chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On January 21, 2021 at the Prospect COVID 19 Vaccine Clinic, an orthopedic 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 (a RN). 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 lead APRN, who escalated the situation to the operations manager. The operations manager then contacted the Chief Quality Officer. 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.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 79 years old female patient who was vaccinated with two dose FLUZONE HIGH DOSE, lot UJ024AC via unknown route in the left deltoid on 01-Oct-2018 and 22-Oct-2018 instead of PNEUMOCOCCAL VACCINE. The patients past medical history, medical treatments, vaccinations and family history were not provided. It is an actual medication error case due to extra dose administered and wrong vaccine administered. It was reported that the patient had two doses within 3 weeks of interval instead of PNEUMOCOCCAL VACCINE for the second dose of FLUZONE HD. It was reported that no adverse reactions were found. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
About 11 hours after vaccine, my temperature went up to 101.5 - pounding headaches and dizzy. No digestive issues this time. My arm was very sore again - not quite as bad as first time. Body aches - general. I woke up drenched in sweat about 4 am in the morning - I went and took a shower and went back to bed. Tuesday, temperature was doing up and down - 100.5 or .6 down to 96.7. Normally I'm 97.2 or 97.4. My arm was sore. By Wednesday, I was feeling much better - 99.3 - 99.8 (may have not hit 100 degrees). My arm was sore but not as achy so it was better on Wednesday. By Thursday, I was feeling a lot better. It didn't last as long as first dose.. I was able to work after that.
Hard Chills, nausea, fatigued, slight cough, headache started early am., very sore arm started 2/1/21 in evening.   All symptoms started getting better after 3:30 pm 2/2/2021 which would have been 24 hours since injection.
Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot # unknown) injection. The physician reported that the patient experienced severe pain after receiving the third dose of GARDASIL vaccine (yeast). No additional information was provided. This is one of two reports from the same source. Additional information has been requested.
SHE SLEPT FOR 3 HOURS RIGHT AFTER THE SHOT.  SHE BEGAN RUNNING A FEVER UPON AWAKING, STATED HER HEAD WAS HURTING, THEN A HALF HOUR LATER STARTED VOMITING.  SHE VOMITED OFF AND ON FOR 3 HOURS OR SO.
Patient began experiencing ascending bilateral arm parasthesia on 11/16.  On 11/17 this progressed to her legs with weakness to all extremities.  She presented to ED and was admitted and treated for Guillain Barre Syndrome.
The past previously got Moderna Bivalent booster on 10/10/2022. No harm came to patient only an extra booster vaccination that did not count.
Since obtaining vaccine heavy mentural period since September of last year. Never experienced that before. As well as swollen lymph which results in need for steroid treatment
ASYMTOMATIC AT THE TIME OF THE FIRST DOSE ADMINISTRATION ON FEBRUARY 16.  FOUR DAYS LATER  THE ATTENDANT TAKING MY BLOOD PRESSURE REPORTED A HEARTBEAT RATE OF 74 bpm,  WHICH IS 34 bpm HIGHER THAN MY AVERAGE RATE AT REST.     I HAVE CHECKED THE HEARTRATE  MYSELF  PERIODICALLY SINCE, AND IT HAS STAYED AT 75-80  bpm.
Information has been received from a nurse (also reported as a health professional) concerning an 8 year old male with attention deficit/hyperactivity disorder and no known allergies who on 02-MAR-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 mL SC in the left thigh (Lot # 632037/1355J). Concomitant therapy included methylphenidate HCl (CONCERTA). The nurse reported that the patient had developed chicken pox on 26-MAR-2007. The nurse reported that the patient had not improved and sought unspecified medical attention. Follow-up information was received from the physician. It was reported that the patient was an 8 year old Caucasian male experienced maculopapular rash with blistering with no other symptoms. Concomitant therapy included methylphenidate HCl (CONCERTA) daily. There was no illness at the time of vaccination. The patient recovered. No further information is available.
