rehabilitation following his hospital discharge and got out of the rehab facility on 14Dec2020). Concomitant medications included apixaban (ELIQUIS) taken for Blood clots in leg after surgery from Apr2021 and ongoing as 5 mg, 2x/day (one in the morning and one at night). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number CR2613, expiration date unspecified), via an unspecified route of ad-ministration, administered in arm left on 30Mar2021 as for covid-19 immunization. No additional administered vaccines. No prior vaccinations (within 4 weeks). No family medical history relevant to adverse events. He reported that what was happening was that he itches all over his body. He reported that he had little bumps and he itches all the time. Her reported that he got some anti-itch stuff and he's been putting that on it.He reported that he just did what he thought was necessary for the itching. He reported that he thought he could take anti-itch stuff and try to correct it that way, but he was still itching. He stated that naturally you say not to itch, but he still itches and he scratches. He reported that he guesses the scratching makes it worse. He reported that his children recommended that he take Benazine or something so that is what he has been doing. He reported that he just got out of the hospital anyway because he broke his femur.He reported that he's been in either a walker or a wheelchair and that he is still not fully recovered from that, so that was one of his deals. He reported that he also has blood clots. Reported that the itching seems a little better but right now it was on his back and it was difficult to put the cream on there. The rash started on the second day, he started itching on the back of his head, he thought it was dandruff or something, so that happened the first day after, and the following day he got itching all over. Was using some itching stuff they get from the pharmacy, they said take certain meds, so he talked to the pharmacy about that, his wife did, and he started doing that, but it's continued on for a week, he did not know if he was doing ok, or if he should be doing something else, or continuing doing what he is doing. Trouble breathing through mask: He reported that he received the Covid-19 vaccine at 12:15 PM on 21Apr2021 and he had physical therapy at 3:00 PM following the vaccine. He reported that he then had a hard time breathing through his mask at physical therapy. He reported that he always has a hard time breathing one way or the other, and that the difficulty breathing through his mask was present before he received the Covid-19 vaccine. Blood clot in leg: reported that after he was discharged from rehab, he went to his own family doctor because his ankle and leg were still swollen. He reported that his physician sent him to (place name) to have a vascular done. He reported that the physician in (place name) determined that he had blood clots in his leg. He reported that he was sent to the emergency room and he started that stuff for about a week until he went to a regular vascular doctor and the physician determined what the caller should be doing. He reported that he was diagnosed with the blood clots after he got out of rehab at (place name). He reported that he went to see his regular doctor on 30Mar2021 and that it had to be after that that they sent for vascular. Rash: His wife reported that the caller has been scratching himself bloody. His wife reported that the rash came out on Friday, 23Apr2021. He reported that he was in a wheelchair. He reported that he has been using anti-itch products but is still itching. His wife provided product details. His wife reported that the patient has already used one tube of the Benadryl Anti-Itch cream. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets; Lot Number: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets; Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube; Lot Number: 3290LZ-1; Expiration Date: Oct2022. There was product complaint. Patient was using Benadryl tablets, Benadryl Anti-Itch Cream, and Benadryl Liquid Capsules and is still itching. The imprint with lot number and expiry date on the Benadryl Extra Strength Itch Stopping Cream was little hard to read. Benadryl Anti-Itch Cream (second tube): Strength: Diphenhydramine 2%, Zinc Acetate 0.1%; Package size: 1 ounce tube; Lot Number: 0051LZ, Benadryl Tablets: Strength: 25 mg tablets; Package size: 100 tablets, Benadryl Liquid Capsules: Strength: 25 mg capsules; Package size: 24 caplets, Benadryl Extra Strength Itch Stopping Cream (first tube): Package size: 1 ounce tube. Additional lot numbers: Benadryl Anti-Itch Cream (second tube): Lot Number: 0051LZ; Expiration Date: Nov2022, Benadryl Tablets: Lot Num-ber: KHL0001; Expiration Date: Jul2022, Benadryl Liquid Capsules: Lot Number: 1795511; Expiration Date: Jul2022, Benadryl Extra Strength Itch Stopping Cream (first tube): Lot Number: 3290LZ-1; Expiration Date: Oct2022. Sample of the product available to be returned, if requested. Packaging sealed and intact. The outcome of breathing difficult and itchy was not recovered, rash was unknown.   No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021479091 same patient, different dose/event