chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump and welt appeared at injection site. I traced a circle around the lump to see if it grew throughout the day, which it did. It's now hot to the touch, itchy, painful, and significantly larger.
Patient presented to the ED and was subsequently hospitalized for GI hemorrhage within 6 weeks of receiving covid booster vaccination.
Within 15-minutes of vaccination, the patient reported swollen lips, tongue, eyes, or face. EMS monitored patient's condition on-site. No further details were given.
Patient was given pfizer bivalent booster dose of 0.2mL for his second dose of his vaccination series.  Patient was suppose to recieve a monovalent dose for his second dose.  No actual advere ever happened, incorrect valent vaccine was used for second dose.
My grandfather was a healthy 83 y/o man who exercised often and was still fully independent.  Three months after receiving the two Covid shots, he was diagnosed with stage 4 esophageal cancer.  I believe he had cancer for quite some time and the vaccine caused him to become immunocompromised, thus allowing the cancer to rapidly progress.  Furthermore, he was taking Eliquis twice/day and he ended up dying from an embolic stroke three weeks after being diagnosed.  I am so convinced that the vaccines played a role in his death.  As  a RN myself, I pray to God that this vaccine's adverse effects are studied more in depth.
Fever, myalgias, flu-like discomfort, sore throat, abdominal pain, discharge from eyes.
Patient was inadvertently administered the Fluzone High-Dose vaccine twice with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a other health professional via Medical Information (Reference number-00319148) and transmitted to Sanofi on 16-Oct-2020.  It was reported that a 73-year old male patient inadvertently administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT twice (extra dose administered), first received on 16-Sep-2020 (lot number: unknown, expiry date: unknown, Route and injection site was unknown) and second dose received on 06-Oct-2020 (lot number: unknown, expiry date: unknown, Route: unknown and injection site was left deltoid).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to an inadvertently administered product twice (same day).  At the time of reporting, no adverse event was reported.  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.
This spontaneous report as received from a physician refers to an unspecified number of 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 GARDASIL 9 lot # L043213, expiration date 28-AUG-2017; lot # M005714, expiration date 03-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 46 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced flu-like symptoms starting about 10 hours after receiving the shot and for the next 36 hours.   These would include aches and soreness all over my body and a terrible headache.  I experienced the same after receiving the second shot, but here, I am reporting my symptoms for the 3rd shot (the booster).  My symptoms persisted from 2 days after receiving the 3rd shot until 6 days after receiving the shot--I had a persistent cough and shooting headache pains during this time.  18 and 19 days after the receiving the booster shot (on 11/21/21 and 11/22/21), I had periodic shooting pains in my head (a headache).  It felt like the headache I had from 2 days to 6 days after receiving the shot.  A vaccine headache feels different from a natural headache to me, and in addition to that, I almost never have natural headaches.
HYPOTENSION 1/15/2023 RECTAL BLEEDING ACUTE RESPIRATORY FAILURE 1/15/2023 RECTAL BLEEDING HYPOXIA 1/15/2023 RECTAL BLEEDING
he tested positive for covid; he tested positive for covid; This is a spontaneous report from a contactable consumer (parent) via Pfizer sponsored program . A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot and expiry date not provided) via an unspecified route of administration on an unspecified date in 2021 (reported as 3.5 weeks ago) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient tested positive for covid. Reporter believes that her son had an exposure with Covid before the 1st dose. Patient just finished the 10day quarantine today and scheduled to have the 2nd dose tomorrow (i.e., 14Apr2021). Reporter would like to know if her son should still proceed with the 2nd dose as scheduled because she believes that her son should not get too many antibodies, since the 1st dose was given almost 3weeks ago. Outcome for the events were unknown.  Information on lot number/batch number has been requested.
Fever - up to 103, chills, nausea, dizzy, shortness of breath, tightening of throat, elevated heart rate, localized swelling and tenderness at injection site despite post injection ice application.
Patient states they "blacked out" soon after vaccination. Patient was unresponsive for approximately 3 minutes. Patient also states they felt "Dizzy" soon after vaccination.
