Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crying, Headache, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Headache; pain in all of the muscles in her legs; tingling feeling in her calves; will then feel like someone is holding her ankles; will feel like someone hit her in he knees; It is in her hands too; It is debilitating and she wants to cry; First dose on 31Mar2021 and 2nd dose on 11Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101068541 (Pfizer).  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021, outcome "unknown", described as "First dose on 31Mar2021 and 2nd dose on 11Aug2021"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in all of the muscles in her legs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling feeling in her calves"; ARTHRALGIA (non-serious), outcome "unknown", described as "will then feel like someone is holding her ankles"; ARTHRALGIA (non-serious), outcome "unknown", described as "will feel like someone hit her in he knees"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It is in her hands too"; CRYING (non-serious), outcome "unknown", described as "It is debilitating and she wants to cry". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received her first dose of the vaccine on 31Mar2021. Reporter seriousness for her first dose of the vaccine on 31Mar2021 was unspecified. Patient reported she was not making excuses for herself, but at the time she was due for her second dose, the Johnson and Johnson version of the vaccine was being recalled and it made her fearful. Patient stated on Thursday she would be 50 days out from when she got her first dose of the product and she knows there is a 28-day recommendation with a 42-day extended window, to get the second dose of the product, but she was wondering if Pfizer has any efficacy data on if a patient gets the second dose 50 days after the first dose. Patient declined to provide address or email address. On 18May2021 at 8:04 to confirm inquiry was for Pfizer BioNtech covid vaccine. Patient stated it was 48 days and had passed the window for the 2nd dose. Patient was due for the 2nd one and they were recalling the J&J and were recalling it for the blood clots don't know where to go, patient told she did not want to take the vaccine if she don't get the benefit from it. Patient got nervous and told she was only a week out so maybe it would still be beneficial. Reporter stated a month ago she had taken a spike protein antibody test, in which she went ahead and performed the test again just to saw where her antibodies were. Patient told the first test ordered by her doctor and performed through Lab was SARSCOV2 AB (IGG Spike Semi-QN) with a reference range of anything above 1. Caller stated her results were 1.62 for that test. Patient told a month and a day later she repeated an antibody test called SARSCOV2 AB Total Spike Semi QN in which the results were "dramatically different" at 62.8. Patient did not provide a reference range for that test nor did she stated anything about receiving a negative antibody test. Patient asked for clarification on the difference between the total spike antibody test and the IGG antibody test that she had performed. Patient reported that she took her second dose 11Aug2021 and said that she had a mild headache for 2 days, but said that a week or so later she had pain in all of the muscles in her legs from her thighs and down to her ankles. She said that she had a tingling feeling in her calves and then felt like someone was holding her ankles. She said that it moved around. She said that it felt like someone hit her in her knees. It was in her hands too. It was debilitating and she wanted to cry. She said that she wanted some comfort that it will go away. Patient looked for information on how long that should last. Dates for all events were unspecified by the reporter. Reason for no lot number of Covid-19 Vaccine was reported as unwillingness of patient to complete the report. Patient declined emails and also declined to complete a safety report.  This case was considered as invalid as there was no indication that the patient experienced an event under suspect BNT162B2. Follow-up (07Sep2021): The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Sep2021, this case now contains all required information to be considered valid.  Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.