chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE DIDN'T WORK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, race, ethnicity and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced and reported that vaccine didn't work. It was reported as "that didn't work". The action taken with covid-19 vaccine ad26.cov2. was not applicable. The outcome of vaccine didn't work was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: Sender's Comments: V0:20221057049 -COVID-19 VACCINE Ad26.COV2.S-vaccine didn't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Fever; migraine; sweats; chills;muscle aches; tiredness head congestion which lasted for 48 hours.
Rash on body 2 days after vaccine was given, urticarial rash primarily on torso as described by mom.
After receiving the Prevnar 13 injection at 10:30 AM, I started feeling ill around 5:45 PM that same day.  My chest tightened, I began wheezing and coughing.  Wheezing/coughing continued the next day (Friday) and into the next 3 days.  I had trouble breathing on Saturday evening, January 8, and went to emergency room at 6:00 AM on Sunday, January 9.  They did an EKG, chest X-ray and blood test; all were normal, so the doctor prescribed an inhaler (Albuterol Sulfate HFA inhalation aerosol) .  A COVID test was done and I am awaiting results.  After inhaling the Albuterol, I am able to breathe better but still have the wheezing and coughing.  No fever.
FLUZONE HD was administered to the patient on 9/14/2017. The patient reports that he suffered some arm pain later that evening, prompting him to call the pharmacy, where he was told it is normal to have some injection site pain after a vaccination.  Six days after the vaccination, on 9/20/2017, the patient was treated for herpes zoster. He states that he had spent some time in the hospital due to illness. He came to the pharmacy today, February 22, 2018, starting that his arm is now paralyzed from the vaccination.
Mother states pt. in bed with her, awoke her from sleep saying "mama". She awoke to find child "convulsing", picked him up. He asked to be put down and continued convulsing for approximately 60 seconds. Afterwards reports patients mouth "locked up", was holding mouth open "funny". Also reports onset of fever at approximately 11PM 9-27-11 with one episode of vomiting. Sleepy, thirsty & lethargic afterwards. Treated with TYLENOL after reporting to RN on 9-28-11.
Right anterior Thigh with red macular lesion 11 1/2 cm x 6 cm warm. Day 2 or 3 after injection started with increased redness and redness, no treatment.
Immediate pain in my shoulder. Pharmacy staff commented that she can't push the syringe in. But when she checked she saw that the fluid was delivered. Pain progressively worse until I could not even hold a fork by 5 pm the same day.
the day after getting the shot my son's being very aggressive, throwing things and mood was all over the place. Since getting the shot he has been upset and continuously wetting himself. I had to take him to a crisis center Sunday night because I was unable to calm him down.   My son has never had this reaction before after getting shot.
Patient called to report localized reaction at the injection site which presented  approximately 8-9 days after immunization was given.   Site was swollen, warm, hard and approx 3 inches in diameter.  Site was also somewhat itchy.
Erythema, cellulitis secondary to immunization in right arm; right deltoid region inflammed and indurated, no tenderness to palpation. Induration 10X6cm; full ROM. Shoulder at 48 hours, post vax, erythema 18X13cm. RX: Keflex and clindamycin X 7 days. Resolved by 12/02/02.
6/15 61y.o. female with PMH HFpEF, COPD, HLD, HTN, GERD, OSA on BIPAP, chronic pain presenting for lightheadedness, dyspnea, nausea.
Loosing my hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Loosing my hair".  Additional information: The patient was loosing hair because of COVID & the injections.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2015 was the first and only year that I received the high-dose trivalent flu vaccine. My Asthma manifests itself in an asthmatic cough. After receiving the high-dose trivalent flu vaccine, I had a persistent asthmatic cough that required several weeks of DELSYM inhaler until I returned to my version of normal. My Allergy and Asthma specialist said that he does not recommend the high-dose trivalent flu vaccine for his Asthma patients. The reason that I am submitting this now is that in 2016 and 2017 I needed to tell the County nurse that I could not have the high-dose trivalent flu vaccine, and that I needed the regular dose quadrivalent flu vaccine because of my previous Asthma reaction. In both years, the nurses were not aware of this. I think that this information should be part of the flu shot protocol, as a prerequisite question, so that it is commonly known. This will prevent Asthma reactions to high-dose trivalent flu vaccine, and allow Asthma patients to not be excluded from flu shots by a computer. Thank you.
p/ pt recv vax approx 3 yrs later pt presented w/approx 20 lesions, covered w/varicella
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.
