chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial Fibrillation (4 days non-stop).  Doctor administered 20mg Xarelto and 25mg Metoprolol day 3 with AF resolved within 24 hrs.  Blood pressure within normal range during episode.  Blood pressure has been resistant to treatment since AF resolved.  Increased Metoprolol to 50mg approximately 5/6/21.  Increased to 100mg 6/16/21.  Blood pressure remains elevated at average 145/97.
Patient stated she awoke Sunday December 2nd early morning with excessive body ache, nausea and headache that lasted three days.
On 11/3/99, the  pt developed large, inflamed, local swelling distal to the injection site resembling a cellulitis. The pt was seen by a physician and treated with ibuprofen and Duricef.
Work up in AM with stroke like or Beal?s Palsy symptoms.  Left half of face could not be moved.  Drooling, hard to talk or eat.  Left eye waters constantly.  Hard to blink.  Pain about 3/4? inside left ear.
having tinnitus or ringing in ears, which is continual; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 13:30 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Vaccine location: Left arm, Time at the Vaccination 13:30 , Batch/lot number: EL9265), administration date: 26Jan2021, when the patient was 70 years old, for covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "having tinnitus or ringing in ears, which is continual".  Additional information: No additional Vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient (Pt) has been having side effects since receiving the second dose Pfizer Covid Vaccine and doesn't know if related. After reading online, he thinks maybe the side effects are related. Pt doesn't know exactly when this began but was thinking within 2 weeks of second dose Pfizer Covid Vaccine or maybe even less. It began the first part of March, which would have been two weeks after the second dose Pfizer Covid Vaccine. Pt states it is ongoing and persisting. No Relevant Tests. No Emergency room or Physician office visit due to events.  No follow-up attempts are possible. No further information is expected.
Per patient on 11/20/09 started having soft/loose stools sometimes normal stools, low grade temp, perspiring, feels weak, shortness of breath. Manually uses Albuterol inhaler in morning having to use it more. Arm aches down to elbow. Receives the flu shot every year and never had a problem. Hasn't taken anything to treat the symptoms.
A reporte was received from a patient advocate on 10/10/2002, concerning a 12 year old female vaccinee who received Fluvirin on 10/10/2002. The vaccinee who is autistic was also receiving 400mg TID Seroquel and 5mg TID ayestin. On 10/10/2002, the vaccinee recieved 0.5ml of Fluvirin via the intramuscular route. Most of the vaccine accidentally spilled out onto the arm of the vaccinee. The vacciee had not experienced any adverse events at the time of the report.
headache approximately 22 hours post 2nd dose; low grade fever (100.2 degrees F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 19:30 (Lot number: FL0007) at the age of 8 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD", start date: May2020 (ongoing). Concomitant medication(s) included: FOCALIN XR ER taken for attention deficit hyperactivity disorder, start date: 01Jun2021 (ongoing). Past drug history included: Amoxicillin, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 07:30 PM), administration date: 09Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 17:30, outcome "recovered" (2021), described as "low grade fever (100.2 degrees F)"; HEADACHE (non-serious) with onset 30Nov2021 18:30, outcome "recovered" (2021), described as "headache approximately 22 hours post 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The patient had not other vaccine in 4 weeks. The patient had received other medications in 2 weeks with multivitamin. The patient had received AE treatment with 1 dose of 10m children's motrin. Patient had not been covid prior vaccination and had not been covid tested post vaccination. The patient had concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event and any drug used to treat the event or taken after event onset. The developed of low grade (100 2 F) and headache starting approximately 22 hours post the 2nd covid vaccine injection resolved with one dose of 5ml children motrin. There were no family medical history relevant to AE. There were no specific relevant test done.  No follow-up attempts are possible. No further information is expected.
no reaction for 6 days not even sore arm. 7th day wake to chest congestion. remained that wa for 3-4 days. then began night sweats and proloned hot flashes.  day 10 began nausea, worse than the cirhosiss usual nausea, and anyphysical activity beyond walking made me feel very fatigued. and at two separate time felt very light headed. after activity.   NO fever 98.5 at mid afternoon. no treatment yet. am holding steady at these symptoms for three days.
