chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
5 min post 1st dose pfizer peds vacc: c/o tingly 15 min after c/o tongue numbness. visually no swelling Vitals normal  called Dr. order to give Zyrtec 2.5ml liquid children, monitored for 30 more min. pt ok after 30 min, went home, informed to seek emergency care if worsens at home. verbalized understanding
Palpitations, Fatigue Narrative; Employee experienced palpitations starting 12 hours after first dose of vaccine and they lasted for about 12 hours. Also experienced fatigue in the same time period.
Patient woke up at 9:00 PM with a fever of 101F and was moaning. I tried feeding her and she was not interested. She only wanted to be held. I finally got her back down at 10:00 PM. She woke up every hour with a fever, runny nose and cough. I gave her Tylenol every 4 hours for about a 24hour time period. It has been 3 days and she still has a very runny/snotty nose with a lot of mucous and a croupy cough.
This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 7 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were received as follows: The patient experienced significant soreness and pain. This case has been linked with the case US2016002741, reported by the same reporter.
HIGH DOSE FLUZONE given to patient under 65 yr. Telephone call to client 10/8/13. Message left. No response. 10/16/13. Telephone call advised # disconnected.
The symptoms felt more like an allergic reaction. I started with a systemic like itching all over my body. Every inch of me was itchy. There was NO rash.  At three different random times that night it felt like my throat was closing up. It would not last long. Maybe 15 seconds at most and would go away.  The next day I would get random waves of itching that would start at my head and gradually make it's way to my feet and then just disappear.  When I went back for my second shot I informed the pharmacist of the symptoms and he told me to report it to the CDC.
Hives, skin turned red, itching, fever, eyes swelled, and ringing in ears
Pt received vaccination. Pt reports that she started feeling more fatigued and short of breath the week following injection. However,  on 09Apr2021 pt had increased SOB and chest pain while shower, went into the doctor. After scan discovered Massive PE. Pt decompensated quickly and required intubation. Upon transfer to medical center, there were complications with ET tube and pt coded and required resuscitation for 6 minutes. Pt recovered and was transferred. Pt had Chest Xray, doppler of Blilateral lower extremities. Confirming PE and also left Popliteal DVT. Pt was on heparin drip which was switched to lovenox for proper anticoagulation.  Pt was extubated on the 11th, is recovering. .
Headache for first one and a half days. Second full day, right under-arm painfully swollen. Persistent bitter taste on tongue.; Headache for first one and a half days. Second full day, right under-arm painfully swollen. Persistent bitter taste on tongue.; Headache for first one and a half days. Second full day, right under-arm painfully swollen. Persistent bitter taste on tongue.; Headache for first one and a half days. Second full day, right under-arm painfully swollen. Persistent bitter taste on tongue.; This is a spontaneous report from a contactable other healthcare professional. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 08Apr2021 at 14:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to the vaccination included atorvastatin (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. 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 09Apr2021 at 06:00, the patient experienced headache for first one and a half days. Second full day on 10Apr2021, his right under-arm was painfully swollen. Patient had a persistent bitter taste on tongue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache for first one and a half days was resolved on 10Apr2021. The clinical outcome of the events second full day, right under-arm was painfully swollen and of persistent bitter taste on tongue was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Information has been received from a registered nurse concerning 3 patients, who on approximately 18-JUN-2012 might have received improperly stored ROTATEQ orally (lot # 672509/0277AE, expiry date 20-SEP-2013, dose not reported). The vaccine was reported to be exposed to room temperature for 48 hours. Also reported that the ROTATEQ was shipped on 14-JUN-2012 and supposedly delivered by 15-JUN-2012, but the vaccine was not delivered until 18-JUN-2012. No adverse effects reported. This is one of the several repots from the same source. All telephone attempts to obtain follow up information have been unsuccessful. All telephone attempts to obtain follow up information have been unsuccessful. Additional information will be provided if available.
20 minutes after shot, slight swelling on left side of face (in cheek). 30 minutes after shot, numbness and weakness in left side of face. Numbness last 4-5 hours
Flu-headache, diarrhea, aches, fatigued, irritable.
Low grade fever redness, tenderness, swelling received vaccine 10/4/11 fever 10/5 Tx: BENADRYL 50 mg IM 10/6/11.
