chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/27/2021 @ 10:30 vaccination. 08:00PM I started to overall low grade fever, chills, sweats, I couldn't get warm enough. 12/28/2021 102 temperature. I stayed home. 12/30/2021 Mouth ulcerations started to appear. I woke up and they were all over my mouth. 1/1/2022 ER, Dr. stated it was due to the booster vaccination and that they would go away on their own. Visual observations. Prescribed numbing medication. I never took as pharmacy was closed due to  the holiday. I used orgel and mouthwash. Presently, 1/4/2022, significantly better. Still on roof of mouth. I was able to eat some solid food starting yesterday. 12/23/2021 - shot of steroids for the ongoing cough from 11/2021.
11/2/2022 bp 154-89, 89% O2 sat (96% after 2L), pulse 140 bpm, temp 100.9-101.3, respiratory rate 24 11/3/2022 bp 90/39, pulse 80, respiratory rate 20, O2 95% on room air, temp 97.3
Pt reported to pharmacy on 10/23/10 that she had redness, itching, swelling at injection site.  She went to PCP and then on to the hospital where she was hospitalized and treated for cellulitis with antibiotics.  She was kept in the hospital for 1 day and then released.
Hand tremors 3 weeks post. Seen by 2 neurologist.  Used Inderal for 2 weeks Tremors continue - both hands.  Leg cramps; 60 day follow-up dated 9/27/00 provided no additional data.
pt recv vax & exp extreme local discomfort & devel nodules @ inj site & extended to entire arm & adjoining chest;pt was unable to move arm for a period of time;pt also exp fever, nausea & vomiting;no tx given; pt recovered;
patient was given a covid bivalent vaccine on 09/13/2023 one day after vaccine was no longer authorized 09/12/2023.
This case meets criteria for vaccine breakthrough review. SxS include SOB, headaches, fevers, chills, weakness, and cough after known COVID exposure from multiple family members.
Received Tdap (L) deltoid which swelled within 3 hours, became red and hot. Administration 1/11/17. Swelling, tenderness persists as of 1/16/17 at follow eval.
This is in follow-up to report(s) previously submitted on 4/15/2008. Information Has been received from a nurse concerning a female who on 30-JUL-2008 was vaccinated live with orally ROTATEQ. Concomitant therapy included all "two month old vaccines" on 30-JUL-2008. The patient was seen in the office on 14-AUG-2008 with decreased appetite, low grade fever 99*F and loose stools. The patient was diagnosed with upper respiratory infection and diarrhea. The patient was seen in the emergency room on 16-AUG-2008 since the infant had vomiting and diarrhea. The patient was given IV fluids in the emergency room and discharged to home. On 18-AUG-2008, the patient was seen in the office for Rotavirus. On 19-AUG-2008, stool came back from hospital positive for rotavirus. It was reported that the patient recovered from the events (date unknown). No product quality complaint involved. Additional information has been received from a physician concerning a 10 week old female with NKDA, no birth defects and no medical history, who on 24-JUL-2008, was vaccinated with the first dose of oral ROTATEQ. Illness at time of vaccination included GERD. Concomitant therapy ZANTAC. On 16-AUG-2008, the patient was brought to the ER with complaints of diarrhea and vomiting. She had diarrhea for the last week, only had 1-2 loose stools a day and she had been vomiting. She was diagnosed with reflux and she had been spitting up. She was seen by her primary care physician earlier in the week and was instructed to continue feeding and to give her Pedialyte as needed. They increased her ZANTAC and switched her to Entamil gentle ease. It was reported that over the last 24 hours she has had about 10-11 watery stools but no fever. She has had a mild runny nose. She had still been waiting diapers, but was eating less. She was not  vomiting but just was not eating as well as her usual. The patient had IV initiated in the ER and was given a fluid bolus. Blood work was obtained. Her white count was 18,00 which is mildly elevated, predominant lymphocyte count rather. Catherized urine sample was negative for any signs of infection, bicarbonate 15 and glucose 117. She was hydrated for several hours. She tolerated a ounces of fluid and did not spit up. She had two small seedy stools one was sent for rotazyme and culture. In the evening of 16-AUG-2008, the stool culture came back positive for rotavirus. The patient's condition improved. She was active and discharged to home. Finial impression was acute vomiting with diarrhea. The pateint's formula was switched to Isomil soy formula to help with the diarrhea. The pateint was to continue with pedialyte and ordered to follow up with pediatrician for reevaluation on Monday. The patient was reported as recovered on 23-AUG-2008. Additional information is not expected.
