chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to hospital with significant confusion and altered mental status. He was somnolent and unable to sustain attention. He received antibiotic treatment with ampicillin, ceftriaxone, and vancomycin for empiric meningitis coverage. Lumbar puncture was benign. Neurology and infectious disease was consulted; no clear cause of his symptoms was identified.  He had improvement in his symptoms from 3/11-3/13 and was discharged home. Given the proximity of his symptoms to vaccination, we are filing for possible vaccine reaction.
I did get the first two shot and the booster last year and then I had Omicron; I did get the first two shot and the booster last year and then I had Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31May2021), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 3030BA) at the age of 75 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I did get the first two shot and the booster last year and then I had Omicron". Clinical course: Patient reported she got the first two shot and the booster last year and then she had Omicron. She had all the symptoms and felt awful. She had other conditions also. She did not undergo investigations. She reported that the Lot number was T.19267 and it was Pfizer, but the printing was so small. Maybe it was not T, maybe it was 1-1or it was L-L.9267. She stated that her card also represented that she got something on 05Mar2021, but she denied and said there were only 3 shot out, first two shot and the booster. She received vaccination at Pharmacy. She did not receive prior vaccinations within 4 weeks. She did not had any lab test for couple of years because she fired her doctor and had an appointment with the new doctor next week.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Soreness and ache in shoulder of arm vaccinated starting about 6 pm, followed by chills until about 1 am the following morning.  Fever of 99.8 at 7 am on 3/24/2020.  Fever subsided by 6 pm on 3/24/2020.  Soreness lessened until it disappeared on 3/28/2020.
Patient given 0.3cc dose of Janssen booster dose instead of standard 0.5 cc. Formally notified heath authorities, manufacturer (Janssen) and all persons reported to Janssen for their pharmacy department. Recommendations provided: Notify all of the recipients that received an incorrect dose and submit a formal report for each.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L036853, expiration date: 24-SEP-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001013:
Paleness, sweating, and loss of consciousness. Patient was allowed to rest in immunization room while breathing and pulse were monitored. Parents were asked if they wanted us to call 911 or an ambulance but they refused. Symptoms lasted for approximately 5-10 minutes. Patient was allowed to leave after symptoms resolved.
Redness, swelling, intense itching at injection site. Benadryl helps but it comes back when the benadryl wears off. It is ongoing so I don't know how to answer question 20. I will answer "yes".
Appeared that most of the vaccine flowed down patient's left arm during administration; vaccination was given in left arm between elbow and shoulder not upper shoulder; Nurse said she overfilled the syringe/Appeared that most of the vaccine flowed down patient's left arm during administration; A spontaneous report was received from a consumer who was an 80-year-old, female patient who received Moderna's COVID-19 vaccine in her left arm between her elbow and shoulder not the upper shoulder, from an overfilled syringe, and most of the vaccine flowed down her arm during administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 01 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm for prophylaxis of COVID-19 infection.    On 01 Jan 2021, the patient was administered the vaccine between her elbow and shoulder. It was reported the vaccine was not given in her upper shoulder. During administration  of the vaccine, most of it flowed down her left arm. The patient stated the nurse advised her the syringe had been overfilled. No treatment information was provided for the event.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, of the vaccine given in between her elbow and shoulder, an overfilled syringe and the vaccine that flowed down the patient's arm, were not provided.; Reporter's Comments: This case concerns a 80-year-old, female patient, who experienced an unexpected event of incorrect dose administered, vaccine leakage and Product administered at inappropriate site. The event occurred during the administration of the first dose of mRNA-1273 (Lot number: 025L20A). This report refers to product administration error for mRNA-1273 (Lot number: 025L20A).
About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious.  She was sitting in a chair slumped forward, we pushed her back in the chair.  The patient was tensed up, sweaty, with labored breathing. She was assessed to not  to be in respiratory distress and held so she wouldn't slide out of the chair she was sitting in. She began to return to consciousness and pulse seemed relatively normal with breathing returning to normal after 3 minutes.  Local EMS was activated.  The patient was given cold water to hold on her neck and was alert.  Local EMS assessed she was ok and the patient's mother refused transport to the ED.  The patient left on her own.
17Dec1997 pt recv vax. 20Dec97 pt devel rash which abated "rather quickly". Another pt WAES98021893 had similar exp.
