chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # K011562, expiry date 08-APR-2017, NDC# 0006-4119-03) for prophylaxis (Strength, dose and route of administration were not reported) (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis.  There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was a temperature excursion of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001491: US-009507513-1707USA001492: US-009507513-1707USA001489: US-009507513-1707USA001488: US-009507513-1707USA001490:
no adverse effects; an expired dose of VARIVAX was given to a patient today; 0.7 mL; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JUL-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (lot #T024287, expiration date: 15-JUL-2022; strength and route of administration were not provided) with sterile diluent (MERCK STERILE DILUENT) (strength, lot #, expiry date, route of administration, and indication were not provided), 0.7 milliliter/once (expired product administered, incorrect dose administered). The vaccine had no history of temperature excursions. The patient had no adverse effects or symptoms from receiving this dose.
Area on lt leg infected fr either the immun (DTP) given @ that site or another source unrelated to immun; Area is raw w/sl drainage; no redness & not hot; Temp 95.8ax-referred to md;
Covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), OMALIZUMAB (XOLAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). On 27-Feb-2021, VACCINATION SITE REACTION (Covid arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included steroid cream and triamcinolone, levocitrizine  dexamethasone 4 mg for 4-5 days, doxycycline,Zyrtec   This case was linked to MOD-2021-089555 (Patient Link).
Patient entered the pharmacy and asked for a flu shot. She was given the paperwork and she marked influenza. She was given a flu shot. When she was scanning her label out she told the cashier she already had her flu shot and wanted a COVID vaccine.
heart pounding; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW191) via an unspecified route of administration in the right arm on 11Jun2021 at 14:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and mitral valve prolapse. The patient was allergic to penicillin. Concomitant medications included SYNTHROID, insulin LEVEMIR, losartan, and insulin NOVALOG, all taken for unspecified indications from unknown dates. The patient previously took ciprofloxacin and EPINEPHRINE and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW178) via an unspecified route of administration in the right arm on 21May2021 at 14:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, two weeks after the second dose, the patient experienced heart pounding. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event heart pounding was not resolved at the time of this report.
6-21-07 pt experienced itching in fingers. On 6-22 pt had swelling around eyes and rash on fingers. Symptoms worsened until 6-24 when pt took Benadryl. 6-25 pt showed multiple papules and vesicles on fingers and in between fingers. Skin around eyes edematous. Fingers pruritic.
I broke out in bumps all over my body which turn to sore they gave me DERMA-SMOOTHE-FS body oil and my insurance won't pay for it.
SORE ARM; This spontaneous report received from a health care professional concerned a 51 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination.  On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Seizure; admitted to PICU. Pt's mother states child was staring and vomited prior to onset of seizure. The child was premedicated with Tylenol and also given a dose that evening. No fever was noted. Discharge diagnosis: febrile seizure.
Patient had a well child visit with vaccines given on June 24th. About 3-4 hours later while playing she experienced chest pain & SOB. Was seen in the ER, given nebulizer treatment. EKG, sent home. The next day had sore muscles and had slow speech, seemed out of it. Was seen in the ER, was told patient was fine and sent home.
The patient experienced a rash, fever, severe muscle aches, sore throat, weakness and was unusually nervous. The patient had a fever, pain and high blood pressure when she was seen in the ER. The patient's temperature started at 2:00 am on 10/25/2001 and ranged from 100.6F to 102.6F and finally broke on 10/29/2001 around noon. The rash was lighter in color on Thursday and Friday after the patient began taking Benadryl. The patient was off work on Friday because she was too weak to move. When seen in the ER, the patient tested negative for strep, but the physician advised not to rule out a strep infection because the rash did not itch. Benadryl did not help the rash. The patient was on antibiotics for 4 days and the rash is disappearing.
Patient reports a large red area on left arm, no itching or swelling, but area is large, approximately 5 inches by 3 inches.
None. Pt. received  PEDIARIX and Hep B (Single dose) on 11/12/2008.
within 2-3 minutes, pt states felt dizzy, lip and cheeks "felt wierd" swelling on left side of cheek and lip; no SOB, no rash, no swelling of tongue; no reaction at site; laid down and APP evaluated; 50 mg Benadryl IM; VS WNL; monitored for 20-30 minutes; given dose of depomedrol; after 1.5 hours swelling subsided; lives 35-45 minutes from clinic; pt went home with pt employee/family for monitoring overnight and follow up with PCP
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 and expiry: 02-OCT-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 17-MAY-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and expired vaccine administered from the vial affected from temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916300, 20210916228, 20210915661, 20210915731, 20210915852, 20210916312, 20210915623, 20210916553, 20210916658, 20210916697, 20210916910 and 20210915719.
