chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHIEF COMPLAINT:   Patient arrive via EMS. C/O elevated temp, N/V. Reports CPAP at night and O2 was 83%. Took 1000mg tylenol at 2045. Pt received antiviral shots today at 1515 at infusion center. SPO2 95% RA for EMS.   HISTORY OF PRESENT ILLNESS:     51 years old female with past medical history anxiety, arthritis, asthma, chronic back pain, medical cannabinoid use, impaired mobility decreased ambulation, history of Covid positive recently, presents to the ER complaining of shortness of breath, on BiPAP CPAP at home oxygen saturation was 83% at arrival EMS found oxygen saturation 95% on room air, she is seen and examined bedside tachycardic, in the ER note saturation was 93% room air patient has a history of receiving antiviral discharge at the infusion center.  Patient reports shortness of breath, she denies nausea, vomiting, abdominal pain, admits to cough, subjective fever, body aches, symptoms have been present since monday.
This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical history of recent massive heart attack and narcolepsy. He had no known drug allergy. He was taking 'a lot of medications' (type unspecified). On 11-Oct-2012 the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL intramuscularly. On the day of vaccination, the patient did not complain of any symptoms and went home without any adverse events. On 13-Oct-2012 the patient was found dead. The cause of death was still being investigated. According to the pharmacist (reporter), the patient had many health problems including a recent massive heart attack (date unspecified).
Pt stated he felt crummy evening of 4-2-15 and by Friday 4-3-15 he was bedridden. C/o ringing in ears, dizziness, light headedness, injection site painful to touch, no appetite could only eat toast and water and lost 10 lbs., achy neck joints, low grade fever. Pt recovered by Sunday 4-5-15. Denied any previous vaccination reaction in the past.
Pt felt light headed after receiving vaccines and throw up. Emergency response activated Dr onsite Pt given Zofran PO 4mg monitored for 25min and released w/out limitations.
8/13/07 EPSDxx done around 10:30am, I may given about 11:00am, about 11:45am mom comes back into health department with child and asks me look at child. Observed macular rash covering both arms and both legs, none on face, back or stomach. No respiratory distress noted.
From march 23 to april 16: Enlarged lymph nodes under arm  and pain on left side? pain sometimes shooting into left breast. March 11- april 16;  headaches 4-5 times a week.  On march 27 i had a series of 4 severe migraine style headaches over a week period? days this was not  even close to the short lived migraines i get a couple times a year.   March 23-April 16:  extreme exhaustion
Patient received 1 shot of the J&J vaccine on 4/9/2021 at 1155 by Fire department paramedic.  The patient was identified as a homebound resident in our community and met screening requirements for in home vaccination.  Patient  was very lucid and verbal prior to the shot, but showed some mild confusion afterwards.  Upon calling her son, FD learned that the patient has been experiencing some confusion lately. FD also learned from son that the patient had already completed her series of COVID19 Vaccine with Moderna.  Her Moderna 2nd shot was completed on 3/8/21.   The patient's registration resulted from a contact list forwarded to the  Fire Dept with the patient's phone number. The patient was registered through phone for the J&J vaccination homebound vaccinations on 4/9.   J&J was notified with anonymous patient info.  Follow up with the son was provided by, PharmD BCGP, who consulted with CDC recommendations: ?The patient may experience the same local and systemic adverse reactions as either mRNA/VV vaccine.  Furthermore the patient may experience a higher rate of adverse reactions which should be monitored closely.  The patient/family should notify the patient?s health care provider about the case.  No additional COVID-19 vaccines should be provided to this patient.?  FD will be following up with the patient and son tomorrow (day after the injection).
pt received 1st dose pfizer. pt was extremely anxious and nervous. After receiving dose patient waited/monitored for 15 minutes. After 15 minutes patient asked to use the restroom and on the way to the restroom vomited. Phoned patients mom later in the day to check on child and she was doing well
7 days following vaccination, patient showered and noted red area  with firmness at injection site. Area itchy with small raised areas.
Rt upper arm red firm at injection site itches, 8 out of 10 pain with arm movement. Referred to PMD.
I got up and I felt really weird and felt like I needed to puke. I was heaving because I had nothing in my stomach. I felt like I was going to pass out and tried to slide myself down to the floor, and I may have passed out for a minute because I knew my head was on the ground. I eventually dragged myself to the bathroom. I also had my husband come back from work because he just left, and I knew something was wrong. He helped me get back into bed, and eventually I woke up 4 hours later and felt better. I've never felt that way before. I was also sweating a lot during the event.
