chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in right arm immediately after injection. Fatigue ensued around 8pm on 9/8/21. Around 4am on 9/9/21 body aches, fever, chills and a head ache came on. Fever rose up to 102* at 10am then up to 103* by 5pm with severe head pains behind the eyes and ears. Nerve pains shot up and down the back of my neck the whole time the fever was active. Took a small dose of Ibuprofen 3 times the day of 9/9/21 along with a cold shower. Fever began to go down around midnight on 9/9/21 and stayed at 101* until  it broke at 9am on 9/10/21. Lingering headache and fatigue the following 4 days after fever broke.
Patient received shots in office at approx 11:52 on 7/25/14 within 15 min or less patient developed a welt and rash on bil. lower legs (mid calf down). No rash noted anywhere else. Parents deny rash prior to patient receiving shots.
Pt had already had vaccine 10 mins prior to fainting spell. Pt was told to sit for 15 mins, nurse talking to pt to make sure pt was ok. Nurse turned away from pt and pat slumped in the chair. No history of previous reaction as per father; pt had a light breakfast. Pt did not suffer injury from a fall.
Ulcerations; Shingles affecting inguinal area; Abdominal pain; Watery stools; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (Ulcerations), HERPES ZOSTER (Shingles affecting inguinal area), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ULCER (Ulcerations), HERPES ZOSTER (Shingles affecting inguinal area), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ULCER (Ulcerations) was resolving, HERPES ZOSTER (Shingles affecting inguinal area) had resolved and ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of ulcerations and shingles affecting inguinal area with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of abdominal pain and watery stools was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Chest pain, shortness of breathing and fatigue.  decompensation of previously well managed cardiomyopathy, CHF
16 yo male with h/o CML in remission without known cardiac dysfunction (no history of cardiotoxic chemotherapy) who had his second Pfizer COVID vaccine on 6/12 afternoon and then presented to the ER with fever, headache, and hypotension requiring multiple fluid boluses and admission.  No complaint of chest pain on admission, but does complain of 6/10 chest pressure in the left chest 6/14, leaning forward, with mild difficulty breathing.  No palpitations, skipped beats, racing beats, dizziness or syncope. Troponin was checked 6/14 at 1020 which was elevated to 0.35. Repeat one at 1600 peaked at 1.35. Then 6/15 at 0350 it came down to 0.5. Antibiotics stopped after one dose 6/13, he received acetaminophen and ibuprofen for symptomatic management.
received a steroid injection 2 weeks ago/unknown condition; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition). At the time of the report, VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  It was reported that patient was requested to receive booster dose  patient received a steroid injection two weeks ago for unknown condition
Tachycardia, up to 140. Woke up with it and then had trouble keeping heart rate below 95 or 100 even when laying down
Administrated  an adult dose of Engerix-B   to a 17 years old; Administrated  an adult dose of Engerix-B   to a 17 years old; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HBV (Engerix B adult) (batch number 5NY2K, expiry date 29th May 2022) for prophylaxis.   On 26th February 2021, the patient received the 1st dose of Engerix B. On 26th February 2021, unknown after receiving Engerix B, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: An adult dose of Engerix-B was administered to a 17 years old male patient which led to adult product administered to child and overdose. No adverse event was reported. The reporter did not consented to follow up.   Upon internal review, following corrections were performed on 23rd April 2021: The exclude from pader classification from general tab was removed. The suspect was updated to Engerix B adult.
