chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when my lips started to burn a little bit. By the time my shift ended at 1pm, the burning had intensified to feeling like my lips were being pricked with needles. The sensation had spread in to my mouth as well. I called my pcp on my way home and was instructed to take a Benadryl and get a ride to the ER, which I did as soon as I got home. I arrived at hospital around 2:15 and by that time my face was itchy. I was given a steroid injection that stays in my system for 3 days and was instructed to take 50mg of Benadryl every 6 hours for 3 days. I was instructed to not drive or return to work until Monday 10/19 due to the high dose of Benadryl. My symptoms improved by evening, but I had long lasting affect from the medications of nausea and dizziness until Wednesday 10/21.
The morning following vaccine I woke up with a bloody nose, which I had not experienced before. I had approximately 5-7 nosebleeds per day tues, wed, thurs and fri. I sought medical attention Friday and had blood work done which was normal. I was prescribed Oxymetazoline hydrochloride 0.05% nasal spray and have not had a nose bleed since Friday.
BASEBALL SIZED LUMP ON ARM, VERY WARM TO TOUCH, VERY SORE. OVERALL ACHY FEELING FOR DAYS
Pt ill w/sore throat & temp elevated admitted to hosp x 2 days;
Received vaccine in the morning of 09/18/2021. Went about my day as normal and shortly before getting ready for bed at 9pm, I started to notice that my skin was very sensitive to touch, I was feeling cold even though I had on a hoodie and joggers. I noticed that my eyes also became very sensitive to light as I continued getting ready for bed. I hydrated well and try to sleep as comfortably as possible, but I woke up many times throughout the night due to the pounding headache I began to experience. Additional symptoms upon waking on 09/19/2021 include swollen joints (hands, feet) as well a slightly swollen tongue. There has been significant discomfort at larger joints (shoulders, hips, knees) with simple movements (walking, sitting, standing). I checked my temperature at 5:21am on 09/19/2021 and it registered 100.5 as an average of three tests. I will continue to monitor and document as time progresses.
Diarrhea, NauseaVomiting, Fever ,HA ,Dizziness, Sharp Chest Pain, Narrative:   Other Relevant History:
induration @ site; severe pain radiating up to neck through clavicular area; t102; lymph node in lt supra clavicular area only; had a dog bite to rt wrist; wound was clean on exam; inject site treated w/ice & ibuprofen;
PATEINT CAME IN FOR 1DOSE COVID VACCINE. PATIENT WAS 16 YEARS OLD AND RECIEVED THE DOSAGE 0.2MG, WHICH IS FOR 5-11 YEAR OLDS, INSTEAD OF THE 0.3 MG WHICH IS RECOMMENDED FOR PATIENT 12 YEARS AND UP. PATIENT HAD NO ALLERGIC REACTIONS, TOLERATED THE VACCINE WELL AND LEFT THE CLINIC AFTER THE RECOMMENDED 15 MIN MONITORING TIME.
Sleeplessness, up and down all night Thursday to Friday Severe Headache Fever  Chills Achiness When he gets sick he says his skin hurts
significant pain radiating from lt deltoid to elbow of lt arm;hives & pruritus between clavicles;phoned MD who ordered DPH;p/1 dose sx subsided;
Patient stated her arm was swollen, red and hot to the touch.  She also had flu-like symptoms.   This could be a normal reaction to a vaccine but her neighbor, a nurse, told her it could be celluitis.  She called her doctor and he prescribed Augmentin.
SHE HAD NUMBNESS AND TINGLING IN THROAT, HEAD, FACE, ARM. LIGHTHEADEDNESS, MILD CHEST PAIN.  she had heaviness in her eyes and arm . This was all starting about 15 min after receiving the vaccine
Patient called to say that he had severe insomnia (not due to pain in arm or other side effects from vaccine) and when he woke up this morning his eyes look "glazed over" and has "grey color in center of eye" - no affect on patients vision, but instructed patient to seek care, especially with worsening symptoms.
