chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Another employee called me about 9AM that patient felt ill & left - maybe the shot? I called her on the cell - left message. I spoke to her by phone later that afternoon. She said she began to feel strange about the time she left the Emp. Health office and really bad by the time she was back in her office. She felt a heat wave sweep through her body and then very weak. She's unaware if she was feverish - didn't take her temperature. She drove home and slept over 3 hours. When she called me back, she said she was feeling normal again. No reaction like this with previous 4 doses.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 yr old received Moderna vaccine. Received second Moderna vaccine on 6/4/21 per CDC guidelines. Patient tolerated well.
No adverse event; 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was provided.  It was reported that on 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster.   Treatment medication was not provided by the reporter.  This case contains information about patient-7 out of 26 patients
2nd booster june 7th, rash on both forearms and low BP 77/35 noticed june 9th
Left side of face and ear became red, hot to touch and then numb approximately 3 1/2 hours after injection and lasted for for 2 1/2 days. Exhaustion lasted for approximately 2 weeks. GI sxs were for a few hours which included severe cramping approximately 12 hr after injection. Lasted approximately 24 hrs.
On the 11th day post-vax, 11/17/21, Patient woke and complained of eye pain. Was later sent home from school due to fever. Was lethargic, displayed photosensitivity, headache and fever worsened. Had a routine (tested weekly at school) COVID test on 11/16, was negative. Tested for strep on 11/19, negative. Taken to ER on 11/22, labs looked ok, perked up with fluids, sent home. 11/23 Tylenol and Motrin no longer able to control headache. He wanted to lay down in dark bedroom. Threw up in the afternoon, then again the next morning after being unable to sleep due to head pain. Admitted to hospital on day 10, 11/24 awaiting results of LP. Started on antibiotics, regular fluids.  HHV6 was found in culture, diagnosed with viral meningitis.
12/17/21 vertigo attack with vomiting, lasted 5 hours, 01/01/22 vertigo attack with vomiting, lasted 3 hours, 01/03/22 vertigo attack with vomiting, lasted 3 1/2 hours, 01/04/22 fullness and tinnitus continues in right ear
mom called MD on 16JUL95 c/o pt walking different, leg turned outward, crawl different & climbs different; no c/o illness or soreness to area of shot;mom states pt doing better today; no other sx;
started feeling very faint 20 mins p/inject; didn't tell anyone until 8; BP 160/106; 820 BP 150/90, P88; 830 BP 164/104, P80; 845 checked by MD 170/104, P82; 2PM BP 136/90 P80 feeling better & reported that became very cold;
Information regarding Prevenar was received from a Complaint Coordinator from the FDA regarding a 2-month-old male patient who experienced death.  The patient received a dose in Dec-2007.  On the same day, the patient received a dose of Haemophilus influenzae B (manufacturer unknown) and a dose of Pediarix (GlaxoSmithKline) in Dec-2007.  The patient received a dose of Rotarix one day prior to the other vaccines in Dec-2007.  Relevant medical history was not provided.  Concomitant medications were not reported.  Approximately two weeks after receiving Prevnar and three other vaccines the patient died on 26-Dec-2007.  No explanation was given for the death.  No additional information was available at the time of this report.  The cause of death was unexplained and the autopsy cause of death was not reported.  4/15/2008 Per FDA: "The cause of death was SIDS, although we don't have a copy of the death certificate.  I don't think we need anything else for this case." Lengthy investigative report received from FDA.  Infant seen 12/11/07 with hx of cough, runny nose and congestion.  Dx'd with bronchiolitis  and started on nebs. Infant received Rotovirus vaccine 12/11/07. Seen in F/u next day with improved sx and given Pediarix, Hib, and Prevnar 12/12/07. Infant had fed normally in the early morning hours of 12/26/2007 and gone to sleep in parent's bed, and when parent awoke the next morning, the infant was dead. DX: SIDS.
Received the shot at 4:45 pm.  A little after 11 pm that night, I had mild fever (did not take temp) and severe chills that lasted about 2 hours.  I had a very severe headache and felt very nauseous.   I was not able to sleep well during the night.  The next day, between 7 am and 5 pm, I stayed in bed with the most severe headache I have ever had, severe nausea and extreme fatigue, and sometimes felt hot and/or had mild chills.   I was not able to go to work, as I could not get out of bed.  I was finally able to get up around 5 pm (24 hours after shot) and eat a little something as the nausea had finally subsided.  I was still very fatigued and had a less severe headache.  I was able to sleep well that night, and woke the next day (about 36-37 hours after shot) with only a slight headache, which went away with a few hours.
Rash at site of varivax vaccine consistent with local herpetic rash appeared 9 days after vaccination
developed guillain-barre syndrome 2 weeks following 2nd vaccine administration. unclear if vaccine is the cause.
