Pfizer

Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with menopause and have not had a period for several years

My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.

Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.

'm post-menopausal, since March 2011 with no issues. 5-6 days after getting vaccination, I spotted very lightly, bleeding vaginally. It happened on and off, for two days then stopped. No cramping or other symptoms. When I read that this had happened to some patients, I thought I'd better report my occurence too. No treatment or doctor visit necessary. It was just a surprise .

Very bad sometimes extreme pain in my left breast area that radiates into my chest area. Hurts to touch my left breast area and the pain is a shooting pain that is constant and feels like a stabbing pain. Hurts to move my left arm. I've been taking 3 Advil at a time and the pain subsides for a couple of hours but comes back. It doesn't matter if I'm sitting up or lying down the pain is always there. I sometimes feel like I've had the wind knocked out of me when the pain radiates to the front of my chest area. There is no longer any pain at the injection site.

Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort

I really don't know if this is at all related to the second vaccination but we were encouraged to report any odd experience. About 27 hours after receiving the second shot, what appears to be a menstrual cycle began. I last had my period in 2015. For additional context, I have a history of fibroids and still have a good sized one. In late February I had a spotting issue but what I'm experiencing now is a full on period. I was already in contact with my PCP and an OB/GYN for testing related to the Feb. spotting event and as a result of that will be having an endometrial biopsy and hysteroscopy. Outside of the above, I had a sore arm and bruising at the injection site. Thank you

Caller received the first dose of Pfizer's COVID vaccine and experienced heavy menstrual bleeding; The caller hasn't had a period in 5 years, she is post menopausal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 (Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included post menopausal for 5 years from 2016, Hashimoto's disease. The patient's concomitant medications were not reported. The patient got her shot on 30Mar2021 and then she didn't notice any side effects, but right now in 2021 she's having menstrual cycles, a lot of bleeding. She experienced heavy menstrual bleeding. The patient hasn't had a period in 5 years, she was post menopausal. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Started spot vaginal bleeding like I was getting my period. I have not had a period for 15 years. Menopause at age 45. Bleeding enough to note, but not enough to cause concerns. Bleeding stopped 24 hours later, this morning 5/25 - 7am.

post menopausal menstrual bleeding; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (Lot Number: ER8735), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 12:00 as single dose for covid-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included thyroid (ARMOUR THYROID); calcium; fish oil; vitamin b complex (VITAMIN B); vitamin C; colecalciferol (VITAMIN D). The patient previously received first dose of bnt162b2 (Lot Number: EN6204) on 25Mar2021 at 12:00 in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced post menopausal menstrual bleeding on 29Apr2021 15:00. The event did not result in emergency room/physician office visit. No treatment received. This case was reported as non-serious by reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.

Found a lump in my left breast. Went to doctor and found it was cancer. I was in remission for 15 years before that date.

Vagina Bleeding and cramping; Vagina Bleeding and cramping; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, Expiry date: not reported, age at the time of vaccination: 60-year-old), via an unspecified route of administration, administered in Arm Right on 17Mar2021 08:15 as dose 2, single for covid-19 immunisation in facility. Medical history included High Blood Pressure, known allergies include Penicillin, Menopause (I have been post menopause for over 15 years.) Concomitant medication within 2 weeks included metoprolol succinate (TOPROL XL) at 50 mg. Previously the patient received first dose of bnt162b2 (Lot number EN6198), in Arm left on 25feb2021 12:00 for covid-19 immunization. On 17Mar2021 20:00, patient experienced vagina bleeding and cramping and the patient had received a treatment as she had contacted her physician. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19, prior to vaccination and since the vaccination. The outcome of events was not recovered.

started having more like a period, but she was going through menopause before had been spotting only.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Jun2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization (to prevent the COVID; at least if patient gets it, she won't get it so hard). The patient medical history was not reported. The patient concomitant medication included vitamins nos (patient takes no prescribed medications, only vitamins) taken for an unspecified indication, start and stop date were not reported. The patient received other vaccine within 4 weeks prior vaccinations. The patient previously took shingles vaccine (both doses, administered in left arm). The patient experienced started having more like a period, but she was going through menopause before had been spotting only on 27Jun2021. Adverse event did not result in emergency room, physician office visit. Patient is a 60-year-old female patient who received her first dose of the Pfizer BioNTech COVID-19 vaccine two weeks ago. Then, four days ago she started having more like a period, but she was going through menopause before had been spotting only. She would like to know if the Pfizer BioNTech COVID-19 vaccine messes with her menstrual period. Patient stated she just turned 60 in February and was just spotting and was told that's part of menopause. Patient has been taking some menopause hormone menstrual support. Patient had her first dose of the vaccine two weeks ago and then maybe 3-4 days ago, she started having more like a period. Patient was talking with a friend who heard on the news two months ago that some Covid vaccines were messing with women's periods. Patient stated her second dose is due on 03Jul2021 and is 21 days after her first dose. Clarified with patient that her first dose was 12Jun2021. Investigations: patient said not yet to any tests, because this is her first experience patient has had. Patient stated she is taking it like it's a period. Patient stated she had the Shingles vaccine three weeks prior to the Covid vaccine. She was told she would have to wait two weeks. By the time she had gotten the Covid vaccine, it had been three weeks. This was her second dose of the Shingles vaccine, the first dose was almost six months before that. Patient stated she was achy and had an achy arm from the Shingles vaccine. The patient received treatment for the event. Outcome of the event was not recovered. Information about lot/batch number has been requested. Additional information has been requested.

Swelling in breaststroke and under left arm; Swelling in breaststroke and under left arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was receiving unspecified concomitant medications. The patient previously received penicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021, the patient experienced swelling in breaststroke and under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event swelling in breaststroke and under left arm. The clinical outcome of the event swelling in breaststroke and under left arm was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.

Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10

Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.

Severe underarm and left breast swelling that lasted 5 days with pain, chills, fever, body aches and fatigue still present 7 days later

started to experience headache, more than just a headache. This captured my attention. Also started to note increase pain in hands, a more intense pain in some digits as well. Made appointments with Neurologist, who after MRI said I had occipital headache and put me on Topiramate, and I take 3 pills every night. He also ran blood tests and found abnormal increased immune system sensitivity and referred me to a Rheumatologist who after more tests , prescribed Hydroxychloroquine, which I now take daily. I never had these types of problems until I received the Pfizer COVID 19 vaccine. Now I have a right breast mass that was found on a recent mammogram just this week.

arm puffiness; her left breast was swollen; had a lot of arm aches where the injection site was; Body aches; swelling in her lymph nodes; had some nerve tingling in her finger; Arm swelling; swelling under her left side of the arm, the left armpit; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264, expiry date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 17:30 in the beginning of February (at the age of 61 years old) as single for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration in left arm on 14Jan2021 in the middle of January (at the age of 61 years old) for COVID-19 immunization and experienced no reaction. Medical history included headache. No family medical history relevant to adverse events was provided. No concomitant medications were reported. Patient occasionally took Excedrin or Avil expectorant for headaches and experienced no reaction on previous exposure to drug but did not take any prescription medication. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any vaccine on same date with the Pfizer vaccine considered as suspect. Patient had no problems with the first injection received on 14Jan2021; all the events started after she received the second dose of the vaccine. On 05Feb2021, patient had body aches. 14 or 15 hours after the injection, patient's arm started aching. Patient had a lot of arm aches on the injection site. Patient took Tylenol for the body aches, which lasted a few hours and recovered on 05Feb2021. Patient was having a lingering symptom. On 06Feb2021, patient's left arm, in the armpit, had puffiness, it was not sore in the tissue and she did not know if it is the muscles or tissue. Patient had swelling under her left side of the arm, the left armpit and noticed the lymph node and got scared. Her arm really hurt on the third day and it was worse than the second day. Swelling eventually went down but not completely. She said it stayed the same and she has not noticed any more improvement for the last few months. She kept thinking it would go down more but it was the same. Patient stated that no one would notice the swelling, but she noticed a protrusion when she lifted her arm up. It did not hurt it was just there. When she lifted her arm up, the left arm was noticeably different than the right armpit. Patient's left breast was also swollen with the whole site near the armpit on 06Feb2021. Swelling started to go down but it took days. Patient had some nerve tingling in her finger on the left side and maybe in her arm, which did not last long, and she figured it was from the swelling pushing on the nerves. She did not notice it that weekend, so it might have been a few days after the weekend when she received the second vaccine. Patient had a gynecologist appointment at the beginning of April and gynecologist did not seem to be concerned, he said it could be her lymph node. Patient did not feel like she needed to go see a doctor because most of the swelling had gone down and just the lingering puffiness was still there, and she kept thinking it was going to go away and it just needed a few weeks. Swelling still had not gone down and patient had given it a few months. Events did not require a visit to emergency room or physician office. No relevant tests were performed. Outcome of the events swelling in her lymph nodes was unknown while of arm puffiness was not recovered. Outcome of the events her left breast was swollen, Arm swelling and swelling under her left side of the arm, the left armpit was recovering. Events "had a lot of arm aches where the injection site was and had some nerve tingling in her finger" recovered on an unspecified date.