Fever - reaching 102.3 degrees between 8pm 1/31 to 3pm 2/1 Chills, aches, dizziness for 48 hours starting around 6pm 1/31  General exhaustion for about 72 hours following shot on 1/31
24 hours after 2nd vaccine, developed dizziness, nausea, fatigue, headache, and body aches. Symptoms lasted 2 weeks.
I got my shot around 11 am and by 9 pm I was feeling very tired and nauseous. I could not sleep at night and developed the chills with a horrible headache. This was also after taking tylenol. I had the chills the following day and could not leave my bed. I slept the whole day and did not have an appetite. I was also constantly checking for a fever and did not have one, but I still had chills. My symptoms were almost gone by 9 pm of the next day. On the second day, I have neck pain on both sides of my neck. It is bearable but still there. I am otherwise healthy and have not been sick at all within the last year.
Hearing loss in left ear and tinnitus.  Went to urgent care (May).  Follow up with primary (July).  Referred to Audiology (July).  Referred to Otolaryngology (Aug).  Had MRI of ear (Oct).  Had Electrocochleography (Oct).  Recommended hearing aids for hearing loss (Nov).  Received hearing aids (Jan).
There were no adverse events. Patient was not in the age group authorized to receive the Moderna booster.
Sudden onset of rash in upper and lower body. No fever with the onset of rash.
Seen in office 9/18 with 3 day hx of fever and rash. Fine blanching red macular rash on trunk and neck. Left thigh with red slightly indurated area about 1 cm. Provider felt it was MMR reaction. Called parent on 9/22; rash improved, afebrile.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of sterile water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Child received Menactra Hep A in right deltoid on 5/20.07. The next day developed a rash and swelling at the injection site. No temp.
pt recv vax 21AUG95 on 25AUG95 mom reports hives on lower extremities; began 25AUG95 AM; treated w/cool compresses & DPH; mom also states had hives on wrists, elbows, cheeks;
Fever of 104 Extreme tired Swollen and very sore Lymph Nodes under left arm  I took Tylenol for fever and pain
17 year old male received first dose of Moderna Covid 19 vaccine at Clinic on 3/11/21.  We completed the series with his second dose on 4/9/21, labeled as "off use", and a VEARS report needed to be completed with vaccines provided to person under the age of 18 years.
Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick".  she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>
lipschutz ulcer 10Dec2021, one day after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left), administration date: 18Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: LIP ULCERATION (non-serious) with onset 10Dec2021, outcome "recovering", described as "lipschutz ulcer 10Dec2021, one day after second vaccine". The event "lipschutz ulcer 10dec2021, one day after second vaccine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of lip ulceration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: withheld. Pain management treatment received for the adverse event. Device Date: 15Dec2021.  Follow-up attempts are completed. No further information is expected.
Developed constant band like burning around upper abdomen; Radiating pain around ribs / left chest under arm and radiating to upper back / bilaterally; Light itch with clothes or fingers worsening; Worsening with touch; HCP says / Post herpetic neuralgia; This case was reported by a nurse via sales rep and described the occurrence of burning sensation in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2020, the patient received the 1st dose of Shingrix .5 ml. On 22nd November 2020, 2 weeks after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced burning sensation, pain, pruritus, tenderness and post herpetic neuralgia. The patient was treated with acyclovir and tramadol. On an unknown date, the outcome of the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the burning sensation, pain, pruritus, tenderness and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of 0.5ml shingrix on 22nd November 2020 at left arm. Patient developed constant burning around upper abdomen with radiating pain around ribs. After 2 weeks patient noted light itch with clothes and fingers worsening, pain moved up to left chest under arm and radiating to upper back bilaterally; again burning sensation and worsening with touch. Patient had CT scan abdomen which did not show anything, also had cardiac catheterization showing no significant obstructive cad, while ECG was normal. Patient had been on cymbals now, Acyclovir did not help for patient, Tramadol worked for pain. Hcp reported that his pain resembles post herpetic neuralgia .  No presentation of vesicles and never hospitalized. Symptoms still present and constant.  No other vaccines given same time or since admin of shingrix.
