chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient who experienced flublok being administered to pediatric patients with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 10-Oct-2022, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine at dose of 0.5 mL 1X lot QFAA223 , Expiration Date: 30-Jun-2023 via intramuscular route in the left deltoid for Flu prophylaxis,  On 10-OCT-2022 the patient developed a non-serious flublok being administered to pediatric patients with no reported adverse event (product administered to patient of inappropriate age) following the administration of influenza quadrivalent recombinant vaccine.  It was reported "Caller reported FLUBLOK was administered to 9 pediatric patients at a vaccine clinic today and is requesting validity information. Please reference FLUBLOK AE cases: 01314863, 01314917, 01314922, 01314927, 01314933, 01314938, 01314943 and 01314953 This situation is reported as a medication error due to FLUBLOK being administered to pediatric patients".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUBLOK being administered to pediatric patients with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patients with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
The patient had redness, swelling, tender over right anterior thigh, site of DTAP, developed approximately 15 days post injection 2-3 " diameter swelling, redness. Resolved after 4 days with warm soaks. No antibiotics.
2 days p/vax t102.5 & runny nose, nasal congestion, sore throat; seen by MD; told had a virus; raised red rash & itching; rubella test done; mom states results pos; looked like had sunburn;
Engerix B + Early 3rd dose; Engerix B Late 2nd dose and 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) and (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Previously administered products included engerix B (received 1st dose in November 2021).   On 15-MAR-2023, the patient received the 2nd dose of Engerix B. On 17-APR-2023, the patient received the 3rd dose of Engerix B. On 15-MAR-2023, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix B Late 2nd dose and 3rd dose). On 17-APR-2023, the patient experienced drug dose administration interval too short (Verbatim: Engerix B + Early 3rd dose). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-May-2023  Medical assistant reported that a female patient received a first dose of Engerix B in November 2021, a second dose on 15th March 2023, which led to later than the recommended schedule, which led to shortening of the vaccination schedule. The patient also received third dose on 17th April 2023, which led earlier than the recommended standard schedule, which led to shortening of the vaccination schedule. The reporter asked how to proceed and safety information on early 3rd dose. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter.
At time of injection had sharp pain in arm, underarm, back of shoulder spreading up neck.  Nurse apologized and told me she thinks she hit a nerve.  Later that day had sharp neck and head pain.  Iced all areas for two days and took naprosyn.  On day 3,  the arm, underarm and back of shoulder pain has resolved.  But the neck and head pain persist.  Was wondering if this is a result of the shot hitting a nerve or is it a side effect of the medicine in the shot.
Information has been received from a consumer concerning her daughter who was vaccinated with Gardasil.  Subsequently the patient experienced "brief pain, lasting less than a second" at the injection site.  No additional information was available at the time of this report.  Additional information has been requested.
I received my vaccine and then was told to go sit in the waiting area.  After 5 minutes or so I noticed my throat feeling thick like it was swelling.  I turned my head from side to side to make sure my throat was swelling (I've had anaphylaxis before).  I got up and went to one of the people in the vests and they took me to the medical tent.  They took my oxygen rate, blood pressure, and checked my heart rate.  I was given (2)  25 mg of Diphen(Benadryl) .  I was monitored till 4 pm when I was released.
Developed fever of 101.7 two days following vaccination. Along with the fever I developed redness under my eyes (Rash) more marked on the right side. Other red splotches on my face. The fever subsided by the next day but the rash continues as of 27 January 2019. It becomes redder at sometimes than others. It is worse today than it was in the beginning, I have not sought medical attention, but am planning to. I kept thinking it would get better. I have felt that this vaccine has caused a flare up of my lupus. I have had increased general feeling of burning under my skin and joint stiffness. I have taken ibuprofen and meloxicam intermittently. My joint pain is improved but the rash does not improve.
Suspected vaccination failure/got shingles AFTER getting a shot; shingles/ got shingles after getting a shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles after getting the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Nurse was giving patient her 3rd dose of Moderna covid vaccine which was not approve yet by the CDC. Nurse reported to the doctor and the supervisor. Nurse called and reported to mom also. Mom stated patient is doing fine. Nurse informed mom if patient have any reactions, make sure to call the clinic or come see the doctor.
