chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confusion for 3 days peaking first day at about 9 pm to 12 including intense fever, confusion, headache, heaviness, dull pain throughout body. I was so overwhelmed with pain I couldn't think of anything else. I thought I might be dying. I was unable to get out of the bed for 2 hours. Before I was unable to leave the bed I tried to go to the bathroom and fell out of bed and had to crawl very slowly and laboriously to the bathroom which was 15 ft away. At this time I took some Tylenol since my roommate who also got the vaccine with me was able to leave the bed after she was trapped for 2 hours too but I was unable to help her since I was so confused and weak. I was able to get some water near the beginning. Neither of us was with it enough to call for help until we were both significantly improved.
Information has been received from a physician concerning a 17 year old female who on 22-DEC-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified). On 22-DEC-2007, about 5 minutes after the vaccination, the patient got stiff, her eyes rolled back, she had a catatonic reaction and passed our for about a minute or two. Subsequently, the patient recovered completely on 22-Dec-2007. Additional information has been requested.
Swollen and painful neck nodes. Then itchy scalp (only on left side of head) rash on forehead. Again, only on the left side. The scalp then turned into more painful/tender/red and the rash on face itchy and also painful. Being treated for shingles as it is on my face and on the left side near eye. Causing me to wake up at night. Painful nodes in neck and in front of ear on the left side.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001701 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via Agency (reference number: USBAV22-0690) and concerns a *24-years-old female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at the *right deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, concerning the same reporter.  Non-significant case correction received from Bavarian Nordic on 29-Jul-2022 included an additional reference number. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 24-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 24-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
pt recv vax 2MAR98 pt devel red papules on chest & a very low fever of 99.5;
The above pt. called on Monday 01/25/2021 and reported having what she intepreted as a severe reaction to the EUA Moderna Covid-19 vaccine that she received on 01/21/2021. She states that the evening after receivng shot that she experienced headache, tingling in hands, swelling of the face and feelings of shortness of breath. States that she has sisters who are nurses and she took benadryl and an injection of epi pen that she had at home and recovered without any other issues. Denies going to the hospital or seeing her private doctor after incident.  Pt. did not report the use of Epi pen injections nor listed any history of reactions on questionaire during visit.
Eight days, post vax, pt developed fever. Nine days, post vax, developed disseminated maculopapular rash covered with measles on face, trunk, arms and legs.
Information has been received from a healthcare worker (medical assistant) concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL (dose, strength and route were not reported, lot # J006850, expiry date: 31-MAR-2016). No adverse symptoms were reported. The temperature excursion for GARDASIL was found to be supported with in-house stability data. Additional information has been requested.
Pt is a 12 month old who developed hives 5 days after vaccine, then 5 days of diarrhea & fever. Exam was normal.
pt presents to ED with SOB and DOE; AHRF; O2 sas 80% on RA; decrease in appetite; found to be positive for COVID; O2 supplementation; steroids and ABX given; sepsis secondary to COVID; bilateral pneumothorax; pt's condition worsened; DNR and eventually made comfort measures only, Morphine and Ativan given; pt died in the hospital
pt presented 20 hrs p/DTP/OPV/PRP in status epilepticus;
Impropertly stored doses of varivax were administered; No patients experienced symptoms.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S036637 has been verified to be valid; expiration date reported and validated as 14-NOV-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of 17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptom.  This is one of several reports received form the same source.; Sender's Comments:  US-009507513-2006USA001819: US-009507513-2006USA001816: US-009507513-2006USA001818: US-009507513-2006USA001641: US-009507513-2006USA001815:
I'm not sure this was the cause, I blacked out from standing to the floor. Woke up on floor, hurt back, took Motrin 800 mg, used Ice and Heat for Pain. Did not report to Dr., just though  I brused Back Badly
HEART ATTACK; This spontaneous report received from a consumer via social media (Mbox Communication (Social Listening)) via a company representative concerned a female of unspecified age, race and ethnicity Initial information was processed with additional information received on 01-NOV-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported,1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The reporter reported, "I believe that every human being has the potential for negativity. Btw, Johnson and Johnson's Covid "vaccine" gave my mother a heart attack." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221107791.  Additional information was received from consumer via social media(Twitter) on 01-NOV-2022. It was determined that AER 20221107791 was a duplicate of this case. All relevant information regarding this case will be submitted under AER 20221107249.; Sender's Comments: V0: 20221107249- Heart attack. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Information has been received from a registered respiratory therapist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced an adverse event.  The patient's outcome was unknown.  Additional information has been requested.
