chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient requested for flu shot in the pharmacy, patient has history of high dose flu shot on 9/22/17. Patient questionnaire was asked/translated by pharmacist. Vaccination administration time between 3:40-3:49pm. After administration of the vaccine, patient was advised that the flu shot may take 2 weeks to be fully effective, she might experience injection site pain, and possible fever. Patient left seating area, walked out of the store, then promptly walked back into the store and fell face first by the doorway. An off duty doctor, first assisted the patient. After pharmacist was paged to the front, the doctor requested assistance to turn patient on her back to see if patient was conscious. Patient was asked if her back, neck, or head hurt, she said no. Patient was asked to squeeze both hands, to which she did so with strength. Patient was asked to provide family member contact info, to which she was able to do so. Pharmacist contact patient son while the doctor stayed with the patient. Paramedics arrived, checked her vitals & motor function.
I was fine after the vaccine but at about 2pm the next day, I all of the sudden I had a slight headache and was cold. About an hour later I had terrible cold chills, extreme fatigue and achy all over. This lasted until about 10:30 pm that night. Woke up next day and felt fine, just had a very slight sore arm.
He then received his first COVID vaccine, was set to have his second 28 days later and was advised to wait 30 days for any other vaccinations. His second dose of GARDASIL 9 was scheduled within the 30 day waiting period. Patient missed his second dos; No additional AE details; This spontaneous report was received from a pharmacist via company representative regarding a male patient of unknown age. There was no information about patient's, concurrent conditions or pertinent medical history. The patient's concomitant therapy included unspecified retroviral medication.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  The patient was set to have his second vaccination of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) scheduled within the 30 day waiting period. Patient missed his second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to needing to wait from receiving a COVID-19 vaccine. The pharmacist enquired if there was an alternative dosing schedule in which the patient could receive his second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine later than 2 months and still complete the series. No additional adverse event details were reported.
This spontaneous report as received from a Registered Nurse refers to a multiple unspecified dates were vaccinated with M-M-R II (dose, indication, route, site of administration and lot # were not reported) that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
full body muscle twitches and continue to have them; Bells Palsy incident; temp of 105 degrees; first dose was given on 21Dec2020; second dose was given on 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 07Jan2021 (at the age of 50 years old) as dose 2, single for COVID-19 immunisation. Medical history included Penicillin allergy. The patient has no history of COVID prior to vaccination. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 21Dec2021 (at the age of 50 years old) for COVID-19 immunisation. No other vaccine in four week and no other medications in two weeks. Immediately following the second shot, on 07Jan2021, the patient had a temp of 105 degrees. On 12May2021, the patient had Bells Palsy incident and on Jun2021, he began having full body muscle twitches and continues to have them. The event resulted in emergency room/department or urgent care. Treatment was given in response to the events which included brain scan on an unspecified date and unspecified medications. The patient underwent lab test and procedure which included COVID test post vaccination via Nasal swab on 14Sep2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
10FEB96 early AM pt had inc temp of 104 & lt upper arm appeared so swollen it appeared bluish in color;lt arm approx 2" larger in diameter than rt;pt appeared pale;saw MD who dx cellulitis & recommended heat packs to site-oral motrin;
Patient phone the office on 01-20-2021 to report that has had increasing nausea since 01-18-2021
Pt started 2 days after vaccine T. 102 + more jerky movements  after 3 days  of vaccination as per mom less of balance and frequent falling lethargy, sleepiness, crying/inj Rocephin x1 Normal CBC - CXR- Pending u/cx - b/cx- no source of lab found in Pt 6am.
Initial report received from other health care profession on 04 Dec 2009. The patient was vaccinated with FLUVIRIN on an unknown date. The patient experienced with face, ears and neck were swollen, accompanied by the presence of redness and itchiness in the swollen areas on 04 Dec 2009. The events was not recovered. Following internal review on 05 Feb 2010, the following correction was made: The case was re-assessed as unlisted.
