chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delirium episode, 3 days at home with wavering orientation and no self-care, the 3 days in emergency room, and 5 days in hospital recovering.  Started with erratic behavior, then progressed to disoriented and confused.  Recovered enough on Aug 4, 2021 to call 911 and self-report.  Recovery was completed without additional medication.  Likely cause was reaction to pramipexole.
My menstrual cycle came late in April (5weeks); My menstrual cycle came late in April (5weeks) and then I had another cycle 2 weeks later and it lasted 13 days; My cycles have been very irregular since; I became pregnant in June and miscarried; This is a spontaneous report from a contactable consumer (patient). A 38 years old female patient received the second dose of BNT162B2 (Batch/lot number: EN6205) at right arm for COVID-19 immunisation on 30Mar2021 at 15:30 (38 years old at the time of vaccination). The patient was not pregnant at time of vaccination. Relevant history included Hashimitos, hypothyroidism, and allergies: Bactrim, adhesive, wasps.  Relevant concomitant drug included Armour Thyroid, multi-vitamin. The patient previously received the first dose of BNT162B2 (Batch/lot number: EN6202) at right arm for COVID-19 immunisation on 09Mar2021 at 15:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's menstrual cycle came late in April (5weeks) and then she had another cycle 2 weeks later and it lasted 13 days. Her cycles had been very irregular since 22Apr2021.  The patient became pregnant in June and miscarried. The outcome of events was unknown.  The patient had visited the doctor or other healthcare professional office/clinic visit.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.    Follow-up attempts are completed. No further information is expected.
Eight days after the vaccine, I noticed in the morning a large red rash around the injection site.  I had not had it before.  The site was initially sore (minimal) after the injection and then no more until the rash showed up.  It was sore, but not excessive.  The rash was about 4 inches  (height) by 3 inches. All of it seemed to be slightly raised.  It itched some, but not excessively.  I did not apply any thing to it, but I did take some Tylenol.  In the evening on the ninth day, the rash was fading some.  It is day ten and it is definitely less.  The area still has soreness and seems more firm around the injection site.  Other than this rash and sore arm, I have not had any other responses to the vaccine.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006064:
17 YO / was administered / adult vaccine instead of the / pediatric vaccine; 17 YO / was administered / adult vaccine instead of the / pediatric vaccine; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received HAV (Havrix adult) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Havrix adult. On 26th July 2021, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The nurse reported that the 17 year old patient received Havrix adult, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Pt developed a high fever and extreme fussiness about 2 hours after being vaccinated. Fever range was 103.4 degrees F to 99 degrees F (today).
Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius; No adverse event; Patient received primary Monovalent doses from red cap vial that experienced excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent doses from red cap vial that experienced excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent doses from red cap vial that experienced excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent doses from red cap vial that experienced excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent doses from red cap vial that experienced excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius).    No concomitant drug was reported. Excursion occurred in the refrigerator on 03-OCT-2022 involving 1 unpunctured Red Cap Vial. Excursion Duration was: 1 Hour and 40 Minutes. Reporter further stated that it was the first time those vials experienced excursion. Currently none of those vials were stored, some were used and some were discarded. No treatment drug was reported. This case contains information for the 3rd of 3 adult patients (received Monovalent primary doses) described by the reporter.
Patient developed lower L leg and ankle pain 12 hours after vaccine was given.  Described as tingling pain.  Very sore to touch.  No fever, leg swelling, color change.
No additional AE; Improperly stored dose was administered; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 01-FEB-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot number: T013205, expiration date: 03-DEC-2021 (strength, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 48 (unit not reported) for 24 hours and 45 minutes. Digital data logger was involved. There was no previous temperature excursion noted. There was no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient me is a physician. I received third moderna vaccine for covid. Within 48 hours I had rigors severe muscle and joint pain. Weakness. Inability to stand. Severe sweating, chills  I then had atrial fibrillation requiring cardio version. I then developed global amnesia  and new onset hypertension of 150/100 and fast resting heart rate ( sinus rhythm).  I was hospitalized twice.  Once at  hospital.   Once at another hospital.    I  improved but continue to have high blood pressure  and fast resting heart rate of 80
The pt developed a short dry cough making him short of breath, no wheezing and no rash. Diaphoretic with flushed warm cheeks. Epinephrine given per protocol. The pt immediately felt relief, coughing stopped, breathing easier, flushing disappeared. Vital signs monitored. Blood pressure was elevated before and after epinephrine. Paramedics called and child treated at hospital.
