chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis; This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2DB5X, expiry date 30th June 2020) for prophylaxis.   On 11th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 11th October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant). The patient was treated with epinephrine, steroids nos (Steroids) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was recovered/resolved.   It was unknown if the reporter considered the anaphylaxis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows:  This case was reported by the medical assistant. The patient received Fluarix Quadrivalent 2019-2020 season vaccine in an unknown arm. The patient went to the emergency room, where he was treated with Epinephrine, IV steroids, and Benadryl.
He got his vaccine, got something to drink and had the weirdest feeling and was not able to remember his pin # for his card, but then collected himself.   He went to bed and at 4:00 AM he started throwing up profusely and was intense and periodic until it lasted until 8:00 AM (4 hours).   He has stomach problems, but not to the extent of this.  He has been trying to control his other problems with Alka Seltzer which normally helps with his regular stomach issues, but did take 3 of them during that 4 hour period which seemed to calm his stomach down, but normally one takes 1.   His stomach is feeling better right now other than having loss of appetite, eating small bites and minimal.   Feels he may have fever right now but not feeling well enough to get up, sweaty and clammy on the back of his neck right now.  Feeling weak due to the 4 hours of vomiting.  He has not called his doctor.
Vaccine admin 7/23 Pt reported arm pain and a rash at injection site that also radiated around arm and some patches on neck on 7/24/19. Ibuprofen and cold compress were advised. The pt then reported an allergic rash throughout body with itching on 7/29/19. She was advised to get Benadryl and she made an appt at Dr office. She was given prednisone taper and clobetasol cream 7/31/19.
fever to 101 x 2 days, decreased appetite-loose stool, 3 vesicular lesions-back trunk-1 hard
Upset stomach that settled with an antacid Fever of 101 for about 12 hours then slightly elevated afterward
pt recv vax 14JUn95 on 21JUN95 devel dizziness, difficulty walking; head CT nl CSF exam nl; dx acute cerebella ataxia;
Information has been received from a nurse concerning a 15 year old female patient with no pertinent medical history and no known allergies who on 15-JUL-2009 was vaccinated in the right deltoid with the first 0.5 ml dose of GARDADSIL (lot number 661953/1130X). There was no concomitant medication. Approximately 3 minutes post administration, the patient passed out. The patient vomited one time, was dizzy. She was mostly unresponsive and very hypotensive for about 45 minutes. The patient "very slowly" became alert and oriented and the blood pressure "very slowly" returned to normal. The patient fully recovered and finished the remained of the appointment without incident. There were no lab diagnostics studied performed. No further information expected.
Information has been received from a physician concerning an approximately 2 month old male with no allergies or past medical history who on an unspecified date was vaccinated with the first 2 ml dose of rotavirus vaccine (human-bovine) PO. There was no concomitant medication. Subsequently, the patient developed a fever of 101 degrees F, vomiting and diarrhea. The patient was seen by the physician two days after the vaccination since the symptoms were persisting. The outcome was not provided. Additional information has been requested.
COVID-19 2nd dose given at 1240. Patient sat in the monitoring area for 15 minutes following injection without incident. She left clinic and returned at 1330. At this time she stated she felt "itchy". Red patchy areas noted to mid chest and forehead. Patient denies shortness of breath and no swelling  to tongue and throat stated or noted upon inspection.  Patient also denies shortness of breath. patient advised to  come back to our first aid monitoring area. At 1345 patient noted to begin clearing her throat and was asked again if she felt short of breath-patient stated "yes a bit". EMS was dispatched and patient was transported to ED.
HPV #1 received 10-17-11 at well check. Headache within 24 hours. Seen 11-1-11 ? atypical migraine. No relief with ADVIL. Seen 11-4-11 continued headache pain 6-10 no relief with IMITREX negative MRI slight improvement with LORTAB. Placed on PERIACTIN. Headache -> 12/1/11. 2nd HPV given 12-20-11 immediate onset headache.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations fast resting heart beat) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PALPITATIONS (palpitations fast resting heart beat). At the time of the report, PALPITATIONS (palpitations fast resting heart beat) had not resolved. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. Treatment information was not provided.