I stated having symptoms on 12/22/2022 like a cold. I had a scratchy throat, headache, congestion, cough, aches. On 12/24/2022 I then went to the urgent care and had a fever of 103 1/2. I also have some loss of taste and smell. The provider prescribed PAXLOVID for 5 day course.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ lot # K019372, expiration date 16-JUL-2016, orally (dose was not reported). No adverse effect was reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Child was given Tylenol prior to HD visit, 94 hrs until hospital visit. Temp 100-101 responded to Tylenol 1:00AM, 6/21/06 temp >103+ increasing took to local ER. Had seizure (eyes rolled back in head) was sponged cool cloth and was given Advil kept until Noon 6/21/06.
As described to this writer-  patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee.  She states she woke up 15 minutes later and had lost consciousness.  She went to her husband who said her words were slurred.  She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
Vaccine administered to veteran was expired by over 1 hour. Vaccine expired at 1415 and dose was administered at 1550. Veteran was monitored for 15 minutes post-vaccination per protocol, no adverse effects noted.
Left voicemail reporting 'shoulder injury'- called back for further information and has not returned calls.
Patient received bivalent booster on 09/21/22 and received an additional booster 03/15/23
Client given HIB vaccine that was not needed, since client was also given a PENTACEL vaccine that contained the HIB. I read the consent form incorrectly (should have just given the DTaP as a separate vaccine, but gave the combination vaccine so the child got an extra dose of HIB).
Member received infant dose of Pfizer: COVID-19 mRNA LNP, PF 6mos-4yrs (PFizer-BioNTech), tris-sucrose 0.2 ml given.
TINNITUS - CONTINUOUS AND UNRESOLVED SINCE THE FIRST DOSE ON 9 FEBRUARY, 2021.
Information has been received from a 63 year old female consumer reporting on herself with intracranial hypertension, allergy to penicillin, sulpha, cephalexin and ciprofloxacin, who on 16-OCT-2011, was vaccinated with ZOSTAVAX (Merck) (lot number, route and dose not reported). Consumer reported that on 18-OCT-2011, a "big lump on her arm and it was hot after receiving the ZOSTAVAX (Merck)". It was spreading and doubled from the vaccination she had on Sunday (16-OCT-2011). On 18-OCT-2011, there was rash on her arm and at the injection site. She also had weird tingling sensations all over her body including her face and lips. She had body aches all over. "Consumer was concerned about encephalitis because she had intracranial hypertension or IH. She had a shunt but it was not working at the time of reporting". Patient did not receive any treatment for adverse reactions. The patient did not seek medical attention. At the time of reporting the patient had not recovered. Upon internal review "concerned about encephalitis" was considered to be other important medical event. Additional information has been requested.
This spontaneous report as received from the treating nurse practitioner refers to a 21 year old female patient, who "some time in the beginning of March 2013" was vaccinated with the first dose of GARDASIL (lot # not reported), "single standard dose taken", intramuscular. "Some time in the beginning of March 2013", after vaccination of the first dose, the patient begun having diarrhea and weight loss. The patient sought medical attention, by office visit. No lab diagnostic was performed. At the time of report, the outcome of weight loss and diarrhea was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Pt passed out for 3-5 seconds following administration of 2nd dose of Hep A vaccine.
