Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Fatigue, Feeling of body temperature change, Full blood count
Clinical narrative: difficulty processing information/ attention deficit; Episodic HAs; earaches worst on the left and fullness/left ear pain (ear pain); earaches worst on the left and fullness/left ear pain (ear pain); Mild sore throat; Upper back muscle pain; redness around the bite; redness around the bite; low platelet volume; severe weakness; pain; nearly passed out 2 times/near syncope; Vomited; Some loose bowel movements; Myalgias/ muscle pains; sweating; feeling cold or hot sometimes; 100/60 and then blood pressure would drop and settle at 85-95/60 or low 90s/60s, hypotension; fatigue/very tired in the mornings/Extreme fatigue limiting activities; Dizziness; pain and numbness of left arm/ pain and numbness on my arms and hands; headache; upper back pain; Numbness in left arm where vaccine was injected radiating down to hand/pain and numbness of left arm/numbness on the arms and hands; Chills/body shivering; Low fever; period of rapid heart rate/episode of tachycardia; This is a spontaneous report from a contactable health care professional (patient's husband). A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 21Apr2021 at 16:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 for COVID-19 immunization. It was reported that immediately after being vaccinated, the patient had numbness in the left arm where vaccine was injected radiating down to hand lasting about 24 hours. Also on 21Apr2021, during the first night after vaccination,  chills, body shivering for a half hour. The patient also had low fever (extremely rare for the patient) for a while and a period of rapid heart rate/episode of tachycardia while in bed lasting for 30 (as reported). The patient had hypotension, 80/58. On 22Apr2021, the patient had fatigue, dizziness, pain and numbness on arms and hands sometimes, headache, upper back pain and myalgias. On 23Apr2021, the patient was very ill most of the day. The patient nearly passed out 2 times/near syncope, vomited, some loose bowel movements (unusual for the patient), extreme fatigue limiting activities, muscle pains/myalgias, headaches, numbness, sweating, feeling cold or hot sometimes. The patient's blood pressure dropped to 80/58 (usually 110/ 70). The patient lay flat on kitchen counter to avoid fainting. On 24Apr2021, the patient had fatigue limiting activities, pain, numbness, dizziness and feeling cold or hot sometimes. The patient felt a bump around her right collar bone in the evening which later turned out to be a tick. The patient's BP was measured every day which generally were initially 100/60 and then blood pressure would drop and settle at 85-95/60 or low 90s/60s, hypotension accompanied with severe weakness. On 25Apr2021, the patient had fatigue limiting activities, pain, numbness, dizziness, constant headache and feeling cold or hot sometimes. On 26Apr2021, the patient was nearly feeling normal in the first half of the day. Then severe body fatigue limiting activities, pain, numbness on the arms and hands. The patient was feeling cold or hot, sweaty at times and had persistent headache in the afternoon. The patient also had upper back muscle pain. In evening of 26Apr2021, the tick was noticed and pulled out dry with fingers and tweezers. The tick was not engorged with blood and appeared dry and dead. The patient had some redness around the bite but no target lesion. The patient was administered 200mg of Doxycycline orally. On 27Apr2021, the patient had fatigue, pain, numbness, cold or hot obviously in the first half of the day. Then feeling better (close to normalcy). On 28Apr2021, the patient was feeling much better in the first half of the day. Then, pain, numbness, feeling little cold or hot sometimes and persistent headache. That day and episodically thereafter, the patient noted left ear pain, earaches worst on the left and fullness and mild sore throat. The patient has also complained of difficulty processing information (attention deficit described in the papers) on an unspecified date. On 29Apr2021, there was severe fatigue all day. Pain, numbness, cold or hot sometimes, upper back muscle pain and sweating sometimes. On 30Apr2021 to 02May2021, the patient was very fatigued and was feeling dizzy frequently, activity was limited, a muscle pain, numbness and was cold or hot. The patient went to Urgent Care and was examined. Limited physical exam was normal. They drew blood tests which showed normal CBC on 23 machine differential both on 23Apr2021 and platelets except Low Platelet Volume on an unknown date in 2021, normal electrolytes and anaplasma test, negative blood sear for Babesia and Anaplasma and neg IgM and IgG for Lyme all on an unknown date in 2021. The patient's creatinine, BUN and renal function (fx) was unknown on an unspecified date in 2021. On 03May2021 and 06May the patient had similar symptoms, lasting about half of each day. On 06May2021, the patient had a nasal swab for COVID. On 07May2021 to 09May2021 the patient was very tired in the mornings, dizziness, episodic HAs, limiting activity. The events were partly improved by rest but the patient had constant ear pain mainly on the left side. The reporter stated that he deeper dive into the literature this weekend and came up with lots of papers of which the following publications are of special interest which includes:  1. One case report of Postural Orthostatic Tachycardia Syndrome (POTS) after Pfizer mRNA vaccine  showing that POTS is frequently associated with auto-antibodies to G protein-coupled receptors, particularly norepinephrine receptors, epinephrine receptors and ACE2 receptors. In addition patients have elevations in a number inflammatory cytokines (IL-1beta, IL21, TNFalpha, IFNgamma, CD30) and platelet pool eficiencies (associated with low platelet volumes, dense granules, easy bruising). By the way, one can see dysautonomic disorder like POTS but without the tachycardia. One report described 31 patients with long COVID who had autoantibodies to the G protein coupled receptors with a variety of symptoms which can act as agonists or antagonists and are associated with a variety of syndromes (see their Table 1) with prominent fatigue, dysautonomic syndromes like POTS, neurologic and pain syndromes and cardiovascular syndromes. A potential synthesis is that these auto-antibodies are fairly common after COVID- 19 and perhaps also after other severe viral infections such as mono. Influenza etc which may lead to what we have called ME/CFS. There are a number hypothesis papers that predict that the spike protein-ACE2 receptor complex would elicit auto-Ab to ACE2. Its plausible that COVID-19 vaccines, particularly mRNAs which express spike intracellularly and cause a lot of inflammation also occasionally induce the syndrome. The reporter's question was whether abnormalities should be documented thoroughly including a full COVID-19 work-up for virus and antibody, auto-antibody panel, inflammatory markers, platelet work-up and a dysautonomia work-up. He added that pending the findings, the case should probably be reported. His most important goal is understanding the pathogenesis since that may lead to a logical therapeutic intervention in the event that these symptoms continue for a long time. The outcome of the events episodic HAs, period of rapid heart rate/episode of tachycardia, pain and numbness of left arm/numbness on the arms and hands, Some loose bowel movements, sweating, Mild sore throat,  difficulty processing information/ attention deficit, severe weakness, redness around the bite and low platelet volume was unknown. The outcome of the events numbness in left arm where vaccine was injected radiating down to hand was recovered on Apr2021 and the events Chills/body shivering and low fever recovered on 21Apr2021. The outcome of  the events fatigue/very tired in the mornings/Extreme fatigue limiting activities, Dizziness, upper back pain, headache, nearly passed out 2 times/near syncope, Vomited, Myalgias/ muscle pains, feeling cold or hot sometimes, 100/60 and then blood pressure would drop and settle at 85-95/60 or low 90s/60s, hypotension, pain, Upper back muscle pain and earaches worst on the left and fullness/left ear pain (ear pain) was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event  Heart attack cannot be excluded.  The case will be reassessed if additional information becomes available.  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.