chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna; Heavy periods; Painful periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESTROVEN for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods). At the time of the report, MENSTRUAL DISORDER (In her 50's who had been menopausal for years and then developed her periods again after her second dose of Moderna), HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided  Patient reported that it is now September 2021 and she has gotten her menstrual cycle 4 times since Moderna vaccination
Patient received expired vaccine. Vaccine expired on 4/4 in the freezer but wasn?t noticed and sent to clinic who administered expired vaccine to patient on 4/5
he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 29Dec2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", SNEEZING (non-serious), PAIN (non-serious), FATIGUE (non-serious), RHINORRHOEA (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "sneezy achy fatigue had sniffles"; OFF LABEL USE (non-serious), outcome "unknown", described as "he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday". The lot number for bnt162b2 was not provided and will be requested during follow up.
SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash.  On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient reported that after PNEUMOVAX vaccine was given, through overnight. He felt numbness, and paralyzed in the morning to the site of injection. Pt was advised to make a visit to ER. Immediately.
Information has been received from a mother concerning her 15 year old daughter who was student with no known drug allergies or illness at the time of vaccination who on 26-MAR-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (Lot #655617/1447F). On 27-MAR-2007 (also reported as approximately 1 to 2 hours after the injection), the patient was lethargic and difficult to arouse. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. Additional information is not expected.
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
Patient called to state that her arm is covered in bruises from the flu shot. She described it as being very colorful and bruised to where she would not be comfortable to show in public. She was getting 6 month blood work and the technician there stated her arm was very bad looking and she should report to pharmacy. The technician told the patient the pharmacist put the shot into the wrong spot. This is the first time the patient has ever had this bad of a reaction from a flu shot. She stated it was discovered after the shot was given but today it was at its worst.
Pt has had DTaP 3x's as PEDIARIX combo. Temp about 102 with "twitches" of arms and legs at times for about 2 days. S/P PREVNAR, DTaP, VARIVAX vaccines on 5/20/08. Pt seen on 5/22 and had pharyngitis with exudate on tonsils.
Fever; Chills; Headache; Sore joints; Body Aches; Fatigue. Severe pain in left arm. I called my doctor's office after feeling very ill and described all symptoms. Was told there was absolutely no way it was possibly from the vaccine and I likely picked something up there during my visit. Even though they gave me a handout that has all these symptoms under "risks".
Vomiting/vomited fully intact second pill; Diarrhea; A spontaneous report was received from other healthcare professional on 10FEB2023 regarding a female patient (age: unknown) who had "vomiting/vomited fully intact second pill" (PT: Vomiting) and "diarrhea" (PT: Diarrhoea) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: 3003789) for typhoid for upcoming trip.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 08JAN2023 (Sunday), the patient began the protocol and took the first dose of Vivotif, followed by the second dose on 10JAN2023. Reportedly, the patient vomited the second dose, which was fully intact. On the same day, in the evening, the patient had a violent reaction to the vaccine with vomiting and diarrhea, and she went to the emergency room (ER), where she received fluids for the events, and she seemed to improve.  Furthermore, it was reported that the patient visited ER five times and was admitted to the hospital to try to determine what was causing her to be so "sick with GI issues".  The outcome of the reported events was unknown, at the time of this report. The action taken with Vivotif with respect to the reported events was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif and had vomiting/vomited the fully intact second pill (vomiting) and diarrhea. Considering the case information, the causality of vomiting and diarrhea is assessed as possible with Vivotif. The case is considered serious due to hospitalization of the patient. Vomiting and diarrhea are listed as per the Agency of Vivotif.; Sender's Comments: A spontaneous case report regarding a female consumer of an unknown age, with no reported medical history and concomitant medications, who experienced vomiting and diarrhea for which she had emergency room visits up to five times following the second dose of Vivotif with the that second pill being vomited in whole. She had intravenous fluids during the ER visits and was subsequently hospitalized. No information regarding the details and treatment of event was provided. The outcomes of the events were not reported. Diarrhea and vomiting are known effects of Vivotif; The causality of these events is assessed as related to Vivotif given the time to onset of the event and biological plausibility.
on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal  in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021
He passed out after 4th day of vaccination.  According to his wife, he drank one glass of wine, but lost consciousness and had a head concussion, nose bleed, and went to ER.  He is complaining massive headache right now.  ER doctor prescribed him Keflex and Gabapentin.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 03/05/2021 and 04/02/2021. They also received the Pfizer product on 12/01/2021. They tested positive for COVID-19 on 08/04/2022 and 08/05/2022, when they presented to hospital. I do not have any information regarding the reason for or circumstances of the admission . The clinical notes note  a request from "Law enforcement requested blood or eye fluid to be collected." I do not have any further information about why this request was made.  Some clinical notes indicate date of death is 08/04/2022 but the death certificate has 08/05/2022.
