Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Chest discomfort, HIV test, Inflammatory marker increased
Clinical narrative: tingling around his clavicle and extreme weakness; inflammatory markers were up to 400; tingling around his clavicle and extreme weakness; severe neuropathy; On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine; On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine; Sedimentation rate increased; couldn't do anything- couldn't boost himself up in the bed; got weaker as the week progressed and by Friday he was extremely weak; discomfort around the upper chest around the clavicle; vasculitis; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6208) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 11:15 as DOSE 1, SINGLE (at the age of 69-years-old) for covid-19 immunisation; Covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), via an unspecified route of administration from 30Jul2021 (Batch/Lot number was not reported) to 30Jul2021, at DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included diabetes mellitus, blood pressure measurement, hypertension. The patient's concomitant medications were not reported. The patient experienced tingling around his clavicle and extreme weakness and was subsequently hospitalized for 13 days from 20Mar2021 to 01Apr2021. Patient reported that no one could tell him how to proceed, whether to get the 2nd dose of the Pfizer product or not. Patient reported not receiving any recommendations, but his doctor told him, "if you insist on getting it, don't get a mRNA-based vaccine" and there were some physicians who told him "given that you have IVIG you probably have enough antibodies" and other doctors saying "if the IVIG was higher prior to getting vaccinated, it might not have given you any benefit". The patient received the Johnson & Johnson Covid19 vaccine on 30Jul2021, having decided on his own. Patient was looking for guidance on how to proceed moving forward, especially with "booster's being recommended". Patient wanted to know how protected he might be having gotten one dose of the Pfizer Covid19 vaccine and one dose of the Johnson & Johnson Covid19 vaccine? Patient stated "I trusted the Pfizer more than any other, which is why I took that" and "I think I'll just stick with J&J. It appears I can take that without side effects. It remains a viable option for me." stating he'd wait for their guidance regarding booster doses. The patient was admitted as an inpatient for 13 days and diagnosed with severe neuropathy from the vaccine. The patient's inflammatory markers were up to 400. The patient was told not to get a second dose of the Pfizer covid vaccine. On the 30Jul2021 the patient got the Johnson and Johnson covid vaccine because no one could tell him when he cold get his second dose. The patient was now wondering how protected he is? Should the patient get the Pfizer covid booster vaccine? The patient started having symptoms on 13Mar2021 but they were never severe. On 15Mar2021 the symptoms the patient had was discomfort around the upper chest around the clavicle, but patient didn't have any pain. On 15Mar2021 the patient PCP diagnosed him with vasculitis and prescribed prednisone. The patient got weaker as the week progressed and by Friday he was extremely weak. The patient's PCP told him to go to the emergency room. The patient went to the emergency room on 20Mar2021 and the providers saw his sedimentation rate was 400 and they admitted him. The other marker they checked was 297, but the patient did not know the name of it. The neuropathy got worse and he could move his limbs but couldn't do anything- couldn't boost himself up in the bed. The patient could feed himself but not get up. The patient was incorrectly diagnosed with vasculitis by his PCP when the weakness was actually severe neuropathy. The outcome of the event severe neuropathy was not resolved and outcome of other events was unknown.  Investigation: On 09Aug2021 the caller got his sedimentation rate checked and it was below 20. The caller was tested in the hospital for everything imaginable because they were looking for any kind of underlying disorders. The caller was tested for HIV and syphilis and was negative. They even considered ALS, Guillian Barre, or a tick borne disease. They found nothing and everything was negative. The last 5 days of the hospitalization the caller had IVIG administered. But the caller was already improving prior to the IVIG, he measured his improvement based on if he could boost himself up in bed. The caller got 5 days worth of the IVIG. Result: 400. The infectious disease doctor had talked to the Pfizer nurse who passed on her their observation of what is going on when the caller was in the hospital. Communication: PC filed. The caller was provided with phone number, option 3, and hours of operation of Monday through Friday, 8AM to 8PM EST, prior to warm transfer to withheld: INT-#. Description of Product Complaint: The caller had the first dose of the Pfizer covid vaccine on 11Mar2021. The caller was told not to get a second dose of the Pfizer covid vaccine. On the 30Jul2021 the caller got the Johnson and Johnson covid vaccine because no one could tell him when he cold get his second dose. The caller is now wondering how protected he is? Should the caller get the Pfizer covid booster vaccine? Pfizer covid vaccine lot EN6208, NDC and expiration date unknown.  No follow-up attempts are needed. No further information is expected.