Pfizer

and her twin sister all got their first period two weeks after vaccination. They both have brown spots for a day or two only, no heavy flow. Their pediatrician said they won't have period for another year during their health check on March 2021.

After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms: Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist, threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47. Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist. She still has an NG tube for nutrition and continues to have GI and urinary retention problems.

vomited small amt 6 minutes after the vaccination. She also c/o lightheadedness and stomach cramping. is menstruating at present. Assisted lay on Yoga mat with legs elevated. Her VS were taken. Her BP was 100/58, P 65;R18 and O2 sat 99%. stated she felt better after lay on yoga mat. Assisted sit up on Yoga Mat at 1:55PM ; VS taken sitting: BP 90/56; P90: Resp 18 and O2 sat 98%. admit she did not drink much water before she came and her menstrual period is heavy. instructed to drink water and electrical flds provided to her while sitting on mat which she did. Her heart rate went back to 70 and her BP went up to 100/60 sitting. At that time states she feels good and she went back to her chair. Observed for another 10 minutes and she left the site with her mother at 2:10pm completely recovered.

My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the second day. Felt very lethargic, fatigue, laying in bed all day, sleeping. She still had nausea also experienced chills, highest temp 99.8F. Her arm pit on the right side where she got the vaccine was really sore. She basically like within a couple of days she started her period cycle again and it was very heavy and lasted one week and half almost two weeks. On 06-08-2021, at about 10pm, she was brushing her teeth when she saw black spots and she went to tell me. At about 11:30pm that night, she squatted to pat our dog and when she got up and she felt really dizzy, lightheaded so I got concerned. Her symptoms persisted and I scheduled an appointment with her pediatrician on 06-15-2021. The pediatrician ruled out anemia. Her pediatrician said she has Postural orthostatic tachycardia syndrome. Her pediatrician said that this is something manageable, she needs to strengthen her calf muscles and drink lots of water. They monitored her heart pressure and blood pressure. Her heart rate had increased to 40bpm. I also gave her Ibuprofen medication after the vaccine. Leading to today she has been having dizziness and light headiness every single day. My daughter is still experiencing symptoms, dizzy and light headed today. For her 1st vaccine- within few days after her 1st dose, she experienced when using the treadmill, she would feel very dizzy. I did not think anything of it at first and this happened three times then it stopped. She also had a sore arm.

Menarche 1/7/21. Periods came: Jan: 7-15 (9 days) Feb: 2-8 (4 days) then again Feb 24-25 (2 days) Mar: 17-21 (5 days) Apr: 7-13 (7 days) May: 8-13 (6 days) FIRST DOSE COVID VAX May 21st June: no period this month. SECOND DOSE COVID VAX June 11th

She has not gotten her period since her first shot (beginning of April)/ had her second one she still hasn't had her period; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old), as a single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother was inquiring about the Pfizer BioNTech COVID19 vaccine. She mentions they all had it no problem. The last person who got it was her 12-year-old daughter. Her daughter has had her period for 2 years. Right before she got the vaccine, she was due for her period. She has not gotten her period since her first shot (beginning of April). Now she's also gotten her second shot and it still did not come. She feels like the only difference in the daughter's life was the vaccine. She wanted to have more information to know how to move forward. She says it's "out of the ordinary, nothing like this has happened since she's gotten her period". Mother wanted to know if we have any reports on the subject. What information was available regarding menstrual changes. There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This is not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. In teens, it is also important to note the natural variability in cycles due to the normal maturation process and the large range of normal menstrual cycles in the first few years after the onset of menses. Stress and weight changes, which have also occurred in many adolescents during the pandemic, can themselves cause these changes. COVID-19 vaccines can be used during puberty and that irregular periods are a common part of adolescence and usually have a wide normal range. The outcome of the event was reported as not resolved. Information about lot/batch number has been requested.

She presents complaining of tenderness over the left breast. Pain began this morning and worsened after a friend socked her in the left arm. Pain is rated 7 out of 10. Approximately, 15 minutes after sucking a 325 mg ASA in the Office pain is down to a "2."

Menstrual cycle has been delayed after receiving first dose. It was on clock work before that. Still monitoring.

Pt missed her menstrual cycle this month. She has been menstruating regularly since age 11 and 5 months without ever missing a period.

Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: 26hrs after 2nd shot, patient passed out & fell at home & brother caught her. 5 seconds later, she tried to get up but collapsed again & siblings saw her spasming for few seconds before regaining consciousness. She immediately complained of ringing in ears/fatigue/dizziness which resolved 40 minutes later. mother confirmed no history of seizures/fainting. menstruating now

Abnormal menstruation. Heavy clotting without normal flow. If in resting state, clots build up and once released there is no flow in between.

Her period had advanced and the bleeding persisted; Headache; This is a spontaneous report from a contactable dentist (Patient's mother reported for her daughter) via medical information team. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date (at the age of 13-year-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation and her period had advanced. Patient's mother reported that she was a dentist, and a mother of 13-year-old. She took her daughter to get the COVID-19 vaccine and noticed that she did not show any reaction during the first dose only her period had advanced. On arrival the second dose plus a reported headache the bleeding persisted. Patient's mother took the patient to doctor yesterday and learned that this was a severe vaccine reaction in her opinion. The patient's mother would like to know if this could compromise patient's health in the future (mainly reproductive) because patient's mother not calm in knowing. The patient's mother reported events as non-serious. The outcome of the event headache was reported as unknown and for another event outcome was reported as not recovered. Information regarding the lot/batch number has been requested.

1. Intense bloody nose that bled for 35 minutes, very heavy flow and had a hard time stopping it. 2. Menstrual cycle started 13 days early with unusually heavy flow and cramping.

Patient has had menses since that first vaccine and it has not stopped to date of this report (2 months). Prior to this, had menses q1-4 months over the past year, lasting 7 days. No other changes other then vaccine. I did order labs today to further investigate.

prior to vaccine she had very regular periods for 12 months. After second dosage of vaccine, she is having cramping, clots, and periods about every 2 weeks

Longer than an 8 day menstrual cycle. At first I didn?t think this was weird but it turns out that many of my women friends are experiencing longer periods, and friends who went through menopause a long time ago are having hot flashes like menopause again. I know of about 6 people now. So that?s when I thought my daughters extra long menstrual cycle could be an adverse event.

Caller stated that 12 hrs after shot his daughter had expected side effects...chills, headache and nausea which lasted 24 hrs. 2 days later she had a very painful very heavy period 2 wks early. (dad stated period has always been regular until after shot)

Daughter is on birth control, and finished her cycle 2 weeks a ago and has started again today. She?s been on birth control for a year and has been regular since. I will be calling her gynecologist today.

Terribly painful menstrual cycle after the 2nd vaccine. Very painful was the description by patient. Since the cycle is coming to an end she indicated she was beginning to manage better but we don?t know what this means for future cycles.

After receiving the vaccine, her subsequent period was anything but normal.; A cycle lasting twice as long and heavy with blood clots is not a fluke.; After receiving the first dose, we are going to delay the second dose until more data is collected; This is a spontaneous report from a contactable other HCP. A 14-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: Was not reported), via an unspecified route of administration on an unspecified date (14-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after receiving the vaccine, her subsequent period was anything but normal, a cycle lasting twice as long and heavy with blood clots is not a fluke, and after receiving the first dose, we are going to delay the second dose until more data is collected. The outcome of all the events was unknown. Information about lot/batch number has been requested.

The next day after vaccination the patient started having vaginal bleeding that lasted for 30 days. She was even bleeding out clots of blood

Regular period started on June 8th. Period lasted for 3 weeks after receiving vaccine. She then started her period again June 28th. Periods have been heavier than normal with increased cramping.

two days out from when her menstrual cycle should have began; This is a spontaneous report from a contactable consumer (patient's Mother). A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration, in left arm, on 21May2021, at 08:45 (at the age of 14-years-old) as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother reported that her daughter received the first dose of Pfizer Covid Vaccine this morning, 21May2021, at 08:45 and daughter was at least two days out from when her menstrual cycle should have begun, no serious heavy bleeding (in May2021). Outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Pt. called me crying in pain saying her stomach hurts and she's having trouble walking. She said she has her menstrual cycle and it has never been this bad. She said she didn't get it last month at all. Prior to this, she said her cycles were normal. She also had pain in her thighs and trouble breathing which resulted in her needing her rescue inhaler. At this time she has been given ibuprofen and is resting with a heating pad. I as pts. mom am concerned that this may be related to vaccine.