After the vaccine observation period, the patient stood up and passed out. This has happened before when he has had blood work completed in the past.
Developed hives over entire body including palms approximately 24 hrs after flu shot. On no meds. No new foods, soaps, etc. No trouble breathing or swallowing.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  N013863 and expiration date 31-OCT-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Vomiting, metal taste in mouth, joints are sore. Right side where the shot was given is swollen.
10 minutes post vaccine administration, patient had a witnessed syncopal episode. Patient was lowered to the floor. No injuries occurred. Vital signs stable. After seconds, patient was alert and oriented x4. Continued to monitor for 45 minutes.
I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; I felt my lips and my tongue my face swelled; It had like fast heart  beat it wasn't severe; I was already feeling like couldn't swallow normally; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613, Expiration date: Not reported), via an unspecified route of administration in left upper arm, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included high blood pressure medication and inflammatory muscle relaxer for her back but not in that morning. Fifteen to sixteen minutes after the vaccination, on an unspecified date, the patient had noticed symptoms but once the patient left the center, she felt that her lips, her tongue and her face were swollen. She also had fast heart beat, it wasn't severe but makes her a little bit concerned about it and felt that she should turn around and go back or driven to the hospital or something but by the time she left home, she already had the feeling like she couldn't swallow normally between 3 hours and it was fine. She also informed that she was definitely going to get the second dose which was scheduled on 13Apr2021. The patient was questioning whether these events happens about 20 minutes later. She actually stayed there for 16 minutes because of long car lines but it hits her like after leaving the facility about 20 minutes later, she started to feel these symptoms. She also questioned that what kind of precaution should she take before her second vaccination and whether she needs to inform the individual who were vaccinating her at that time to let her stay more than 15 mins until an hour. The patient also reported that she was more concerned about having a stronger reaction after the second vaccine. The patient received antihistamines as treatment for these events. The outcome of these events was recovered (reported as improved) on an unspecified date.    No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable Nurse. A (Age-57, Units-Unknown) male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown) via unknown route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown) via unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient developed fever, body aches, chills and a headache. Seemed to last about 24 to 34 hours after the vaccine. The outcome of the events were recovered. No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Large location reaction with associated swelling, erythema, and induration starting within several hours, worsening over first 24 hours
On 5/19/99, the pt received the 1st injection of Engerix-B. On 6/14/99, the pt received the 1st Injections of Hib-Titer, Acel-Imune, IPV, and Rota Shield. On 6/18/99, the pt developed a fever of 99.6F, was seen by a physician and hospitalized with a dx of fever of unknown origin. During hospitalization, the maximum fever was 100.9F. The infant recovered and on 6/20/99, the infant was discharged.
Sharp pain at the injection site, the pain has continued. I have pain on a scale of 1- 9 as "9". Worse when laying on side, pushing, pulling and moving arm. No longer have full range of motion in the limb. I believe I have SIRVA (Shoulder injury related to vaccine administration).
Patient presented as pale skinned and complained of lightheadedness. She was advised to lay on the floor. Blood pressure was 110/70. Patient was advised to drink water and then juice. Cold compress applied to patient's forehead. Patient returned to her normal feeling and activity within 45 minutes. Patient stated that she felt "fine" at that time.
Posterior head and neck tingling and warmth and flushing in cheeks. Resolved at after given 50 mg of Benadryl P.O.  Advise to follow up her PCP
Approximately ten days after shot, the injection site started itching, and I noticed a large circular rash covering my upper arm. I have seen articles that state this is not unusual so I will not go to a doctor, however, this rash was not explained as a possibility and perhaps more should be notified?
I did not have an adverse reaction to the vaccine. On 04/26/2023, a lump was found in my right breast during a routine mammogram. A biopsy was taken on 05/05/2023.
Patient reported getting her 2nd dose of Moderna on 5/18/2021 at 9:37am, and symptoms started at 12:30pm on 5/18/21. She said she experienced cold sweats, shaking, chills, and vertigo. She also reported nausea, headache, and skin pain. She said skin pain was not localized to injection site. She reported symptoms resolved in about 24 hours. She did not report seeking medical help or using any medications for symptoms.
tore the muscle / went to the hospital and has been in PT since; arm got so inflamed / went to the hospital and has been in PT since; arm / infected / went to the hospital and has been in PT since; This case was reported by a pharmacist via sales rep and described the occurrence of torn muscle in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced torn muscle (serious criteria GSK medically significant), inflammation localized and arm infection. On an unknown date, the outcome of the torn muscle, inflammation localized and arm infection were unknown.   It was unknown if the reporter considered the torn muscle, inflammation localized and arm infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the 1st dose of Shingrix and less than 4 months after the vaccination she experienced inflamed arm and it got infected and tore the muscle. The patient went to the hospital and had been in PT (Physical therapy) since after 1st dose. The reporter stated that they called the patient to schedule 2nd Shingrix dose.