Patient is a 64 y.o. female with a past medical history of hyperlipidemia, IDDM2, OSA, anxiety/depression, and chronic back pain who presented from Clinic on 9/4/2021 with acute respiratory failure due to COVID-19 infection. Required intubation secondary to refractory hypoxemia with worsening mental status and increased work of breathing on 9/6. Was initially on paralytics and intermittently in prone position following intubation. Hospital course complicated by persistent fevers up to 103.9, multiple infectious workups negative.    On 9/16/2021, Patient had acute decompensation with hypotension, hypoxia and ventricular tachycardia requiring defibrillation. CTPA revealed pulmonary embolism. EKG with anterior leads concerning for ischemia, on-call cardiologist notified, stat echo ordered. See code documentation from 9/16 for further information. She continued to decompensate despite maximal support from vasopressors and mechanical ventilation.    Family present at beside, pt husband expressed wishes to transition to Home Care. Code status changed to DNRCC, pt compassionately extubated with time of death at 2051 on 9/16/2021.
Pt received first and only dose of Janssen J&J COVID vaccine on 4/5/2021.  2 weeks later, patient would have been considered to reach full immunity.  On 4/21/2021, pt went to the ED with symptoms of COVID and tested positive via SARS-CoV-2 PCR.  Pt was not ill enough to be admitted.  "Symptoms include nonproductive cough, pleuritic chest pain, shortness of breath, arthralgias, myalgias, fever, vomiting, diarrhea."
pt felt dizzy and shaky after about 5-10 minutes of 2nd dose of Moderna. Pt was given a coke and cold compress. Pt started stuttering. Pt said they can have seizures in stressful situations. 911 was called. Pt was alert and seemed stable by the time they left. Course of time from injection to leaving the pharmacy in ambulance was about 1 hour.
routine back pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 15Mar2021, outcome "unknown", described as "routine back pain". Therapeutic measures were taken as a result of back pain. Additional information: The patient received BNT162B2 between 10:00 AM to 10:30 AM (as reported). The patient received ibuprofen (taken at about 12:00 PM to 12:30 PM) as treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced redness, pain and swelling at the injection site.  She went to the urgent care and they said it was infected and prescribed her Bactrim DS.
Total lost of vision in the left eye for about one minute; This spontaneous report from a contactable consumer reporting for herself   An 83-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Mar2021 at 09:00 at single dose via an unspecified route of administration  on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included unspecified antidepressants and levothytoxine. On 30Mar2021 on 15:30 the patient experienced total lost of vision in the left eye for about one minute. The patient recovered from the event on 30Mar2021.    Information on the lot/batch number has been requested. Follow up attempts are needed.
Pt came in with fly to have imm. administered with no c/o Imm. given with no problems. Fly. left prior to 20 mins but returned stating pt having asthma attack. Pt. wheezing with retractions noted. BP 110/70. Referred ER ASAP.
Information has been received from a physician concerning a 9 week old male with no medical history or allergies who on 25-SEP-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot # 661031/0467X).  Concomitant suspect vaccine therapy included a dose of PEDVAXHIB (manufacturer unknown).  Other concomitant vaccine therapy included a dose of PREVNAR and a dose of DTAP (manufacturer unknown).  The physician reported that on 26-SEP-2007, the patient was in contact with a child who was ill with an E. coli infection.  On 27-SEP-2008, the patient developed mucous and blood in the stool, diarrhea and became dehydrated.  A stool culture was done, results are pending.  The patient sought medical attention at an office visit (date not reported).  The course of treatment was not reported.  The patient's outcome was reported as recovering/resolving.  A product quality complaint was not involved.  Upon internal review blood in the stool was considered an other important medical event.  Additional information has been requested.
