chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of pneumonia in a 82-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis. On 2 January 2007 the subject received primary course of Flulaval (.5 ml, unknown). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. The consumer considered that the events were disabling and life-threatening. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.
Wife let us know that injection site was sore and warm to the touch, the day after vaccine. Recommended OTC analgesic and will contact tomorrow to see how they are doing. Called office (PCP) they will note in chart and let provider know  Followed up with pt on 8/17/19, everything is much better now, healing just fine. No further follow-up needed
Chest Pain with elevated ST at urgent care.  Sent to Hospital.  All tests at Hospital (Blood & CT with contrast) ruled out heart attack.  Only item of note is D-Dimer was 0.84 ug/mL. Treated at Hospital with Colchicine and Motrin.   ECG was normal prior to release from ER.   Doctor diagnosed Pericarditis based on symptoms and all other negative test results.   This included Pain getting worse when laying down.
swelling of left thigh.  Was given keflex, oraped, and benadryl at ER.
Pediavix and Hep B given instead of Pentacel and Hep B.
Throat swelling, hard to breath, wheezing, went to employer ER.  Prescribe a steroid and antihistamine.
A burning, itching rash developed on my right arm at the injection site and spread to my elbow over the course of three days. My skin was hot to the touch. I melted ice cubes over the affected area to relieve the burning and itching, which did provide relief and the rash disappeared. However, it reappeared four days later, and did not go away for two weeks. In addition, at the same time the rash first appeared, I began to experience numbness and tingling in my right arm, hand and fingers. I had never experienced this prior to the vaccine injection.
Pneumococcal vaccine received on 3-4-16. States "hurt immediately" then "became sore". Does not report any swelling or redness. No edema or redness at site noted this visit 3/7/16.
Fever Tmax 103.8 degrees 4 hours following PEDIARIX and PREVNAR.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 74-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in April 2018). On 14th August 2018 18:00, the patient received the 2nd dose of Shingrix. On 14th August 2018 23:00, 5 hrs after receiving Shingrix, the patient experienced chills, nausea, pain and viral infection. On 15th August 2018, the patient experienced fever. The patient was treated with Aspirin. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to Shingrix. Additional information was received as follows: The healthcare professional stated that all night he felt like he had a virus. At the time of reporting, the reporter stated that he had chills, nauseous, and achy. The reporter thought that he would feel better at morning of the reporting day and took couple aspirins, but at the time of reporting, he was experiencing symptoms again. The reporter also stated that at the time of reporting, he had the fever. This case is one of the four linked cases, reported by the same reporter.
awoke 2 hr p/inj w/unusual cry, low grade fever & unresponsiveness;evaluated in ofc then transferred to ER;had poor perfusion & unresponsive, irritability;poss sz activity;back to nl w/in 2 hr;
only received about half the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number Y9JS7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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: Reporter's Comments: The case was reported by pharmacist. Pharmacist reported patient was being administered a dose of Fluarix QIV vaccine on when patient jerked arm, and only received about half the dose.  At the time of reporting, the dose had not yet been repeated. Additional supportive information: As patient jerked arm, and only received about half the dose, which led to accidental underdose.
Outbreak of pityriasis rosea rash with no history of this condition. First outbreak in August 2021. Second outbreak in November 2021.
This spontaneous report received from a patient via a company representative concerned a male of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, It was reported that, patient had been battling reoccurring bouts of pericarditis and vasculitis that was started five weeks post receiving the J&J shot. Only thing that keeps it at bay was massive daily doses of prednisone which comes with his own problems. Treatment medications (dates unspecified) included: Prednisone. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reoccurring bouts of pericarditis, and reoccurring bouts of vasculitis. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220455313-COVID-19 VACCINE AD26.COV2.S-reoccurring bouts of pericarditis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt began to feel nauseated and fainted, Pt fell to the floor and had convulsive like behavior for less than one minute. Pt responsive and answering questions. Pt, head supported and evaluated. Pt assisted to one of the giving stations and then layed down on ground with legs elevated. Pt given water to drink. pt waited in room until she felt better.