Itching and redness (L) arm - at site of injection, no SOB - no chest pain.
Rash on arm that I got the vaccine.  Gradually getting larger since after the vaccine.  No pain, but some minor itching.
Admitted to Medical Center 11/15/21 for DKA, also with worsening respiratory status and AMS requiring intubation. Reportedly + COVID test on 11/10.
Patient completed consent and denied any allergies, contraindications, including recent (last 2 weeks) vaccinations.  Did not acknowledge receiving a previous COVID-19 vaccine.  Patient was vaccinated in a local. Patient did request assistance to complete the consent, stated, "I can't write that by myself."  All information was reviewed regarding questions on the consent, Pfizer EUA, and patient stated agreement with being vaccinated.  The patient tolerated vaccine and 15-minute observation period without adverse reaction, or other distress/concerns.   Later while documenting the vaccination in the WIR system, it was realized that he had previously received a Johnson & Johnson vaccine on 3/17/21 at the Department.  Pt. was advised that his record showed 2 vaccines (Johnson & Johnson and Pfizer).
child presented to er on 3-20-09 with a full body rash and fever of 105 F.  Admitted to hospital the next day.  currently the rash has faded, no temp., lab work show viral infection.  4/2/09 Received ER medical records.  3/21/09 ER visit FINAL DX: none provided Records reveal patient experienced red cheeks, rash over body x 2 days, vomiting & diarrhea x 1 day, reduced oral intake x 1 day.  Tx w/IV antibiotic & antinausea med.  Improved & d/c to home.  Hospital medical records of 3/23-3/28/2009. FINAL DX: no d/c summary available Records reveal patient irritable w/vomiting & diarrhea, diet refusal & rash all over.  Tx w/IV antibiotic & antinausea meds.  Admitted ICU.  4/7/09 Received additional hospital medical records of 3/23-3/28/2009. FINAL DX: Henoch Schonlein purpura, viral syndrome Records reveal patient had maculopapular rash, vomiting & diarrhea x 4 days.  Had been seen in ER & d/c to home.  Vomiting & diarrhea continued, developed fever, sleepiness & increased rash.  Exam revealed areas of petechial hemorrhage c/w vasculitis, swelling of feet & periorbital edema, OM, irritability.  Admitted overnight to ICU then to reg floor.  Improved w/IVF & IV antibiotics.
No additional Adverse events; expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.     On 16-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S019463 has been verified to be valid expiration date 24-JUN-2021, 0.5 milliliter for prophylaxis (strength, frequency and administration route were not reported), (experienced expired product administered). No adverse event was reported .
Lymph Node in neck has a painful nodule, pain radiates up neck and and radiates across clavicle area all the way to the vaccination site on left arm. Very painful to touch.
Pt arrived to ER for acute psychosis. Pt swabbed for COVID due to potential admission to psych unit, but was COVID-19 positive and asymptomatic.
Felt dizzy, warm, light headed. Pulse 60 BP 130/48 oxygen sat 89. Laid on floor and elevated feet. O2 increased to 99. Rested until felt better.
Spouse of pt called at  8:45 PM on 3/11/00 to say wife had a rash and itching since day before (3/10/00). Had applied alcohol only. Advised to take wife to hospital since face was swollen as well.
I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks; I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 15:30 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Costracontritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Cats" (unspecified if ongoing); "known allergies: Crabmeat" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL; AMLODIPINE; SIMVASTATIN; ALPRAZOLAM. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone"; Iron injections, reaction(s): "known allergies: Iron Injections", notes: known allergies: Iron Injections. The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious) all with onset 18Feb2021, outcome "recovering" and all described as "I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks". Therapeutic measures were not taken as a result of nausea, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks later. Since the second shot, I have had more of the exhaustion and nausea - daily and the first couple of weeks were the worst - but it is now somewhat different as I have more energy and the nausea is not all day every day like it was but I'll have a day of being very nauseous and then a day or even two of not feeling that at all, which gets my hopes up, but then the next day it is back again. Better now than the first three weeks but this has been six weeks long and all I hear is that aftereffects last only 24-48 hours after the shot. I am very sensitive to medications (especially antibiotics, Prednisone, sulfa) and, consequently, kind of hard to treat but I thought you should have this information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse and described an adult female pt who did not respond to the hep b vaccine recombinant (Engerix B).  The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the pt received the third dose of Engerix B (lot ENG5446A4). On an unspecified date approx one to two months later, a hep B surface antibody titer was negative.
Bruising at the site of injection and a red, irregular patch of skin under the area of injection.