chrisvoncsefalvay/vaers-outcomes huggingface dataset:
underwent temperature excursion on 15-17Aug2022; NO ADVERSE EVENT; underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (NO ADVERSE EVENT) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (underwent temperature excursion on 15-17Aug2022).    No concomitant products reported.  It was reported that the lot number underwent temperature excursion on 15 to 17 Aug 2022 and was administered to 16 patients post temperature excursion.   No treatment products reported.
This spontaneous report as received from a registered nurse refers to a 16 years old male patient. The patient's medical history and concurrent conditions were not reported. 29-MAY-2015, the patient was vaccinated with GARDASIL 9 be default (dose, frequency and lot number were not reported) at the age of 16. No adverse effects were reported. The patient's concomitant therapies were not reported. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/2/2023 SHORTNESS OF BREATH R09.02 HYPOXIA 3/26/2023 SHORTNESS OF BREATH J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/2/2023 DM 2 W PERIPHERAL NEUROPATHY R09.02 HYPOXIA 3/26/2023 DM 2 W PERIPHERAL NEUROPATHY
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Patient presented with increased fussiness and episode of blood in stool, found on ultrasound to have intussusception
Received dose on Monday 4/12 at 7:15am. Low grade fever, neck ache and chills developed that evening and went away by next morning.   On 4/16, woke up with almost no ability to hear out of my left ear and there was a very loud ringing sound in my ear. Happened off and on throughout the day but by evening, I only heard a ringing noise. I went to the urgent care and they said my ear had no sign of ear infection or allergies.   Next morning, I couldn?t hear almost anything out of my ear with a very loud ringing noise. Was consistent through 4:30pm that day.  Went back to the urgent care and a different nurse practicing confirmed my ear looked completely normal.  I?ve never experienced deafness or ringing in my ear before.    Since this morning (4/18) I have had a low ringing sound in my left ear, but no more deafness.
09/09/22 presents to ED for "multiple episodes of syncope". PMHx of "heroin IV drug use still active, false positive hep C"
48 Hours after receiving vaccine I woke up with sever vertigo and passed out briefly. Felt dizzy most of Saturday. Sunday morning about 1:00, I woke up with severe vertigo and could not sit up or stand up to go to the bathroom. My husband had to help me. I then experienced severe, repeated vomiting that lasted until 5:30 AM. I was sick and dizzy all day Sunday. Began feeling better that evening. Next day (today) I am much better. But I was desperately ill all Saturday night.
his vision in one eye went blind and came back, then had partial vision and came back again; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, caller stated that after getting the shot, his vision in one eye went blind and came back, then had partial vision and came back again. Caller stated it happened to him 3 times. The patient had visited physician office. Caller wanted to know if between the EUA and FDA approval, there had been case reports of vision loss. Outcome of event was recovered on an unspecified date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 09-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Onset pain in his right arm ever since receiving the vaccination, worse with moving his right arm/shoulder. He denies any swelling, numbness, tingling, or facial swelling.
An hour afterward, noticed a rash around neck, then it moved up to the left side of my mouth and lips became numb, left side of face became numb and puffy. Eventually went away by the evening. Then she referred me to the doctor at the Allergy & Asthma Associates. Saw the doctor and they believed it might be neurological. Advised me to take Allegra the day before the 2nd Pfizer vaccine and the day of.
Information has been received from a  health professional concerning an adult male employee who, within the last month, in April 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient developed a whole body rash. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Mother called our office this morning at 8:06 a.m. stating that patient received her HPV vaccine yesterday afternoon and woke up this morning with severe headache. She also mentioned that her face was red and swollen and she had tightness in her throat and her voice was raspy. In addition, her arms were achy. Mother brought her to ER where she was found to have a fever of 101.0 degrees. She was given MOTRIN for headache. She was also discharged on BENADRYL. I called mother at noon and she told me that patient was improving. I spoke with Dr. He felt this was a vaccine reaction. He did not recommend any other treatment at this time. I asked mother to call back in a.m. if she is not improving or sooner if worse. I will file a VAERS report. I told mother I would not file the report until I see what patient's final outcome is.
Soreness in the left arm at the injections sites (essentially same spot) which is accute when I raise my arm up and back.   There also appears to be a "dimple" or indention at the site of the injections in the muscle.
A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 15-year-old male. On relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Vomiting for hours, sore throat, stabbing pain near heart when breathing, severe headache, body aches, fever, fatigue
Information has been received from a physician concerning the mother of a patient who mentioned that on an unspecified date, she received an adult dose of RECOMBIVAX HB (manufacturer unknown). It was reported that the titers were low. It was also stated that the mother had to be revaccinated. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information is not expected.
?Feeling a bit sick?, more tired than usual, soreness in the left arm, feeling a bit inflamed, stuffy nose, just a bit slow today.