About a week later,  my arm is swelling at injection site,  it's very red,  and itchy
Immediate (within 30 seconds)  rash on neck/face/ears/upper chest - Slight tingly feeling in tongue within a couple minutes - Took 2 Benadryl and then got Shakes within about 5-10 minutes - eventually symptoms subsided before leaving facility in about 45 minutes - 1 hour
Patient is experiencing hives on his torso and fine rash on his legs bilaterally.  They tried a topical Benadryl spray but he continues to have itching so they are going to try an oral Benadryl.  The rash and hives appeared approximately one week after the vaccine and the patient denies any other changes with hygiene products or medications.
Both eyes began to water and had lots of tears; Both eyes began to burn; Hard to see; Shooting pain from eyes; Eyelids became very red almost purple; Through the night eyes seemed to shut with crusty substance and had trouble opening them back up; The white part of eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes) and ERYTHEMA OF EYELID (Eyelids became very red almost purple) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red). On 21-Dec-2021 at 6:00 PM, the patient experienced LACRIMATION INCREASED (Both eyes began to water and had lots of tears) and EYE IRRITATION (Both eyes began to burn). At the time of the report, LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red) outcome was unknown.            Concomitant information was not provided.  Patient went to doctor on 22 Dec 2021 and the treatment medication included antibiotic eyedrops.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 expiry date 15-JUN-2017, lot # L013429 expiry date 21-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
pt recv vax 12OCT95 & 13OCT95 pt devel cellulitis 2 inches below the inj site, which was treated w/ATB;as of the reporting date, pt remained w/some residual erythema @ the site;however, swelling & pain had resolved;this is one of two pt;
Flu vac. left arm 2.5" diameter swollen. Very raised and red got 3" in diameter.
One week after the vaccine I noticed a red patch like a sunburn on my upper left arm. My arm also hurt like the shot was new. The next day the area was larger and it was itchy. It grew over the next few days to an area of ten inches. The middle was white and it almost looked like Ringworm and the outside area shrank from the outside in. I took Benadryl for the itch. It was better twelve days after the vaccine. I did not receive the second shot yet.  Due Date-09/23/2021 Pregnancy- Second
Pt received both doses of the Pfizer COVID-19 vaccine (on 1/26/2021 and 2/16/2021).  On 8/31/2021, pt tested positive for COVID-19 at her PCP's office, with mild symptoms.  On 9/6/2021, pt presented to the ER with worse symptoms and was subsequently admitted to hospital with an admitting diagnosis of COVID-pneumonia.  Currently on Med-Surge unit.
Patient came to get her second dose of Pfizer vaccine.  After administration it was found that the shot was 7 days too soon for patient.  Initial vaccine was 12/04/21.
0844: pt to triage area via wheelchair for c/o throat swelling, "heaviness" sensation in her chest, feeling hot.  Pt awake, alert, respirations easy and unlabored, skin warm and dry, pt speaking in complete sentences, pt managing oral secretions. nurse practitioner at bedside assessing patient, offered pt water/juice and crackers, no new orders.   0850: pt tolerating po intake well, no difficulty noted- water, juice, crackers.   0857: pt c/o "stomach upset".  nurse practitioner and physician assistant brought to bedside.  Order for Cetirizine 10 mg PO x 1 received from nurse practitioner.  Pt swallowed medication with no difficulty.   0906: pt stated she is feeling better- sensation of throat swelling, heaviness in chest, feeling hot, stomach upset have resolved.  Will continue to monitor.   0916: pt c/o "throat squeezing" and mildly blurry vision.  Pt awake, alert, speaking in complete sentences, no respiratory distress noted. nurse practitioner at bedside assessing pt. Pt continues to tolerate po intake with no difficulty.  Pt continues to deny difficulty swallowing.     0920: Benadyrl 50 mg given PO.  0923: pt on phone with her dad, arranging for a ride home, no respiratory distress noted.   0935: nurse practitioner at bedside.  Pt stated she is feeling better- "throat squeezing" sensation improving, almost gone.  No distress noted.   0948: pt's dad at bedside with pt permission. Pt continues to state she is feeling better, symptoms have resolved.    1000: nurse practitioner at bedside, pt stated she is feeling better and feels ready and comfortable going home.  nurse practitioner states ok for pt to go home with a driver.  Pt stated understanding that she may not drive due to taking Benadryl.  Pt's dad will drive her car home, pt's boyfriend will drive pt home.     1004: RN advised patient to call the 24 hour advice line for new or worsening symptoms, advised pt to call 9-1-1 or go to the nearest Emergency Department for difficulty breathing.  Patient stated understanding and agreed.  Pt exits ambulatory with steady gait, accompanied by her dad.   Chart routed to pt's PCP, pt advised to follow up with PCP, pt agreed.