ADMINISTRATION ERROR! I went to the pharmacy to get my flu shot--- and at 3:10 p.m. on September 16th 2021 was given INSTEAD --- BY ACCIDENT OF THE TECHNICIAN---- THE PFIZER VACCINE INSTEAD OF THE FLU SHOT.  I  had the PREVIOUS 2 Pfizer VACCINES in FEBRUARY 2021 and a 3RD PFIZER (recent booster) in AUGUST 2021... ( I had my Pfizer vaccines in February 2021 and I had my booster August 8th 2021. ) SO THEREFORE I HAVE NOW RECEIVED A 4TH(FOURTH) PFIZER VACCINE BY ACCIDENT on September 16th 2021.      That is 4 VACCINATION DOSES in all of the PFIZER VACCINES . I'm concerned because of getting that extra vaccination.  I also got the flu shot afterwards on 9/16/2021-- because I asked that I receive the flu shot-- since that is what I came to the pharmacy to get originally before the mistake was made.
I became easily agitated and my right shoulder and joint became stiff and painful (9 out of 10 pain) since the first injection  3/12/21.   I was in a fair mood prior to the second injection. Shortly afterwards I experienced the normal side affects but also the irritability x 1 day. Right shoulder and injection site continues to hurt (7 out of 10) with movement.
About 4 hours after receiving his first COVID-19 vaccine, the patient noted that his cheeks were red.  About an hour later, as he was going to bed, the patient's wife said that his chest and back were red.  He took one dose of Benadryl, went to bed.  He awoke the next morning asymptomatic.  He denied having generalized pruritic, hives, angioedema, respiratory, airway, GI, or cardiovascular symptoms.
High Blood Pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood Pressure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Yearly, IM and Fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Pollen allergy and Dust allergy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In September 2021, the patient experienced HYPERTENSION (High Blood Pressure). At the time of the report, HYPERTENSION (High Blood Pressure) had not resolved.            Concomitant medication was not reported. Patient was taking High Blood Pressure Medication (Unknown brand).   This case was linked to MOD-2022-548401, MOD-2022-547040 (Patient Link).
My first dose of the vaccine I broke out in a rash face, neck and chest. They were red like bumps and extremely itchy.  The rash covered the bottom half of my body and it was the same experience. Red, small bumps, itchy, and painful rash with my 2nd and 3rd dose. I have not fully recovered from the rash as the rash comes and goes often and causing itchiness. I was prescribed a steroid cream anytime the rash flares.
Patient received COVID19 Pfizer-BioNTech vaccine, remained in observation for 30 minutes (per immunizer request) since patient had taken a dose of Benadryl prior to vaccine. Patient left vaccine clinic and was in car with husband when she thought she noted mild face swelling and she also started to feel light headed. She returned to vaccine clinic where VS were taken: BP 180/111 HR 76 - 85 O2 sat 99%. She denied SOB or difficulty breathing. She reported taking BP usually running 117/70-80 while on her BP meds. Patient referred to Hospital ED for further evaluation. Walked patient over to room after speaking with RN.
Patient received flu vaccine at clinic through Health Department.  Patient called to day to report that she has pain at the site and when she raises arm overhead.  In am, upon rising, has to do ROM exercises to get the arm functioning.  Does not take OTC medication of any kind so tried heat with no improvement.  Has not discussed symptoms with physician.  Instructed to follow up with physician and provide update after visit.
Slight itching near vaccine site on day 6-7 after vaccine, then on day 8 there was a swollen, erythematous, painful area ~4cm in diameter below injection site.  Saw primary care doctor and was started on Bactrim because of history of MRSA abscess 10 yrs ago.  Rash enlarged throughout the next 24 hours, was ~4 inches by day 8 still tender. Later on day 8, pain and swelling decreased but redness increased On day 9, there was little pain but now lesion included darker center with ring (target-like) and still large, ~5 inches
This spontaneous report was received from the patient's mother referring to his 12 year old son. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, lot number and expiration date were not provided) for prophylaxis. On 13-NOV-2017, after three hours of receiving the PNEUMOVAX 23, the patient experienced injection site pain, fever and difficulty sleeping. The next day on 14-NOV-2017, the patient experienced vomiting, nausea and chills. No treatment was given. At the time of the report, the outcome of pyrexia, vomiting, nausea, chills, insomnia and injection site pain was reported as not recovered. The reporter did not assess the relatedness between pyrexia, vomiting, nausea, chills, insomnia and injection site pain and PNEUMOVAX 23.
