chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago") was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00510, and 0708USA00512). Additional information has been requested.
Pain in right armpit approximately five days after vaccine. Lasted approximately 2.5 days.
Heart Failure With Severely Reduced Ejection Fraction Following Covid-19; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (batch/lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation. The following information was reported: CARDIAC FAILURE (medically significant), 1 day after the suspect product administration, outcome "unknown", described as "Heart Failure With Severely Reduced Ejection Fraction Following Covid-19". The patient underwent the following laboratory tests and procedures: B-type natriuretic peptide: 310; left heart catheterisation: no disease, notes: normal coronaries; transthoracic echocardiogram: left ventricular ejection fraction 20-25 %; left ejection fraction: 20-25 %, notes: severely reduced/significantly reduced; cardiac MRI: dilated LV; no gadolinium enhancement; sedimentation rate: 17; ferritin: 47.4. Therapeutic measures were taken as a result of cardiac failure. With the rise of the pandemic, the development of the COVID-19 vaccine has helped alleviate the burden on the healthcare system. However, rare cardiac side effects have been reported, especially within the young healthy population. Herein, authors present a case series of four patients who received the Pfizer mRNA COVID-19 vaccine and were noted to have heart failure with severely reduced ejection fraction (<= 25%) a few weeks following the 2 dose of the Pfizer vaccine. Patient is a 42 year old male. Symptom onset was 1 day after the second dose of Pfizer. Patient had no prior known cardiac history or predisposing conditions. All patients commonly reported clinical symptoms of heart failure including fatigue, orthopnea, paroxysmal nocturnal dyspnea, and peripheral edema starting within three weeks from receiving the second dose of the Pfizer COVID-19 Vaccine. Guidedline -directed medical therapy given to the patient was Lisinopril, Metoprolol, Sacubitril-Valsartan, Spirinolactone. Conclusion: The relationship between the novel mRNA COVID-19 vaccine and cardiomyopathy remains to be an area in need of further investigation. Despite the unclear mechanism, management remains to be with GDMT and advanced therapies as indicated. EF recovery and improved clinical outcomes can be achieved in some.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between suspect drug BNT162b2 and the reported event Cardiac failure 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.,Linked Report(s) : US-PFIZER INC-PV202300072743 same article/drug/event and different patient;
HEART ATTACK; This spontaneous report received from a patient via a company representative via social media (JNJ Corporate) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. 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 2 weeks after vaccination, the patient experienced heart attack. As per the patient, "Had a heart attack two weeks after receiving vaccine. Had just had a great physical wo any problems". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221161632- Heart attack. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
has a small red rough spot at injection site; injection site taht is tender\ injection site pain; has a small red rough spot at injection site; has a small red rough spot at injection site; Incomplete vaccination schedule; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, injection site dryness, injection site rash and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site dryness and injection site rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site dryness and injection site rash to be related to Shingrix.  Additional details were reported as follows: The age of vaccination was not applicable for 2nd dose. The patient received 2nd dose of Shingrix and still had a small, red, rough spot at the injection site that was tender. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
No additional AEs; Caller reported expired 1st dose of GARDASIL 9 was administered.  Caller asked what side effects would be expected.  No other information provided.  No additional AEs or PQC reported.  See related AE cases 02510121 and 02510150.; Information has been received from a pharmacist, referring to a 11 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-NOV-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
PATIENT RECEIVED 2 DOSES OF ADACEL WITHIN 3 MONTHS.  PATIENT WAS NOTIFIED ON 9/24/19 ABOUT ADDITIONAL DOSE.  UPON SPEAKING TO HIM, HE COMPLAINED OF NO ADVERSE EVENTS.  HOWEVER, HE PHONED ON 9/25/19 TO LET ME KNOW HE WAS NOT FEELING WELL THAT MORNING AND HAD GONE TO HOSPITAL TO RECEIVE CARE.  HE STATED HE HAD MUSCLE PAIN.
This infant had local erythema with some swelling, and a fever of 103 at home. Temperature in the office 97 AX.
Sizure; Initial information was received on 27-Jan-2020 regarding an unsolicited valid serious case received from a pharmacist.  This case involves adult female patient (currently 29 year old) who experienced sizure (seizure), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date five years ago the patient developed a serious sizure (seizure) on an unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  Final diagnosis was seizure.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of seizure.  Information on the batch number was requested.; Sender's Comments: This case concerns an adult female patient who experienced seizure after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset was unknown. Patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Redness to site reaction leading to red streaks for 1 week. Site reaction had resolved by 10/13/17 when personally got to see it.
