chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe and intense left arm pain starting 2 hours after administration. Limited motion in left arm. Pt used heating pad and Tylenol to treat pain but with no effect on pain. Pt was prescribed acetaminophen-codeine to treat the pain, no effect on pain. 5-6 days later, pt noted a decrease pain. Spoke to pt on 9/22, still notes a limited range of motion.
Patient received Janssen Covid vaccine. He then becam diaphoretic, dizzy and nauseous. Patient went to restroom and was found sitting on the floor.
-Appendicitis  June 8th started with an upset stomach, loss of appetite and nausea. On june 11th at 11:30am severe stomach pain.
Initial report was received from a health care professional on 13 December 2011. A 59-year-old female patient had received an injection of FLUZONE, sanofi pasteur, lot number UH463AB (route and site of administration not reported) on 19 October 2011 and three days later, she developed ringing in the ears. Hearing tests were performed on 12 December 2011 and the report was pending. The patient had no known allergies and took ALLEGRA concomitantly. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none. The follow up information received on 07 May 2012: The patient had history of neomycin allergy, when she applies it topical and was told that this shot contain neomycin like product as well. The patient otherwise had allergies to erythromycin, ciprofloxacin and IV contrast. The patient reported that 10 years ago she had shingles on the left side of her face and had vesicles and was not sure whether there was any hearing loss associated with it. The patient denies any vertigo. Denies any hearing change, although states that she favors her left ear and always had slight difficulty with speech discrimination. The physical examination revealed blood pressure- 112/70, Respiratory rate- 20 and Temperature: 97.3. Nose: nasal examination shows mild rhinitis, septal deviation towards left more than right with large turbinate. Oral cavity: normal findings. Neck: No abnormalities. Ears: No any overt skin changes. Ear canals show chronic eczematoid changes. No sign of acute inflammation. The patient underwent audiogram and tympanogram which showed a slight asymmetrical high frequency sensorineural hearing loss, worse on the right than on the left. The patient underwent an ABR which showed no evidence of any retrochochlear pathology. The patient had subjective tinnitus with mild sensorineural hearing loss on the right side. The patient still not recovered from the event.
Flushing/sweating, light-headed. Vitals wnl. Patient placed on cot until stable.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. From August 2014 until the time of reporting, these patients were vaccinated with GARDASIL (lot#, dose not reported) which were improperly stored. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
She received PNEUMOVAX on her left deltoid (IM) started to have swollen left upper arm and fever max 101.0 next day. She came back to our clinic for follow up on 10/15/12. Her left upper arm had 13 x 17 cm erythematous mildly swelling with 6 x 5 cm light colored ecchymosis. Mildly tender to prep.
Information has been received from a physician's assistant, for the Pregnancy Registry for Gardasil concerning a 21 year old white female with pelvic inflammatory disease and a history of gastrooesophageal reflux disease and penicillin allergy. On 04-DEC-2006 the patient was vaccinated with the first dose of Gardasil (Lot # 653736/0868F) 0.5 mL IM in the left arm and on 23-MAR-2007 with the second dose of Gardasil (Lot # 657006/0188U) 0.5 mL IM. Concomitant therapy included PREVACID and NESTABS FA TABLETS. The patient developed abdominal cramps on 23-APR-2007 and presented to the doctor's office. Medical attention was sought. Serum beta-human chorionic gonadotropin and urine beta-human chorionic gonadotropin tests were performed to confirm pregnancy. The patient was referred to a Ob/Gyn for follow-up care. No additional information was given. The date of the last menstrual period was 14-MAR-2007, the estimated conception date is 28-MAR-2007 and the estimated delivery date is 20-DEC-2007. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician's assistant for the Pregnancy Registry for GARDASIL concerning a 21 year old female with pelvic inflammatory disease and a history of gastrooesophageal reflux disease and penicillin allergy. On 04-DEC-2006 the patient was vaccinated with the first dose of GARDASIL (Lot # 663736/0868F) 0.5 mL IM in the left arm and on 23-MAR-2007 with the second dose of GARDASIL (Lot # 657006/0188U) 0.5 mL IM. Concomitant therapy included PREVACID and Nestabs FA tablets. The patient developed abdominal cramps on 23-APR-2007 and presented to the doctor's office. Medical attention has sought. Serum beta-human chorionic gonadotropin and urine beta-human chorionic gonadotropin tests were performed to confirm pregnancy. The patient was referred to a Ob/Gyn for follow-up care. The date of last menstrual period was 14-MAR-2007 the estimated conception date is 26-MAR-2007 and the estimated delivery date is 20-DEC-2007. No additional information was given. Follow-up information was received from a healthcare worker. The health care worker indicated that the patient delivered a normal healthy baby girl. Additional follow-up information was received. The baby was born on 16-DEC-2007 weighed 5 pounds and 12 ounces. The length was 19 1/2 inches and was 48 weeks from LMP. The head circumference was 12 1/2. The patient had a low fundal height and her pitocin was enhanced. On an unspecified date an ultrasound was performed. Additional information is not expected.