Swelling, erythema and pain right upper extremity associated with fever, chills, weakness and fatigue. Swelling extends from shoulder to mid humerus and extend from the axilla down to the level of the breast. Large palpable mass adjacent to right breast. Seen in PCP's office on 6/29/21. Started on Bactrim without responce. Currently on Clindamycin

On May 8th, I discovered a lump on my left breast. Tender to touch. Went to Dr. on May 10;May 20, mammogram/Ultrasound,;June 3 core biopsy; June 7 - disagnosie - Invasive ductal adenocarcinoma - triple negative. ; July 7 lumpectomy and sentinel node biopsy

I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.

Had the 2nd Pfizer shot on 4/9/21 -- 4/10/21 Diarrhea in a.m. 4/11/21 Diarrhea, extreme fatigue during the day, during the evening developing tenderness in right side of right breast (top to bottom) 4/12/21 Diarrhea, minimal fatigue, very tender in right side of right breast 4/13/21 No diarrhea, continuing tenderness in right side of right breast (no better or worse than 4/12/21).

To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

At 6:00 p.m. on April 23rd I realized my lower back was hurting on the left side. The pain became worse gradually throughout the evening and extended to the front pelvic/ groin area on the left side. Buy the middle of the night, I was able to make it to the bathroom but could not get back to the bedroom alone because of the severity of the pain. I had to call my husband to help me back to bed. The pain was severe the next day and my husband called the doctor on call. She prescribed large doses of tylenol, ibuprofen, and she gave me a muscle relaxant. I took those as prescribed for a week and stopped gradually when I saw blood in my urine. For about 5 days after the onset of pain, I was unable to put my pants on unaided, tie my shoes, or climb into bed. There was also an area on the lower left pelvic area that was numb. The pain and numbness gradually subsided over a number of weeks. At this time, there is still a small amount of pain and numbness in the pelvic area at times, but my back is fine. It felt like the vaccine affected a nerve in my lower spine that went to the pelvic area. This was my second dose of the Pfizer vaccine. When I got that second dose on April 7th, I had poison ivy. I also got a different rash on my left arm on April 14th. The vaccine rash lasted about 2 weeks.

Under arm lymph nodes swollen, breasts swollen and painful, brain fog, headaches, all over body pain, jaw pain, eyesight worse, arthritis pain much worse. Started about three weeks after second vaccine and continues today

Breast tenderness; Diarrhea; Break through bleeding; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient (age at vaccination 62-year) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6207) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 15Mar2021 14:00 PM as dose 1, single for COVID-19 immunization. Medical history included nausea (had a little stomach nausea the day before); menopause (States that she has been menopausal for 15 years) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 17Mar2021 the patient experienced break through bleeding and diarrhea; on 18Mar2021 the patient experienced breast tenderness. AE does not require to visit Emergency room/Physician office. The patient was calling about the COVID-19 vaccine. States that she had some strange symptoms after her 1st dose on Monday. States that she doesn't really like her primary care practice. They weren't offering the vaccine, and even their nurse wasn't going to take the vaccine, she said she was just going to wait and see how it played out. States that she has been menopausal for 15 years, and had break thorough bleeding for a day, and had breast tenderness for a day after receiving the vaccine. States she has never had that happen in 15 years. She also had crazy diarrhea for 12 hours; it was intense. List of other relevant diagnostic and confirmatory test results for event was not reported. The clinical outcome of the events "break through bleeding" was recovered on 17Mar2021, "diarrhea" was recovered on 18Mar2021, "breast tenderness" was recovered on 19Mar2021. No follow-up attempts are possible. No further information is expected.

Immediately following the second dose, I had a lot of trouble with insomnia and nightmares that continued for almost 3 weeks. The nightmares stopped and even tho I am 9 years POST menopausal, I began bleeding again on April 28. Basically, it has only stopped for 3-4 days at a time in between. And I have been bleeding almost constantly ever since except for 10 days. I have had a uterine biopsy at Hospital. And Ultrasounds and there are no issues other than my uterine tissue is thicker than it should be. My joints are painful and enlarged too. That began at the beginning of May. I have had xrays and have been treated with steroids to get the tissue under control. I also am now experiencing Night Sweats and Hot flashes. Mayo doctors believe I need a hysterectomy or D&C to stop the bleeding issue.

Swollen, severe pain, red ring around right breast that has a titanium clip inserted. Underarms discoloration from dark to red color with ring. Vulva pain to the touch, groin pain, lower back pain. Stomach aches, swollen hot feet, hot flashes, sweating, heartburn, cheeks on face became flushed first hour after vaccination

She noticed swelling on the left side 24 hours later.; Headache; Lump the size of an orange under her right arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: EL3247 expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 14:00 (at the age of 62-year-old) as dose 2, single for covid-19 immunization. The patient did not have any medical history (was reported as none). There were no concomitant medications. History of previous immunizations was not provided. There were no additional vaccines administered on same date of Pfizer suspect. Prior vaccinations within 4 weeks or any adverse events following prior vaccinations. After second dose of COVID vaccine, patient had a giant lump the size of an orange under her arm. It went down from there and felt like when her milk came in after having a baby, but not as bad. Her breast hurt and she could not use the injection arm. She had the second COVID Vaccine on Thurs-day. She had some soreness on Friday (26Feb2021), but thought it was no big deal. By Friday evening, it was not just a little sore. On Saturday (27Feb2021), she looked at it and noticed the lump the size of an orange. The swelling was down to the size of a golf ball. She also had a headache on an unspecified date. Patient was asking if the agent thought she needed to see a doctor. Patient was assuming the lump would eventually go away. It was clarified the lump and swelling began in the right arm. The swelling did spread to the left side, but not nearly as bad. She noticed swelling on the left side 24 hours later. The outcome of outcome of headache was reported as resolving, and outcome of lump the size of an orange under her right arm and swelling was unknown. No follow-up attempts were possible. No further information was expected.

dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue

had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.

dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left flank, low back and upper back pain; headache; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL0142) via an unspecified route of administration left arm on 14Jan2021 08:15 at single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications included colecalciferol (VITAMIN D) and vitamin b complex. Patient previously took BNT162B2 (lot number: Eu1685) on 23Dec2020 07:45 to Left arm for COVID-19 immunization. On 26Jan2021 Lab data was reported as PCR test, Nasal Swab and Veritor rapid test results were negative. On 15Jan2021 the patient experienced with dysuria, abdominal pain, pelvic pain, bladder spasms, left flank, low back and upper back pain, headache. Patient received Bactrim, Toradol and Advil as treatment for events. Seriousness was reported as non-serious. Outcome of events was unknown. No follow-up attempts are possible. No further information was provided.

Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.

I'm 63 years old and have not had a menstrual period in 6 years, but on March 9th I started spotting after having two days of sore breasts. The spotting turned into a full-on period, lasted 6 days, and came back again the following month. I had called my GYN and she tested me for cancer etc. and put me on progesterone, however that seems to not be working just yet. Most of all this is super annoying.

