chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a physician via Medical representative concerning one of two patients whose other details were not reported. Medical history, concurrent diseases and concomitant medications of the patient were not provided. On an unknown date, nasal FLUMIST QUADRIVALENT was started. Therapy dates, indication, dosing and frequency were not reported. The patient experienced nosebleeds immediately after receiving FLUMIST QUADRIVALENT. They inquired if it was normal. The action taken with the suspected product was unknown. The outcome of the event of nosebleed was unknown. The report was considered to be non-serious by the reporter. Corrected report on 10-Apr-2014: full narrative added.
Persistent Tinnitus in both ears.  Absolutely a problem that did not exist prior to receiving the Maderma booster  several weeks ago.  Pfizer 2 dose vaccine taken April 2021. Boost Received second week of December and within three days after, loud persistent hissing sound in all settings and surroundings.  My wife who received the same is also reporting the same condition  she too is exepireincing.
4 hrs after onset of severe headache and body pain in lymph nodes under arm pit breast, on top of kidneys and in stomach   fatigue  low fever.  After 4 days of that I got a really super heavy period with cramping and blood clots in my menustral flow.  It was a horrible period, while the one after the surgery in Feb was very light.  Dizzy and fatique  10 days after shot on the April 8 I took a fall from a chair outside, and from Thrusday to the Saturday  10th I ended up in the Emergency room with a concussion and head symptoms including dizziness and nose bleeds.  This was from a simple fall, and i suspect the covid shot might have caused complications after the fall with additional swelling and brusing.
On 2-1-10 (AM) aches at back R shoulder over next few days progressed down R arm and axilla to R side of torso to midline of breast and down to waist. Achy to burning of numbness - continues through 2-12-10. MD diagnosed as shingles. OXYCODONE 5/325 mg PO Q 6 hours for pain.
uticaria on left arm where vaccine was given. Arm was red, itchy, and swollen. Symptoms started the day after vaccine was given. Provider referred patient to an allergist
He had a seizure. Weeks afterwards he wasn't himself, he was throwing extremely rambunctious tantrums. He had very little appetite, and wasn't sleeping very good and kept waking up screaming in the middle of the night. In general wasn't as happy. Now he has ADHD.
vaccine administered too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine administered too early) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine administered too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine administered too early) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Leg became red, swollen and large blister/abscess developed. The blister broke was a half dollar sized wound.
Red, raised, erythematous areas (hives) to arms, torso, legs per pt family reported.
Pain from elbows to shoulders and down back after PNEUMOVAX, EMS was called, no treatment or hospital visit was necessary.
Pt received FLUZONE PF - next day arm felt sore, itchy and burning. Red mark on arm. Pt took BENADRYL for sleep it helped with the redness and itchiness.
HOT SPOT SENSITIVE; ROUND BUMP RED CIRCLE ABOUT AN INCH ON ARM NEXT TO THE INJECTION SITE; FELT TIRED; MILD HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, fibromyalgia, non hodgkin's lymphoma, and sulfa allergy.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042172117 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced felt tired. On 18-MAY-2021, the subject experienced mild headache. On 19-MAY-2021, the subject experienced round bump red circle about an inch on arm next to the injection site. On an unspecified date, the subject experienced hot spot sensitive. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild headache on 18-MAY-2021, was recovering from felt tired, had not recovered from round bump red circle about an inch on arm next to the injection site, and the outcome of hot spot sensitive was not reported. This report was non-serious. This parent/child case is linked to 20210540029.
There was no actual adverse event but the product was recalled on 10/12/2022 due to a short date from the manufacturer. Therefore, a VAERs must be completed as the vaccine was given after the 09/30/2022 date.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 08:30am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 2/4/2022. No adverse side effects or event as result of dose.
PATIENT STATED REACTION STARTED WITH LIGHT ITCHING AT INJECTION SITE WHERE FLU SHOT WAS ADMINISTERED (RIGHT ARM). BUT HAS PROGRESSED TO THE WHOLE ARM ITCHING AND IS WARM TO THE TOUCH. PATIENT TOOK BENADRYL AND STATES IT IS HELPING A LITTLE.
One day after shot was given arm was very sore. Next day (2) arm was very hot and sore. Felt like I was running a fever ache in all muscles, day (3) stayed home, fever felt like I had the flu arm sore.
On 11/22/2021, I received my third Pfizer injection. On 12/24/2021, I was diagnosed with a breakthrough case of COVID-19.
