chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of excessive eye blinking in a 15-year-old male patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced excessive eye blinking and blepharospasm. On an unknown date, the outcome of the excessive eye blinking and blepharospasm were unknown. It was unknown if the reporter considered the excessive eye blinking and blepharospasm to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: This case was reported by the patient's father. The patient who was athletic and healthy received a dose of FLULAVAL QUADRIVALENT vaccine. The patient developed severe ticking, and constantly blinked his eyes. The reporter was not happy and indicated involving a legal action against GlaxoSmithKline. No further details were provided.
I have itchiness around the injection site and redness. I have body aches and a head ache as well
This spontaneous report as received from a non-pregnant female patient of unknown age refers to herself. The patient's medical history included an allergic reaction to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTAP), the patient experienced a high fever and swelling in her legs. On an unknown date, the patient was vaccinated with a dose of M-M-R II (albumin status, lot#, expiration date, dose, route and site of vaccination were not reported). There was no concomitant medication. On an unknown date, the patient experienced high fever. The patient had an office visit on an unspecified date. The outcome of high fever was reported as recovered/resolved on an unspecified date. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Patient developed pneumonia exactly 1 week after second dose. She had no issues before the shot, but had a high fever and breathing issues 1 week afterwards which was found to be pneumonia. While she is unsure if it is a result of the vaccination, she reported to the pharmacy and asked us to report to the manufacturer.
Arthritis; Swelling; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), SWELLING (Swelling) and INJECTION SITE SWELLING (Injection site swelling) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis), SWELLING (Swelling) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, ARTHRITIS (Arthritis) had not resolved, SWELLING (Swelling) was resolving and INJECTION SITE SWELLING (Injection site swelling) had resolved.            No concomitant medications were reported.  Patient received Humira (1156159).  Patient received booster dose.  No treatment medications were reported.  The reporter assessed all the events as possibly related to Moderna vaccine.  The reporter assessed the event of arthritis as reasonably possible with Humira and event of injection site swelling as not reasonably possible with Humira. The reporter did not provide any causality assessment for the event of swelling with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient of unknown age with concurrent condition of psoriatic arthritis, who experienced the unexpected non serious event of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved.  Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with concurrent condition of psoriatic arthritis, who experienced the unexpected non serious event of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved.  Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
After vaccination, client cried vigorously for about 30 seconds, then stopped and went limp. His eyelids fluttered and he appeared to have lost consciousness. This lasted less than 15 seconds. After regaining consciousness, client remained pale (but not cyanotic) and with a "dazed" look. No difficulty breathing or other distress noted, and no signs of an allergic reaction. Client's behavior after vaccination was markedly different than prior to vaccination - he was not babbling or crying, and showed minimal movement of extremities. He did not appear in acute distress, and safety was maintained. RN called 911 for further evaluation and support. Paramedics arrived on scene within 5 minutes, and in that time client became more alert and less pale. Paramedics monitored client in clinic for about 15 minutes and after discussion with mother, client was transported to ER via ambulance.
Wed nite-itching on arms & legs; Thursday night worse; Friday still had redness on Arms & legs; MOnday felt joint pain;
the patient was "7 weeks pregnant" at time she received first dose of GARDASIL 9./ the patient received second dose of GARDASIL 9  on 11/12/2019; This spontaneous prospective pregnancy report was received from a business/individual referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 10-SEP-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R030453, expiration date was not reported, but upon internal validation established as 23-JUL-2021; dose, frequency and route were not reported) for prophylaxis. The patient was 7 weeks pregnant at time she received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exposure during pregnancy). The patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R030453, expiration date was not reported, but upon internal validation established as 23-JUL-2021) on 12-NOV-2019. The patient was not aware she was pregnant when she received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was now 31 weeks pregnant. Last menstrual period (LMP) was assumed as 23-JUL-2019, date of conception was assumed as 06-AUG-2019 and the estimated due date (EDD) was 28-APR-2020. Pregnancy outcome was pending.
