Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache; swelling at injection site; vomiting; fever; coughing; muscle soreness; wicked nauseous; jerking her body; She had the bathroom problems with her stomach; She was tired; her head was hurting; chills; This is a spontaneous report from a contactable consumer (patient herself). This is the case 1 of 2. A 55-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6208/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 (at 55-years age) as 1st dose, single for covid-19 immunisation. The patient Medical history included cardiac failure congestive from an unspecified date in Nov2020 to an unspecified date (they hospitalized her for, and she had never been hospitalized other than to have a C-section for her beautiful baby), migraine from an unknown date and unknown if ongoing (she got when she was in college at around 20 age but not exactly specified, she has had those for a while but they tried all kinds of medicine that did not work so they did Botox and it worked), asthma from an unknown date and unknown if ongoing (diagnosed 4 or 5 years), immune system disorder from an unknown date and unknown if ongoing, dental operation from an unknown date and unknown if ongoing and surgery from an unknown date and unknown if ongoing. The patient Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE; dose: 25 mg, daily) taken for fluid retention, hypertension, start and stop date were not reported (no high blood pressure seen), vitamin d nos (VITAMIN D NOS; dose: 1000 UNK) taken for an unspecified indication, start and stop date were not reported (it was reported that the doctor did not know if she should take this the week before. No additional details provided), pantoprazole (PANTOPRAZOLE; dose: 40 mg, daily) taken for gastrooesophageal reflux disease, start and stop date were not reported, salbutamol (ALBUTEROL HFA; dose: 90 ug) taken for asthma, start and stop date were not reported, botulinum toxin type a (BOTOX; dose: every 3 months) taken for migraine, start and stop date were not reported (Patient had went to neurologist and they put needle in head, neck, temple, back. No additional information provided; Immunoglobin start and end date not specified) and furosemide (LASIX [FUROSEMIDE]; dose: 20 mg, daily) taken for cardiac failure congestive from an unspecified date in Nov2020 to an unspecified stop date. The patient experienced swelling at injection site, vomiting, fever, coughing, muscle soreness, wicked nauseous, jerking her body, she had the bathroom problems with her stomach, she was tired, her head was hurting, chills on an unspecified date in Mar2021 and headache on 16Mar2021. Patient had taken both vaccinations 3 weeks apart and she had reactions and was looking at paperwork. The reactions said to update. She called the first number to update, and they said they are mailing her a form to update at the CDC/FDA address reporting system and then there is also a number to call Pfizer as well with a telephone number. Most of her side effects were listed and the swelling for bigger day by day. Caller adds that she wants to say she had vomiting on both vaccinations. She has immune deficiency. She threw up the first time, for four days, and thought she ate something bad. For 24 to 48 hours, she threw up again after both vaccines for four days. Physician or primary caller stated she did not give her the actual vaccine. She had not been dealing with her physician and if she gave it to her, then she would give this information but she went to a different location to get the shot. She called 211 because her doctor's office was trying to make her wait a long time. Caller waited to call Pfizer because she was trying to feel better. She forgot to call. She was going to call during her symptoms but pulled out the pages of symptoms and most are normal. She called urgent care and talked to them and they said if she could not stop throwing up or was dehydrated and could not keep anything down then to call back in 24 hours because it could be a stomach bug or anything. She waited it out to get better and finally it did. The headache started immediately, the whole 15 minutes she was waiting. It was worse and worse. She could not wait to leave and take Tylenol. It ended up going away, but it took a while. It was so bad for about a week on both shots. Throwing up, redness and swelling at injection site: first one she had some swelling, it got a lot more red and swelling then at the second. She does not know why it was there and got bigger and bigger. The throwing up started within 48 hours of getting the vaccine. When she went to sleep, it started. She was wicked nauseous and tried not to throw up for hours. She stopped drinking but still threw up even though whatever was in her stomach. She violently threw up for days and could not stop it was horrible. After the first and the second vaccine. Anything she ate her 14-year-old ate too, they had the same meal, they would have both gotten sick from it if it was just a bad meal. It stopped, and she thanked God, but it took 4 days the first time she just kept throwing up and trying to sleep to not throw up. Her son asked if she was okay and wanted drinks, so she put a drink in the freezer to soothe her throat and not throw up. Everything in her stomach came up. The second day, it was more bile no more food left. She stopped drinking the first day and did not want to get dehydrated. She went between water and soda. Her son was worried and wanted to know if she should call the doctor, but she called and they cannot do anything and would rather her not come in if she had symptoms and that if she does not get better to go to the