chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortly after receiving the vaccine (approximately 5-15 mins), patient developed a burning headache. Upon interview of patient, he states he had not had anything to eat or drink today and walked to this appointment (4 blocks approximately). Pharmacist monitoring patient noted the extreme heat in the room, gave patient water to drink, and walked with him in the hallway away from the hot room for about 30 minutes. Patient states he felt much better and reports his headache had improved enough to return home.  Pharmacist had patient fill out safecare event for hospital reporting and gave patient numbers to call if feeling ill again.
A few hrs post inject noticed 2 marble sized lumps in rt arm; got up 15NOV, took shower & noticed red area, size of hand, sl raised warm to touch @ inject site;
Had anaphylactic reaction after Prevnar and Hib. Got pale, stop breathing and bradycardic. No rash. Epinephrine 0.1 ml and CPR done. Vital signs improved transferred to ER.
lhe patient was vaccinated wilh improperly stored M­R II on 03JAN2020; The patient did not experience any symptoms; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical condition and current condition were unknown.  On 03-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (1 dose, lot # S004118, expiration date: 11-FEB-2021; route unknown) for prophylaxis with sterile diluent. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to temperature of 72.5 degree Fahrenheit for 10 minutes and 51.4 degree Fahrenheit for 2 hours and 4 minutes previously, and the data logger was involved. The sterile diluent was not reported as improperly stored. The patient did not experience any symptoms. The outcome of events was unknown.
Angioedema of lips, earlobe, and cheeks (all prior sites of cosmetic filler injection)
Information has been received from a consumer concerning her son with allergy to eggs who on an unspecified date was vaccinated with a dose of ATTENUVAX (lot number not reported). When was given the vaccine the patient developed "dots all over his torso like he was having a reaction to eggs". The patient also developed gastritis after vaccination. It was unknown if medical attention was sought. The outcome of the patient was not reported. No further information is available.
little bumps under her arm and it looks like bee sting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious) with onset 29Jul2021, outcome "unknown", described as "little bumps under her arm and it looks like bee sting".  Additional Information: "My daughter (consumer) ended up getting shot today the Pfizer Covid-19 Vaccine and she have like little Bumps under her arm and it looks like bee sting." In response to file safety report, reporter stated, "I am just trying to figure out, do I need to take her Emergency room or not because I can't understand what you are saying."  No follow-up attempts are possible. No further information is expected.
Patient developed worsening shortness of breath and hypoxemia.  She also had hypercarbia.  Troponin (0.43) and BNP (877) were elevated from baseline of normal previously.  CTA without PE though she is on chronic anticoagulation for A fib.  new pulmonary nodules and patchy infiltrate noted.  She continued to have shortness of breath and fatigue and pulmonary was consulted on October 29th to see and assist.
5-30-07 At 1:00am began with body chills and hot flashes very nauseated worsen at 4am no fever started headache continued this morning with headaches nausea and chills but feels a little better. Site tender to touch no swelling. Tylenol and Motrin.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and osteoporosis. Concomitant products included LUMIGAN, Enalapril and Risedronate. On 26th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 27th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, chills, weakness, muscle pain and tiredness. On an unknown date, the outcome of the fever, chills, weakness, muscle pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, weakness, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included eye drops. The patient did not have this reaction after her 1st dose. At 15:00 hours, the patient received dose of SHINGRIX in left deltoid. On the day of reporting, she woke up with fever, muscle pains, tiredness, weakness and chills. The patient had denied permission to contact physician.
cough on 10/4/21 That lasted a couple of days, and has nearly resolved. She has some nasal congestion and decreased smell as a result of congestion. She was with her brother 10 days ago, and afterward he ended up getting sick and being diagnosed with COVID-19.
Pt recv vax on 1/28/99; on 2/1/99 pt exp headache, bilateral jaw pain & base of skull pain
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: The needle initially did not go in easily (only the point) so I changed the needle. During 2nd attempt, needle went in fine, I administerd the vaccine, upon removal of the syringe, there was slight bleeding and I used a cotton ball and it stopped bleeding. Afterwards I noticed swelling at the injection site the size of a nickle. Pt had no other reaction.