got the COVID vaccine and the second shot threw her for a loop and she developed flu like symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 55-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "got the COVID vaccine and the second shot threw her for a loop and she developed flu like symptoms.".  Additional information: The reporter reported on behalf of her mother. Patient's mother got the covid vaccine and the second shot threw her for a loop and she developed flu like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheadedness, shaking. H/o of passing out. Cleared by EMS and NP
Kawasaki disease diagnosed after 6 month vaccines. Of note, this was his first PCV20 immunization. Documentation suggests immunization 8/22/23 and fever, rash, nasal congestion 8/27/23 but parents deny nasal congestion/ viral symptoms being present at that time. RPP was negative. Admitted 8/29 with fever and rash; discharged 9/2/23. IVIG given 2 mg/kg 9/1/23. Aspirin given and stopped after discharge. No cardiac sequelae; discharged from cardiology.  Also interesting, I do not see record for checking COVID-19 antibodies during hospitalization. There is significant overlap between MIS-C and Kawasaki disease. I wonder if MIS-C could have been possible after very mild COVID-19 infection sometime in the prior months.  I did report this to VAERS since this would not typically be a vaccine reaction we think of. Especially with new PCV20 vaccination, this was reported.
An apparent hypersensitivity. Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Significant change in demeanor, dizziness, fatigue, Weakness, Eyes roll back, Sweats, Rapid breathing, Tiredness, Nausea, Insomnia, High pitched cry lasting hours.
Redness, swelling, painful, warm to the touch. Defined area. Worsening throughout the day. Approximately 2" in diameter. Recommended ice, ibuprofen, benadryl. We have had multiple patients with similar adverse reactions following pneumonia vaccine.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot#M047666, expiration date 24-OCT-2019; lot#N003701, expiration date 01-NOV-2019) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003595: US-009507513-1709USA003596: US-009507513-1708USA008381.
After vaccine administration, patient was bleeding from site and a bump under the skin was left on deltoid muscle.
Not an adverse reaction however, wrong drug was administered to the patient. Patient was 5 at the time of the visit was given Pfizer 6m - 4y instead of the correct drug which should have been Pfizer 5 - 11 y/o.  On call MD was contacted suggests that this patient should not receive the 6 months to 4 but should receive the appropriate age group vaccine to complete their series which would be pfizer 5 - 11.
Localized erythema and swelling above and around deltoid noted by mom a day and a half after vaccination. 10 days later still with 10cm x 8cm erythema. Treated with few day Augmentin for mild cellulitis. Still slight redness.
Initial report was received from a consumer, who was also the patient, on 08 October 2012. A 47-year-old female patient had received an intramuscular injection in the deltoid of FLUZONE, lot number UH752AA, on 04 October 2012 and experienced wheezing, cough, tight throat and temperature of 38.8 degrees Celsius (100 degrees Fahrenheit). The patient self treated the events with PULMICORT inhaler, cough syrup with codeine and ADVIL. The symptoms resolved. The patient was not acutely ill at the time of vaccination. The patient had a past medical history of gastroesophageal reflux disease (GERD), high cholesterol and pneumonia. The patient received an influenza vaccine 15 years ago. The patient's outcome was recovered. Documents held by sender: None.
Information has been received from a registered nurse concerning a 29-month-old white male who on 10-FEB-2006 was vaccinated subcutaneous (lt) with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649992/0791R). Concomitant vaccine received on 10-FEB-2006 included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # B08640A). On 23-JUL-2007 the patient presented during a medical visit with fever and a rash, and was diagnosed with varicella. It was reported contacts at the patient's daycare were also diagnosed with varicella. The patient's symptoms were treated with an unspecified therapy with no complications. At an unspecified date the patient recovered from all adverse events. Follow-up information was received on 19-SEP-2007 via a phone call with the doctor's office. It was reported the patient had chickenpox and his daycare center was positive for other children having chickenpox. The doctor's office does not know how many kids at the daycare center had chickenpox. Additional information is not expected.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site nodule. On an unknown date, the outcome of the fever and injection site nodule were unknown. It was unknown if the reporter considered the fever and injection site nodule 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 had fist size knots at injection site and fever. Because of adverse reaction, the patient was advised by the reporter's office that not to get 2nd dose. This case linked to US2018GSK142323, reported by the same reporter.
