chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning an approximately 12 month old male who "11 or 12" days ago", on approximately 12-May-2007 was vaccinated with Proquad. The patient developed breakthrough disease after receiving the vaccine. No further information was provided at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M009746 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced expired product administered. No adverse event was reported. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PROQUAD. Additional information has been requested.
Information has been received from a registered nurse concerning a female with no relevant medial history and no known drug allergies who on 25MAY1995 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient's mother reported that the patient developed multiple vesicles and papules on the trunk, back and scalp. It was noted the vaccine was administered at another practice and that the patient's sibling had chickenpox 11 days prior and was evaluated on 26DEC2003. Medical attention was not sought. It was noted that the patient recovered. No further information is requested.
This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323; US-009507513-1902USA009445: Original Case: 1902USA009323; US-009507513-1902USA009446: Original Case: 1902USA009323; US-009507513-1902USA009447: Original Case: 1902USA009323; US-009507513-1902USA009448: Original Case: 1902USA009323; US-009507513-1902USA009449: Original Case: 1902USA009323; US-009507513-1902USA009450: Original Case: 1902USA009323; US-009507513-1902USA009451: Original Case: 1902USA009323; US-009507513-1902USA009452: Original Case: 1902USA009323; US-009507513-1902USA009453: Original Case: 1902USA009323; US-009507513-1902USA009454: Original Case: 1902USA009323; US-009507513-1902USA009455: Original Case: 1902USA009323; US-009507513-1902USA009456: Original Case: 1902USA009323; US-009507513-1902USA009457: Original Case: 1902USA009323; US-009507513-1902USA009458: Original Case: 1902USA009323; US-009507513-1902USA009459: Original Case: 1902USA009323; US-009507513-1902USA009460: Original Case: 1902USA009323; US-009507513-1902USA009461: Original Case: 1902USA009323; US-009507513-1902USA009462: Original Case: 1902USA009323; US-009507513-1902USA009463: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009444: Original Case: 1902USA009323; US-009507513-1902USA009443: Original Case: 1902USA009323; US-009507513-1902USA009442: Original Case: 1902USA009323; US-009507513-1902USA009441: Original Case: 1902USA009323; US-009507513-1902USA009440: Original Case: 1902USA009323; US-009507513-1902USA009437: Original Case: 1902USA009323; US-009507513-1902USA009438: Original Case: 1902USA009323; US-009507513-1902USA009439: Original Case: 1902USA009323.
On 11/1/13 pt felt tremulous, wheezing, SOB presented at ER approximately 30 min after vaccination. Pt had hx of wheezing for previous 2 wks. Labs normal; no fever; no chills. Pt asymptomatic on release.
Activated Dupytren's which had not been active since initial onset roughly three years ago. Awoke to find formation of four nodules, one each on the index, middle, ring, and pinky finger. Nodule formed in identical location on each finger just below joint between the metacarpal and the proximal phalanges. Can also feel the Dupytren's is active in the right palm.
Resident received vaccine dose early. Pharmacy notified and stated resident may develop reactions if any that resemble first vaccine. Administer  Moderna  0.5ml in 28 days.  MD notified.
SUBCONJUNCTIVAL HEMORRHAGE IN THE RIGHT AND LEFT EYE; This spontaneous report received from a health care professional concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure, migraine headache, fibromyalgia, Benadryl allergy, non-smoker, non-alcoholic and other pre-existing medical conditions included: Patient had no any drug abuse or illicit drug usage. Patient was seen by HCP on 04-NOV-2020. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced subconjunctival hemorrhage in the right and left eye. It was stated that, patient had been seen twice by HCP (physician office visit), two other HCP saw her in summer and fall of last year. On 25-JUN-2021, probably was the first visit. Patient's HCP reported that she had a subconjunctival hemorrhage in the right eye (on 04-JUN-2022), it was about the 20th time that was happening since patient had her vaccine, it was in the right eye but it had been in left and right eyes, patient had her blood work checked twice with her HCP (complete blood count) CBC to determine if patient had any bleeding disorder and it came back as normal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from subconjunctival hemorrhage in the right and left eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220609898 -Covid-19 vaccine ad26.cov2.s -SUBCONJUNCTIVAL HEMORRHAGE . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
never received a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received a second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt date: 23-Aug-2023 Education provided per content regarding vaccine schedule and disease control recommendation. The reporter was the patient who stated she received first dose of Shingrix in 2018 but never received a second dose, which led to incomplete course of vaccination The reporter did not consent to follow-up.
