chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced increased pain with PCV13 than with PCV7. The patient received a dose on an unspecified date. The patient experienced increased pain with PCV13 than with PCV7. The outcome for increased pain with PCV13 than PCV7 was not reported. Follow up (05Jan2011): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report or other company report may indicate in the appropriate field that it is an initial report. This physician reported that PCV13 causes greater discomfort on administration than any other vaccine. MMR was previously known to be the painful, PCV7 seemed more painful. PCV13 causes more screaming, louder screaming, than any other vaccine. Pediatrician now gives it last due to the response of patients. The physician wanted to know if it can be formulated to decrease the pain. No follow up attempts possible. No further information expected.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Pertinent medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck). No symptoms were reported. The outcome of the events was unknown. The case is linked to MARRS # 1502USA002982 (same reporter link). Additional information has been requested.
Patient received first Pfizer vaccine dose on 8/20/21. To meet the 21 day interval, 2nd dose was supposed to be 9/10/21.  Patient was mistakenly scheduled by clinic to receive 2nd dose on 8/31/21, and was given the 2nd dose on that day.  Per CDC website patient's that inadvertently receive the 2nd dose sooner than 21 days do not need to have the dose repeated.
Sore injection site; headache; fatigue; overall not feeling well feeling; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old-female non pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 05Mar2021 at 13:15 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history of the patient included high blood pressure, vitamin d deficiency, elevated cholesterol. Concomitant medications were not reported. The patient was allergic to sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient tested negative for COVID-19. The patient experienced sore injection site, headache, fatigue and overall, not feeling well on 05Mar2021 at 16:00. The patient underwent lab tests and procedures, which included nasal swab test on 12Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the sore injection site, headache, fatigue and overall not feeling well feeling was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to unspecified number of unknown patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB lot # M014926, expiry date 17-FEB-2019 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced temperature excursion ranged from 1.8 to -1.5 degrees Celsius for cumulative time of 11 hours and 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Patient had slight itching at vaccination site with no symptoms of throat or chest tightening or other life threatening symptoms. Patient requested something for the itch and Benadryl was provided. No further complaints were made after administration.
rash on face, eye swollen, h/a, vomiting;As of 4OCT95, eyes still swollen & sl h/a;
Severe headache, fever, nausea, vomiting, chills, ringing in right ear.  Treated with rest and ginger ale.
Information has been received from a health care professional concerning a patient who approximately "1 to 2 years ago" was vaccinated with one dose of varicella virus vaccine live. On 04/20/2000 the patient developed a mild breakthrough of chickenpox with approximately 75 pox and no fever. The patient sought unspecified medical attention. Also reported was the patient's sister, one other sibling, and several other patients who were vaccinated and experienced similar events. Additional information was requested.
Dose prepared by pharmacist for an adult first dose of Moderna. Pharmacist stepped away briefly and returned to discover dose was given to her child.
Soreness at injection site after first and second doses for a few days.   Soreness in left armpit (swollen lymph nodes) after first dose for a few days.   Tingling/burning/chilling sensation in feet (almost constant from onset till time of reporting - 10 days), sometimes also in legs and arms, and once in scalp.  Rash at injection site two days after second dose (05/21/2021), still present at time of reporting.  Swollen lymph node near left clavicle two days after second dose, still present at time of reporting.   Swollen
He spiked a high fever to over 103 degrees. His temperature has since come down.
Physician Discharge Summary   Patient ID:   56 y.o.    Admit Date:  7/8/2022   Discharge Date:   7/12/2022   Discharge Diagnosis:  Principal Problem:   CVA (cerebral vascular accident) Active Problems:   COVID-19 virus detected   Seizure   Tobacco abuse   Alcohol abuse     Hospital Course:  56 year old female with alcoholism was admitted with right side weakness while drinking a pint of whiskey. She had a seizure in the ER also. Ethanol level was 164 on arrival here. MRI head showed 10 mm infarct in the left posterior putamen extending superiorly into the corona radiata. She has been on Keppra and PT/OT. TTE showed LVH with normal EF. EEG was normal. She has been on CIWA protocol. She will be discharged home today in stable condition. Patient educated on appropriate level of care post-discharge. Follow up with neurology.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98 °F (36.7 °C) Heart Rate (Monitor): 69 Pulse: 78 BP: (!) 146/93 Respirations: 18 SpO2: 96 % General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone
Low fever (99F), chills & constant shivering, dizziness, headache, mild nausea - all started about 12 hours after injection and lasted about 4 hours. It was difficult to get out of bed and walk without holding on to something. The next morning mild headache, tiredness, and weakness remained. Fever, shaking, dizziness returned the second evening but in milder form. Very sore arm started night of injection, gradually subsided over a few days.