Typical symptoms began the evening of the day I got the shot (March 21st): sore arm, achy, headache, dizziness, and just generally beginning to feel ?off?. Took Aleve. Symptoms worsened the next day and I was extremely fatigue and that carried into Tuesday.  Taking Advil as needed. Started vertigo exercises ?just in case? to help with the dizziness. By the end of day on Tuesday, all symptoms had cleared except headache, dizziness and fatigue. However, I was beginning to feel a sense of ?brain fog?? I was starting to have a really hard time writing a simple email without it being littered with typos or inconsistent thoughts.  By Thursday I was in my doctor?s office/prescribed meclizine and by Friday he sent me to the ER: EKG, CAT scan and blood work all checked out. No ?real? explanation for my symptoms except a weird reaction to the second shot.   Over the course of the following three weeks, the headache has subsided but flares up from time to time however the ?dizziness?, disorientation, brain fog has continued. Sometimes it feels like I have a focus problem too? like it takes me a while to register what it is I am looking at. Then the more I try to live a ?normal? day, the more I seem to experience something that I refer to as a ?neurological meltdown? starting mid-afternoon and by dinnertime I can barely think my way through dinner preparation. ANY stimulation like children singing, TV noise, dog barking, etc. feels intolerable. It is all I can do to keep myself upright and engaged in the evening routine and then I am passed out on the couch. The other way to describe this is that I feel ?concussive?? like I have a concussion. I have to wear sunglasses now. I can?t listen to music through my headphones anymore? it is just too much for my brain. It is like by the end of the day my ?brain battery? is drained and if I doesn?t recharge overnight, I wake up off and dizzy and just can?t think clearly or remember much of anything.   I saw an ENT on April 12th and am scheduled to see a neurologist on May 3rd. I have NO idea what has happened to me but I was a high energy, multi-tasker, never sit down kind of person who exercised daily until the second shot.  NOTE: Prior to the second shot, I was running 6 miles three times a week and swimming 1 ½ miles three times a week.
PNEUMOVAX given 6-8-12 (L) delt. IM - some soreness that evening. Sat & Sun progressively worse - redness this a.m. - swelling size of baseball - feverish- body aches - T - 100 to 102, ADVIL didn't touch it. Seen in office this a.m. Rx antibiotic given - azithromycin 250 mg 2 daily for 5 days.
it feels bruised and hurt; it was difficult to stand on her leg; Numbness and burning below the knee; Numbness and burning below the knee; hard to walk; Joint pain; Left upper leg pain totally increased after vaccination; Left upper leg pain totally increased after vaccination; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 30Apr2021 at 09:52 AM at 72 years (Lot Number: EW0164), as single dose, for COVID-19 immunisation. Medical history included ongoing leg pain. Concomitant medication included rosuvastatin calcium (unknown manufacturer). The patient previously took unspecified statins which caused arthralgia and pain, and pravastatin 40 mg which caused arthralgia. The patient experienced left upper leg pain totally increased after vaccination (non-serious) on 01May2021 with outcome of unknown , it feels bruised and hurt (non-serious) on an unspecified date with outcome of unknown, it was difficult to stand on her leg (non-serious) on an unspecified date with outcome of unknown, numbness and burning below the knee (non-serious) on an unspecified date with outcome of unknown, hard to walk (non-serious) on an unspecified date with outcome of unknown, joint pain (non-serious) on an unspecified date with outcome of unknown. Patient took some ibuprofen which only relieved the pain a little bit.   No follow-up attempts are needed. No further information is expected.
FLUZONE QUAD. given approx. 0920 on 10/21/16. 40-45 min later, pt became nauseated and had lg. emesis x 3.
Swollen Lymph Nodes under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 15:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to codeine (MANUFACTURER UNKNOWN). The concomitant medications included hydrochlorothiazide tabs 25mg (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and cholecalciferol (VITAMIN D3) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL9266), via an unspecified route of administration in the left arm on 13Feb2021 at 15:15, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 07Mar2021, the patient had swollen lymph nodes under left armpit. The patient did not receive any treatment for reported events. The clinical outcome of swollen lymph nodes under left armpit was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Localized erythema reaction at injection site on upper lateral left arm.  Hand sized area of erythema with site blisters or vesicles.  Treated with cold packs.  Seen by physician 3 days after injection.
