chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-MAY-2010, patient received improperly stored VARIVAX dose 2, from batch/lot #665413/1128Y (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Around 6 p.m., my throat tightened up somewhat significantly and lasted maybe 5 to 10 minutes. I wasn't choking, but I was coughing some. I kept drinking cold water, but it really didn't help much.
After dose #1 Redness, pain, swelling, itching at injection site. Circumference of inflamed area was approximately 2 inches x 4 inches.  Body aches, headache, chills, fatigue also experienced.  As treatment, 50mg of diphenhydramine taken every 4-6 hours and .25% Desoximetasone steroid cream used to treat reaction at injection site over a period of 4 days. After dose #2 Body aches, headache, fever, chills, fatigue.  As preventative to deter a repeat adverse reaction at injection site: 50mg of diphenhydramine taken approximately 1hr before second dose.  Then for 3 days following second dose, 50mg of diphenhydramine taken every 4-6 hours along with application of .25% Desoximetasone steroid cream twice a day.
After a run I developed a rash that start at my neck, arm pit and inner thighs and spread overnight. The next day it was at my chest whole arms and legs/feet. I took benadryl  for the next couple of days and it has gotten better. I have pictures but did not see a doctor
Information has been received from a registered nurse referring to a girl patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported. On 07-MAR-2018, the patient was vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N015475 with expiration date 18-MAY-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA011819: US-009507513-1805USA011818: US-009507513-1805USA011821: US-009507513-1805USA011822: US-009507513-1710USA004084.
Fever, chills, aches, headache onset approx 21 hours post vaccine.    Fever subsided 36 hours post vaccine but aches, etc are still occurring 48 hrs post vaccine.   Managed with OTC ibuprofen and/or acetaminophen with varying degrees of success.
On January 21, 2021 at the Clinic, an PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the APRN who escalated the situation to the manager. The manager then contacted the Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a ?near miss? event and is being reported out of an abundance of caution.
Case number PHEH2014US000529 is an initial spontaneous report received from a consumer on 02 Jan 2014: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly on 13 Sep 2013. On an undetermined date after vaccination, she experienced flu symptoms which were described as fever, body aches, chills and a cough. Outcome of the events was reported as unknown. No further information about seriousness and causality was mentioned.
Runny nose, headache, sore throat , very tired and cough for 4 days.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Within 24 hours a severe swelling (nearly double) of the injected right deltoid with heat and redness.  Placed on prophylactic antibiotics although I suspect no infection at the time.   Recovered 3 - 4days.
No A/E; Nurse calling to report temperature excursion. She states PROQUAD was administered/Which point in the process the medication error ocurred: Administration/Storage in clinical practice; Which point in the process the medication error ocurred: Preescribing; Which point in the proecess the medication error ocurred: Dispensing; Which point in the proecess the medication error ocurred: Preparation for administration; This spontaneous report was received from a nurse concerning a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot# W023870, expiration date: 24-JAN-2024, 0.5 milliliter administered subcutaneously as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), after the vaccine underwent a temperature excursion (Product storage error). According to the reporter, the medication error occurred at the prescribing (Product prescribing issue), storage in clinical practice, dispensing (Product dispensing issue), preparation for administration (Product preparation issue) and administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Additionally, the patient was previously vaccinated with another dose on an unspecified date.   It was reported that the vaccine was stored at the following temperatures: 14 Fahrenheit degrees (F) up to 46 F (33.4 F) for 8 hours and 45 minutes; 14 F up to 46 F (28.6 F) for 5 hours 11 minutes; 14 F up to 46 F (20.3 F) for 7 hours 46 minutes; 14 F up to 46 F (19.9 F) for 7 hours 56 minutes; 14 F up to 46 F (15.6 F) for 41 minutes ; 6 F up to 14 F (6.8 F) for 12 minutes; 6 F up to 14 F (7.2 F) for 13 minutes; and 6 F up to 14 F (9.1 F) for 19 minutes. No additional adverse events were reported.
Feet are both swollen, left foot more than usual; feet and he uses walker but now they are so swollen and unbearable; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044M20A) for COVID-19 vaccination.     Concurrent medical conditions included Leg deformity NOS (Patient uses walker.) and Walker user.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable). At the time of the report, PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter. Treatment information was not provided.
With in the 30 minutes after vaccine administration, became diaphoretic, racing heart, and shaky. Sent to ED for further evaluation
One week after receiving the injection, developed a large reddened area over most of upper arm.  Still there as of 04/04/2021. No soreness. Slight warmth to area and occasional itching but no pain.