04/24/17 client called and left a voicemail stating she had been having side effects and wanted to confirm whether she should go see a provider. Called client back and client states on friday after the shots were administered (4/14), she had "achiness," sore arm, and general malaise. States this week, she felt tired, had headaches, and starting having a painful spot of skin on the back. She described it as "sensitive and painful" and that "pants and moving hurst the worst." states it "does not hurt with pressure." denies fever, rash or any injury to lower back (are where sensitiveness is felt). States the sensitive area is about 6x6 inches. States she feels the same in "lymph node in groin area." when inquiring further about lymph enlargement, client disclosed she actually was not sure what a lymph node is. Upon description, seems like she feels the same skin sensitivity in this area without lymph node involvement. Informed client that malaise is expected as a side effect and can happen a week or more after immunizations when a live attenuated vaccine is administered. Recommended going to see a provider if sensitive skin area increased or pain worsened. Agreed to call tomorrow to check in. RN.     04/25/17 Called client. She states she ended up going to see a provider at urgent care and they initially diagnosed it as shingles and would wait for rash to appear before prescribing acyclovir. Agreed to call client later to check in. VAERS report not yet filed. DLMH, RN.  05/01/17 Called client to check in. States she did not develop a rash and went to see provider at urgent care again today. States she feels better: "no sick feeling." States she has "still tingling feeling" on back. States it was more painful last week and that it just feels irritated now. Irritation does not change with movement. Discussed risk of YEL-AND and instructed her to watch for paresthetias, extension of "skin irritation/sensitivity," changes in movement, nerve pain. Agreed to check in the future. DLMH, RN.   05/10/17 Left voicemail. DLMH, RN.   05/12/17 called client. States she went in to see actual PCP issues have resolved for the most part. Per client, she never had a rash and was not treated for shingles. States provider thought it could be a pinched nerve. States she still has "weird nerve stuff." States she feels "tingling" down her hip in the morning, but she is not concerned anymore. VAERS report submitted today. DLMH, RN.
60 outdated (06/30/07) influenza vaccines were given to employees of Medical Center during the month of November 2007
Pt was hospitalized with acute onset thrombocytopenia one day after receiving flu vaccine. She had bruising around vaccine site, petechial rash and platelet count < 5,000. She was treated with IVIG x 6 days plus steroids. She had been previously very healthy.
Patient because dizzy, developed chest pains, and collapsed. EMS was called to the scene and patient transported to nearest hospital.
Difficulty hearing; Ringing in ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears) and HYPOACUSIS (Difficulty hearing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears (after taking chloroquine in 2013). Concurrent medical conditions included Depression. Concomitant products included SERTRALINE from 10-Jan-2019 to an unknown date for Depression, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-Jan-1997 to an unknown date for Prevention.   On 30-Dec-2020 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 1:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced TINNITUS (Ringing in ears). On an unknown date, the patient experienced HYPOACUSIS (Difficulty hearing). At the time of the report, TINNITUS (Ringing in ears) and HYPOACUSIS (Difficulty hearing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) Loss of high frequency.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ENT offered vitamin b, hearing aide, cognitive behavioral, and white noise.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up Information was Received  on 04-JUN-2021: Event still ongoing On 04-Jun-2021: Follow-up Information was received on 04-JUN-2021 and does not contain new information
Fever (102.0°F), Body aches, Migraine, Nausea, Lethargy This continued until 1:00 AM, 11/8/2021.
After the second dose I was tired, and I had a terrible headache for two days. I didn't have any arm soreness. but I was very tired. After the first dose of the vaccine I was dizzy for four days. It started 24 hours after the shot. My doctor advised that I may have had Covid-19 and that was why I had such a strong reaction to the first shot. I had an illness in January of 2020 that was not identified.
I would like to put in a complaint for the Moderna vaccine shot that I got; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got). At the time of the report, VACCINATION COMPLICATION (I would like to put in a complaint for the Moderna vaccine shot that I got) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
no pain at shot site all day but about 9:00 pm at night my arm and legs felt numb, Next day whole right side feels numb. from head to toes.
High fever, Chills, Soreness for over 2 weeks, Headache for over two weeks
Nausea that lasted about 18 hours, extreme tiredness that started to subside after 18 -24 hours headache and fever that lasted about 18 hours
Started with itching, swelling and burning of lips the day of.took benadryl then all day the 13th.  That evening I started feeling it in my tongue and throat I did benadryl and epi went to emergency room and was given steroid
This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015) (dose and route were not reported). This is one of the several reports received from the same source. Additional information has been requested.