gave the liquid DTAP IPV component of PENTACEL without reconstituting it without the ACTHIB component. with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 4 months old male patient and reporter stated gave the liquid dtap ipv component of diphtheria/tetanus/5 hybrid AC Pertussis/ipv(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] without reconstituting it without the acthib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar); and rotavirus vaccine.  On 17-Nov-2022, the patient received first dose of 0.5 ml total of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(VERO)/HIB(PRP/T) vaccine with standard strength (lot UJ664AAA and expiry date: 04-May-2023) via intramuscular route in the left vastus lateralis for Immunization.  On 17-Nov-2022 the patient was given the liquid dtap ipv component of pentacel without reconstituting it without the acthib component. with no reported adverse event (product preparation error) (latency: same day) .  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  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 the guidelines. 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.
DURING LATTER PART OF FEBRUARY PATIENT REPORTED TO LOCAL EMERGENCY ROOM WITH COMPLAINT OF WEAKNESS AND LEG PAIN.  WAS TOLD HE HAD A MUSCLE STRAIN GIVEN ANTI-INFLAMMATORY (IBUPROFEN) AND SENT HOME.  RETURNED A SECOND TIME SOME DAYS LATER UNABLE TO WALK AND IN EXTREME PAIN.  THE EMERGENCY ROOM PHYSICIAN AT THAT TIME WITH THE HELP OF NEUROLOGY SPECIALIST AT CLINIC GAVE THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME.  PATIENT WAS SUBSEQUENTLY TRANSPORTED TO THE HOSPITAL WHERE HE WAS STABILIZED AND THEN SENT TO THE REHABILITATION SECTION OF THIS HOSPITAL.  THE PATIENT IS CURRENTLY (03/27/2009) IN THIS FACILITY.  4/15/09 received hospital medical records of 3/8-3/24/2009. FINAL DX: acute Guillain-Barre syndrome; UTI; stage 2 coccyx decubitus ulcer; hyponatremia, resolved; neuropathic bladder; deconditioning. Records reveal patient experienced progressive LE weakness, left facial droop; UE weakness; urinary retention.  Had been out of country 1/09 & had cold, fever, cough, nasal congestion.  Approx 2/28/09 began to feel unwell, developed pain in legs & back.  Seen in ER & dx w/muscle sprain.  No improvement w/meds & in fact developed weakness of LEs requiring walker use.  Saw PCP & noted to have UTI & tx w/antibiotics.  Progressive weakness continued until pt unable to get OOB & developed left facial droop.  Seen again in ER & transferred to higher level of care.  Neuro & Uro consults done.  LP done.  Tx w/IVIG x 5 days.  Feeding tube placed.  Gradually improved & transferred to inpatient rehab.
Fifteen minutes after injection, the patient reported tingling in her hands and feet, pale color of hands, flushed and sweaty face, blurry vision, dizziness, increased pulse rate. She requested orange juice but refused any medical treatment or contact to her PCP. She rested in the IMZ private area while being monitored by RPh and Mgr. At 8:12PM, she stated she felt alot better, had no more symptoms of reaction, her pulse reduced back to normal level after taking blood pressure, and thanked the pharmacist and assistant manager for their care and concern.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient (age not reported) who inadvertently received two injections of vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On an unknown date, the patient received two doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) lot number not reported (dose, dose in series, route and site of administration were not reported). It was a case of actual medication error due to extra dose administered. It was reported that there was some confusion with the medical assistants if the patient actually received a dose or not, and she was inadvertently given a second dose of FLUZONE HD before they saw her paperwork from her first dose. No adverse event occurred. 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 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.        .