Monday night was up all night with severe cramps & began vomiting; Monday night was up all night with severe cramps & began vomiting; This is spontaneous report from a contactable consumer. A 14-years-old (Adolescent 12-17 Years) non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0173) intramuscularly, administered in right arm, on 13May2021 (Thursday) at 16:00 (at the age of 14-year-old), as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no known allergies. It was reported that, patient started period on 15May2021, Friday night on schedule. On 17May2021, at 10:00 AM, the patient had started experiencing severe cramps on Monday at school. It was reported that patient never had cramps before and has been having periods for 14 months. It was reported that Monday night was up all night with severe cramps and began vomiting. And still experienced cramping on Tuesday morning with vomiting. No treatment was received. The outcome of the menstrual cramps severe was resolved on 18May2021. The outcome of the event vomiting was not recovered. Follow-up attempts are completed. No further information is expected.

made her four days late for her monthly menstrual cycle; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reporting for a 14-year-old female patient (reporter's daughter) that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, Expiry Date, NDC number, UPC number: Unknown), via an intramuscular, administered in left shoulder (Arm Left) on 21May2021 at 12:30PM (vaccinated at the age of 14 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included asthmatic. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma (she was currently not taking any medications. She had an inhaler. She would use it as needed. She had not used it). The patient did not receive any other vaccine 4 weeks prior to COVID shot. no investigation assessment done. For the first dose it made her four days late for her monthly menstrual cycle on an unspecified date in 2021. No treatment received for event. The outcome of event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected

she was always regular with her period. she was due to get her period on June 21. She never got it. She finally got it during the week of July 19th, but only for 2 days and very light. Usually she is regular, with a 28 -30 day period cycle. Last about 6 days, usually comes with a lot of back pain and starts light, then heavy, then light as it ends. It was very strange she not only missed it, but the following one was for 2 days and more spotting then an actual flow.

since receiving second dose of COVID vaccine in JUNE, my daughter has not had her menstrual cycle since MAY 2021

3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk - she had extreme pain with urination and defecation. She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.

Driving her to school this morning, she had a grand mal seizure for a little more than a minute...a couple hours until back to communicating. She's recovering perfectly as usual. She has them occasionally (every few months) but normallly driven by her menstrual cycle which is not coming up and made this uncommon. I just wanted to report it so you have the information. It could be in the birth defect category below, but I'm not a doctor so not sure and selected none of the above.

My daughter had started her menstrual cycle a day or two prior to receiving the vaccine. She has had her cycle since August 2020. Her bleeding became VERY heavy after receiving the shot, where she was bleeding through super plus and ultra tampons in just a couple of hours. She is still bleeding like this 6 days later. It has not stopped. Her regular periods are quite lite and nothing like this.

already had her period and started having heavy bleeding 2 days after the vaccine; This is a spontaneous report from a contactable physician (patient's father). A 15-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 15 years on 13May2021 05:30 (Lot Number: EW0173) as single dose for covid-19 immunisation. Medical history reported as none. No know allergies. The patient's concomitant medications were none. No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID. vaccine Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had already had her period and started having heavy bleeding 2 days after the vaccine on 15May2021. No treatment received. The outcome of the event was not recovered. Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bleeding menstrual heavy cannot be excluded. The case will be reassessed if additional information becomes available. 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.

5/25 vaccine; 5/27 menstrual cycle began; 5/28 much heavier menstrual bleeding, 5/29 mild epistaxis noted, sister sick with viral URI symptoms, 5/31 patient began to have cough, congestion, body aches; later noted bruising to right upper arm and right hip with no known trauma; 6/1 petechia to lower extremities; 6/2 started new oral contraceptive pack; 6/3 continue w/ menorrhagia & noticed many clots (very atypical, usually menstruation ceases at this point) 6/4 seen by PCR, CBC w/ platelet count 2,000, sent to hospital

Patient had started her period prior to the vaccine on Sunday. On Monday, she described having the worst cramps and nausea she'd ever had and bled through a tampon in a short period of time. She had to go home from school and hates to miss school. This was very unusual for her.