pt recvd vax;devel a little red knot,was raised, & a warm area near the inject site in the thigh;
PATIENT IMMUNIZATION CONSENT FORM WAS REVIEWED AND CONFIRMED PATIENT IS NOT SICK AND CAN  RECEIVED SECOND DOSE OF MODERNA COVID VACCINE. PATIENT DID NOT FEEL DIZZY OR FAINT ON FIRST DOSE OF MODERNA OR ANY PREVIOUS VACCINATION. AFTER GETTING THE  VACCINE, PATIENT WAS TOLD TO SIT AND WAIT 15 MINUTES IN THE PHARMACY FOR ANY VACCINE ADVERSE REACTION. PATIENT STARTED TO FEEL DIZZY AND HIS WIFE GOT HIM AN ORANGE JUICE TO DRINK. PATIENT WAS ALSO SITTING IN THE BLOOD PRESSURE MACHINE AT THE TIME. SO AS THE PATIENT DRINKS THE ORANGE JUICE, HE PASSED OUT AND HIT THE BACK OF HIS HEAD ON THE FLOOR. WE IMMEDIATELY CALLED ED, AND PHARMACY EMPLOYEES WERE THERE TO ASSIST AND HELP OUT WITH THE SITUATION. PATIENT WAS THEN BROUGHT TO THE ER
Feet became numb and traveled up the body and eventually completely rendered my husband unmovable with Guillain-Barre Syndrome.  12/01/09 DC summary, ED and hospital records received for DOS 10/06/08-10/17/08. Pt. woke with loss of sensation to distal lower extremities. Numbness progressed up legs throughout the day and by following evening pt. had significant loss of sensation to midabdomen level.  Pt. presented to the ED at this point and was admitted. Neurology consult obtained and a 5-day course of intravenous gamma globulin was completed. Pt. developed progressive respiratory distress, was transferred to ICU, was  intubated and trached. Pt. was unable to be weaned from mechanical ventilation and transferred in stable condition to subacute facility. DC DX: Ascending paralysis secondary to peripheral neuropathy secondary to acute Guillain-Barre syndrome; acute respiratory failure seondary to ventilatory failure; surgical tracheostomy 12/08/09, 12/09/09, 12/11/09  Discharge summary and medical records received for DOS 10/17/08-04/08/09.  Pt. transferred for chronic respiratory failure, ventilator management.  Gastroenterology consult obtained and gastrostomy tube placed.  Pt. was becoming anemic and hematology consult obtained;  Rheumatology consult for elevated sedimentation rate and multiple problems. Pt. underwent 7 bronchoscopies where left lung collapse was noted. Treated with multiple antibiotics. Persistent conjunctivitis and possible need for surgical intervention in additon to ongoing need for bronchoscopy and multiple episodes of sepsis and septic shock prompted transfer to acute care. DC DX:  Guilian-Barre syndrome; acute respiratory failure; hypertension; s/p gastrostomy tube; diabetes mellitus type 2; fungal UTI; pneumonia; sepsis; conjunctivitis; congestive heart failure; malnutrition 12/11/09 DC Summary and Hospital records received for DOS 05/16/09-06/15/09. Transferred to neuro intensive care care for further evaluation and testing; infectious disease consult for drug resisistant infection; opthalmology consult for  bilateral corneal erosions; wound care for stage IV decubitus (coccyx). Transferred to less acute facility for possible vantilator weaning.  DC DX: Axonal polyneuropathy secondary to vasculitis, respiratory failure; glucose intolerance.
1 hour after receipt of nalsal Flu Mist vaccine Temp orally to 102 F, hives, "migraine" headache
I had a routine follow-up with this patient who reports receiving her second dose of the Moderna vaccine on 4/4. During our discussion, she reports experiencing new onset pain in her right hip, groin, extending up  to her spine. She denies that her lymph nodes in the groin region were swollen or hard to the touch. Of note, this patient reports hip and knee replacements on both sides. Despite this information, she reports that his new pain is unrelated. She reports using her walker sparingly to only using her walker since this second dose.
Swollen, redness at injection site (right thigh). Fever (101 plus). Restless. Then excessive sleep. Inconsolable, Crying lasting 12 plus hours. Seizures/infantile spasms. Rigidness, abdominal pain, diarrhea, lethargic.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or drug reactions/allergies were not provided. It was reported that "over a year ago" on unknown date, the patient received the first dose of GADASIL (route, dose, lot # and expiry date were not provided), and at the time of the report the patient received the second dose of GARDASIL (route, dose, lot # and expiry date were not provided). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
About a month after the vaccine I started having heart palpitations. Which lead me to go to the ER.