22MAR06 had MMR shot. 27MAR-31MAR06 Daycare noted she was fussy and only took a 20 minute nap the whole day & woke up crying. Also, she is refusing to eat at school and home.  01APR06, she threw up at home. 02APR06 mother (me) noticed a few "red dots" on her face.  03APR06, her father noticed rash over her face increased (many red dots) and her temperature was 100.5.  04APR06, the rash is now on her stomach.  I gave her ibuprofen (1.25) for her fever and Benadryl (1 ml) for her rash. Her fever was 99.0 when she woke up this morning.  I called the DR's office and informed them of her fever and rash.  They said this is expected from MMV shots.
My mom get 2nd dose Shringrix vaccine at pharmacy, after a few hours later she developed generalized itchy urticarial rashes. 2 to 3 days later she noticed pain over the whole body and swelling of joints of hands. She did not have any reaction with the first dose. Then we went to urgent care. Doctor said she is allergetic to the vaccine.
Received injection in left upper arm about 10:30am at Pharmacy. About 5:00pm noticed itching on upper left chest. There were whelps and small bumps covering about a four inch square area.  Took a Benadryl and treated with cortisone cream.  Took another Benadryl before bed.  Still itching this am. More Benadryl and cream.  Same issues about noon. Another Benadryl.  Called Pharmacy. They told me if I started having breathing problems to go to emergency and told me to report to VAERS.
Pt vaccinated with Recombinant developed soreness, pain at the injection site, vertigo, hypotension, lightheadedness, weakness, decreased muscle tone to upper ext.; upper resp. infec.
sore injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
BP 101/60 (BP Location: LA-LEFT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult)  | Pulse 59  | Resp 16  | SpO2 99%     Location of event Vaccine Center   Description of Event: Pt appeared pale and nurse asked if he was ok. Pt slumped over and didn't respond to questions momentarily. When pt finally did respond he said he was ok but looked pale and diaphoretic.   Interventions: Given water, juice, brought to gurney, assessed, vitals taken.   Medications administered:  None   Response to interventions and/or medications given: Improved to baseline   Additional information: Mom was present for whole event.   Disposition: Home Treatment
p/vax pt had high pitched screaming late at noc-every noc, loss of  eye contact;stopped speaking;refused to wear clothing;very upset all day;began running head-first into walls, would stare into space for hours; Annual FU: autism - PDD, trouble sleeping, does not talk.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given. Sender's Comments: US-009507513-1701USA009558: US-009507513-1701USA009559.
Patient reported getting Covid on 31May2022; Patient reported getting Covid on 31May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: el3302), on 04Feb2021 as dose 2, single (Lot number: EL9264) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 31May2022, outcome "recovering" and all described as "Patient reported getting Covid on 31May2022". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Follow-up (02Jun2022): Follow-up attempts are completed. No further information is expected.
At 3:00 AM. --12 hours after the shot I was sick to my stomach & vomited. I had chills, a sore arm & very fatigued for the next 24 hours.   I am very healthy & was surprised when I threw up.
Word disruption; inability to complete thoughts; difficulty speaking; also, patient had redness, swelling over large area of upper arm.
red rash approx 6 inches x 2 inches,  surrounded by red, swollen area approx 4 inches x 6 inches; severe itching continuing today, 2/22/21.