4/27/21 started having scant/light vaginal bleeding dark in color that persisted through that day resolving. Spoke with her liver specialist who ordered CBC, PLT which was interpreted by MD Liver as normal. Follow up with gyn

vaginal blood spotting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Lot Number: EN6202, at the age of 63-year-old) as single dose for covid-19 immunisation. Medical history included abnormal cervical papanicolaou smear, ongoing eustachian tube dysfunction, ongoing Factor V Leiden Thrombophilia, ongoing hearing loss, laparoscopic Gynecology (GYN) surgery in 2007, an outpatient surgery to scrap the walls of her uterus similar to a dilation and curettage (D&C) in 2005, blood clots, excessive bleeding, ongoing Factor V Leiden heterozygote. Concomitant medication included ongoing multivitamins. Soon after her first vaccine on 08Mar2021 she started vaginal blood spotting. She had not had a period for over 15 years. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

I had already been scheduled for a mammogram three days before my mammogram. I had to do my annual breast check up and noticed a big mass I never felt before. That same day it was confirmed that it was a mass but the doctors didn't know what it was. Then I was scheduled five days later to have a biopsy with an oncologist Dr. from Hospital. Everything started moving fast in my body once they detected what I have. I have o negative blood. When I have anything foreign in my body in causes my body to overreact.

Developed arthritis symptoms with swollen knuckles in right hand, hard to open jars etc. Also breast tenderness couple weeks after second dose and still tender.

Experienced heavy bleeding coming out of the vagina this morning.; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 81 mg for an unspecified indication. Medical history included and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced heavy bleeding coming out of the vagina this morning on 24Apr2021 07:00 with outcome of recovered with sequelae. No treatment was received. Follow-up (24Jun2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer reported for the female patient in response to Non-HCP letter via follow-up letter which included the information. Follow-up attempts are completed. No further information is expected.

Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE). The patient had known allergies: DILAUDID. The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump. by evening could feel pain down into left breast. following morning--could see little "lumps"/swollen areas on left side of left breast. Armpit still swollen and sore

The next day following the vaccine my arm hurt slightly at the injection site, my head felt strange slight pressure maybe inflamed my face was red my blood pressure was higher for the first day. The following days my head felt strange again and my face would get red and it would come and go. but blood pressure was normal. Mid week the entire left side of my body felt like my body worked out but I didn't exercise. Today eight days after the vaccine blood was on the tissue after urinating in the morning upon waking again in the evening there was more blood on tissue.

First dose on 3/5/21 in left arm - muscle tenderness & some fatigue. Second dose given on 3/26/21 in left arm. Some tenderness in left upper arm. About a week later (April 1) I had left upper back & chest pain (just left of thoracic spine area and forward to left of my sternum bone & left shoulder pain). The area of discomfort increased to under my left armpit. I used Tylenol every 4 hours but still had some pain. The pain was bad enough that I had trouble sleeping at night and reaching for objects in my home. I noticed an "engorged" feeling & tenderness in my left breast. Swollen lymph nodes were present under my left arm - breast was too tender to check for more lymph nodes. No fever. Wasn't sure if I should go to an ER so checked the internet & 4/14/21 Contacted & consulted with my family doctor (Dr - My Chart messages) to let her know. Found information on Web (internet) that some women are having this kind of reaction in lymph nodes so was less worried about something more serious like a heart attack). Afternoon of 4/15 and today 4/16 feel the symptoms are beginning to go away - pain in my axilla area is better, lymph nodes not as hard & tender, left breast and left side of backbone have decreased discomfort.

Swelling in lymph nodes under my right arm with a good amount of discomfort for two days following shot, on third day after, the swelling, which felt like fluid, had drifted into my right breast, with a great deal of swelling/fluid. I'm having a lot of discomfort with an achy pain in my underarm. It feels like the shot was given to me in my underarm more than my arm.

feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.

Rash up and down and all over her arms; Couldn't breathe when laying down; Tiredness; Heart rate high; She felt hot and cold all day; Breasts were tender; She couldn't sleep; She doesn't feel like herself. She is scared.; MRSA; Bronchitis; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Swelling and pain under breasts, under armpits and in lymph nodes; Fever; This is spontaneous report from contactable consumer. This consumer (patient) reported that the 64-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 like 11:00 12:00 in morning, was before noon (Batch/Lot number was not reported,Is hard to read, could be EN8208 or EN6206, either of the 8's could be 6's; Expiration Date: 30Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing (Diabetes is not very high. Is almost like Pre-diabetic. Recently diagnosed with it, she has been sitting around because of Covid.), anxiety from an unknown date and unknown if ongoing. Family Medical History was none. Concomitant medications included ongoing lorazepam (LORAZEPAM A) at 0.5mg as needed for anxiety for a couple of years, about 3 or 4 years; ongoing metformin hydrochloride (METFORMIN [METFORMIN HYDROCHLORIDE]) at 500 mg, 2x/day (500mg twice a day) for diabetes mellitus for a couple of months (She started this medication 2 months before the covid vaccine); cannabidiol (CBD OIL) takes as needed. The patient experienced mrsa (staphylococcal infection) on an unspecified date with outcome of unknown , bronchitis on 16Mar2021 with outcome of unknown, fever on 14Mar2021 with outcome of recovered , swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, swelling and pain under breasts, under armpits and in lymph nodes on 15Mar2021 with outcome of unknown, rash up and down and all over her arms on an unspecified date with outcome of unknown, couldn't breathe when laying down on an unspecified date with outcome of unknown , tiredness on an unspecified date with outcome of unknown, heart rate high on an unspecified date with outcome of unknown, she felt hot and cold all day on an unspecified date with outcome of unknown, breasts were tender on an unspecified date with outcome of unknown, she couldn't sleep on an unspecified date with outcome of unknown, she doesn't feel like herself. she is scared on an unspecified date with outcome of unknown, had the vaccine 9 mar 2021/she is 65 and is afraid to get the second shot but is also afraid to not get the second shot on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included echocardiogram normal: normal on unknown date. Therapeutic measures were taken as a result of bronchitis , heart rate high. The clinical course was reported as follows: Caller received the first dose of the Pfizer COVID vaccine on 09 MAR 2021. Caller states the past couple of months she has experienced a lot of adverse events. Caller states she has had issues with bronchitis and went to a pulmonologists and cardiologists and she has been put on 27 different medications. Caller states after all of these things going on she is not sure if she should receive the second dose. Caller states one doctor told her she should not receive the second dose and one doctor told her she should. Caller would like to know if she should receive the second dose of the Pfizer COVID vaccine. Caller states her doctor doesn't want to tell her what to do because she thinks he is afraid that she might sue him. Caller thought that by calling Pfizer she would get some advice but she is getting nowhere. Caller would like to know if she can receive the Johnson and Johnson Covid vaccine as her second dose instead of receiving the Pfizer COVID vaccine? Had the vaccine 9Mar2021 and is just recovering now. Last week, she was finally feeling like herself. She had some medical conditions that put her at risk. She is 65 and is afraid to get the second shot but is also afraid to not get the second shot. Her doctor thinks it is too coincidental that this happened right after the vaccine. Has been talking to a lot of doctors. Is afraid to get the second vaccination. So now, she is just trying to figure it out. It really knocked her out, she has had 27 medications, she's been to the ER 3 times, been to the doctor 7 times, it just really knocked her out, they first thought it was a heart condition, then a lung condition. Has been having rashes and all kinds of stuff. Is afraid to not get the second dose. One of her doctors recommended the Johnson & Johnson, but is that safe, no. Weight was about 200 pounds. Started 5 days after the vaccine. Fever: On Sunday, started to get a fever. It was on and off all day. She thought it was a normal reaction and didn't think much of it. It was weird. It would be like 20 minutes and then fine, and would be off an on all day. It was a low grade fever, never more than 100. she felt hot and cold all day. It was most of Sunday and stopped in the evening. Treatment: none. Swelling and pain under breasts, under armpits and in lymph nodes: Started Monday. Breasts were tender as well as if like she was having a period. There was pain underneath her arm and in the lymph nodes. Lasted for 2 days. Treatment was none. Felt like bronchitis: On Tuesday, it started to get what she thought was bronchitis. She has a propensity to get bronchitis. She hasn't gotten sick in 2 years. She immediately went to the doctor. This went on for 2 months. Treatment: They prescribed Prednisone, nebulizers and antibiotics which she finished everything 3 weeks ago. She couldn't sleep and had to sleep sitting up, she couldn't lay down, it started right away when she felt she had the bronchitis. Rash up and down and all over her arms: She then developed a reaction and had a rash up and down her arms, all over her arms. Felt the bronchitis symptoms right away. It was the weirdest thing and she couldn't lay down. Every time she would get up, she couldn't breathe. Went to the emergency room 3 times but was not admitted. At one point, she had a rash all over her body. Her doctor thought it was MRSA. This happened a month into all of this. She got the vaccine 8 or 9 Mar 2021. This rash occurred some time in mid April. When it started, the rash was everywhere in her body. It was so severe, that they thought it was MRSA. Gave her another bout of antibiotics. She had sores that were opening all over her body. She then went to the Emergency room and they treated her there. The other time she went to the emergency room because she couldn't breathe. She had to sit in a Lazy boy chair for 2 months. The pulmonologist and the heart doctor couldn't find anything. When they though it was bronchitis, they treated her for 2 months with Prednisone. She got Candida's from the Prednisone. They put her on 27 medications total. The pulmonologist said it was not the lungs, it was the heart. She was put on medication to slow down the heart rate. It had been running about 119. The medication she was put on was Metoprolol Tartrate 25mg. It slows down the heart rate, it has been so high. She was put on the medication 23 Apr 2021. It went so high. Her oxygen has been good. Her heart rate was never slowing down. She is still taking the Metoprolol, her rate is running like 118 and 108, it never slows down. The pulmonologist said it was not the lungs, its the heart and she is going to see him tomorrow for a follow up echo. She is so sick from so many medicines. Is still experiencing a lot of tiredness. It is the weirdest and is very strange. When she was laying down and couldn't breathe, the doctor said they felt like she was going into heart failure. The Echo didn't find anything wrong. It was a weird thing. She talked to both of the doctors, the pulmonologist and the family doctor who said that it was too coincidental that it was from the Pfizer. The Echo was a week and a half ago. The family doctor read it sand it looked normal. The pulmonologist who ordered the test is going to check it tomorrow. Her family doctor said to not get the second shot. The other doctor said she could probably take it. She doesn't feel like herself. She is scared. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Event bronchitis like symptoms required a visit to Emergency Room for 3 times and Physician Office and has been to the family doctor at least 5 times. No prior Vaccinations (within 4 weeks) but had the flu shot in the fall. AE following prior vaccinations was none. Relevant Tests was none or Unknown. Caller states that she is overweight. Caller states that she is trying to get out of here to go to a doctors appointment. Caller states that she has the bottle, she will ask her spouse to read it since she can see better, the product is Metoprolol Tartrate 25mg. On the bottle it also described the pill as Round white tablet 51:M18. Caller needs to obtain a magnifying glass. Caller states that she wants to give enough information to what happen to her. She states that the Manufacture is Mylan. Information about the lot/batch number has been requested.

