chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;pt stated rt arm was swollen at least twice nl size (deltoid area) & was red & hot for 3-4 days; inject site remained a blister for 2 wks later & 1 mo later, there still remains a scab;
Information has been received from a 19 year old female patient with no pertinent medical history or allergies who on in the end of July, approximately 31-JUL-2008 who completed the 3 dose series and was vaccinated with GARDASIL (dose and route not reported). Concomitant therapy included birth control (unspecified). A couple of weeks ago in approximately September 2008, the patient experienced a little bump on the genital area that had not gone away, she has not experienced itching or pain. The patient stated she had had the same boyfriend for eight months. The vaccine was administered in one state and she is now in school in another state and the patient had no physician. As of 15-Sep-2008, the patient had not recovered. No laboratory test was performed. The patient did not seek medical attention. Additional information has been requested.
severe swelling of the arm the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given). At the time of the report, VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Patient became diaphoretic and light headed. Patient had some apple juice and stated he felt better. VSS HR 56; BP 104/84
Received vaccine on Wednesday 1/20/21 at 11:00am and had no issues until the next am. Woke up on 1/21/21 with no fever but had dry mouth, chest pain, muscle fatigue, and severe headache. Clocked in at work at 0530 and could only work til 7am as symptoms were getting worse. Went home took temperature with tongue thermometer and was running 101.5 fever... proceeded to take X2 IBU Profin then in another 4 hrs took Tylenol. Rotated them every 4 hrs. By 01/21/21 evening still had fever and headache but chest pain was gone. By 1/22/21 morning all symptoms had subsided except for the red circle around the injection site which is still warm to the touch.  Employee reports fever, nausea, vomiting, severe headache, muscle pain, joint paint. Employee reports missing a day of work due to side effects, is feeling better today 1/22/2021, still has nausea from stomach and injection site looks like a red flower all the way around it.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient fainted after receiving the flu vaccine attended patient they wer responsive after and aware
patient received ActHIB with expired diluent with no reported adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01182877  This case involves a 1-year-old female patient who experienced patient received HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3) (Mmrvaxpro) for Prophylactic vaccination; Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination; and Pneumococcal Vaccine (Pneumococcal Vaccine) for Prophylactic vaccination.  On an unknown date in 2022, the patient received ACT-HIB vaccine ACCINE (lot: UJ524AA, expiry: 11-Jul-2022, lot: U6998BA, expiry: 25-Jun-2022) at unknown dose once intramuscular route in the right thigh for immunization (expired product administered, same day latency).  It was reported that "Health care professional (HCP) reports patient received Act-HIB with expired diluent. She said she thought the year was 2025 but that the day was 25."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.95.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
w/in 4 hrs p/vax pt exp generalized urticaria which would come & go, but never totally resolve; mother reported that during the noc, pt had low grade fever & urticaria worsened; tx included DPH/Calamine lotion & cold compresses;
Patient experienced apprehension, flusing and numbness and tingling, patient moved to the floor in a supine position and was monitored by staff at medical center.  Patient left on her own after observation.
not feeling well; tremors (symptom of Parkinson's which he has but they had been under control with medicine); Gout which has flared occasionally but had not caused problems recently; tremors (symptom of Parkinson's but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently; This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included Parkinson's and gout. The patient didn't have COVID prior to vaccination. Concomitant medications were not reported. The patient with other health problems got vaccinated. Next day was not feeling well and the day after was admitted to the hospital complaining of tremors (symptom of Parkinson's which he had but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently. Adverse events started from 30Jan2021. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Treatment received included medication for tremors. The outcome of the events was recovering. COVID was not tested post vaccination.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), METHYLPREDNISOLONE and CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONE (CIPROFLAXINA HC LAZAR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details also included steroids and allergy medications.  Treatment information was not provided.
Initial misuse report received from a healthcare professional on 13 January 2014. A patient (demographics unknown) had received a dose of DAPTACEL on an unspecified date. It was reported that during vaccination, syringe or needle leaked and patient did not receive full dose resulting in vaccine under dose. No adverse event was reported. List of documents held by sender: none.
anaphylaxis reaction; severe allergic reaction; throat closing up/throat started swelling; dizzy; lack of appetite; vertigo; headaches; started to feel hot; breaking out in a rash/skin began to break out; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criterion medically significant), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), VERTIGO (vertigo), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out) had resolved and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included: Epinephrine given in hospital, Benadryl and Predisone Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Swollen lymphnode in left armpit 48 hours after vaccination. Developed red mottled rash. 7 days post vaccination, skin around vaccination site became grey & flaked off. Resolution 3 to 4 weeks post injection. No treatment provided.
Nausea and dizzyness started at 2 AM,  about 9 hours after the vaccine.  3 incidences of syncope occurred in short succession thereafter. Checked ECG on apple watch and I was in atrial fibrillation with a heart rate over 160. Went to ER when I was able to get childcare. A Fib had stopped by about 5 AM, high heart rate continued until about 7 AM. They treated me for dehydration and tested me for multiple things - all negative. I am still dizzy and nauseous. I am feeling a little "fuzzy" in the head.
