Pfizer

--2 reactions to report: --After the first dose of Pfizer shot, patient experienced shortness of breath immediately after with tight, constricted throat. An hour later reports having severe chills and fatigue which lasted the next 24-36 hours. This then subsided. --After the second dose, patient reports the same respiratory reaction, but this time also had severe pain in the arm at the injection site, along with heat and redness and itch down the arm. 24 hours later patient reports significant swelling in the right breast (patient was being treated for breast cancer with radiation) went to see dermatologist and other doctor to have it examined. They determined that the breast tissue that had radiation is where the reaction occurred. Doctor described seeing several patients on radiation who had the Pfizer shot report the same side effect. Patient reports the inflammation in the breast took several weeks to fade away, estimates 4 weeks. And now still experiences heat and itch in the arm 2.5 months later to this day.

same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, where knee replacements; Pain; pain in her pelvis; Standing up feels weird; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in the left arm on 28-JAN-2021 16:00 as 1stdose, single for covid-19 immunisation. The patient received second dose BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in the left arm on 05-MAR-2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history included ongoing cardiac disorder heart condition , ongoing hypertension high blood pressure , cardiac operation from 25Jan2020 to 25Jan2020 heart surgery , knee arthroplasty from Jan2014 to an unknown date double knee replacement surgery made out of unknown titanium and plastic , office visit from an unknown date and unknown if ongoing foot doctor appointment , biopsy uterus from an unknown date and unknown if ongoing scheduled for a biopsy on her uterus , breast cancer from Sep2020 to an unknown date breast cancer , arthritis from an unknown date and unknown if ongoing arthritis , immunisation from an unknown date and unknown if ongoing very active , genetic counselling from an unknown date and unknown if ongoing genetic testing relative for breast cancer, heart surgery for other conditions was 2 heart stents placed, double knee replacement surgery was the prosthetics are each 9 inches made out of unknown titanium and plastic. Caller interchangeably referred to surgical date as Jan2014 and about 5 years ago. She was fine without any assistance for about 4 years never needed to use canes or walkers only at 1st when had replacements-did for that immediate after surgery-was down 4 months with replacements. Foot doctor appointment was she will tackle soon. Scheduled for a biopsy on her uterus was she is concentrating on that once she gets past that they picked that up in annual pelvic exam about a month ago; if that doesn't have any lasting need for any further treatment she will tackle this knee pain, breast cancer was 1st stage taken care of no further mammograms not on any medication for it; operated on Sep2020 until now another part of her needs to be looked at no reason it won't be nothing just questionable if something might be brewing; just going to do a biopsy of uterus because of ultrasound need to be looked at again. Arthritis was definitely what caused the knee surgeries. Very active gone on to have a full life radio program curates the art in her town. Does her own grocery shopping. Lives alone since husband died. Patient tested her for genetics relative to breast cancer she is not passing anything on to her daughter of the female breast genes don't think it goes any further. Patient does not take a lot in the past she had very serious lyme disease; no real relapse in that last 10 years; before that she spent 10 years in treatment for lyme disease so she could go back to that. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Concomitant medication(s) included celecoxib (CELEBREX) taken for pain, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for thyroid disorder from 2001 to an unspecified stop date. The patient experienced pain in her pelvis on 31Jan2021, same pain feeling in bladder and pelvis on an unspecified date, sore arm on an unspecified date, had pain that was just in the knee replacements, where knee replacements on unspecified date, pain on 31Jan2021, standing up feels weird on 28Jan2021.This is report 1 of 8. The patient who reported pain standing up feels weird and sore arm after first dose of Pfizer Covid-19 Vaccine. Pain on the 3rd day after the first dose of Pfizer Covid-19 Vaccine she woke with pain in her pelvis and thought she had a urinary tract-captured as provided as only urinary tract- which she doesn't usually have. Then on the 4th day after first dose of Pfizer Covid-19 Vaccine she had the same pain feeling in bladder and pelvis. She was seeing a cancer doctor that day for a 6-month check-up who ran a urine sample, and it was negative. She knew