Dose given to patient expired on 5/10/2022. No adverse effect noted. Primary provider instructed patient to return in 90 days for non-expired vaccine
Growing red zone around the injection site, itching, swelling of the left arm. Dizziness and fatigue. Daily headaches
VERY TIRED; This spontaneous report received from a patient via a company representative concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number .No concomitant medications were reported. On 30-APR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very tired. This report was non-serious.
14AUG95 body rash tx w/DPH saw MD; 17AUG95 h/a, vomiting, fever saw MD; 18AUG95 feeling better;
Patient reports joint pain, mild fever, headache, chills, and shaking for 4-6 hours after getting the vaccine. Feels fine today (1/20/2021)
Severe arm pain, throbbing headache, fever (Tmax 101.7 F), chills, myalgias  Beginning ~12 hours after injection, some improvement ~24 hours later, resolution ~48 hours later Took ibuprofen 400 mg Q 6 hr x 4 doses
At 6:00pm I was sitting in a movie theater. Got very hot, sweaty and nauseous. Ended up leaving. Made it to lobby. Got extremely light headed and almost passed out. Whole body ached. Arms, legs including fingers and toes felt were extremely tingly and felt like they were going to explode.  All this lasted about 45 minutes.  Went to urgent care. Heart was sore for the 3 hours I waited to see someone.  When in a patient room, while blood was being drawn though the IV, another episode (same as above) happened. EKGs were "troubling". Sent to Hospital for more tests.
Information has been received from a health professional concerning an 83 year old male patient who on 22-OCT-2009 was hospitalized due to cardiac failure congestive and hypoxia who on 25-OCT-2009 while he was hospitalized was vaccinated in the left deltoid with a dose of PNEUMOVAX and also was vaccinated in the right deltoid with a dose of influenza virus vaccine (unspecified) (manufacturer unknown) the same day. The patient was vaccinated with a dose of PNEUMOVAX 10 years prior, in 1999. The patient was discharged from the hospital on 25-OCT-2009. On 16-NOV-2009 the patient was seen in the physician office because he developed cellulitis in the left arm. The injection site area was red and swollen and there was a 5x5 area of induration. The patient had pustules and purulent drainage from the area. A culture was performed but no microorganisms were seen. The patient was change from CIPRO to LEVAQUIN. On 23-NOV-2009 the patient returned to the office for a follow-up visit, the physician observed some improvement but the purulent drainage continued. The wound was incised and drained. On 28-NOV-2009 the patient was readmitted to the hospital for shortness of breath and difficulty breathing. The cellulitis on the left arm was still mildly tender and draining. On an unspecified date the patient was discharged from the hospital. On 07-DEC-2009 the patient had a follow up visit with the physician. At the time of the report the patient's outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Patient was administered the MENACTRA vaccine. Approximately 5 minutes after receiving vaccine patients aunt retrieved Pharmacist and stated niece was incoherent. When pharmacist approached patient she was unrespponsive and began to seize. Patient was moved to the floor and turned on side for approximately 1 minute, the duration of the seizure. Patient regained consciousness and stated she felt sleepy and that her lips were numb. 911 was contacted. They arrived at store and assessed patient and stated that she probably was stressed due to vaccination. Upon sitting in chair, patient again stated she felt like passing out. Family decided to have ambulance take patient to Emergency Room.
Three weeks following the vaccine I continue to have shoulder pain, limited range of motion, and my level of physical activity has been hindered by the pain.
Description: Headache, SOB and chest pains 9 days following his primary smallpox vaccination. The pains were located in his left chest and radiated into his neck and left arm. He described them 'like someone sitting on my chest'. He had 2 episodes with the second episode so severe '10/10' on the PAS that he sought medical care. He admitted to a civilian hospital medicated for pain and  was discharged with complete resolution of his symptoms on 6 June 06. Symptom: Chest Pain Start; 06/02/2006 End: 06/03/2006 Comment: 2 episodes; 1 lasted @ 30 minutes; 2nd with pains 10/10 on PAS.  09/24/2007  VAERS report received with medical records attached. Link requested to 291063.  No further records available as event happened overseas and pt was treated in a foreign hospital. Patient experienced  headache and chest pain radiating into the L neck and arm x2 episodes on 6/2/06. Experienced SOB on 2nd episode. Seen in clinic and transfered to hospital due to an abnormal EKG.  DX: Myopericarditis in temporal association with smallpox vaccine. F/U 9/2007 with report that stamina and energy not back to pre AE levels.  Recovery time post exercise is greater as well. Occasional mild chest pains.
Pneumonia given 10/21/02 seen at physician office on 10/24 for cellulitis at injection site. Treated Keflex, Rocephin IM. Per verbal report of granddaughter.
4:30 P child noted to stomach ache and nausea, felt warm. The following morning noted T103.1, continued c/o stomach, nausea, slight dizziness. Symptoms seemed to resolve over 24 hours.