Initial report received from healthcare professional on 18 November 2013. The case is linked with the case number 2014SA045502. The case was received on 21 March 2014 at GPV. A '14-year-old' patients whose gender, medical history, and concomitant medication were not reported had received dose of FLUZONE ID (Lot number, expiration date, dose number, route and site of vaccination was not reported) on an unspecified date, whose age falls outside the product indication i.e. inappropriate age at vaccination administration. No adverse event was reported.
pain on her arm; hardly lifts her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 18Feb2021, for COVID-19 IMMUNISATION. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain on her arm"; HYPOKINESIA (non-serious), outcome "unknown", described as "hardly lifts her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Aching, listless,couldn't sleep, not hungry, but NO temperature.  Lasted about 30 hours, then feeling o.k.Required no treatment.
1 DAY POST VACCINATION CHILD HAD A LARGE SWOLLEN AREA ON RIGHT ARM WHERE TDAP AND IPV WERE GIVEN.  MOM CALLED POISON CONTROL CENTER TO SEE IF SHE SHOULD APPLY HEAT OR COLD.  GIVEN ADVIL, TYLENOL, BENADRYL AND HEAT.  MOM WILL TAKE TO MD IF DOES NOT GO AWAY OR STARTS TO LOOK INFECTED.
Pt enters IZ room anxious about receiving the shot but sat still for the injection. Observed pt make a few facial grimaces soon after the shot but no signs or symptoms of acute distress were noted.
14 days after recieving J&J vac. I noticed some tightening in my rt. knee.  Then the swelling went down to my calf.(another 5 days)   the swelling, and tightness , and a dull ache was my symtoms.  Made an appointment to see my doc. on 6-3-2021, she made lab work for 6-4-2021.  The ultra sound came back pos for a blood  clot behind my rt. knee.  Started taking Eliquis on 6-4-2021.
moderate swelling up into the eyes down to the oral commissures; moderate swelling up into the eyes down to the oral commissures; This is a spontaneous report from a contactable other hcp. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 43-year) on 29May2021 as dose 1, single for COVID-19 immunization. The patient was injected with 1mL Restylane to the nasolabial fold areas on 08Jun2021. The patient medical history and Concomitant medication were not reported. The patient previously took Desyrel and experienced drug hypersensitivity (allergy to Desyral). Patient has not had other vaccines or dental procedures in the past 6-12 months, and she did not have any illness the month prior to her treatment. On 08Jun2021 the patient experienced moderate swelling up into the eyes down to the oral commissures. She was prescribed Elocin 0.1% cream on 08Jun2021. The events were ongoing. The clinical outcome of the events was not recovered.  Information about lot/batch number has been requested.
10/3 Achy flu like symptoms started around 1pm with neck stiffness. Took 2 Tylenol at 7:30pm and went to bed, woke up fine 10/4. 10/4 1:00pm again felt neck stiffness, took 2 Tylenol and stiffness is gone at 3:30 p.
fever, cough, shortness of breath, chest pain, diarrhea, arthralgias
Rash on chest and back - light red, mildly itchy; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1685), intramuscular on 06Jan2021 at single dose at arm right for COVID-19 immunization. Medical history included Multiple Sclerosis, hypertension, depression/anxiety, chronic sinusitis. Concomitant medications included dimethyl fumarate (TECFIDERA), gabapentin, buspirone hydrochloride (BUSPAR), fluoxetine hydrochloride (PROZAC), losartan, fexofenadine hydrochloride (ALLEGRA), and montelukast sodium (SINGULAIR). The patient previously took benazepril and has Known allergies: Benazepril. On 08Jan2021, the patient experienced Rash on chest and back - light red, mildly itchy.  The events were assessed as non-serious. The patient did not receive treatment for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.
