chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse, refers to a currently 13 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excursions and the aforementioned one were not  identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-APR-2015, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
improperly stored; Information has been received from an unknown age and gender consumer referring to himself/herself. The patient's concomitant therapy included sterile diluent. The patient's other concurrent condition and medical history were not reported.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live ( PROQUAD) (1 dose, lot# T013537, expiration date 17-OCT-2021; strength and route were not reported) for prophylaxis (Incorrect product storage). The vaccine was exposed to temperature excursion of 22.4 degrees Fahrenheit for 44 hours 10 minutes and the data logger was involved. There was no previous temperature excursion.
Information has been received from a obstetrics registered nurse and a physician via medical records for VARIVAX (Merck), a Pregnancy Registry product, concerning a female baby patient whose 29 year old mother was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 664355/0655Y) on 07-OCT-2009. Concomitant medications included vitamins. The patient's mother was subsequently discovered to be pregnant on a serum pregnancy test on 21-OCT-2009 (WAES # 0910USA02803). The patient was born on 21-JUN-2010 via normal spontaneous vaginal delivery, her weight was 8 pounds 7 ounces. APGAR score was pending at the time of dictation but the initial APGAR was quoted as 8. The pediatric team was called because of the patient's baby particulate meconium aspiration, and although the baby had a spontaneous and vigorous cry, oxygen supplementation was necessary to keep the pulse oximeter reading appropriate. Because the reading was borderline, the decision was made to take the baby to the special care nursery. The baby was hospitalized for 4 days in the neonatal ICU due to meconium aspiration. On an unspecified date, the patient was sent home with her mother. At the time of the patient's mother postpartum visit in August 2010, no problems were reported with the healthy patient. Additional information has been requested. All available medical records will be provided upon request.
collapsed. He awoke confused; fatigue and feeling main in his head and joints; He awoke confused; Feeling pain in his head and joints; Feeling pain in his head and joints; collapsed. He awoke confused; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown). On an unknown date, 5 days after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), circulatory collapse (serious criteria GSK medically significant), fatigue, confusion, headache and joint pain. On an unknown date, the outcome of the passed out, circulatory collapse, fatigue, confusion, headache and joint pain were recovered/resolved.   The reporter considered the passed out, circulatory collapse, fatigue, confusion, headache and joint pain to be related to Bexsero.  Additional details provided as follows: The age at vaccination was not reported, however the patient could be of 15 or 16 years old at a time of vaccination. The patient received Bexsero and experienced several adverse event. The patient was about 5 days post dose and symptoms lasted about 4 days. It started when he collapsed, he awoke confused, very fatigue and feeling main in his head and joints. The patient was unsure of the root cause of these symptoms because it was in late summer during the very intense football workout. However Nurse quickly concluded that the events were consequential to his first dose of Bexsero.
24 hours after receiving vaccine injection, had 2+ hours of tachycardic episode with resting heartrate between 100-110 bbm. Heart rate went into the 90's for several hours and by 6pm, resting heart rate resumed to normal ~80 bbm. While heart rate was elevated >100 felt weak and not well in general. Had the episode lasted any longer, I would have sought medical attention. I am someone who goes to the doctor about 1x/year.
Evening of injections pt had red, hot, swelling to (R) deltoid area. Extended from shoulder to elbow. 3 blistered areas near injection sites. Possible infection. Prescribed Cetirizine and cephalexin for allergic reaction and cellulitis.
Vaccine 1 side effects: Felt like giant jujube (a rod but gummy like) was in my arm but got smaller as days progressed. Hurt if touched the area. By Day 6 the rod felt smaller than a regular sized jujube and after that it was gone.  Vaccine 2 side effect Had 102 fever next day but felt OK the preceeding day. Arm where injection was also itches a little from time to time, but not as much as it did the day after getting the Vaccine.
Patient mother called and said that they were experiencing body aches, nausea, and redness and warmth of the upper right arm. He had no fever.  Dr. advised mother to give patient Motrin and 12.5mg Benadryl every 6-8hrs.  If patient got worse was to go to ER, otherwise appointment was made for 1/19/2006 at 11am and patient was a "no show" for appt.
First two days: Low grade fever (100.8, 100.1) and chills  Following two days: Low grade fever in evening and night (99.7 and 101.0) no chills, but light headache. Headache would worsen when standing up.   At the time of reporting, still dealing with light fever at night.   Treatment: 600mg of ibuprofen every 8-10 hours. Typically around noon, and 8pm. Large amounts of water, pedialyte consumed while experiencing symptoms.
