chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 minutes after the dose I became flushed and jittery.  My blood pressure was 165/90(usually is 130/80.  My heart rate was also raised.   My blood pressure was down to 136 about an hour later.   The flushing of my face and the jittery feeling lasted about 24 hours.  I also had a headache and fatigue the next day.  All symptoms were gone 48 hours later.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JAN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 13-JUN-2016, the patient was treated by a physician for the onset herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Not a terribly adverse reaction, but wanted to report that I had read only Moderna gives some women a "covid arm" or delayed cutaneous hypersensitivity.  I have had an itchy injection spot for the last 6 days (each day getting less itchy), and slight redness around the injection site.  All is much better now, but since I had read only Moderna and I had Pfizer I wanted to let you know.
Patient came to the pharmacy to receive her Covid Janssen vaccine. On her vaccination list she stated that she is allergic to many thing including some foods and medication. She stated that her doctor still wants her to receive it due to her condition(immune system disorder). She came with her husband. They had a case with medications in case she experiences reaction. He had Benadryl and EpiPen in his case. First 15 minutes she was feeling fine, on the 25-30 min I asked them how was she doing and husband said she is not feeling very good. we measured her heart rate and it was around 150bpm.  Husband said her lips and tongue  are starting to swell. I asked him if they want me to call 911 but he refused. He preferred to take her home and observe. I called to check on patient few hours ago. He told me she was stable but her tongue is still swollen. I told them to go to ER if the symptoms get worse. He said she is improving and feeling better now
Complaint of shortness of breath, difficulty breathing, cough, chills, headache, runny nose/congestion, loss of taste and smell, myalgia and malaise.
First dose of COVID-19 vaccine was J&J vaccine. Starting 06/07/2022, I had a runny nose and cough (after being at a public event) and I tested myself with an At-Home COVID-19 test which came back positive. The next day, 06/08/2022, I called my doctor's office and they prescribed me Paxlovid. I took the medicine as instructed. I didn't have a fever and didn't have any other symptoms to the virus. I only had some mild side effects from the antiviral.
Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old female patient who received 0.5 ml MENACTRA, once on an unknown date of Sep-2018 (lot number not reported) and again on 07-Feb-2019 (lot U6207AB) via unknown route in unknown administration site) in an interval of 5 months. In the same interval on an unknown date of Sep-2018, the patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tdap) (produced by unknown manufacturer lot number not reported) and on 07-Feb-2019, 0.5 ml ADACEL (lot C5585BA) both via unknown route in unknown administration site. 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 extra dose administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Headache: 1.5 days day Ibuprofen  Fatigue: 1.5 days Fever: 1 day Sore arm, red (6 inch circular), warm 3 days and continuing although lessened from yesterday),. Ibuprofen
Extreme pain/stiffness in my right knee starting 8-9 hours after the injection....currently 23 hours after my shot I can?t even bend my knee to put a sock on.  No fever, no swelling, just intense gout-like pain in my right knee
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 26-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of Sterile water for injection, lot # 54-152-DK with expiration date 01-JUN-2018" instead of Merck supplied diluent. No adverse effect reported. This is one of the twelve reports received from the same source. Additional information has been requested.
chills on day of site; aches on her back; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills on day of site. Took Advil and went away within the hour. Next day (today) aches on her back and hasn't resolved. Event took place after use of product. Therapeutic measures were taken as a result of chills on day of site which included Advil. The outcome of the event chills on day of site was recovered while for aches on her back was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Narrative: COVID infection following completion of COVID vaccine series 01/12/21 COVID vaccine dose #1 02/09/21 COVID vaccine dose #2 04/17/21 Pt presents for preop COVID test with no symptoms; COVID NEGATIVE 05/21/21 Pt presents for preop COVID test with no symptoms; COVID NEGATIVE 08/02/21 Pt presents to screening reporting cough and congestion; COVID POSITIVE 08/03/21 Pt states symptoms started 07/31; reports cough, fatigue, low grade fever, headache muscle pain; states urine incontinence started 08/02
This spontaneous report was received from a licensed practical nurse referring to a 6 month old patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 09-OCT-2018 the patient was vaccinated with ROTATEQ (dose 3, lot # R002517, expiration date 19-SEP-2019) orally for prophylaxis. On the same day, the patient was also vaccinated with PREVNAR 13 (0.5 ml on the left thigh via intramuscular; lot # W28770, expiration date 30-MAY-2020) at 16:46 and PENTACEL (dose 3, on the right thigh via intramuscular; lot # C5527AA) for prophylaxis. It was reported that the temperature excursion of vaccines was out of range for 11 to 12 hours with highest temperature at 69.1 degrees Fahrenheit. The patient received improperly stored vaccines. No adverse reaction reported.
