chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated his wife passed out and hit her head on the floor; hit her head on the floor and split it open; transferred to hospital due to cardiac complications; fall; His wife passed away; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (His wife passed away), LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor) (seriousness criteria hospitalization and medically significant), SKULL FRACTURE (hit her head on the floor and split it open) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (transferred to hospital due to cardiac complications) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) outcome was unknown. The patient died on 04-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  On 03 Apr 2021, the reporter stated approximately 45 minutes after receiving the COVID-19 vaccine, the patient passed out in the parking lot and hit her head on the floor which caused it to split open. The patient was taken to a hospital but had to be transferred to another hospital after experiencing cardiac complications.   On 04 Apr 2021 at 4:00 am, the patient passed away.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
RESIDENT RECEIVED BIVALENT VACCINE IN ERROR FOR 1ST DOSE. ADVISED FACILITY THAT BIVALENT DOSE CAN BE COUNTED FOR 1ST DOSE.  RESIDENT CAN BE ADMINISTERED A MONOVALENT VACCINE IN 21 DAYS FOR 2ND DOSE.
Severe headache, weakness,  sudden loss of energy, drowsiness, blurred vision, loss of balance.   The day of vaccination, it was mainly the severe headache and some swelling in my face. Mainly along my jaw line and gums. Day 2 all of the other effects I mentioned above hit me when I woke up and persisted until today. Still feeling some of it, mainly a slight headache, some loss of balance and I still get hot and start sweating at random times for no obvious reason.
TDAP given 1/14/09 in L arm Patient states an initial 2-3 days of sore arm, 2 days of no symptoms, then 1/20/09 awoke with excruiating pain in L arm, pain gradually subsided with no treatment but now has constant dull ache and occasional pins and needles sensation in L hand  notified administrator of symptoms 1/29 and seen in clinic 1/30  examined by administrator and Dr. has tried no treatment until after call to administrator who advised a 3 day course of Motrin Q6hours nothing observable at site (no discoloration, swelling,or redness), no pain with touch, ROM compromised when lifts forearm and elbow to shoulder height, can lift arm over head advised to avoid heavy lifting for 2 weeks and f/u w/PMD
7day p/vax pt vomited, felt warm, began twitching. hosp temp 102. intubated; IV med stopped seizure; transferred to 2nd hosp; started on po phenobarbitol-doing fine-no further sz
By 5 PM on 8/27/12, patient felt tired, had itchy eyes, also red eyes. Low-grade fever, patient states 101 degrees. Chills, body aches.
Pt describes going to the bathroom to get ready to take a shower. Then out of nowhere she lost complete control of her bowels (released excrement) and then collapsed. The only injury (other than cleanliness and embarrassment) was a scrape on the patient's left arm.
1/28/21 vaccine received; couple mins after receiving numbing, tingling in arms, flush feeling, stabbing pain in chest area/back for about an hour, arm sore, lightheaded. PT has had to take Tylenol as needed
received a dose of MENACTRA intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 years old male patient who received a dose of Meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event.  The patient's past vaccination(s) included Menactra on 18-Oct-2021.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Influenza vaccine) for Prophylactic vaccination; and HPV vaccine (HPV vaccine) for prophylactic vaccination.  On 03-Nov-2022, the patient received a 0.25 mL to 2 mL dose for vaccines or 0.1 mL for TB skin test: 0.5ML once, dose 2 (booster dose) of suspect Meningococcal A-C-Y-W135 (D conj) vaccine with standard strength intended as a booster dose, but patient received his last dose in 2021; was behind on vaccinations with no reported adverse event (inappropriate schedule of product administration) (lot U7483AA, expiry date: 20-Oct-2023) via intramuscular route in the right deltoid for immunization with unknown form, .  Action taken: not applicable.  Outcome: Unknown.  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.
passed out a total of 3 times; blood pressure went so high; This is a spontaneous report from a contactable consumer reporting for her sister-in-law's sister-in-law. An about 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The reporter stated the patient's blood pressure went so high after she received the COVID-19 Vaccine, that she passed out a total of 3 times. She said she had no clue as to how patient's blood pressure was treated. The reporter thought the 3rd time of passed out from her blood pressure being high, the patient made her husband take her to the Emergency Room. She said adverse reaction occurred around the same time frame as hers, in either Feb2021 or Mar2021. The patient underwent lab tests and procedures which included body height: 5'6" or 5'7". The event outcome was unknown.  Information on the lot/batch number has been requested.