Took second dose of Vivotif two days after taking first dose and took subsequent doses correctly; Spontaneous report received on 02NOV2020.  A healthcare professional reported that a male consumer "took second dose of Vivotif two days after taking first dose and took subsequent doses correctly" (PT: Inappropriate schedule of product administration). He was receiving Vivotif for immunisation. On 28OCT2020, Vivotif was dispensed to consumer and he took the first dose of Vivotif on same day. The consumer took his second dose incorrectly after a gap of two days (on 31OCT2020) instead of every other day as recommended. He took his subsequent dose correctly. He had not taken all four doses of Vivotif yet. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif two days after taking first dose, and took subsequent doses correctly (inappropriate schedule of product administration). Vivotif doses should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif two days after taking first dose, and took subsequent doses correctly (inappropriate schedule of product administration). Vivotif doses should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated orally with ROTATEQ, (lot number reported as K002939 and expiration date 16-JAN-2016; lot number K007244 and expiration date 16-MAR-2016) dose and frequency were not provided, which, on an unknown date, underwent temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
10/11/16 Child r/d Tdap on 6-20-16 @ Dr's office w/o incident. Today patient rc'd HPV - Men. Had LOC x 10 seconds with fixed stare, jerky movements of both upper extremities x 5 seconds, very pale and diaphoretic, vss. Client assisted to floor where he was awake but not feeling able to sit up x 10 minutes. Juice and crackers given. Reviewed VIS with Mom and when to contact Dr if needed. Recomended patient receive next vaccines in Dr's office vs. and off site clinic with HD.
Vaccine administration error of Pediatric Pfizer (age 5-11 YR) vaccine. There was an error discovered that the Pediatric Covid vaccine was mistakenly not diluted prior to administration of vaccine to child resulting in higher than authorized dose (0.2 mL of undiluted vaccine administered).  Upon discovery of error, management consulted Health Department pharmacist, Medical Director, Administration, and Pfizer. Parent was notified on 03/22/22 of error and given guidance based on CDC and manufacturer's recommendation to not repeat dose and inform recipient of the potential for local and systemic adverse events.  Mother states child has not had any adverse effects after her vaccine. States she had a sore arm, but she was able to go to school today without problems. Questions answered.  Informed to seek medical care and inform us immediately if child experiences adverse effects. Health Department to follow-up with family over the next days and week.
on and off with fever; back pain; loss of appetite which made patient loss 12 pounds; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (on and off with fever), BACK PAIN (back pain) and DECREASED APPETITE (loss of appetite which made patient loss 12 pounds) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (on and off with fever), BACK PAIN (back pain) and DECREASED APPETITE (loss of appetite which made patient loss 12 pounds). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at a dose of 2 dosage form twice a day. At the time of the report, PYREXIA (on and off with fever), BACK PAIN (back pain) and DECREASED APPETITE (loss of appetite which made patient loss 12 pounds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, SARS-CoV-2 test: normal (normal) Normal. On an unknown date, Urine analysis: normal (normal) Normal. On an unknown date, X-ray: normal (normal) Normal.
FACIAL BUMPS, RASH ITCHY, SCALP, EARS, A FEW BUMPS ON SHOULDERS
Patient given 6 month-old Immunization on a delayed scheduled. While being given the vaccinations, eyes rolled back, stiffened, held breath, went  limp-lasting a couple of minutes; after 20 minutes of observation was back to baseline. This was the first of two similar reactions. The other patient was a 2 month-old who had a similar reaction.
Vaccine was stored at refrigerated temperature, with 70 day expiration dating and expired 7/3/23. Vaccine was administered 11 days after expiration.
Covid-19 arm -  raised rash type swelling, itching, light redness.  Currently treating with generic Benadryl, which seems to be resolving issue.
Red rash on her face; It was a red rash on her face, upper body, and her two upper extremities. It was the whole arm down to wrist. The rash goes down to lower abdomen; This is a spontaneous report from a Contactable Nurse (patient, self-reported). This 72-year-old female nurse patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration, in left upper arm, on 11Jan2021, as a single dose for COVID-19 immunization at vaccination facility. Time the vaccination was given between 11:15AM and 11:30AM. The patient's medical history included penicillin allergy (she had not done nothing out of the ordinary, no introduction of new foods into diet, she took vitamins and supplements. She had a rash. She was diagnosed with Penicillin allergy a long time ago. She didn't have NDC, lot, and expiry for Penicillin that she was allergic to. She assumes Penicillin was different. She didn't know if it was something in Penicillin or if it was the Penicillin it-self she is allergic to). Historical vaccine included Shingrix and Flu vaccine and had normal side effects. Concomitant medication included trazodone (she has taken trazadone for years). The patient reported that she received first dose on 11Jan2021. On 14Jan2021, she developed a rash, and she was not sure if it would be considered severe or moderate on the third day after vaccine. It was a red rash on her face, upper body, and her two upper extremities. It was the whole arm down to wrist. The rash goes down to lower abdomen. The rash started very close to 72 hours after vaccine. It could have been around 12 pm on 14Jan2021. She took Benadryl and within a couple of hours the rash was gone. She had no other symptoms like shortness of breath. She was due for second dose this coming Monday. She was concerned whether the second dose will produce the same delayed symptoms or more severe symptoms. She was afraid of anaphylactic reaction. She was just under 5 foot 3 inches. The event did not require a visit to emergency room and physician office. The seriousness criteria included that she would say not serious because it didn't affect her respiratory or blood pressure. The reason she was calling was because after reading the brochure that came with the vaccine a bad rash all over the body was one of the side effects listed under severe allergic reaction. That stood out and asked was the rash she described considered severe or moderate. Outcome of the events was recovered on 14Jan2021.  Follow-up attempts are completed. No further information is expected.
About 6 months after receiving the 3rd shot I began to experience severe, reoccurring abdominal pain to the point where it hurt to breathe if I stood up. It happened nearly 10 times within a year after vaccination. Pain would cease sometimes for 6 months then happen sometimes weekly for the next couple months. I was diagnosed with gallbladder disease in March of 2012 which I believe was caused by the Gardasil shot and I am scheduled for surgery to have my gallbladder removed next week.
10 cm x 10 cm red, warm, swollen,  & rash area around injection site (L) arm.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB. Strength, dose, route and lot number were not provided. RECOMBIVAX HB was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014; Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range from 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004216 and 1405USA002823). Additional information has been requested.