chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with cases 2018SA315884, 2018SA315882, 2018SA315878, 2018SA315886, 2018SA315885, 2018SA315888 and 2018SA315883 (same reporter). This case involves a 71 years old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (lot number: QFAA1815, expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 06-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage as Vaccines were exposed to a Max temp of 52 F for 27 hours- patient inadvertently received FLUBLOK QUADRIVALENT. It was not reported whether the patient had any adverse events. 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. List of documents held by sender: none.
fatigued, unusually fatigued/tired; sore arm; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 14:25 (Lot number: EN6198) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "fatigued, unusually fatigued/tired".  Additional information: Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s) was None.AE(s) following prior vaccinations was None.Pertinent Details (include surgical procedures and dates) was not reported.Patient received the first dose of the Covid vaccine on 05Mar, this past Friday. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None.History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None.For the last couple of days, had been tired, fatigued, unusually fatigued. Knows that from the literature given that this was one of the possible side effects of the vaccine. Plus, patient  had a sore arm. The fatigue was still there and it had been 5 days into this since the vaccine. Wants to know if this was a normal reaction or is this something should be worried about. Noticed the tiredness and fatigue about the day after receiving the vaccine, that Saturday. States it was persisting and a little worse and then clarified outcome as persisting. States the sore arm started the same day of getting the vaccine, that night, but that had gone. No further details provided. Unable to provide the expiry or dose for the Covid vaccine given. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Asks why was it asked his reason or indication for getting this vaccine. Reporter informed this was asked with all products. No further details provided. Family Medical History Relevant to AE(s) was as None. Patient did not visited Emergency Room and Physician Office.Relevant Tests was none.Noticed the tiredness and fatigue about the day after receiving the vaccine, that Saturday. States it was persisting and a little worse and then clarified outcome as persisting. States the sore arm started the same day of getting the vaccine, that night, but that has gone.   No follow-up attempts are possible. No further information is expected.
Severe heart palpitations-suddenly going 150-160 beats per minute multiple times a day, and it lasted several weeks. I did not see a doctor about it. I have had this occur (but not this severe) after each Covid shot. My two originals were Pfizer as was my first booster. My second booster was Moderna, and the bivalent just now was Pfizer.
Sore arm Day 2 & 3 -- Headache, body ache, exhaustion, queasiness Day 2 & 3. Fatigue needing nap Day 4. Vertigo on rising or laying down (when standing feels like swirling and lose balance, when lying down feels like swirling and like I'm on a boat.) That started several days after vaccine and still have that today. Not sure if vaccine related but I've been staying hydrated and drinking electrolytes and still have it on and off.
significant pain in both feet the morning on the morning after vaccination, to the point of having difficulty getting around the house. Lasted throughout the day. Pain resolved after a week
Swelling. Obvious in hands, rings tight, could not remove. +3 pound weight increase overnight decreased in 48 hours, persists in shot arm, axillary and arm
Pt had a rash on arms, welts on abdomen and back with itching. Also had trouble swallowing.
Fever 100 degrees, red swelling at injection site, chills, full body aches, fatigue
This report described the occurrence of myalgias in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient's attorney reported that the patient received injections of Lymerix on 12/9/99, 2/28/00 and 5/10/01 according to the client and medical records. However, an immunization record supplied by the attorney indicated that the dates of immunization were 12/9/99, 2/17/00, and 8/10/01. This represents a schedule of 0, 2, and 20 months rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered myalgia, aching hands, feet and legs, fatigue, joint swelling, night sweats, numbness and headaches. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
I ended up testing positive for COVID-19 in December 2021 after being vaccinated. I had a scratchy throat, fever, runny nose, and loss of taste and smell. This lasted for about 5 days.
The next morning after the vaccine, I woke up with a migraine, achiness all over my body, and tiredness. I slept it off for about 72 hours afterwards and felt really sick and took off work. The body aches left 2 weeks after, as well as the migraine, and I was able to go back to work after 3 days. Somewhere between 2-3 days after my booster, my Left arm by my vaccine site got hot and there was a hard nodule under where I got the shot, and it was itchy as well. My husband is a Doctor and didn't know what it was and he found out it was Covid arm and I had a hypersensitivity response to it. It took 3 days to respond and it was hot and hard to touch and it got worse 24 hours after but nothing severe. Within 2 weeks I was back to normal.
Pt was seen for 1st dose Pfizer COVID-19 vaccine, 0.3mL, IM, RA. Stated that she has a Hx of vasovagal reactions to vaccines. Vaccine administered in the supine position and instructed to wait in lobby for 15 minutes for monitoring. 8-10 minutes after administration, pt stated she felt dizzy and nauseous. Denied SOB, chest tightness, difficulty breathing, swelling of face or throat. HM2 placed pt in supine position. Initial vital signs taken at 1348, BP 84/55, HR 73, O2 Sat 95%. Pt was evaluated by LT. Vital signs stable, pt states dizziness and nausea were subsiding, but was experiencing a headache. Pt moved to sitting position and then to standing position, tolerated well. Patient vitals remained stable and was d/c after an additional 30 minutes.