ER. She would sleep, wake up, and grab bucket right away. She did not even make it to the bathroom she was throwing up so violently. Headache, vomiting: It was not projectile across room but every time she would when she was throwing up really bad, going pee. As soon as she woke up, she does not know if it was that she had to throw up, so she woke up. She was tired, her head was hurting. She could not keep medication down. The second day, she realized it was the 3rd morning. She knew if she couldn't keep it down, she would have to go to the emergency room, so she stopped drinking completely and tried not to throw up. Her headache got better, not worse, but the throw up continued. She kept going to sleep. Fever and chills: she did have fever and chills; she does not know if from throwing up. That started the 2nd day after both vaccines, and it happened both times which is why she knows it was the vaccine. Redness and swelling at injection site: the first time, very small amount the size of a dime. The second time dime the day it happened and much sorer, it got bigger and bigger. The size of a nickel, then quarter, then half dollar. Coughing, muscle soreness: She was trying to write down her symptoms but was so sick. She had the bathroom problems with her stomach, coughing but that was from throwing up. Soreness in muscles was like from throwing up and jerking her body. She does not know if it has to do with that or from her body. No additional details provided. Indication: she as immune deficiency, low IgG she is diagnosed with for now. She did not want to catch it and die. She heard discrepancies; she wants her 14-year-old to get it. She wants to live for her 14-year-old. She heard it was approved for 14-year-olds but her 14-year old's primary doctor is not acknowledging this and said over 18, but she heard 16 and over, and then now 12 to 16. Caller wants to know if a 14-year-old can receive the vaccine. Lasix: in Nov2020, they gave her Lasix. She was given 20 mg Lasix. She was in the hospital for Congestive Heart Failure which is fluid build-up around the lungs which was watery tension. She was admitted into the hospital for Thanksgiving. Since hospitalized, she has never had a problem. One pill daily. Hydrochlorothiazide: caller states this may have been from sickness or illness, they gave her this for high blood pressure and water retention. They called it HCTZ or something. Lasix: caller states she was on the generic for Lasix, she took both. The other is called Furosemide 20 mg and she took them both as a fluid pill just the manufacturer changed. She changed it to Lasix 20 mg. They gave generic she guesses. PSCC Communication: medication left as Lasix as caller states this is the one, she was currently taking. Pantoprazole: stomach medicine, interchanged for Protonix. Her stomach gets really upset, they said she had GERD and it bubbles sometimes when she lays down long period of time like at night. When she was throwing up, for a few days, she could not stay down for long. It kept coming up. She would eat saltines, jello, anything. The third day she finally stopped throwing up at night that morning or night on the 4th day she tried to have anything jello, cracker. The threw up day and night. Thank god she is feeling better. Immunoglobin: caller states the last one is for low IgG, immuno deficient. She just found out about this two years ago. She used to get Hyvantera subvQ. Caller confirms spelling and states she thinks that was what it was called. It went into the fat places. Then, they started doing IV. She does not know; she thinks the new one she gets now is called immunoglobin and the nurse comes once a month to do an IV infusion for it. She did get that, approximately week to ten days before the first vaccine. Caller states she can only get it, maybe, she can't remember, every 3 months so she does not have to go for another one. Caller then states she is not sure if she had it before the vaccine, maybe it was after, she cannot remember. Investigations: not but if she does not feel better she is going to see her primary care because she does not know when she sees them, but she gave her something. Treatment: caller states she did see her doctor on 15Apr2021, and she gave her benzonatate 100 mg because she was coughing and it hurt her ribs and she was complaining and can still hear it in her voice. She had a few pills left. Caller adds she was also given a steroid to help her get better. It was not like a flu or stomach bug and the doctor did not think, and they did not know if it was something she ate because they did not have a sample of the food and she did not eat out. The doctor gave her low dose of steroids, she did not want to give her a high dose. It was 7 days after, she said it was okay, 4 mg dose of, what is the name - not a z-pack, a medrol pack. She thinks that is how i is spelled. Medrol pack Prednisone. 4 mg tablets and she does 5, 4, 3, 2, and 1. Caller asks if that dose sounds right. The adverse event, there was no need to visit the emergency room. Also, there was no need to visit the physician office. Prior to vaccination, within 4 weeks the patient had not taken any other vaccines. she told the lady that she had low IgG, so she updated them and they did not say anything was different. They said she could still get the shot and everything. They asked about the Botox and then said as long as it was over a week ago, or seven days ago. The patient underwent lab tests and procedures which included blood immunoglobulin g decreased: low on an unspecified date in 2021. Therapeutic measures were taken as a result of headache and coughing. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.