I had soreness in my left breast and in my shoulder, I went to my PCP and they advised to get a routine mammogram. They saw a mass on the mammogram. They sent my PCP a recommendation to get an ultrasound. They concluded after the ultrasound that it was a cluster of lymph nodes.

2-3 days later after the 2nd dose, my lymph nodes and breast was swollen under my left arm. That swelling lasted for almost a week. At the same time, I also have fatigue, palpitation, pressure on my chest, and SOB. I did go see my PCP and they did lab work and echo and everything came back normal except low vitamin D and high vitamin B12. My PCP has referred me to a cardiologist. The fatigue is constant and everyday. I can get out of breath from just walking from one room to the next. I am waiting for my appointment to see the cardiologist on 7/21/2021.

Patient presented to the ED for lower abdominal and upper pelvic pain within 6 weeks of receiving COVID vaccination.

One afternoon in May 2021, erratic heart beat for approximately 25 minutes. I was home and working, not engaged in any physical activity. Also in mid-May, I began to experience pain in lower right pelvic area which increased in severity over several weeks. I had pelvic ultra sound to rule out anything. Nothing was detected and the pain resolved within a few weeks. My doctor stated that he had other female patients who experienced similar symptoms after the COVID-19 vaccine.

Lump in left breast. Resulting in imaging and consult with breast surgeon. Needle biopsy to follow. Dr. thinks this is an intramammary lymph node inflammation that has resulted in a lump.

Got the vaccine, got home and was fine. She waited for the same reactions that she had with the first one, felt perfectly fine. She went to sleep at around 11:00 AM, and got up around 7:00 and as soon as she woke up she could feel the lump under her arm. It was a little smaller than a baseball, soft, cystic like. I couldn't put her arm down, had to keep her hand on the hip due to this. The following day the left breast started to feel funny and hurting, but cannot feel a lump but it feels swollen and went up into the shoulder and neck. She cannot turn her neck as if she has a crick in it. She had a headache for a couple of days on and off, and then it goes away. She has taken the arthritis Tylenol. She has called her doctor and told her to take the Tylenol as needed.

Joint aches - starting 3/21/2021, lasting 24 hours Swollen lymph gland in left armpit - starting 3/22/2021, lasting 36 hours Acute swelling of pre-existing small sebaceous cyst on left breast, becoming 5 times the size it had been for 12 years prior, with additional larger swelling behind it - started swelling 3/23/2021; extreme tenderness and redness developed with continued swelling, then infection, over the next two weeks, despite taking prescribed 10-day course of antibiotic (Cephalexin 500 mg) -- ultimately required surgical lansing, irrigation, and draining and follow-up with breast surgery center 4/7/2021 (cont.)

I did fine until 5 days later when I had postmenopausal spotting on 4/3/21. It was very light, but abnormal. The next day, 4/4/21, I went to the ER, since it started being a little more than spotting. I had an U/S. The PA said I may have uterine and/or ovarian cancer. I saw a gynecologist who didn't think I had cancer. He was unable to do an in-office biopsy, so scheduled a D&C. The biopsy was non diagnostic, since he was unable to get a sufficient tissue sample. The spotting had stopped approx on 4/8/21. The Dr can't say for sure whether it is related to the vaccine or not. I had gone through menopause at 51. I turned 66 on 4/3/21. The Dr will repeat an U/S in a month.

1st Covid shot had extreme pain in left arm and couldn't sleep, had to take tylenol. Experienced short dizziness episodes but on March 18 and 19 had nausea. After the 2nd covid vaccine my left arm hurt but pain went away after third day but periods of dizziness continued for a couple of weeks. During month of April had increase of pain in pelvic area and lower back. In May spasms in pelvic area which got worse. couldn't sleep by May 24 and called 911 togotothe Emergency Room

28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48). Had second smaller incident on 6/20/2021

28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48).; This is a spontaneous report from a non-contactable consumer or other non hcp. A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 28Feb2021 16:30 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07Feb2021 15:30 (Batch/Lot Number: EN9581) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included high blood pressure from an unknown date. The patient is in her menopause since she was 48-year-old. Concomitant medication included candesartan (CANDESARTAN) 8mg taken for an unspecified indication, from an unknown start date. The patient is allergic to aspirin and amoxicillin. On 07Mar2021, the patient experienced 28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48). Had a second smaller incident on 20Jun. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the event. The outcome of the event was reported as unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Benign Uterine Polyp: I have no idea if this is related to the COVID vaccine, but I was seeing articles about vaccinated women experiencing menstrual irregularities when I experienced some unexpected vaginal bleeding after being menopausal with no bleeding for over a decade. May 3, 2021 vaginal bleeding after menopause May 10, 2021 OB/GYN Dr. appointment May 20, 2021 Vaginal ultrasound - hemoragic appearing mass in uterus found June 21. 2021 Pre-Op Dr. appointment June 30, 2021 Hysteroscopy - Uterine Polyp found and removed July 6, 2021 Notified of Lab results: Polyp was benign

Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, soreness at injection site 1/12/21 6:30 am, soreness at injection site, slight swelling in right axilla 1/13/21:6:30 am, soreness at injection site, moderate swelling in right axilla, headache, body aches 1/13/21 4:00 pm, temp 99.8, soreness at injection site, increased swelling and redness in right axilla extending to right breast, severe headache. body aches, fatigue 1/14/21 6:30 am, afebrile, increased swelling and redness right axilla extending to right breast, headache, body aches. 1/14/21 10:00 am, Called PCP office. Told to take Tylenol and use ice at axilla, and report to CDC

on the fourth day following the second dose A red area painful appeared on my right breast with a lump about size of cashew nut just above nipple area. It is still there on 6th day although not as sore. I have not received treatment or gone to doctor, waiting to see if it goes away in a few days.

burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported. Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged was recovering, other events was not recovered.

Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.

Started with profuse eye tearing. Woke up with extreme headache, teeth aching, non stop runny nose, it felt like aching golf balls in my left breast, armpit and upper back. (lymph nodes) Extreme fatigue, could not eat for 23 hrs. As of 5 days later I still am having pain and swelling in my armpit. Dizziness.

Pain in kneecap and wrist, and top part of foot:; Pain in kneecap and wrist, and top part of foot:; Feeling different pains today; Tired; Muscles, feels lethargic/weakness; Pain, in the pelvic area on the side, and along the side of her thighs, feels like the pain is in her bones; Joint pain in her knee; Pain, in the pelvic area on the side, and along the side of her thighs, feels like the pain is in her bones; Pain, in the pelvic area on the side, and along the side of her thighs, feels like the pain is in her bones; Muscle pain, in the arm, at the injection site; Muscle pain, in the arm, at the injection site; Muscle pain, in the arm, at the injection site; Tightness in right calf; She is feeling anxiety about the side effects she is experiencing; She is feeling nervous; This is a spontaneous report was received from a contactable consumer or other non health Care Professional (patient). A 66-years-old female patient received unspecified dose number of bnt162b2 (Formulation: solution for injection) via an unspecified route of administration on 13Apr2021 at 13:00 as single dose for Covid-19 immunisation. The patient's weight was 81.65 kilograms and height was 170 centimetres. The patient medical history was not reported. The patient's concomitant medications were not reported. She was feeling anxiety about the side effects she was experiencing. The patient doesn't know if it was normal, to still have them, after the vaccine. She had read online, that some people experienced side effects for several days, but then resolved. She did not provide specific examples. The patient stated that she got the vaccine this past Tuesday, at 1 pm and reclarified that when she was walking out of the building, after the vaccine, on 13Apr2021, about a half an hour later, she started driving back to work and felt, tightness in her calf when she pressed her right foot on the accelerator. Tightness in right calf which was the first symptom she felt after the shot, even before feeling pain at the injection site. The patient was having muscle pain at the injection site on 13Apr2021 at 16:00, and joint pain in her knee, was feeling nervous, concerned, that on day 3, she was still having side effects. The patient woke up at 7 am on 14Apr2021, she felt pain in the pelvic area on the side, and along the side of her thighs. The patient reclarified, that she felt this pain on 15Apr2021, and it felt like it was in her bones but she is also feeling different pains today at 7am. She was concerned about the pain in the kneecap and wrist, and now her muscles feel lethargic. She was having weakness, later reclarified as her muscles feel lethargic, tired on 15Apr2021 10:00, and was having joint pain, reclarified later in the report. At 16Apr2021 08:00, the patient had pain in kneecap and wrist, and adds top part of foot, in the morning her muscles, feels lethargic. The outcome of the events muscle pain, in the arm, at the injection site was recovered on 15Apr2021, the outcome of the events pain, in the pelvic area on the side, and along the side of her thighs, feels like the pain is in her bones was recovering, tired, pain in kneecap and wrist and top part of foot, muscles, feels lethargic/weakness were not recovered, tightness in right calf, joint pain in her knee, she is feeling anxiety about the side effects she is experiencing, feeling nervous, feeling different pains today was unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.

itching where her bra hooks; pain under left breast; Under the caller's left breast it is tender to touch; it feels like it would have something on her skin.; The caller didn't even want to touch her skin.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200), via an unspecified route, (left arm at the top) on 05Mar2021 09:00 (at the age of 66-year-old) and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9267 and Unknown NDC and expiration date), via an unspecified route, on 11Feb2021 as single dose for COVID-19 immunization. The patient was 66-years-old at the time of vaccination. Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was first dose of the covid vaccine. No prior Vaccinations (within 4 weeks), No AE(s) following prior vaccinations, No family Medical History Relevant to AE. Patient relevant medical history included renal cell carcinoma from 2001 to an unknown date had renal cell carcinoma in 2001 and had to get 1/3 of her kidney removed, diabetes, thyroid, stomach. The patient concomitant medication(s) included acebutolol hydrochloride (ACEBUTOLOL HYDROCHLORIDE) taken for blood pressure measurement, (200 mg, 1x/day); losartan potassium (LOSARTAN POTASSIUM) taken for blood pressure measurement (100 mg, 1x/day (once a day in the mornin), amlodipine besilate (AMLODIPINE BESILATE) taken for blood pressure measurement (5 mg, 1x/day (once a day in the afternoon), metformin hydrochloride (METFORMIN HYDROCHLORIDE) taken for diabetes mellitus (500 mg (at night, one tablet), pantoprazole sodium (PANTOPRAZOLE SODIUM) taken for gastric ulcer (40 mg (in the morning ), levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for thyroid disorder (0.125 mg (1 tablet once in the morning), allopurinol (ALLOPURINOL) taken for renal cancer (300 mg); linagliptin (TRAJENTA) taken for diabetes mellitus (5 mg, 1x/day); chlorpropamide (CHLORPROPAMIDE) taken for diabetes mellitus, 10 mg (once at night), start and stop date for all were not reported. The patient experienced itching where her bra hooks, pain under left breast, under the caller's left breast it was tender to touch, it felt like it would have something on her skin, the caller didn't even want to touch her skin. On 11May2021, the patient underwent lab tests and procedures which included x-ray was not have the results yet. No any AE(s) required a visit to emergency room. Events required physician office visit (primary care provider). The outcome of event for itching where her bra hooks, pain under left breast was recovering and for under the caller's left breast it was tender to touch, it felt like it would have something on her skin, the caller didn't even want to touch her skin was unknown. No follow-up attempts are needed. No further information is expected.

Patient is a 66 y.o. female with an unknown PMHx admitted with DKA and found to have thrombocytopenia, an intraparenchymal bleed on Head CT 2/2 to dural venous thrombosis. Course also complicated by saddle submassive PE w/ + biomarkers and mild RHS. Given unclear etiology of thrombocytopenia, venous thrombosis, and PE, suspect a precipitating/underlying etiology and cannot rule out possible occult malignancy, autoimmune disorder or alternative hypercoagulable state such as APLS. Possibly bacteremic given GPB and Staph on blood cx, though likely contaminant. DKA resolved, anion gap is closed, continued monitoring of glucose and insulin adjustment .OB/Gyn following for heavy vaginal bleeding and possibly gyn malignancy workup, endometrial biopsy pending. Heme also following.

Bleeding; Spotting; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 08-FEB-2021 12:00 at the 66 years old at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient was not pregnant.There was no other vaccine in four weeks. On 22Feb2021 the patient experienced Bleeding, Spotting with outcome recovered in 2021. All of events resulted in Physician Office Visit. There was treatment for events. The patient underwent lab tests and procedures, which included Biopsy : Unknown results; Ultra sounds: Unknown results. There was no COVID prior vaccination. There was no COVID tested post vaccination. Information about Lot/Batch number has been requested.

I had a complete hysterectomy in March of 2021 with no complications . Over 2 months later, 13 days after the vaccine I started vaginal bleeding which is inexplicable because I no longer have a uterus.