Pt experienced itching after receiving influenza vaccine inadvertently. The intended vaccine was tuberculin. Itching resolved within 24 hours.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided        Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.
Headache, Fever, Diarrhea, Tired, Chills Narrative:
The following day, 12/23/20, I kept feeling like I was having brief waves of anxiety, with nothing to be anxious about. The anxious feeling kept occuring, but it wasn't until a week later than I realized that each time I felt that anxiety, my heart was actually palpitating.  I had a 12 lead EKG done via local EMT to confirm that it was actually happening, then made an appt with a local cardiologist.  Stress test, cardio sonogram, and 24 hour heart monitor tests were completed on 1/13/21.  My follow up is on 2/3/21.  Fortunately, I have not felt a palpitation since 1/10/21.
This non-valid spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD, GARDASIL 9, ROTATEQ, PNEUMOVAX 23, all for prophylaxis (lots# and expiration dates were not provided). PROQUAD was reconstituted with improperly stored sterile diluent (manufacturer unknown). No adverse effects were reported. Temperature and time frame of the excursion were not provided and there was no previous excursion. The digital data logger was involved. Follow up information has been received from the nurse on 16-JAN-2019. Lots# and expiration dates for the improperly stored vaccines were provided. PROQUAD lot# non valid reported as N55860, expiration date reported as 02-MAR-2018, excursion date: from 05-JUL-2017 till 29-JUL-2017) (temperature of excursion (T) ranged from 36 to 46 degree Celsius for 1.5 to 12 hours (h)), lot# R008196, expiration date: 16-SEP-2019 and lot# R012416, expiration date: 28-OCT-2019, excursion dates: from 02-JUL-2018 to 03-OCT-2018, T 9-10 degree Fahrenheit for 2-25 h), lot # non valid reported as E98765, expiration date reported as 01-JAN-20XX (T 6-14 degree Fahrenheit for 3 days, and 47 to 77 degree Fahrenheit for 2 h) administered on an unknown dates. GARDASIL 9 (lot# non valid reported as H12345, expiration date reported as 04-JUL-20xx, T 68 Fahrenheit for 1 month), lot# non valid reported as K08421, expiration date reported as 12-SEP-2018, excursion date: from 01-JUN-2017 to 18-JUL-2017, T range from 28 to 33 degree Celsius, for 0.5 to 8 h) vaccinated on 05-JUN-2017, 08-JUL-2017 and 22-JUL-2017, lot# R017134, expiration date: 29-APR-2021 (excursion date: 31-OCT-2018, T 34 degree Fahrenheit, 8 h), lot# R020947, expiration date: 04-MAY-2021 (excursion date: 31-OCT-2018, T 34 degree Fahrenheit, 8 h) and lot# R017457, expiration date: 10-APR-2021 (excursion dates: from 02-NOV-2018 to 19-DEC-2018, T 33-47 degree Fahrenheit, 5-8 h). ROTATEQ (lot# N030996, expiration date: 08-SEP-2019, and lot# R012957, expiration date: 11-JUN-2019, excursion dates: from 31-OCT-2018, to 19-DEC-2018, T 33-47 degree Fahrenheit, 5-8 h. PNEUMOVAX 23 (lot# non valid reported as G67891, expiration date reported as 31-DEC-20xx, T 22 degree Fahrenheit for 3 h), (lot# R027299, expiration date: 09-APR-2020, excursion date: 19-DEC-2018, T 47 degree Fahrenheit, 8 h), (lot# R011632, expiration date: 02-FEB-2020, excursion dates: 02-NOV-2018, T 33 T 33-47 degree Fahrenheit, 5-8 h, 5h and 28-NOV-2018, 47 T 33-47 degree Fahrenheit, 5-8 h, 8h). The patients were also vaccinated with improperly stored ZOSTAVAX, lot # non valid reported as E34567, expiration date reported as 28-FEB-20XXm T 6-14 degree Fahrenheit, for 120 h) on an unknown dates. The primary reporter nurse confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored (considered as concomitant therapy).