Smelling like somebody smoking cigarettes around me all the time and nobody is smoking around me; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 03Sep2021 as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Sep2021 the patient experienced smelling like somebody smoking cigarettes around reporter all the time and nobody was smoking around reporter. When asked permission for further probing, consumer stated, No, you are fine now. just call them in the morning you are fine. When probed for any further assistance, consumer stated, No, you are fine. LOT# and Expiration Date: Consumer stated, reporter have like card here. Reporter don't have the expiration on the doses that reporter got. No, patient don't have anything on here that patient understand. As consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Symptoms of anaphylaxis , pt taken to ER.  Received Solumedrol, Benadryl and Pepcid with a liter of NS, then was sent home.
The evening of the vaccine patient's arm got very red, hot,  and swollen just below administration site.   The next morning the swelling was very pronounce  all the way down to the elbow and she was in excrutiating pain and her fingers were numb.  We advised her to go to urgent care.  They gave her IV dose of antibiotic and a prescription for cephalexin.   Patient took 4 doses of cephalexin but swelling, redness got worse and she developed a fever.   She went to hospital ER and was admitted.    Was given IV antibiotics for 3 days and discharged on Augmentin.   Still a lump in arm with some redness, but not near as bad, swelling and arm is warm to touch and still a little sore.
I received my vaccine at 9 am 02/01/21 and felt exhausted that evening. My arm of injection, was extremely sore and it was hard to sleep. I had chills and night sweats and woke up with my heart racing at 150 bpm. My resting heart rate is usually 90-100. When I finally got up to go to work, I felt dizzy and completely off balance, bumping into walls.  I  feel extremely nauseous, weak and have a migraine.
Elevated fever 8 days later papular rash with itch appeared on face and spread all over body. Seen in clinic 12 days after immunization given.
time course: sudden deterioration within a week  adverse event(s) - upper body muscle/bone pain (symmetrical left and right arm pains and joints) -- left arm symptoms of frozen shoulder - lower body muscle/bone pain (symmetrical left and right hip joints and feet) - fingers (symmetrical left and right) - weak muscles all over body  treatment(s) - Advil/Ibuprofen for immediate use - following up with doctor next week for treatment  outcome(s) - pain still exists
About 2 minutes after vaccination the patient got sweaty, her eyes went blank, and she appeared to have a minor seizure. She felt better after a few minutes. 911 was called.
A legal complaint was received from an attorney concerning a male child who received injections of ORIMUNE, DTP/ACTHIB, MMR II, Recombivax HB, Varivax, polio virus, DTaP, and DTP/HIB vaccines as well as tine/PPD from October 1995 through September 1999. The legal complaint states that the child was poisoned by the cumulative doses of mercury in the thimerosal and suffers from the toxic neurological effects of mercury poisoning. Mercury poisoning was considered medically important. No further information was available at the date of this report.
Experienced chills, muscle aches, fatigue for three hours starting  21 hours after vaccination.
Initial case report received from a consumer on 07 OCT 2009. A 73-year-old female patient, born on 18 JAN 1936, was vaccinated with I.M. with an Influenza Virus Vaccine on an unknown date. Ongoing as of 07 OCT 2009 the patient experienced sore throat and she had a flu shot previously. She had been taken oxybutine for a few years. She had rheumatoid arthritis and had been on continuous infusion since 1997. She had got an infusion every six weeks with REMICADE and was changed to ORENCIA which she was infused every four weeks for her rheumatoid arthritis. Concomitant medication: oxybutyn, REMICADE, ORENCIA, folic acid, vitamin, calcium, LIPITOR, high blood pressure medications. Medical history: rheumatoid arthritis. The patient had not yet recovered.
Immediately after the shot, I began to feel light headed. The first time I felt like I was going to faint was 04/11/2021 within 24 hours of getting the shot. I began to feel lightheaded over the next few weeks. On May 2, 2021, I collapsed and fainted
This spontaneous report as received from a patient's mother refers to her 14 month old female daughter. On 09-DEC-2005, the patient was vaccinated with an unknown dose of M-M-R II, unknown route, lot number, expiration date and dose. On 09-DEC-2005, after received M-M-R II, the patient cried all night on the first night and she was not herself the whole week. She did not remember any more details of the adverse experience of her first daughter which occurred after receipt of M-M-R II on 09-DEC-2005. She did not have the physician's name who was attending her daughter at that time, but she stated that there was a new doctor who had her daughter's medical records now. She stated that when this adverse effect occurred, she did not report it at the time. She did not know if the previous physician reported it, either. The outcome of cried all night and she was not herself the whole week was reported as recovered/resolved in December 2005. This case is linked to case 1402CAN003590 via same reporter link. Additional information has been requested.