Patient was given a flu shot on 9/26/11 around 4PM. By 8PM, her left arm started to swell up to the point where she could not lift her arm. She decided to sleep it off and when she woke up the next morning, she passed out. She went to hospital emergency room, her blood pressure had dropped low, had difficulty breathing, and was nauseous. The hospital did not think that it was caused by the flu shot. After leaving the hospital, the pain remained a level 8 out of 10 until Saturday. The inflamed ball on her arm dropped down to the middle part of her arm. After speaking with her today, she is doing better and returned to work.
This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with improperly stored (temperature 47.5 Fahrenheit degrees (F), for 16 minutes) doses of ROTATEQ (lot #L035511, expiration date 21-MAY-2017, orally, dose was not provided). No adverse symptoms were reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
Tremors, vomiting, shortness of breath & dizziness within 30 minutes of administration.  Vaccines administered around 9:11am on 07/24/23.  Pt was brought back into the office on 07/24/2023 at 1:50pm - (3) sets of vitals completed around 2:00pm which were:  110/71 w/ HR of 94.  118/74 w/ HR of 87.  114/68 w/ HR of 76 & SPO2 of 97 on room air.  EMS was contacted and pt was transported to ED
Information has been received from an health professional concerning a 25 year old white female with a positive tuberculin test and no known drug allergies who on 30, Nov 2005 was vaccinated IM with two  pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast (lot # 648240/0812O),  There was no concomitant medication. On 03, Jan 2006 the patient was vaccinated Im with two pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast) (lot# 651494/0458R). On 12, June 2006, the patient was vaccinated IM with tow pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast) (lot # 651494/0458R). On 03, Aug 2006, the patient had blood work which was non reactive for the hepatitis B surface antibody. The chest x-ray was done for positive tuberculosis test and it was normal. Follow-up information from the health professional indicated that the patient was vaccinated with two 0.5 mL pediatric doses of hepatitis B virus vaccine rHBsAg (yeast) on 30, Nov 2005 (lot# 648240/0812P; right deltoid), 03, Jan 2006 (lot#651494/0458R; left deltoid), 12, June 2006 (lot#651494/045BR; right deltoid), 18, Aug (lot# 653268/0202F; left deltoid) and 26, Sep 2006 (lot# 652882/0038F; right deltoid). On 05, Dec 2005 the patient did not receive medication for preventative measures. On 8, Dec 2005 was negative for tuberculosis, with a result of 3mm. On 01, March 2006 the patient had no evidence of pulmonary tuberculosis. On 03, Aug 2006 the patient underwent a hepatitis B surface antibody test that was non reactive. At the time of the report the patients outcome was not known. Follow-up information from the health professional indicated that the patient received a repeat three dose series of RECOMBIVAX HB. Hepatitis surface antibody and hepatitis surface antigen were negative after the six doses. It was reported that the  patient was obese and over 300 pounds. Additional information is not expected.
pt recv vax & 8JAN96 pt exp thrombocytopenia & was hosp x 5 days;pt platelet count dec to a low 1,00 & was tx w/steroids & IV immune globulin;pt recovered;
developed angioedema of the lips with concurrent fever, mild pharyngitis and worsening of chronic migraine headaches. Phone visit performed and rx cetirizine and 5 days of prednisone prescribed. RAF placed for allergy/immunology. ER precautions and s/s concerning for anaphylaxis reviewed in detail.
Rash on right buttock after first vaccine and went away. Came back after 2nd vaccine with burning and itching and more places. No pus just red and angry
slo mildly pruritic and warm.  Tx with Augmentin 500 mg po bid x 10 days (Pt already had taken 7 days of tx for another diagnosis).  Pt to f.u if no improvemnt or sorsened s/s.
