chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; patient was meant to have received MMR, not PROQUAD; This spontaneous report was received from a nurse regarding a 17-month-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 16-OCT-2019, the patient was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at the same office visit (strength, dose, route of administration, lot numbers and expiration dates were not provided). The patient was meant to have Measles, Mumps, and Rubella (M-M-R) administered instead of inadvertently being administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). No adverse effects were reported.
Kept complaining of sore arm - felt that was normal because of the muscle ache sometimes felt at the site after shot. However on inspection had had a red patch a couple of inches over from the shot site, no clearly defined outer margins - a large blotchy mis-shapen patch. Very red and hot to the touch. Measuring proably about 2 inches by 2 inches or so.  Was larger in size on 11/14. Also complained of aching legs and muscles all over his body. Possible low-grade fever. Did not act well, and was very tired and irritable.
I have a metallic taste in my mouth and my arm still looks like covid arm and it?s been 2 weeks. It?s still warm to the touch
R face droop --> Bell's palsy. 9/16/08-records received -office visit 6/24/08-C/O hip pain.  6/30/08-C/O right side of mouth droop and also around right eye. C/O pain at injection site with swelling.
This initial spontaneous case, was received on 10-Oct-2017, by other non-health professional, concerning a 56-year-old female patient. The patient's historical drug included influenza vaccine. The patient's concomitant medications were not reported. On multiple seasons (including 2016), the patient received INN flu vaccine, (dose, route of administration, anatomical location, batch number, expiry date was not reported). It was reported that, over multiple seasons including Fall 2016, after vaccination, the patient had stiff arm routinely and often felt tired for a few days after getting the shot. It was reported that, the patient recovered from the events several days after vaccine administration. The reporter provided the causality of the events as related to the suspect vaccine. The reporter assessed the event as non-serious.
Pt exp mental confusion, slurring of speech, hypertension, & vomiting immediately p/vax; treated in ER w/meds; Seem to be improving but MD had pt admitted to hosp for continued observation;
Previous pap smear before vaccine was normal, all pap smears after vaccine have been abnormal. I now have cervical dysplasia and presence of HPV. I've had 3 colposcopy's because of abnormal cells.  My partner of over 2 years developed genital warts following the second dose of garadisil. I was administered one shot on 7-11-07 and a second shot 9-17-07.  In October of 2007, he started developing bumps in his genital region and in December of 2007 he routinely began getting them burned/lasered off. His dermatologist initially thought it was contagisom molluscum, but now over a year later and with them still not gone, she believes it to be genital warts. He has never had any previous problems/signs of this disease ever before and neither have I. I was never asked what medications I was on prior to the shots or if i was sick and might have a low immune system. (I have ashtma, severe allergies, and often get sick).  Also, I was not tested prior to the shots to see if i had been infected with the HPV virus in the past. I believe that these incidents are a direct result of the gardasil vaccine.  I had been in a monogomous relationship for a year without any problems or symptoms.  It was not until I started getting the gardasil vaccinne that we both started noticing adverse side effects. I do not think that doctors are asking the proper questions before administering this shot. Whose to say everyone's body can fight off the virus in the vaccines, especially if the person has already been infected and has a low immune system?
In August 2020 had a reaction presumed it may have been from the Bicillin Shot, Soldier stated he did not have allergy to this. Broke out in hives approx. 1-2 hrs. given Benadryl and sent to ER. 2nd dose of Varicella on Twin Shoot and this happen again approx. same time frame.  Sent to CTMC for evaluation then sent to  ER
Now has a rash all over her body; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced now has a rash all over her body on 13Apr2021. The outcome of event was unknown.
Information has been received from a registered nurse concerning a 7 year old female with an amoxicillin allergy on 09/13/1995 was vaccinated with varicella vaccine. On 10/30/2001, the pt developed chicken pox. The pt had a low grade fever and 7-8 2mm papules on her trunk, scalp, and legs. Some of the papules were simple pustules, two were almost vesicular and two had crusted centers. The pt received medical attention for her experience. Additional info received from the nurse indicated that the office did not have the name of the pt. Therefore, no additional info could be provided. No additional info is expected.
