chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine changed my menstrual cycle. It increased the average duration of my period from 6 days to 9 days.; It also shortened the length of time between my cycles.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ER 8730) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "The vaccine changed my menstrual cycle. It increased the average duration of my period from 6 days to 9 days."; POLYMENORRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "It also shortened the length of time between my cycles.". The events "the vaccine changed my menstrual cycle. it increased the average duration of my period from 6 days to 9 days." and "it also shortened the length of time between my cycles." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oligomenorrhoea, polymenorrhoea.  Additional information: 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. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
BNT162B2: COVID-19 Treatment; BNT162B2: COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE taken in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 17Jul2022 to 21Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. woke up early AM c/o severe burning in her throat w/ sporadic coughing. Had also taken 1/2 AMBIEN (2nd time she had that med ever.) No SOB. Went back to sleep propped on pillows. Rest of that day no burning, and sore throat, cough resolved.
such as passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (such as passing out) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (such as passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (such as passing out) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.  Company comment: This spontaneous case concerns an adult male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness, with an unknown time to onset, after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness, with an unknown time to onset, after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Client stated two weeks after her first Pfizer dose, she experienced one day of heavy period with clots. This lasted one day and then her period ended when expected. She received her second Pfizer dose per guidelines.
12 hours after 2nd dose, I had the worst headache lasing a day and went away. I had my annual physical and I told her about my pain in my calves, mostly the left. She order the doppler and it wasn't covered by the insurance and did not do it.  Having COVID now, the headaches started in 11Oct2021. Went to urgent care on 12Oct2021. Only had headache. I had COVID before in Mar2020.
mild nausea, headache, sore muscles more-or-less throughout body, fatigue
Information has been received from a physician concerning a 25 year old female who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, the patient fainted.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from an office manager refers to an unknown number of patients of unknown age and gender. On an unknown dates in 2016, reported as since August 2016, the patients were inadvertently vaccinated with doses of ROTATEQ lot # M004883, expiration date 02-OCT-2017, expiration date 30-MAY-2018 that had been improperly stored. No adverse event was reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 30 minutes. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent to contact a healthcare professional.
Dry heave. BP 132/111 (pulse 82). Benadryl 25 mg PO given.
Fast heart rate, dizziness noted a couple of hours, post vax. Advised to go to ER. He states that he did and was briefly observed and released without intervention, symptoms resolved.
Breakthrough COVID-19 infection. Pt received Pfizer on 6/3/21 and 6/24/21
18 Nov 08 Afternoon Knot, redness, swelling, and hot to the touch of right arm. Evening Fever started along with flu like syptoms.  19 Nov 08 Morning More swelling of the arm, redness, itching, hot to touch.  Face & neck swelling red and blotchy. Joint stiffness & pain of upper body.  Rash right above injection site. Vomitting, dizziness, headache.
Varicella rash on 8/17/05 despite, Varivax on 12/16/02 .
Began feeling feverish and generally not well around 2 pm. Fever was 100.4 by 5:30 pm; went to sleep, and when I woke up at 8:30 pm it was 101.9. Took 2 regular ADVIL and fever started to decrease and broke around 10:30 pm. Fever gone by 6:00;am and felt better by 9:00 am  Also, injection site was sore and very red. Redness has decreased in intensity and size, but still present at 4:00 am. Soreness has also slowly decreased, but still achy at 4:00 am.
Hives on legs about 5 hours after the vaccine was given.  Lasted approximately 24 hours.  Took Benedryl for 24 hours.
Pneumococcal 0.5cc given SC @ RA per MD order and patient consent. Presented with warm, reddened, and swollen area. Slightly below the injection site down to the elbow . Instructed 03/30/2005 to elevate, ice packs, and Tylenol/Motrin for sx of arm and recheck arm on 03/31/2005 @ office.
My daughter complained for a few weeks of leg pain. She started out with a few red bumps. On the morning of December 24th, the rash had spread and moved down her leg. Took her in to Urgent care bc it was Christmas Eve. Diagnosed with Chicken Pox. On Tuesday, December 27th I took her back to Urgent care to have rash looked at because the chicken pox had not spread beyond her leg. It was determined that my child in fact has shingles and not chicken pox. At the age of 3.5, my child has shingles.
Nodule size of silver dollar a injection site. Redness radiating towards elbow. Hot to touch as well as painful at touch.
This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 16-SEP-2017, the patient was vaccinated with improperly stored M-M-R II, lot # M045392 17-NOV-2018, and VAQTA, lot # N008823, expiry date: 26-MAY-2018; dosing details were not reported, both for prophylaxis. The lot # of M-M-R II was reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Itchy rashes across torso, thighs, and arms started to appear. Itching is not extreme but noticeable and bothersome throughout the day. Have taken over the counter Zyrtec and Benadryl but has not taken it away or reduced discomfort.
Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 07-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine for the intended purpose of prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed and was diagnosed with shingles on two separate occasions. As a result of the shingles outbreaks, the patient has developed and continues to suffer from and seek treatment  for persistent severe post herpetic neuralgia. As a direct and proximate result of ZOSTAVAX vaccine, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was unknown. Causality assessment was related. Post herpetic neuralgia, persistent strain of herpes zoster and vaccine did not prevent shingles as intended were considered disabling. Additional information has been requested.
Onset after one week of receiving vaccine. Weakness and numbness in both legs, pins-and-needles sensation in foot, toes, forearms, hands, fingers, fingertips, hip. Pain in thighs and lower back. Ongoing symptoms, no treatment available.
Right arm where injection was administered on second and third day has large raised red circle about 3" diameter around the injection site.  The right arm muscle is hard. The second day the red circle did not itch.  The third day (September 18) the red circle got darker and started itching.  The arm muscle at injection site on third day September 18 is still hard.
