Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram thorax abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Paralysis
Clinical narrative: Received Prevnar 13 in Oct2018 year and got Guillain Barre; Paralyzed; This is a spontaneous report from a contactable consumer . This consumer reported similar events for five patients. This is 1st of five reports. This female consumer reported for herself that a 48-year-old female patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in Oct2018 (either on the 11Oct2018 or 12Oct2018,  when she was discharged from the hospital) at single dose for immunization, anatomical location of administration was her left shoulder. Medical history included her white blood cell count was over 25,000 in Oct2018, walking pneumonia from Oct2018 and fully recovered in Oct2018.  Family Medical History Relevant to adverse event was none. There were no concomitant medications.  She was in the hospital prior to receiving the pneumococcal 13-val conj vac (dipht crm197 protein) and they didn't know what was wrong and she had been admitted on 09Oct2018 and discharged on 13Oct2018. They administered the vaccine right before she left the hospital. They pumped her with antibiotics in Oct2018 because her white blood cell count was over 25,000. The patient hadn't had a vaccine for probably 13 years. They did a computerized tomogram of her lungs and on 11Oct2019, they found markings on her lungs. They assumed it was walking pneumonia and told her they would be giving her a shot before she left the hospital. Her white blood cells had gone down at that point and they had discharged her. She never had pneumonia before and thought it was just a shot for the pneumonia. About a week later she returned to the hospital in Oct2018 the patient got Guillain Barre syndrome (GBS); This syndrome should be documented on the literature that health care providers receive, and it is not. The patient did not know if she will walk again. In patient's city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair. She was still in a wheelchair. The patient did not see any information on company website about GBS with pneumococcal 13-val conj vac (dipht crm197 protein). She felt this information should be on company website along with statistics. She felt patients should be made aware of this before they take it. She had been paralyzed since Oct2018. She was getting better, but was still in a wheelchair. She was hoping that in about 6 more months she would be recovered, hopefully 100%. She believed the symptoms of the GBS starting after a few days of receiving the pneumococcal 13-val conj vac (dipht crm197 protein). The AEs required a visit to Emergency Room (ER) and she went to the ER four times before being diagnosed with GBS. It wasn't until later that she realized it was a vaccine. When she got to the rehabilitation facility, she told them about receiving the pneumococcal 13-val conj vac (dipht crm197 protein) and they started looking at GBS. The patient stated that sometimes immunization shots and being sick can cause Guillain-Barre Syndrome, but there are no solid answers because the (Agency name) won't say that it caused  it because people have gotten Guillain-Barre from other things. The patient confirmed that she was not speaking of behalf of any patients in particular or any patient that can be identified, she is just speaking in general from information she found on the (Agency name) website and a support group she was in. Treatment included she had gone to rehabilitation twice and will be going for a third time soon because she is trying to walk again. She was in ICU(intensive care unit)  from 20Oct2018 through the beginning of Nov2018, either 04Nov2018 or 09Nov2018. She was then discharged from the ICU and stayed in the regular hospital to make sure there was no regression for a week. She was then discharged from the hospital to a rehabilitation facility in (name), which was at a separate hospital until 07Dec2018. The patient did testing before they gave her the pneumococcal 13-val conj vac (dipht crm197 protein), but she didn't know what those were yet. The patient was fully paralyzed by 21Oct2018 and was receiving intravenous immunoglobulin (IVIG)therapy at that point. The patient did not have the NDC number, lot number, or expiration date to provide for the IVIG. The patient thought she was discharged from the hospital in the afternoon. The patient was stating if she had known it was a vaccine then she would have refused it. The events symptoms noticed within a few days of receiving the vaccine. She has been paralyzed since Oct2018 and was fully paralyzed by 21Oct2018. The relevant tests included other relevant diagnostic and confirmatory test results for events: The patient stated they did 'tons of stuff' for the Guillain-Barre, but she did not have any specific tests or results to provide. She was waiting to receive her medical records.  The patient was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019268993 Same reporter/products/events, different patients;US-PFIZER INC-2019268994 Same reporter/products/events, different patients;US-PFIZER INC-2019268995 Same reporter/products/events, different patients;US-PFIZER INC-2019268996 Same reporter/products/events, different patients