Paxlovid :Treatment of COVID-19; Paxlovid :Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 12Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9792), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea. Concomitant medication(s) included: ESTRADIOL, start date: 01Mar2020; PROGESTERONE, start date: 01Mar2020. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin, Bactrim DS; Bactrim ds, reaction(s): "Known allergies: Bactrim DS", notes: Known allergies: Amoxicillin, Bactrim DS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid :Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (03Sep2022) Positive, notes: Positive rapid antibody test again day 10; (06Sep2022) Positive, notes: Positive antibody test continue today, day number 13; SARS-CoV-2 test: (Aug2022) Negative, notes: Negative rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had other medication in 2weeks. The patient started Paxlovid (Lot not: 1919255A) treatment from 25Aug2022 to 06Sep2022 for covid-19. The patient had rebound COVID symptoms. Completed 5 day course of Paxlovid started in day 1 after symptoms started. Symptoms were sore throat, body aches, congestion. Negative rapid antigen test and symptoms resolving day number 5 and 6. Developed cough on day 10. Positive rapid antibody test again day 10. Cough, headache, body aches with positive antibody test continue today, day number 13.
At 1:40 PM patient returned to the infection control office with symptoms of upset stomach, diarrhea, redness and swelling of his left hand, and over all distress. B/P was 130/84 pulse was 76 resp 18. Dr present noted congestion in chest. Epi Pen given at 1:50 PM. Symptoms resolved very quickly within 30 minutes redness and swelling of hand went down. Recommended he go to the Hospital ER for further evaluation but he refused. Then recommended he at least call his MD for follow up.
received her second dose of Twinrix 3 months after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received 3 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was 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: 14-Sep-2022 Reporter's comment: The pharmacist reported a patient received her second dose of Twinrix 3 months after dose 1. The consent to follow up was granted. There was no date of administration available for dose 1 and 2. Additional Supportive information: The patient received 2nd dose longer than the recommended interval, which led to lengthening of the vaccine schedule.
This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 3NY5G, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX (received about 5 years before the reporting date and had no symptoms) and Flu vaccine (no symptoms). On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chills, influenza-like symptoms and sickness. On 15th September 2018, the patient experienced thirst, dehydration and fever. On an unknown date, the patient experienced mobility decreased. On an unknown date, the outcome of the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever were unknown. It was unknown if the reporter considered the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported. The patient experienced mild body aches and pain at the injection site. Within hours, I felt much worse and developed chills and much more flu-like condition. Even though the patient was an active and also a dancer but found it difficult to move about at all and felt very sick. On the morning of day 2, the patient was still very cold with chills and felt very sick. The patient had to turn on the heat in 70 plus degree C weather and wear warm clothing. Again, the patient felt as if I had the flu and could not move about easily. The patient experienced all around body aches. By the end of Day 2, the patient became enormously thirsty and drank about a gallon of water. The patient suddenly became dehydrated and added electrolytes to the water. After that, the patient developed a fever and became overheated for the remainder of the evening. On both days, the patient felt incapacitated with illness. On Day 3, I woke up feeling much better and I am still not quite well and still feel the effects of the vaccine. The patient had no idea I could get this ill by getting the SHINGRIX vaccine. The patient was afraid of having a second dose, and a local pharmacist indicated the 2nd dose could be worse. The patient was not allergic to any drug, medication, or vaccination ever received.
Patient developed a rash and warm area on her left arm around 6 hours after receiving vaccine.  The area was swollen and did itch a little according to the patient. The area did not get better so did go to the emergency room 2 days later because it was a Sunday and  a clinic was not open.  In the emergency room, they ran labs to make sure her eosinophil count was ok.  Labs came back normal so patient was sent home with a prescription for cephalexin.  Patient said her arm was feeling better after the 1st dose of antibiotic and was completely resolved 2 days later.
It was reported in a published article, that a mother, with a history of being measles susceptible, was revaccinated with a dose of measles virus vaccine live because she was carrying twins. It was noted that this required by the hospital where she was seeking employment. One twin was stillborn at term, and the surviving twin was described by the mother as "vaccine affected, high needs," with many social sensory integration issues." The mother remained susceptible to measles today. The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and 'vanishing twins' and ' it can also be frequently associated with early onset autism." It was also reported that "in spite of its limitation, this study suggests that an autism/vaccine connection may exist." Upon internal review, social and sensory integration issues were considered to be important medical events (OMIC). It was unknown if medical attention was sought.
pt recvd vax 9OCT95 & was in second wk of gestation @ time of vax;LMP was 17SEP95 & estimated date of delivery was 24JUN96;pt aborted pregnancy @ 7wks gestation;No further details are expected
No additional adverse event; Incorrect storage of drug; administered post temperature excursion; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2020 , the patient was vaccinated with an unspecified dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe, dose:0.5 milliliter,  lot # T007024, expiration date: 23-APR-2022 for prophylaxis (dose number, and route of administration were not reported) post temperature excursion, but it was reported The vaccine administered experienced a temperature excursion of 9.2 degrees Celsius (C), for a time frame of 9 minutes. There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.  This is one of several reports received 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: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA000834: US-009507513-2012USA000976: US-009507513-2012USA000997: US-009507513-2012USA000913:
Pt was found on floor after falling from chair. Pt was shaking and jerking while on the floor with possible seizure activity that lasted approx. 3-5 seconds. Patient sat up on his own and was confused and alert. Once patient became more coherent, he was able to answer questions. Alert and oriented x3. Abrasion noted to left side of face. Vital signs obtained with BP 110/78, HR57, 02 100% on room air. Patient was warm to touch. Cool compresses applied to neck and back areas. Patient stated he, "thought he fell asleep and when he awoke all the people around startled him." Patient refused EMS care and transportation to hospital. 2nd set of vital signs obtained with BP 106/78, HR 70, O2 100% on room air.  Mother was contacted about incident. Patient was monitored for an additional 30 mins. After the additional monitoring, patient insisted that he felt better and ambulated to lobby to self.  At time of exit, patient was alert and oriented x3.
