chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, 120 Y (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved, No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
On 4/5/99, the pt received his first IM left arm dose of Lymerix. Immediately following vax, the pt experienced soreness at the injection site which resolved.   On 5/13/99, the pt received th second dose of Lymerix, immediately he experienced bilateral shoulder and elbow pair which was dx as rotator cuff tendonitis left shoulder.  Medical record notes: 8/20/99, the pt experienced weakness, fatigue and abdominal distension without pain or nausea. Exam: +2, tenderness over the right lateral epicondyle, although ROM is good, no particular signs in the right shoulder. Assessment: weight gain, weakness and abdominal distention, and tendonitis. The MD advised ice to the area.  On 10/5/99, the pt denied any injury to the shoulder or elbows. He did admit to a fair amount of lifting activity at his job previously, but nothing out of the ordinary more recently. Pt has palpable tenderness over the posterior aspect of the shoulder on the left. He had painful internal and external rotation with mild restriction of both. He had mild tenderness over the Lateral epicondyle greater than medial epicondyle, left greater than right. Neurovascularly intact. Assessment of hypertension and rotator cuff tendonitis. Treatment increase Norvasc and stretching exercises to perform.  On 10/27/99, with Daypro, pain is a little better. His Mobility has also improved. However he continued to have symptoms. Left shoulder has mild tenderness in the biceps tenson insersion as well as the posterior scapular ridge area. Has full ROM although with discomfort at the extremes.   On 12/21/99, the pt finished a brief course of physical therapy without a whole lot of changes in his left shoulder. The pt did not feel that the Daypro added a whole lot either. Pain primarily with pressure or sudden abduction. Internal and external rotation just slightly limited.   The most recent information received on 3/17/00, reports the condition of the pt as unknown.
She waited the 15 min period but look flushed and said she felt some light-headedness. After 10 more mins she state hear rib on the left felt discomforted/"tightness", and some discomfort in her throat but said she did not have SOB.  She took a 5ml dose of diphenhydramine 12.5mg/5ml.  Called to to check-on on her at 7:30pm and she said "she was fine and relaxing".
I got my booster yesterday; I got my booster yesterday; arm started to hurt from the injection site; I woke up with trouble chills;  there were lot of chills; Headache; I had a pain on my lower right side by my waist going towards the back; still have that pain on my right side in the back; Fever; first this was 99 and then it was 100; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 28Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19. immunisation. Also, patient has received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE for covid-19. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, the consumer stated, okay it is not urgent or anything. I got my booster yesterday my Pfizer booster and I seem to be fine and then last night my arm started to hurt from the injection site but then in the middle of the night, I woke up with trouble chills and I had a headache. I got a headache. I am not sure if that was just from the weather but yeah there were lot of chills are very (Incomplete Sentence). That my pain and stuff. I had a pain on my lower right side by my waist going towards the back not revolving the back. So at 2 o clock in the morning, I took the sheet of medicine (Further clarification unknown) and not seems to help (Further not clarified) so I still have that pain on my right side in the back. Consumer further stated, I also had a fever this morning. Well first this was 99 and then it was 100 but I was not going to take it again (Not clarified) but I thought I take an Ibuprofen. The patient underwent lab tests and procedures which included body temperature: 99 and 100 Fahrenheit on an unspecified date. The outcome for the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Shortly after receiving the flu vaccine, patient presented with nausea, diarrhea, frontal headache. Patient was flushed and C/O itchy skin. 10:20 AM BP=115/70, P=100, R=24, blood sugar was 138. He had taken LEVEMIR 72 mg at 6 AM. Administered 25 mg BENADRYL with good effect. 10:35 AM BP=120/68, P=100, R=24. Released pt to supervisor and he went to primary MD right away. MD said remain on BENADRYL for rest of day until symptoms totally resolve.
Patient got his modern shot on August 6th, 2021 between the time of 11:00-11:15 at Pharmacy.  Less than 22 hours later he was violently ill, and started vomiting.  He also had joint pain in his right hip and was unable to walk.  For one week he stayed at home and was weak and was unable to walk.  On August 15th, Patient was brought to Hospital with c/o right hip pain.   At ER, he was diagnosed with fluid collection on right hip.  It was a rule out septic joint.  The next day he went to IR where he had 150 ml of fluid drained off his hip.  At this time they placed a drain and it was draining fluid.  The next day he was brought to OR  with Orthopedic surgeon and he had more fluid drained off his right thigh.  They said the procedure was a incision and drainage.  They pulled the old drain and placed a new drain.  He stayed in hospital 2 more days with the drain and received Rocephin and Vancomycin via IV catheter.  While he was in hospital they were treating him with lovenox SQ injection because patient kept telling everyone he was not sick or had not fallen prior to receiving his vaccination.    On Thursday he was discharged to home after the drain was pulled on just Cephalexin, and no lovenox.  On Monday August 23rd 17 days after his moderna vaccination patient died at home by what was said by the coroner as "Natural Causes" .  patient had not been to the Dr since 2016.