Immediate dizzy and nausea, ice pack given and pulse taken by clinic staff. Sat for 15 minutes. Felt better so I returned to work. But throughout the next hour the dizzy and nausea returned with some light headedness. I had to leave work.
Immunization given 3/19/07, child had slight runny nose at time Now until sneezing, cough and low grade temp.
Very uncomfortable ache in arm for 3 days several days (after initial expected and familiar post-injection soreness that only lasted 24 hours).  New ache impacted sleep and daily activities. Feels like what I would imagine a blood clot would feel like but did not notice redness and heat. Discomfort currently focused near inner elbow and underarm area. Discomfort increases with applied pressure to area. Massage has not helped. Sx have diminished since insert but still present after 3 days.
Information has been received from a female physician who on 10-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The physician stated that the night of the vaccination day her arm started to swell at the injection site. At the time of reporting the patient had not recovered. Additional information has been requested.
Left side of face feels numb and warm; Left side of face feels numb and warm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 25Mar2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetic and overweight. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included pioglitazone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test on 21Mar2021 which included nasal swab and the test result was negative. On 25Mar2021 at 14:30, the patient's left side of face felt numb and warm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left side of face feels numb and warm. The clinical outcomes of the events left side of face feels numb and warm were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Woke up at 5 AM with numbness and tingling of right hand, gloved distribution, non-progressive, normal neurological exam with reproducible numbness in the right hand.
Four days post-vaccination, developed tingling in both feet, primarily big toes (sometimes slight numbness during heavy activity) Five days post-vaccination, developed tingling in right hand, primarily fingers - progressed to both hands 19 days post-vaccination Five months post-vaccination, symptoms remain and intensify - tingling progresses to all toes and balls of both feet, developed temperature sensitivity in both hands, both arms, both feet, and both legs.  Developed scalloped tongue. Seen by primary physician in January, hematologist in April, and Neurologist in March and June.  No active treatment so far.   Symptoms remain.  Diagnosed with small fiber neuropathy.
bad headache; low grade fever; fatigue; body aches; dizziness; migraine; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; etanercept (ENBREL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient received her 1st dose of BNT162B2 for Covid-19 Immunization and experienced just some arm soreness. It was reported that there was a call from a caller who had migraine for past 9 days since receiving the 2nd vaccine dose. The patient received her 1st Pfizer vaccine dose 4weeks ago and received her 2nd Vaccine dose last Tuesday, 09Feb2021. Patient states she was never asked about medications or hx at vaccination location. Patient states after receiving the 2nd vaccine dose she experienced a low grade fever, fatigue, body aches, dizziness and a bad headache on an unspecified date in Feb2021. The patient states she takes Enbrel once per week and received IV IGG, Methyl prednisone and Toradol to prevent a headache from this treatment on Friday, 12Feb2021. She was seen by an Internist on 15Feb2021 at an ED like place where she received IV Toradol, IV fluids and Zofran for treatment of the post vaccine headache. The patient stated her headache was a little better after receiving this treatment. She routinely sees a Neurologist and a Rheumatologist for her multiple health issues. One doctor wants to put her on steroids and the other doctor said to wait 14 days from the 2nd dose because it may effect the efficacy of the Pfizer vaccine. The action taken in response to the event for etanercept was unknown. The outcome of the event headache was recovering. The outcome of all the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Right deltoid started itching 11/19.  Redness, swelling and warmth.  Went to MD today 11/20.  MD prescribed Allegra 180mgm 1 daily for 4 days.
Patient received Shingrix and the Flublok on 11/7/2023, she reports that her right arm (Shingrix side) began to swell and become warm the following morning.  She went to Urgent Care today 11/13/2023 and was told she most likley had an allergic reaction to the vaccine and that then turned into Cellulitis.  She was prescribed Cephalexin 500mg q 6 hours for 7 days.   Urgent Care also advised her to use Benadryl before and after all vaccines going forward.