Pt woke up at 3 am on 12/4 with neck and shoulder pain took Tylenol. 1 hour later LUE had numbness had started patient went to ED. Pt able to walk into ED. MRI/MRA completed negative for stroke. LUE and LLE became numb and weak. MRI cervical spine showed severe DD at c5-c6 with moderate canal stenosis with small area of myelitis. Pt has no history of autoimmune disorders. A lumbar puncture, MOG, NMO, Culture, west nile and o bands tested. Pt tested positive for MOG. IV steroids and multiple plasmapheresis treatments were given. Pt symptoms began to improve. He was still weak on left UE and LLE. He was was sent to inpatient SAR and discharged home on 12/27 with outpatient PT. Pt now has to ambulate with 2 wheeled walker and has not completely recovered the strength of LUE and LLE.
patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.
High fever, chills, pain all over body, tired, headache, cough, producing mucous, sweating, cold sensation inside chest area which suggests lung infection.
inadvertently given expired product with no adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious received from a other health professional.  This case involves a 2 years old male patient who was given an expired influenza quadrival a-b vaccine [fluzone qiv] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, (latency: same day) the patient inadvertently received a 0.5 ml (once) dose of expired influenza quadrival a-b vaccine with no adverse event (expired product administered) (lot UT7378MA, expiry date: 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  Action taken: not applicable.  Outcome: Unknown.  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 the 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.
not feeling well on the way home; warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast; face tingling; chest felt heavy and  pressure in chest; face flushing; scary symptoms, felt difficult and frightening symptoms; still not totally out of woods; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest) and FLUSHING (face flushing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Pre-diabetes and Cholesterol. Concomitant products included ATENOLOL, HCTZ, FELODIPINE, ATORVASTATIN CALCIUM (LIPITOR) and ACETYLSALICYLIC ACID (ASPIRIN ) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods). At the time of the report, ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Klorcon 10MEQ for an unknown indication. No treatment information was provided.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Muscle spasms-Medium, Systemic: Shakiness-Mild, Additional Details: Patient coadminstered Moderna Bivalent and Fluad (>65). Patient recently turned 66. No issues with arm with Moderna vaccine, however patient immediately said her right arm was stinging and grabbed it. Patient felt lightheaded, felt dizzy, felt a sensation go from neck to to back. and started immediately stretching. No known allergies, patient has a hx of tolerating vaccines,
swelling, muscle soreness, and red rash at and below injection site; affected area @ 3.5 inches by 3 inches that began approximately 6 hours after injection and still persists. Area is hot to touch. Also one and one-half days of shivering with mild diarrhea; temperature @ 97.6 degrees (normally 98.7). Mild dizziness on first day. Unusual tiredness on first and second day. Cough and tightness in throat beginning second day and persists.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 29-JAN-2015 the patient was inadvertently administered an expired dose of M-M-R II (expiration date: 09-JAN-2015). No adverse effects were noted. Additional information has been requested.
Seen in hospital on 2-21-07 by doctor for rash on face (right) and left leg edematous. Given ibuprofen.  Observation of site x 24 hrs and follow up with primary physician.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, since 05-MAR-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot number M010480 with expiration date on 01-MAR-2018 (dose and routes of administration were not reported). The vaccine underwent a temperature excursion of -14 to 10 degrees Celsius for 3 hours and 25 minutes on 03-MAY-2017 and for 6 minutes on 03-JUN-2017. Digital data logger was used to record the excursion. The vaccine underwent unspecified previous temperature excursions. No adverse effects were reported. A properly stored sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) was used to reconstitute the doses of VARIVAX. Vaccination occurred 05-MAR-2017 through 30-MAY-2017. Additional information has been requested.
Initial report received from a health care professional on 14 Oct 2010: On 01 Oct 2010, the patient received a intramuscular dose of only the MenCYW-135 conjugate component of MENVEO (batch number: 090701), (dose unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported. The outcome of the event was not reported.
