Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: Very overtired, from first vaccine; This is a spontaneous report from a contactable consumer (mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number EW0169 and expiry date was not reported), dose 1, via an unspecified route of administration, administered in right arm (right shoulder) on 18Apr2021 at 12:00 PM hours as DOSE 1, SINGLE (at the age of 17-years-old) for COVID-19 immunisation. The patient family history includes withheld carries gene for Hashimotos (tested b/c of father history of disease) but withheld currently has no thyroid disorder. Concomitant medication included loratadine (CLARITIN [LORATADINE]) taken for heat allergy from Aug2018 and ongoing; drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for control menstrual cramps from Feb2021 to Jul2021. The patient was very overtired, from first vaccine from18 Apr 2021 To 20 Apr2021. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot number: EW0186), via an unspecified route of administration administered on deltoid right (right shoulder) on 16May2021 at 09:00 AM hours as DOSE 2, SINGLE (at the age of 17-years-old) for COVID-19 immunisation administered in school/student health clinic. 2 months after they reported to VAERS as 2 in half weeks after getting the vaccine got symptoms of headache, tachycardia, dizziness and felt horrible. She was diagnosed with POTS (postural orthostatic tachycardia syndrome). Her symptoms have been debilitating at times. Asking whether Pfizer has any reports on this in younger people after getting the vaccine. Stated that no medication was working very well as they were trying to treat these symptoms. Asking whether symptoms will worsen if the patient gets COVID because she responded this way to the vaccine. Also, information on booster shot for people with POTS. Asking where she could see more information about clinical trial. Stated that non information has Pfizer has provided from the life changing event that her daughter was experiencing was appalling. The reporter was calling about the Pfizer vaccine, reclarified as the Pfizer Covid vaccine, was calling about her daughter, who got the second dose of vaccine. The reporter stated 4 weeks, her daughter woke up on 11Jun2021 with a severe headache and ended up in the emergency room. The patient was also passing out and felt like a light switch went off and was hospitalized. The patient has no prior medical history and has seen a series of doctors and she, herself, was feeling desperate. The patient was later diagnosed with POTS (postural orthostatic tachycardia syndrome). The patient also had dizziness and tachycardia, was followed by a cardiologist and a neurologist. The reporter was calling various institutions, could not get an appointment for 14 months, because they were inundated with post vaccine injury cases and post COVID cases of POTS. The patient was a national level swimmer, saw a doctor, who assumed the patient had a migraine, and started her on medication, which had no effect. Specifics identified later in report. The reporter stated that the patient had dizziness, and the room was spinning, had an MRI (Magnetic resonance imaging), which was normal. The patient was referred to a neurologist, was diagnosed with POTS by neurologist on 21Jul2021. The patient did see a cardiologist, who did various tests, and she was ruled out for myocarditis, and all the tests came back normal. The patient still has tachycardia, was constantly dizzy, her heart rate will go from 50 to 100 without warning and feels like she was going to pass out. The patient feels horrible and can't really function. The reporter stated that her husband was in the medical field, and she does understand that reactions and POTS can occur. The reporter was looking for any studies that can provide information, was looking for information, to find out how she can understand any data on POTS and the vaccines, what the findings were, or whether she can be directed to any studies that were being done. The reporter stated that her daughter's life has changed overnight. The reporter was just trying to get information. The patient was on medications to treat some of the symptoms, but they did not work. The reporter stated that another reason for reaching out today to Pfizer, was she understands the recent FDA decision to provide boosters to certain population and stated no one truly knew the data well enough to know how the vaccines, affect children. The reporter stated that before they put another vaccine into her daughter's arm, the patient has gotten a medical exemption, because of the way the patient responded to the Covid vaccine. The reporter queried because of the reactions; will her patient have worsened symptoms if she contracts COVID. The patient did not have any issues prior to the vaccination. The reporter clarified from earlier in call that the doctors tried the patient on a two-medication trial for headache. First medication was a migraine medication that did not work. The medication should have worked quickly if the patient truly had a migraine. The reporter does not know the name of the medication. The reporter stated that the doctor determined quickly that her daughter did not have a traditional migraine. Second medication was Gabapentin, with titrating dose of 100mg for 3 days, 200mg for 3 days, 300mg for 3 days. The reporter stated that this medication did not work. The reporter stated her daughter had a reaction and it actually made her headaches worse and felt more dizzy. The reporter stated she went through all the medications that they were not using and disposed of any medications not used. The reporter stated later that after the second vaccine, the patient had chills