Pt. received vaccines Monday 6/29/09 and mom notice swelling and redness Wednesday morning on 7/1/09.  Pt. not complaining about arm, he said his arm itches.
This is a spontaneous report from a contactable consumer. A 50-year-old female patient received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on 23Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I had pain in my arms that affected so much that I could not move my arms" on the evening of 23Aug2018. During Friday morning (24Aug2018), the patient stated "I had redness and inflammation in the arms. I have like almost like flu symptoms like headache, and muscle ache, "throat" little stuffy. I still have little bit of rash in my arm not too much but a little of rash. I guess instead of rash leave it as redness." Therapeutic measures were taken as a result of the events of arm pain and included treatment with TYLENOL at 1000 mg tablet orally once a day and ADVIL orally at 2 tablets 200 mg a day. The patient recovered from the events of inflammation in the arms on 26Aug2018 with duration of 2 days. The outcome of the event of "pain in my arms" and redness in the arms was recovering. The outcome of the other events was unknown. The information on the batch number of the vaccine has been requested.
On 2/21/2021, I woke up about at about 2:00 AM freezing, covered in sweat, and shivering. I took my temperature, which was 101.8. At about 6:00 AM, I went back to sleep. When I woke up again a few hours later, I was again covered in sweat, but my fever had broken and my temperature was at about 97, which is normal for me. Since then, I have woken up in the middle of the night feverish, chilled, and covered in sweat several times. The highest my fever has gotten was 101.2.   About a month after the second vaccination, I developed swelling that runs from my left temple all the way to the middle of my right eyebrow. It is less concentrated on the right side and is concentrated mostly from my left eyebrow to the inner orbit of my left eye near the sinuses.   I was admitted to Hospital on 8/13/2021 at about 7:00 AM and was released about 1:30 PM the same day. I underwent two MRIs: one orbital and one of the brain.
feeling crappy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling crappy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling crappy). At the time of the report, FEELING ABNORMAL (feeling crappy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient has received the primary series dose of the Moderna COVID-19 vaccine.  The patient had 2 days of feeling crappy and it was over after that.  Treatment information was not provided.
an expired dose of Daptacel was administered/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient who received an expired dose (Expired product administered) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) (no dosing details reported).  On 10-Feb-2020, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA (expiry date: 30-Jan-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
PT WAS SEEN ON 03MAR2008 WITH COMPLAINT OF HEADACHE TO LEFT SIDE OF HEAD AND LEFT SIDE OF NECK STIFFNESS. PT CURRENTLY TAKING ASPIRIN AND MOTRIN FOR PAIN MANAGEMENT. DOCTOR CLEARED PT AND PLAN TO CONTINUE JEV SERIES AFTER PT RECOVER FROM ABOVE SYMPTOMS.
Rec'd Moderna as second COVID-19 dose, should have rec'd Pfizer. No adverse reaction.
11 days following receipt of the Moderna booster vaccine, I began experiencing spontaneous urticaria on my body, which is often followed by dermatographia. These hives show up in different areas on my body, but most commonly on my back and stomach.
Suddenly experienced dizziness, fast heart rate, sweating, nausea, ringing in ears, blurred vision. Low blood pressure. Almost fainted. Lasted about 2-3 mins.
patient received dose from a vial that was opened at 2pm yesterday; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
Information has been received from a physician concerning a 92 day old patient who has vaccinated with the first dose of ROTATEQ. The patient sought medical attention in the physician's office. There was no product quality complaint. No other information noted. Additional information has been requested.
Large swelling in right arm from shoulder to elbow, hot to touch, rather painful. Could not sleep from pain first night. Treated with ice and Benadryl. Swelling and pain still present but somewhat diminished by 6/18/2010. Area of maximum swelling moved down arm from shoulder to below elbow.