4/10/21 Immediate headache, dizziness and tachycardia requiring monitoring for 45 minutes. Within 36 hrs spiked a temp of 101 that resulted in night sweats, lethargy & nose bleeds 5/5/21 0 symptoms until 5/5/21 @ 5pm 5/5/21 Vaccine #2 continued. 2nd vaccine was @ 10:40am on 5/5 but by 5pm on 5/5, went to bed with lethargy, headache that intensified over night. Severe low back and hip pain, fever, loss of appetite that was so intense, I remained in bed for 25 hours. I was slightly nauseated and only drank water until I was able to make some soup on 5/6 @ 6pm. I've never been this sick & the headache was intense. 5/7/21 I began moving more, pushing fluids and getting out of bed. Two weeks later, 5/19/21, my left upper thigh hurt, followed by three herpes blisters and general malaise. I haven't had a herpes outbreak since 1991. It took several weeks for the blisters to resolve. Then I began experiencing menstrual discharge (I'm 66 and post-menopausal) I hadn't had a menstrul flow or discharge since menopause 13 years earlier. I am still spotting and waiting another couple of weeks since I have numerous women clients experiencing menstrual abnormalities. I'm assuming all of the carrier and preservative vaccine ingredients are a huge to my llver detoxification and of estrogen metabolism. I'm sad that I got the vaccine but am a traveler and will most likely require proof to

About six weeks after receiving the second vaccine I noted a red hard very sore lump the size of an almond in my right breast encircled by a big red orb that was hot to the touch and very very painful to the touch. I felt inordinately exhausted as well. The exhaustion lasted about 24 hours, the soreness, lump and redness at least 10 days gradually shrinking. Then another same scenario popped up in my right armpit and then another on my left breast and today 6.23.21 I'm experiencing the same intense exhaustion for no reason, and a soreness in my right armpit which I've explored and found another almond sized hard red sore lump.

vaginal bleeding after approximately 12 years post menopause; abdominal pain; severe headache; neck pain; Periodic heart rate increase.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 15:30 pm (age at vaccination was 66 years) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, atrial flutter, ablation surgery and menopause (age 51). Concomitant medications the patient received within 2 weeks of vaccination included thyroid (ARMOUR THYROID) and acetylsalicylic acid (ASPIRIN) both taken for an unspecified indication. The patient previously took amoxicillin, codeine and nizoral for allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06May2021, the day after injection, the patient experienced severe headache and neck pain for several days. On an unspecified date in June2021, the patient experienced abdominal pain and vaginal bleeding after approximately 12 years post-menopausal no bleeding. On an unspecified date in 2021, the patient experienced periodic heart rate increase. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with Tylenol for neck and headache. The patient underwent lab tests which included pap test and biopsy with unknown results on an unspecified date. Since the vaccination, the patient has tested for COVID-19. The patient underwent lab tests which included SARS CoV-2 test (other): negative on 24May2021. The outcome of the events severe headache and neck pain was not resolved. The outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected. Follow-up (16Jul2021): Follow-up attempts are completed. No further information is expected.

I received the 1 dose on Feb 2nd at 10:30pm. I came home and went to bed. I slept in but when I woke up I had a small red bump on the outside of my left breast. That bump continued to grow larger. I went in to my Radiologist a week later and was put on antibiotics. I saw my doctor, my breast surgeon (Lumpectomy Mar 3, 2020). I had the Bracey Therapy for my Radiation. The diagnosis is that I have MRSA in my left breast. I am on a coctail of non-penicilin antibiotics. My Dr said I was ok to get the second dose so I had that on Feb 23, 2020. I didn't think this was related but I'm not sure. I think I would have noticed if I had it prior to the shot.

Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain under left armpit. Felt a lump in my left breast. Feels like someone punched me real hard in my armpit. Took Ibuprofen for swelling. Swelling and pain lasted 3-4 days then subsided and now there is no longer any pain. Don't feel the lump any longer in my left breast.

Seven weeks after my second Pfizer vaccine I developed 5 hard lumps in my left arm pit. Also my left nipple developed one lump. All lumps were very sore. I used hot compresses and Tylenol for discomfort .

blister outbreak on top / roof of mount with swelling after 1st vaccine burning/tingling of both lips with blister formation, itching/burning under nose and corner of left mouth after 2nd vaccine swelling, cramping, pelvic pain right > left with "needle like" sharp pain after 2nd vaccine - improvement in blisters after Acyclovir but recurred so, not complete resolution - pelvic symptoms are intermittent without treatment

I am 67 years old and post-menopausal. On April 26, I began experiencing what looked like menstrual bleeding. There was no warning: no pain. No cramps. Very few clots. Flow was moderate, but lasted on and off until it stopped completely on May 1. I want to report this, because I have seen recent reports (just beginning) to emerge from credible sources that other post-menopausal women are experiencing this type of bleeding after being vaccinated. I am concerned, frightened, and trying to make an appointment to see my gynecologist. The flow and length of days involved pretty much mimicked the menstrual pattern I had before menopause. But I should not be bleeding at this age. This has never happened since I ceased menstruating at age 52 or 53. I think the CDC should know my story, here.

After receiving the vaccine, I started to have lower, right abdominal pain. I went to an urgent care and after they did an ultrasound, they did not find anything wrong. I went to the dentist and he noticed that I had high blood pressure. I have never had blood pressure problems before. On 05/12, I had an abnormal mammogram. The doctor called me and I had to go back in for a biopsy. They found a mass and it is cancer. I'm not sure if it's because of the vaccine, but I've never had these problems before in my life.

had medication taste in mouth and it lasted for a few hours, throwing up saliva, stinging in arm that vaccination was given, 2nd dose she experienced she had pain in her left arm up to her shoulder and that pain is still there, swelling in the shoulder, the pain began in her lower back, and both sides of lower body and pelvic area bones began to hurt, an area she got antibotidics 45 years ago began to hurt as well, pain in her knees, her feet were swelling so badly, woke up with pain in her left knee, the next morning she called the ambulance and went to the hospital, on a sunday morning and she came back home that day, after a few days from the hospital her leg began to shut down, she would fall because her leg would give out, this has happened to her 8 times,

Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.

Symptoms occurred 8-12 hours after injection and were mostly gone within 24 hours. mild rash on abdomen, swelling of right breast, shallow breathing No treatment.

low-grade fever chills tightening in chest headache pain at injection site In addition, I had a mammogram and a bilateral ultrasound on 4/6/21. I didn't know anything about waiting 8-10 weeks. None one at the Center told me that I should wait. They did, however, ask me when I had my second vaccine. I told them 4/1/2021. They still proceeded with the mammo and ultrasound. My right breast at the 10:00 position (right adjacent to the injection) showed a tiny mass with benign properties (according to Dr.). She told me that I should have it biopsied. the mass wasn't there last year. I have an appointment for a biopsy tomorrow, 4/13/2021.

Mid day on April 2, I suddenly developed vaginal bleeding then within 8 hours bleeding stopped. In the meantime, that afternoon I went to see Dr. and I was still bleeding when I went there. He did a biopsy and scheduled me to get a Vaginal ultrasound the next week. He also gave me some hormonal pills but my bleeding had stopped. For the next 25 days, I had no spotting, no bleeding or anything at all. At around noon time, on April 26, I began bleeding again but this time it wasn't bright red but it was a light brown color. By that afternoon, it had stopped. In the next 5 days, I had similar episodes but it got very light until it faded. Later on May 17, I had a very light yellowish brown discharge. Since then, this has been it.

breast pain, swelling of the breast, and swelling of the lymph nodes underneath my right arm, breast soreness, sensitivity, could not wear clothes, had trouble sleeping on my side, but the right side was the worse. Was told to apply warm compresses and Evening primrose oil and vitamin E oil a couple of times a day and especially at night.