Afebrile, BP elevated to 177/100 Pulse to 105, developed chills, itchiness (resolved)
my blood clot was caused by the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (my blood clot was caused by the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (my blood clot was caused by the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (my blood clot was caused by the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment:  This is a spontaneous case reported by a consumer of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of thrombosis (AESI). It is reported that the event occurred after the administration of the dose of mRNA-1273 vaccine. No further information was disclosure. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of thrombosis (AESI). It is reported that the event occurred after the administration of the dose of mRNA-1273 vaccine. No further information was disclosure. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Symptoms started an hour to two hours after receiving vaccine. Patient started with chills and the shakes, then several bouts of vomiting, followed by a fever, and fatigue on 9-9-2021.  Mom stated that patient was conscious but states that patient doesn't remember some of the reactions that happened to them. Parents called for an ambulance because their child was in distress. Parents cancelled the ambulance once patient came to and they were able to get their child in their car. Patient was seen in the emergency Room at Hospital.
Little lump on the side of her neck; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 29Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 06Jul2021 patient found like a little lump on the side of her neck. She does not know if she should go to the doctor or put something or ice on it. The little lump is not in the center; she was searching on the internet and knows it's very common to get lump under the armpit or center of the neck but hers is on the side. She wanted to know if there have been some other cases like this. The outcome of the event was unknown.  Information about lot/batch number has been requested.
17hrs post injection: Nausea  Headache Fever 100.6 Injection site soreness   24hrs post injection: Fever 101.8 Headache Nausea  Injection site soreness
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Allergic reaction was reported for unspecified drug.     On 08-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-May-2022 to 31-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medication included Birth Control Pills. Patient previously received a COVID-19 Vaccine. It was reported that on 05-JUN-2022  at 07:00, five days after taking Paxlovid, patient had higher viral load of Covid again. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 06-Jun-2022.  Company comment-This spontaneous case concerns a female patient aged 29 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 27th May 2022 to 31st May 2022 for 5 days. Patient reported five days after Paxlovid she had higher viral load of covid again. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 29 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 27th May 2022 to 31st May 2022 for 5 days. Patient reported five days after Paxlovid she had higher viral load of covid again. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Warm injection site; Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025PZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hives and Speech disorder (he cannot read the handwriting of the lot #s of his wife or his vaccine card very well but will try his best.).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area). At the time of the report, VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use reported as none Treatment information was provided as none.   This case was linked to MOD-2021-062491 (Patient Link).
PT. VOMITING AFTER BEING GIVEN THE ROTATEG (ORAL) VACCINE 3X. PT THEN BROKE OUT IN A RASH ON ENEST & ABDOMINAL AREA
Convulsions/Seizure and rapid onset of (seconds) of a 103+ fever. Taken to ER immediately and fever meds were provided to break the fever. First ER doctor providing treatment connected episode to the vaccine, then all other doctors dismissed the correlation but provided no alternative cause.
Patient complained of upset stomach, nausea, vomiting and lethargic, weakness.
"noc of inj swollen, red, hard all upper area & around inj site;?fever;no recall of similar rxn to prior immunization;lasted several days;"
Patient fainted post administration of Janssen vaccine patient sitting in chair in observation area leaned over to right side fainted for about 5 seconds, patient did not fall or sustain any injury. Nurse observed patient leaning to right side, immediately assessed patient. Nurse assessed alertness, patient able to speak, and sit up 90 degrees in chair without difficulty, respiration even, and unlabored no respiratory distress noted. Patient assisted to yoga mat on the floor, minimal assistance provided, elevated patient legs on chair. Patient forehead cold to touch, and clammy. Vital signs at 1852, temp 96.4, BP 111/71, HR 63, RR 18, O2 95%. Patient stated he ate today, but had not eating anything for the prior 7 days due to inability to obtain food. Patient awake, alert, and oriented, able to verbalize. Patient remained laying down on mat for 20 minutes. Patient stated he is feeling better, reassessed vital signs at 1920, temp 96.8, BP 124/86, HR 81 RR 16, O2 95%. Assisted patient chair observed patient ambulate to chair with no assistance, observed steady gait and sat upright in chair for another 10 minutes. Patient given water to drink, patient able to drink, and swallow water without difficulty. Instructed and educated patient on possible side effects post vaccine administration, and instructed reinforced education on when to seek medical attention, go to nearest hospital, or call 911, patient verbalized understanding of instructions. Patient went back to hotel room, patient able to ambulate with no assistance with steady gait, and balance. Outcome is that patient self recovered and vital signs stable, no respiration distress, or dizziness, denies any chest pain.
