Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Fatigue, Malaise, Muscle spasms, Muscle tightness
Clinical narrative: muscle aches and spasms; muscle aches and spasms/she was having muscle pain, just a burning pain; having body aches; epigastric pain; not feeling well; Fatigued; diarrhea; nausea; vomiting; Anxiety; Weak; Voice is raspy from the nausea; muscles feel so tight; sciatica; feels really heavy; This is a spontaneous report from a contactable nurse (patient).  A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169; Expiration Date: 31Aug2021), in Arm Left on 23Jun2021 at 07:30 (at 49 years) at single dose for covid-19 immunisation. Medical history included ongoing depression (diagnosed about 3 months before maybe before that, she just hadn't taken anything. Patient reported that if she had to really say, she would say that she's had depression for 3 years since she lost her father; she had done counseling but this was first time she had asked for anything), anaphylactic reaction to meloxicam (MOBIC) in 2017. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for depression from 21May2021 to Jun2021. On 24Jun2021 patient started having body aches, epigastric pain, not feeling well, fatigued, Diarrhea, nausea and vomiting.From Jun2021 Anxiety, Weak and voice was raspy from the nausea, muscles felt tight, sciatica and felt really heavy.On 26Jun2021, she had spasms and muscle aches . All events required Physician Office and were serious as medically significant. Clinical course was reported as follows: patient took her first of the vaccine on 23Jun2021.Ever since taking the vaccine, by 24Jun2021, she was starting to feel body aches, epigastric pain, and was not feeling well. She did a tele-visit on 25Jun2021 and on 26Jun2021 with her health care provider. On 26Jun2021, she was having spasms and her muscles were just hurting/ muscles were just on fire. Patient reported that she was completely out of commission on 26Jun2021. She reported that it was her and her 10 year old. She did the tele-visit because she couldn't get herself in the car and wasn't going to call an ambulance and scare her 10 year old.She has not felt fine since then. She has felt fatigued, weak, and achy, but she did not have a fever. Her physician called in Nexium and Pepcid AC over the counter for her epigastric and abdominal pain. Then she got steroids and Ibuprofen 800 for body aches.Patient reported that for the muscle spasms, she told her health care provider that she had a muscle relaxer. She reported that the muscle relaxer was old and it made her feel loopy. Patient reported that the muscle relaxer she took was Flexeril 5 mg (manufacturer Qualitest). Patient reported that she wanted a steroid because she was having muscle pain, just a burning pain. Patient reported that her health care provider did call in a Medrol Dosepak, too. She stated that she felt completely, if this is what Covid feels like, she's feeling it. She reported that this whole time she's gone without being sick at all, and she's been out working and everything. Patient reported that she was so terrified, she didn't want to get this again and she didn't want to get the second dose of the Covid-19 vaccine. Patient reported that she was still nauseous. Patient reported that the body aches and muscle spasms were not constant any more. On 28Jun2021, was the first day that she could get up and do research to see who she needed to call and research for these things. On  26Jun2021 she couldn't do anything and on 27Jun2021, she started to get up and kind of tried to do some stretches. She can't explain it, her muscles felt so tight and she's just trying to move around a little more. On 28Jun2021 she going to call her physician as she didn't feel well enough to drive there. Patient informed her physician that the muscle spasms felt like sciatica. It was a shooting pain on the left side where she got the Covid-19 vaccine injection. She was really scared. The muscle spasms have stayed the same; she felt really heavy, very heavy, and was making herself move. Patient reported that she felt more awake on 28Jun2021. Patient reported that the pain was so bad, and this was not her, not her at all, that she was hollering like she couldn't stand it. Patient reported that once she did the tele-visit and got ice on board and tried to numb the left side, it felt like she could tolerate more.She reported that she's sure that anxiousness got the best of her, but she has never experienced anything like that before. She had not done anything different other than she got the Covid-19 vaccine. Even her voice was raspy from the nausea. On 28Jun2021 she felt like she's more awake. The pain was not constant, it's intermittent. She felt like she's gotten past the worst of it, the worst part of it. She felt like that for sure, but the anxiety that it's given her to not know what the heck just happened to her, will this happen again, will it be long term - all these things that she's feared for a year were here. She inquired what she needed to do to make sure that she never has to get the Covid-19 vaccine injection again. Patient stated that she didn't want to feel this way again, she didn't want to feel worse after the second dose, and as a hospital employee they're going to make her get the second dose of the Covid-19 vaccine if she can't get any documentation. Patient reported that she thought that on 26Jun2021 when it all came to a head, it was bad. Caller reported that she was on the floor on 26Jun2021, was up more on 27Jun2021, and on 28Jun2021, she's up. She did have a moment where she felt that her side effects were medically significant, but she's past that. Patient wished she could have gotten to the emergency room on 27Jun2021, but with the tele-visit her health care provider only called in the prescriptions. Outcome of body aches, spasms was not recovered; Outcome of not feeling well, muscle aches/ burning pain, Voice is raspy from the nausea, , muscles feel so tight, sciatica and feels really heavy was unknown;Outcome of the other events was recovering.Events Body aches, Fatigued, Weak, Diarrhea, nausea and vomiting , abdominal pain upper, anxiety,asthenia,muscle spasm and voice is raspy from the nausea  were reported as related to the vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pain (body aches), abdominal pain, malaise, fatigue, diarrhoea, nausea, vomiting, anxiety, weakness, dysphonia, sciatica, discomfort, muscle spasm, myalgia and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.