Nausea and vomiting the morning after receiving (2nd) dose the previous evening. General malaise. No fever.
Patient received improperly stored vaccine. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, the patient will need revaccination information about pregnancy is unknown
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media via a company representative concerned a 64-year-old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 01, 01 total, was administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 01).  The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 02, 01 total, was administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient (reporter's buddy) experienced suspected covid-19 infection and had suspected clinical vaccination failure (Dose number in series 2). As per the reporter, "My buddy got his shots and still died when he got coronavirus disease (COVID-19)". On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported and suspected covid-19 infection was fatal. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000218432.; Sender's Comments: V0: 20220248641-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220248641-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
10x11 cm area of redness, induration, warmth around left deltoid. 1 day after immunizations. ? tender.
PRESENTED 08/18/21 TO GET HER SECOND COVID VACCINE AND TOLD ME ABOUT HER REACTION TO FIRST.  THE DAY AFTER RECEIVING HER FIRST DOSE SHE WAS RIDING A LAWN MOWER AND HER LEGS STARTED TO GO NUMB AND FEEL REALLY HEAVY.  THEN WITHIN 30 MINUTES IT WAS IN HER ARMS TOO AND SHE COULD BARILY MOVE.  HER HUSBAND HAD TO HELP HER INTO THE HOUSE.  THEY DID NOT REPORT THE SYMPTOMS TO ANYONE.  IT PROGRESSIVELY IMPROVED OVER 4 DAYS.  I WAS WORRIED IT WAS GBS,
Fatigue, joint and nerve pain, muscle pain, headaches, memory loss, gastrointestinal issues, sleep apnea, insomnia, respiratory and neurological disorders, unexplained rashes or other dermatological signs or symptoms, allergic, neuropsychological signs.
The next morning after receiving the 3rd dose I woke up with sizable swelling on the underarm lymph node on the side of my body which caused pain. Throughout the day I pressed on it to help disperse the fluids because the swelling wasn't hard. It just felt like it was filled with fluid. It got painful enough for me to take Tylenol to help ease the pain throughout the day. It did disperse a bit by the next day but continued until today. I'm calling my doctor to see if they have any suggestion or remedies for the swelling because I'm a little concerned with how my body reacted. I had no injection site reaction at all.
slight sore on the arm; This is a spontaneous report from a contactable consumer (parent). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28Jan2021 as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced slight sore on the arm after vaccinated on 28Jan2021. The outcome of the event was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
metallic taste in mouth, feeling of swollen lips, blurry vision, lethargy, nausea, headache, body aches. Started in am of day after vaccine received - 2/7/09. continued until afternoon of 2/9/09. did not seek medical treatment.
CHILD'S DATE OF BIRTH WRITTEN AS 11/2/2008 AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS DAD. CHILD'S ACTUAL BIRTH DATE IS 11/2/2009. CHILD TOO YOUNG FOR VACCINE ON 7/24/2021.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (strength, dose and route of administration were not reported) lot # M041768, expiration date 25-JUN-2018, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA005415: US-009507513-1708USA005626: US-009507513-1708USA005627:
Patient had breast cancer (Right) gave PNEUMOVAX 23 in left deltoid. Patient arm to bicep is swollen - Req. also under DR arm pit - has Dr. appt. 1/26/17.
acute progressive lower extremity weakness, beginning on 7/25.  Worsened and seen in a different ED, on 7/30.  Observed overnight and family felt patient was better.  DCd on 7/31, but progressively got worse.  Seen again on ED 8/2 and transferred to our care for inpatient visit.  Patient is on day 3/5 IVIG treatment today.
patient reported having a metal taste in her mouth after taking the first dose of the pfizer covid vaccine while on; This is a spontaneous report from a Pfizer-sponsored program from a contactable other health care professional (HCP) and a contactable consumer (patient). A 58-year-old female patient received first dose of  bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) 11 mg, oral from Feb2021 (Lot number was not reported) and ongoing at 11 mg daily for rheumatoid arthritis. Medical history included right total knee replaced 7 years before the time of the report and left total knee replacement on 21Apr2021 as outpatient. Concomitant medications were not reported. Patient reported having a metal taste in her mouth after taking the first dose of the pfizer covid vaccine while on tofacitinib citrate. No exact dates, further details reported, and md is aware. Patient reported (per md order) she had been off of tofacitinib citrate since 25Apr2021 due to having taken the second dose of the pfizer covid vaccine. Action taken in response to the event for tofacitinib citrate was dose not changed. Outcome of the event was unknown.  The information on the batch number has been requested.