Headache, body numbness ,muscle cramp,tingling all over the body, extreme pain, not able to walk  As of today, june 12 2021, he still in pediatrics department, since June 7 2021.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media.  The reporter stated that the patient got shingles right after their shingles vaccine. Additional Supportive Information: This case has been linked with the case US2022AMR094584 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094584:Same reporter
Profound swelling starting at injection site and involving large portion of upper arm, redness, warmth, arm weakness. Pain level 8 out of 10. Coldness in hand of the vaccinated arm. Patient went to the emergency room for treatment with Cleocin, Medrol Dosepak and naprosyn.
I've had a terrible breakout since I got the 1st dose; Condition aggravated; It's the most painful thing I've ever experienced; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lichen sclerosus.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced). At the time of the report, LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 6MAY97 & 20MAY97 pt devel a vax related rash described as a varicella rash that consisted of 3-40 lesions;
No adverse event; Pediatric dose was given to adults mistakenly; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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 (Pediatric dose was given to adults mistakenly).    No concomitant information was reported. 051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use. Pediatric dose was given to adults mistakenly and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. No treatment information was reported.
There was an excertion on Sunday July 9,2017, where the temps went up to 60.6.  Patient was monitored for 15 minutes with no adverse reactions noted.
Patient is having arm pain over two weeks following the injection. She says it feels like muscle pain. She pointed to it and it is lower on her arm almost to the back of the arm. She says it hurts all the time but more when she moves it and when she touches it.
Information has been received from a RN concerning a 27 yr old female employee born in another country who on 24Apr02 was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live (lot640154/0156M) and a second 0.5mL dose of varicella virus vaccine live (lot 643597/0895M) administered SC on 25Aug03. There was no concomitant medication. It was noted that in 2004, the pt developed gestational diabetes and delivered her baby in Jan 2005. On 02May05 a titer was performed and resulted 0.55. It was reported that the pt's present outcome is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Information received on 05May05 contained the following adverse event gestational diabetes.  Additional information has been requested.
1530-infant experienced a seizure. 1630-brought to health unit, temp 103.1 axillary. Hospitalized 1/14/11-1/18/11 diagnosed with febrile seizure. No further incident reported.
C/o fever,myalgia,nausea & vomiting;dry heaves;CBC & urinalysis WNL;givrn 4 mg Zofran for nausea & Toradol 60mg;Ibuprofen rx 600mg q6-8 hrs prn;advised bland food prn;Temp 99.8;Pulse117;BP 117/79
Swollen lymph node armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 10:45 (at the age of 21-year-old) as single dose for COVID-19 immunisation. The medical history included covid-19 and no known allergies. The concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph node armpit. The patient underwent lab tests and procedures, which included nasal swab test on 23Mar2021 and the result was negative. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lymphadenopathy axillary was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
The pt developed a large hive around where the MMR vaccine was give. The pt's doctor looked at it and ordered Benadryl. The pt stayed for 20 minutes to assure the Benadryl worked and the hive is better. Hive is better and less swollen. Cold compress was applied at short intervals with positive results.
headache, fever/chills, nausea, body aches began at 2:30 am the day after the 2nd dose (11 hours after) and lasted 20 hours took 400 mg/Motrin 2x, then 2  capsules of Excedrin Migraine
Received vaccine 9/14. On 9/24 pt reported itchy red streak at site measuring 2" wide x 3" long. Reported to Md. Md started Hydrocortisone 1% Tid x 7-14 days. Pt says it's resolving well without issue. Possibly RXN to Bandaid Adhesive.
pt recvd vax;onset on 12mar94, Lt ankle swelling progressed to bilateral swelling w/ ecchymosis feet;seen 17mar94 w/ finding consistent w/ henoch-schonle? in purpura;trace blood in urine & stool;cbc electrolytes, kidney func nl;platelets nl
PATIENT RECEIVED 0.5 MLS INSTEAD OF 0.25 MLS. WE CALLED PATIENT AND EXPLAINED THE SITUTATION AND PATIENT SEEMS TO BE SATISFIED WITH THE OUT COME
Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60
Welt appeared inferior to the vaccination site on both legs.  Worsened over about 10 mins and then seemed to resolve over an additional 30mins.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with M-M-R II (lot # K005574 with expiration date of 17-APR-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range(incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from a nurse on 24 May 2018. This case involves an adult patient (age and gender not reported) who was vaccinated with expired dose of ADACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported as one month ago). It was a case of actual medication error as expired vaccine used. No adverse event was reported. 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. Documents held by sender: none.
Right ventricular heart failure, right ventricular outflow obstruction, pulmonary blood clot, disseminated intravascular coagulation, DEATH