PM on 9/11/2017 "Rash all over and lips were swollen" per mom. Mom gave BENADRYL and shortly after the reaction had stopped." Mom believes the reaction was from the vaccine. Called the office 9/12/17 to report it. Sx gone at that time. Mom refused to come in for office visit.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 05-OCT-2010, patient received improperly stored VARIVAX dose 1, from lot # 666851/0280Z expiry date: 12-FEB-2012. On 06-MAY-2011, the patient received second dose of VARIVAX from lot # 0552Z (dose an expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Fatigue and headache for 3 days. No fever, vomiting, or LOC
itching; scratched arm and felt a tiny blister like hair follicle blister; arm felt hot on right arm at injection site; red hot rash, hot red and itchy about 3 inches in diameter; covid arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm). On 03-Mar-2021, PRURITUS (itching), BLISTER (scratched arm and felt a tiny blister like hair follicle blister), FEELING HOT (arm felt hot on right arm at injection site), RASH ERYTHEMATOUS (red hot rash, hot red and itchy about 3 inches in diameter) and VACCINATION SITE REACTION (covid arm) had resolved.        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.   Treatment information was not provided.  Patient mentioned she was currently enrolled as a participant in the Astrazenica covid vaccine trial (AZD1222) in which both of her injections were placebo. The trial started 11Nov2020 and she will continue to be monitored for 2 years. Astrazenica is aware that she has received the Moderna vaccine.
pt recv vax 9AM;pt was back in office around 12Pm w/hives to body;pt was given DPH;
Rash covering neck, arms chest and back. Small red bumps that are somewhat itchy. Rash has slowly spread from first sighting on 2/21 where it started on neck initially.
Local redness and edema right arm from shoulder to elbow area warm to touch. Ice to area for 20 min at a time. Ibuprofen prn.
Sudden severe pounding headache associated with nausea & vomiting lasting 6 days.
Night sweating; He couldn't do activities; Fever; Chills; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweating), MOBILITY DECREASED (He couldn't do activities), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced NIGHT SWEATS (Night sweating), MOBILITY DECREASED (He couldn't do activities), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Fatigue). On 29-Apr-2021, NIGHT SWEATS (Night sweating), MOBILITY DECREASED (He couldn't do activities), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants and treatments were not provided.
Urticaria/itchy rash generalized over body.  Seen in EC and treated with Benadryl, Zantac and Prednisone.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (For tolerance to the flu vaccine received 3 years ago, refer case US2018GSK146090). Concomitant products included SHINGRIX. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 9 days after receiving SHINGRIX, the patient experienced hives and pruritus. On 17th July 2018, the patient experienced headache, feeling cold, influenza-like symptoms, pain in arm and chills. On an unknown date, the patient experienced red blotches and injection site erythema. The patient was treated with BENADRYL. On 18th July 2018, the outcome of the headache, feeling cold, influenza-like symptoms and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, red blotches and injection site erythema were recovered/resolved and the outcome of the hives and pruritus were recovering/resolving. It was unknown if the reporter considered the headache, feeling cold, influenza-like symptoms, pain in arm, hives, pruritus, chills, red blotches and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the first dose of SHINGRIX two months ago. At 12:00 pm, the patient received SHINGRIX in the left arm. The next day after receiving the vaccination, the patient woke up with a bad headache, sore arm, chills, freezing and flu-like symptoms. Less than a month after receiving vaccination, the patient also had red splotches extending from the injection site under her armpit up to her shoulder. The headache, chills, freezing and flu-like symptoms resolved by the next day. The sore arm and splotchiness resolved within a few more days. About seven days after the headache, chills, freezing, and flu-like symptoms resolved, the patient broke out in hives that itched. The patient had total of seven hives which were resolving. The patient was taking BENADRYL orally and using BENADRYL topical cream to treat them. The patient had denied permission to contact their physician. Unable to obtain additional information.
about a week after the vaccinations she developed a few pox-like lesions to right thigh near VZV vaccination site.  Over the next 2 weeks developed pink papules to other leg and to other leg, buttocks and trunk.  on 12/20 vomited x 1, then fever to 101.8 and tired and listless and decreased PO.