severe chest on 8/23/22 presents to Facility. EKG shows inferior ST elevation and taken to cath lab to rule out obstructive CAD. No obstructive disease was found but patient had significant troponin rise to peak of 18,000. Started on NSAIDs for peri/myocarditis,
Started breaking out in red rash/ chicken pox- like break out on day 10 after vaccine on the arms. On day 11, it spread to all over body - legs, arms, stomach, back, and also started on the face by day 13.  The red spots were very itchy. VIsited my primary doctor who said that it could be the vaccine. Gave me steroids and  benadryl that relieved the itchiness, But when the effect of the meds faded, the itchiness was back. All red spots were yery itchy all over my body. They were not contagious as my children and wife did not get it. My wife got the same vaccine on the same day as me, but did not have a reaction as mine. . The red spots started growing in size and combining with other nearby spots on the legs. over day 12, and became brighter. They are fading now, but I still have the red spots all over my body.
Fever; headache; body aches; joint pain; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101.3 °F High and 99.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After first dose I had a rash over my stomach and back for a couple of days.  After the second dose, my arm was extremely painful, started with 2 red spots -injection site and one larger.  The next day my arm was more sore and there was one large red splotch and several bumps by the end of the day I could feel a harness/swelling in my arm and it felt like a bad sunburn -heat radiated off.  The 17th (day 3) I had a rash over my entire belly and my back looked like I had a bad sunburn - heat & dryness.  I took a Xantec during the day and a Benedryll at night. 18th (day 4) my entire torso and both arms were covered with either spots or what looked and felt like a sunburn- spots were advancing up my neck but the pain in my arm was lessening.  I used teledoc and was prescribed Prednisone - couldn't pick it up until the evening. 19th I started the day with Prednisone, the rash seemed to be lessening but was now itchy like a healing sunburn.  Today I am feeling needles of pain on occasion in my torso but the rash has mostly subsided and the pain in my arm is gone.
14 weeks pregnant Estimated due date is June 2022.  Uncontrollable diarrhoea. Drowsiness. Lack of appetite. Dizziness arm tenderness at injection site. Hard limp at injection site.
Child blacked out. C/O dizziness and light headedness. Lowered to ground and unresponsive approximately 5 seconds and then responsive.
Myalgia, Fever, NauseaVomiting, Swollen Glands/ Fatigue/ Swelling Narrative:   Other Relevant History:
Left arm at site of injection occurred 1 week after vaccine admin. Intermittent pain for 2 weeks. No treatment.
RTIM 1" x 1" Red knot, warm to touch, allergic reaction. Dx. Pt will call if redness spreads. Next time Prevnar is given, it will be given by itself.
pt recvd vax; tired, h/a for 2 days; by 4th day spiked t, ached all over; by 5th day, t still 101 & entire body ached; felt washed out;
I contracted COVID-19 with symptoms of sore throat, congestion, severe headache, cough, loss of smell, loss of taste, fatigue, and laryngitis. I was prescribed PAXLOVID but instructed not to take it if I felt better by day 5. I was ill for 5 days before my symptoms began to resolve so I did not take PAXLOVID. I am still experiencing fatigue, and lingering cough. I am still not fully recovered.
Two red, round, slightly raised areas approximately 2 inches in diameter distal to the injection site. One is on the anterior portion of the bicep and one is more lateral between the tricep and bicep.
On 24JAN91 pt rec'd DTp/HIB approx 24 hrs post vax developed fever of 99.0; 48hrs post vax blotchy, scaley rash over entire body w/vesicular lesions; Also would become very stiff & cry;
Injection painful, then severe pain in upper arm and shoulder and pain down entire arm into hand. Cannot lift arm. Swelling of shoulder. Not inflamed. 2 days later, cannot lift arm, but able to move fingers now.
At approximately 2:40pm Rapid Response heard on radio to observation area.  This RN presented to observation area immediately, noted employee hovering over trash can reporting nausea. Employee received vaccine about 10 minutes prior.  Employee denies any breathing difficulty, chest pain, dizziness, itchiness, tongue or throat swelling. No visible facial swelling or rash noted. Skin is warm to touch, not cool or clammy.  Dr. presented to scene and report given.  Vital signs taken, employee is not actively vomiting, but intermittently spitting clear saliva to trash can.   Employee states she was feeling overwhelmed/stressed given some concerns at home with her mother. She denies any reactions to vaccines in the past.  Offered apple juice and crackers.  Per Dr. employee advised to remain in clinic area for additional observation, no epi advised at this time.  Pt observed for approximately 10-15 minutes. She reports improvement of symptoms and denies any new sx.   She feels well enough to leave accompanied by her co-workers who were also here for their immunization.  Plan: Reviewed with employee emergency warning signs and advised she should call 911 should she develop any symptoms. Patient shows good understanding and is receptive to plan. Pt left in NAD.
Inadvertently administerd DTAP-IPV, <7Y (KINRIX). Child is 2 years old.
