chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came up to immunizations 10 min after receiving the covid pfizer vaccine, complaining of dizziness and chest tightness. Member was told to lie down, while a provider was being called. The patient refused to lie down and started being verbally combative and undressing herself. A provider was brought to the room and managed to calm the patient down. Patient was transported to the ER due to her chest tightness, with suspected panic attack.
Patient observed by RN to be having slight distress. Pt taken to observation gurney and assessed. Complains of lightheadedness and no pain or other symptoms.  13:47 Vital signs  BP 128/76 Pulse 65 02 99%  Water and crackers given to patient and she states she is feeling better. Husband is with patient and states he will drive her home.   14:04 Pt left with husband with no distress and states she feels fine. Patient discharged from nursing care.   Electronically signed by: RN 2/1/2022 2:05 PM
On 12/13/2021: It started with a stuffy, runny nose and sneezing. No fever
Pt started feeling some pain in the left arm radiating bilaterally till the wrist, felt some numbness and burning sensation. Went to the Dr, told her that she shouldn't have gotten it that day as the pt was having muscle stiffness and tenderness, gave the pt some ibuprofen, told it might go away in few days till 3 months.
9/1/11 - PENTACEL & Flu vaccine in Rt thigh. 9/2/11 - local reaction 3 cm redness around combined injection site - slightly warm. Per dad - redness has reduced in size since this AM.
Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient was given a Dtap and should have gotten Tdap. parent was notified and child had no symptoms.
no adverse event; Inbound call transferred from specialist received. called to report expired administered VAXNEUVANCE. Caller was on delayed hold while sought guidance; agreed to returned call with additional guidance for expired administered vaccine. ; This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAY-2023, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #U036156, expiration date: 25-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).  No additional adverse event (AE) or product quality compliant (PQC). Inbound call transferred from specialist received and called to report that expired administered pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). Caller was on delayed hold while employee sought guidance; agreed to returned call with additional guidance for expired administered vaccine. Complete AE details not received at the reporting time.  The causality between the event and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.
pt limp & lethargic for several days following shot; did not sleep or eat good for several days;
At the time of the shot, it was extremely painful- unlike the previous ones.  The technician said he must have hit a nerve.  I felt very bad the next morning to the point of almost feeling faint, broke out in a sweat.   Within about 5 days of the 4th shot, I began having a change in stools.  They became smaller, looser, sometimes do not hold together.  On occasion- diarrhea. This is a very different status from normal for me.  A return to pre-last booster has not occurred yet.
A nurse reported that a pt received vaccine on 3/10/2000, later that night she experienced a reaction to the injection site, characterized by redness, heat, bruising and induration. Pt self treated with warm soaks. The physician treated with ice applications and ibuprofen. Follow-up info received from the reporter on 01/25/2001 indicated that the pt recovered.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Lymph Node Swelling-Medium
This subject is an eight month old female, who was admitted to the hospital due to right cerebellar mass and 3rd and bilateral ventricular enlargement while enrolled in a Safety, Immunogenicity and Lot Comparability of CPDT Vaccine Absorbed When Administered with Other Recommended Vaccines at 2, 4, 6, and 15 to 16 months of age, Protocol Number P3T06. The subject received three doses of study vaccine; the last dose prior to the event was given on 6/25/02. The subject developed vomiting and became lethargic and was admitted to the hospital 54 days post immunization. She was found to have right cerebellar mas and 3rd and bilateral ventricular enlargement. The event of right cerebellar mass and 3rd and bilateral ventricular enlargment was reported by the investigator as unrelated to the study vaccine. Discharge summary and reports from the investigations done in the hospital have been requested by PPD. From additional information received on 12/11/02 from PPD, it was reported that this patient was hospitalized secondary to vomiting and was later diagnosed with ependymoma. The treatment options for this child are systemic chemotherapy. On 8/18/02, the subject was admitted to the hospital after three weeks of