Information has been received from a health professional concerning a 12 year old white female patient who on 24-JAN-2007 was vaccinated IM with a first dose 0.5 mL of Gardasil lot #655619/1427F. Concomitant therapy included hepatitis A virus vaccine (unspecified) also administered IM on 24-JAN-2007. In approximately 27-JAN-2007, the patient developed joint pain and stiffness after receiving the vaccination. Subsequently, the patient recovered from joint pain and stiffness after few weeks. Additional information has been requested.
On 09/10/2001 night right arm started getting red/hot and swollen without itch. Prednisone Taper for four days and Claritin for seven days.
Patient received a third Havrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19-NOV-2023) for prophylaxis.   On 11-APR-2023, the patient received the 3rd dose of Havrix. On 11-APR-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Patient received a third Havrix dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-MAR-2023 The reporter reported that by mistakenly patient received third dose of Havrix vaccine. The reporter wanted to know safety information regarding this situation. The reporter stated that the patient also received an extra dose of hepatitis B vaccine from Merck. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received extra dose of Havrix vaccine in error, which led to extra dose administered.
DEMAND ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/28/2022,  11/17/2022,  1/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Initial case report received from physicians on 19 NOV 2009. A 45 year old female was vaccinated i.m. for the first time with S-OIV Fluvirin ( H1N1 influenza virus vaccine, batch no. 102046P1) on 17 NOV 2009. On 17 NOV 2009, later in the day, she presented with confusion, weakness and inability to speak for 30-second intervals. In the emergency department the diagnosis was panic attack and the patient was treated with VALIUM orally. Her condition did not improve and she was admitted to hospital on 18 NOV 2009. While hospitalised, she received intravenous fluids and intravenous Valium. A neurologist ordered amantadine and an EEG to be performed on 20 NOV 2009. The patient had no history of psychosis. At the time of this report, the patient's condition had not improved.
Information has been received on 25-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In or around October 2015, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered an outbreak of painful shingles. The patient suffered multiple more outbreaks of shingles since October 2015 to the time of this filing. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX.  Shingles was considered to be disabling.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-NOV-2015 the patient was vaccinated with oral, ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported) which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Pediarix given instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   Previously administered products included IPV (received a series of 3 doses on an unknown date) and Hepatitis B (received a series of 3 doses on an unknown date).   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix given instead of Infanrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The reporter reported that a patient was given a Pediarix in error instead of Infanrix.  This was the patient's 4th dose of IPV and Hepatitis B.  The reporter consented to follow up via email.  At the time of reporting, the patient was given Pediarix in error instead of Infanrix, which led to wrong vaccine administered. Extra dose administered was not coded in this case because a 4th dose of IPV and Hepatitis B was allowed in individuals.
Nausea and fatigue 6 hours after vaccination. Resolved at 24 hours post Vaccination.
Fever for 24 hours, headache for more than 24 hours, nausea, soreness of eyes
Shortly after receiving my vaccine I had heart/chest pain.  In the first few days the pain would come and go and many times throughout the day if felt as if I had run a marathon. I have never experienced any heart pain before. On Saturday August 28th 2021 I went to the emergency room because of the pain. I was told I needed to see a cardiologist because of my EKG. I went to the cardiologist on Friday Sept 3rd and he has requested a echocardiogram and stress test
Within 8 hours I started to have chills/shakes fever to 101 and heart rate of a steady 90. During the night I drank water - took extra strength Tylenol. I was soaked from sweat and fever down to 100. shakes and chills dissiapated within 2 hours last night after Tylenol. During the day fever slowly reduced to 99.4 by evening and Heart rate to 80. Yesterday fever normal - heart rate 70 - usually I'm at 60. Last night I noted that I was in A-Fib with heart rates between 80 and 90 which is where I am currently.
Pt recvd 2 doses of Engerix-B FEB92, MAR92; p/2 doses pt exp severe abdominal pain, jaundice, elevated liver enzymes; pt was hospitalized; reporter indicated no tx yet;
Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the Clinic. At approx. 8:14 ambulance was called to truck stop. Patient was having weakness, shortness of breath and tongue swelling. Patient brought to Emergency Room.  See enclosed notes.