GIVEN SECOND DOSE EARLY AT 21 DAYS INSTEAD OF 28 DAY DURATION. NO SYMPTOMS, REPORTED
fever, temperature of 102 degrees; cold spells; general fatigue; patient was not felt good,general malaise; felt weak; patient felt hot and then cold; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for self. A 60-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EV0150, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Right on 31Mar2021 at 10:10 as dose 1, single (at the age of 60-year-old) for COVID-19 immunisation. Medical history included hang nail from an unknown date and ongoing (hang nail that got infected). Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM F) taken for Infected hangnail 2x/day. Prior Vaccinations (within 4 weeks) was reported as None. Patient stated that, he feels cold. It is really warm there. Last night, he had a temperature of 102 degrees. This morning he took his temperature and it was 100 degrees. He has general fatigue. He just does not feel good. He feels weak. He was hot and then he was cold. slightly better. He was drinking a lot of water to stay hydrated. He just does not feel good. He thinks its called general malaise: The day was still early so he was not for sure, but he thinks it was improving. He has a headache that has not gone away: He took Tylenol for his headache. He does not like taking medications. But the Tylenol really helped his headache. He had a hang nail that got infected. His doctor put him on an antibiotic called Bactrim. He takes two doses a day. On 03Apr2021, the patient experienced headache, patient was not felt good, general malaise, general fatigue, felt weak, patient felt hot and then cold; cold spells on 04Apr2021; fever, temperature of 102 degrees on 06Apr2021. Seriousness of the event was not specified. Events were not resulted in visit of emergency room or physician office. The patient underwent lab tests and procedures which included temperature: 102 on 06Apr2021 and 100 on 07Apr2021. Therapeutic measures were taken as a result of all events and Tylenol for headache. The outcome of the events headache, cold spells, patient was not felt good, general malaise, patient felt hot and then cold was recovering, fatigue was unknown, fever, temperature of 102 degrees, felt weak was not recovered.   No follow-up attempts are needed. No further information is expected.
THE SECOND DOSE OF COVID19 VACCINE WAS ADMINISTERED 20 DAYS AFTER THE FIRST DOSE. THE PATIENT REPORTED EXPERIENCING NO ADVERSE AFFECTS OR REACTIONS.
***Initial c/o " The client informed he experienced blurry vision, sweating, and low blood pressure after receiving his MPX1 vaccine and was evaluated, cleared and released from the clinic by the Post Vaccination Clinician"   --- Vaccination MPX1 on 8/18/2022. 9/9/2022 - Call made to patient by RN. Feeling well now. Asks, "what should I do about my MPX2 vaccination since I had a problem after receiving MPX1?  No community medical provider to see for evaluation and direction. Instruction: in the interim,  Seek Urgent/EMS for recurrent, related complaints.  For next dose/MPX2, Return for MPX2 as scheduled - asure speaking with clinician to report symptoms within 15 min past MPX1 vaccination. On return - would remain at least 30 min past MPX2 and seek Urgent/EMS care for any related concerns after MPX2 vaccination.
The evening of receiving dose 1 I had fever, felt bad and had a headache. The headache lasted until the next evening. I used to just get little headaches once or twice a month. Now 4 days a week I'm getting severe migraines, they light sensitive, sound sensitive, vomiting, nausea, weak and see spots when I open my eyes. They have me stuck in the bed for several days. EXCEDRIN migraine and TYLENOL would not help with pain. I have taken TORADOL at the hospital and it helped a little bit. My OBGYN had prescribed me a migraine medicine but she stated she can't keep me on it due to possibility of having a mini stroke. So now I will have to consult with a neurologist and my primary care doctor to find a better option. In June of 2022 I did go to the ER and they do believe I had a mini stoke.
l felt clammy, lightheadedness lasted few hours. Also exp shoulder/neck pain left side and difficulty swallowing food,water lasting couple days.I still have periodically swallowing issues not sure of this related to reflux or vaccine.On 1/16 palms felt clammy and red I told pharmacist at my local grocery store was told to take Benadryl.
Narrative:  Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.