Minimal injection pain.  Approximately 2:00 PM pain, pressure and upper arm muscle weakness limited range of motion.  Upon examination noticed egg size lump directly under injection site. Lump had white center with red ring similar to reverse bullseye ring. Pain increased and increasing arm paralysis from enlargement of swelling.
No initial reaction to vaccines given. Later that night pt reported severe difficulty breathing that lasted most of the night. Pt stated he "thought he was dying."
Patient reported facial paralysis on one side two days after her Moderna covid19 vaccine.  Her school nurse (she works at a local school) confirmed that it looked like Bell's Palsy.  We and the nurse recommended that she go to the emergency but she wanted to wait until the next morning to see her physician.
Chills and body aches started in the middle of the night. In the morning I had vertigo, a massive headache and joint/nerve pain in my hands and feet. It's hard to move my fingers or walk. It's 2PM now and my headache is a little better, the rest is the same.
arms have been hurting for about3 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arms have been hurting for about3 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced MYALGIA (arms have been hurting for about3 weeks). At the time of the report, MYALGIA (arms have been hurting for about3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
"Received vaccine in the morning and by late afternoon had a migraine type HA.  Attempted to sleep through but later in the overnight hours developed fever, chills, arthralgia, left arm pain.  These symptoms continued for about 48 hours.  As these symptoms began to taper, I started have severe diarrhea (going 10-11 times/day), abd cramping, nausea, exhaustion and continued fever.  These symptoms lasted for about 10 days.  I was seen in the ED 9/5 because I was experiencing muscle twitching, dizziness/lightheadedness and palpitations.  There I was given IV fluids and medications to manage symptoms along with being COVID tested.  I was seen by my PCP which she recommended being re-tested for COVID and an infectious disease consult. "
Patient is hypertension, hyperlipidemia, asthma, paroxysmal atrial fibrillation, sleep apnea, obesity who presented to the hospital on 5/6/2022 due to abnormal labs outpatient.  Recently diagnosed with valvular cancer and started chemotherapy recently.  She had labs done outpatient by oncologist which displayed a sodium level of 120.   Denies any chest pain, shortness of breath, fevers or chills, lesions or syncope no extremity edema.  Vital signs in the ER were stable.  Chest x-ray displayed no acute findings. Na 116. Cr 2.4.  BNP 179.  Globin stable.  Tested positive for COVID.
mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade the emergency departments, 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 17 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM, RT-PCR and viral culture at buccal. All results were postive for mumps at bilateral buccal. It was confirmed that the patient experienced mumps parotitis and developed airway involvement and retropharyngeal spread related to parotitis. The patient required pediatric intensive care unit (PICU) admission. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience. Literature report: This is one of several reports received from the same literature. Sender's Comments:  US-009507513-2011USA012662: US-009507513-2011USA012663: US-009507513-2011USA012664: US-009507513-2011USA012665: US-009507513-2011USA012666: US-009507513-2011USA012667: US-009507513-2011USA012668:
This spontaneous report was received from a pharmacist, concerning an 18 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In November 2012, the patient received the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis. In January 2014, the patient received the second dose of GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis; which was considered an inappropriate schedule of drug administration. No adverse effects were reported.
On 8/9/18 The client called me and reported the following information: The client received rabies #4 dose on 7/16/18 and it hurt while the nurse gave it to her. The client states it was given high on the Lt arm next to the shoulder and it left a bruise. The client told the nurse it hurt. The nurse told her "I am having a hard time pushing it in." The client states the Lt arm became increasingly painful from 1-4 PM. At approximately 4PM she developed radiation of pain into her neck and down the Lt arm. Since 7/16/18, the Lt arm pain continues. She has sharp pain that can be an "8" and intermittent tooth like achy pain a "4". She states pressure will trigger the sharp pain. States has difficulty putting on a shirt over her head. She doesn't have strength in her Lt arm to pick things up. Advised to see her physician and that I will fill out a VAERS report. The client will call me back once the appointment is scheduled. Appt scheduled at 1:30 on 8/10/18. She would like a copy of the VAERS report. RN. 8/9/18 Section #22; Please see the attached ER record for the administration for rabies immunoglobulin and Rabies IM fibroblast culture, RN. 8/9/18 the client received rabies dose #4 on 7/23/18 and Tdap on 7/23/18 and given both in the Rt deltoid, RN. 8/10/18 Client came in and signed consent for release of confidential information. Client given a copy of the VAERS report. Client stated made an appointment with Dr. for Monday 8/13/18, instead of other. RN. 8/14/18 Client called and she states Dr. is not sure but thinks it was given in the tendon. It appears like a rotator cuff tear. She is going to make a referral to an orthopedic physician. The physician states she may need ultrasound and should get physical therapy. I asked the client to let me know how she's doing - RN.
