Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | — | SYR / LA |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | OT |
COPD would not flared up on nothing; started having the problems that night ended up in the ER; cannot be at home by herself; dropped her heart rate/heart rate drop down below 40 something/dropped her heart into bradycardia; dropped her oxygen/oxygen dropped below 80 something; taking all my energy just to talk; her weight, she has lost; gas was on down to everything, your arterial blood and all that; blood pressure go up sky high; heart rate go up sky high; The shot almost killed her; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29Aug2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years intramuscular for immunisation. The patient's relevant medical history included: "Post-traumatic stress disorder" (ongoing); "Osteoporosis" (ongoing); "Arthritis" (ongoing); "bone density problem" (ongoing); "Acid reflux" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "inflammation" (unspecified if ongoing); "memory was not like it was supposed to be" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease; CELECOXIB taken for arthritis; PROXYM [ETODOLAC] taken for inflammation (ongoing). The patient also took other concomitant therapy. The following information was reported: NEAR DEATH EXPERIENCE (medically significant) with onset 2025, outcome "unknown", described as "The shot almost killed her"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization) with onset 05Sep2025, outcome "unknown", described as "started having the problems that night ended up in the ER; cannot be at home by herself"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization), outcome "unknown", described as "COPD would not flared up on nothing"; BRADYCARDIA (medically significant), outcome "unknown", described as "dropped her heart rate/heart rate drop down below 40 something/dropped her heart into bradycardia"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "dropped her oxygen/oxygen dropped below 80 something"; ASTHENIA (non-serious), outcome "unknown", described as "taking all my energy just to talk"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "her weight, she has lost"; BLOOD GASES ABNORMAL (non-serious), outcome "unknown", described as "gas was on down to everything, your arterial blood and all that"; HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure go up sky high"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart rate go up sky high". The patient was hospitalized for loss of personal independence in daily activities, chronic obstructive pulmonary disease (start date: 05Sep2025, discharge date: 08Sep2025, hospitalization duration: 4 day(s)). The event "started having the problems that night ended up in the er; cannot be at home by herself" required emergency room visit. The event "copd would not flared up on nothing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood gases: down to everything; Blood pressure measurement: go up sky high; Cardiac monitoring: Unknown results, notes: done all the readings that they needed; bradycardia; Heart rate: below 40 something, notes: drop; go up sky high; Lab work: Unknown results, notes: did all that in hospital; Oxygen saturation: below 80 something, notes: dropped; dropped; Weight: 112, notes: lost. Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, near death experience, bradycardia, oxygen saturation decreased, asthenia. Clinical course: The reporter informed that she went in and took your Pfizer shot on the 29th and she had a reaction to it and she wanted a compensation on that shot. The shot almost killed her. She'll be on oxygen rest of her life. It was the pneumonia shot. She thought the doctor's office said it was Pfizer 20. (later clarified as Prevnar 20). She went in for a well checkup on the 29th of last month. All she knew was they said the pneumonia has the number 20 on the end of it from her understanding. All she knew was the doctor's office when she went back to him after she got that shot, her primary doctor they checked her for the flu to check her for the pneumonia, and they checked her for the COVID, didn't have that. The emergency room checked me for all that didn't have that such a reaction from the shot. The patient informed that the doctor gave her the shot. She got the hospital papers in front of her now. The hospital did not give her that shot, her provider did for her well check-up. She wrote it down somewhere in the hospital papers. This was what it was, it was Prevnar 20. That was the shot that she was given. The doctor's office gives you the shot. She did not give it to herself. They have you the shot in the doctor's office. She received this shot by her primary care doctor. She went there for a well visit and got the pneumonia shot. The patient informed that the route of administration was intramuscular given to her in left shoulder. She started having the problems that night ended up in the ER, just got out of the hospital on the 08th. Now, she cannot be at home by herself from 05Sep2025 to 08Sep2025. The patient