A nurse reported the occurrence of injection site cellulitis in a 23 month old female who was vaccinated with Infanrix for prophylaxis. The vaccine provider submitted a report directly to VAERS. The subject had no reported medical history and was described as a "well child." She had no known drug allergies and received no concurrent medications. On 10/28/02, the subject received her fourth injection of Infanrix (557A2). On 10/29/02, the subject developed an area of injection site redness greater than three inches; the injection site was painful to the touch. The subject had noticeable limping and was febrile. The affected thigh area measured 26cm horizontally and 19.5cm vertically with a circumference of 37cm. The subject was seen in the ER, where the physician made a diagnosis of injection site cellulitis. She was treated with IM injections of ceftriaxone 750mg on 10/29/02 and 10/30/02. The reporting nurse considered the injection site cellulitis to be related to Infanrix administration. The injection site cellulitis resolved on 11/14/02. This report has been linked to reports A0389653A, A0389651A and A0389650A due to same reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 46-year-old male patient who received FLUARIX QUADRIVALENT (batch number 45YJ4, expiry date 16th June 2016). On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced diarrhea. In September 2015, the patient experienced nausea. On an unknown date, the outcome of the diarrhea and nausea were unknown. It was unknown if the reporter considered the diarrhea and nausea to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient stated  that, he was experiencing food poisoning like symptoms. In September 2015, less than a week after receiving FLUARIX QIV, the patient experienced nausea.
pt recvd vax;HA,stiff neck,n;aseptic meningitis suspected;lower extremity weakness,urinary incontinence to severe paresis,numbness mid-chest;unable to move legs;weakness upper extremities;dx post infectious immune;myelopathy/radioculopathy;
No serious symptoms after the vaccine, early this month I had a cold, it got worst, and I had a mucus and called my doctor, and he said I have sinus infection and gave me some antibiotics.
03/13/2021: Presented to the emergency room after a syncopal episode. Patient admitted for observation and discharged the next day.
Dizziness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Vomiting, nausea, headache, stomach ache; tried Pepcid and Pepto Bismol to no effect; went to ER and was given antiemetic (nausea) and donnatal (pain) to no effect; given 1 liter IV, which helped a lot. Symptoms reappeared after each subsequent dose.
He told his mother he had a bug bite on his left arm this morning.  A few hours later she noticed the left deltoid region had some redness and swelling. His vital signs were normal.  No red streaks.  CMS intact distally.  Full ROM of left shoulder.  No lip/mouth/throat swelling/lesions. Lungs: CTAB.  Heart: RRR. Advised to use an OTC non-drowsy antihistamine and a cool pack.  Area is marked with a sterile skin marker.   She is asked to have a recheck in 2 days, sooner with spreading of the area of redness, difficulty in moving joint or any systemic symptoms-headache, body aches, fever, fatigue, lethargy.  She is advised to call 911 with ANY swallowing or breathing difficulties, lip/mouth swelling, red streaks or ANY worsening or concerning symptoms.  She agrees and understands.  I called pt's mother again this evening and he is doing well; area of redness is the same. Mother gave an antihistamine and cool pack.
lip swelling after 3 hours of vaccination; arm pain on the vaccination location; This is a spontaneous report from a non-contactable healthcare professional. A patient of unknown age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 17:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 19:00 the patient experienced lip swelling after 3 hours of vaccination and had arm pain on the vaccination location. Therapeutic measures were taken as a result of the event arm pain on the vaccination location and included treatment with tylenol but the arm pain did not get better. The clinical outcome of the events arm pain on the vaccination location and lip swelling were not resolved at the time of the report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Around 10 minutes after getting the shot, felt sudden wave of light headedness/dizziness. About 40 minutes prior I had a snack and immediately after the shot I had another snack. I also had been drinking water. At one point I felt that I was close to passing out. I also had tingling/numbness in my feet/legs in certain positions and had to move them. I went through the drive through for the vaccine and so I sat in the car drinking water and breathing deeply for about 20-30 minutes. It gradually got better but never fully gone. When I got home some of the light headedness got a little worse when I had to stand up and walk even though I did it slowly. Even an hour after, side effects still lingering and have not yet gone as I fill this out.