Age: 65.0
Sex: F
Vaccine: FLUR3, PNC13
Symptoms: Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: muscle itself was very stiff; evidently the inflammation was still there; where muscle it went in was warm; Skin over muscle itself very pale; she felt chills and was feeling really bad, did not feel very well; she felt chills and was feeling really bad, did not feel very well; she felt chills and was feeling really bad, did not feel very well; redness and swelling of areas of the left arm, around the affected muscle of her left arm and down to her elbow; redness and swelling of areas of the left arm, around the affected muscle of her left arm and down to her elbow; redness and swelling underneath the muscle of left arm where Prevnar 13 was administered; redness and swelling underneath the muscle of left arm where Prevnar 13 was administered; Hurting of left arm; after Prevnar 13 shot administered in the left arm muscle her the muscle where she got the Prevnar 13 shot hurt; This is a spontaneous report from a contactable Pharmacist (patient). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration in left arm on 07Nov2020 at single dose for immunization. Medical history was none.  Concomitant medication included influenza vaccine rha 3v (baculovirus) (FLUBLOK) shot administered to right arm on 07Nov2020 for immunization and administration site hurt, sore, it went away in short time, no problems or redness. The morning of 07Nov2020 after pneumococcal 13-val conj vac (dipht crm197 protein) shot administered in the left arm muscle her the muscle where she got the shot hurt and did not stop hurting. The muscle itself hurt for some time. She took some ibuprofen (ADVIL LIQUIGELS, Lot: R72816, Expiry: Apr2022) and put something warm, like a heating pad on the site at first but the site just kept hurting. She repeated over the last 2 days the ibuprofen 3 times at quite a high dose of either 600mg or 800mg depending on how much it hurt; but she noticed by evening of 08Nov2020 that the muscle itself was very stiff so evidently the inflammation was still there. Underneath the muscle of left arm that was hurting across her arm it is very red; she took the ibuprofen; she did not have an antihistamine yet. Night of 08Nov2020 she felt chills and was feeling really bad, did not feel very well; she took ibuprofen and went to bed. It is very strange; where the muscle that it went in it was not red; it was warm, but it was not red. Night of 08Nov2020 when she noted the redness and swelling underneath the muscle of left arm where pneumococcal 13-val conj vac (dipht crm197 protein) was administered. The redness and swelling under the muscle is about 3 inch width all the way across the front of her arm; but the redness and swelling was all around the muscle, not over the muscle itself. The skin over the muscle itself was very pale; unknown if that is because of the swelling but the redness was underneath the muscle; it ended up in a 3 inch path that was still there across the front of her arm, around the affected muscle of her left arm and down to her elbow and arm still hurt. When she woke up this morning on 09Nov2020 she took ibuprofen. She saw on the site it said take diphenhydramine hydrochloride (BENADRYL, 1-25mg tablet taken on 09Nov2020, Lot: CS13685, Expiry: Oct2021, UPC: 366715970626). She took diphenhydramine hydrochloride 09Nov2020 maybe an hour or 2 before this call. The hurting of left arm, pain is a little bit less than initially was; but the redness and swelling of areas of the left arm are about the same if not worse even though she took diphenhydramine hydrochloride. There might still be some swelling, but not horrific. Seriousness criteria provided by caller of events reported was medically significant; she can still breathe normally and does not have a rash on her body. The reporter considered the events hurting of left arm and redness and swelling of areas of the left arm were related to pneumococcal 13-val conj vac (dipht crm197 protein). She had not seen her primary care physician regarding these events yet. She knew one thing is if you were allergic to something they made the needle out of or on the needle itself; but she was thinking that was not the problem, she had no problem with the influenza vaccine rha 3v (baculovirus) given at same time in right arm on 07Nov2020. The outcome of the events hurting of left arm, after pneumococcal 13-val conj vac (dipht crm197 protein)  shot administered in the left arm muscle her the muscle where shot hurt were resolving,  outcome of redness and swelling of areas of the left arm, around the affected muscle of her left arm and down to her elbow were not resolved, outcome of the rest events was unknown.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site induration, vaccination site inflammation, and vaccination site warmth were related to PREVNAR 13 based on known drug safety profile. Based on the temporal relationship, the association between the events vaccination site pallor, pain, erythema, peripheral swelling, chills, feeling bad, and feeling unwell with PREVNAR 13 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.