Student reported to nurse that he "didn't feel well". On clinic during P.E @ 1:20 pm TEMP 101.1. Rechecked after 30 mins 100.7 child states fine until in P.E.; was bumped on back of head by another student, no bump / abrasion noted, states hurts with ice resting in clinic, calling foster parents, continued to monitor @ 2:30 99.7, child c/o back of head hurting, where he bumped into another student, but stated can return to class, foster parents never returned call.
blood pressure and found that it has decreased; high fever; body ache; some swelling at the inection site; This is a spontaneous report from a contactable consumer, the parent. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 24Apr2021 as dose 2, single for covid-19 immunization. The medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced a high fever that he had struggled to bring down, along with body aches and swelling at the injection site. On an unknown date, the patient checked his blood pressure and found that it had decreased substantially. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
This spontaneous report was received from a physician via a company representative, concerning a 14 year old male patient with Tourette syndrome. Drug reactions and allergies were not reported. On an unknown dates the patient was vaccinated with GARDASIL dose 1 (lot number J011272, expiration date 21-APR-2016, route and dose were not reported) for the prevention of the Human Papilloma Virus (HPV) virus. On 04-DEC-2013, patient was vaccinated with the 2 dose of GARDASIL. Co-suspect and concomitant therapies were not reported. On 04-DEC.2013, the patient developed dizziness, cold sweats, nausea and was "pale" after receiving the 2nd shot of GARDASIL. The representative did not have specific information about when the 1st shot of GARDASIL was administered and if this patient will receive the 3rd shot of GARDASIL. The patient saw the physician for medical attention. At the time of the report the outcome of the events were reported as recovering.  Treatment and lab diagnostics studies performed were not reported. Additional information has been requested.
Started with slight chills during the night Thursday into Friday morning.  Then when I got up Friday, I had low energy level and a slight headache. I was not able to go to work.  As the day progressed (aroun noon) I confirmed a 99.3 fever.  No energy at all to get up only wanted to sleep bounced back in forth from being hot to being chilled.   Slight headache (about a 3 out of 10) some stiffness in my neck.  By 3:45 p.m. no interest in food, very tired, and fever hit 100.1. Took tylenol to help with symptons.  Slept off and on and ate what I could, and slept between eating and taking tylenol.  By 8:00 p.m. fever was gone.  Energy level was  still very low.  Slept as much as I could and continued eating small amounts often, hydrating with Gatorade.    Saturday morning felt like I had energy, but still had some stiffness in my neck and a slight headache (1 out of 10).  Took tylenol and returned to work.  Worked four hours came home ate and napped again.  Stiffness in neck would go away with Tylenol but return.  Woke up Sunday morning to only a slightly stiff neck, but that was gone by noon.  So as of noon Sunday all symptoms were gone.
No adverse reaction. Patient given Moderna monovalent booster instead of Moderna bivalent booster. Patient notified.
her muscles became sore.; her arm started getting sore about 3 hours after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0167) at the age of 73 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: MYALGIA (non-serious) with onset 05May2021, outcome "recovering", described as "her muscles became sore."; VACCINATION SITE PAIN (non-serious) with onset 05May2021, outcome "recovering", described as "her arm started getting sore about 3 hours after the vaccine".  Additional information: Reporter stated that she got the Pfizer Covid-19 vaccine day before and she had some questions regarding the Approval, stated that her muscle was sore day before, stated this was minor. Reporter queried that why the vaccine was not yet approved and asked when the full approval by the would be given. Reporter was wondering why it takes so long for the to give the full approval. Response was Spoke and explained from attached documents, also as per Q&A (section: What is Emergency Use Authorization, Is it the same. Reporter also queried that Pfizer-BioNTech COVID-19 Vaccine; where the vaccines are made. Reporter seriousness for arm sore was Unspecified.   No follow-up attempts are possible. No further information is expected.
Left forearm rash. Left wrist vesicular rash eventually to cellulitis. Left chest vesicular rash.
Mother reports small round red area (nickle size) around injection site on left deltoid after the shot, the next morning when child woke up it was the size of a peach. Today, woke up and size of baseball. It was hot red, tender to touch. No fever. In my office, it was 11x12 cm red, hot indurated and tender area on left deltoid. No skin breaks or scabs or discharge noted. temp 97.5 degrees.