Day 1 - Injection given around 8:30am - developed fever and headache around 2pm, muscle aches and fatigue started shortly after. Fever (101) broke around midnight.  Day 2 - Headache lasted until 1pm (I took two OTC Tylenol at 10am), Entire body was extremely sore and I felt very exhausted. Day 3 - Felt almost back to normal. Day 7 - Injection site is still red, swollen, and hard. On my neck there are lumps that just appeared and cause some discomfort. Fatigue is still there. On another note I have found it difficult to catch my breath at times this past week.
made us sick as dogs; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a unspecified number of patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: This case reported via interactive digital media. Patients received dose of Shingles vaccine, which made them sick as dogs but so worth it in the long run. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case is linked with case US2022AMR118995, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR118995:Same reporter
about 24/7 hours later i had fever was achy and had chills and my arm was really sore the symptoms lasted about 36 hrs.
Dose given from vial opened/punctured on 09/09/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/15 from previously punctured vial. Vial kept in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
This spontaneous report as received from a nurse refers to a 12 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 28-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
right arm is aching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 12Feb2021 as Single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. The patient experienced right arm is aching on an unspecified date. Reporter stated that just got the second dose today and asked if she could take TYLENOL because her right arm is aching and the caller mentioned she took 81mg aspirin before she got the second dose The outcome of the event was unknown.  Information on the lot/batch number has been requested.
BUZZING IN HIS EARS; RINGING IN HIS EARS; BAD RASH ALL OVER HIS BODY; BOTTOM OF HIS FEET HURT TO WALK ON; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach disorder. The patient was previously treated with esomeprazole magnesium for stomach disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced buzzing in his ears, ringing in his ears, bad rash all over his body, and bottom of his feet hurt to walk on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the buzzing in his ears, ringing in his ears, bad rash all over his body and bottom of his feet hurt to walk on was not reported. This report was non-serious. This case, from the same reporter is linked to.
Information has been received from a 31 year old female in her second trimester of pregnancy with no medical history or allergies who in April 1995, was vaccinated SC with a dose of Varivax. There was no concomitant therapy. The patient reported that on 27 APR 2006, blood work revealed that she was "not immune to chickenpox anymore." Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No further information is available.
Left thigh swollen, warm, tender on injection site for Pediarix about 3" by 3" cellulitis left thigh, treated with KEFLEX, ATARAX, compresses.
Pt had a 2-5 minute tonic/clonic seizure right after DTaP, IPV, MMR, VARIVAX.
This spontaneous report as received from a Certified Medical Assistant refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (one dose: lot number M032497, expiration date 02-JAN-2018; 4 doses: lot number reported as M031943, expiration date 27-DEC-2017) (dose and route not reported). Temperature and time frame was (-)minus 9.7 degrees Celsius (C) for 1 hour. There were no previous temperature excursions. This was reported because of a data logger. No adverse events have been reported. Additional information has been requested.
Still having aches, chills, and sweating at night over a week later.  I had the same shot the day before and my issues were gone 48 hours later.
Pt recv vax on unknown day; post vax pt exp granuloma at the vax site x 1-4 wk; tx=warm packs, move legs a lot, massage
The day after receiving the vaccine, flu-like symptoms began. I ached all over my body and bones. Fever of 102. Fatigue.
Pain in left leg at site of admin and refusal to walk, persisted from day 4 to day 8 after vaccination.
Pain and swelling on day 8 with a hives-like rash, there is a red swollen area now at the injection site but the blisters have subsided.  It looks exactly what the internet is referring to as covid arm.  No fever or other symptoms.  Is still itchy and the swelling was the approx size of a tennis ball but has gone down slightly today. I emailed my primary care physician and he said not to worry.
No additional AE reported; a dose was administered after expiration; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) intramuscular injection, lot #T032918, expiration date: 12-NOV-2022 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). No additional adverse events were reported.
Information was received from a nurse concerning a fifth grade student who on 07 APR 1997 was vaccinated with a dose of Varicella.  During the Christmas break 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
Expired Engerix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 21st February 2023, the patient received Engerix B. On 21st February 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-Feb-2023  Reporter's comment: The medical assistant called to enquire if patient should be revaccinate as they inadvertently administered an expired Engerix dose to a patient in their facility.  The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Engerix, which led to expired vaccine used.
Menveo given instead of Men B vaccine; Third dose of Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 31-MAR-2024) for prophylaxis.   On 04-APR-2023, the patient received the 3rd dose of Menveo. On 04-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo given instead of Men B vaccine) and extra dose administered (Verbatim: Third dose of Menveo administered). The outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 04-APR-2023 and 05-APR-2023 The medical assistant reported that the patient received third dose of Menveo instead of Men B vaccine. The reporter consented to follow up. The patient received third dose of Menveo instead of Men B vaccine, which led to wrong vaccine administered and extra dose administered. The case US2023050262 was identified as duplicate of this case. The case US2023050262 was deleted and all future correspondence would be added in the present case, which stands as case of record for this patient.
