chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 66 year old male patient with drug allergy to sulfa based medications refers to himself. The patient had no pertinent medical history. In October 2012 the patient was vaccinated with ZOSTAVAX (lot# reported as 8012576, exp September 2013) one time vaccine subdermal in the right arm. Other suspect therapies included influenza virus vaccine (lot# reported as 123023, exp May 2013) (manufacture: Narvartus). There was no concomitant medication. The patient was advised that he had itchiness starting on his back, but that the itchiness and blotches on his skin have settled into his forearm to his elbow (In October 2012) on his right arm, where the vaccine was administered. The patient had sought unspecified medical attention. No lab was given. Unspecified treatments was given for the events. No PQC involved. The outcome and action taken was not provided. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapies. Additional information has been requested.
Potentially expired ACTHIB was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 17-May-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ457AA via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date the patient developed a non-serious potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Potentially expired ACTHIB was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports immediately she developed diffuse aches in the left arm and hand. In the week to follow she developed joint pain along hands/knees/arms bilaterally. Now having bilateral hand numbness tingling.
Patient received vaccine on March 11, and reports that she began experiencing arm soreness immediately afterwards.  She was reporting soreness with pulsating pain for the first 2 to 3 days, now reports a constant dull and achy pain that is worse with activity and movement.  She has been using Tylenol, which she reports does help reduce pain symptoms.  She denies any reduction in her range of motion, but states pain symptoms are more prominent with movement.  She is also reporting daily headaches that occurred starting the day after getting the vaccine.  Patient reports headache is bilateral in nature with a dull, aching quality.  She states headache starts within 10 to 20 minutes of waking up.  She takes Tylenol to help with headache symptoms, which does seem to relieve the headache.  Some days, she reports headache comes back in the afternoon or evening.  She denies any nasal congestion, vision problems, tinnitus, postnasal drip or sinus pressure. No balance, near syncopal, or syncopal problems. Denies any sensory or motor impairment accompanying the headaches.
4:35 pm patient became pale after injection. Patient was very nervous. He never lost consciousness, assisted to lie down for 10 minutes and then was feeling better. 4:45 left clinic with mother and went home and had something to eat. Spoke to mom via phone call and no further problems were noted.
Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome
Patient had sore arm with mild skin rash around the arms and chest. The rash is being fading since then. Patient is doing fine.
Inflammation to left arm started 4/28/2021; Chills and fever started 4/29/2021; Left canine discolored - turned dark brown on Friday.  Client wears invasalign clear braces.  went to the dentist today (5/3/2021).  tooth is "still alive".
Immediate numbness to right side of face around the mouth. Later ~12:00 am fever, chills, headache and backache.
Patient received immunizations and bicillin shot IM. While sitting for observation began to complain of itching.  Taken to med asses department for evaluation.  Observed for 1 hr.  Treated with Zyrtec. Itching resolved. Allergy  consult requested by  providers.
Mom reported child crying, aching, acting as if severe abd pain, taken to ER-  Barium enema given- infant immed stopped crying per mother.  was discharged from ER.  12/23/2008 MR received for ER visit 11/18/2008 with DX: Intermittent irritability w/o evidence for Intussusception.  Pt presented with several day hx of intermittent inconsolable crying, back arching and tucking legs into fetal position. Normal feeding and stools. PE WNL. IS r/o via BE. D/C home.
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 24-JAN-2017 at 13:56, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 32, 192, 1000, 24, 480, 208, 472 and 136. The lowest recorded temperature were of 32,31,30, 29, 28, 27, 26 and 34 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
12/29/2020 Covid Vaccination given at approximately 7:50pm.  Patient complained that "throat is tight".  Physical observation included no shortness of breath, eyes closed fine, but minimal asymetric puffing of cheeks.  Employee/patient was observed for an additional 30 minutes.  Follow up on January 7, 2021, patient states she is feeling fine.
heat; rash; injection site swelling; redness on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site). At the time of the report, INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The events were treated with three doses of acetaminophen 325 mg. The patient also applied cold at the injection site.  Case comment: 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.; Reporter'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.
On 08/08/2016, patient noticed warmth and redness around injection site. On 08/10/2016, patient came to pharmacy with symptoms.
Pt is pregnant at the time approx. 22 wks. FLUZONE that was administered is not preservative free.
chest pains March  19 went to hospital admitted was given potassium for chest pains. May 24 in the evening had a stroke on left side . called 911 . was admitted . stayed 3 days .3 days in rehahab
Dizziness Start in 20 to 30 minutes after the vaccine bad headaches started in Leston an hour followed by chills in the afternoon  Two days to 3 days of dizziness headache nausea
Reports onset of muscle aches evening of 10/14/10. Reports worsening and peak of muscle aches all over on 10/15/10. Diminished 10/16/10 and none present when called clinic 10/18/10.
Three days after his vaccine, my son woke up not very hungry and before he ate breakfast, he started to vomit everything that was in his stomach. That began at 8:00. We gave him some oat milk after that and within five minutes he'd thrown it up. We then tried water and within five minutes he'd thrown that up too. He was tired and dry heaving every fifteen minutes until about 900. Then he only vomited if he drank water. By 10:00 he was asleep again. he woke up at 1:00 he drank  some water, threw it up, but he seemed more awake. We waited a half hour, so 130 we tried water again and he didn't throw it up. By 2:00 I gave him a banana and he didn't throw up again. By 3:00 he was eating regularly again.
