Age: 65.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Feeling abnormal, Influenza, Injection site erythema, Pain, Pain in extremity
Clinical narrative: didn't feel good, but it was nothing compared to how bad the night before had been; wiped out; Big red area around where the shot had been administered; Her arm hurt; Felt like she had a major flu, her body ached all over/ soreness and achiness; Felt like she had a major flu, her body ached all over/ so miserable/it was like a horrible flu; Had a high fever of like 103 degrees; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at right arm site on 12Dec2020 at single dose for immunization; influenza vaccine, via an unspecified route of administration at right arm site on 12Dec2020 at unknown dose for immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine. Clinical course: Patient had never had a Pneumonia shot before, and she got it, and she does not know how many hours it was before she had the side effect, but she got the shot in like the afternoon on 12Dec2020, and that night when she went to bed, there was a big red area around where the shot had been administered, the area had turned red, but it was not as bright when it started, as when she went to bed, and her arm hurt. She had the worst night that night, she felt like she had a major flu, her body ached all over, and she took Aspirin, and she had a high fever of like 103 degrees, and she had body aches. The next morning (on 13Dec2020), she didn't feel good, but it was nothing compared to how bad the night before had been, it was like she had the worst flu ever. On 13Dec2020, the patient was just wiped out, but she did not feel like she was dying, like she had the night before. it was stated, with a laugh, that she ever told her husband to shoot her because she was so miserable. She has never had a pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) before, but she is 65, so she was told she should get one. She had been taking influenza vaccine every year since like 1999, and she has never had a problem with the influenza vaccine. So, she did not think it was the influenza vaccine. When she actually received the Pneumonia Vaccine, the injection itself did not hurt, but it was like later when the caller went to bed that her problems started. When she rolled over on to her arm, her arm hurt, and then as she was going to sleep, her symptoms just got worse overnight. It was like a horrible flu, where her body was achy, and she had a fever. She took 5 baby Aspirin, or like the heart ones that are 81mg. She is not currently home, and where she is staying is like an hour from the closest hospital. Several hours after the first set of Aspirin she took, she took 5 more of the 81mg Aspirin, and then she took some Ibuprofen later because she was hurting. On 13Dec2020, she still was hurting, but it was nothing like that first night, and on 14Dec2020, she is feeling a lot better. It was stated that if she knew how severe the side effects might be, she might not have taken it. Immediately after receiving the vaccine, she felt great, but it was not until after she went to bed and went to sleep that the side effects started. It did not last for days and days but did stay in bed yesterday. She still felt like she has had some energy taken out of her, but it was nothing like that first night. She had not had any fevers since 13Dec2020 afternoon, and it was all lighter, but she still didn't get out of bed much on 13Dec2020. On 14Dec2020, she had been able to get up and get on her computer and such. she did still have body aches and soreness and achiness at this time, but they had improved. Her weight is somewhere between 130 and 135 pounds. She did not know the name of the influenza vaccine and pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) she received, nor did she know the manufacturer, NDC number, Lot number, Expiry, formulation, or dose. She knew some people say to not get the Flu Shot but the she was a firm believer in it, she had done it so many years, since 1998 or 1999, and had never had a problem, but she had never had a pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein), this was her first one, and she had the problem; so she couldn't say 100% it was the pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) that caused her problem, but she was assuming it was. The outcome of event vaccination site erythema was unknown; while of rest events was recovering.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.