vomiting, lethargy, and progressive head tilt. Treatment included ventriculostomy with externalized drain for decompression. The subject was taken to surgery on 8/23/02 because of an acute development of the left sixth-nerve palsy and agonal respirations. Since surgery, the course has been complicated by a failed swallowing study, therefore, a Gastro-tube was placed without a Nissen fundoplication. The subject developed aspiration pneumonia on 9/1/02 and the treatment included clindamycin and Reglan. The subject has also experienced a small gastrointestinal bleed. The subject was given chemotherapy since this hospitalization and has had to be re-hospitalized several more times due to complications of the underlying ependymoma. From additional information received on 2/5/03 from PPD it was reported that this 13 month old subject who was previously diagnosed with ependymoma recently expired secondary to aspiration. This subject had been on experimental chemotherapy and was given a very poor prognosis. From additional information received on 2/13/03 via a MedWatch from PPD it was reported that this 14 month old subject experienced aspiration requiring hospitalization. On 2/2/03, the subject aspirated at home. Paramedics were called to the home. The subject was taken to the hospital where she was pronounced dead on arrival. On 10/9/03: As per investigator's site, no additional information is expected, therefore this case is considered closed.  Follow up on 10/22/2003: "On 10/09/2003: As per investigator's site, no additional information is expected, therefore this case is considered closed.  On 10/14/2003 a new version was created to correct latest received date to 10/09/2003." Discharge Summary received on 10/22/2003 states cardiac arrest. Medical records received on 10/22/2003 states hydrocephalus.
COVID + on 2/12/22. Had been previously admitted to hospital from 2/22-26 for COVID pneumonia. Discharged on doxyxyxline and prednisone. Admitted opn 3/10/22 for hypoxic respiratory failure. Had completed previous medication and had started having symptoms again 3 days prior to admission.  Treated for multifocal pneumonia with broad spectrum antibiotics and steroids.  Progressive decline in respiratory failure  with intubation and ICU care. Extubated  4 days later, but again continued to remain on max Vaptherm. Highly suspicious for  post covid organizing poneumonia. Patient and family decided on DNR status. Further decine in his work of breathing and given comfort care.
Pfizer vaccine was administered outside of our facility - reported by patient  J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/31/2021 ACUTE EXACERBATION OF COPD
This spontaneous report as received from a nurse who was also a patient's mother refers to a 19-year-old male patient. The patient had no pertinent medical history, drug reactions, or allergies. His concomitant medications included prednisone (manufacturer unknown). On 24-AUG-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided). On 27-AUG-2017, the patient experienced developed hives all over his body the size of a coffee saucer, chest tightness and throat swelling. On the same day, the patient went to emergency room (ER) and received 1 dose of epinephrine, BENADRYL, and an unspecified steroid. On 28-AUG-2017, the patient went back to the ER because his eye was swollen shut and he developed new hives around his ear. He received intravenous BENADRYL, intravenous unspecified fluids, and an unspecified steroid medication. The patient was not hospitalized and had no laboratory diagnostic studies performed. On an unknown date in 2017, the patient recovered from all adverse events. The relatedness between the adverse events and GARDASIL 9 was not provided. The reporter considered the adverse events to be life threatening.
Hot flash and lip swelling. lips did not appear swollen, No other symptoms. drank water and symptoms improved. refused transport. observed transport for 30 minutes.
Shortly after receiving the shot, I began to get phantom smells. I smelled a perfume that smelled like laundry detergent, natural gas, and smoke/burning. I do not have natural gas at this house, which is why I felt this was a strange thing to smell. The phantom smells lasted about 1-2 hours, coming and going, and afterwards my sense of smell was almost diminished. I could smell some, but it felt like 90% of my sense of smell was gone. I could not smell soap, hand lotion, or any of the normal scents in my home. This lasted for about 24-36 hours. I had the typical side effects that I'm used to with covid shots/boosters on 9/14 (body aches, headache, flu, fatigue) as well as the new issue with smell. When I woke up on 9/15, my sense of smell had fully returned and my other symptoms were gone. I did a home test to make sure I didn't have covid since losing smell wasn't listed as a side effect, and my test was negative. I have not had any issues since.