This spontaneous report as received from a nurse practitioner via Pfizer refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with GARDASIL (route, anatomical location, lot# and expiration date were not reported). There was no concomitant therapy reported. On an unknown date, the patient experienced vaccination complication reported as "the nurse mentioned that her patient had a unusual reaction to GARDASIL. The outcome of vaccination complication was unknown. The nurse queried if GARDASIL could be administered again to the patient again as it is a three dose course and the patient already had an unusual reaction to it. Additional information has been requested.
One week after the vaccine I had swelling & itching at the sit of injection. It has was also very hot measuring 99 - 102, the redness grew to cover a significant part of my upper arm.
MODERNA COVID-19 vaccine EUA. Redness and swollen below area of injection (left arm) persisting after 10 days of first dose.
Large 17cm x 20cm area of redness and induration of left thigh.  Patient developed fever and had 1st febrile seizure.  02/29/2008 MR received for DOS 2/21-22/2008 with DX: Febrile Seizure and vaccination reaction. Child presented to ER after an episode of body shaking and back arching lasting ~ 1 minute. Temp was 103'F. Pt vomited prior to arrival in ED. Redness, swelling and warmth noted on L thigh. Txd with Tylenol, Motrin, and Rocephin and d/cd next day.
No additional AE/PQC.; PROQUAD and VARIVAX was administered to a patient concomitantly instead of MMR II and VARIVAX; Accidental overdose; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, rHA, 0.5 ml/once, lot # W006587, expiration date: 23-AUG-2023, administered for prophylaxis (strength and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, lot #U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) concomitantly instead of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (MMR II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered and accidental overdose). No side effects reported.
Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Vaginal bleeding for 2 days, patient has not had period for 7 years prior-Medium, Systemic: Joint Pain-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Being checked for anemia post bleeding
Edema 13 cm by 19 cm, erythema 5 cm by 6 cm, unable to bear weight secondary to pain.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 12-MAR-2015 the patient was vaccinated with one dose of (Oka/Merck) VARIVAX (route, lot# and expiration date were not reported), which had been exposed to temperature outside of the recommended range. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Severe arm pain in left arm, nausea, fatigue, rash, swelling, and pain under left arm
Migraine headaches - Emergency room treated w/ pain meds  - several days, still occurring. Migraine has not gone away yet.  Following up w/ GP (Dr visit 4/29/2021).  Eyes burning and red - still occurring mostly in the left eye Shooting pains in left ear - still occurring  Shooting pains in head all over - Still occurring  Leg pains - Shooting pains all areas of both legs  Abdominal pain - shooting pains on and off in the abdominal and rib cage areas Shortness of breath - still occurring, not quite as bad as initially  Fatigue, no energy - still occurring
Narrative:  Patient received the two doses of COVID 19 Vaccine in Jan/Feb 2021. The patient tested positive on 15 August 2021 and was admitted to the hospital with fever, hypoxia, and COVID 19 pneumonia. The patient died due complications of covid 19 (sepsis, respiratory failure, and urinary tract infection, and COVID pneumonia). The EUA for the vaccine requires that all patients testing positive for COVID 19 and requiring hospitalization or death is reported.
I became ill after taken the last vaccine and i am upset because the truth was not told and I am a Registered Nurse and have been one for decades please  do not lie to me.I  work with  COVID_19 patients everyday    I  had  soreness  over  my whole body I could not talk   or move my   body at all
PATIENT FELT TIGHTNESS IN THE CHEST/ARM. WENT TO EMERGENCY ROOM WHERE TESTS SHOWED MUSCLE ENZYMES IN THE BLOOD. CARDIAC EVENT WAS RULED OUT & LUNGS WERE CLEAR. DR ADVISED THAT IT WAS A REACTION TO VACCINE.