Resident was identified needing bivalent booster on 12/16/2022 and booster was administered.  Later discovered the resident received bivalent booster on 09/15/2022.
p/vax pt exp sensation of pins & needles in hands & legs; BP 120/80 at the time; further lymerix was discontinued
Onset of fever 101-102 degrees F, aching body on 7/6/03. 7/8/03 vomiting, persistent fever of 102 degrees F.
Patient lost baby 4 weeks prior to estimated date of birth. Emergency c section.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was pregnant at the time of vaccination was reported. Due date of pregnancy was 30Aug2021, gestation period of 12 weeks [unspecified]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, patient lost baby 4 weeks prior to estimated date of birth. Emergency c section. Adverse event resulted in Emergency room/department or urgent care, hospitalization, Congenital anomaly or birth defect. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101016957 Mother case/Fetal case
faint, short of breath, high heart rate, irregular heart beat, muscular weakness, rapid weight gain, changes in menstruation
Pain in arm, swelling, temperature and rash happened that night of shot. Called doctor. Treatment was TYLENOL, warm packs applied to arm.
Headaches that continued for two weeks. went to ER . Stroke on Left side of brain. Was hospitalized
First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.
Received MMR and Tdap immunization. Couple days later developed induration and slight fever. Given Duricef prescription by doctor.
no adverse effects; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 20-JUN-2019, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018142, expiration date 25-JUN-2020 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. The reported vaccine was exposed to the temperatures of 15 to 46 degrees Fahrenheit (39 degrees Fahrenheit) for 19 hours and 15 minutes. No previous temperature excursions were reported. A digital data logger was not involved. No adverse effects were reported.
Began slightly itching 4 days after injs w/redness, swelling, at antecubital area then next day bumps appeared (Flat) red colored. Then 3 days later the bumps became fluid filled. Then redness approximately 4 inches going up and down arm from antecubital area. Blisters now gone; bumps have increase in number.
Patient started with Hives on bilateral knees, cheeks and stomach, she was also irratable. Patient also mild circumoral cyanosis (Upper Lip),  She was administered. Epinephrine Injection, USP 0.1 mg auto injector  Also was given Diphenhydramine 4ml.    She was observed and vitals were taken. 96 SPO, 160 pulse @ 2:35 pm  97 SPO, 160 pulse @ 2:50 pm  She was kept for observation and discharged at 4:05 pm
ACUTE NON ST ELEVATION MI 2/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Headache lasting nearly 18 hours, cold sweat and flu-like symptoms overnight, visual light sensitivity from the morning to the mid-afternoon following the vaccination. All symptoms resolved within 24 hours.
Irritable, low-grade fever, tired.  09/17/2007 MR received from PCP with DX of Speech Delay dated 10/2003 and DX Mild PDD (verified with PCP) dated 5/2004 on cover sheet.  6yr old WCC on 1/18/2007 with Assessment:  Well child.  Autistic Disorder. Esophagitis, unspecified. Completed chelation therapy 4/2007 for Autism. Homeopathic MD reports child has yeast overgrowth in bowel./pc 10/01/2007 MR received from MD for visits beginning 12/14/06 through 8/20/2007 with intial dx of regressive autism with very little language  from age 13-15 mon.  Regression noted after MMR and antibiotics.  Esophagitis on Prevacid.  Diarrhea resolved.  Had chelation tx with increased connecting and cuddling w/ parents.   Dx of ADHD noted on 3/25/07 as well as reflux, malabsorbtion, yeast overgrowth. Per 60 day follow up: Heavy metal poisoning, autism, compromised immune system, GI tract issues, speech delay, global developmental delays. We parents need the government agencies to support us in recovering our children! Our children deserve the quality of life they were ment to have. Please correct the vaccine program so the next generation will be protected from this medical vaccine tragedy which affects 1 out of 9 vaccinated boys and 1 out of 150 vaccinated girls. Please help these affected children my child was born normal!
Bloating; diarrhea; nausea; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to foods and environmental (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 04:00, about 16 hours after vaccination, the patient experienced bloating, diarrhea, nausea and sore injection site (vaccination site pain). 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. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events bloating, diarrhea, nausea and sore injection site were not resolved.  No follow-up attempts are needed. No further information is expected.