Bone pain two days after vaccination that lasted a week/general bone pain; severe peripheral nerve pain; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular on Jul2021 as dose 2, single for covid-19 immunisation. Medical history included known allergies: Salmonids and known allergies: juniper. The concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162b2 on 22May2021 for covid-19 immunization. On Jul2021 the patient experienced bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The treatment received for the adverse event was Medrol pack. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The outcome of both the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4/15 5:00pm: headache and confusion  4/15 8:00pm: fever, chills, body aches  4/15 11:00pm: Nausea
pt recvd vax 28JUL94 & went home to be slept for around 5 hrs; mom went to check on pt & pt was blue & limp & pale & unresponsive was taken to ER & seen by MD;
Local allergic reaction at site of injection immediate onset. Treated with 50mg of BENADRYL.
pt recvd vax 10OCT95 & exp local swelling, redness, pain-severe;pt almost went to hosp-probably should have w/severity pt described;returned to office 12OCT95 & sxs improve but still very apparant; checked by MD
APPROXIMATELY 3 HOURS AFTER RECEIVING THE VACCINE,  RECIPIENT STARTED ITCHING IN HER EXTREMITIES. SHE INFORMED THE NURSE AT THE DESK WITH HER AND THE NURSE NOTED THAT RECIPIENT HAD WELPS FORMING. RECIPIENT TOOK AN OTC ANTIHISTAMINE (CLARITIN). BP WAS NOTED TO BE HIGH (194/104), RECIPIENT STATES SHE DOES NOT HAVE HTN, SHE WAS ANXIOUS ABOUT THE WELPS THAT WERE DEVELOPING.  RECIPIENT DENIES ANY RESPIRATORY DISTRESS OF ANY KIND. STATES SHE MET WITH AN MD  (PRESUMABLY THE MEDICAL DIRECTOR AT FACILITY) WHO TOLD HER TO TAKE A BENADRYL WHEN SHE GOT HOME, WHICH SHE DID. SHE IS BACK AT WORK TODAY AND STATES THAT ALL SIGNS/SYMPTOMS OF A REACTION ARE GONE. BP WAS NORMAL THIS AM AND THE WELPS /HIVES SHE DEVELOPED YESTERDAY HAVE SUBSIDED.
patient woke up next morning with cold sweats and headache. also had swollen arm, red bullseye around shot spot, blurry vision and metallic taste in mouth
Couldn't swallow. Pt's "throat" was closing. Had to go to ER for anaphylactic event. Given SOLU-MEDROL, BENADRYL, Cortisone, ZANTAC, PEPCID, Prednisone. Was able to leave ER around 1 AM.
fell asleep while working after Covid until her 2nd dose of vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19 Positive" (unspecified if ongoing); "Severe fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "fell asleep while working after Covid until her 2nd dose of vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started upon rising from sleep on morning after vaccine.  Very dizzy, needed help to bathroom, began dry heaving, did not feel sick to  my stomach.  Dry heaved 3 different times, then vomited 2 times.  Still Dizzy.  My roommate called ambulance and  I  had just finished vomiting as they  arrived.  My blood pressure was 227/70.  They monitored me for a while until my blood pressure was at 160/72.  I opted not to be taken to the hospital at that time.  I ate a slice of toast, which stayed down, them took my morning medications.  They also stayed down.  I had liquids all day and some crackers.  Was dizzy all day. Blood pressure before retiring was 150/74.  Slept well last night and am still a little dizzy yet today, but appetite has returned.  Blood pressure is now 135/74.  which is about my normal.
pt rcvd vax; pt exp numbness & tingling in fingers of inject arm; inject site was swollen, painful, throbbing & warm to the touch;
c/o pain and erythema at the base of posterior scalp.  no tenderness with palpation.  full rom of neck, recommend ibuprofen
This spontaneous report as received from a registered nurse refers to a 64 years old female patient with penicillin allergy and with a history of localized reactions to vaccines (names unspecified). The patient was vaccinated subcutaneously in arm with a single 0.65ml dose of ZOSTAVAX (Lot# 671786/0254AE) on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient experienced an injection site reaction. The patient developed "a rash that went from the injection site on her arm up to her neck". The patient had reported this to the office but there was no emergency room or doctor's visit. No lab diagnostics studies were performed. The patient took some ibuprofen and was using cold compresses for treatment. At the time of this report the patient's status was not known. Additional information is not expected.