Collapsed 6 hs after the shot; can´t move for a while; Collapsed 6 hs after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Collapsed 6 hs after the shot), HYPOKINESIA (can´t move for a while) and FALL (Collapsed 6 hs after the shot) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Collapsed 6 hs after the shot), HYPOKINESIA (can´t move for a while) and FALL (Collapsed 6 hs after the shot). On 08-Feb-2021, MUSCULAR WEAKNESS (Collapsed 6 hs after the shot) and HYPOKINESIA (can´t move for a while) had resolved. At the time of the report, FALL (Collapsed 6 hs after the shot) had resolved.            Very limited information regarding these events has been provided at this time. Patient's advanced age may have been contributory for the occurrence of the events. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age may have been contributory for the occurrence of the events. Further information has been requested.
Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; Severe flare up of arthritis in hip and knee causing extreme pain and mobility.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 16:15 (Lot number: Fl3209) at the age of 46 years as dose 1, single for covid-19 immunisation.  Relevant medical history included: "known allergies: Sulfa medicine" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The following information was reported: ARTHRITIS (non-serious), MOBILITY DECREASED (non-serious), ARTHRALGIA (non-serious) all with onset 08Jan2022 16:15, outcome "not recovered" and all described as "Severe flare up of arthritis in hip and knee causing extreme pain and mobility". Therapeutic measures were not taken as a result of Severe flare up of arthritis in hip and knee causing extreme pain and mobility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Extreme fussiness (11/30/2009 until Now), Runny Nose (11/30/2009 until Now) , Fever (12/1/2009 at 8:31 AM and 10:07 PM)
pt recv vax 25SEP96 & 20OCT96 pt devel Henoch-Schonlein purpura w/only skin & joint involvement; (no renal or GU involvement);NOV96 pt sx were still being followed;
Lt eye dec vision about 12Feb91, appt /w eye MD 5Mar91, 12Mar91 DX /w ocular neuritis.
All symptoms started about 18 hours after second dose.   Chills, lasting 3-4 hours Extreme fatigue, lasting for entire day, 16 hours Arm pain at vaccine site Loss of appetite for16 hours
Breakthrough bleeding; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Breakthrough bleeding) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopause.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (Breakthrough bleeding). At the time of the report, INTERMENSTRUAL BLEEDING (Breakthrough bleeding) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Unresponsive; A spontaneous report was received from Pfizer concerning a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 04 JAN 2021, at 7:20 am, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 04 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The cause of death was unknown. Plans for an autopsy were not provided. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Patient stated she felt weird 1-2 minutes after injection. Patient then lost color in her face, eyes rolled back, had muscle twitching, urinated on herself, and lost consciousness for 15-20 seconds. This happened from 10:18 am -10:20 am - patient regained consciousness.
Every time, it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Every time, it itches".  Additional information: Caller had no dates or Lot numbers available for any of her previous doses of the COVID vaccines. Caller did not recall how many COVID vaccines she had over time. Mentioned that every time, it itches. Caller mentioned having her second dose of the COVID vaccine, she thought, on 06Jul2021. Caller denied any concomitant medications, medical conditions relevant to report, any lab testing or treatments to report. The patient's other condition and investigations were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322830 same reporter/patient/event, different drug dose;US-PFIZER INC-202201322508 same reporter/patient, different drug dose/event;
Swelling in 10 fingers and 10 toes after injection. Swelling lasted 1 hour.
headache; dizziness; photophobia; Fatigue; nausea; Right arm pain; This is a spontaneous report from a non-contactable consumer.  The reporter reported two reports, This is the 1st of 2 reports, for the 1st dose.  A 67-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm Right on 16Feb2021 12:15 (Lot Number: EL9267) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Headache, Dizziness, photophobia, fatigue and nausea on 16Feb2021 12:58, Pertinent details: patient felt to ill to work whole day migraine type HA/fatigue/nausea. Patient also experienced right arm pain on 16Feb2021. Patient recovered from Headache, Dizziness, photophobia and fatigue on 20Feb2021, recovered from nausea on unknown date, outcome for event Right arm pain was unknown.  Tylenol/acetaminophen received as treatment for Right arm pain and headache orally from 16Feb2021 to 19Feb2021, also reported as ongoing as of the report.    No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021234032 same drug/reporter/patient, different dose
Headache for 3 days. Sore throat for 1 day. Nose bleed - bruising.