Local Reaction - 2 blisters formed near injection site. Given Triamcinolone cream 12/19/16. D.S% apply TID.
vaccine administered on 5/18, rash started 5/25. red raised rash to torso, b/l arms and legs and neck
Site Swelling and redness 3 days prior to onset of rash/hives on Torso, Neck, Face, Arms, Diaper area.  Treatment as prescribed by physician is 1/2 tsp of Children's Zyrtec two times daily for 5-7 days.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that shingles vaccine made him/her just a little sick, but he/she would put up with the sick than actually having the shingles. Follow-up would not possible as no contact details were available.
nausea reported after injection given (within 4 mins). patient had ondansetron at home and took 1 pill. patient was instructed to take another dose in 6 hours if need, per instructions on prescription. After 15 minutes of observation, patient told nurse that nurse can leave he is alright.
Pod 3 Patient experienced blurred vision and dizziness, Patient experienced syncope but was caught by a vaccinator. Gave oral fluids and crackers in med observation 1. Took vitals on patient at 4:40 pm heart rate 75, o2 98, BP 104/62. Patient was feeling better and we released him at 4:48 pm by himself.
Two unexplained fevers two weeks apart, Chills resulting in massive body shaking, Temp just below 100. The temp started in the evening, lasted through the next day, broke the next evening. Came on unexpectedly, felt fine after the fever broke except for fatigue and some dehydration. After first fever I went to the Urgent Care for a Rapid Covid test. The result was negative. Two weeks later when the fever showed up again I made an appointment with my family doctor. Due to some acid reflux problems she is sending me to a gastroenterologist. No explanation for fever.
Pt. rec'd vac DTaP on 10/15/12 at OV. Mom called 10/17/12 and stated quarter size red raised hard area at site of vacc. inj. - mom advised cool compress 10 min at time, MOTRIN if needed, 1% hydrocortisone cr for itching.
Lower extremity tingling sensation same night and sporadically over the next 2 days. Then started progressing to heavy legs, numbness, tingling/pins & needles, and pain. While running on 4/5/21, my right foot got numb. Symptoms present all day, nonstop.   Other symptoms experienced: muscle pain, fatigue, headache, diarrhea. All, except fatigue, have now subsided.
Pt developed welt on forearm, redness and tenderness at the site.  It lasted for about 30 mins and no other symptoms.
Rash to ABD & face 20 min after inj.  30 min. after rash appeared man gave BENADRYL apx. 3 tap.  Last night pt felt warm to touch.  Pt with c/o of nausea-dizziness + vomit.  Rash subsided 15 min after BENADRYL given.  Pt still has rash this AM again BENADRYL given- Pt ok.
Pt was admitted to HCF with Carotid artery stenosis on 4/5/21 after getting the second dose of vaccine on 4/1/21
VACCINE WAS LEFT AT ROOM TEMPERATURE FOR APPROXIMATELY 4 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAY-2021, the subject experienced vaccine was left at room temperature for approximately 4 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was left at room temperature for approximately 4 hours after first puncture was not reported. This report was non-serious.
breakthrough case w/ cough fever, likely complicated by underlying COPD, thigh abscess, cellulitis and sepsis
Very sore upper left arm (Injection site)  about 12 hrs. later  chills, fever, body aches, very tired  lasted full day
Soreness of shoulder girdle muscles, progressive weakness of deltoid, biceps, and triceps muscles.  Tenderness of above muscles plus trapezius of right.
Fever (100.7), chills, nausea, diarrhea, swelling at the site of injection, redness, and itching.