PATIENT REPORTED AN INCREASED SHORTNESS OF BREATH, OVERALL CHEST HEAVINESS AND GENERALIZED SHAKINESS WHILE RETURNING HOME FROM GETTING THE VACCINE. PATIENT WAS TRANSPORTED TO THE ED AND RECEIVED ALBUTEROL, PREDNISONE, BENADRYL AND CETIRIZINE. PATIENT DISCHARGED HOME SAME DAY.
On 6/9/00, patient went to see the MD for his asthma and allergies bothering him, he mentioned he was traveling abroad, the MD gave him a PPD. On 6/12/00, he started feeling nausea and was running a very high fever. On 6/13/00 the fever got even higher resulting in him not begin able to breathe and was rushed to the hospital. He also experienced diarrhea with some bloody mucus in stool. Fever reached 106.
Redness, pruritus, after 2 or 3 hours vesiculization (blisters dry up. >5 mm) rupture of vesicles.
Intense local reaction to immunization site - right ventral thigh (documented as DTaP #4) Administered 04/23/2002  (11 cm wide/5 cm tall; very sharp borders, induration, purple, painful), Treatment: Benadryl PO, Triancinaline 0.1% TID to area, Motrin PRN.
Within 24 hours of shot, mother called, spoke with MD stating child was crying x 4 hours.
fever 104 in 6 hrs; cough & sheezing in 24 hrs; seen by MD on Amoxicillin, hosptialized 1 wk later w/severe coughing & wheezing;
Pt. to primary care Md with weakness in arms and legs.  LP done.  Being treated for possible Guillain-Barre per Dr (time above onset unknown) 10/16/09:  the neurologist-who is treating this patient. gave me the following info: This case is Level 1 confirmed GBS. The pt was given IVIG dose 1 as an outpatient and is improving.  Onset of symptoms was about 12 hours after receipt of H1N1.  Pt had no URI or diarrhea symptoms in the last month.  The pt has not been hospitalized. 10/16/09-neurology records received for date of service 10/16/09-felt weak, progressively worse with hip,  knee and other joints hurting, trouble climbing stairs, tingling of left middle three fingers. Presented with new and progressive onset of bilateral upper and lower body weakness, arms greater than legs with absent upper extremity reflexes.  Neuro exam:strength 4/5 both deltoids, finger range of motion limited in upward direction. Sensory evaluation reduced distally bilaterally. Mild tremor left greater than right with protracted extension of arms.
Rash followed by swelling at site of shingles shot. Patient applied anti-itch cream and advised to apply cold compresses.
four weeks after "my" first dose "I" have have loosestool every two to three days.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on an unknown date in Mar2021 (at the age of 70-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 18:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension, type 2 diabetes and hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) and glyceryl trinitrate (NITROGLYCERIN) on unknown dates and experienced allergy. On 12Apr2021, four weeks after the first dose, the patient experienced loose stools every two to three days. The patient reported that it was not an adverse event and he just wanted to mention that he was experiencing loose stool every two to three days after the four weeks of his first dose. He further stated that it was not an adverse event, but at his age was a concern for him. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loose stools every two to three days was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 3 vaccines Moderna 3/7/21 Lot# 030A21A;  Moderna 4/6/21 Lot# 018B21A;  Moderna 11/12/21 Lot# 033F21A
Throat and chest tightness and respiratory distress within 10 minutes after vaccine while sitting in car after vaccine.  Nurse and EMT evaluated patient who could not talk.  IM Epinephrine 0.3 mg administered in thigh.   patient monitored on site for 1 hour, symptoms resolved, and patient drove home.  She called Dr office later in the day- patient's allergist.   Another Dr was covering her Dr's messages this week while her Dr is away.