This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient. The patient did not have any known drug reactions or allergies and her medical history included myasthenia gravis. On 11-APR-2017, the patient was vaccinated with a ZOSTAVAX for shingles prevention (dose, route of administration, lot# and expiration date were not reported). In approximately April 2017, the patient experienced swollen area at unspecified injection site that was initially size of a 50 cent. The swollen area expanded to several inches and was also warm, slightly firm and tender, on an unknown date in approximately April 2017. The patient experienced also fatigue, in approximately April 2017. The patient sought medical attention and phoned to the pharmacist, on an unknown date. No laboratory tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter
Received early second dose of Shingrix was administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 25-AUG-2023, the patient received the 2nd dose of Shingrix. On 25-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received early second dose of Shingrix was administered to patient).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter reported that the patient received an early second dose of Shingrix vaccine. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Information has been received from a certified medical assistant referrng to multiple unspecified patients of unknown age and gender. On an unknown date, these patients were vaccinated with ROTATEQ (strength, lot number, expiry date, route and dose were not reported) post supported excursion. No adverse effects were reported. This is one of two reports received from the same reporter (linked to 1502USA0007950). Additional information has been requested.
Information has been received from a nurse practitioner concerning a 31 year old female patient, with allergy to ADVAIR, who on 05-MAY-2011 was vaccinated intramuscularly in the left deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported). Concomitant therapy included ZOLOFT, FLOVENT, VENTOLIN HFA, metformin, PREVACID, FLONASE and aspirin. Nurse practitioner reported that on 06-MAY-2011, the patient developed pain and swelling at the injection site down to her elbow. Nurse practitioner also reported that patient had chills, a 100 f temperature, body aches, throat pain and headache. No treatment was given for the events. The patient sought medical attention by calling the office. The patient had not returned to office since administration of PNEUMOVAX 23, for evaluation. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
1230 pm Received 2nd dose of Pfizer chief compliant generalized pruritus and headache after vaccine, administered Benadryl 25mg @ 1235pm continued to experience itching in back of throat . 1245pm another Benadryl 25mg capsule given.  started to feel better itching less intense. 1255 pm  Exited home in stable condition.
Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days.  (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)
headache, red eyes, sore throat, swollen all over body, couldn't walk or use hands for ADL's
I woke up at 12:39am feeling nauseous and with a pounding heartbeat.  I also had a headache and severe body aches, and chills, but no fever.   I drank some water and sat up in bed for a while.  The pounding heartbeat settled down in about half an hour.  I did not take Advil or anything else because of the nausea.  Later in the morning I had some nasal congestion.  Symptoms persisted but slowly waned until 6:00pm that day.  After that, fatigue was the only symptom that lasted until about the 48 hour mark.
Wife states that he received his vaccine around 1pm and then the next morning his arms and legs were very swollen and he couldn't move them.  They waited to see if it would get better.  A home health nurse came to the house 5/23/22 (scheduled) and she had them call emergency. he was evaluated and admitted to the hospital on 5/23.  He was treated for CHF and extremity weakness.  She states they did some tests but couldn't figure out what was wrong and then Dr (cardiologist) came in and stated it was a reaction to the vaccine.  She prescribed steroids and by the next night he was better. He was discharged to a rehab facility on 5/25/22 and then discharged from there to home on 5/26/22.
1.  My entire face went a little numb. From the top of my forehead to under my chin (not neck) left and right side of my face , equally numb allover face.  Could still feel, not paralyzed, but definitely partially numb. Started 25 mins after shot. Lasted about 3 hours. 2.   Left eye twitching.  Started about 25 mins after shot (along with the face numbness)  Only left eye.  Would twitch intensely for 2-3 seconds, approximately  every 20 minutes.  This lasted for 9 days, then subsided for 3 days until stopped completely.   3.  Very mild, strange feeling washed over me approximately 5 seconds after the shot.  It subsided after maybe 20 minutes.   4.  Weird taste appeared in mouth about 30 seconds after shot.  Lasted only a few minutes.  5.   Achy, headache, 101 temperature.  Started 8 hours after shot.  lasted for 3 days.