Patient tested positive a few days after COVID vaccine; Patient tested positive a few days after COVID vaccine; This is a spontaneous report from a contactable consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE), on an unspecified date at single dose (Batch/lot number: Unknown) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient tested positive a few days after COVID vaccine. It was unknown if treatment received for the adverse event. The test for investigation of the patient was unknown, result was positive. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics,  patient general health condition and the immune system function. On conservative basis, the possible causality cannot be excluded.
the pain is just bothering me; Pain in my arm from first dose; my left arm is hard to move; I can not lift my clothes or pull my pants; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (my left arm is hard to move), MOVEMENT DISORDER (I can not lift my clothes or pull my pants), PAIN (the pain is just bothering me) and MYALGIA (Pain in my arm from first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced HYPOKINESIA (my left arm is hard to move), MOVEMENT DISORDER (I can not lift my clothes or pull my pants) and MYALGIA (Pain in my arm from first dose). On an unknown date, the patient experienced PAIN (the pain is just bothering me). At the time of the report, HYPOKINESIA (my left arm is hard to move), MOVEMENT DISORDER (I can not lift my clothes or pull my pants), PAIN (the pain is just bothering me) and MYALGIA (Pain in my arm from first dose) had not resolved.            No Concomitant medications were reported. No treatment medications were reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Case Received From deleted, Correspondence Contact selected, Medically Confirm removed.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 09-APR-2013 (lot number: H031350; exp date: 21-FEB-2015) (dose, frequency and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, lymphedema, neuropathy, sore muscle joints, afib, bipolar disorder, high blood pressure, hypothyroidism, diabetes type 2, copd, high cholesterol, non smoker, non alcohol user, and epilepsy medications sensitivity, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling, flu-like symptoms, vomiting, dizzy/lightheadedness, off balance, sore, and legs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, vomiting, dizzy/lightheadedness, and off balance, and had not recovered from sore, leg swelling, and legs hurt. This report was non-serious.g
H1N1 vaccine administered in left arm, within 1 min started having chest tightness, within 4 min had redness, itching, and hives spreading from left arm to chest received DECADRON 10mg and BENADRYL 50 mg IM in emergency department. Symptoms improved *after DECADRON and BENADRYL.
I can barely move my left arm. I believe the injection was injected high upon my arm (almost my shoulder) and hit a nerve or bone. I al unable to have full range. It is painful to use and I am unable to sleep at night. My whole upper left side has seized up.
Information has been received from a pharmacist concerning an approximately 4 week old neonate infant in the intensive care unit, who on approximately 30-APR-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine, instead of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  The patient was febrile and fussy.  The pharmacist reported that the patient was in the hospital at the time of the experience.  The pharmacist indicated that the order for the vaccine was placed into the computer as "pneumococcal vaccine" without reference to the trade name.  The dispensing pharmacist did not know the difference between the vaccines, and the order was filled with pneumococcal 23v polysaccharide vaccine instead of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  The pharmacist stated that all orders for pneumococcal vaccines will be entered with the trade name instead of "pneumococcal vaccine" in order to prevent the event from occurring again.  The patient's symptoms resolved on an unspecified date.  Additional information has been requested.
Information has been received from a consumer concerning his 82 year old mother with hypertension who "eleven to twelve weeks ago" on approximately 20-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included unspecified hypertension and heart medications. Five days after vaccination on approximately 25-MAR-2007, the patient had a "very bad reaction" and experienced "very bad pain in her abdominal and hip area". The patient was in the hospital for a day and was sent to a specialist. The consumer reported that his mother was no longer able to live alone and was now in assisted living. A MRI was performed, results not reported. As of 13-JUN-2007 the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Confusion immediately lasted for @ 2 hrs Lightheaded immediately lasted @ 2hrs Slurring words 30 mins after Swollen lymph nodes on forehead immediately  Following day itchy rash under armpit in lymph nodes lasted 1 day 2 days later itchy rash around diaphragm lymph nodes lasted 2 1/2 days 3 days after injection itchy swollen very hard big bump at injection site (COVID ARM) lasted 4 days harder and more swollen on day 4 and even more so on day 5
Intermittent sharp chest pain beginning approximately 10 minutes after vaccine administration. Symptoms subsided after several hours without treatment.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates from 19-MAY-2017 to 08-JUN-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M040146, expiration date 26-SEP-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour 30 minutes. Concomitant therapies included sterile diluent (lot# M010689 with expiration date 11-MAR-2018) which was not improperly stored. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Pt was observed to be slumped over in chair approximately 7min into waiting post vaccine  in waiting room. np alerted. Breathing , appeared to have fainted.  Pt  started to have  jerking entire body movements as staff trying to get pt to wake up.... pt noted to have spit in mouth on lips and was making grunting noises as jerking . Staff assisted pt safely to floor. Epi retrieved but as came back to pt. And pharmacist also present w NP pt was breathing , slowly coming to , no swelling noted so then it became more clear poss vasovagal response ... in the beg it was unclear so Ems was activated . Pt  continue to stay w clinic for an hour waiting on ride . Pt had declined Ems . Pt vitals pulse 55-65.... coloring better initially very pale . Mother came and reports that it gets nervous and has passed out before after blood draw but not a shot.