Pt had a somulent behavior; Very groggy to dozing off; When awake-very irritable; Started 2 days p/DTP/HIB/OPV; Pt also had ear infect;
died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.      No concomitant medications were provided. No treatment medications were provided.  Company Comment: This case concerns a male patient (unknown age) with no relevant medical history, who experienced the unexpected event of death of unknow cause. The event occurred unknown date after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient (unknown age) with no relevant medical history, who experienced the unexpected event of death of unknow cause. The event occurred unknown date after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
BURNING IN MOUTH; SWOLLEN TONGUE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning in mouth, and swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning in mouth and swollen tongue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534846.
i have an area of redness to my right upper arm close to the injection site the area is tender to palpation
Hard to breath.  Muscle aches.  had flu like symtons.  Was in bed for over 24 hours and the extreme symtoms are still continuing.  Whole body was aching.  Worst pain ever.
Patient presented to Immunization Clinic for Monkey Pox Vaccine. Patient experienced syncope minutes after receiving dose. Patient expressed during screening and while receiving vaccine they have experienced syncope prior to medical treatments. Patient was placed in lowest position possible prior to experience full syncope episode. Patient regained consciousness seconds after fainting. Patient evaluated, observed and provided water, juice and crackers.  Patient was alert and oriented and stated they feel "perfectly fine" forty minutes after experiencing syncope. Patient asked to stay in observation for an additional ten minutes prior to exiting Immunization Clinic.
Patient received first dose of vaccine on 01/22/2021 (manufactured by Pfizer).  Patient reported to clinic for second dose on incorrect day and received second dose of vaccine on 02/02/2021 (manufactured by Moderna).  Patient had no immediate symptoms post-vaccination and did not subsequently report any issues related to second dose.
Aching all over; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 015M20A, 088D21A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, BUDESONIDE and PANTOPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient does not remember which arm she received the vaccine in. The patient had fever, chills, and aching all over after first, second, third and fourth dose of Moderna. The patient received their fifth Moderna vaccine as the bivalelnt vaccine on 11-Oct-2022 lot number 050o22A. The patient received her Spikevax 2023 2024 vaccine on 18-Oct-2023. No treatment medication reported.   This case was linked to MOD-2023-746962, MOD-2023-747032.
pt devel fever day p/vax t103.4, vomited x 1; fever cont until responds to APAP or Ibuprofen;sl lethargic, not feeling well overall;observing pt;22AUG97 pt much better;
encephalitis 24 h after guardasil vaccination.  Right temporal-occipital T2 flair on MRI with negative HSV PCR.  3/26/09 Received hospital medical records of 2/17-19/2009 & 3/2-3/17/2009 & GYN & Neuro clinic records.  2/17-2/19/2009 FINAL DX: Seizure & Migraine headache Records reveal patient experienced bifrontal HA w/neck pain, dizziness, photophobia, phonophobia, nausea, vomiting, flashing lights x 4-5 days.  Was traveling to ER when had seizure & possible tongue biting.  CT scan in outlying ER was neg & d/x to home w/outpatient neuro f/u.  Now admitted, tx w/pain meds, antiseizure meds & anatinausea meds      3/2-3/17/2009 FINAL DX: presumptive herpes simplex virus meningitis Records reveal patient experienced intractable HA, stiff neck, retrobulbar eye pain, blurry vision, ear pain, teeth pain, tinnitus, N/V, decreased appetite, coryza, constipation, generalized weakness & vision flashes since 2/16, seen multiple times in ER & 1 admission for same.  Had been tx inbetween with steroid taper w/temporary improvement.  Several days prior to this admit developed fevers, night sweats, hallucination single episode & was essentially bedbound due to worsening pain when standing.   Neurosurg, Neuro & ID consult done.  Tx w/IV antibiotics, pain meds, IV caffeine, antinausea meds & antivirals.  Improved slowly & was able to ambulate w/o HA & d/c to home on continued oral antiviral meds & to return for repeat MRI.  GYN Clinic 2/12/2009 FINAL DX: HPV #1 administered, no Lot #s available.     Neuro CLinic 2/23/09 FINAL DX: persistent migraine HA Tx w/steroid taper, IV antihistamine/antinausea meds & was instructed to return as scheduled.
Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, Twice the size of his right leg; Really tight; Very uncomfortable; Can't walk dog; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable) and GAIT DISTURBANCE (Can't walk dog). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable), GAIT DISTURBANCE (Can't walk dog), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was not given No concomitant medication information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.