Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Gait inability, Headache, Injected limb mobility decreased, Loss of control of legs
Clinical narrative: Couldn't walk, she had complete loss of muscular control of her legs; Couldn't walk, she had complete loss of muscular control of her legs; Severe headache; Started having massive shaking; Chills; It was very sore to the point that she couldn't move her arm; Arm started getting sore; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in the left deltoid on 27Jan2020 at 10:00 AM at a single dose for immunization in the physician's office. Medical history included multiple sclerosis from Jul2000 and ongoing, autoimmune hepatitis from 2001 to an unknown date, the patient stated that the autoimmune hepatitis had been stable and inactive for 17 years. There were no concomitant medications. The patient had no relevant family medical history and did not receive any prior vaccination four weeks prior to the first administration date of the suspect vaccine.  The patient thought she had received a PREVNAR 13 injection before but the doctor didn't have a record of it. She thought she had gotten one 4 years ago at a pharmacy but she wasn't for sure and she doesn't have any records to check. e patient knew she received a pneumococcal vaccine polysacch 23v (PNEUMOVAX) many years ago for immunization but she was not sure about the PREVNAR 13. The patient received the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine on Monday, 27Jan2020, at 10:00 AM and she knew her arm would be sore and it started getting sore at 3:30 PM that day and it was very sore to the point that she couldn't move her arm at 5:30 PM. She stated that at 5:30 PM she started having massive shaking and chills. She stated the shaking and chills stopped that same day at 10:00 PM. She stated at 8:00 PM she couldn't walk and had lost complete muscular control of her legs. Then patient stated that went on until 2:00 AM and she woke up and was able to walk a little with assistance. At 6:00 AM the morning following the injection (28Jan2020), she was about to walk independently but not as well as her baseline. She stated it took like 2 days to get to the point where she was feeling completely better. She stated she had several auto immune disorders but she says her doctor looked it up and could not see where it was contraindicated for her in anyway. She stated that she would say recovered completely from not being able to walk but she has multiple sclerosis so her walking was affected some by that but she says now she was back to her baseline. Her doctor said it was a severe reaction. She didn't go to the hospital because she thought it was a reaction and would get better with time and treatment. She took BENADRYL and Ibuprofen. Another thing she had was a severe headache that started about 8:00 PM the same day as the injection. She cannot remember what time that resolved but it was sometime after midnight so the date would have been the 28Jan2020. The reporter considered the seriousness of her inability to walk was disabling because her husband had to carry her. She stated that the shaking and chills was medically significant. She says the soreness of her arm and the headache she was not sure about. She stated it was just more than what she anticipated. She had no idea if her medical conditions were relevant and her doctor didn't have any idea either. She stated he looked through the stuff and did not find any contraindications. The adverse events did not require a visit to the emergency room and physician's office. The patient recovered from the events of shaking and chills on 27Jan2020 at 10:00 PM; recovered from the events of "Couldn't walk, she had complete loss of muscular control of her legs" and severe headache on 28Jan2020 and recovered from the events of arm started getting sore and it was very sore to the point that she couldn't move her arm on 30Jan2020.  The reporter considered the events of arm started getting sore, couldn't move her arm, started having massive shaking; couldn't walk, she had complete loss of muscular control of her legs and severe headache as related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein).  The information on the batch/lot number has been requested.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of massive shaking and chills complicated by loss muscle control leading to inability to walk cannot be fully excluded, considering the apparent temporal association.  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.