Woke up with body aches, head ache and slight nausea.  Symptoms lasted thru the day after the shot and into the following day.  Still a little tiredness in to the second day after the shot.
She completed Moderna vaccines in May, 2021. She came to Hospital ER due to fall on 10/25/2021. She was admitted for backpain and interaticularis fractures. She was tested COVID PCR for skilled nursing facility placement screen purpose, and it resulted in positive on 10/27/21. She has been asymptomatic.
Headache that did not dissipate with normal migraine meds or 1000 mg Tylenol. Fatigue. Brain fog, poor ability to concentrate and word find, almost slurring words. Dry, wheezing cough. Shortness of breath.   All acute symtpoms began 4 days after injection, lasting 24 hra. Wheezing, dry cough, and shortness of breath are now lingering
Rash at site injection site Rt upper arm (plue) and (L) FA.
Felt dizzy and nauseous, very tired went to sleep for several hours.  Didnt feel like eating and had a headache.  Injection site very warm and reddish. Went to bed and woke up at @1:30 AM with excruciating pain in arm..took asprin..very woozy and delirious..had vivid nightmares..arm very very painful...put cold pack around arm and fell asleep.  Did not wake up until about 9:30 AM 09/29/2009..knuckles hurt, knees hurt,hips hurt injection site lobster red and swollen felt feverish, no temp. redness appeared to wrap around arm...couldn't stay awake went back to  bed and slept 3-4 hours..called health dept. they were to call back. Felt worse as day progressed. 09/30/2009..fainted when making coffee,felt horrible, called health department.  P.A. called back in afternoon and said drink fluids, take tylenol and alternate with ibuprofen..ice packs only (Ihad asked about heat)..keep eating and monitor temp.None to date.  Checked back w/health dept. next day left message and no return call. This is 10/03/2009 and I am really starting to feel human again. Redness completely gone from site, but I still am experiencing some joint pain, hardness at site and solar plexus pain.  I think I am going to live...it really felt like the Flu I experienced 3 years ago, but the P.A. said it probably wasn't the Flu vaccine, it was the PPSV. Thank goodness you only get it once every 5 years.
25AUG98 vomited, became limp, pale-gray, altered level consciousness, dropped 02 sat, vomited again, apneic x 20sec;no overt sz seen;lasted approx 2hr then recovered;
Pt received only 1 primary dose. Booster given on 10/26/22
Information regarding Prevnar vaccine injection was received from a consumer regarding a 12-month-old patient who experienced petechiae all over her body and elevated liver enzymes. At 12 months of age, the patient received the first dose in Nov-2005. The patient's concurrent illnesses includes von Willebrand's disease. She was adopted (from China); there are no known allergies, no history of abnormal blood work prior to adoption and no history of blood transfusions. Indication for Prevnar was immunization. Product was administered in Nov-2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medication were not reported. The patient's mother reported that the patient developed generalized petechiae (petechiae) after receiving her first dose of Prevnar in Nov-2005. She also noted that the child's liver enzymes elevated (hepatic enzyme increased) after this dose. The petechiae resolved; the outcome of the increased liver, enzymes is unknown. See related case(s): HQWYE166406MAR06 (adverse event, expedited). No additional information was available at the time of this report.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm) and ERYTHEMA (redness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported.   This case was linked to MOD-2021-315988 (Patient Link).
Pt had fever to 104 and bulging fontanelle.  Fever may have started 1/23 pm or 1/24, but went up to 104 on 1/25 and only on 1/25 did mom feel that fontanelle was bulging.  Pt went to ER, where blood, urine, and csf were obtained.  pt had cbc w/ wbc of 8.6, hgb 11.5, plts 182, w/ 34N 1B 50L 14M, and was sent home to f/u the next day.  She was still fussy for the next couple of days, but now (1/30/04) has returned to baseline, eating well, normal activity level and mood. of note, pt's blood and csf cultures remained negative.  urine grew 3000 c/hpf strep milleri on cath specimen, and pt was called and started on omnicef.  today, ID fellow contacted and recommended stopping omnicef, as believed to be a contaminant, and to repeat Urine cx 2/2/04.