informed that the shot did to her was it dropped her heart rate. It dropped her oxygen. It did everything. So, it was taking all of her energy just to talk. She had to take her medicine before she got on phone here. She did not adapt that word where you cannot breath so that she can be able to talk to you. The patient informed that her weight, she has lost. She may be 112 now. The patient informed that she has COPD. She did not want to get pneumonia. She did not want to get sick but if she knew that shot was going to do this. She would have reacted. She would have never took it. The patient informed that the medications that she was taking right now was the medications she has to be right now. She was taking prednisone. She was taking albuterol nebulizer medication. She was on oxygen. One of them was oxygen, tiotropium bromide and albuterol sulfate inhalation that was nebulizer breathing treatment. Albuterol sulfate and tiotropium bromide and albuterol sulfate inhalation solution with 0.5 milligrams/3 milligrams. She was taking this right here was also she cannot breath of that shot, that was why. She take albuterol inhaler when she had an actual, that was her rescue inhaler. She was taking another inhaler that was called Breztri inhaler, she took 2 puffs of that in the morning, 2 puffs at night. The patient informed that gas was on down to everything, your arterial blood and all that. Her heart rate drop down below 40 something, her oxygen dropped below 80 something. They kept a heart monitor on her in the hospital and done all the readings that they needed. This showed every time it dropped her heart into bradycardia. It showed every time her oxygen level dropped. It showed every time that it made her blood pressure go up sky high and made her heart rate go up sky high. The patient informed that she was taking prednisone, the prednisone that they sent her home with which when she go back to her lung doctor he was going to put her on more, 20 milligram for now, take 2 tablets by mouth in the morning for 5 days until she see her lung doctor. The indication of prednisone was for the shot put her in. The patient informed that all this medication she was telling you the shot did this. This was a lot of new medication (treatment) that she was taking now. She did not have to take this before this shot. She was well. Her COPD would not flared up on nothing. She was well breathing fine. The patient was admitted on 05Sep2025 and discharge date was on 08Sep2025. She went in after the shot. She did not drive. She cannot drive. She was admitted to the hospital emergency room on the 05th. She was discharged on 08th. The patient informed Breztri inhaler, the medicine was taking because she was having to do all this other stuff. This padded inhaler, to keep trash from getting in her mouth, from taking that kind of stuff you get that stuff in your mouth. She has to take that sometimes so her mouth did not get raw. That medication was taken because of that shot. Now she has to take that before. She did not. The patient informed that she was given steroid shots, potassium. She had to take Magnesium, She had to take antibiotics. She had to take breathing treatments. She had to do the whole 9 yards. The patient informed that all these shots that you all giving people that they were taking for pneumonia, flu and all that was killing people all, was making them disabled. Is that the foreign ways people were not touching them all but killing them, they need to give it to their own people. The patient knew it was not from the United States because she has been already called and talked to somebody that gave her your number. For the compensation she got her e-report and she has got their numbers where it should already been reported. The patient wanted to know that when you all do a follow up on me if she was dead, what happens then, her family gets compensation or not if that shot killed her. 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.
Arthritis; Bone density abnormal; Osteoporosis; Post-traumatic stress disorder
Medical History/Concurrent Conditions: Acid reflux (esophageal); Arthritis; COPD; Inflammation; Memory impairment
OMEPRAZOLE; CELECOXIB; PROXYM [ETODOLAC]
Test Name: arterial blood gas; Result Unstructured Data: Test Result:down to everything; Test Name: Blood pressure; Result Unstructured Data: Test Result:go up sky high; Test Name: heart monitor; Result Unstructured Data: Test Result:Unknown results; Comments: done all the readings that they needed; Test Name: heart monitor; Result Unstructured Data: Test Result:bradycardia; Test Name: heart rate; Result Unstructured Data: Test Result:below 40 something; Comments: drop; Test Name: heart rate; Result Unstructured Data: Test Result:go up sky high; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results; Comments: did all that in hospital; Test Name: Oxygen level; Result Unstructured Data: Test Result:below 80 something; Comments: dropped; Test Name: Oxygen level; Result Unstructured Data: Test Result:dropped; Test Name: weight; Result Unstructured Data: Test Result:112; Comments: lost