9/15/13 10:26AM pt received pneumonia and flu vaccines. Right after vaccination pt c/o her throat and tongue swelling. EPI-PEN given. Vitals after EPI-PEN 116/69 - 97.9 - 68 - 16. O2 sat 100% on room air. Sent to ER for eval. Treated with prednisone and BENADRYL for hives and resp. reaction. Returned to facility several hours later feeling better. Pt completely recovered.
administrated only diluent portion; administrated only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva6028, expiry date 31st August 2022) for prophylaxis.   On 1st March 2022, the patient received Menveo. On 1st March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was inadvertently received only the diluent portion of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No further events were reported.  The reporter did not consent to follow-up.
Patient is saying she has had a sore arm sometimes severe pain also in shoulder since getting the flu vaccine in that arm. She also says sometime the pain is there & sometimes there is no pain.
The patient woke up at 4:00am with sneezing, headache, nausea/vomiting, and tingly tongue. The vaccinated arm was red and swollen. There was no other swelling elsewhere on the body. The patient had completely recovered when they presented to the pharmacy today.
Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms.  He felt awful over the weekend and spoke to his doctor on Monday, 3/1.  The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.
Patient noticed red rash on right forearm/wrist area when reaching for phone, otherwise, she denied further symptoms. No breathing complications or edema noted or reported. Continued to assess area, approximated 3 x 2 inches on lateral aspect of Right forearm. Area slowly increasing. No other symptoms noted/reported. BP 112/86, Resp. 18 BPM. BENADRYL 50 mg/ml administered IM (0.5ml) in left deltoid. Continued to monitor area, stopped increasing in size. No further symptoms noted.
Within 10 minutes of receiving first dose of Moderna COVID 19 vaccine, pt complained of scratchy throat, and flushing, prickling sensation on face and head. Pulse of 80 and bp of 130/90 obtained with pt stating that is higher than usual. Within 10 additional minutes, pt complained that throat was more scratchy, and her voice was becoming noticeably hoarse. Benadryl 50mg IM given in left deltoid and pt continued to be monitored. Within 10-15 minutes, the prickling and flushing sensation was reported to be resolved and throat was feeling less scratchy, although pt complained of a bad headache. She reports a history of chronic migraines. 15 minutes later all symptoms but headache resolved. Pt felt well enough to leave. She waited an additional 15 minutes and was accompanied home by her coworkers.
15 minutes post vaccination administration I developed tingling of the tongue and bilateral arms. I also had an increase in heart rate from 70 to 130. I felt a pounding in my chest. It felt difficult to talk to due tingling of the tongue.  I took Benadryl 25 mg PO 30 minutes prior to vaccine due to history of anaphylaxis with shell fish.
Throat began to swell shut and itch within minutes of receiving vaccine.  My heart rate and blood pressure were high with difficulty breathing.  I was given a dose of liquid Benadryl then a second dose when the first dose didn?t work.  Within one day of receiving vaccine, I developed approx 5-8 raised itchy red/purple bumps.  They were located on right arm (shot was given in left arm), left leg, chest, and torso. I did take a couple pictures.  These went away after a couple weeks with hydrocortisone cream.  Typical swelling at injection site with no other illness.
Immediately after the shot I felt sick, light-headed. Also the tattoo I had done that was healing/scabbing over had stopped healing and was weeping pus, color was falling out, which was unlike how any of my other tattoos had healed. I got a bump on the tattoo of the same arm as the vaccine and the bump caved in, opened up, widened, and it had a bad smell. My whole arm was puffed up and it hurt. A couple days after the vaccine I woke up in my bed with a concussion and couldn't remember anything from the day before. It hurt with a sharp stabbing pain unlike previous concussion I'd had. I went 5 days without sleeping, couldn't eat, and they could not find any reason for why the tattoo was infected.