09/23/09 Employee complains of feeling dizzy and faint. Donor laid in office x 30min. No medications given.
pt recvd vax;rt arm became very painful;pt's condition was dx as neuritis;tx w/ steroids & problem resolved;over the yrs problem returned w/ inc frequency;has been exp numbness in rt arm fr shoulders to fingers;
15 y/o F with no known prior medical conditions or NKDA presented for her first dose of Pfizer vaccine. 5-min post vaccination the patient began to feel dizzy and light-headed. The patient experienced a syncopal event resulting in an assisted fall from chair.  The fall was atraumatic and the patient instantly regained consciousness. Patient was alert and oriented x3, and rapidly improved back to her baseline. Patient denied any SOB, difficulty breathing, throat swelling, itching, or HA. Parental guardian was advised to keep patient hydrated and educated on any signs or symptoms that would warrant urgent care.
Narrative:  COVID INFECTION AFTER COMPLETION OF COVID VACCINE SERIES 01/06 COVID VACCINE DOSE #1 02/02 COVID VACCINE DOSE #2 04/13 PRE-OP TESTING FOR ENT PROCEDURE-COVID TEST POSITIVE, NO SYMPTOMS
Itching, tight chest, joint pain and rash. No treatment. Symptoms resolved 2 weeks except Allegra.
More pain on spot on chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of painful rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (4 years ago) and skin irritation (very mild). Previously administered products included Shingles vaccine (old vaccine), flu shot with an associated reaction of rash (refer case US2023AMR041283) and Covid shot with an associated reaction of rash.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced painful rash (Verbatim: More pain on spot on chest). The outcome of the painful rash was not reported.   It was unknown if the reporter considered the painful rash to be related to Shingles vaccine.     It was unknown if the company considered the painful rash to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR041280, US2023AMR041283   Additional Information: GSK receipt date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she I had shingles four years ago and still had some pain on chest.  Most time it was just a very mild irritation, but when he/she got a flu shot, or Covid shot that spot on chest was more painful. The reporter had both the old and two new shingles shots since, and they also caused more pain on that spot on chest. The reporter advised to get the shot, if they don't want shingles. The follow-up could not be possible as no contact details were available. The patient received extra dose of Shingles vaccine than the recommended doses, which led to Extra dose administered.; Sender's Comments:  US-GSK-US2023AMR041280:Same patient different dose US-GSK-US2023AMR041283:Same patient different vaccine
Initial and follow up information has been received from a registered nurse, concerning a 14 year old female patient with no known medical conditions or allergies, who on 21-AUG-2007 at 1:30 pm was vaccinated IM in the right deltoid, with the first dose, 0.5ml, of Gardasil (Lot 659556/1060U), and IM in the left deltoid with the first dose of ADACEL  (lot# C2769AA). There was no illness at th etime of vaccination. Following the first vaccination, she was fine, but after the vaccination she "slumped and passed out", and blacked out for a few seconds. She was pale when awake. She was monitored, given juice and crackers, and after 15 minutes had recovered and was discharged to home.   Additional information has been requested.  Additional information is not expected.
3:00AM Friday 3/18/11 fever, nausea, vomiting, joints ached, pain in kidneys, shortness of breath, headache, took TYLENOL in afternoon & night. Felt better Saturday.
On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and  small amount of corn at 5:00pm.  I started having diarrhea about 5:30pm.  Later in the evening  around 8:30pm, I had more diarrhea.  Around the same time I became very, very sleepy and had extreme fatigue.  My right arm where I received the shot did not hurt and still does not hurt.  Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm.   On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating.  At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes.  Around 5:00pm, I had diarrhea again.  I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day.  At 6:30pm, I had more diarrhea.  Soon after, I took two imodium gelcaps and hoping they will help the diarrhea.  My left arm has become increasingly more sore and hurts in the muscle.  No other symptoms.
A week after receiving my COVID-19 vaccine and 3 days after y yearly flu shot I woke up with an earache. Went in to doctor on 10/31/2022 and found out that I had an inner ear infection in both ears. Prescribed augmentin. After about 5 days on antibiotics I began to see improvement in my ears. Ears are much better but still not 100%.