chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One hour after vaccine administration, patient suddenly lost consciousness while sitting at his computer. After a short period of time, he woke up with his head laying on his keyboard after his wife found him. Upon waking up he reported confusion, an inability to remember where he was/the time/who he was, and an inability to communicate verbally. He was also unable to move his body. Emergency medical services were called, and his initial workup with them was apparently negative. At some point, he was so scared that he did not think he would survive this incident. He also endorsed some flu-like symptoms. He is not able to recall the entire event due to memory loss.   The day after the event (the day in which he reported the event to local Pharmacy), he was back to his baseline (i.e. able to speak, move, communicate coherently, etc.) but was still experiencing latent flu-like symptoms and fatigue.
p/ vax,pt lied down because pt was pale,rested a few mins,walked out to lobby & passed out;BP 122/80;pt lost consciousness few secs,became pale;tx w/ & pretzels & punch;pt had only eaten 1/2 piece toast;
Administration of a invalid dose; administered Moderna vaccine which had been left at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature). On 07-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Fever; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (fatigued) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer (Immunocompromised). Concomitant products included NIVOLUMAB (OPDIVO), IPILIMUMAB (YERVOY) and PREDNISONE for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PYREXIA (Fever) and FATIGUE (fatigued). At the time of the report, PYREXIA (Fever) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 101.5 f (High) Patient reported 101.5 F fever.         No treatment information provided.
Pt. had a red, swollen, itchy, and hot to the touch area about 2 inches long around injection site.
Rash over entire body lasting 4 days lower (L) side lip swollen stiff neck.
This spontaneous report as received from a physician refers to a 15 year old male patient. On 22-APR-2013 the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). On 22-APR-2013, after administering GARDASIL, the patient developed a headache and tingling in the hands on the day of administration and the pain progressed to back pain over the next three days. The patient sought medical attention by visiting to physician's office. At the time of reporting, the patient's outcome was recovering. The relationship between all events and GARDASIL was not reported. Additional information is not expected.
Information has been received from a registered nurse (R.N.) concerning a 21 year old female with significant mitral regurgitation and an allergy to VERSED and a history of miscarriage (at age 18), gallbladder surgery and appendicectomy (in 2000) who on 02-AUG-2007, 30-OCT-2007 and 19-FEB-2008 was vaccinated intramuscularly with 0.5 ml first, second and third dose of GARDASIL (lot #658556/1060U, 659437/1266U and 659653/1448U), respectively. Concomitant therapy included NUVARING and VALTREX. On 30-OCT-2007 and the patient weighed 144 lbs. "After her third dose", the patient stated that she lost 25 pounds after receiving GARDASIL. Colonoscopy was performed and the result indicated negative. The nurse did not have the current weight of the patient. The nurse also mentioned that recently she observed that the patient's teeth were brown and white which resembled someone who had anorexia or bulimia. The patient initially called her primary care physician and was told to contact the nurse's office. At the time of this report, the events persisted. Additional information has been requested.
accidently administered two Adacel vaccines/no AE; Initial information received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 46 years old male patient who accidently received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice on 17-Jan-2020.(lot U6539AA via intramuscular route in the left deltoid).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for Immunisation.  It was an actual medication error due to extra dose administered.  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from the patient mother refers to her child of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # were not reported). Concomitant therpay was not reported. The reporter reported that her child could not handle M-M-R II. The reporter did not go into detail about what could not handle. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. Additional information has been requested.
The patient received a first dose of GARDASIL 9 and the patient has not received a second dose.; no adverse event; This spontaneous report was received from a pharmacist concerning a 24 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient had not received a second dose (inappropriate schedule of product administration).   No adverse effects reported. The outcome of inappropriate schedule of product administration was not reported.
The patient showed no signs or symptoms of having the booster, but I am reporting because it was given to him before the approved age of 12 years. He is 11 years and 9 months old. After checking the database, it was noticed that he had also received 2 prior doses of the Pfizer monovalent vaccine at 10 years of age, after his initial first dose with us. The child received in total 5 COVID vaccinations, including the booster that we inadvertently gave.
redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; redness, swelling and pain from the elbow to her upper arm; This spontaneous report as received from a physician via a company representative refers to a 75-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-JUL-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot number: S00258, expiration date: 10-AUG-2020, dose and route of administration were not reported) in the left arm.  On 12-JUL-2019 (reported as on the same day), the patient developed redness, swelling and pain from the elbow to her upper arm. She sought medical attention. Lab diagnostics and studies were not performed. The patient was treated with diphenhydramine (BENADRYL), loratadine (CLARITIN) 10 mg and prednisone ice for pain. She recovered on an unknown day in 2019.  The relatedness between the events and the vaccine was not reported.