Family friend of the wife, called our pharmacy on  04/28/2021 and reported that wife's appointment would need to be canceled for 04/29/2021 because her spouse passed away the previous night. This prompted our staff to look further and it was noted that her spouse, received his first Moderna vaccine on 4/26/2021 at our pharmacy. Friend was not reporting his death due to the belief that the injection was the cause. Only to report, so upcoming appointment for his wife could be canceled.  It was reported to our Medical staff that Patient n has Chronic COPD and had difficulty breathing on the evening of 4/27/2021 and was taken to the hospital where he later passed away.  Patient was on portable oxygen and resembled shortness of breath while ambulating at the time of his vaccination appointment on 4/26/2021. Patient immediately recovered from Shortness of Breath once seated in exam room for injection for a few minutes.
The next morning after the vaccine my fingertips went numb at 10 am.  This numbness persisted approx 8 hours despite my pumping my arms and flexing my fingers, which would normally get circulation pumping and alleviate "asleep" finger feeling that might occur on a rare occasion.    The numbness in my digits came back a week later on Tuesday, July 13, and was later followed about an hour later by a tingling burning feeling in my hands late Tuesday night.  It was uncomfortable and kept me from sleeping much the night.  Now it is Wednesday, July 14 and my hands are better and I don't feel that prickly sensation at this moment of writing this report - just a bit of fingertip numbness.   I would like to be contacted regarding what step I can and should take regarding my numbness and prickly hands.    I also had injection site soreness for 5 days after the vaccine on my left shoulder.  That is now better.
Mom called office and stated child was given immunizations in left thigh, stated leg swollen hip to knee, warm to touch.
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported.  4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
Inflammation of cerebrospinal fluid increasing size of previously asymptomatic sacral Tarlov cysts to 4-5 cm causing debilitating pain, loss of function, and nerve impacts. Symptoms began to be noticeable 3 days after booster. Symptoms became so severe that three trips to the ER were required over the next three days.
p/vax pt devel small red bumps that disappeared w/in a day;pt exp 20 vesicular lesions;pt was seen by MD & dx w/chickenpox;
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA298692, 2018SA298603, 2018SA297575 and 2018SA298695 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route and site of administration arm nos on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage (patients were injected with this previously frozen FLUZONE HD). It was reported that patients were injected with previously frozen FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
a slight headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a slight headache on an unspecified date. The patient reportedly took 2 tabs of paracetamol (TYLENOL) as treatment. Outcome of event was unknown.  Information regarding lot/batch number has been requested.
Patient's daughter reported malaise, fevers, nausea, labored breathing X 24 hours. Patient's physician contacted who requested the information on the vaccine.  Symptoms reported as improving.  Daughter reported similar reaction to the high dose vaccine in previous year.
I had a stroke affecting the left side of my body.  The stroke was in the pons area of my brain stem.  I noticed tingling in my left hand and the bottom of my left foot.  I assumed it was just my back being out a bit and was going to get it put back in line the next day.  When I woke up on Friday 4-23-21 my left side from the top of my head to the bottom of my left foot was numb and tingling.  I went to the ER at that point to find out about the stroke.
The night I developed chills and I was up with chills and shivering and a low grade fever and body aches. I just ached all over. The next day I had fatigue, body aches and developed hives on the trunk of my body-my back, my stomach, groin and arm pits. I went to Urgent Care, I took topical Benadryl and slept most of the day. They hives went away the evening of the day after the shot. The fatigue lasted a long time. The hives were a surprise for me and made me suspect an allergic reaction because they lasted two days. Since then I've been okay, just really tired. When I spoke with someone at Urgent Care, he had prescribed prednisone and Claritin, and Pepcid, but I didn't take any of those. I just took Benadryl. I had been running a fever of about 2 degrees. He did say that I might want to be careful about another shot because i could have anaphylactic shock next time.
The patient described severe joint pain from waist up with pain in bilateral shoulders. Also arm pain left. The patient stated this reaction started at 1pm on 10/5/04 and was gone by 11pm.
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a nurse regarding a now 3 year old male patient who received a third dose on 11/19/02. Additionally, the child received a fourth dose to complete his primary series of Act-HIB on an unspecified date. In December 2004, he was diagnosed with autism. Relevant medical history was not provided. Indication for HIb-Titer Vaccine was immunization. Product was administered on 11/19/02. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Act-HIB administered as a fourth dose in the primary series on an unspecified date. Concomitant medications were not reported. On an unspecified date, the child completed his primary series of haemophilus B conjugate vaccine when he received a dose of Act-HIB. On 11/19/02, the child received a third dose of Hib-Titer. On an unspecified date, he was evaluated at a child development clinic and received a behavioral assessment (results unknown). In December 2004, he was diagnosed with autism. As of 5/12/05, the patient's outcome is unknown. Information regarding this event has been forwarded to the manufacturer of Act-HIB. No additional information was available at the time of this report.
Received shot in L deltoid muscle at 11AM on 1/17/22. About 9PM on 1/17/22, developed worsening pain in L arm pit region. By the morning of 1/18/22, developed severe swelling in arm pit, down to breast and across front of chest.  It is now 1/20/22 and the swelling and pain in the L arm pit region has not improved. It continues to be very painful to move, to the touch, and swollen. There is no swelling or pain at actual injection site though.
product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was mentioned that the vial was initially refrigerated on 22-Sep-2021, the vial did not undergo any temperature excursion and the patient did not experience any adverse events.  Treatment medication was not provided by the reporter
Fever, GI symptoms, headache, back pain, general achiness, nose bleeds, blood in urine