VARIVAX has been administered with an inappropriate storage; No adverse event; This spontaneous report was received from a customer and referring to a patient of unknown age and gender.  The patient's medical history, drug reactions, allergies, concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039949 with expiration date: 16-DEC-2023, for prophylaxis (strength, dose and route of administration were not provided) (product storage error). The vaccine underwent temperature excursion of -14 Celsius degree up to-10 Celsius degree for 2 hours 5 minutes; -10 Celsius degree up to 8 Celsius degree (-0.4C) for 1 hour 25 minutes. Previous temperature excursion was -14 Celsius degree up to-10 Celsius degree (-12C) for 50 minutes; 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes. No additional adverse event details was reported.  This is one of 13 reports received from the same reporter.
This spontaneous report was received from a registered nurse. It was reported that ROTATEQ had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1210USA000958, 1210USA000959, 1210USA000960, 1210USA000961, 1210USA000962. Additional information has been requested.
I developed an excruciating pain in my right lower leg.  It didn't feel like muscle pull or cramp.  It was deep in leg and acetaminophen didn't help the pain.  I Had x-ray but no break found.  I could not see my family Dr for a week and by that time the pain had ceased.
5/11/2022: 5:00 am Chills, achy, fever 101.7, extreme fatigue, headache, nausea,  6:00 pm vomiting
Elevated (183/??) blood pressure discovered at home on April 6, 2021 after wife checked her own after doctor visit approx. one week after her own second Moderna vaccine.
2/15/23 I woke up feeling bad. The next day I took an at home COVID test and it was positive. I had a telehealth. I was not prescribed any medication. I did not ever really feel bad. I ran a low-grade fever, congested and coughing. The congestion and coughing would not clear up. I had to go to the emergency room on 4/21/23 and was started on methylprednisolone, azithromycin and an albuterol inhaler. I am doing better now.
After getting vaccinated and escorted to waiting area patient fainted out of chair and hit head on floor.  She was briefly unconscious and pale for a few minutes after coming back to consciousness.  She remained on the floor feeling dizzy, shaky, and nauseous until she was taken to the hospital by paramedics.
sweaty that night, woke up itchy,4am hives.has continued on & off. Tired.   previous ABX  Loribid
nose bleed reported 24 hours post-vaccination.  He does not typically have nose bleeds, a rare occurrence for him to have one.  He was able to get it to stop within 10 minutes with pressure.
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   HCP  stated We are primary care clinic for senior citizens. We began administering Moderna on 03Nov2021. While doing quality assurance on 19Nov2021, they discovered an open vial in the refrigerator. Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured. Patients after 05Nov2021 were potentially getting their doses from vials punctured longer than 12 hours ago"
pt received 1st Covid vaccine while in car with Mom. He fainted right after. paramedics right  there. came to in about 1minute. Declined urgent care/hospital.  Didn't eat lunch prior history of  near fainting while donatingblood. Fully recovered.
Severe chest pain 12 hours post vaccine, shortness of breath, and dizziness.
Syncopal episode with minor tonic-clonic movements 3 min after injection. Pt hit R temple on the ground. Pt was kept at facilty with an ice pack and evaluated/monitored by physician.
A few minutes after pt received vaccine pt fell down was unconscious and started seizing for approx. 15 to 20 seconds. He remained uncounsious for an additional 30 seconds and woke up 30 seconds later. He awoke very disoriented and tired. He remained lying down until ems was able to come.  He was then taken to the ER.
Syncope-called 911 classic symptoms; dx at hospital was fear of needles; no meds needed.
1-2 hours after injection got very flushed and diaphoretic, later came the body aches, headache and fatigue.  She also woke up with very swollen hands this morning.  Continues to have body aches, headache, and diaphoresis.
Left Eye twitching for 2 week; Taste of metal in money for a few hours; This is a spontaneous report from a contactable consumer (patient) via a Covid-19 program.   A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Jul2021 14:00 (lot number: ew0198; expiry date: unknown) at the age of 37-years-old, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 23Jul2021 at 14:00, the patient experienced left eye twitching for 2 weeks and taste of metal in money for a few hours. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
c/o muscle cramps 2 wks prior to admission; MMR given 23AUG93 seen in office 3SEP93; duration of pain in 2 wks, inc h/a & muscle pain; 4SEP93 devel rt sided weakness, DTR's dec; dx GBS;
Well this is my job so, anyway, I received the shot and waited the 15 minutes and got up to turn in my paperwork and I got dizzy and all that. I fainted and they put me in a wheelchair and put me in the ER there. I had dizziness, aches, my tongue felt sick and I felt tingly all over. They gave me some medication by mouth I don't even know what that was. They gave me an IV for fluids as well. They watched me for a couple of hours and then I left.