Patient states that his body got extremely cold, to the point that his lips were blue approximately 1.5 hours after receiving the vaccine.  The patient continued to feel cold for approximately half an hour, then turned into a fever.  The patient's fever at 7:30pm was 103 degrees Fahrenheit.  He woke up again the next morning feeling groggy and his fever was still 102 degrees.  He reports no flu-like symptoms, just fatigue and a high fever,
Pinpoint scattered rash on trunk and arms; larger rash neck, ears. Reports tongue feels swollen.
a burst blood vessel in my eye; injection site pain; low grade fever; fatigue; body pain; This is a spontaneous report from a contactable consumer (patient). A adult female patient (age at vaccination 53-years-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:00 (Batch/Lot Number: EW0176) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Known Allergies: Seasonal allergies. The patient has no covid prior vaccination and not covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Pharmacy/drug store. Concomitant medication included drospirenone, estradiol (ANGELIQ); cetirizine (CETIRIZINE) and; fluticasone (FLUTICASONE, reported as 50), all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6204) first dose on 15Apr2021 13:45 PM at the arm left for covid-19 immunization. It was reported that on "Saturday afternoon, about 48 hours (08May2021, 05:00 PM) after the shot, I noticed a burst blood vessel in my eye, which is atypical for me. I had not been coughing or vomiting, had only experienced low-grade fever, fatigue, body pain, and injection site pain since receiving the second shot." The outcome of the events was recovering. No treatment was initiated. Events were considered serious by the reporter.   Information on Lot/Batch number was available. Additional information has been requested.
Began with scattered papular rash to upper back and chest, spreading down to trunk, some were fluid filled
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL, on 30-DEC-2015, with the second dose of GARDASIL, and on 03-MAR-2016, with the third dose of GARDASIL (route of administration, lot number and expiry date for all three doses were not reported). It was confirmed that, it was not GARDASIL 9. No adverse symptom was reported. Concomitant therapy was not reported. Additional information has been requested.
Friday following vaccine client felt fatigue. 1 day post administration of vaccine (Saturday), client stated "my left arm was red and itching with small welt" client apply hydrocortisone ointment. Return to office Tuesday, October 29. Rash Lt. arm 14x14, red.
How long will muscle pain last after do you have the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long would the muscle pain last after do you have the vaccine. For tolerance after 2nd dose refer case US2020AMR072631.
2 month-old healthy baby boy received his 2 months shots, Hep B, PCV13 in the right leg, PENTACEL in the left and oral Rotavirus at 10:00am. He was fussy most of the day but feeding well and had wet diapers. By 11:00pm he had a fever of 100.7 axillary, was not feeding well and sleeping a lot/hard to wake. He was seen in our clinic on 9/8/2018 for evaluation. At that visit he had a rectal temperature of 98.9 and his exam revealed he had two areas of induration on the right thigh associated with his injection sites. No lethargy noted during that visit. One area was 1cm x 2.5cm and the other was smaller at < 0.3cm round induration. No fluctuance. Baby continued to have fever of this magnitude or lower for 3 days, have poor feeding and hard to wake. Parents describe him as "lethargic and could barely lift his head". He was treated with TYLENOL PRN and small frequent nursing. It took 1 week for him to fully recover, per parents, he did seem to recover fully. He has had 2 Well Child Checks since this event and he is growing, thriving and developing normally.
Open vial on 07/12/2021 at 9:00 am. Use by expiration date is 07/12/2021 at 9:00 pm. Vaccine was administered from open vial on 07/13/2021 at 1:15 pm. Patient was called and informed. She is doing  well no adverse side effect noticed during her 15-30 minute wait period at time of administration and called today 07/14/2021 at 10:00 am, patient has no adverse side effects.
Patient was given a pediatric dosage of 0.2ml. Patient is 14yr of age and should have been given the adult Pfizer version of the vaccine. Age was noticed by RN giving the vaccine after administration. Patient displays no adverse reaction and no harm done during administration. Mother of minor was notified of error.