Patient broke out in hives, which developed into swollen joints and dermatographia. Symptoms developed on the evening of Saturday 19 March 2022 and have continued without improvement. Patient has been treating with antihistamines and a six day series of dexamethasone. Medications have had little to no effect.
chills, extreme body aches, fever, migraine, loss of appetite all lasting about 36 hours
Tinnitus got worse, hair thinning/breaking, more fatigue, extreme brain fog, red spots and blisters on toes, and skin rashes.
Information has been received from a physician concerning a female (age unknown) who on an unknown date was vaccinated intramuscularly with a first dose of GARDASIL (Lot # unknown).  Subsequently on an unknown date, the patient developed "papilledema".  Unspecified medical attention was sought.  Outcome unknown.  No product quality complaint was involved.  Additional information has been requested.
Limited mobility of right arm; Red dots/three in number/ inner portion of the right arm.; Soreness/of the right arm; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injected limb mobility decreased, red rash and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased, red rash and pain in arm were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, red rash and pain in arm to be related to Shingrix.  Additional details was reported as follows: The patient experienced red dots, soreness and limited mobility of the right arm. The dots was three in number, circular, the size of a quarter, and located on the inner portion of the right arm. The patient could only lift his arm to a certain point due to soreness and limited mobility of right arm. The pharmacist did not have lot number or expiration date to provide. The reporter consented to follow up.
Pt returned to clinic with erythema to left upper arm.  Size was length wise - 150mm by width 170mm.  Pt was assessed by a provider in Clinic.
Muscle pain in my back, legs; Hard for me to walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am calling for the side effects of the Vaccine, I am calling to see about it." When probed to clarify if consumer wanted to know about the side effects of COVID Vaccine, consumer stated, "Yes, because I am having muscle pain in my back, legs and it's hard for me to walk." The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Fever, arm sore. The follow up states reaction occurred on 5/19/03. 5/20/03 came in to doc office. Pt was given Td and Hep B #2 on 5/19/03. Td was given in Rd that is where reaction occurred.
pt states queezy after one min after receiving vaccine, vision went dark while sitting and pt felt ringing in ears and muffled sounds. mother with pt due to being minor, mother helped lower pt to floor  pt states never lost consciousness   placed feet on chair with knees bent   OBS team arrival  pt feeling better while laying on ground,. with little assistance stood and pt back to laying on stretcher in trendelenburg position taken to OBS 1, VS as noted  pt feeling better while in OBS, given water tolerating well.  after a few minutes  out of trendelenburg, then high fowlers position, to dangle to standing   position change over 20 minutes  first time standing pt felt dizzy  back to sitting in bed given more water and apple juice  then dangle then standing second time. bp stable upon standing second time and pt feeling better  feeling okay to go home, pt sent home with mother  ambulated to exit per request at 0850. VS 0815 bp 99/61 hr 81 rr 16 o2 100  0820 bp 109/62 hr 74 rr 18 o2 100 out of trendelenburg, 0825 bp 108/66 hr 88 rr 16 o2 100 high fowlers, 0830  bp 102/54 hr 86 rr 16 o2 99 standing,, 0834 bp 109/61 hr 78 rr 16 o2 98 high  fowlers, 0836 bp 91/67 hr 71 rr16 o2 100 dangle, 0840 bp 95/66 hr 90 rr 18 o2 99, 0845 bp 104/57 hr 76 rr 18 o2100, 0850 bp110/61 hr 85 rr 18 o2 99 standing
Time lapse after initial dose Moderna; had health complication/had a flare up; This spontaneous case was reported by an other health care professional and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up) and PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna) in a 23-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products.  The patient's past medical history included COVID-19 on 18-Nov-2021.    On 01-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In April 2022, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (had health complication/had a flare up) was resolving and PRODUCT ADMINISTRATION INTERRUPTED (Time lapse after initial dose Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Symptom was reported as improved.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2022: Live significant follow-up received and included reporter's phone number, patient demographics updated and vaccination date updated and newevent general physical health deterioration added.
pain, itching in fingers,numbness Narrative:  She reports reaction to injection.She states that her arm is very painful,warm to touch and is experiencing numbness and itching in her fingers. She denies difficulty breathing,CP.
After receiving my shot I started experiencing shortness of breath on the 8th of January. I then felt it was accompanied by a lot of chest pain, especially mid chest and right under my rib cage. I was having trouble breathing and catching my breath, that started on the 9th of January. That was the worst on that day. I went to the ER on the 9th of January 2022. I still am suffering from shortness of breath, and I feel abnormal chest pain off and on. Not as severe as when it initially started, but it lingers from time to time.