Patient is an 87-year-old vaccinated female who lives at an independent living facility.  She states she has been compliant with wearing a mask since the onset of the pandemic.  About a week ago, she started having cough, fevers, nausea, vomiting, runny nose, and malaise.  She tested positive for COVID on 9/18/21.  Over the last few days, her daughter has checked on her and she has become lethargic, weak, and developed some delirium.  She was brought to the  ER. Patient was admitted to the hospital on 9/24/21.  She had acute hypoxic respiratory insufficiency. She received remdesivir. She is allergic to steroids so she was not treated with steroids. Her oxygen requirement was stable and she was weaned off of oxygen and did not desaturate after walk test. However, she had a syncopal episode after walk test. BP, HR telemetry at the time was stable. Patient prefers to get stronger after current COVID illness and address moderate to severe aortic valve stenosis as outpatient. Isosorbide was discontinued, metoprolol decreased, and losartan decreased. Patient was discharged to rehab.
Developed hives 2 days post vaccine; required Medrol dosepak and Benadryl lasted approximately 1 week.
SKIPPED TWO DAYS BETWEEN THE SECOND AND THIRD DOSE; This spontaneous case report was received from a caregiver (PVX2019-555) on 01-Mar-2019. The report describes a female consumer who "skipped two days between the second and third dose". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer skipped two days between the second and third dose". The doses were taken on 22-Feb-2019, 24-Feb-2019, 27-Feb-2019, and 01-Mar-2019 respectively.  The action taken with Vivotif with respect to the event "skipped two days between the second and third dose" was not applicable.  The clinical outcome of the event "skipped two days between the second and third dose" was unknown.  Company's Comment: The causality of the event "skipped two days between the second and third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "skipped two days between the second and third dose" was considered as not applicable.
3hr p/vax pt devel severe pain in hips, feet, knees, calves of legs & top of thighs got worse over 2wk 20OCT98;Saw MD dx as arthritis;rx med;
Patient had a red rash that he reported was itching approx 10 minutes after injection on the same arm. Pharmacist gave the patient 10mls of Benadryl liquid. Patient waited for 20 minutes. Pharmacist checked the site again and it didn't worsen.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5ml.                                 No treatment information was provided by the reporter. This case contains information for the 23 of 27 adult patients described by the reporter.
Immediately after injection pt stated the left side of her face hurt. She was talking and laughing and no other symptoms. I told mother they could stay and wait after 10 minutes she stated she felt fine and they left facility. 30-40 minutes later returned to the unit stating that the left side of her face was swollen. They were instructed to go to the ER with the immunization record.
Patient has cellulitis with bullaes tx elevated arm, ice compress TYLENOL and return in 2 day.
Within 15 minutes of receiving vaccine, c/o tingliing in right upper extremity.  Hand strength equal, color pink and warm.  Overall color pink, and denies any other symptom.
Pt states redness below site, under arm and armpit. Some swelling and bruising. Some pain and inability to move arm which has resolved. No itching present at all. Started 5 hours after administration of vaccine. Fully recovered by 10/8/13.
pt devel fever 1 1/2 hrs prior to event given APAP; put down to sleep, father noted pt not breathing x 30 seconds, dad did mouth to mouth, pt started breathing but unconscious x 2 notes; eyes rolled back in head; t103.8; OM;
Nausea, runs, dehydrated. Couldn't eat dizzy falling. Mind not functioning. Arm hurt. Body aches Vertigo. Had to use cane. (Out of touch with life til November). Lost 20 pounds.
Weakness in arm, ache, hard time picking up items, pincher response not there. Motrin tid.
10 cm area that is bright pink on the left lateral thigh with very mild induration, 5-6 cm diameter bright pink area in the left inguinal area surrounding a approximately 1 cm lymph node.