If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Felt like a sunburn or wind burn on head, cheeks, both sides, and upper arms/Face on the right side felt like a sunburn or windburn; face on the right side became numb-like and it went to the other side; right breast was swollen; This is a spontaneous report received from a contactable consumer reported for self. A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in Arm Right on 19Mar2021 (Lot Number: EN620P) as single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. Medical history included Diabetic from 1995 and ongoing, blood pressure high from 1995 and ongoing (just took her usual medications); eczema from 2014. Family medical history relevant to AEs was none. The patient's concomitant medications were none. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (Lot Number: EX9266) for COVID-19 immunisation; took the shingles shot and broke out they claimed that she had topical eczema. She thinks it was from the shot. That was in 2014. After the second or third day, her face on the right side became numb-like and it went to the other side on 22Mar2021. And now, on her head and on her body, it felt like a sun burn or wind burn. She took Benadryl and it is not going away. She didn't know if it was from the shot. It started 3 days after she had it on 19Mar2021. It started on the third day in her face and seemed to work its way down. Her right breast was swollen on Mar2021, and her daughter took the shot and got deathly sick, her right side was swollen to 3 times its size on her breast. She didn't swell that much and hers has gone down now. Her arms are really tender like sunburn or wind burn. As long as she is sitting still it doesn't bother her but if her clothes hit it or anything it is annoying. She didn't know if other people have complained about that. The patient stated it hurt on her head, like a sunburn. She said there was no numbness, it was more like a sunburn. It doesn't hurt unless touched, like her bra rubbing against it and agitating it. She didn't have this until she had the shot. She got the shot on 19Mar2021, and about 22Mar2021 it started with her face first. It worked its way down her body. It was about a week later that it spread to other parts of her body. She waited about calling because every day she thought it would be getting better. but it hasn't. she took Benadryl for a sunburn-type feeling on her body and it hasn't helped. She had not received any other treatment. There no AEs require a visit to emergency room or physician office. She had a physical done in between her first and second dose. She had routine bloodwork. Outcome of the event right breast was swollen was recovered, of the other events was not recovered. No follow-up attempts are needed. No further information is expected.

N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness N93.9 - Abnormal uterine and vaginal bleeding, unspecified

This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) intramuscularly on arm left on 17May2021 at 09:45 AM at age of 69-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included arthritis, penicillin allergy and latex allergy. Concomitant medications included levomilnacipran hydrochloride (FETZIMA) received within 2 weeks of vaccination. Patient experienced large painful lumps in breasts, pain in ribcage and across back. Patient was bedridden and this was the 6th day (23May2021). Onset date of events was 17May2021 at time of 02:15 PM (reported as 02:15). Events were reported as serious as disability. Outcome of the events was recovered with sequel. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Information on the lot/batch number has been requested.

vaginal cramping; spotting; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 11Mar2021 at 10:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 06:30 the patient experienced vaginal cramping and spotting the morning after the vaccination was received. The clinical outcome of the event spotting vaginal, cramp was unknown. No follow-up attempts are needed. No further information is expected.

Left breast generalized tenderness, warmth and mild swelling with focal area of induration to inferior breast tissue. Warmth, tenderness and generalized swelling resolved after 5 days. Induration, ? mass persisted 1 week later prompting diagnostic work-up in clinic with imaging ordered

VAXINATION GIVEN IN LEFT ARM AND LEFT BREAST IS SWOLLEN AND SORE, DO NOT FEEL INLARGED LYMPH NODES, JUST SORE BREAST AND UNDERARM.

Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202. Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.

breast tender; Right breast nipple very itchy; breast felt a bit full; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 06Feb2021 at 16:15 (at the age of 70-year-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6202) via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history included menieres disease and the patient was allergic to iodine, sulfa antibiotics, shellfish, fish, mushrooms and animals. Concomitant medications included triamterene/hctz (hydrochlorothiazide) 37.5/25 (unit unspecified) (MANUFACTURER UNKNOWN), travoprost (TRAVATAN), timolol (BETIMOL) and levocabastine hydrochloride (ZYRTEC) for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 (3-4 days after vaccination), the patient experienced right breast nipple very itchy and then tender. The breast felt a bit full and slightly tender. It was reported that, the patients symptoms were improved, then felt of fullness and tenderness in right breast again after second dose. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events itchy, breast heaviness and breast tenderness were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Left upper arm pain and redness Rash left upper arm to left mid forearm Swelling and tenderness left axilla Swelling and tenderness left breast

Pt recived her 2nd pfizer covid 19 vaccine on march 28th. hospitalized 3 weeks later with chest pain and possible new breast lesion and non specific lung nodules and elevated d dimer. -cardiac cause ruled out - seen by cardiology -Pt with tender pea sized nodule to 9 o clock position of left breast which reproduces her pain. ordered breast u/s of the area asap as out pt CT scan chest showing Non specific Multiple bilateral lung micro nodules, none measuring larger than 4 mm.

On the day of the vaccination, March 27, 2021, I had a sore arm and a headache. The next day I was lethargic and felt mild chills. These seemed like flu-type symptoms. On the third day, March 19, I felt fine during the day, but by 10 pm, my breasts were warm and hurting. Over the next 5 days they got much worse. My nipples were noticeably swollen, hot to the touch, and so sore that I couldn't wear a bra or a blouse that pressed on my skin. Overnight I had discharge from my left nipple (about 1/4 teaspoon worth on my night clothes); this occurred again on the next night. By the 5th day, my breasts felt mostly back to normal.

Shot administered in right arm. Swelling/fluid build up under and right area of breast around armpit. Soreness and tenderness in and around area. This occurred after the second injection of the Pfizer vaccine. Currently length of time for swelling is now 3 months exceeding recommended time for swelling to go away. Swelling still exists and there seems to be no remedy.

got my period again; got my period again; Shingles; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via intramuscular, administered in Arm Left (she thinks) on 26Feb2021 as DOSE 2, SINGLE for covid-19 immunisation (possibly received second shot at 28 days). The first shot of bnt162b2 was received 28 days before dose 2. The patient medical history and concomitant medications were not reported (When probed for any concomitant products and medical conditions, the caller states she didn't change anything, every thing was the same). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not having any other event. The patient all of a sudden got period again on an unknown date. The patient also reported also got shingles about a week ago on 16May2021 (Right after the shot, she had gynecological problems. She is 71 years old and all of a sudden, she got her period again. A week ago, she got shingles. She just wanted to confirm if things like this has occurred with other people). Biopsies were taken and they were negative. She also had a sonogram done (When probed for results of this testing, the caller states she was told she has a very thin lining and if she starts bleeding again, she may have to have surgery). She was informed if her period started again, she might have to have surgery. She confirms she is not bleeding at this point. Right now, everything is okay. It's just that she is 71 years old and all of sudden, she got her period again. She still has the shingles but she is not contagious as she took viral medication and just finished it. She explains she went to an urgent care. She clarifies Sunday, 16May2021, she woke up and all the shingles were on the left hand side of her face. She had a visit with her primary care physician for the event (got my period again). Outcome of all the events was unknown. Information on the lot/batch number has been requested.

Vaginal bleeding; excruciating headache; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199, Expiry date: 30Jun2021) via an unspecified route of administration on 04Mar2021 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced excruciating headache and on 10Mar2021, she experienced vaginal bleeding. She does not think call handler can help, but she had the first dose of the shot and the side effects, aside from what was listed, she has excruciating headache, four to five days after the dose and bleeding, clarified to vaginal bleeding, like menstrual cycle. Both started a few days after the shot. She further clarified and said she got the first dose date of vaccine 04Mar2021 and 3 to 4 days after was when her headache started. She later clarified the excruciating headache started on 07Mar2021. She states the headache was still ongoing. Bleeding started yesterday morning. She states the bleeding was still ongoing. Caller states she will not do the second dose. She said it will kill her. She regrets that she did it because it was unproven. We only know what reactions are today but she does not know what is going to happen to her in the future. Besides it was so frightening. She said she was just rambling right now, maybe in a year or in the fall when they have new stuff coming out, she does not know but it was not proven. Outcome was not resolved for both the events. No follow up attempts are possible. No further information is expected.

Two days after vaccination, I experienced vaginal bleeding which has continued until today (2/21/21), and has shown no signs of stopping. Question: should I take second dose on March 5 or at any time thereafter?