Red swollen welt approximately the size of a silver dollar around injection site.  Hot and sore to touch.  Advised patient to take Ibuprofen and Diphenhydramine OTC, and add ice to the injection site to reduce pain and swelling.  Also told patient to see her physician if no improvement within 2-3 days.
Information has been received from a pharmacist concerning his 77 year old father who on 14-AUG-2007 was vaccinated with a 0.5 mL SC dose of varicella virus vaccine live (Oka/Merck). On 19-AUG-2007, the patient developed tingling to the eye and skin around the eye. Unspecified medical attention was sought. Additional information has been requested.
My wife is having fever, feeling cold, sore throat, headache. We don't know if she should visit Dr.'s office or emergency room ?
There may have been a break in the cold chain storage of the vaccine upon arrival.  We reached out to pfizer and got an incident number.
Pain in left testicle; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Mar2021 08:00 (Batch/Lot Number: En6199) as single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL), chronic obstructive pulmonary disease (COPD), diabetes. The patient had no known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. No Covid prior vaccination. The patient had not tested Covid post vaccination. The patient experienced pain in left testicle on 14Mar2021 11:00. No treatment received for AE. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a registered nurse via a company representative referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (strength, dose, lot #, expiration date and frequency were not provided). Concomitant therapies were not provided. The registered nurse also reported that no adverse effects occurred. Additional information has been requested.
Employee came to Employee Health due to redness, swelling and aching of the left arm. Verbalizes swollen glands under left arm and fever of 100.7. Instructed to take Motrin and apply heat for not more than 20 minutes at a time.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had four temperature excursions: 24, 48, 16 and 24 hours respectively. The lowest recorded temperatures were 34 (-1.111111111 Celsius degrees), 32 (0 Celsius degrees) and 33 (0.555555556 Celsius degrees). The highest recorded temperature was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Child's arm became swollen, tender and flushed. Bicep circumference (left) where KINRIX was given was 22 cm, compared to 17 cm on the right side. Child also developed cellulitis and is being treated with antibiotics.
The patient is having a should pain that has persisted for several weeks after initial vaccine.    It is possible that the vaccine may have been too high and caused a bursa injury.   They have not done a follow up with a primary doctor.
This spontaneous report as received from a licensed practical nurse refers to a 12 month old male patient with amoxicillin allergy and no pertinent medical history. On 18-DEC-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (route, dose and frequency unknown) and the first dose of M-M-R II (route, dose and frequency unkown). Concomitant therapies included ZYRTEC and albuterol. On 20-DEC-2014, 3 days after onset of therapy the patient experienced the Flu and ear infection. The patient first developed a low grade fever, which progressed to cough and a runny nose prior to "testing positive" for the Flu. The patient developed vomiting and diarrhea after taking amoxicillin (manufacturer of amoxicillin unknown). TAMIFLU, TYLENOL, ibuprofen and OMNICEF were given to treat the adverse event. The patient sought medical attention via office visit. The outcome of adverse events was reported as recovered/resolved. Additional information has been requested.
Redness of lower portion of upper arm, swelling and increased heat.  Initally entire upper arm, after 2 days has decreased to lower 1/2 of upper arm.  Started evening of injection.
rash, high fever, diahhrea 1/27/2010 Autism Spectrum Disorder
Patient returned to Urgent Care 6 days after administration stating that hardness, redness, swelling, warmth to area she received her tetanus immunization has increased daily since 2 days after receiving immunization.
I had been experiencing slight intestinal/abdominal discomfort for a week, continuing to increase during the few days prior to the acute event.  In the middle of the night, while trying to sleep, I was woken by intense and painful intestinal pain and cramping, followed by severe diarrhea and nausea and vomiting,  I also had a temperature of 100.5.  My chest and torso broke out in a red rash.   The temperature subsided after a day, and the severe diarrhea and vomiting subsided; yet the diarrhea continued.   The red rash continued for three days.     I had not eaten any different foods, nor had I gone anywhere out of my house , and did not have any visitors, since I had the J&J vaccine.