Adverse Event Safety Officer Reports: Guest who received the Pfizer vaccine (Lot# EW0164) in the Left Deltoid reported that she was feeling ?hot?, ?nauseas and vomited x1?.   Intervention\Treatment\Why it Happened Aid (EMT?s) called. (B\P: 130\90, P-90, SPO2 ? 98). Guest assessed by EMT?s and no further treatment indicated. Outcomes Guest released and escorted to check-out by EMT?s and reports ?that she is back to her normal?.
patient was given one vaccine as 2nd dose instead of other to complet the series.  patient doing ok as of today.
Still have excruciating pain in both shoulders. Shoulders lock up, cannot reach, extend arms or carry groceries. In 2013 I received the flu shot at the outpatient clinic. When I got the shot my right shoulder was sore for 2 weeks and I could not move my shoulder or arm. The shot has severely injured my right shoulder, it is now 2 years later and my shoulder still locks up, excruciating pain 100% of the time in my right shoulder while sleeping, excruciating pain 50%-80% of the time in my right shoulder while trying to extend my arm. Excruciating pain most of the time in my right shoulder while carrying groceries. In 2014 the outpatient clinic gave me the flu shot in my left shoulder. 1-3 months later I had excruciating pain in my left shoulder. I have excruciating pain 100% of the time in my left shoulder. I have excruciating pain 50%-80% of the time in my left shoulder trying to extend my left arm or carrying groceries. OTC and prescription pain meds do not help at all and I have tried many of them. I do not ever sleep. I roll around in the floor in pain. I only rest....
I ended up getting COVID-19 from my fiance. Two days after he was diagnosed, I started getting sick: fever, sore throat, feeling achy, throbbing headache and having a cough (without chest congestion). That day I went and got tested and I was positive for COVID-19. After 3 days, the fever peaked and that's when I noticed I lost my sense of taste and smell. I was out of work for about a week. The entire family was vaccinated and we all ended up testing positive for COVID-19.
Starting 9/28 PM redness at site left arm, 9/29/16 PM some swelling. On 9/30/16 PM more swelling and pt went to ER.
This spontaneous report was received from a nurse practitioner via company representative regarding a female patient of unknown age. Past medical history, drug allergies/reactions and concomitant medications were not reported. On an unknown date in 2016 (reported as 2 years ago), the patient received a dose of GARDASIL or GARDASIL 9 for prophylaxis. The nurse practitioner didn't know if the product was GARDASIL or HPV GARDASIL 9, since she was not the person who administered it. The patient had received the vaccine from a different healthcare provider. On unknown date, the patient's arm became red, inflamed and very tight. It was not specified which arm was affected. The patient's mother questioned the nurse practitioner if the patient should receive another dose of GARDASIL. It was not specified if the patient received any further doses of Quadrivalent GARDASIL. Outcome and causality of the events was not reported. No product quality complaint was involved.
She got her vaccine, had fatigue, headache, tired, achy.  She had the feeling that she thought she had too much of the immunity stuff in her.  She felt like she was going to explode.  She had little headaches that kept popping up, and was walking still and could put your finger down on it and that's where it was.  She mentioned this to her husband who said he had them as well but said they would go away.  That went on until she had a stroke on 4/7/22 and those headaches went until July or August.  The type of stroke she had was a hemorrhagic stroke.  She was in the hospital/rehab until 5/20/22.  She went to Hospital for about 11 days, on 4/18/22 she was then sent to the rehab hospital.   When she went to the rehab hospital they got her up and walking, and she had therapy while in the hospital.  She was in the rehab center for about a month, which got her up and walking again.  She still walks with a cane but does not walk well with a cane.  She has been in out-patient therapy until mid November and is going back in a week to get her walking better.  She has enough function that she has figured out that she walking so wrong that she is breaking down (hips aches, back hurts) other parts of her body.  She was healthy as a horse up until she had the vaccine.   She feels that once she gets her body retrained she will be able to walk better with a cane.  Her upper body is pretty good she said.