Had muscular pain in pelvic area and in back. Had to take Tylenol for pain. Lasted all day but gone today, Thursday March 18, 2021. I feel fine today.

Lymph nodes under Right arm swelled and it was painful down my whole arm. Swelling and pain was even into the right side of my breast. I also had some loose stool. These lasted about 2 weeks. I used ice packs under my arm and on my breast and that helped quite a bit. The swelling went down a bit every day but was still a bit painful. I still have a bit of pain but nothing extreme like before. I had no fever, nausea, or pain in any other part of my body.

Dizziness ,nausea, diarrhea, first and second day . Blurred vision still present sometimes. Very steep drop in blood pressure. I?m treated for high BP with Norvasc , but after vaccine mu BP was 102 / 46 and is still like that at night . During day time became very unstable . Very disturbing side effect was vaginal bleeding on the 3rd day after vaccine . Never happened for 20 years post menopause .

itching started all over; extremely exhausted; very sick; terrible rash; trouble with breathing; she feel lumps under the chest; very nauseous; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection), via an un-specified route of administration on 28May2021 (at the age of 72 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient got the vaccine on May28, three days later (31May2021) patient broke out in a terrible rash; then itching started all over and the rash has ex-tended, She was extremely exhausted and she feel lumps under the chest and indicated something is wrong; she was getting very sick, she has no strain, she was getting worst and now she was having trouble with breathing and she was very nauseous. Additional Context: Reporter stated, "I just talk with my sister, I just want to know how many people have gone through with Pfizer, My sister got the Pfizer vaccine, she can hardly talk, I just spoke with her and she just can't deal with it anymore, she got the vaccine on 28May, three days later she broke out in a terrible rash and then itching started all over and the rash has extended whenever the pharma-cist need couple of check they said Oh my god what is wrong with you, now this was 28May. Today not only she had rash and extreme itching that is not gone, Now she is extremely exhausted and she feel lumps under the chest and indicated something is wrong, she is getting very sick, she is really exhausted, she has no strain and I don't know whom to concern from Pfizer". Reporter was informed about the Pfizer Medical Information and asked to provide the number. Reporter added, "We had an online interaction with the doctor couple of weeks ago, she prescribed the Prednisone, anti-histamine and she prescribed the cortisone cream, nothing helping her and she is get-ting worst and now she is having trouble with breathing and she is exhausted and she is very nauseas and I don't know who to contact in Pfizer and I also want to know if anybody else had a reaction with Pfizer with this vaccine". Reporter was informed about the role of Pfizer Drug Safety and also informed about the Pfizer Medical Information and asked to provide the number. Reporter was again informed about the Pfizer Medical Information and provided with the number as and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM. Reporter added, "I did and I connect to you". Reporter was again requested to dial the option 3 after dialling the number. Re-porter added, "I am saying if it's your sister and she is extremely suffering and I can't be there." (Incomplete sentence). When requested for probing, Reporter stated, "I actually wrote a letter to the CEO of Pfizer and that's why # called me she was # she called me but yesterday my sister was not bad as today, they gave me some information and she said it was the legal department, you can write to the legal department but I am worry about my sister, I feel like she is going to die from this vaccine, it has really affected her". Reporter was again informed about the Pfizer Medical In-formation. When Probed for Calling Pfizer first time for this incident, Reporter Stated, "Not that really, yes I called, No it's not the first time, I had a number, I have the number and I have the Pfizer Medical information number." (Further not clarified hence captured as Initial report). Reporter stated, "Not taken the 2nd shot, she was suffering from the first one, yes she only took the 1st shot and three days later she get ill." Treatment: Reporter stated, "Yes, she call doctor, she put on steroid and Prednisone, a cortisone cream and an anti-histamine (Unspecified Medication), doctor prescribed doxepin but it wasn't cover by and she wasn't going to pay. Dose of Medication used as treatment, Reporter stated, "I will have to ask for the dose, I don't know the dose, it's my sister." When Probed for Route of administration: Reporter Stated, "What is that mean, Oh my god it's so difficult. Therapeutic measures were taken as a result of events with Prednisone, a cortisone cream and an anti-histamine (Unspecified Medication). The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR). Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown. Additional Information is requested.

had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ENE202), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:00 as 2nd dose, single for covid-19 immunisation. Medical history included pain in extremity. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, A female consumer had both doses of Pfizer COVID vaccine on 06Feb2021 and 27Feb2021. She had a mammogram on 21Apr2021 and had a bad reading. She has a 3mm mass or cyst and they are not sure what it is. She was talking to her physical therapist who told her that you have to wait 3 months after your last vaccine for a mammogram because there have been having false readings. She has been wondering if that was true. The outcome of the events was unknown on 21Apr2021.The patient underwent lab tests and procedures which included mammogram abnormal: 3-millimetre mass or cyst on 21Apr2021 Bad reading on mammogram; 3-millimetre mass or cyst. Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included. Information on Lot/Batch number is available; Further information has been requested.

Beginning 4 days after shot and running for 8 days, had significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, e.g. standing straight, bending, getting into bed, moving around in bed. Pain moved around - intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Normally active, flexible, healthy, mentally alert, more like a 50 year old. Weight appropriate for height. Eat well and pay attention to staying healthy. Don't like taking medication, so only took one tylenol when temp got to 100.8.

Pain in left mid-thigh, and pain in left lower back pelvic area. Taking Advil during past four days. Appointment with orthopedist is scheduled for 02/22/2021.

headache; Pimple on right breast; achiness; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm on 04Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, at about 4PM, then that night in the evening the patient had a couple reactions from the first dose. The patient stated that she was achy and had a headache. The patient stated that her achiness was not bad at all, and she had gone through much worse and stated that achiness lasted for just one evening. The patient was not sure whether she had last effects of it or if she was just old. The patient also stated that she experienced her headache prior to the first dose and she actually has a light headache almost everyday. On 16Feb2021, the patient had a sort of broke out, like there was a pimple on the breast. The patient stated that it is just one pimple and it has the size of a nickel. The patient stated that the pimple was on her right breast and she put some salve on it. She was scheduled to take the second shot on 25Feb2021 but she couldnot get through it and was supposed to get it next week. The patient wanted to know whether she was late in getting the second shot. The outcome of the events was resolved achiness, while the patient had not recovered from the events of for headache and pimple on right breast. No follow-up attempts are possible. No further information is expected.

Neck swellling with in two weeks of the injection, no pain initially. April 13, 2021 diagnosed with pneumonia, Chest x-ray & treated antiobiotics & steroids at Urgent care; nearly resolved with 7 days. April 21, 2021 appointment to scan neck ultrasound & scan lungs. Experienced a panic attack Experienced increased breathing on May 29, 2021 admitted the hospital for 5 days. Found lump on breast. Wanted to insert stint in my heart which they couldn't perform due to a mass on my left breast. Biopsied Left breast. Still do not know results.

significant abdominal aches; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; pains in hip, pelvic areas as well as mid-spine to lumbo-sacral areas; Temperature range 96.2 to 100.8; night sweats; At times had hard time getting around, e.g. standing straight, bending, walking, getting into bed, moving around in bed; Sleep interrupted for 8 nights sometimes for long stretches; Pain moved around intense in one area and then 6, hours later, intense in another area; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL1283) via an unspecified route of administration in right arm on 26Jan2021 at 12:45 (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunization. Patients medical history included osteoarthritis. Patient was allergic to sulfa drugs. Patients concomitant medications included Calcium, Magnesium, Cranberry and Vitamin D NOS for supplement. Patient did not receive any other vaccines within 4 weeks prior to 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 30Jan at 15:00, patient experienced significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, example like standing straight, bending, walking, getting into bed, moving around in bed. Pain moved around intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Patient don't like taking medication, so only took one tylenol when temp got to 100.8. Never had this kind of reaction to a vaccination. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature: 96.2 100.8 (unit not provided) and pain assessment 2-7 on 30Jan2021. The outcome of events was recovered on 06Feb2021. Follow-up attempts completed. No further information expected.