Slight Bell's palsy in left side of face; left side of face feels a bit numb/swollen/puffy and it takes more effort to smile and talk out of left side of face
Experienced excessive fatigue 6 hrs post vaccination.  Not concerned.  Following morning noticed an increase in tinnitus symptoms.  I had longstanding, mild tinnitus, in one ear, however, this was whistling in both ears and an order of magnitude worse.
Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, stiff joints.  Went to ED.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient with FLAGYL allergy and no pertinent medical history. On 19-MAR-2013 the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # H013938, expiry date 25-OCT-2013) subcutaneously. There was no concomitant medication. On 20-MAR-2013, the patient experienced rash which was red and spreading around the injection site area. No laboratory diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. The patient had contacted pharmacist for medical attention. Additional information is not expected.
This spontaneous prospective pregnancy report as received from a consumer (patient's mother) refers to a female patient of unknown age with none pertinent medical history or drug reaction allergies. On unknown dates the patient received all three shots of the GARDASIL vaccine (Lot #, dose and route not reported). There was no concomitant therapy. On an unknown date, after receiving the shots of GARDASIL the patient developed a viral skin infection and had chest pain. The reporter stated that the patient also became pregnant on an unspecified date after receiving the GARDASIL vaccine. The patient became pregnant with Last Menstrual Period of 24-APR-2013 and Estimated Date of Delivery of 29-JAN-2014. The patient was now 21 weeks pregnant and the baby had developed a heart problem known as transposition of the great arteries. The reporter also stated that the baby  had a high risk of being born with Downs Syndrome. The pregnancy outcome was pending. The patient sought medical attention saw the doctor on unspecified date and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The outcome of viral skin infection and chest pain was unknown. This case is related with 1309USA009423 (Baby report). Additional information is not expected.
When giving child a bath on the night of 10/16/17, mother noticed large red area and swelling that started at injection site and went down around 2-3 inches on the arm. Mother reports the skin feels hard and tight. Does not bother the child at all.
Herpes simplex 2 outbreak on left glut lasting 3-4 days.   Previous outbreak was about 10-15 years prior.
Significant fatigue, headache and dizziness  x 4 weeks similar to fatigue after having COVID illness.
Patient experienced syncope upon exiting pharmacy after vaccination. He was assisted to a nearby chair before falling and sustained no injury. Patient and father declined emergency medical services to be requested. After an additional 15 minutes of monitoring, patient reported feeling well and was permitted to leave.
100 fever for 18 hours, lethargy, followed by painful swollen lymph nodes approx 32 hours after administration of vaccine
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm 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) and as dose 3 (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 "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Aug2023 to 05Aug2023. 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.
Had flu shot morning of Oct. 16. Woke me at 2 AM in excruciating pain in his right leg. We went to emergency room. They x-rayed but could not find anything. Went home. Sunday, he was back in pain. We were back in emergency room. X-rayed higher; could not find nothing. Mon. saw his doctor, had MRI - nothing - went to sports doctor and could find nothing. They said to take him to his neurologist. We did, he couldn't find anything wrong with his leg. Some arthritis in hips, and back only. He was on medication for Alzheimer, after this incident he went into full blown Alzheimer and I had to put him into a nursing home December 14, 2007.
Rash and itching starting 8 days after vaccine was given across chest, upper inner arm, posterior knees/thighs
Severe muscle pain at certain postures. Can not bend arm to back. Greatly changed life quality. The muscle pain at first localized in injection site. Now it migrant to adjacent muscles.
Swelling in left side of neck, dizziness, upset stomach and headaches.  01/06/2021 fell while walking and could not get up without assist.  General fatigue, cough and aching muscles.
top of arm down to elbow, hard to move, discoloration edema, very sore, never went away using cold compresses; tx w/ATB
9/24/04: 30 minutes after shot, got dizzy and warm feeling, not hot flash. Nose running non-stop. 4 hours after shot, very tired. 6 hours after shot, blisters on back of neck, 9/25/04: tongue red, swollen with blisters on it nauseated, achy, very tired, shot  site very sore. Same on 9/26/04. 9/27/04 better...tongue with less blisters...used saline solution to help tongue.
Severe Asthma; Uncomfortable; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Shortness of breath), ASTHMA (Severe Asthma) and DISCOMFORT (Uncomfortable) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNEA (Shortness of breath) and DISCOMFORT (Uncomfortable). On 29-Mar-2021, the patient experienced ASTHMA (Severe Asthma). At the time of the report, DYSPNEA (Shortness of breath), ASTHMA (Severe Asthma) and DISCOMFORT (Uncomfortable) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Asthma medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated outcome of event Shortness of breath, Asthma, Discomfort from Unknown to Recovered.
1st Pfizer vaccination 1/21/21, lot # EJ1686. 2nd Pfizer vaccination 2/10/21, lot # DW8936. On 2/25/21 pt had decrease in meal intake and began refusing meals.  On 3/1/21 was sent to hospital for rectal bleed