experienced "COVID arm" and her arm was tender, blotchy, and red.; arm was tender; arm was red; arm was blotchy; sore arm for a couple days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (experienced "COVID arm" and her arm was tender, blotchy, and red.), VACCINATION SITE PAIN (sore arm for a couple days.), VACCINATION SITE PAIN (arm was tender), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE RASH (arm was blotchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm for a couple days.). On 13-Apr-2021, the patient experienced VACCINATION SITE REACTION (experienced "COVID arm" and her arm was tender, blotchy, and red.), VACCINATION SITE PAIN (arm was tender), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE RASH (arm was blotchy). At the time of the report, VACCINATION SITE REACTION (experienced "COVID arm" and her arm was tender, blotchy, and red.), VACCINATION SITE PAIN (sore arm for a couple days.), VACCINATION SITE PAIN (arm was tender), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE RASH (arm was blotchy) outcome was unknown.        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.   No Concomitant Medication was provided. No treatment  was provided.
Localized rash to left arm, steroids, BENADRYL, ZYRTEC.
ALLERGIC RXN TO BIVALENT MODERNA COVID BOOSTER.  EPI PEN ADMINISTERED, EMS CALLED, PT TO LOCAL HOSPITAL
This spontaneous report as received from a Pharmacy student refers to a unspecified number of patients of unknown ages and genders. On unspecified date, the patients were vaccinated with PNEUMOVAX 23 (route, dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The Pharmacy student reported that unspecified number of patients might have received two doses of PNEUMOVAX 23 about 5-6 months apart. No adverse effects reported. No additional information provided. Additional information is not expected.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Weakness-Mild, Additional Details: only welt at injection site
Back started aching; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809, expiry date: 30Jun2021), via an unspecified route of administration in the deltoid left on 08Feb2021 at 13:30 (at the age of 73-years-old) as 0.3 ml for try to avoid getting COVID. Medical history reported was his main artery is plugged up, High cholesterol, Type II diabetes and Blood thinner, all ongoing. It was reported that patient was not vaccinated with any other vaccinations prior (within 4 weeks). Concomitant medications reported was metformin at 500 mg daily for type II diabetes been on it two years, simvastatin at 20 mg daily for high cholesterol been on it approximately 3 years, aspirin [ACETYLSALICYLIC ACID] at low dose daily taken it for three years, cilostazol for blood thinner at 100 mg twice a day been on it two years, all ongoing. It was reported that patient got the Pfizer COVID19 vaccine on Monday, 08Feb2021. On Tuesday, 09Feb2021, in the afternoon his back started aching. By 8 o'clock Tuesday night it was hard to stand up without excruciating pain. He was having to use a heating pad because the back pain has not gotten better. Caller was calling for the symptom he had yesterday (10Feb2021). He wanted to know if there had been reports of lower back pain with the Pfizer COVID-19 vaccine. It was reported that patient did not required visit to emergency Room or physician Office. There was no family medical history relevant to adverse event. No additional vaccines were administered on same date of the Pfizer Suspect. There is no history of previous immunization with the Pfizer vaccine considered as suspect. Outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
The patient came in for her 4month old visit and shots, MA on shift confused the Pentacel with Quadracel and drew up the wrong vaccine, she did not notice the error until the vaccine was already administered. This error was reported and they stated that we needed to report to Vaers and that the patient does not need to be re-vaccinated, she only need to get the Hib vaccine that she missed.
This spontaneous report was received from a medical assistant and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M024261, expiration date 30-JUL-2018 (dose and route of administration were not reported). No adverse effects were reported. The temperature excursion lasted for 5 minutes and ranged from 47 to 77 (also reported as 48.8) degrees Fahrenheit. There was no previous temperature excursion. Digital data logger was not used. The product quality complaint was not involved.        Additional information has been requested.
Seen at ER for probable seizures with fever.  Rectal temperature 99.6.