sniffles; felt like she was coming down with something; dry cough in morning and evening; muscle ache; occasional headache; feels like she is feeling her liver; 3 days ago had fever at around 99.6F; felt a little tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening) and FATIGUE (felt a little tired/fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic to cats (allergic to cat dander.), Nickel sensitivity (allergic to nickel.), Pollen allergy, Hypertension and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID), MULTIVITAMINS [VITAMINS NOS], MAGNESIUM and COLLAGEN for an unknown indication, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE ORION).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt a little tired/fatigue). On 04-Aug-2021, the patient experienced PYREXIA (3 days ago had fever at around 99.6F). On 07-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (feels like she is feeling her liver) and HEADACHE (occasional headache). On an unknown date, the patient experienced RHINORRHOEA (sniffles), FEELING ABNORMAL (felt like she was coming down with something), COUGH (dry cough in morning and evening) and MYALGIA (muscle ache). At the time of the report, RHINORRHOEA (sniffles) had resolved and FEELING ABNORMAL (felt like she was coming down with something), ABDOMINAL DISCOMFORT (feels like she is feeling her liver), COUGH (dry cough in morning and evening), FATIGUE (felt a little tired/fatigue), HEADACHE (occasional headache), MYALGIA (muscle ache) and PYREXIA (3 days ago had fever at around 99.6F) had not resolved.            No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow-up received contains no new information.
2ND HPV VACCINE GIVEN ON 4/2/09. ON 7/9/09 CLIENT HAD HIVES FROM HEAD TO TOE INCLUDING ARMS, LEGS, AND TRUNK. HIVES ALSO INSIDE HER MOUTH. SHE WENT TO E.R. AND RECEIVED A CORTISONE INJECTION. ETIOLOGY OF THE HIVES UNKNOWN BY PHYSICIAN. ON 7/10/09 SHE SEEN PCP WHO OBTAINED LAB WORK AND MEDROL DOSE PACKET PRESCRIBED BUT CLIENT WAS UNABLE TO SWALLOW PILLS. 7/11/09 WENT TO E.R. R/T HIVES TO LIPS AND MOUTH AND PT. WAS HAVING DIFFICULTY BREATHING FEELING TIGHTNESS TO CHEST. SHE WAS GIVEN EPINEPHRINE AT THE E.R.-THEN ALL SYMPTOMS RESOLVED WITHIN 48 HOURS. THEN ON 8/20/09 CLIENT RECEIVED HER 3RD HPV INJECTION. ON 9/5/09 CLIENT EXPERIENCED LOWER RT. ABDOMINAL PAIN AND BLOATING. ALSO HAD 3 MENSES IN 9/09 AND REPORTS IS USUALLY REGULAR WITH MENSES OCCURRING EVERY 28-30 DAYS. THE 2ND WEEK OF SEPT./09 SHE WENT TO CARE AND SEEN PHYSICIAN WHO ORDERED AN ABDOMINAL CT SCAN SHOWING FECAL IMPACTION. THE CLIENT TOOK MAGCITRATE WITHOUT RESULTS. CLIENT STATES SHE NORMALLY HAS REGULAR BOWEL MOVEMENTS. HER ABDOMINAL PAIN CONTINUED EVEN AFTER HAVING A BOWEL MOVEMENTS. TWO DAYS LATER SHE WENT TO URGENT CARE AND HAD LAB OBTAINED TESTING HER URINE AND BLOOD WHICH SHE REPORTS CAME BACK NORMAL. SHE REPORTS THE SEVERE ABDOMINAL PAIN CONTINUED. ON 9/22/09 CLIENT COMPLAINED OF LT. ARM PAIN AT THE HPV INJECTION SITE AND HAVING 1 SMALL HIVE AT THE INJECTION SITE WHICH WAS NOTICED BY HER MOTHER-LATER IN THE DAY THERE WAS A RAISED INDURATION GREATER THAN 1CM PALPATED AT THE INJECTION SITE. CLIENT ALSO REPORTS ON 9/22/09 HAVING A RASH TO BOTH UPPER THIGHS, TIGHTNESS IN HER CHEST, AND DIFFICULTY BREATHING. CLIENT PLANS TO FOLLOW-UP WITH HER PCP AND WILL REQUEST AN ABDOMINAL ULTRA SOUND.  9/28/09 Urgent care records received DOS 9/16/09. Assessment: Abdominal pain, constipation. Patient presents with abdominal pain of one week duration. 10/19/09 Primary care records received for dates of service 8/28/97 to 7/9/09 Assessment:  Seen for hives on 7/9/09. Right lower abdominal pain and sore throat on 9/25/09.
Patient became listless and unresponsive. EHS called by parent. Taken to ER and observed. No treatment given. Did have rash on R side of face. Right ear, temple, nose, and near eyes lasting approx. 12 hours.