A serious report of lymphadenitis has been received from a study investigator concerning a female child participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. ON 18-OCT-2008, the subject received FLUMIST. The subject was admitted to the hospital for lymphadenitis on 25-Nov-2008. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the event as not related to FLUMIST.
Body aches, headache, shivering began in approx 19hrs.  Swelling under left arm /arm pit began approx 48 hrs after injection.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 8-year-old female patient who received HAVRIX Junior (batch number F3J75, expiry date 18th November 2017). On 11th February 2016, the patient received HAVRIX Junior .5 ml. On 11th February 2016, several hours after receiving HAVRIX Junior, the patient experienced fever. In February 2016, the patient experienced chills, muscle pain and headache. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever, chills, muscle pain and headache were unknown. It was unknown if the reporter considered the fever, chills, muscle pain and headache to be related to HAVRIX Junior. Additional details were provided as follows: The patient did not have any other significant medical history that the reporter was aware of. The patient was not receiving any other concomitant medication. On 11th February 2016, within a few hours after vaccination, the patient experienced waxing and waning fevers, which spiked as high as 103.1 degrees F. In February 2016, less than a week after receiving the vaccine, the patient also experienced chills, muscle aches and headache. The patient went to the Emergency Room (ER) within a day or two and she began receiving ibuprofen and TYLENOL. On 17th February 2016, the patient was seen in the urgent care clinic and it was determined that she had 2 plus protein in her urine. The reporter's call was escalated to Medical Information System.
welts all over body, worse on arms & legs, very heavy on lt leg @ site of inject; DPH given;
tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) 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.
Pain/soreness around injection site beginning approx 2 hours after vaccine. Fatigue and body aches beginning approx 11 hours after vaccine administration. Fever began approx 12 hours after vaccine -- peaked at 100.4 degrees. Treated with acetaminophen 20 hours post-vaccination, which brought fever down to 99.1. Took another dose of acetaminophen 27 hours after vaccination. Body aches subsided approx 42 hours after injection. Nose bleed 50 hours after vaccine -- this also occurred for me after receiving the first dose, but did not report.
really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.            No concomitant medications were reported.  No information on treatment is provided by the reporter.
RN administered COVID-19 Pfizer Bivalent 12+ 0.3mL to patient, RN referencing the database for immunization record at the time of vaccine preparation and administration. The database record lists 2 previous Pfizer 12+ PURPLE doses on 3/09/2022 and 3/30/2022 administered by a health care provider.  As patient is currently 11 years old, he should have received Pfizer Bivalent 5-11 year 0.2mL dose instead. Upon realizing medication administration error, RN discussed with caregiver possible side effects from incorrect age product. RN followed up with caregiver on 11/04/2022 at 8:55 am to inquire about patient's condition. Parent states "everything is normal", reports arm soreness as the only side effect experienced by patient. Denies need for pain reliever/fever reducing medications or medical attention.
No adverse effects were reported; the patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 28-MAY-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R011952 and expiration date 27-MAY-2019; strength and dose were not reported) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. There was no temperature excursion.
This spontaneous report as received from a nurse practitioner refers to a 79 years old male patient. On 24-AUG-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). Nurse practitioner stated that on 24-AUG-2012, the patient received ZOSTAVAX and had a pruritic rash that the patient had for the last 4 days. The patient was seen in the office and saw tiny fluid filled vesicles. The patient had no pain, no fever, and no chills. At the time of the report, the patient's outcome was unknown. The relatedness for patient events were unknown for ZOSTAVAX. Additional information has been requested.
Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache.
Large hives, itchy.  Low dose prednisone and benadryl for treatment.  Still have haves 3 weeks later all over body.
red band around the bicep. 3" by 4" red band that wraps around the arm that is hot to the touch. Was advised to seek urgent care if it becomes worse or severe
Nurse inadvertently administered Zostavax rather than Varivax on 6/25/15. On 6/26/15 Mother noted skin lesions on torso and right leg similar to insect bites. Child has redness and swelling at injection site. Later in day complained of pruritis and would not bear weight on left leg. Redness and warmth left kinee, redness, warmth, and swelling left ankle.
12 y/o female presenting today for her first HPV vaccine. Received seasonal flu shot earlier same day. No previous reaction to any vaccines, NKDA. Patient stated she does not have a history of fainting with vaccines. No history of seizures. Vaccine administered by NP. About 10 seconds after administration, patient stated she was feeling lightheaded. Father was present in the room and stated patient was passing out. Patient's eyes had rolled up and she was slumping sideways. NP caught patient and laid her down on exam table. Patient grunted and stiffened, seizing for about 5 seconds with hands fisted and toes pointed. Laid unconscious for about 10-15 seconds, before jerking awake. NP asked if she felt okay, patient stated she felt numb. NP asked patient if she could move her fingers, and patient shook her head no. NP tapped patient's left foot and patient was able to state where she was being touched. Patient regained movement of toes about 30 seconds after awakening, and fingers 30 seconds after that. Was able to sit up independently 2 minutes later. Patient stated she could feel the herself regain feeling starting at her toes and moving upwards. Alert and oriented x3, cranial nerves intact with full strength in all limbs. 10 minutes after seizure, patient stated she had a headache and felt tired. Recommended call to EMS for transport to ER; father declined and said he would drive her. Patient remained in clinic for 15 minutes after seizure. Seizure precautions provided, instructed to call with any questions or concerns. Patient and parent state understanding and agree to treatment plan. Patient left with father to go to ER.