In March 1993, pt experienced repetitive behavior and playing without imagination. In June and July 1993 the pt experienced lack of communication. In October 1993, the pt experienced flu and vomiting. In December 1992 the pt experienced echolalic speech, lack of bowel control, and chronic soiling. The pt experienced upper respiratory tract infection in February 1994, September 1994, October 1994, November 1994, February 1995 and June 1995. In December 1994 pt experienced temperature, earache and diarrhea. In July 1995, pt experienced enteritis. The pt also experienced chronic constipation. Autism was diagnosed in 1996. The autism was considered a significant medical event. No further info is available.
Tachycardia/palpitations in 160s - EKG not done Chest pain  Numbness/tingling both hand and both legs Hot/cold   Lasted for about 25-30 minutes.    Exact same symptoms re-occurred 2 weeks later
Tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Em9809) via an unspecified route of administration in the right arm on 28Feb2021 at 09:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021, the patient experienced tinnitus in both ears, it was reported that the patient did not have any noise exposure. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient had received any treatment for the event experienced. The clinical outcome of the event tinnitus was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed a red rash on left arm where vaccine was received (3/10/21). Started 24 hours after receiving vaccine. Patient reported this to me on 3/13/21. Still had rash.
Right upper arm and right inner thigh muscle pain till now, already more than 4 months. And Diarrhea most days.
About 1 hours after shot given, arm started (aching whole arm) and up into neck, site of where shot was given, was red and hard knot (2-3 inches) arm and neck ached all day Saturday, seemed somewhat better, but still had large, red, knot. Accidently rubbed arm against clothes dryer and arm, neck, and back around left shoulder blade started hurting like a stiff neck, used icy hot and heating pad on back and neck helped a little. Neck, back and arm are still hurting today, but a little better.
Got second dose 20 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On 14th November 2022, the patient received the 2nd dose of Shingles vaccine. On 14th November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The nurse reported that the patient received the second dose 20 days earlier. Additional Supportive Information: The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
suspect bowel obstruction/ septic Narrative:  Pt was admitted to ICU with a suspected bowel obstruction / possible sepsis 2/1/2021, Vaccine was administered 1/6/2021, Moderna Lot 039K20A Exp 6/20/2021.
Shortness of Breathe, possible heart palpatations on Saturday morning--subsided at 4:00am  and began again at 11am on Sunday 12/06/2009 this time with sweating, no fever, no palpitations but shortness of breathe in the throat region--higher up than on Sat. am
Immunization was given in Left arm SQ. Next day area swollen, per staff, approximately 4" x 3". Youth c/o itching at site along with pain. Youth was given an ice pack along with Ibuprofen and staff monitored.
Vertigo 4:25AM 3/18/21 After hours call to primary  Prescribed Valium
After receiving the vaccine, I developed a constant dizziness that has persisted for 28 hours now. Injection 3/31/21 15:00 This report 4/01/21 18:30
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication was not reported. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (lot # R004689/expiration date: 29-NOV-2020) via intramuscular (dose, unit, frequency, anatomical location: unknown) for prophylaxis. On 28-MAR-2019, the reporter informed that the patient received two doses of GARDASIL 9 (extra dose administered). It was reported that there were no adverse effects at the time of reporting (no adverse event).
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I am experiencing muscle spasms, muscle twitching, extreme restlessness, muscle tightening, all over my entire body. All of which began the very next day after I received the Hep A vaccine. My doctor is treating these symptoms with restless leg medication "Pramipexole." It has subdued the symptoms slightly.
the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing/ another friend, she told the same way; the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing/ another friend, she told the same way; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend) with unspecified age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration at arm on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported another friend, she told the same way that the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing in Jan2021 with outcome of recovered in Jan2021.