Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Movement disorder, Near death experience, Pain
Clinical narrative: sick; night-fever; clammy; hurting from head to toe/general pain; a red, hot area at her arm at the injection site; a red, hot area at her arm at the injection site; felt like she was going to die/ She felt bad enough she would have gladly died laying in the bed; hurt with movement/ She was in so much pain that she couldn't move; feel bad; She was crying; laid in bed for 2 days; fibromyalgia and has a lot of pain anyway/and if the vaccine hitting them harder; felt like she had the flu; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in left arm on 22Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing fibromyalgia which diagnosed in her 40s, trouble walking and arthritis. The patient had a medical history of fibromyalgia for 30 years and reported having trouble walking and also has a medical history of arthritis who received her first dose of the PFIZER COVID-19 vaccine back on 25Mar2021 and get it in her left arm for covid-19 immunisation. HCP reported that she had mild side effects from the first dose of the Pfizer Covid-19 vaccine, the first vaccine made her feel a little bad. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunisation, the patient received the flu vaccine about 3 weeks ago (in 2021), she just got her regular flu shot in her right arm; hydrocodone taken for fibromyalgia, start and stop date were not reported. HCP reported that after the second dose of the Pfizer Covid-19 vaccine she had complaints of a red, hot area at her arm at the injection site (Apr2021), she had a bad local reaction on just her upper arm. Her arm was red and hot. It was kind of just really a big red splotch. She was not concerned with that, but then she started to feel bad (2021). Her arm started probably 24 hours after the shot, but she wasn't really paying attention to it because she felt so sick (22Apr2021). Her reaction lasted about 2.5 days after the shot. She got a light fever (22Apr2021), and just felt really clammy (22Apr2021). She got really sick that night-fever and clammy, she had the shot that Friday morning, and by that evening she started to feel bad. She felt like she was running a fever that night. It lasted two full days. The third morning afterwards, she got up and didn't feel real good. As that day progressed it was like she kept turning the page. She got to feeling fine like normal that third day. She got to the point where she felt like she had the flu (2021). She was expecting that. The first vaccine made her feel a little bad, but nothing like the second vaccine. The night of the second one she was in bed hurting from head to toe that night (22Apr2021). She basically laid in bed for 2 days (2021). She would move and whimper. She was crying (2021). She was in so much pain that she couldn't move (2021). She was hurt with movement, felt like she was going to die, in general pain but did recover. She had fibromyalgia and had a lot of pain anyway (2021). She had severe pain from fibromyalgia. She didn't know whether there was any information about patients with fibromyalgia, and if the vaccine hitting them harder. She had pain medicine for her fibromyalgia, and she didn't know how she would have survived without it. She had hydrocodone. She felt bad enough she would have gladly died laying in the bed. She wasn't going anywhere. HCP was asking if there was any information about people with fibromyalgia having worsened side effects with the Pfizer Covid-19 vaccine. No investigation assessment. The outcome of a red, hot area at her arm at the injection site; night-fever; clammy; hurting from head to toe/general pain and laid in bed for 2 days was recovered in 2021, of other events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the causal association between the event Near death experience and the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once additional information is 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 RAs, Ethics Committees, and Investigators, as appropriate