it was negative because that symptom was pretty intense on 3rd and 4th day but then it was gone. The pain took her all the way back to when she had the knee replacement surgeries; she was on Morphine then which she can't do that now; they wouldn't give it to her. She had using Advil and some Celebrex which she was not supposed to use those because of her heart condition which was under control. Advil and Celebrex taken for the pain have done nothing for the pain they are doing nothing they don't touch the pain. Her family doctor suggested she try marijuana. her cancer doctor was trying to get her medical marijuana; but nothing's happened in 6-8 weeks. Pain was making her crazy, did buy the marijuana it comes like candy like little gummy bears to try to alleviate the pain that way but did not get the medical marijuana. The oncologist talked to his secretary and she was told they would contact her in 6 weeks. 6 weeks went by and they haven't contacted her. The Oncologist texted her she told him she hasn't gotten the medical marijuana card yet and you have to pay for the card. So her daughter in Massachusetts can buy marijuana that's legal there-so the patient tried little bit of a gummy bear which did nothing for the pain; so she tried a little more of a gummy bear which still did nothing for the pain; then another day she tried a whole gummy bear which still did nothing for the pain in her knees but she felt kind of fogged up in the head, after 6 days after the first dose of Pfizer Covid-19 Vaccine she woke up with both knees that she had a knee replacement in in 2014; and she had basically gotten over most of it; the 6th day after the shot she woke up and had pain that was just in the knee replacements where knee replacements both were. It was excruciating pain it woke her up and she has been pretty bad ever since. That was the most extreme day of pain was 6 days after the first dose of Pfizer Covid-19 Vaccine. It was pretty bad and then it woke her up 10May2021 also. For the pain Advil doesn't touch it she has taken 600mg of Advil every day which she was not allowed to take because she had 2 stents in her heart during heart surgery performed in 2020. They don't really want you to take Advil or anything after that. She's pretty much suffering and was probably going to end up in pain management. She got the second dose of Pfizer Covid-19 Vaccine and that second dose didn't make any difference did not worsen or affect events. She has to use a walker now; she had really gotten pretty much through that major surgery 5 years ago the double knee replacement surgery which she verified as being in 2014. She never got really great, but she could walk without a cane or any assistance. 09May2021 she when went to the cemetery to spread her deceased husband's ashes and had to use 2 canes so the pain definitely came from the Pfizer Covid-19 Vaccine. The patient reporting adverse events with Pfizer Covid-19 Vaccine. Mentioned she has been using Advil and some Celebrex taken for pain which have done nothing for the pain they are doing nothing they don't touch the pain. Advil expiry: Jul2023 Lot: WJ22828 UPC/NDC was Unknown on top over the code they use when they do inventory or all. Patient has friends with hip replacements and knee replacements, and no one was saying anything about pain with their replacements. She was thinking the Pfizer Covid-19 Vaccine was just attacking the foreign particles in her body which are the knee replacements. Celebrex: Lot/NDC/Expiry: Unknown dispensed in pharmacy vial. The outcome of the event pain in her pelvis was recovering, same pain feeling in bladder and pelvis, sore arm, had pain that was just in the knee replacements, where knee replacements was unknown, pain was recovering, standing up feels weird was recovered on unspecified date. No follow-up attempts are needed. No further information is expected

I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.

Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.

Swollen lymph nodes under left arm; swollen left breast; redness on breast; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 15Feb2021 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to wasp bites. Concomitant medications received within two weeks of vaccination included statin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via an unspecified route of administration in the left arm on 25Jan2021 at 00:00 (at the age of 82-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Feb2021, the patient experienced swollen lymph nodes under left arm, swollen left breast and also redness on breast. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph nodes under left arm, swollen left breast and redness on breast was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Developed large swelling under and around left breast. . Under left arm it will hurt real deep once in a while.

headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown. No follow-up attempts are needed. No further information is expected.