Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Muscle spasms, Myalgia
Clinical narrative: Caller states she has COPD, she was recently in the hospital for a flare up.; muscle aches; Spasms/Muscle cramps/Even my breasts were moving. It was contorting. It was in spasm; headache; Anxiety; blood work showed that Magnesium level was little low; Fatigue/Tired; This is a spontaneous report from a contactable Nurse (reported for herself). A 66-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in right arm on 16Feb2021 (at the age of 66-years-old) as Dose 2, Single for COVID-19 immunization. The patient's medical history included ongoing chronic obstructive pulmonary disease COPD (Coded to Chronic obstructive pulmonary disease) and high blood pressure. Concomitant medications were none.The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021),via an unspecified route of administration, administered in right arm on 22Jan2021 (at the age of 66-years-old) as Dose 1, single for COVID-19 immunization. On an unspecified date, the reporter stated that she got spasms. Even her breasts were moving. It was contorting. It was in spasm. Putting on her socks, she got a spasm. It started within 10 days to 2 weeks after the second vaccine. She had normal side effects shortly after the vaccine with headache and fatigue. Then that started to subside. Then the muscle aches started until it got to the point that her hands would contort and twitch. She couldn't put her socks on. It goes through her stomach, back, shoulders, and even her neck. The reporter states that she tried everything, and her doctor said to her there's something definitely wrong. She has COPD, she was recently in the hospital for a flare up. She's having muscle cramps, its been going on since her Covid vaccine, her second one, to the point that she cannot function, it sounds terrible, she can't comb her hair and she couldn't put her sock on the other day and it got pretty bad and her doctor said you need to make Pfizer aware of this. The reporter stated that in the hospital, they had her on with IV drip of magnesium to try and ease the muscle cramps and spasms and they also gave her Valium, which has helped. The reporter states her doctor, her primary care doctor, says they have been through everything to try and nail this down. The reporter states it's debilitating, she can't even roll over at night sometimes in bed. It was in her breast the other night and it was so bad; she could see it moving. The reporter states right now, she's loaded up on Flexeril and valium, and anything to relax the muscle, they gave her so that she could function. The minute she waits for it to wear off, it comes right back, and it doesn't completely go away, there's a buzz to it. The reporter states while speaking, she was experiencing a muscle cramp in one of her legs because she's leaning on it. She didn't have this problem before she got the second shot. Before the second vaccine, it started, she had the normal headache and this and that, but the muscle spasms came on slowly and now they are at a peak where its hard to function. When probed to determine NDC, Lot number or expiry date for the Flexeril and Valium she mentioned earlier in the call, the caller states these medications are dispensed in regular prescription bottles. She clarifies the names of the medications are Diazepam and Baclofen. Baclofen: Reporter reports Baclofen is 10 mg. Reporter states this is the same thing as Flexeril, but it's easier on the stomach. Reporter states she takes it every 8 hours as needed by mouth. Diazepam: She took one last night. Reporter states she takes the medication as needed, but on the bottle it says to take every 8 hours, two tablets by mouth. It also says to not take Xanax with it. Reporter states no LOT or Expiry date. Reporter states the bottle doesn't have all that information. Manufacturer: Mylan. Reporter adds three weeks ago, they put her on Xanax because the anxiety was horrible from it. Magnesium: Reporter states they told her she could continue taking the Magnesium, but they had to cut the dose in half because she was getting diarrhea from it. Reporter states it's just regular Magnesium off the shelf, it's a chelated blend, for sleep support for bone and muscle. Reporter states she was initially taking 200 mg but they cut her back to one a day so now she is taking 100mg once a day by mouth. Reporter provides LOT: 448151B, EXP: Jan2023. Reporter states no NDC or UPC. Reporter states its in a bottle, she sees the barcode, with very little numbers on it, but it doesn't say that.  Reporter states in the hospital, she was on IV, she came home the day before Easter, she had quite a bit of it when she was in the hospital. She clarifies the medications are Baclofen and Diazepam, they are dispensed in pharmacy vials. Baclofen: 10mg; Reporter states this is the same thing as Flexeril, but it's easier on the stomach. Reporter states she takes it every 8 hours as needed by mouth. Lot/Exp: Unknown. Diazepam: 5mg. On the bottle it says every 8 hours, two tablets by mouth. Reporter states but she is not supposed to take Xanax with it. Caller states no LOT or Expiry date. Reporter verifies Baclofen and Diazepam are from the pharmacy and are in prescription bottles. Magnesium: Caller states she was initially taking 200 mg but they cut her back to one a day so now she is taking 100mg once a day by mouth. Reporter provides LOT: 448151B, EXP: Jan2023. Reporter states no NDC or UPC. Reporter states its in a bottle, she sees the barcode, with very little numbers on it, but it doesn't say that. Reporter states in the hospital, she was on IV- she had quite a bit of it when she was in the hospital. The reporter stated, "Yes my doctor has first it started I went in the hospital because I had an attack of the, from the COPD and when I was in there, they did blood work and the blood work showed that Magnesium level was little low and I told the doctors that I had muscle cramps, I told them when I was in the hospital that I was having severe muscle cramps ,and they giving me Magnesium in an IV form and it seemed to help minimally and I was also on IV for, IV prednisone, it was actually a, it was cause my breathing, it is a steroid". The events she has COPD, she was recently in the hospital for a flare up assessed as serious (hospitalization). The patient underwent lab tests and procedures which included investigation: little low on an unspecified date (blood work showed that Magnesium level was little low). Therapeutic measures were taken as a result of events. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.