pt's LMP 29JAN933; recvd vax on 23FEB93; tx w/Zoloft in 1st trimester; exp hypoglycemia; POL, tx w/terbutaline; 26OCT93 delivered 8#12oz baby, EGA 38 wks; Apgar 8/9;
o Patient had a seizure on Monday 1/31/22 at 3PM - Patient complained that he hit is funny bone, dropped his mouse and seized for 4-5 minutes.  Family called emergency and he was taken to Hospital - MRI/Xray  were normal; swelling on forehead  - EEG confirmed myoclonic/general seizure - Neurology dx him with general/myoclonic seizure on Sunday and prescribed Keppra as maintenance and Nayzilam for a future seizure.  o Hx of ticks, but no personal hx of seizures nor family hx of seizures
fever started 9-10PM t103.2; screamed for 3 days; drank well;
67 y.o. female admitted 1/13/2022 with a past medical history significant for CAD, hypertension, HLD, follicular lymphoma on chemotherapy, and GERD. She present today with complaints of progressively worsening SOB going on for the past 8 days. Dyspnea worse with exertion. There is associated non productive cough, generalized weakness, decreased PO intake, nausea without vomiting, diarrhea, and subjective fever. She is fully vaccinated for COVID-19 with a booster. Patient was initially evaluated by PCP at onset of symptoms wherein she reportedly tested negative for COVID-19. She was subsequently started on tamiflu prophylactically without improvement. She called PCP today who subsequently directed her to ED for further evaluation and treatment. Patient report that she and her daughter were exposed to Covid at a new years eve party. She states he daughter had covid after this event but quickly recovered. There are no complaints of chest pain, syncope, or lower extremity pain or swelling. No abdominal pain, dysuria, or flank pain. No headache or focal weakness/parathedias. Will admit to inpatient to hospitalist service and consult nephrology and ID in the AM.
Doctors' diagnostic: Erythema Multiforme  Rash in whole body,  itching and burning could not sleep   out of control, have to use Prednisone ( Steroid) : 40mg for 4 day, and it is still on 20 mg
pt recvd vax & exp local redness-warm rt leg; cold compress applied cried w/o stopping-could not be comforted high pitched cry; no fever; mom took temp & reported nl); APAP given;
Pt recv vax on 12/27/88; on 12/28/88 pt exp flu-like sx, headaches, body aches, memory loss, fatigue, depression, neck pain (heavy head), hypertension
Pt experienced severe erythema with warmth & center blistering at the injection site in the rt lateral thigh after receiving DT.
This literature marketed report as received from a health professional refers to unspecified number of 27-39 years old female patients who started therapy with quadrivalent human papillomavirus (type 6, 11, 16, 18) recomb. vaccine (manufacture unknown) (dose, route and lot# not reported) on an unspecified dates. The literature background was to describe population-based rates of quadrivalent human papillomavirus (HPV4) vaccine uptake and coverage from its licensure in June 2006 through December 2008. In this period, quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was licensed for use in 9-26 year old females. Methods: Data were from 4 managed care organizations in the Vaccine Safety Data link. It was described uptake of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (number of doses given per month) in all persons aged 0-39, and coverage (percentage of eligible persons who received 2:1 dose) in all females aged 0-39, stratified by age and history of HPV-related disease. Results: In this study period, 166,975 quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) doses were administered to 79,235 persons, with the greatest number given in the 3rd and 4th quarters of 2007. The therapy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) coverage increased steadily; by December 2008, coverage rates were 1% (female 9-10 years old), 34% (11-12), 55% (13-17), and 36% (18-26). The rate of increase in coverage was reduced by late 2008. After mid-2007, female aged 9-26 with a history of HPV-related disease had significantly lower rates of HPV4 vaccination than those without HPV disease. It was reported that minimal off-label use occurred: 6 males received vaccine; 153 doses were given to girls < 9years, and 3,518 doses to women 27-39 years old. A copy of the published article is attached as further documentation of the patient's experience. This is one the several reports from the same reporter. Additional information has been requested.
Patient complained of burning at the injection site and felt flush within a few minutes of administration. Patient then complained of nausea, clammy, and dizzy. Patient vomited at 2:12 PM. Patient was assessed by a provider at 2:27 PM, further monitored and released home.
GBS/CIDP diagnosed 2/23/18 by Dr. Unable to walk, pick things up, weakness of right side.
dose reconstituted with sterile water; dose reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32, expiry date 20-AUG-2024) for prophylaxis.   On 04-SEP-2023, the patient received the 1st dose of Shingrix. On 04-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: dose reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: dose reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 2 Oct 2023: The pharmacist reported that a nurse administered Shingrix first dose reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine. The reporter consented to follow up.
I woke up early in the morning 12 hours after getting the vaccine and I laid in bed unable to move my whole entire body. Every single joint in my body including my head was in so much pain.