The patient was given a booster at the wrong interval and dosage. He received a Janssen vaccine on 1/6/22. A dose of Moderna at 0.5mL  was given as a booster on 1/27/2022..
Reaction to it because it contained latex; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent 2016-2017 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that 3 or 4 years ago in 2016 or 2017 got a flu shot and was not sure it was Fluarix but thinks that was the name of it and had a reaction to it because it contained latex. The patient said that she received the shot intramuscularly in the left deltoid via pre-filled syringe. The caller was the patient and did not want to share her email or date of birth.  The patient did not had a personal fax number. The patient was calling to make sure that Fluarix Quadravalent 2020-2021 prefilled syringes have no latex in them.  The patient doctor had called the manufacturer possibly GSK of the flu shot prior to giving the shot to confirm it was latex free and he was told the vaccine was latex free but they were referring to the vials not the pre-filled syringes.   The reporter wanted this information shared with GSK safety department because she believes that her doctor received incorrect and misleading information.  After that the doctor began ordering using the vials instead of the pre-filled syringes. The reporter did not want to share her MD contact name. and said that she was living in another state when she had the reaction.   No further questions were asked.  The reporter was calling from her allergist's waiting room. The reporter did not consent to follow up. The Reporter provided limited information and did not want to share her MD contact name.
27 y/o female with history of migraines, seizures, blindness s/p eye prosthesis, VP shunt for hydrocephalus presenting for intractable migraine. Patient was seen in Dr.s clinic who recommended admission for trial of DHE. Patient had admission in June/July and had occipital nerve block and trial PO dilaudid. She states that she has migraines daily but this is unbearable. She was admitted, found to have covid 19.  She was seen by ID and treated with remdeisir. Spoke with father on 8/16, patient is doing well, fiorect is helping. No respiratory issues. Parents also had covid-19. She had intractable headache was seen by neurology, Drs. She had norflex iv and headache and migraines improved significantly. She was eating well and also she ran out of her Quilipta and mothe rwas to bring in a refill. She improved and was discharged home. covid 19 isolation and precuations were discussed
Pt had Varivax on 5/6/08 - had a rxn that started on 5/7/08 up to 1 1/2"-2" by 5/18/08.  Red & puffy, no itching, no fever.
SHE WAS EXPERIENCING NAUSEA VOMITING, PASSED OUT LATER CALLED EMS AND THEY TOOK HER TO ER.
Fever-developed 8 days after vaccination papular/morbilliform rash- developed 8 days after vaccination.
malaise, low grade temp, joint pain, rash-exanthematous & swollen nodes-cervical lymph;
This spontaneous case reported by a consumer, describes the occurrence of blurred vision, oral hypoesthesia (numb nose and lips) and oropharyngeal discomfort (throat felt heavy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031B21A) for COVID-19 immunization. No medical history reported. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 31, 2021, patient experienced blurred vision, oral hypoesthesia (numb nose and lips) and oropharyngeal discomfort (throat felt heavy). The patient treated with Benadryl (diphenhydramine), paracetamol, phenylpropanolamine hydrochloride; ongoing from Mar 31, 2021, at an unspecified dose and frequency. At the time of the report, blurred vision, oral hypoesthesia (numb nose and lips) and oropharyngeal discomfort (throat felt heavy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759348A, A0759350A, A0759351A. Follow up information received on 06 January 2009 indicated that about one week after receiving Flulaval the subject developed a rash on his face which was later diagnosed as facial psoriasis. The events resolved and were not considered to be related to Flulaval.
On the evening of 4 OCT the patient developed a rash on his face that spread cephalocaudally; spared the left palm and bilateral soles; very minimal involvement of right palm. Rash was erythematous, maculopapular, and blanching. Appearance of rash was classic for measles exanthem. Patient also was fussy and had a mild runny nose. Decreased appetite also noted by parents. No other symptoms. Patient remained afebrile.
Seizure went to hospital ER, given TRILEPTAL po 60mg/mL; give 1ml po BID x 4days then 2ml po BID.