Swollen lips; Lightheaded; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Apr2021 at 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 19:45 the patient experienced swollen lips, lightheaded and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lips, lightheaded and diarrhea was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monovalent Booster given instead of Bivalent Booster there have been no adverse reaction at all
This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). On an unknown date, the patient experienced injection site reaction and became sick after receiving ZOSTAVAX. The outcome of the injection site reaction and became sick was unknown. This is one of 2 reports received from same reporter. Additional information has been requested.
A week after the shot the injection site was sore, swollen, hot, red & itchy.  I got worse for 2 day and then after 2 more day it was gone.
Itching on back left shoulder, injection side on left arm that night. next night more itching and noticed hive on breast. Also had tiny red bumps on back, neck, and legs as well as injection site. injection site red and lifted. Also swelling of throat but not enough to interfere with breathing. Just swallowing. Have not felt the need to go to the hospital yet.
pt recvd vax 27SEP93 & 4OCT93 pt devel bell's palsy; No further details were provided;
9/20/02 headache with pressure lasting several days after receiving the vaccine. 10/2/02 last vaccine changed to Hdcv-pt continues to have pressure headache.
The patient received her second covid vaccine at outside facility on 10/23/21.  She was seen in my office on 10/292021 reporting developed of eye swelling, fever, body aches and fatigue on the night of 10/23/2021.  All symptoms resolved in 24 -48 hours except for eye swelling.  She was seen in my office with upper lid edema treated with prednisone.
Extreme redness, swelling, burning, blistering at injection site starting 1 week after injection
5 inch x 5 inch swelling, redness, heat, pain at injection site with axillary LAD.  As of 2/1/2021 had not resolved.
9/3/21 Fever 100.9 F. tingling of the extremites, extreme tireness 9/4/21 Joint pain, few red spot on the body (resolved within 4 hours) 9/5/21 Rash on one side of the upper body, tingling sensation on extremities
Case number PHEH2016US026455, is an initial spontaneous report received from a nurse on 10 Oct 2016. This report refers to a 01 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620001) at a dose of 0.25 ml intramuscularly on 10 Oct 2016, when he was at the age of 01 years old. No adverse event was reported following this administration error (Drug administered to patient of inappropriate age). The case was lost to follow up at initial.
Patient was given a 2nd flu shot for the season, a 3rd MCV4, and the 3rd dose of HPV9 at 11.5 weeks instead of at the minimum 12 week interval. This miss-administration of these 3 vaccines was due to a technical error with immunization records not uploading from the clinic electronic medical record into the state record system. Patient reported sore injection sites on each arm and a scratchy throat. Provider believed the scratchy throat to be unrelated.
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; This adverse event has previously been reported to the FDA by the reporter;
This spontaneous report as received from a registered nurse refers to an unknown number of patients. The patients were vaccinated with RECOMBIVAX HB series (route, dose, lot number not reported). No other co-suspects or concomitant medications were reported. The patients had low or negative Hepatitis B titers. No treatment information was reported. The outcome was unknown. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This non-serious spontaneous case, was initially received on 05-Oct-2017 from other non-health professional, concerning a 29-year-old, adult, pregnant patient. The patient was not enrolled in the pregnancy registry. It was reported that the last menstrual date was 11-Aug-2017 and estimated delivery date (EDD) was 18-May-2018. On 05-Oct-2017, at gestational age of 8-weeks (first trimester of pregnancy) the patient was administered with FLUCELVAX QIV (dose, route of administration, batch number, expiry date and anatomical location: not reported), which was considered as vaccine exposure during pregnancy. It was reported that, after the administration of vaccine, the patient did not experience any adverse event. The reporter assessed this case as non-serious. Follow up report received on 01-Dec-2017: The patient's date of birth, last menstrual date (LMP), estimated delivery date (EDD) and date of vaccination was added. It was reported that, after the administration of vaccine, the patient did not experience any adverse event. The narrative was amended accordingly.
Chills, fever at 6:30 PM. Awoke with redness, swelling, itching upper arm, Tuesday, July 24. Severe tenderness. Continued swelling for 48h. Presented to MD Wednesday afternoon. Intense redness, swelling, warmth to touch, very tender to touch. Given IM injection of ROCEPHIN, 1 gram in addition to cephalexin 500 mg Q8h for 10 days, prednisone 10 mg, tapering schedule, 30 tabs, oxycodone for cellulitis pain 5-325 mg PRN pain.