SCARRING AT VACCINATION SITE; INDENTATION AT VACCINATION SITE; MASS AT THE VACCINATION SITE; LOSS OF SOME MUSCLE MASS; CUT IN ARM THAT GOES TO BONE; PAIN/TENDERNESS AT VACCINATION SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, lacunar stroke, and hysterectomy, and concurrent conditions included: low blood pressure, cigarette smoker (average 1pack/3days), alcohol use, chronic back pain from car accident (uses marijuana), seasonal allergies, allergy to penicillin, drug allergy (Heparin, Lovenox, Lasix, IV Gentimicin), allergic to bee sting and marijuana use for pain (rarely, average 1/month). Also patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 18-JUN-2021 at left arm for prophylactic vaccination. It was unknown whether patient experienced any adverse reactions following vaccination with covid-19 vaccine ad26.cov2.s. Caller stated that she had no issue with the initial vaccination The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-FEB-2022 at left arm for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On an unspecified date in 2022, within a month post the booster shot, the patient experienced loss of muscle mass so severe that she has skin on bones for which the patient was told to fix it with plastic surgery but plastic surgery was elective, also patient had the side effect of pain/ tenderness, scarring and indentation at the site on her Left arm in which she received the booster Janssen Covid-19 Vaccine and also had loss of some muscle mass with cut in her arm that goes to bone(Dose number in series 2). The patient had seen the nurse for the scarring, indentation and pain/tenderness at vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scarring at vaccination site, indentation at vaccination site, and pain/tenderness at vaccination site, and the outcome of mass at the vaccination site, loss of some muscle mass and cut in arm that goes to bone was not reported. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were unknown. It was unknown if the reporter considered the injection site pain and fatigue to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced some local pain after injection immediately, with fatigue 28 hours later. The reporter did not agree to follow up from GlaxoSmithKline.
Deep Vein Thrombosis, both legs below knee 11 days after first vaccine injection
1.5cm lump left distal thigh at site of Hib injection within 24 hours of injection. Persistent 3 day. No treatment indicated
Chest pain and shortness of breath. Difficulty breathing. Dr gave me breztri inhaler
Vaccine had expired prior to being administered.  No adverse effects noted.  Order received to administer new booster.
Red patch about the size of a quarter. Persistent itching, possibly infected from scratching. Darker area (bruise?) inside area at exact injection site. Counseled to contact primary care doctor.
Rash between neck and chest; Pain [and swelling] at the injection site; Swelling at the injection site; This is a spontaneous case initially received from other non-health professional (consumer) on 14-Dec-2018, concerning a 65-year-old elderly male patient.  The current condition of the patient included high blood pressure (reported as for many years). Patient's concomitant medication included enalapril, that the patient was taking for years for high blood pressure.  On 08-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.   On the same day after vaccination, the patient experienced pain and swelling at the injection site that went away in a couple of days. On 14-Dec-18, 6 days after vaccination, patient started having rash, not at the injection site, but between the neck and chest.  It was reported that, the patient was not hospitalized.  The patient had recovered from the events.  The reporter assessed this case as non-serious.  Follow up received from other non-health professional (consumer) on 10-Jan-2019: Added concomitant drug details (enalapril) in product tab, updated outcome of the event rash from not recovered to recovered. The narrative was amended accordingly.  Non-significant case amendment (10-Jan-2019): The follow-up sentence in the narrative was corrected from Added concomitant drug details (enalapril) in patient tab' to Added concomitant drug details (enalapril) in product tab'.; Reporter's Comments: A 65-year-old male patient experienced pain and swelling at the injection site on the same day and rash six days after administration of Fluad (TIV). The company assessed the causality of the events (pain and swelling at the injection site) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events and site specificity. The company assessed the causality of the event (rash) as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the event.
This case was reported by a other health professional via call center representative and described the occurrence of jaw pain in a 11-year-old male patient who received BOOSTRIX. In March 2016, the patient received BOOSTRIX. In March 2016, less than a week after receiving BOOSTRIX, the patient experienced jaw pain. On an unknown date, the outcome of the jaw pain was unknown. It was unknown if the reporter considered the jaw pain to be related to BOOSTRIX. Additional details provided were as follows: The medical assistant reported that a patient who received a BOOSTRIX vaccine last week and was now (at time of reporting) complaining of a sore jaw. The reporter did not provide any additional information.