2 weeks of intense nausea, confusion, foggy, fatigue, motion sickness, headache, arm numbing, heart burn, short of breath, neck pain, shoulder pain. Neck pain and shoulder pain remain at 4 weeks post vaccine. Pain level 9 on a 1-10 scale.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Patient with a history of incomplete rotation of bowel and gastroesphageal reflux. Patient into office on 1/17/05 for 2 month well child check. Patient fine at appointment time. Vaccines were administered. No problems reported. Mom checked on child at 3:00 AM on 1/20/05 and patient was fine. Then around 7:00 AM, patient was found unresponsive. Patient taken to ER. ER physician states crib death. Received medical records from PCP which revealed patient treated for URI approx 1 mo prior to death. Received Autopsy Report which revealed COD as SIDS.
Patient experienced swelling of her tongue and dizziness.  Administered 100 mg Benadryl, which lessened symptoms.
I began to have worsening fatigue and then started walking slower than normal and then started noticing cramps in legs and then calf pain and finally shortness  of breath.   The onset and progression was subtle and so I can not say over how.many weeks it occurred.  My symptoms continued to worsen and I eventually saw a dr and was worked up and confirmed to have a dvt.  2 days after diagnosis,  I progressed to having a bilateral PE.
SYMPTOMS AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced symptoms after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms after receiving vaccine was not reported. This report was non-serious.
Started with numbness and tingling throughout both legs and progressively worsening to severe full body burning/buzzing pain. Also experienced dizziness and slight loss of muscle strength/coordination. Difficulty breathing.
Wife exposed to husband's smallpox vaccination site and child who has eczema vaccinatum. Exhibited multiple facial lesions/right index finger with concomitant fever and generalized myalgia. Treated with VIG,isolation and prn analgesia. Resolution of symptoms and skin lesions after approximately 10 days.
Immediate itching/hiving @ site & lip tingling.  No other symptoms BENADRYL by mouth given + sent to ER for further obs -> no further Rx needed.  Sent home after 4 hours.
Besides soreness on the injection site, I woke up the next morning with an incessant cough.  The cough was so often and intense I developed a headache and abdominal muscle pain the following day.  This incessant cough lasted approximately 3-ish days, but a cough persisted for 3+ weeks.
Despite screening process patient was not 18 at time of vaccination. After speaking with parent of patient no adverse effects have been seen.
Patient reports soreness at site of injection, fever, night sweats and localized rash to injection site.
Blotchy skin on bilateral arms, and lower left leg and posterior Left leg. Itchy and some redness.
3/17/21-3/18/21: Nausea, vomiting, high fever (103F), diarrhea, muscle soreness & weakness, shakes, dehydration, migraine 3/19/21-3/21/21: chest tightness, muscle pain and weakness, low grade fever (100-101F), sore throat
On 6 Oct in the afternoon I experienced severe joint pain and stiffness in the right hand. I had not experienced any problems with the old arthritis since about 2002.  This subsided in about 2 hours but the hand occasionally gets achy now.  A blood draw from the back of the hand on 25 October brought excruciating pain (10) as I have never experienced.  On the 15 Oct I was on a 3 day heart monitor and had incidents of resting pulse at 150bpm.   On the 16th I was aware of feeling hot while at rest.  Temp was 100, pulse was 125.  I had experienced high resting pulse rates 3 years before and this was attributed to the Hashimoto's.  Three days later the cardiologist informed me of the intermittent tachycardia and he could not treat such fluctuations.  By now I developed a swelling of the throat, and soreness in the area of the thyroid.  I contacted my endocrinologist but he stated the tachycardia could not be caused by the thyroiditis.  This contradicts my previous endocrinologist.    Labs to test thyroid levels were severely delayed due to clerk error and showed no increase in the T3 or T4.  The thyroid is still swollen although it has decrease with use of aspirin (99 mg /day).
RECORDS INDICATE CLIENT RECEIVED ONE PREVIOUS MODERNA COVID DOSE ON 2/4/2021 FROM HEALTH DISTRICT CLINIC OR OUTREACH EVENT.
just sore arm; Initial information was received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age of male patient who experienced just sore arm after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, lot number, expiry date not reported) via unknown route in unknown administration site for Flu vaccination.  On an unknown date the patient developed a non-serious event of just sore arm (pain) (unknown latency) following the administration of influenza vaccine.  It was reported that "Gotme my husband and grandson that lived with us got our flu shot in October me my grandson got two covd one booster and fixtung to get our updated one he got his at Walgreens the Phyfer I got my two covds at health center and my booster at Walmart we didn't have one side affect from all of them."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (just sore arm).  At time of reporting, the outcome was Unknown for the event just sore arm.
mom called our office and stated that pt. broke out in a full body hives. mom gave Benadryl and hives became less inflamed