05/10/2022 I started having mild fever and mild fatigue. After testing positive for Covid -19 I did not take any medication. Symptoms on going. Also MRI shown Hyperlucent areas
Pt developed a fever and is possibly developing a rash, subsequent to receiving one dose of varicella virus vaccine live.
1st day shooting pain headache Next 2 days tender scalp sensitive to touch. Soreness around ears
Cellulitis developed over vaccine injection site on right leg after receiving varicella and PCV 13.
I was thought to be given the Moderna booster (4:15) until I was called (4:39) and told they mixed up the vaccines and I was given the flu. I went back and received the booster minutes later (4:46). This was my second dosage of the flu in 2 weeks. I am also currently 7 months pregnant.
itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: PRURITUS (non-serious), outcome "unknown", described as "itching". The event "itching" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
weak for over a year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, 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: ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weak for over a year".  Additional information: The caller stated that she was wondering if anyone else has commented that it made them weak. Caller states that she has been weak for over a year. States she took the vaccine in Feb2021 and it still just as weak as can be. Caller states that she thought it was her thyroid, but it isn't. Caller states that she has a beep and needs to go. Asks if she can call back before no longer responding to call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After leaving the immunization room the patient fainted and fell on the floor. Patient lost consciousness for a moment but then was breathing and talking without difficulty. 911 was contacted. At some point before the patient left the store she vomited. Patient parent was contacted the next day; patient did go to hospital and was checked out and given the all clear and was then at home resting.
At about 5:30 pm Monday night of the shot, I notices muscle soreness in left shoulder and tenderness in left upper shoulder at injection site.  By ten was feeling overall body muscle aches, took two Tylenol and went to bed still unconcerned, assumed I'd be fine int he morning.  Was feeling unusually cold at bedtime.  At 2am woke up freezing, shivering hard enough to make the bed vibrate, and was very nauseous and with a bad HA.  Started vomiting at 3am and this repeated about 8 times until 6 or 7 am.  The next day I continued to have a a very bad HA in the front of my head and also at the back of my skull.  On a saltine diet all day.  By Wednesday morning I was basically better and able to return to work and eating.
Three to 4 weeks after the shot I recognized pain in my shoulder, knees and hip joints. Also pain in muscle group in right upper arm. Taking aspirin daily to relieve pain.
Information has been received regarding a case in litigation concerning a male, who prior to 11/15/88, was vaccinated with one dose of HIB conjugate vaccine. It was also noted that the patient received 4 diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid injections, 3 of which were administered on 9/9/86 (lot # 6K71122), on 1/2/87 (lot # 6E81034), and on 2/9/88 (lot # 7D91033), respectively. It was noted that the 4 diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid injections and the one HIB conjugate vaccine injection all contained mercury and were administered prior to 11/15/88. The patient first manifested regression of neurological abilities and on 6/5/90, was noted to be partially autistic and was subsequently diagnosed on 9/13/90 with persuasive developmental disorder and moderate to severe mental retardation. Between the dates of 11/15/98 through his diagnosis on 9/13/90, he did not receive any vaccines. Subsequently, starting on 6/6/91 through 9/95, he did resume with vaccinations, but received no substantial or additional injury of any kind associated with any vaccine given after the enactment of the vaccine injury program. The patient was exposed to high levels of mercury from thimerosal through exposure to thimerosal-laden products. In addition, the patient was exposed to mercury from continually inhaling and ingesting mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal-laden products and power plant emissions together caused the patient to suffer serious and permanent neurological injuries. The patient was exposed to airborne mercury vapor and mercury through the food chain. His exposure to airborne mercury in the environment through inhalation, the food chain, and other sources contributed to the cumulative mercury toxicity and was a substantial factor causing his neurological damage. He had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. As a direct and proximate cause of the toxic mercury exposure to the patient, he was caused to suffer serious and permanent neurological damages which include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments. Upon internal review, persuasive developmental disorder and moderate to severe mental retardation, toxic mercury exposure, and neurological damages which include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments were considered to be other important medical events (OMIC). Additional information has been requested. Per follow up report received on 06/14/2005:  Patient's still has not recovered.
Waking up in the middle of the night, (3:00 or 4:00am) by very sore left arm, almost like a cramp, most prominently around muscles of injection site and then down my arm.  This has occurred each night beginning 2 DAYS AFTER the injection.  Except for local burn or swelling the first day, the adverse reaction did not begin until 2 days later.  I moan in my sleep because of the pain, awaken and jump out of bed, flinging my arm around, grabbing it, massaging it, desperately trying to relieve the pain then take 2 500mg acetaminophen which helps it subside quickly and enables me to go back to sleep.
Lump; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump) and VACCINATION SITE SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for Hypercholesteraemia, VALSARTAN and AMLODIPINE for Hypertension, FENOFIBRATE for Hypertriglyceridemia.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE MASS (Lump) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient's lump and swelling was not as bad as after getting the first dose.   This case was linked to MOD-2021-013865 (Patient Link).
Dizziness, loosing attention, vomiting with blood, falling asleep at all the times.  Treatment: Meclizine 25 to stop dizziness.
Complained of feeling "loopy", which he described as feeling drunk, nausea and metallic taste in mouth. Symptoms resolved on their own at 10:40 a.m. which was 23 minutes after onset.