Started yesterday and mu arm was itching and i had a red circle . this morning  the circle is now about the size of .50 piece called dr and was told to take Benadryl
Flu like symptoms. Body ache, fever, headache. Over counter Tylenol and Nyquill
Initial report was received from a health care professional on 17 September 2010. An unidentified patient had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced redness, swelling and pain at the injection site. No further information was available at the time of this report. The patient's outcome was not reported. Follow-up information was received 01 October 2010 from a health care professional. The patient was a 77-year-old male who had no concurrent illness and he had not been taking any concomitant medications. He had not received any other vaccines within four weeks of FLUZONE HIGH-DOSE and he had not experienced any adverse events following prior vaccinations. No additional information was provided at the time of the report. Follow-up information was received 21 October 2010 from a health care professional who replied, "Error - pt had Lyme Disease". Based upon new information received, it was determined this case now meets seriousness criteria and this case had been upgraded from non serious to serious. No additional information was provided at the time of the report. Documents held by sender: none.
BLOOD CLOT IN ARM; FEELING SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced burning sensation in arm, tenderness of arm, and pronounced veins on arm; also she was feeling sick. She saw the healthcare professional (HCP) after these symptoms. She was told about a blood clot (tenderness / burning sensation/ pronounced veins) in the arm. HCP recommended her taking aspirin and applying heat to the arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in arm, and the outcome of feeling sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  This 47-year-old female patient reported burning sensation and tenderness in arm, pronounced veins in arm, and feeling sick after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  HCP was consulted and was "told" about a blood clot and prescribed aspirin with advice to apply her to the arm.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Terrible headache; Feet are swollen from knee all the day down to her foot; Blood pressure shot up to 189 when she got the second shot; A spontaneous report was received from a consumer concerning 82 year old, female patient who developed feet are swollen from knee all the day down to foot, blood pressure shot up to 189.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received the second of two planned doses of mRNA-1273 (Batch number:030L20A) on 17 Feb 2021 intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection. On the same day the patient experienced terrible headache. Approximately after one day she developed swollen knee and blood pressure 189. The event high blood pressure 189 was considered as medically significant.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the events was not applicable.  The outcome of the all events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received 2nd shot of Zoster vaccine on 11/16/18 and had an allergic reaction to it. Very swollen, red the size of a saucer at the injection site, fever and shivering for 2 1/2 days, tired and weak. No reaction to the first shot received on 6/18/18. Got the shot at my local pharmacy. SHINGRIX 50 mg.
First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 prophylaxis.     Allergies (medications, food and other products) were none It was unknown if the patient ever had COVID positive test or diagnosis. Had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2022-593416 (Patient Link).
The patient received her second Shingrix vaccine and reported arm soreness and nausea, vomiting, and diarrhea a few hours after receiving the vaccine. She did not report having any of these symptoms after her first Shingrix shot and so it was quite a surprise to the patient.
Terrible migraine headaches with aura; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE WITH AURA (Terrible migraine headaches with aura) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tetracycline, Clindamycin).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE WITH AURA (Terrible migraine headaches with aura). At the time of the report, MIGRAINE WITH AURA (Terrible migraine headaches with aura) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Healthy pregnancy 3rd pregnancy past two were full term.  20 weeks ultrasound looked good.  reported decrease movement to doctor after first dosage at 31 weeks. After second dosage repeat decrease movement which continued to become less. Ultrasound done at 34 weeks diagnosed with IUGR at 35 weeks IUGR and oligohydramnios. All preeclampsia testing negative. Baby delivered  via c section 4lbs 11oz on 4/4/2021. Required supplemental oxygen support, low glucose, high billi. With delayed feeding. Infant spent 19 days in scn.
Patient may have received undiluted Pfizer COVID-19 vaccine 0.3 ml= ~120 mcg
Within hours of receiving flu vaccine, started to lose her voice, ran a fever-99.3, and ached all over. The following day she complained of a headache. Patient instructed to call primary physician and report symptoms. Took Ibuprofen 600mg as needed.
Rash appeared on my arm when I woke up the next day. A week later, the rash got way bigger in size, was very itchy and swollen. I then became itchy and swollen all over my face, neck, chest, arms, legs. My throat started to hurt and I had chills. I still have a rash on my arm and the itchy ness just went away today.