Mild to moderate flu like symptoms first 3-4 days, dryness, metallic taste in mouth. Thought I was in the clear but day 7 I started with periodic PVCs that progressively got worse and more frequent. By day 14 I was having series of PVCs every 5-10 minutes along with changes in bowels and chills (ie autonomic dysfunction) since I have dysautonomia I made an appointment with my cardiologist  and an NAET acupuncture appointment. Acupuncture eliminated the autonomic issues and reduced the PVCs by 90%. I still followed up with cardiologist who was ble to confirm PVCs via auscultation and EKG.  He advised me since acupuncture helped to proceed with second dose and if PVCs worsened again he would do a echo and halter monitor.
This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on Jan2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date in 2021, Patient stated, she received her Pfizer covid vaccine first dose in end of Jan2020 and 4 days later, she was tested positive for covid-19. Patient wanted to know about taking the second dose. she waited for 90 days and received bam therapy. Patient wanted to know about taking the second dose. She has not taken the second dose yet and wanted to know if she should. She also received antibody therapy, Bam therapy. Description of complaint: She tested positive for Covid-19 4 days after receiving her first dose of Pfizer Covid-19 Vaccine. The patient received treatment for this event. The seriousness reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  .
Patient misrepresented  the fact that she had received a Jansen dose in Oct of 2021 after  she received Moderna 0.5mg dose and when she arrived at the mobile vaccine clinic today she brought in a card that she had falsified  with only one dose of Moderna listed on  the card, despite her receiving 2 doses of a vaccine  already and told both practitioners that she was here for her second dose of Moderna. After she received the dose of Moderna and was confronted she stated, the government  did this to us, they lied and gave us a vaccine that they knew didn?t work. I am only doing what I have to do to protect myself.
PATIENT CAME IN AND SAID SHE WAS HERE FOR HER SECOND COVID VACCINE. WHEN LOOKING AT VACCINE CARD, THE FIRST VACCINE DATE WAS INCORRECTLY SEEN, SO WE THOUGHT SHE WAS DUE FOR HER VACCINE. AFTER ADMINSTERING, WE REALIZED IT WAS 1 WEEK EARLY FOR THE VACCINE. ORIGINAL VACCINE 8/8/21, DUE DATE WOULD HAVE BEEN 8/29/21, BUT SHE GOT VACCIN ON 8/21/21
Experienced a numbing sensation in her head and forehead; Burning sensation in her chest; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) 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: HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Experienced a numbing sensation in her head and forehead"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "Burning sensation in her chest".  Additional Information:  Caller received the first dose of the Pfizer Biontech COVID19 vaccine on 19Aug2021 and has not yet received the second dose. Caller experienced a numbing sensation in her head and forehead as well as a burning sensation in her chest that comes and go. Caller wants to know if it is safe for her to receive the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BLEEDING IN BRAIN; INTUBATED; SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 45 year old female with unknown race and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced severe headache and went to the hospital and diagnosed with bleeding in brain. During hospitalization patient was intubated .On 18-Mar-2021,patient died  due to bleeding in brain. Patient was hospitalized for 1 day. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intubated and severe headache was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210517658- covid-19 vaccine ad26.cov2.s-Bleeding in brain, intubated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLEEDING IN BRAIN
The morning after the CoVid Moderna injection at 8:30 I was sitting in room at home and at one point when I blinked my eyes, I could see nothing but dark gray.  I closed my eyes and repeated, nothing but gray.  No sight.  I did this numerous times breathing deeply for 20-30" approximately between eye opening.  This continued for approximately 6 minutes.  The experience was terrifying.  At one point, I opened my eyes and my sight was returning.  I lay down and slept for approximately 3 hours.  I had eye aches and significant headaches following this event which were new and sought the advice of an Optometrist since I could not get an appointment with my ophthalmologist for weeks.
Information has been received from a nurse concerning her 16 year old daughter with questionable allergies to penicillin and a history of Bell's Palsy who in December 2007 or January 2008, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  In February 2008, the patient was vaccinated with a second dose of GARDASIL intramuscularly (injection site and lot number not reported).  There was no concomitant medication.  On 25-JUN-2008 or 26-JUN-2008, the patient had a relatively high fever of 101.9 F.  She was put on ZITHROMAX from 26-JUN-2008 to 30-JUN-2008.  On 02-JUL-2008 the patient had a seizure, her eyes rolled to the back of her head and she had a loss of memory.  The patient was taken to the emergency room and the following tests were done: CT scan, EEG and MRI which were all normal.  The ER did not find the cause of the seizure.  Subsequently the patient recovered from the events.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested. 8/13/08-records received for DOS 7/2/08-presented to ED after loss of consciousness while eating lunch. Coherent and confused enroute to ED. In ED awake, alert oriented with no specific complaints. Unaware of any antecedent symptoms prior to episode. DX: Syncope, probably seizure.  8/15/08-records received-1st Gardasil received 12/26/07-2nd Gardasil received 3/6/08. On 7/10/08-Parent contacted PCP office concerned about seizure after 2nd vaccination. Seizure occurred 1 week ago.  8/13/08-experienced second seizure. Will continue to follow in office.
pt reported slight tenderness at injection site the day of vaccination. 3 days later, the pain is worse and she has pain in her armpit
Seizures, Raynaud's disease, vasculitis, weakness in arms and legs, drooping of the mouth, slurred speech, constant burning sensation in the head, loss of vision.
