Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Grip strength decreased, Hypoaesthesia, Insomnia, Mass
Clinical narrative: did not sleep at night; lump appeared on her wrist/lump has worsened and gotten bigger; felt a weird sensation after injection / feeling funny and weird; pain radiated from her neck all the way down to her foot on her left side/could not lay on her left side; numbness and tingling in left hand/no feelings in her fingers, very limited hand grip on her left side; numbness and tingling in left hand/no feelings in her fingers, very limited hand grip on her left side; This is a spontaneous report from a contactable nurse reporting for herself.  This 69-years-old female patient injected to herself a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not provided) on an unspecified date in 2015, in left arm, for immunization. The patient's medical history was none. The patient was not taking any concomitant medication. On an unspecified date in 2015, the patient felt a weird sensation after injection and experienced pain radiated from her neck all the way down to her foot on her left side, numbness and tingling in left hand. These events were reported serious as medically significant. 6 hours after the injection, she started feeling funny and weird. After she got home, close between 10 PM to midnight, she had no idea where she was. She was pacing the floor, holding her arm. She had the vaccine injected in her left arm, but her neck started bothering her. She did not sleep at night and she could not lay on her left side. She had no feelings in her fingers, she had very limited hand grip on her left side. Then, all of a sudden, a lump appeared on her wrist. She first noticed it in Nov2019. She went to have a physical in Dec2019. The doctor was baffled and stated it could be a cyst. The doctor just sort of dismissed the issue. The patient explained she had an adverse reaction, severe enough that it had to be reported to the CDC. Weird sensation after injection and did not sleep at night outcomes were unknown. The other events had not yet resolved at reporting time (lump appeared on her wrist was reported as worsened and got bigger). The patient added that it had already been four years since she had the vaccine and she had not got any better and that pain, numbness, and tingling had stayed about the same.  Information on the lot/batch number has been requested.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. 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.; Sender's Comments: Based on the temporal relationship, the association between the events "felt a weird sensation after injection and experienced pain radiated from her neck all the way down to her foot on her left side, numbness and tingling in left hand" with pneumococcal 13-valent conjugate vaccine can not be fully 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.