Received May 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | UN / UN |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
got an ear ache; felt like she was being stabbed with a knife over her right eye; was feeling feverish; upper respiratory virus; pains; her coughing got progressively worse and her chest congestion was really bad and got really hard to manage; her chest congestion was really bad/coughing and chest congestion; she is still pretty sick/got sick right after; next day she started coughing had kind of phlegm; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 21May2026 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for immunisation. The patient's relevant medical history included: "allergic to Penicillin and Ceftin", start date: 1990 (unspecified if ongoing), notes: broke out. The patient's concomitant medications were not reported. Past drug history included: Ceftin, start date: 1990, reaction(s): "allergic to Penicillin and Ceftin", notes: broke out. The following information was reported: RESPIRATORY TRACT CONGESTION (non-serious) with onset 22May2026, outcome "recovering", described as "her chest congestion was really bad/coughing and chest congestion"; PRODUCTIVE COUGH (non-serious) with onset 22May2026, outcome "recovering", described as "next day she started coughing had kind of phlegm"; ILLNESS (non-serious) with onset 22May2026, outcome "recovering", described as "she is still pretty sick/got sick right after"; CONDITION AGGRAVATED (non-serious) with onset 23May2026, outcome "unknown", described as "her coughing got progressively worse and her chest congestion was really bad and got really hard to manage"; EAR PAIN (non-serious), outcome "unknown", described as "got an ear ache"; EYE PAIN (non-serious), outcome "unknown", described as "felt like she was being stabbed with a knife over her right eye"; PYREXIA (non-serious), outcome "unknown", described as "was feeling feverish"; VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "upper respiratory virus"; PAIN (non-serious), outcome "unknown", described as "pains". Therapeutic measures were taken as a result of productive cough, respiratory tract congestion, ear pain, eye pain, pyrexia, illness, viral upper respiratory tract infection, pain (acetaminophen). Additional information: The patient stated she had the pneumococcal vaccine 20 on Thursday the 21st and she got sick right after. That evening she felt something coming on, but it was not too bad. The patient stated the next day she started coughing and had kind of phlegm. The next day her coughing got progressively worse and her chest congestion was really bad and got really hard to manage. Patient stated she didn't start coughing from it until the 22nd. She was fine after she got it, though she was feeling feverish, but she never got a fever. Then the congestion, coughing and pains occurred. Patient stated Monday, the 25th was the worst and she is still pretty sick (stated she is slightly recovering, but she is still coughing). The primary infection site was reported as "upper respirator virus". She went to the doctor yesterday, the 27th, to double check if she needed an antibiotic, but her doctor told her to keep doing what she was doing and her doctor didn't give her any antibiotics. Additionally, the patient stated she lives up in the mountains and when she went down the mountain to go to the doctor yesterday, usually her ears will pop when she's driving down, but it felt like she was being stabbed with knife over her right eye, in her sinus area. She got an ear ache as well. The patient stated her doctor checked all of that, there was no infection in her ear or anything. The patient used acetaminophen (she used some cold medication, once she got sick enough), to alleviate symptoms and stated she had not been using anything prior to getting sick. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Penicillin allergy (broke out)