Patient began fevering (up to 102 degrees F) about 5 hours after vaccination. Loss of appetite and fever lasted about 2 days.
COVID 19 Treatment; 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2022 as dose 4 (booster), single (Lot number: FPu55u) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: COVID 19 Treatment with Paxlovid (Lot number: 2707499), Treatment start date was 29Dec2022, Treatment stop date=03Jan2023.
Hospitalized for 3 days. Admitted with right-sided abdominal pain, and tested positive for COVID on admission. Reported nausea, decreased appetite, cough and headache. Hypoxic. Given Supplemental oxygen, albuterol inhaler prn, Vit C, D and Zinc. Remdesivir and decadron. Acute renal failure limit nephrotoxic drugs
Arm was stiff and pain was shooting down into her hand. Took ALEVE in the morning and the pain resolved, she had difficulty lifting her arm in the evening but by morning it was resolved.
Sore arm at injection site, extreme fatigue, sudden onset uncontrolable menstrual bleeding & blood clots, felt faint & had some blurred vision.  Heavy bleeding & heavy clotting continued until next morning (I have not had any issues with my cycle since my surgery last year so this was not normal).  Woke up with fever of 100.7 Saturday morning at 4:57am; fever did not go away until Saturday 8:45pm.  Had flu-like symptoms, fatigue, fever, chills, intense all over muscle soreness.  Felt better & symptoms were gone by Tuesday 03/02/2021.  Menstrual cycles went back to normal following month after 2nd vaccine.
Drooling, hives, sensory issues like something crawling on the skin lead to excessive scratching, fussiness, crying, and irritability. Patient was given 1/2 teaspoon of BENADRYL in office at 4:26 pm.
I received the Pfizer booster on 10/29/21, 24 hours later my lymph nodes at the base of my skull and neck became swollen and it felt like someone had hit me in at the base of my head with a baseball bat.  I had issues regulating my temperature, one minute I was hot and the next with chills.  This last about 16 hours.  The next day my lymph node under my arm of the vaccination site became swollen and tender for about a week.  I have also noticed a huge change in my menstrual cycles after the booster.  In Nov. my cycle lasted about 3 days, my normal is around 7-9 days.  In Dec it also only last a few days but was heavy bleeding.  Now In Jan. I am over a week late which has never happened.  There is no physical way that I would be pregnant so that is not the issue.  I currently have no signs or symptoms like I normally do prior to starting my menstrual cycle.
vomiting; diarrhea; not his true self; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced vomiting, diarrhea, and not being his true self (feeling abnormal).   The patient's medical history was not provided.  No relevant concomitant medications were reported    On 01 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified date, the patient was hospitalized overnight due to vomiting and diarrhea. The reporter stated that the patient was not his true self. The patient missed his second dose appointment that was due on 01 Mar 2021.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was unknown.   The events of vomiting, diarrhea, and feeling abnormal  were considered resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Right knee has normally level 2 pain from arthritis and possible torn maniscus. 24 hours after 2nd shot extreme pain in knee, turning over in bed, walking, putting on shoe, getting into shower extreme; knee would snap; This is a spontaneous report from a contactable consumer(patient). This 55-year-old male consumer reported for himself. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:00 (at the age of 55-years-old) as a single dose for covid-19 immunization. Medical history included skin cancer, dermatitis contact. Concomitant medication(s) in two weeks included beclometasone dipropionate, chloramphenicol, clotrimazole (CBC); ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: En6208), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 13:00 (at the age of 55-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. 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 had allergies with Mastisol, adhesive on steri strips. On 06Apr2021 11:00, the patient experienced right knee has normally level 2 pain from arthritis and possible torn maniscus. 24 hours after 2nd shot extreme pain in knee, turning over in bed, walking, putting on shoe, getting into shower extremely painful, 7 on scale, leading up to this knee would snap while letting off of gas pedal while driving (loud electrical arch type snap). Received cortisone shot for relief. No known reason for sudden amplification of symptoms. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on Apr2021, x-ray: unknown on Apr2021. The adverse event resulted in emergency room/department or urgent care visit. The patient received treatment with cortisone shot to knee, X-ray and mri. Outcome of the event was recovered, at the time of this report.   No follow-up attempts are needed. No further information is expected.
itching @ site noticed 8NOV97;bruising quarter size-rash underneath inj site area 2" x 4" red, raised per MOC;MOC gave DPH po 9NOV97 & 10NOV97;
Diagnosed with COVID19 on 07/25/22  (self tested positive on 07/24/22) flu-like symtoms. Prescribed Paxlovid and antibiotics - took one dose of Pax could not keep down did not take anymore. Moved into chest thought was getting better, tried to work but something not right.  Suffered a setback on 08/07 coughing very seriously, doctor diagnosed on 08/08 as post COVID atypical pnemonia. Prescribed another antibiotic. Have recovered.