I received three vaccinations (12/30/20; 01/22/2021; and 12/06/2021) and tested positively for Covid on 12/27/2021.  I experienced coughing, congestions, body aches and pains, fatigue, and mild headaches from 12/26/21 to 01/02/22.  I seemed to recover, along with my husband and five-year-old son who also had the same symptoms and tested positive for Covid on the same day, but then I experienced extreme fatigue on 01/04/21 and 01/05/21.  I had to stay in bed all day and could not work or carry out my daily activities.  On 01/06/21, I got a severe headache in the evening.  For the next five days i tried to treat it with Ibuprofen and Tylenol but could not get any relief.  By 01/13/21, the headache was a 10 on a scale of 1-10, and so sever that I got an MRI that showed abnormalities. My doctor prescribed Sumatriptan (spelling?) but it did not help. On 01/14/21, I went to urgent care because the headache was so extreme that I couldn't move. CT scans confirmed that there weren't any blood clots and I was told the headache was caused by inflammation of blood vessels. I was given IV steroids and a week-long oral taper of steroids.  I feel back to normal now.
i bumped and scratch my skin near elbow. Days later I noticed a strange bruise scab color.  look more like skin cancer color then a bruise. Made a doctor appointment and won't be seen until Feb 17,2021.  No pain or irritation ,it just has not healed.
Redness and swelling of left deltoid area 9cmx12cm. No fever. Symptoms appeared 24 hrs after DT injection, 5th dose.
All of events lasted about 30 hours. No local adverse reactions. General adverse events that occurred were fatigue, shivering and myalgia. Reminded me of a mild case of influenza.
About twelve hours after receiving vaccination I had. Chills and 100 degree fever. Even with a fever I felt very cold.i took two 500 mg acetaminophen gelcaps around one a.m.
Blisters in my mouth. Extreme tiredness. Headache. Soar throat. Slight fever.
3RD DOSE PFIZER COVID VACCINE GIVEN 12/10/21, #FE3594; pt admitted to local Hospital on 8/31/22; found to be positive for COVID; stayed stable; oxygenation when down when pt was taking 3-4 L of O2 via NC; stable for dc; 9/7/22 pt admitted to alternate Healthcare with worsening SOB; placed on NRB; pancytopenia, low Hgb, elevated WBC count; tachycardia; EKG showed Atrial Fibrillation with RVR; tx with medication; transferred to ICU; given 1 U of blood; ABX; DNR; pt's condition worsened; transitioned to comfort care; consulted with hospice; pt passed away in the hospital
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
This spontaneous report was received from a retired nurse (who was also the patient's wife) and refers to a 68 years old male patient. The patient had a history of bladder cancer in 2011 that was treated with unspecified chemotherapy at an unspecified hospital. While on chemotherapy in 2011 the patient developed an unusual full body rash which was attributed to doxycycline (manufacturer unknown) or omeprazole (manufacturer unknown). On 28-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route of administration and anatomical location were not reported). On the same date, the patient was also concomitantly vaccinated with PREVENAR 13. Other concomitant therapies included unspecified blood pressure medicine. On an unknown date in September 2015, the patient developed headache and soreness at the injection site after vaccination. The patient also stated that "it felt like needle went in pretty deep, not under the skin". The patient was not treated for the symptoms he had experienced. No lab diagnostic studies were performed. The outcome of the events was reported as recovering. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter and concerning the same patient. Additional information has been requested.
Hours after the vaccine, right arm is very sore, tired, heavy and weak. Soreness or pain of the arm is very bothersome. The next day when I woke up, there?s a stabbing pain or headache  on the right side of my head. The headache comes and goes all throughout the day. Until to this day, I still have the stabbing pain and headache that I experience all throughout the day, just a little less frequent but the intensity of the pain didn?t diminish at all.
Within one month after the first vaccination (2/8/21) migraine intensity increased significantly. Second vaccine was on 3/22/21. Migraine became so unbearable that I was admitted to ED on 3/25/21.
Two weeks after receiving my third dose of Pfizer, I went into A-fib. I found out because I mentioned to my doctor about a health tracker and I noticed that I was in distress. I contracted my cardiologist. I spoke with a nurse on the phone. I went for an appointment on 12/27/2021. I was given Coumadin and metoprolol (which I'm not taking anymore because the dosage was too high), it's been replaced by warfarin. I had a Zio-patch given by Dr. I have since mailed that off to be checked. I am currently waiting for results from that.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2020 as dose 1, single (Lot number: EK5730), on 09Jan2021 as dose 2, single (Lot number: EL1284) and on 05Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "HLD" (unspecified if ongoing), notes: HLD; "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took anti viral product paxlovid for covid 19. The patient previously receive a COVID-19 Vaccine. No known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.