AM of 4FEB pt noticed small golf ball size lump above rt clavicle-tender initially;by 10FEB non tender;to MD 10FEB ?parotitis, thyroiditis;referred to ENT;2AM 9FEB woke w/lt upper arm tenderness, swelling & warmth, induration, erythema;
Patient was vaccinated with booster Moderna on 3/4/22. Patient states no discomfort over the weekend but noticed discomfort on Monday 3/7/22 when walking to class. Patient reports having swollen, discolored, painful toes. Pain and discomfort from toes keeping patient up at night and making it difficult to walk. Patient states discomfort increased around 3/14/22.
When the patient returned for his second Modern pt. reported that 6 hours after his first injection, he experienced pain in his shoulder and was unable to move his arm more than an inch without pain.  He reports that he wore a sling for about a week to immobilize his shoulder, so that he could at least use his lower arm and hand.  There was no discomfort from the elbow down. Pt. pointed to a spot more in the area of the clavicle that was the size of an eraser head.  There was a darker red pinpoint in the center and a lighter red area surrounding it.  He states that there was no pain upon pressing at the site nor swelling or larger area of redness, at what pt. says was the injection site.  He states that states that a band-aid was placed over this site, as described.  Currently, he states that he has full movement of his shoulder but will occasionally experience discomfort in his shoulder.  He reports that he believes it was not the Moderna vaccine that was the problem but the location of the injection site. Pt. was willing to receive his second Moderna vaccine on 04/08/2021 in his right arm, but his main concern was whether or not he received full protection from the first vaccine.  The health Department nurses contacted Moderna by phone ,at the clinic ,to describe the scenario of the first injection. RN was told that the injection site as described would deem the vaccine as invalid.  However an additional vaccine beyond the one already scheduled on 04/08/2021 would not be recommended. Pt. received his second vaccine as scheduled in the right deltoid muscle.  Today, 04/09/2021, pt. states he has no pain whatsoever in his right arm.  His concern continues to be the level of protection he has from Covid-19 that would enable him to visit his grandson after a long year of not seeing him.  Any documentation that would alleviate this concern would be helpful to both the health department and the patient.
Left shoulder and deltoid pain right after injection, left shoulder and deltoid pain radiating to left elbow reported on 10-22-16, pain continues. Complaints of upper arm at injection site always sore and decrease range of motion on 11-10-16, anti-inflammatory and ice not helping, pain manageable but wakes her up occasionally at night reported on 11-17-16, PT ordered 11-17-16, reported to PT that it feels better if she holds her arm close to her body, diagnosed by PT the her left shoulder pain is due to instability on 12-16-16.
Experienced chest pain, especially on exertion, for 2 days after receiving COVID booster vaccination. Received vaccine on 12/30/21, adverse event began on 12/31/21, continued on 1/1/22. Less in severity on 1/1/22. Accompanied by body aches, injection site soreness and slight chills on 12/31/21.  Vaccinated with Pfizer for initial series in December 2020 and January 2021 and received Moderna as booster in December 2021.  23 weeks pregnant at time of booster vaccination, estimated date of delivery April 2022. First pregnancy.  Of note I am a pharmacist for a health system.
RLE DVT--Acute, occlusive deep vein thrombosis in the right gastrocnemius  vein--started on anticoagulant--apixaban
Moderna COVID?19 Vaccine EUA Symptoms: Chills - onset approximately 8 hours after shot to 20 hours after shot.   Fever -103.8 approximately 12 hours after shot given. Fever subsided approximately  30 hours after shot given , headache onset 8 hours after shot given - subsided approximately 36 hours after, rash  on side of chest between  armpit and breast on opposite side of body from the shot given appeared approx  30 hours after shot given.
Noticeable arthritis flare, beginning in jaw w/referred ear pain, Achilles heels, chest. 9/30  Progressing to multiple joints ? hips, lower back, shoulder, hands.  Low grade fever around 100 degrees Fahrenheit.  Constant headache.    Treatment Called dr for prednisone taper.  Started 10/5 not feeling better yet. Hopefully soon
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R029815 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA000965: US-009507513-1907USA001843: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970:
TD vax given in lt deltoid on 5FEB91 w/gradual increase in wheal w/erythematous, edemedous well circumscribed wheal non tender measuring 64 by 77 millimeters on 11FEB91.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received PREVNAR 13 injection a week a go and arm was still hurting since an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
reddish rash on arm at site of injection 2" x 3"     slight itch at first not now   24 hours later still there
Pt. received Comvax in right leg and DTaP and IPV in left leg on 02/04/2003.  On 02/06/2003 the pt's mother came in with a note from a MD. The note stated that the pt. had a temp of 100.4, erythema and swelling on right leg about 2.5 cm in diameter and was lethargic and irritable.
Red rash at injection site that looked like a bug bite had radiated outward. About 2 inches in diameter. A little bit itchy, but no other concerns.  This happened a few days after the first injection too. Faded on it's own after a couple days.