Developed redness, swelling, pain and welts on left arm from shoulder to elbow. Saw MD on 2-5-09. Given Z-Pak, NAPROSYN, steroid and steroid cream.
Pt with local reaction 3 inch area of induration, erythema, edema that is pruritis/burning at the vaccination site.
Information has been received from a Pharm D concerning a pt (age and gender not reported) who on 19Aug04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). The pharmacist reported that a nurse told him that the pt received the vaccine intradermally and the injection site was red and swollen. This was reported to be an other important medical event (OMIC). Unspecified medical attention was sought. Cool compresses were applied. The outcome was not reported. Additional information has been requested.
I received 2 vaccines of Pfizer on 12/21/20 and 01/12/21. ~ 3-4 mo thereafter i developed irregular menses with  hair loss and intermittent mild hot flashes. Initially, I thought i entered perimenopause but after talking to my GYN that seemed too early as my mother's menopause was at 50 y/o. I still have same symptoms to date. I also have iron deficient anemia thought to be due to menses (that started before my vaccination, 5/2020-> i was placed on oral iron).  I do not have an alternative explanation for my symptoms. After hearing that some of my female colleagues had similar issues with irregular menses and breast tenderness, I thought it would be wise to report it to to start gathering data on long term side effects.
PT C/O RIGHT UPPER ARM INCREASE WARM, HOT TO TOUCH, SWOLLEN, REDDENED, S/S STARTED ON 3/11/2021, PT ADVISED TO SEEK MEDICAL ATTENTION AT HER PCP OFFICE OR STAT CARE, AWARE, VERBALIZED UNDERSTANDING
Initial case received 19 February from a patient. A 45 year old female patient received a left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UPU112A-not a valid sanofi pasteur lot number) on 29 October 2009. Five days post vaccination (approximately 03 November 2009) the patient experienced intermittent weakness in both legs. She was able to walk, but had paresthesia, numbness and "felt like legs were so weak that she was going to fall." The patient had no illness at the time of the vaccination. Concomitant medications included multivitamins. She had an allergy to Sulfa and a sensitivity to latex. The patient reported that the weakness of legs lasted a couple of weeks. She had no further problems or symptoms as of this report. Documents held by sender: None.
The patient experienced a local reaction to the right upper arm. The slight swollen area was red and warm to the touch.
PATIENT CALLED PHARMACY WITH SHORTNESS OF BREATH AND CHEST PAIN, REPORTED 30 MIN POST VACCINE
Given FLUMIST on 8/23/10 seen in office 9/1 -Dx with pneumonia/wheezing - hospitalized that night.
Vivid dreams; Mild headache; This is a spontaneous report from a contactable nurse, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 25Mar2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medication within two weeks of vaccination. 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 vaccine. On 26Mar2021, the patient experienced vivid dreams and mild headache. The patient did not receive any treatment for the events. The clinical outcome of the events vivid dreams and mild headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
NOT FEELING WELL; FEVER; NAUSEA; VERY TIRED/FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included light headed /dizzy after flu shot, drop in blood pressure after flu shot, and active covid-19 infection, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. Concomitant medications included influenza vaccine for prophylactic vaccination. On 15-APR-2021, the subject experienced not feeling well. On 15-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced nausea. On 15-APR-2021, the subject experienced very tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from fever, nausea, and very tired/fatigue, and the outcome of not feeling well was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD lot # L011080 with expiration date 10-OCT-2016 or lot # L023114 with expiration date 24-DEC-2016 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 0.5 degrees Celsius for 12 hours. A digital data logger was  involved. Additional information has been requested.
** VACCINATION ADMINISTERED BY INCORRECT ELIGIBILITY **  THE PATIENT WAS GIVEN VACCINATION ON 10/27/21 ON AN OUTSIDE CLINIC. AFTER PATIENT SUBMITTED THE FORM, PHARMACY SUPERVISOR FOUND OUT THE PATIENT HAS HER SECOND SHOT ON 5/26/21, WHICH WAS LESS THAN 6 MONTH AGO, VIA DATABASE. THE FORM WAS REMOVED FROM THE FILE, BUT WHEN I AND NURSES AT CLINIC WENT TO THE UPSTAIRS TO GIVE PATIENTS SHOTS, I RUSHED AND GAVE THE PATIENT VACCINATION WHICH THE NURSE POINTED (WHO WAS USING THE OLD LIST). AFTER GIVING THE SHOT, I REALIZED THE RX HAD BEEN REMOVED FROM THE FILE BECAUSE OF THE ELIGIBILITY ISSUE.