Information has been received from a registered nurse concerning a 9 month old male who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# 655174/0848F) on 21-JUL-2006, 18-SEP-2006, and 13-NOV-2006, respectively. On 01-MAR-2007 the patient experienced vomiting and diarrhea. The vomiting stopped after about four days. At that time the diarrhea persisted off and on. On 01-MAY-2007, the patient started having either vomiting or diarrhea every night. There was no dehydration. The patient was advised to be on soy milk and use Lactobacillus rhamnosus (CULTURELLE), sprinkled on food. The patient had a follow-up well visit on 17-MAY-2007. On 17-MAY-2007 the diarrhea symptoms had resolved. Additional information has been requested. 3/25/2010 Follow-up information from a registered nurse indicated that the patient recovered on 17-MAY-2007.
Pain at shoulder and neck, moving to shoulder and back.  Has lost some mobility in arm and has difficulty lifting items.  Cannot sleep on that side and wakes frequently during the night due to pain.
The patient is a G3P2 with a history of 2 prior term vaginal deliveries.  Her last menstrual period was 1/15/21.  Estimated due date was 10/22/21 based on her last menstrual period.  She had her first covid vaccine on 3/4/2021.  She saw me for her first prenatal visit on 3/24/21 and was asymptomatic.  Fetal heart tones were not appreciated on doppler.  She was referred for a dating ultrasound, which she never completed.  She began having some bleeding sometime after the appointment on 3/24.  She got her 2nd covid vaccine on 4/1/21.  She began having pelvic cramping on 4/3.  went to emergency dept 4/4.  u/s showed an 8week 2 day gestation with no heart beat.  she continued to have bleeding and cramping 4/5 and likely completed the miscarriage that day.
Throbbing pain; unusual sensation at injection site; cannot move the hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand). At the time of the report, PAIN (Throbbing pain), INSTILLATION SITE PARAESTHESIA (unusual sensation at injection site) and HAND DEFORMITY (cannot move the hand) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
CHILLS; LOW GRADE TEMP; STOMACH CHURNING; CONSTANT HEADACHE SINCE WAKING UP; BODY ACHES; WEAKNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 24-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced stomach churning. On 24-MAR-2021, the subject experienced constant headache since waking up. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced low grade temp. Laboratory data included: Body temperature (NR: not provided) 100.3 (unspecified unit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach churning, and had not recovered from body aches, low grade temp, chills, weakness, and constant headache since waking up. This report was non-serious.
PERIPHERAL NEUROPATHY 4/13/2023 CHRONIC ATRIAL FIBRILLATIONHYPOTENSION 4/20/2023 CHRONIC ATRIAL FIBRILLATION PERIPHERAL NEUROPATHY 4/13/2023 CHF EXACERBATION, UNSPECIFIED HYPOTENSION 4/20/2023 CHF EXACERBATION, UNSPECIFIED PERIPHERAL NEUROPATHY 4/13/2023 ANASARCA HYPOTENSION 4/20/2023 ANASARCA
DULL THROBBING HEADACHE FEVER CHILLS ACHES AND PAIN ALL OVR BAD NAUSEA FATIGUE HALF DOLLAR SIZE HARD KNOT ON THE TOP OF MY LEFT ARM, THE COLOR OF PINKISH RED RASH THAT ITCHES.
pt became very pale & dizzy & almost fainted; father picked pt up & put pt on the stretcher;
5/26 60y.o. female who presented to the hospital with COVID-19 viral infection diagnosed as outpatient.  Patient tested positive at home and had video visit with her primary care physician who advised her to come to the hospital.
Call on 9/24/02 from relative stated left arm swollen, rash and warm to touch. 9/25/02 Mom grought child in left arm swelling from shoulder to elbow. Asked if she had put ice on it; No. Showed on VIS stat which was given to him where it states it can involve whole limbs for 1-7 days. Called 9/26/02, Arm is a little less swollen.
6 hours after receiving my second vaccine I started feeling achy and experiencing fatigue which has continued until the time of this report - Saturday, April 17, 2021 12 noon - no fever has been present
At 0600 patient was given a flu shot.  At 0800 patient called for help.  RN found patient on the floor diaphoretic but awake and verbal.  Pt complained of chest pressure w/ radiation to both arms.  He stated he had been having chest pain symptoms for three days prior.  911 was called and at 0805 epinephrine was given.  0810 RN reported incident to office as paramedics were arriving.  After being evaluated in ER it was determined patient suffered a heart attack w/ no correlation to flu shot.