Shot was given on 9-24-18 - hives started on 9-27-18. Went to local clinic. Was given a short course of prednisone-50mg for 5 days. Helped for one week - then the hives started again. On Nov 27, 2018 went to Dr. - suggested antihistamine and clobetasol topically - helped but no cure. Had blood drawn on Dec. 31, 2018 to look for food allergies.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MC0A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included GABAPENTIN, LISINOPRIL, TAMSULOSIN, CYCLOBENZAPRINE, PRAVASTATIN, ISOSORBIDE MONONITRATE, DILTIAZEM and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078366 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078366:Crossed linked (Second Dose)
(R) arm - swollen to shoulder & down to end of deltoid muscle observed in office. Dad reported red swollen - req. Abx. therapy.
Case number PHHY2011US60076 is an initial spontaneous report received from a nurse practitioner on 05 Jul 2011 with a follow-up from the nurse on 25 Jul 2011. This report refers to a 12 year old female patient. She was vaccinated with MENVEO (batch number: M10047) 0.5 ml, intramuscularly on 20 Jun 2011. But the patient was administered Men A which was reconstituted with sterile water instead of men CYW-135 liquid component. On the same day she was also vaccinated with the booster dose of BOOSTERIX (other manufacturer) intramuscularly at a dose of 0.5 ml. No adverse event was reported following this drug administration error. Follow-up received from the nurse on 25 Jul 2011: Updated information about concomitant vaccination.
This spontaneous report was received from the patient's mom concerning her currently 25 years old son. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (doses, route of administration and lot # not reported). There were no concomitant, pertinent medical history or drug reactions/allergies. On an unknown date, after the first dose, the patient got a case of shingles. It was on his left hand side of his torso, had the blisters. The patient was given antibiotics but did not remember the name (also reported as the patient did not receive treatment for the event). The patient sought medical attention. It was reported that no lab diagnostic studies were taken. The outcome of got a case of shingles. It was on his left hand side of his torso, has the blisters is unknown. The patient discontinued the course of treatment and went in to get the remaining 2 shots. Additional information has been requested.
My child stopped making sounds or attempting to talk. She never made a sound except cry for the next year. Her speech is very delayed and unable to pronounce all words.
Shot was in the upper right arm. I developed a very large (size of a softball) growth in my armpit. It seemed to be full of liquid. After a day it shrank to 20% of the size but then another identical growth occurred in my left armpit! It is 20% the size of the first one in the right arm. I have pictures of all the occurrences.
mild symptoms of body aches; flu-like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain and influenza-like symptoms. On an unknown date, the outcome of the general body pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the general body pain and influenza-like symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR080509   Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she recently had the shingles vaccine, with the first injection he/she had mild symptoms of body aches and flu-like symptoms. Additional Supportive Information: The follow-up would not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR080509, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080509:Same reporter
bite marks developing little heads; bite marks started on the side of her neck; bite marks expanded to the other side of her neck, cheek, arms and one leg; bite marks itches; bite marks hurt; pretty sore arm; A spontaneous report was received from a Healthcare Professional concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pretty sore arm, bite marks started on the side of her neck, bite marks expanded to the other side of her neck, cheek, arms and one leg, bite marks itches, bite marks hurt, bite marks developing little heads.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events pretty sore arm . On 30 Jan 2021, the patient experienced the events bite marks started on the side of her neck. bite marks expanded to the other side of her neck, cheek, arms and one leg, bite marks itches, bite marks hurt. On 3 Feb 2021, the patient experienced the events bite marks developing little heads.  Treatment details included For the symptoms: antihistamines, cortisone cream, scrub for poison ivy, showers., Other: Ibuprofen one time a day., 03Feb2021  Action taken with mRNA-1273 in response to the events was not reported.  On 29 Jan 2021 the outcome of events pretty sore arm was resolved. On an unknown date the outcome of events, bite marks started on the side of her neck, On an unknown date the outcome of events, bite marks expanded to the other side of her neck, On an unknown date the outcome of events, cheek, On an unknown date the outcome of events, arms and one leg, On an unknown date the outcome of events, bite marks itches, On an unknown date the outcome of events, bite marks hurt, On an unknown date the outcome of events, bite marks developing little heads was not reported.
allergy; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and TETANUS VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy (Verbatim: allergy). The patient was treated with antihistamine (Antihistamines). The outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.     It was unknown if the company considered the allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2023 The patient self-reported this case. The patient mentioned that she had allergic responses to a tetanus vaccine and also a shingles vaccine in the past. The product names and manufacturers were unknown.  The allergic response required antihistamines to treat. It was unknown if the reporter considered the allergy to be related to Tetanus vaccine. The reporter did not consent to follow-up. No additional information was provided.
2 days later swelling hands & feet, fever & rash over entire body. Treatment: oral steroids x 5 days recheck 2 days.
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
been throwing up yesterday and felt hot and cold Adverse events experienced and are they still occurring now:   unknown--sleeping now--had a cup of tea and cereal this afternoon and tolerated it w/o vomiting