1/31/2023 started with a little bit of a cough with some head congestion and a sore throat.  That evening body aches and headaches started. Tested 2/1 at Home COVID-19 Test, positive. Fatigue set in, and symptoms worsened.   Televisit 2/2 Prednisone and Azithromycin were proscribed.  Z-pack taken, prednisone not taken as cough became wet and productive.  Fatigue and headache continued as did previous symptoms.  It took 2 weeks before symptoms abated and over the next 2 weeks the symptoms diminished slowly until gone or attributable to seasonal allergies.
PATIENT NOTES RED, PRURITIC RASH TO SITE OF YELLOW FEVER VACCINE. DENIES SYSTEMIC REACTION, WHEEZING, SHORTNESS OF BREATH. RASH IS LOCALIZED.
Pt received x3 doses of covid vaccine and was admitted to the hospital o 3/24/22 with covid and died on 3/25.
flush feeling; night sweats; lightheaded, dizzy; fever; body aches; felt heat on the outside/it's a weird, a weird type of heat; not felt well/ bad; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: HOT FLUSH (non-serious) with onset Sep2021, outcome "unknown", described as "flush feeling"; NIGHT SWEATS (non-serious) with onset Sep2021, outcome "unknown", described as "night sweats"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "lightheaded, dizzy"; PYREXIA (non-serious) with onset Sep2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset Sep2021, outcome "recovering", described as "body aches"; FEELING HOT (non-serious) with onset Sep2021, outcome "recovering", described as "felt heat on the outside/it's a weird, a weird type of heat"; MALAISE (non-serious) with onset Sep2021, outcome "recovering", described as "not felt well/ bad"; HEADACHE (non-serious) with onset Sep2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset Sep2021, outcome "recovering", described as "fatigue".  Additional information: No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had first dose of the Covid vaccine and was not due until the 17th or 18th this month for the second one. Had the first vaccine about 2 weeks ago. Time the vaccination was given: 10-11am. Seriousness of events was unspecified. Events were not resulted in visit to emergency room and physician office. No relevant tests reported. The events were improved, but still possibly may have the hot/heat, sweats, but caller was not really sure, unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101340609 same reporter/drug, similar events, different patient
Client was vaccinated with Pfizer vaccines for Covid on March 2 and March 30, 2021.  Covid symptoms started 9/10/2021 - sinus congestion, cough, headache.  Tested positive for Covid with rapid test on 9/12.  Client vaccinated x 2 and reported as a case of breakthrough Covid.
quivering of his lower lip; numbness of his lower lip; slightly sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 22Feb2021 16:00 (Lot number: ENG198) at the age of 73 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Polio" (not ongoing), notes: victim of Polio in the 1950s. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "slightly sore arm"; TREMOR (non-serious) with onset 10Mar2021, outcome "recovering", described as "quivering of his lower lip"; HYPOAESTHESIA ORAL (non-serious) with onset 10Mar2021, outcome "recovering", described as "numbness of his lower lip". The events "slightly sore arm", "quivering of his lower lip" and "numbness of his lower lip" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, tremor, hypoaesthesia oral. Additional information: The patient received the 2nd dose of BNT162B2 (Lot number: EP7534) on 16Mar2021. The patient saw his physician on 05Apr2021 and had some bloodwork to make sure it was not post-polio syndrome.  No follow-up attempts are possible. No further information is expected.
Child had red, warm, nickle to a quarter size blotches on body for 3 days, post vax. The 1st area started on 1st day with a 1/2" to 1" area on stomach. The blotches became worse on 1st and 2nd days. There was a distinct line around blotches. The blotches became lighter by the 3rd day. On the 2nd day after a bath, the child's feet and legs were swollen and bluish, hands were swollen, also. Mother reported reaction on the 5th day and child has been fine.
first dose of Shingrix in March of 2019./ not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Patient developed two red rings on his abdomen--stated they looled like tick bites with out the center spot. they were not itchy. He stated he had not other symptoms--no dificulty breathing or any thing else.  it resolved by the following morning.
Patient lost her balance and fell, in the waiting room after receiving vaccines. Patient states that she was not injured and thinks that she did not fall as a result of the vaccine.
Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who was vaccinated (date unspecified), with the second dose of Gardasil. The patient indicated that the shot "was very painful," and the physician reported that her arm was "still hurting" two weeks later. At the time of this report, the patient had not recovered from the arm pain. The patient sought unspecified medical attention. Additional information has been requested.