Sore arm, neck, and shoulder.  Tingling feelings in my arm and fingertips.
Patient received vaccine and waited in the store for 15 minutes. She had some dizziness when walked away however it went away after a few minutes.  She thought it might have been from her diabetes. Two days later her arm at injection site became swollen, itchy, redness, warm to touch, knot at site. Patient also states she has had a headache, dizziness that was off and on.  She also has drowsiness since the vaccine and again she states she can not tell if it is from her diabetes.
CHEST TIGHTNESS; LEG HEAVINESS; LEG TIGHTNESS; TIREDNESS; THROAT CLOSING UP ON HIM; SWEATING; DIZZY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, pollen allergy, asthma, chronic obstructive pulmonary disease, colon disorder, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, Laboratory data included: Blood test (NR: not provided) high cholesterol. On 06-APR-2021, the subject experienced throat closing up on him. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced chest tightness. On 13-APR-2021, the subject experienced leg heaviness. On 13-APR-2021, the subject experienced leg tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and dizzy on 06-APR-2021, and had not recovered from throat closing up on him, tiredness, chest tightness, leg heaviness, and leg tightness. This report was non-serious.
chills; exhausted; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiry date: unknown) via unspecified route of administration, in left arm on 17Feb2021 16:15, as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included known allergies of latex from an unspecified date and unknown if ongoing. Concomitant medications were not reported. She did not take any other vaccine in four weeks or medications in two weeks. On 18Feb2021 10:00 AM, patient experienced chills, exhausted. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given as a result of the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
headache, chills, body ache, 101.4 temp/fever; none yet Adv ok to take some APAP PRN if this is something safely taken according to dosing on the bottle, can try heat pad, stay hydrated. Call back if any issues worsen/persist provided number and PCC will FU tomorrow.
Flu shot given on 10/15/15. Not allergic to eggs. No hx of Guillain Barre. Patient called on 10/19/15 reporting that he had gone to the hospital 5 hr. after the injection because he could not breath. He found relief after they gave neb tx. Sent home on prednisone and abx. 10/19 reported feeling normal.
pt recv vax 23AUG95 & MAR99 pt had a definite chickenpox exposure & 2-3wk later had full chickenpox illness confirmed by MD exam;sx include fever, malaise, h/a & rash;
pt recvd vax & 7APR94 there was no concomitant meds; approx 30 minutes p/vax blacked out while driving car & became involved in accident; pt was hospitalized; addtl details are being requested;
Patient received a third dose of the moderna covid vaccine bedside at the LTCF. A VAR form was provided and staff of the LTCF stated this was the patients second dose and not third dose. After further investigation, it was discovered the dose we provided was the third dose. There were no immediate ADRs.
After receiving the vaccine, I experienced severe pain from my shoulder and part of back on left side all the way down my arm to my hand and fingers on left side. Injection was in the left arm. Within the next day, my hand started swelling. I kept waking up from pain due to back, arm, and hand. I got a fever, chills, diarrhea, nausea but all of those subsided within the span of 3 days, the only thing that didn't subside was the pain in my arm and swelling in my hand. I've been taking two aleve twice a day and icing my hand and arm. Pain has improved but left hand is still swollen even after 8 days since injection. I haven't been able to drive or use my hand regularly.
Brought in by ambulance to behavioral ED for "bizarre behavior" and found to be COVID-19 positive.
Ear ringing, headache, body aches, neck pain, 102 fever, lethargy, winded, cough. Symptoms still persist three days after shot.
Had syncopal episode lasting about 30 seconds, a few minutes after receiving 3 vaccines Tdap, Menactra and Flu shot.
Dose 2 - 03/17/2021 ,  04/18/2021 16 days after vaccination start spotting which is unsual for her then she went to the OBGYN PAP was  done and was told to comeback in June/2021 April had a heavy period cycle and no period to 06/04/201 which was 46 days after the spotting on 04/18/2021.  14 days later got a min period. 06/18/2021. Regular cycle is normally 25 days apart for as long as she could remember. Light  Discharge 06/18/2021-06/29/2021 two weeks a  36 days since the spotting of mini period mention earlier, period 07/23/2021 was very heavy. 14 days 09/2021 Went to the Doctor for blood work and intro Vaginal Ultrasound  New medication TransExamicAcid  to reduced blooding during heavy period began after dose 3.  09/27/2021 under arm pain on the injection site and missed work for tired fatigue and headache and noticed two days later had swelling below and above shoulder in neck area an went to urgent care and diagnoised with the vaccination and advised to go to General Practicer next week.