on 16May2021 at 20:00 hours, and lymph node swelling in armpit on the same day. The reporter thinks left armpit, and she thinks, left breast enlargement (probably in the morning) on 17May2021. The reporter stated it was on the same side as vaccine but cannot remember whether it was on the left or right side. The reporter understood the risks and common side effects. The development of POTS triggers in her system. She said when it was in the percentage it was lifechanging. The patient developed tachycardia; debilitating dizziness; headaches that were excruciating; even had an MRI (Magnetic resonance imaging) done and she did not have a brain tumor. There were severe symptoms. She said they were a drug company they were collecting data all the time. They were compiling information; someone she spoke with before said they were seeing clusters of symptoms, but they were not calling it POTS. She has tachycardia, fatigue, and headaches. They were not getting diagnosed. She knew they have this. She wanted to know the ideology of this going forward. She wanted to know whether her daughter gets a booster; both cardiologist and neurologist said not to. They were looking for medications. She was on 2 cardiac meds that were not helping. What were they seeing in POTS diagnosis, whether there was a study. They were being followed by people and were taking the information. She did not know whether it was going to be compiled. It was frustrating. The drug company have got studies and investigators. They were acting like nothing was going on. Other have a POTS clinic and it was inundated with post COVID POTS and vaccine related POTS. It was incredibly frustrating. Where can she be followed? She was frantically looking for help. NIH has been more helpful. They gave her specific information on places that were studying this and who to contact. The CDC does nothing: they say report an adverse event and look for studies. The website: Pfizer vaccine/research: that website does not give you contact person. She and her husband were not antivaxxers. They were grateful for the company, but there has to be moral responsibility. It was not being talked about. When it was presented, you were sent through these dead-end holes. If it was the president's child experiencing this, they would be doing everything to help. She wanted useful information. She knew that was not their fault. The reporter was upset there was not more information Pfizer MI could present. She was upset that they were collecting this information, but it was not available, was not being talked about. Upon follow-up, the reporter stated that the patient was diagnosed with POTS three weeks post second COVID vaccine. The patient was previously healthy with no significant medical history. The symptoms were severe headaches, dizziness, and tachycardia. The reporter has a case number from VAERS, and also Pfizer gave a case number and told to look into the study that was being conducted. The reporter queries whether there was someone to speak to about the patient or whether there was a trial for her, or whether Pfizer know about these symptoms. Further probing could not be done as reporter was unwilling to further answer the questions and wanted to talk to someone else. Call back was initiated however, it was not successful. Hence, details were unknown and limited information was available over the call. Upon follow up, the reporter stated that the patient was diagnosed with POTS on 11Jun2021 in the morning and visited physician office due to it. The event was considered as serious disability and medically significant and in Jun2021, the patient underwent brain MRI and result was normal. On 03Jul2021, the patient had severe dizziness and tachycardia and visited emergency room due to these events. The patient received treatment for this events, she was placed on multiple med for headache most did not work. Current meds: flounet. 2mg of undecipherable 5 mg 3xs daily. It was reported that patient woke up with whole headache, and they tried advil/Tylenol cambo. After three days they went to the doctors. They thought migraine initially and prescribed medication which didn't touch. Along headache she was extremely dizzy back to md who diagnosed with tachycardia. Referred to neurologist. 03Jul2021, dizziness to tachycardia very bad she went to Er. Ekg performed. Referal to neurologist and cardiologist. Undecipherable were 21Jul2021 and 22Jul2021 respectively. Diagnosed pots, cardiologist did echocardio and 2 weeks later study. All heart studies were normal except significant tachycardia. Meds currently aware undecipherable. Some what helpful, but every day has both dizziness and headache. She did not have these symptoms prior to the second dose of pfizer vaccine. Vaccine was not administered at military facility, The patient had no Prior vaccination. The HCP reported that patient provided information to them regarding the reported averse event(s) with the use of the product and do not consider the pfizer product had a causal effect to the adverse event. And HCP saw for the above complaints but can not certainly correlate it with vaccination. Symptoms started 2 weeks after 2nd dose. Unclear if caused by vaccine. The clinical outcome of the events passing out and fatigue was unknown; outcome of postural orthostatic tachycardia syndrome/symptoms of headache, tachycardia, dizziness and felt horrible was not recovered; outcome of event chills was recovered on 17May2021, and Lymph node swelling in armpit was recovered on an unspecified date in 2021; and the outcome of breast enlargement was recovering. The event outcome for overtired was reported as recovered on 20Apr2021.   No follow-up attempts are possible. No further information is expected.