Pediatric Pfizer dose (10 microgram) was given to 12 year old child instead of adult dose (30 microgram dose). No other side effects are reported
This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 05Aug2022 at 16:00, outcome "recovering", described as "Return of symptoms, fever, positive COVID test after being symptom and fever free except for fatigue with negative test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of disease recurrence. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19, disease recurrence and the suspect drug cannot be excluded.
soreness of injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness of injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20a and 006m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness of injection site). On 24-Jan-2021, INJECTION SITE PAIN (soreness of injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment IV fluids
Within 3 hours of injection came severe diarrhea and vomiting with sweats & chills lasting about 6 hours immbolized & exhausted.
1st shot:  severe left arm pain and shoulder pain-improved but not resolved on 5/28/21 fatigue for 2 weeks resolved Increased Inflammation of arthritis in many joints that were not previously affected-has not resolved headache
HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported.; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported.; This spontaneous report was received from a HBP responsible for vaccines referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 01-SEP-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered after a temperature excursion (product storage error) lot # W017570 with expiration date of 29-NOV-2023, for prophylaxis. No other event reported.      The vaccine underwent to temperature excursion as follow:  Temperature: 5.7 F (Fahrenheit); Time frame: 0 Hours 30 Minutes and 0 Seconds. The vaccine had previous temperature excursions: 6°F up to 14°F (9.1F) for 1 Hour 6 Minutes and 0 Seconds and 6°F up to 14°F (10F) for 1 Hour 8 Minutes and 0 Seconds.       No additional information provided. No additional AE reported. No PQC reported.
COVID breakthrough case. I received my 1 booster shot on 11/26/2021 and My COVID symptoms started on 02/07/2022  sore throat, body aches different than any other. Cough, blood oxygen level was down. 2 weeks it lasted. 03/25/2022 went to cardiologist because the breathing treatments were helping me. I tested positive for COVID on 02/08/2022. 03/04/2022 I went to see my PCP because I couldn't breathe. My doctor gave me antibiotics and inhaler told me if I had pneumonia to take it since I didn't have, I did not take it. I have problems with my heart since of the vaccine. I never had problem with my heart before now I will have to take medication for rest of my heart. 03/20/2022 I had to go to urgent care because I couldn't breath and the cough won't stop.
The patient was given a Janssen Covid-19 vaccine. About 5 minutes after receiving the vaccine,  while he was waiting in his car, he began to experience light headedness, roaring in the ears.
Patient reports day of vaccination 10/16/18, mild local reaction that improved 10/17/18, but then starting 10/18/18 increased swelling, redness and pain of whole right arm that worsened. Patient was seen in office 10/20/2018 and was noted to have significant swelling and redness to > 50 % of the right arm, due to lapse of time, unsure if direct vaccine reaction or subsequent cellulitis, prescribed NSAID and antibiotic with improvement in symptoms.
In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up.  Patient's daughter was talking to her and she would orient to her but not answer any of her questions.  EMS called and by the time they arrived patient was acting her normal self.  Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult.    Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with.  These include her getting up at night and sundowning as well as yelling and screaming during the day.  Daughter states that she gets in the shouting matches with the patient during the day.  Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors.  Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam  -Received 1L IV NS in ED  2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility  Discharge summary Principal Problem:   Comfort measures only status Active Problems:   Chronic atrial fibrillation   Essential hypertension   Dementia with behavioral disturbance   Recurrent falls   Dysphagia   COVID-19 Resolved Problems:   Cough with hemoptysis   Leukocytosis   Dehydration   Inadequate oral intake  Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia.   She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19.  She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur.   Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021.   She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided.   She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am.   Deceased 3/8/21
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: pt developed hives after first dose, resolved after 48 hours
16AUG98 fever 104, runny nose;17AUG98 fever, rash on face;18AUG98 fever 104, rash on face & torso, lymphadenopathy;MD dx viral exanthem, measles caused by vaccine;
Mother notified office of increase in hyperactivity more emotional liable after 1-2 after shot. Patient has PMH of Autism and behavior issues. Mother reports persistent significant change since shot.
was given the less than 5 year , instead  of the 5-11 year dose
Have a reaction from the Moderna Booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have a reaction from the Moderna Booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Have a reaction from the Moderna Booster). At the time of the report, VACCINATION COMPLICATION (Have a reaction from the Moderna Booster) outcome was unknown.            No concomitant medication were given. No treatment information were provided.