HEADACHE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: fibromyalgia, and concurrent conditions included: non-alcohol user, non-smoker, and blood pressure. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (unspecified manufacturer) (Dose Number In Series 1) and experienced drug allergy when treated with hydrocodone (for fibromyalgia), duloxetine hydrochloride, fluconazole, diltiazem, doxycycline (received only for 7 days), famotidine, fluticasone, irbesartan, gabapentin, carisoprodol, budesonide/formoterol fumarate and topiramate.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). No concomitant medications were reported.  On 17-NOV-2021, the patient experienced headache. Treatment medications (dates unspecified) included: hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-NOV-2021. This report was non-serious. This case, from the same reporter is linked to 20211142554.
the daughter underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia despite completing the 3 dose GARDASIL series and having limited unvaccinated partners; the daughter underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia despite completing the 3 dose GARDASIL series and having limited unvaccinated partners; daughter was administered 3 doses of GARDASIL (4 valent) on 6/19/2009, 11/17/2009 and 7/2/2010; This spontaneous report was received from a physician via a company representative, regarding her daughter - a 22-year-old female patient. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-JUN-2009, the patient was vaccinated instramuscularly with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (exact dose, anatomical location, lot # and expiration date were not reported) as a normal childhood vaccination. On 17-NOV-2009, she was given the second and on 02-JUL-2010, the third dose of the vaccine.   On an unspecified date in September 2019 (reported as in the fall of 2019), the patient developed cervical dysplasia despite completing the 3-dosage regimen of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and having limited unvaccinated partners. At that time, she underwent a loop electrosurgical excision procedure (LEEP) for cervical dysplasia. The outcome of the events was unknown.  The causality assessment between cervical dysplasia and vaccination failure was not reported.
Pt recv vax on 4/13/99; on 4/15/99 pt exp sleepiness, shaking episode, seizure; tx=seizure medication
Information has been received from a health professional concerning a 5 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Pt was given TWINRIX in left arm and reported feeling some pain/sting. But did not feel dizzy. I then gave the FLUZONE into the right arm, a few seconds later he said he felt dizzy and shaky, he was shaking but conscious. He was supported and propped against table. I was terrified so I left the room to call for help (I work alone as an overnight pharmacy in the pharmacy department). I paged the manager to watch the patient while I called 911. The patient said he had fainted in the few seconds I was gone but was alert and conscious when I returned. The manager and I both offered him water. The patient said he didn't think he hit his head on the table nor the floor. He did scrape his knee a little. I called 911 to be on the safe side and also called the police because he said he still felt dizzy but was  talking and conscious. I communicated what happened and they came 30 minutes later, around 2:00 am. They took his BP, which was 120/100. I told the EMS what happened, what shots I gave and gave the pt an immunization record card so he knew as well. They asked him if he wanted to go to hospital . He seemed hesitant, but eventually said yes and they took him away on stretcher even though he seemed okay, alert and conscious and able to stand up fine. I called patient today at 9:30 pm to follow up and check he was okay. He said he was fine and doctors at emergency room ran tests and didn't find anything wrong with him. He appreciated my concern and said he probably just felt tired. Patient said he will meet with him primary care doctor this week just as a precaution too even though he feels fine.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Task Force, after speaking with CDC, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
a 18 year male patient received Menactra instead of Menveo vaccine,No AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 18 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination instead of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  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.  There will be no information available on the batch number for this case.
rash & fever on 23APR95 (12 days p/vax) temp as high as 105; was seen by ER MD on 23APR95; dx gastroenteritis; both ears red; vomiting
Pain at site, soreness from elbow to mid back, dizziness, weakness, hives on face, chills, mild nausea, fatigue worsening on the next day (today) after an early morning walk.
Pfizer booster dose given early. Original series was given 8-23-21 and 9-13-21. Booster given on 1-3-22.
PATIENT REPORTED A RASH AT INJECTION SITE THAT SPREAD TO PATIENT'S STOMACH. ISSUE RESOLVED IN APPROXIMATELY 48 HRS
Red welt about 1" across, tender on palpation and red welt from 10/13/00 to 10/15/00; faded to bruise-like discoloration. On 10/17/00, still have discoloration and still sensitive.
This spontaneous report as received from a Health care worker refers to 25 patient of unknown age. The patient pertinent medical history and concurrent conditions were not provided. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # J009033, Expiry date: 19-JUL-2015, Dose: 0.5 milliliter, Route: subcutaneous) (exposed to -13C for 14 hours). No adverse effects were reported. Additional information has been requested.