Upon waking next morning, and standing up, complete exhaustion, every joint and muscle hurt, headache
On 5/6/2021- I noticed continuous bleeding in my urine for several weeks .   I saw my doctor on 5/11/2021 and was referred to a specialist.  I saw  a urologist on 5/18/2021 and was diagnosed with bladder cancer.  I did a CT scan to confirm the diagnosis.  I am scheduled to have surgery on 7/1/2021.   I did have a single episode of urinal bleeding last year 8/2020 after a bike ride.  Dose 1 lot 010A21A Dose2 lot   045A21A
Patient reports pain upon injection and there was bleeding after the injection.  The bleeding stopped after a band aid was placed on the site.  Immediately following the injection, the site was swollen, red, and painful.  We called the patient the next day and she reported her arm has gotten better.  It is still a little swollen and tender but is no longer red.
This case was received by a pharmacist via call center representative and described the occurrence of periorbital swelling in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced periorbital swelling. On an unknown date, the outcome of the periorbital swelling was unknown. It was unknown if the reporter considered the periorbital swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional had a patient who was complaining about periorbital swelling after receiving flu shot. Only information the health care professional had, was the symptom the patient was complaining to have.
Pt recieved her vaccine, then was waiting  for her 15 minute period post vaccination. ABout 10 minutes in, pt reports that she felt extremely light headed, saw bright lights, had difficulty hearing, and then went limp. Pt vomited. PT responded when asked if she was ok.
Severe chills although I was in bed with 2 covers, stomach pain, diarrhea, breathing shallow and at a faster rate than normal, hoarseness, I believe my heart rate was faster than normal, but I didnt take my pulse, weakness, at one point I felt I was going to faint but didn't. After a while I was very overheated (no more chills). I did had pork for dinner on Sunday 11/07/2010 I wonder if that somehow helped create the adverse reaction, took my temperature several times the highest reading was 100.1 degrees. I believe I probably was pale, but didn't look for it specifically.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Aug2023 to 08Aug2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Localized non-blanchable, calorous erythema, with a 1 inch radius circumferentially surrounding injection site of Pediarix on right anterior thigh. Area first noted by mother of patient approximately 43 hours following vaccine administration. Patient also had temperature of 101.4 F.
felt woozy; BP of 100/60mmHg; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt woozy(Dizziness), bp of 100 60mmhg(Blood pressure decreased).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021,at 11am prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) felt woozy. bp of 100 60mmhg.  He felt nothing until this morning, after breakfast he felt woozy. He said his BP normally measures 110 70mmHg, but it read 100 60mmHg. He noticed getting slight headache on the left quadrant of his head. Treatment given was not provided Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), felt woozy, bp of 100 60mmhg was unknown.
The patient was given a higher dose of the vaccine than needed.  The patient was then observed by the nurse for over an hour. The doc of day went in and assessed the patient. The manager was informed and spoke with the family. Called the on-call pediatrician for advice on what to do next and informed family of his recommendations.  Nurse followed up with family on 04/17/23 to which the dad stated that the patient was doing fine.
Narrative: Headache, Myalgia, NauseaVomiting, left axillary lymph swollen
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot#K005083, expiration date 04-NOV-2016 or lot #K006117, expiration date: 14-JAN-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
vomiting/nausea 1230AM; fever 102 ax @ 3PM 27AUG92; local induration, reddness @ inject site; seen @ ER for sore throat;
Female pt, unknowingly pregnant (missed menses by 14 days), was administered MMR vaccine on 12-NOV-2001. Referred to OB and Fetal Assessment Unit for follow up.
Started as itchy red raised spots on rt arm upon awakening 10/29/09, quickly moved to include lt arm and cont to spread to entire forearm-many in linear type fashion, to mid upper arm over next 24 hours which continued, and today noticed some on dorsum of hand. He had been out of state, came back in to see me today -I told him to if anything out of ordinary happened-I gave him rx prednisone x 5 days, recommended Benadryl at night, Zyrtec day and cool compresses which he is to start immediately. The rash almost appears like poison ivy but he denies being near any bushes/trees, started no new drugs, new lotions, soap etc.
The PHN came back twicw since the last booster; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included hearing impaired.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix and the booster 5 years later. After receiving the last dose (booster) of Shingrix, the patient experienced post herpetic neuralgia (PHN) which came back twice since the last booster in the summer and goes away in the fall. The patient asked could I get a third booster. The patient's only concern was if Shingrix could prevent a 2nd round why could not it be used for a 3rd. After all the booster kept the PHN away for almost 5 years. The patient stated no phone call hearing impaired.