pt recvd vax;that eve had t of 105.8;tepid baths & apap given;t persisted 103;seen by MD;fever 100.8 & lymphocytosis
pt recv vax 16DEC97 6PM & pt was very fussy-took temp was 104 ax;called ER & was told to give APAP & luke warm bath;pt also cried inconsolable for 4 1/2hr from 630Pm-11PM temp did start coming down;all sx gone by 9AM 17FEB98
Patient experienced shortness of breath a few days leading up to the adverse event. On the evening of March 11, 2021, he collapsed.  An ambulance was called and he was taken to  Emergency Room.  He stayed there until the morning of  March 12, 2021 when it was discovered that he had multiple blood clots in his lungs.  At that  time, he was  air lifted to  Hospital Intensive Care where he stayed until March 17, 2021.  At that time, he was moved to Health Rehabilitation Hospital of where he stayed until March 27, 2021.  First vaccination was on   01/22/2021; Second was on 02/17/2021.
Stomach issues; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues) 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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.No treatment information was provided.
4DEC pt had difficult breathing-turned blue pt broke out in a rash; parents took pt to ER; By the time react ER pt now breathing OK;5DEC pt w/fever, rash still on body; 6DEC pt OK
someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event; Initial information was received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who reported that someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. The information on batch number was requested.  It was reported that "Caller stated that someone in the office gave the dtap/ipv component without the hib as the mixture twice to two separate patients. Caller stated that are not sure who the patients are yet and are investigating, but she wants to know if when the patients are revaccinated, do they need to be given the entire PENTACEL vaccine."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event someone in office gave dtap/ipv component without hib as mixture twice with no reported adverse event.  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 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.
Patient came to the pharmacy on September 24, 2019 at approximately 11:15 AM and stated that he had a reaction from the Shingrix vaccine he received. He brought pictures of his break out- pictures showed patient's arm with red, blistering spots. Pictures were of patient's arms, but patient stated he also had blistering spots on both legs. Patient stated he went to his primary care provider where they gave him a prescription for an antiviral and the blistering spots have since cleared. The primary care provider instruction him not to receive the 2nd dose of the Shingrix vaccine.
Immunization given and immediately following reports being hot. Becomes diaphoretic to forehead and extremities. Has syncopal episode lasting 10-15 seconds and remains in chair for 5 minutes and reports feeling "good, fine". Diaphoresis stops patient able to stand without dizziness.
Limited information of: 12/30/21 Positive COVID Test 12/30/21 Admission to local hospital Inpatient Service 1/4/22 Discharge from Inpatient Service 1/22/22 Positive COVID test 1/22/22 Admission to local Hospital Inpatient Service 1/25/22 Discharge from Inpatient Service. 1/26/22 Treated in local Hospital ED.   A caregiver from local facility reported patient to be SOB, though patient did not report this. No record of admission to Inpatient Service. ED visit is the last record of service for this patient at local Hospital. Received Death Abstract documenting Patient died at local Facility with assistance provided by local Hospice care. Patient died 2/5/2022 at 10:50 of COVID Infection/acute respiratory failure.
Severe calf cramps in both legs in the early morning which awakened me and were present for approximately 5-minutes and gradually subsided.  I awoke every morning afterwards for approximately 2-weeks with a headache and cold sweats throughout the day.  I had chest "tightness" off and on for several days intermittently during the day.  I experienced significant fatigue for 2-weeks following the vaccination.  I developed cold-like symptoms for 2-weeks with chest and head congestion which gradually reduced over a 4-week period.  I did not feel sufficiently recovered to take the 2nd vaccination..
Pt developed swelling and tenderness at injection site several hours post vax. The area was 5 x 5 cm with 3 x 3 cm central erythematous, elevated area on left anterior thigh. Recommended treatment was cool compresses and NSAIDS.
On 2nd day after 2nd GARDASIL arms & legs shaking unsure of which side. Now having c/o frequent passing out lasting ? 30 sec. to one minute but unsure how long. Has never timed them. Frequent headache & feeling shaky inside. Has seen Dr. several times but no diagnosis yet.
This spontaneous case was initially received on 29-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA. No additional drugs suspected. On 23-Sep-2015, after starting treatment with AFLURIA the patient experienced improperly stored dose of AFLURIA was administered. On an unknown date, after starting treatment with AFLURIA the patient experienced improperly stored dose of AFLURIA. For relevant test results see appropriate report section.