booster; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; fatally sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick"; ILLNESS (non-serious), outcome "unknown", described as "fatally sick". Reporter's daughter mentioned that she works at a small clinic in (Withheld) and all the staff there, the small staff have received the Pfizer COVID Vaccine. She reported that two of the people received the COVID Vaccine and they were given about the same time, reporter thought that they schedule to have all the staff vaccinated same time and two of them were now fatally sick with COVID, confirmed COVID cases. Reporter understand that have vaccine failure, so felt like needed to report, because it is a small group receiving a same potentially same lot of the vaccine. That they are sick after booster (COVID Vaccine). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101798362 same reporter/drug/event, different patient
Systemic: Asthma Attack resulting in treatment at Urgent; symptoms lasted 5 days
07/07/2021 1325: At approximately 1324, pt noted to lose consciousness for approximately  10 seconds after vaccination. RNs and patients mother present during situation. Patient regained consciousness and responding to questions. Denied SOB. Bp 84/67. SPO2 98% and pulse rate 61. Able to ambulate to recovery room with no issue with RN and mother closeby. BP 96/60 at 1334. 1340 Patient in stable condition. Patient's mother stated, husband with similar reaction. At 1350, patient released from monitoring. Left the facility in stable condition.
Flu-like symptoms for 48 hours, starting about 12 hours after vaccine initiated (severe nausea, aches, chills).
This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis. On 9th June 2022, the patient received Shingrix (subcutaneous). On 9th June 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional Information: GSK Receipt Date: 23-JUN-2022. Reporter's Comment: The reporter was medical assistant. The reporter stated that, The patient was administered with a dose of Shingrix subcutaneously instead of Intramuscular. The reporter reported that patient had no additional symptoms. Warm transferred HCP to medical information for further guidance and provided adverse event reference number. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Shingrix subcutaneously instead of Intramuscular, which led to intramuscular formulation administered by other route.
Pt received TDAP on 7/31/08. pt called the clinic 8/4/08 stating that her injection site left deltoid is warm to touch, red, swollen and the symptom is getting worst. pt feels feverish also. Since no available appt in the clinic until 8/6/08, instructed pt to go to ER to be evaluated.
My Dentist reported to me his prostate was swollen after his second shot and he had a fever.  I experienced the same thing and has been going on for a week now with sweating throughout the night.  Prostates still has  low flow and many weakups in the night that I have never had before.
diagnosed with COVID; Second dose missed, more than 36 days have passed since first dose; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (diagnosed with COVID) and ASTHENIA (weakness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).  Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, LINAGLIPTIN (TRADJENTA) and PIOGLITAZONE for Diabetes, LEVOTHYROXINE for Thyroid disorder NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (diagnosed with COVID) (seriousness criterion hospitalization). In February 2021, the patient experienced ASTHENIA (weakness) (seriousness criterion disability). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose missed, more than 36 days have passed since first dose). The patient was hospitalized from 13-Jan-2021 to 28-Jan-2021 due to COVID-19. In March 2021, ASTHENIA (weakness) had resolved. At the time of the report, COVID-19 (diagnosed with COVID) and PRODUCT DOSE OMISSION ISSUE (Second dose missed, more than 36 days have passed since first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included plasma and antiviral therapy Patient has past medical history of Diabetes Mellitus, High blood pressure and Hypothyroidism; Sender's Comments: This report also refers to a case of inappropriate schedule of product administration for mRNA-1273 with additional history of AEs of COVID-19 Infection and asthenia following first dose of mRNA -1273 with lot # 037K20A. Based on biological implausibility, the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. However for the event of Asthenia, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded This report also refers to a case of intentional product use issue for mRNA-1273,  with no associated AEs.
Neck became itchy and later broke out in what appeared to be a "rash/hives". Very itchy, slightly swollen on neck & throat area that lasted for 3 days. Treated with creme that was given to me for poison ivy which helped with itch & swelling.
At approx 23:31 03 Apr 2021 I experienced uncontrollable shaking and muscle rigidity. This lasted approximately 1 hour where upon I began to experience chills and extreme coldness. Approximately 1 hour later at approximately 01:30 I began to experience a spike in temperature around 101/102 degrees. I began experiencing shortness of breath, cough and congestion with rapid onset of nausea . Around 02:30 I had rapid onset increased heart rate, sweating, and severe headache. This lasted until approximately 07:30 on 04 Apr 2021. Upon waking I continue to experience low grade temperature around 100.4, moderate headache, joint and muscle pain, moderate fatigue and nausea.  I took 2 Tylenol arthritis beginning at 08:00 on 03 Apr 2021 and repeated every 8 hours to current time of 17:00 on 04 Apr 2021. I have also taken meloxicam QD in addition to my rescue inhaler Xopenex and Zofran ODT for nausea.
pain, redness, soreness, swelling at injection site x4-5 days mild headache, fever, muscle aches, weakness x2 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-MAR-2014 the patient was vaccinated with a first dose of GARDASIL (lot number, expiration date were not reported), 0.5ml, intramuscular. No concomitant medications were reported. On 16-AUG-2014, the patient was vaccinated with a second dose of GARDASIL (lot number, expiration date were not reported), 0.5ml, intramuscular. No adverse effects were reported. Additional information is not expected because there was no consent for follow up.
Child was not bearing weight on legs post immunization. Mother gave MOTRIN, child was able to bear weight, treatment: q 6 - 8 hours MORTIN PRN. Complete recovery by 2 days.