Pt completed dose, she went to sit in the observation area. She stated she dropped her paper, when pt bent down to pick up dropped paper, she proceeded to fall to the floor onto her butt, then onto her back.  States she was dizzy. No loss of consciousness, pt alert and oriented. No sweating or high heart rate ntoed.
The patient called into the pharmacy complaining of redness, swelling, and warmth around the injection site on 5/16/17 after waking up.  She had not taken anything for these symptoms at the time of the call.
Child given flu shot and approx 15 sec later leaned back in assistants arms and passed out-eyes remained open. Pt quickly responded to stimulation, cold compress to head. Vital signs returned to normal. Pt taken to nurse's office where she rested until color was back to normal, vital signs stable for at least 20 min and tolerated apple juice. Child stated she had not felt good today. Child had runny nose. When mom phoned, she stated that she (mom) had also experienced passing out with injections and blood draws all her life. Pt did go home with mom with no further interventions or complications. Per school nurse, child returned to school and had no further events or reactions. Child was not evaluated by ER after event though it was offered. There were 4 nurses to evaluate pt during event.
Patient within a minute of the vaccine felt dizzy light headed, bp 151/123 117. I had her lay down and put her knees up  she immediately felt better bp 99/66 85 at 4:05pm after  five minutes I had her sit up in the chair and she felt faint again. I had her lay down with knees up for 15 minutes, she felt much better bp 84/66 77   I then had her sit on the floor for 5 minutes before returning to the chair. she felt much better and I had her stay there until 4:30 . she felt fine again and left with her boyfriend. I told her to discuss the next dose with her doctor and have I given in their office where there is more support.
Within 30-36 hours of receiving the MMRV, patient developed painful swelling at bilateral parotid glands, right worse than left. This worsened over the next few days. No fevers. No purulent drainage at Stensen's duct. Given the multiple possible etiologies of parotitis (post-viral, viral, bacterial, MMRV vaccine), I started him on AUGMENTIN for possible bacterial etiology. He plans to f/u in one week.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical conditions, concomitant medications and concurrent conditions were unknown. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX for prophylaxis, lot# N031938 and expiration date 13-NOV-2019 or lot# N028715 and expiration date 13-OCT-2019 (dose, strength and frequency were unknown). It was reported that the vaccines had a temperature excursion of 15°F to 46°F (28.23°F) during 1 hour and 30 minutes. No previous temperature excursions were reported. Data logger was involved.
Right arm swollen, red and hot to touch. Pt treated with Keflex 250mg/15cc 1 tsp TID x 10 days.
pt recv vax 29JUL96 & 3wk later 11NOV96 pt devel symmetrical, gen papules;biopsy revealed hepatitis C negative;the papules persisted until 21DEC96;pt recovered & MD had no further contact w/pt;
Woke up in the night with chills.  In the morning.....headache, body ache, chills slight nausea. (No vomit). He spent the day on the couch trying to stay warm.  No energy.....felt terrible.  Next morning  MUCH better later in the afternoon he was up and out.  No stuffy nose, no cough or sore throat.  Never lost taste or smell.  He has no idea what was wrong.  He has been very careful, wears mask, washes his hands and other than the store stays away from people.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tired; Upper lip in left side swollen; Aches; Flu kind of thing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Aches), INFLUENZA LIKE ILLNESS (Flu kind of thing), FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (patient says that she has not known allergies or medical conditions, she states she is quiet healthy.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and OMEPRAZOLE (OMEPRAZOL 1 A PHARMA) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Aches) and INFLUENZA LIKE ILLNESS (Flu kind of thing). On 15-Jan-2021, the patient experienced FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen). On 15-Jan-2021, PAIN IN EXTREMITY (Aches) outcome was unknown. At the time of the report, FATIGUE (Tired) and LIP SWELLING (Upper lip in left side swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was that patient spoken to her plastic surgeon who told her that she received fillers for the last time about a year ago, and prescribed steroids to treat the swollen lip.   Patients concomitant medication include statin 40 mg.; 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.
Left the store and drove to a doctor's appointment. I parked, and went to get out of the car I felt like I was having dizzy and couldn't focus. I said to myself "I am gonna pass out! I layed on my horn and rolled down the window and I yelled and someone finally came out of the facility and asked if I needed help. He got me in a wheel chair. I sat in the chair and was very thirsty. They called EMS and within an hour or so after getting to the hospital I was able to focus. I was tested for a stroke and didn't have one. I was released 3 hours after getting to the hospital and am fine now.
Arm swelling and redness. I now have a 4 inch purple hot spot at injection site. The redness and swelling has changed daily since my shot. It?s 4 days after and my arm is swollen red and hot past my elbow and it?s itchy.
Seen 8/22/ for cellulitis at right deltoid site of IPV. Treated with Keflex and Motrin. Follow up in 2 days.