Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence, Weight, Weight decreased, White blood cell count
Clinical narrative: pain with bowel movements; lack of appetite; lost 25 pounds; white blood cells being elevated; pain in hip and knees; platelets were a little high; low iron reserves; wants to go to sleep; Bone pain; Chills; Low grade fever; Migraine; headaches; lightly sore arm/pain in her legs; slept extra; lightly sore arm/pain in her legs; This is a spontaneous report from a contactable Nurse (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided),via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:15 (at age of 70 years old) as single dose for COVID-19 immunization. Medical History included: IBS Diagnosed over 20 years before, Arthritis From 1992, Asthma From 1980, Diabetes Diagnosed in 1995 or 1999, something like that, allergy to latex. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 03Mar2021 (at 70 years old) at single dose for COVID-19 immunization; The patient had a Flu vaccine and the pharmacist put the needle through the Band-Aid to give it her. The caller then developed a red spot at the injection. She thinks it was because there was latex in the bandage and she is allergic to latex. The patient underwent lab tests and procedures which included body temperature: 100 on unknown date, low grade fever on 04Apr2021, strep throat test: negative on 01Apr2021, Platelet count: a little bit high on 26Apr2021, COVID-19 virus test: negative on 04Apr2021, negative on 07Apr2021, negative on 24Apr2021, White blood cells: being elevated on unknown date, 13.7 on 24Apr2021, weight on unknown date: lost 25 pounds. Patient had Migraine From 03Apr2021, Reporter seriousness for Migraine was Disabling. Low grade fever from 04Apr2021, Reporter seriousness for Low grade fever was Medically significant, Disabling, Bone pain from 05Apr2021, Reporter seriousness for Bone pain was Disabling, pain with bowel movements From Unknown, seriousness for pain with bowel movements was Disabling, Chills From 04Apr2021, Reporter seriousness for Chills was Disabling, lack of appetite From Unknown, Reporter seriousness for lack of appetite was Medically significant, lightly sore arm from 25Mar2021, Reporter seriousness for lightly sore arm was Not serious, wants to go to sleep From: 05Apr2021, Reporter seriousness for wants to go to sleep was Unspecified. The caller is calling to report her side effects on the Pfizer COVID vaccine, the second dose. The caller received her second dose of the Pfizer COVID vaccine on 24Mar2021 and she had a lightly sore arm with a dull ache and pain the first day and that next day, it responded well to Tylenol. 9 days later (03Apr2021), the caller had a migraine with aura for 2 days and she hasn't had a migraine in 20 years. The highest it got was 99.9 axillary. Caller clarified that she had chills and bone pain- on unknown date pain in her legs, hip and knees. The caller was burning up but also freezing at the same time. All of this lasted for about 4 days and then went away. 9 days later, all of this started again so she went to see the doctor on Saturday, 24Apr2021. The caller was told to come back on Monday, 26Apr2021, and she had blood work done: Her platelets were a little high and they said it was low iron reserves. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. The caller's bone pain is in her knees, back, and lower pelvis in the groin area. This is still going on. The caller has lost 25 pounds because of her lack of appetite (both on unknown date, medically significant). The caller mentions that she usually runs a subnormal temperature so her low grade fevers are scaring her. The caller wanted to make sure these symptoms weren't a reaction to the vaccine. Something is going on with the caller, with her white blood cells being elevated on unknown date. The patient slept extra on 25Mar2021. The migraine went away, but she has had headaches (03Apr2021) every now and then with these aches and pains. This is debilitating and really depressing. The bone pain is deep and severe and her bones hurt, its really effecting the quality of her life. Right now she is having pain in the hips and groin area and the bone area, but she is not having fever right now. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot: BLV2169 or 8LV2169, she is not sure, unknown NDC. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller had to stop her blood thinner to take the ibuprofen. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot BLV2169 or 8LV2169. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. NDC, lot, and expiry not provided for Cefdinir. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. Caller stated she already spoke to the safety department but did not have any reference number to provide. Caller Stated she received the second Pfizer COVID vaccine and wanted to know if similar side effect were reported of what she is experiencing and the length of time. She received her second dose on 24Mar2021 and from 03Apr2021 she is having Migraine headaches, On 04Apr2021 she had fever and chills. they resolved and stated again 9 days later. She tested negative for COVID. Has really bad "bone pain" loosing weight, no appetite, pain is still there. her white cells count is 13.7 (24Apr2021), she is getting antibiotics. her side effects are intermittent. The caller's temperature was 100 and her son had strep throat so she went to the urgent care and got tested for strep. The Nurse Practitioner there said she had typical side effects from the vaccine. Physician office visit for all events. Treatment received for event Migraine, Low grade fever, Bone pain, pain with bowel movements, Pain in extremity, headaches, Platelet count increased, Iron deficiency. The outcome of the event Migraine was recovered on 04Apr2021, Bone pain was recovered in 2021, lightly sore arm/pain in her legs recovered on 26Mar2021, pain in hip and knees was recovered on unknown date, lack of appetite, lost 25 pounds was recovering, for Low grade fever, wants to go to sleep, slept extra, Chills, pain with bowel movements was not recovered, for other events was unknown. Event relatedness: Pfizer covid vaccine with lightly sore arm was Related, with pain with bowel movements was Unknown, with lack of appetite was Related.  information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug.  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.