Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Throat irritation, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: she has a tennis ball size knot in her arm; headaches; lightheadedness; she has also been coughing up yellow and green liquid; scratchy throat; she still has stiffness in her neck; swelling she has had at the injection site; arm swollen from the base of her neck down to her elbow on her left arm; she was in pain the entire day; Injection site pain with redness; tiredness; injection site pain; muscle pain; she only felt warm/hot at area of injection; red in the injection arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 22Jun2021 at 10:00 (at the age of 46-year-old) as a single dose for covid-19 immunisation at other facility. The patient medical history included gastric Bypass Surgery from 2019 to an unknown date (she had herself checked because she did have bariatric surgery in 2019 and she has to do a checkup). Concomitant medications included ibuprofen (ADVIL) (Expiration Date: 19May2021). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot number: EW0121, Expiration Date: unknown), administered in left Arm on 01Jun2021 at 10:30 as a single dose for COVID-19 immunization and experienced pain at the injection site and sore arm (that went away in 2 days). The patient previously received Pneumonia vaccine and Flu Vaccine for immunization and experienced flu and pneumonia (stated she was hospitalized after receiving the vaccines. NDC, Lot, Expiration: Unknown. She does not get sick with the flu unless she takes a flu vaccine, and she does not get pneumonia unless she gets a pneumonia vaccine, she got this vaccine and now she is sick, she will not do a vaccine ever again). Patient did not administer additional vaccines on Same Date of the Pfizer Suspect. Patient did not receive any prior Vaccinations (within 4 weeks). Patient did not have family medical history relevant to adverse events (no one she knows of had a reaction). Patient received second dose on 22Jun2021 and reports tiredness, injection site pain/with redness and felt warm/hot at area of injection, muscle pain, scratchy throat, swollen and red in the injection arm, also with now a tennis ball size lump there along with headaches and migraine, light headedness and coughing up green and yellow liquid (she does have sinus issues so she was not attributing it all to the vaccine, but she usually has a tan color, and this was yellow and green). She said that she also get the flu and Pneumonia after receiving those vaccines and she had a green and yellow like mucous, the next morning (23Jun2021) noticed swelling from the base of her neck to the elbow/ arm swollen from the base of her neck down to her elbow on her left arm on the side the injection was given, also states unable to turn her head to the left all the way/ Stiffness in neck cannot turn her neck to the left, turns entire body around to look. She has read some of these symptoms on the paper but not all and would like to know what to do. On 24Jun2021, the patient had tennis ball size knot in her arm, warm to the touch. Patient was upset that she has to consult her doctor in order to get help and that is where this is where this was faulting, that is where she felt like maybe she has been injected with something to track her and all these other things are flooding through my mind as to it relates as to why it was so important for us to get a vaccine, was not having that at first but now she was thinking that and she did not want her daughter to get it, completely blind and has to go to school to be educated, not comfort, but they decided to take it as a family. She was calling because she took her second shot on Tuesday morning and she was in pain the entire day and then she woke up the very next day with her arm swollen from the base of her neck down to her elbow on her left arm and now the swelling partially has gone down, but she has a tennis ball size knot in her arm. She stated the only way she got the swelling to go down was by taking Ibuprofen and a muscle relaxer. Patient stated on top of that, she has headaches, lightheadedness and she is now on day 4 after the vaccine. She stated she was coughing up yellow and green liquid and she does have sinus issues so she is not attributing it all to the vaccine, but she usually has a tan color, and this is yellow and green. She wants to report this because she does not know what she is supposed to do, especially after the second shot. Patient stated the symptoms they list, she has had some, but she has not had joint pain, she has had tiredness, injection site pain and muscle pain, but no joint pain, no chills, no fever, and she only felt warm/hot at area of injection. The swelling she has had at the injection site with swelling and redness, her arm was noticeably swollen, she was heavy set but if she would have shown her arm on Wednesday, it was obviously swollen. She has had no nausea, but she does have a scratchy throat. Patient enquired if is this normal or is she supposed to feeling this way. She stated if not, she needs something to be done. She states she is not one that does well with vaccines and after getting the flu and pneumonia vaccines before, she has been hospitalized. She does not know if she needs to go to the ER. Flu and Pneumonia Vaccines: NDC, Lot, Expiration: Unknown. After her first dose, she had pain at the injection site and so did her entire family, but they had that pain for 2 days and then it went away. She still has stiffness in her neck, the tennis ball knot in her arm, she is still tired but functionable, headaches but does not feel like a migraine like the last 2 days. The only thing that has recovered is the swelling, well she does not have as much swelling, just the tennis ball size knot. Yesterday morning the swelling was gone but the knot is still there and it is warm to the touch and had stiffness in her neck and she cannot turn her neck to the left, she turns her entire body around to look. Patient received Treatment: Ibuprofen and Muscle Relaxer, she only took it once yesterday because the pain was so bad. and could bear it on Wednesday but Thursday it was too bad, she had an old muscle relaxer from a couple of years ago that she had in the closet and so she took one of those and 2 Advil/Ibuprofen 400mg and the 5mg muscle relaxer. She took that and it put her to sleep and that helped with some of the pain. Advil/Ibuprofen: UPC, Lot, Expiration: Advil 250mg coated. 49035-604-85 Expires: 19May2021. Muscle Relaxer: Adverse Event, took a muscle relaxer from a few years ago that was prescribed for something else. Cyclobenzaprine 5mg; NDC, Lot, Expiration: Unknown, Pharmacy Bottle. Date filled: 26Oct2019 discard after Oct2020. Patient stated that she does not do well with vaccines but she could not stomach giving her daughter a vaccine that she would not take, now she feels she should not have taken it and just kept taking her natural immune boosters and vitamins because she did fine. She was around people that had Covid 19 and she has been around lots of people and traveled and was fine. She would not have taken that vaccine. Her vitals and blood work and everything were tested, and the only thing she needs more of Iron and Vitamin D. The only tests that came back that she needed to be aware of and do something about, outside of that nothing. States she was going to the doctor to get an iron infusion. Patient did not visit emergency room and physician Office for the events. She looked on the sheet and most of her side effects were on there, so she thought this is normal. She looked at the swelling on her arm and neck and thought this is just temporary and she took a muscle relaxer, used ice, heat pad, and thought she would see how that works. There was no investigation assessment and no relevant tests. The outcome of events arm swollen from the base of her neck down to her elbow on her left arm/swelling she has had at the injection site was recovered on 24Jun2021, recovering for headaches and rest of the event was not recovered.  Follow-up attempts are completed. No further information is expected.