The pt developed a "brain reaction", ataxia, collapsed and was hospitalized. The pt sought unspecified medical attention. Additional information has been requested. Follow-up info received on 09/10/2001 states the pt has chronic seizure disorder, neurological disorder, and partial brain damage. The follow-up info from a registered nurse indicated that the pt was vaccinated on 06/26/2000 with one dose of varicella virus vaccine live. Concomitant therapy included MMR, DTP, polio vaccines. she reported that she did not have any info on an adverse event post vaccination on this pt. She stated that their office only does immunizations and well baby care. She noted that it is possible that the mother may have taken the pt to another pediatrician for care, but their office was never notified of any adverse event post vaccination. She reported that she did not have the lot numbers of the vaccines that the child had received; she would need to put in a request for that day of immunizations to be pulled from the warehouse for the lot number info. Additional info has been requested.
Information has been received from five authors of a published literature article concerning a patient who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 30 month old patient with hb-ss disease with crisis was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was reported that the patient was compliant with penicillin therapy. In 1996 the patient developed severe pneumococcal infection and subsequently the patient died. It was noted that the patient was discharged from the local ER a few hours earlier. The cause of death was pneumococcal infection NOS. Patient developed severe pneumococcal infection was considered to be immediately life threatening. It was reported that two other patient developed pneumococcal infections. At this time, relationship of the patient's pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. Additional information has been requested.  Reported on 03/26/2003: "Follow-up information received from the Primary Author revealed that the year of death was December, 1996.  The parents reported that the child was on oral penicillin prophylactically.  However the child was very non-compliant, and it was questionable as to whether or not the child had ever been vaccinated with pneumococcal vaccine 23 polyvalent, since there were no records of vaccination dates.  The childd was seen in a local emergency room and had an elevated temperature (which would have required the child to be admitted and the organism was penicillin sensitive pneumococcus.  The child was sent home and was found dead in the AM.  No autopsy was performed.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
throughout the day of April 29, 2021 I started get tingling on my lips, and my right side of my face was feeling different in a weird way ... once I left work at 5 pm, I went straight home and by then, the right side of my lip was drooping since I was not sure of what was happening to me, my husband took me to the hospital where they treatment me with possible stroke.  After all test had be performed, the outcome was that I had a case of bell's palsy on the right side of the face.
pt recv vax 7JAN97 presented to employer 1115AM w/ c/o upper body achiness & sweaty;sent to ER for tx & eval;dx probable viral illness, possible rxn to vax;
Pt reports shortly after " a few hours later" L deltoid became very swollen, tender, 1 day later developed headache, chills, shakes, joint pain, body ache. Treated - Tylenol/Aleve/Motrin, Ice pack.
Moderna Fact Sheet reviewed with the client along with V-Safe Information. COVID-19 screening reviewed. Per Report, patient had completed observation after vaccination without problems. She was a passenger in her husband's vehicle- they left the county fairgrounds (Vaccination Site) . Per report, her husband looked over and the client was passes out- he proceeded a measurement of feet down the street and pulled back into the fairground entrance. He immediately requested the  staff to call the squad. The patient came around prior to the squad arrival. the staff estimated that the client was potentially " out" for a matter of 3 mins. between leaving observation and returning to the grounds. Our Staff report the client was "out" for approximately 1 min while waiting for the squad to arrive.  Client was unconscious per report at time of calling the squad. However prior to the squad arrival the client awoke. Any clinical assessment is unavailable after that. The client and her husband refused treatment from the EMS responders and left the site at will.  The client reported a history of "passing out" after receiving vaccines.
Given an extra dose of COVID-19 which did not cause an adverse event.  This is a vaccination error that is not a safety risk.
This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age. It was reported that unspecified number of patients received improperly stored GARDASIL on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.