Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Agitation, Arthralgia, Asthenia, Back pain
Clinical narrative: Severe pain in all of my joints/ all over my joints down to my toes are probably sore; didn't feel good and went to sleep; I have like some nerve pain, started in my, is like tingly; like nervy on my right. I don't know, if it's connected or not on my right arch of my foot,; I just felt 'lack' of any energy; My back feels like every nerve is on fire, there is electricity; my rib and the front of my upper abdomen and all over my joints down to my toes are probably sore; my rib and the front of my upper abdomen and all over my joints down to my toes are probably sore; I am so agitated; Fatigue; My back feels like every nerve is on fire, there is electricity; Severe headache; Stiff neck; This is a spontaneous report from a contactable other health care professional (nurse). A 58-year-old female patient (nurse) received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left upper arm on 07Jul2021 11:00 (at the age of 58-year-old), as Dose 1, single for Covid-19 immunization. Medical history included the patient had shingles a long time ago. Patient did not report any other medical conditions. The patient did not receive any other vaccine in four weeks prior to vaccination. Concomitant medications included Trazodone; Cymbalta; atorvastatin (LIPITOR [ATORVASTATIN]) (referred as generic cholesterol medicine); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and coffea canephora (ZENAC), mild daily. On 07Jul2021 patient had first shot at about 11 o'clock and within hour she just felt lack of any energy and was started getting massive/severe headache and stiff neck, severe pain in all of my joints but also my back feels like every nerve were on fire, there is electricity (serious as medically significant event), the back of her left side of her head and neck and just feeling a lot of fatigue. Patient came home and got in bed, she took two Tylenol 1000 milligrams at 3 o'clock (Intent: treatment) and went to bed and she immediately went to sleep and slept for 4 hours straight. She thought what woke her up like her back was on fire and for some reason, she felt very agitated (patient did not mean to be personally agitated to anybody) that she could not stand it and that was not her. The patient further stated, "severe pain in all of my joints, I can't stand it and that's not me, didn't feel good and went to sleep, all over my joints down to my toes are probably sore; on an unspecified date, she stated that "I have like some nerve pain, started in my, is like tingly, like nervy on my right and she don't know, if it's connected or not on my right arch of my foot". When probed for the permission to ask further questions, Nurse stated, "That's okay because like I said like is it normal and my back is on fire, I just feel very agitated and I don't know why, I just woke up that way. I don't usually feel that way, so I don't mean to be personally agitated to anybody, you see what I mean." When probed for clarification if consumer wants to know the side effects are normal, Nurse stated, "Well, I am just reporting. I don't think, it might be, it might not be. I don't know but I just wanted to report it because in all the literature, it doesn't say anything about it." The patient received treatment for events Headache, stiff neck, nerve pain in back and joints to upper abdomen, fatigue, with Tylenol, 1000 milligrams. Causality for the events "My back feels like a campfire like the nerve endings are electric; it's actually coming around to the like sides of my rib and the front of my upper abdomen and all over my joints down to my toes are fore ably sore; It's feels like nerve pain in my back and then in my joints to my upper abdomen; horribly agitated; 'I have like some nerve pain, started in my, tingly like, nervy on my right. I don't know if it's connected or not. on my right arch of my foot when I just got up and walk. Since I pressure on it'; and Like sides of my rib and the front of my upper abdomen and all over my joints, down to my toes are probably sore', was reported as related by the reporter. The outcome of all events was reported as unknown.  Causality: Nurse stated, "Well, I would say, yeah, because I never had this. Well, I have never. Yeah, that's definitely. I just feel like my joint hurts, my muscle ache, you know, I got that weird. I had shingles a long time ago in my back and that what if feels like shingles pain in my back and then in my rib and then my head, like I said, very, I don't usually have headache and stiff neck so, yeah, I think it's as far as the foot thing. I have no idea (As the Nurse was not sure about this hence not captured in tab) but yeah." Nurse was informed about Pfizer Medical Information and telephone number was shared. ; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of neuralgia and suspect drug bnt162b2 cannot be 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.