3 inch red, warm area around injection site, painful enough to keep awake at night. Treated by physician on 5/25/2010, use of ice packs, Benadryl, and Motrin.
flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the patient via social media.  This case involves an unknown demographic patient who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
MODERNA COVID-19 VACCINE .  12/22 Headache started at 4pm 1.5 hours after receiving vaccine. At 7pm muscle aches started and headache became worse. I took 400mg of Ibuprofen and was asleep by 730. 12/23 Woke up at 5am. I still had the headache was dizzy and nauseous and had all over muscle pains. I stayed in bed as much as possible and took another dose of 400mg Ibuprofen with some lunch. Headache and nausea went away at around 5pm.  12/24 Muscle aches and dizziness continued through the day but less severe. No Ibuprofen. 12/25 No longer dizzy but muscle aches in lower back and upper thighs persisted until I was asleep. 12/26 Some pain in lower back still but not much. 12/23 - 12/27 Pain at injection site. Unable to lift arm above shoulder level until 12/26.
Within 3 days of the vaccine my shoulder started to stiffen up and ultimately froze where I couldn't lift my arm.  Only to discover that it was possible that the injection was not administered properly  could have been a SIRVA situation.  Since that time I've been to three different doctors, x-rays, MRI, and a cortisone injection. I have currently limited range of motion and I'm hoping that with physical therapy my rotator cuffs and the area of my shoulder will come back to normal. This so far has cost me in copays and my business of teaching children dance and outdoor activities is now gone.
No additional AE/PQC reported.; a healthcare provider administered her 3 year old granddaughter the GARDASIL 9 dosage that was intended for her 18 year old daughter; This spontaneous report has been received from a consumer referring to a 3-year-old female patient. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On an unspicified date in 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age) that was intended to 18-year-old woman. The patient had not had any side effects. No additional adverse event (AE) reported (no adverse event).
This spontaneous report as received from a healthcare worker refers to an approximately 10 week old male patient. No medical history was reported. On 27-FEB-2015 the patient was vaccinated with ROTATEQ, (oral liquid, dose and frequency not provided, lot # K006805, expiry date 24-MAR-2016), PEDIARIX HIB and PREVNAR 13. No concomitant therapy was provided. On 27-FEB-2015, within 12 hours of receiving the vaccines, the patient developed a temperature of 99 F and mushy stools with incredibly foul odor with severe bowel cramping which was followed by massing stooling. Approximately on 01-MAR-2015, 3 days later, the patient's stomach cramping resolved. On 03-MAR-2015, the patient sought medical attention by visiting physician's office and the physician suspected intussusception, although the foetor had diminished and the intussusception was resolving but the patient was not fully recovered yet. Treatment rendered for the patient was unspecified. The patient's parents have been instructed to take patient immediately to the hospital upon any reoccurrence of pain or worsening of symptoms. The outcome of the events pyrexia, mushy stool and massing stooling was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Information has been received from a 70 year old female consumer with mild diabetes, high blood pressure, hyperlipidemia, and drug reactions/allergies to sulfa, calcium channel blockers, all statin drugs and pseudoephederine, who on 02-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not provided). Concomitant therapy included sitagliptin phosphate (MSD), multivitamins (unspecified), hydrochlorothiazide (manufacturer unspecified), ubidecarenone, TYLENOL, TRAMADOLOR, losartan potassium (manufacturer unspecified), famotidine (MSD), montelukast sodium (MSD), BYSTOLIC, meloxicam and ezetimibe (MSD). The patient reported that on 02-APR-2011 (also reported as "2 days after receiving the vaccine"), she experienced that her arm was hurting, itching, swollen and that there were actually blisters. The patient stated that it was a bright red rash and that it measured about 1x2 inches. The patient stated that the rash was uncomfortable but that she also experienced a lot of pain at the site. She stated that her doctor said upon examination that the rash was actually an outbreak of the singles. The patient stated this diagnosis was confirmed by her doctor's partner. The patient stated that the rash diminished but had not gone away and that it was a pinkish purple in color and still itched. The patient reported that there were a lump there and a slight indention that she stated felt like was in the muscle. The patient stated that some of the itching had subsided but she sometimes experienced reoccurrences. The patient stated that her arm got very sore when she did any kind of work. The patient stated that her doctor expressed concern over the reaction because she had not been sensitive previously to other vaccines. No treatment was given for the adverse event. No lab studies were performed. At the time of the report, the patient had not recovered. Follow-up information has been received from an unspecified source, concerning the 70 year old female patient, who, on 02-APR-2011 received the ZOSTAVAX (Merck). Reporter stated that, on 04-APR-2011, patient developed a small outbreak of shingles at site of vaccine given (Right deltoid). There was no illness at the time of vaccination. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.