This case was reported by a nurse practitioner and described the occurrence of unspecified adverse reaction in a male subject of unspecified age who was vaccinated with Fluarix for prophylaxis. On an unspecified date in November 2006, the subject received unspecified dose of Fluarix (unknown). On an unspecified date, in November 2006, but prior to 28 November 2006, after vaccination with Fluarix, the subject experienced unspecified adverse reaction. At the time of reporting, the nurse practitioner stated the subject received the Fluarix approximately one month ago and was complaining of several adverse events (unspecified). The nurse practitioner was to see the subject the next day and was to call back with further details of the adverse events. At the time of reporting the outcome of the event was unspecified.
Fever of 106.3, chills, headache, lightheaded, dizzy, sore arm
8 ounces of red/brown urine almost 24 hours after injection of Moderna  covid -19 Vaccine EUA
Injection itself had a stinging sensation when the First and Second Vaccinations did not. Several minutes after I had hot flash sensation. I am not sure if it was from the vaccine or actual hormonal or emotional hot flash. Pharm Tech gave me an ice pack I felt better. Later that evening I had chills and my left arm was very painful. Into the evening the pain went to my shoulder blade and under my arm. I had taken 1 Aleve in the afternoon.  I took two the following morning. I also had lethargy that evening and on the following day 11/3, I noticed swelling under my arm. It was painful. I dont remember if I had chills on 11/3. I was still dragging on 11/4 and still swelling and pain under my arm. It is 11/5 today I feel better except for the swelling and pain under my arm. I have not gone for medical attention as I really don't know what could be done. I probably should be applying heat and cold packs but I have only applied a little heat. It has been 4 days and I have NOT RECOVERED YET
Swollen red eyes and cheeks, red itchy rash started on left arm, red streak on left arm, rash spread over body.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: 20210921000818. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypersensitivity (allergic reaction) and urticaria (broke-out in hives), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
The next day after the injection, my knees were so sore that I could not walk and I was not sure they would hold me up.  It felt like the bones were rubbing against each other. (I have strong knees, and have never had any problem with them. ) Advil relieved the pain immediately. I slept at night with a heating pad on them, which helped.  This week, March 12, I am finally able to walk without pain or  wrapping my knees with ace bandages.  They are still not ?normal?.  I may have strained them in a  3-ft snow drift on Feb. 4, but I had no indication they were hurt at the time.    I have had sprained ankles and recently broke my leg.  The pain in my knees was like nothing I have endured so far...it?s onset was immediate.
slight fever 24 hours after; 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 PYREXIA (slight fever 24 hours after) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever 24 hours after). At the time of the report, PYREXIA (slight fever 24 hours after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Ever since my second dose of the COVID vaccine I have now had my menstrual cycle for about 5 days for the last three months. This is significant since I have PCOS and usually don't have my cycle at all, this was the first cycle without having to use provera or birth control to trigger it and the first cycle I've had in three years. I wouldn't call it an adverse event but I am wondering as to why would this vaccine trigger my cycle to start, and to continue.
Information has been received from a nurse practitioner concerning a number of patient who were vaccinated with VARIVAX (Oka/Merck). The patients were getting varicella breakthrough chicken pox in her area. No further information provided. This is one of several reports from the same source. Additional information has been requested.
DEATH; BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 14/Sep/2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported, expiry: unknown) dose, start therapy date were not reported, administered 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection after vaccination (suspected covid 19 infection) and suspected clinical vaccine failure. On an unspecified date, the patient died from unknown cause  It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of breakthrough infection and suspected clinical vaccine failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case is associated with product quality complaint number 90000193360; Sender's Comments: V0: 20210923788-COVID-19 VACCINE AD26.COV2.S-Death, Breakthrough infection. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210923788-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Fever noticed morning after shot at 99.3  then continued to rise to 102.1, controlled w/ibuprofen and then would rise again. At 10 am 6/11/21 she has a temp of 103.8. Given more ibuprofen. Also, with fatigue and headache. Following night temp at 103.4. 6/13-6/14 low grade temps at 99,100
12/13/2022 tested positive even though I had no symptoms. I went to the ER locally. Due to my ongoing medications I was not a candidate for PAXLOVID so I received 3 days of IV remdesivir. I tested positive for 19 days after onset.
pt recv vax & 2-3 hr post vax pt exp a gen sl raised, itchy rash on arms, legs & trunk;sx subsided;