The adverse event lasted about 36 hours and involved intense soreness in left arm; high fever and chills; intense body aches; muscle cramps. Although I was very sick I did not seek medical attention as this was not unexpected. I received outstanding information pre- and post-injection from officials involved with the vaccine process at vaccination site.
pt recv vax 29MAY97 & 17JUN97 pt devel swelling on the side of neck;it is being referred to as parotitis;
4/8 - Developed headache within 4 hours of vaccine. 4/9 - Felt like she head cold with cough and congestion. 4/10 - coughing and breathing worsened, went to ER treated with IV benadryl, famotidine and steroid. 4/11 - mild improvement. 4/12 - Went to PCP with facial swelling, shortness of breath, and rash. Received solumedrol's IM injection. 4/13 - slight improvement. 4/14 swelling returning. 4/15 - Return to PCP with facial swelling and rash worsening, another solumedrol IM injection given and PO prednisone ordered. 4/16 - 4/21 swelling worsened until pt began taking prednisone 40mg twice daily. Between 4/21 and 6/19 pt was tapered down on oral prednisone. Patient had return of facial rash, dermatology considered possible development of rosacea and treated with IM kenalog. Patient then had rash develop within approximately 3 weeks and biopsy is pending. PT had another ER visit in May due to severe shortness of breath and pulmonary embolism was ruled out. 7/19 ER visit due to severe shortness of breath again and cough, hypoxia present.
Unilateral hearing loss, tinnitus- began within 24 hours of vaccine, still ongoing 2 days later
Information has been received from a pharmacist concerning an adult female pt who was vaccinated with MMRII. Within 2 days, post vax, the pt developed a "local reaction" and fever. Two to three days after the fever, the pt developed a rash. Unspecified medical attention was sought. Additional information has been requested.
There is no way to know if my strong, (low grade fever for 24 hours, fatigue, all-over body ache, big soreness in injection arm & bad headache), but not serious (no trouble breathing) reaction to Shingrix evoked an auto-immune response.  Every year I receive the influenza vaccine and I like to stay up-to-date on any vaccines I think I should, i.e. Pertussis and Tetanus. Usually I have no reaction nor soreness; if I added the reactions to all of the vaccines that I have ever received, it would not be nearly as much as the reaction I had to Shingrix. I think I have RA genes that were going to get turned on sooner or later. I received the first dose of Shingrix on 03/16/18. It was almost 3 weeks later, on 04/05/18 between 7:00 P.M. and midnight when I went from never having had ANY joint pain to what I now know was the initial R.A. flare-up with most joints hurting and swollen, skin hot to the touch.  (Twenty four hours prior to that I did get a non-itchy prominent rash everywhere except my face, palms and soles of feet). My reaction to the second dose of Shingrix administered on June 20th was the same as what I experienced after the first dose. However, on June 21st I took Naproxen and it greatly relieved my symptoms.
Bitten by an animal; This spontaneous case was reported by a pharmacist and describes the occurrence of ANIMAL BITE (Bitten by an animal) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B28A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANIMAL BITE (Bitten by an animal). The patient was treated with RABIES VACCINE for Rabies, at a dose of 1 dosage form and IMMUNOGLOBULIN ANTI-RABIES for Rabies, at a dose of 1 dosage form. At the time of the report, ANIMAL BITE (Bitten by an animal) outcome was unknown.        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.   Concomitant medication information was not reported by the reporter.
A rash just above and below the injection site.  Red, bumpy and hot.  As of this writing, 6 inches in length and just over 3 inches in width at the widest location.
Fever began two days after shot was given (103F) mother gave Tylenol.  Child taken to ER with c/o seizure.
We administered the Varicella vaccine separately not realizing the MMR vaccine was combined with Varicella therefore administering 2 doses of Varicella on same date of service. Patient had no reaction, mother was advised of error and monitored for the next 2 days.