Very heavy period began, 2 weeks ahead of schedule. Much heavier bleeding began after about 12 hours and has continued for 3 days. This level of bleeding is not typical. Many blood clots have also been passed.

Pt reports she had her first dose of Pfizer Covid vaccine on 5/17/21. The following week she had a very heavy period that lasted longer than usual with severe cramps and occasional lightheaded/dizzy spells. After her cycle ended, she continued having brief episodes of dizziness, usually when going from sitting to standing, usually resolved quickly (after a few minutes) with rest. Over the past two weeks, the episodes have become more frequent and intense, and over the past few days episodes also include s/s of seeing spots and having blurred vision with nausea, SOB, and palpitations/tachycardia. Tonight while at lacrosse practice, pt suddenly became dizzy and felt like she might pass out, became diaphoretic and pale.

4-5 days after dose # 1 she started with heavier than usual vaginal bleeding, passing clots, persisting in the 10-15 days following with dizziness, HA, fatigue, heart racing

Patient had always had regular periods. Had completed her last period May 22-28. Received the first vaccine on May 30th. Started with vaginal bleeding 6/7-6/11 and again 6/18-present.

Severe menstrual cramping -doubled over, crying, in pain, vomiting, heat sensitive and light sensitive, dizziness.

Bleeding excessively; It was 4 days early and was the worse period she has experienced in 3 years; Extreme cramps; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female (non-pregnant) patient received 1st dose of BNT162B2 (lot#EW0196) on 30May2021 11:00 AM, vaccine location=Left arm at single dose for COVID-19 immunization. Relevant medical history was Asthma. No any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination included salbutamol (ALBUTEROL), paracetamol (TYLENOL) as needed. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps on 02Jun2021. We thought maybe it was a coincidence. She is only 15 yrs old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun2021 and I pray it was not as bad as last month after the shot. Outcome of reaction/event at the time of last observation was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts needed. No further information is expected.

Abnormal menstrual cycle started on June 25, the day after dose 2; she already had a period June 10-16. This involved increasingly heavy bleeding, with large blood clots. My daughter became very pale, weak on the morning of Mon, June 28, she fainted, then vomited. Made dr appt and got bloodwork. Started her on iron supplements. Dr said the hemoglobin was at 10.6, but had us get blood checked 3 more times, lowest hemoglobin was at 7.3.

Abdominal pain the evening of July 10th. Vaginal bleeding during the night of July 10th, 2021. Menstruation not expected for 5 days (not until July 15th). It (vaccine) may be coincidental and not the cause. Abdominal pain subsided the night of July 10th (lasted a few hours). Two nurse lines were consulted the morning of July 11th. Both recommended reporting to VAERS. Bleeding continues.

Menstrual period started 5 days after 2nd Covid vaccination. It was MUCH heavier then normal and it lasted for 11 days. Previous periods last about 7 days. The period after that started on the 20th day after the above mentioned period started (only 9 period free days between cycles). Will wait to see if cycles return to normal

Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21). The bleeding was very heavy (changing overnight pads every 1.5 hours) and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate. Sent for CBCs which showed drop in hemoglobin. Bleeding stopped 6/29 and restarted briefly on 7/3. Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.

About 30 hours after receiving the 2nd does of the Pfizer vaccine (6pm, June 24), my daughter started experiencing severe neck pain concentrated around the base of her head and eventually extending down her neck and shoulders. Her neck was very stiff and she had a constant severe ache. We treated it with moist heat (wet hot towels) and when that failed to work, gave her Advil even though we usually avoid it given her single kidney. The Advil provided temporary relief. The pain subsided on its own after about 3 days. My daughter also got her period off cycle two days after receiving the second Pfizer dose (June 25.) She is on a BCP for acne and was taking the active pills at that time so did not expect her period. It lasted nearly 2 1/2 weeks even though she was on the active BCPs the entire time. The flow was never as heavy as a typical period but it was more than spotting.

Caller stated 2 days after the vaccine, patient had a cycle that was short. She spotted for a week after that. Patient has not had a cycle for July. Patient is not sexual active. Patient is six days late as of July 28th. Patient first started having a cycle December 2019. Patient has kept track of cycle since the beginning and has not been late or missed any cycles.