Headache, Myalgia, Arthralgia, arm pain, swelling, chills and fatigue
Within 5 minutes of receiving the vaccine, I had changes to the hard palate. The ridges on the hard palate (plicae) became completely smooth and remained this way for 36 hours. No treatment was needed.  Pharmacist instructed me to report this into VAERS.
16 x 8.5 cm area of erythema, slight induration, slight warmth, no streaks.
Patient was given Pfizer as his first dose and Moderna as his second dose. Patient did not experience any symptoms, waited 30 minutes after injection before allowing  patient leave.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 43-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Sore arm and sore shoulder on same side as injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Nurse Practitioner concerning a female patient who on 04-OCT-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. On 05-DEC-2007 and 06-OCT-2008, the patient was vaccinated with the second and third dose of GARDASIL respectively. It was reported that the patient had high risk PAP smear after getting all three doses of GARDASIL. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has received from a physician via medical records concerning a 17 year old female student who on 12-APR-2007 was vaccinated with the first dose of GARDASIL IM, (Lot number: 657006/0188U), on 28-JUN-2007, received her second dose of GARDASIL IM, (Lot number: 657736/0389U) and on 31-OCT-2007, her third dose of GARDASIL IM, (Lot number: 659437/1266U). On the same day the patient received a dose of FLUZONE I.M. (Lot number: U2500AA). There was no concomitant medication reported. On 22-APR-2010 the patient had a combined HPV/gynecology report which showed low grade squamous intraepithelial lesion (LSIL), encompassing mild dysplasia (CIN I) and/or associated changes. At the time of reporting the patient present status was unknown. The patient's immunization record included Hib (manufacturer unspecified) 05-Oct-1992, 08-DEC-1992, 19-FEB-1993 and 13-OCT-1993. DTaP (manufacturer unspecified) 05-OCT-1992, 08-DEC-1992, 19-FEB-1993, 21-JAN-1994 and 29-Aug 1997. HepB 21-JAN-1994, 24-AUG-1994 and 28-OCT-1994. MMR II 05-OCT-1992, 08-DEC-1992, 19-FEB-1993 and 13-OCT-1993. IPOL 05-OCT-1992, 08-DEC-1992, 21-JAN-1994 and 29-AUG-1997. On 27-AUG-2004 patient received a dose of tetanus toxoid and tuberculin purified protein derivative. Additional information has been requested.
patient moved while administering second hep a vaccine, patient did not receive full dose. patients primary care provider was notified and spoke with patients mother, will repeat vaccine
Sore arm at injection site; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. Patient gave consent to follow up given.  On 29 Jan 2021, the patient experienced the events sore arm at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm at injection site was unknown.
+ COVID 19 test fatigue, congestion, cough, myalgias, headache
I was diagnosed with 'cervical myelopathy'.; I had swelling of right side of my face, near nose & eye area; severe pain in the back of my head; This spontaneous case was reported by a patient and describes the occurrence of MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:I already have migraines & allergy stuff.  Concurrent medical conditions included Migraine and Allergy NOS.    On 14-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) (seriousness criterion medically significant), SWELLING FACE (I had swelling of right side of my face, near nose & eye area) and HEADACHE (severe pain in the back of my head). The patient was treated with HYDROCODONE at an unspecified dose and frequency; CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 milligram. At the time of the report, MYELOPATHY (I was diagnosed with 'cervical myelopathy'.) and SWELLING FACE (I had swelling of right side of my face, near nose & eye area) had not resolved and HEADACHE (severe pain in the back of my head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: After 2 MRIs, I was diagnosed with 'cervical myelopathy'.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had had swelling of right side of face, near nose & eye area before the head pain. Patient had severe pain in the back of head that began a few weeks after getting the 1st dose. Patient going to see a surgical spine surgeon soon, because they said they saw something else on the 2nd MRI.  Company comment: This spontaneous case concerns a 61-year-old patient of unknown gender with no relevant medical history, who experienced the unexpected serious (medically significant) event of Myelopathy (cervical myelopathy) which occurred unknown days after administration of first dose of mRNA-1273 vaccine. Patient had severe pain in the back of head that began a few weeks after getting the vaccine. MRI was performed and patient was diagnosed with cervical myelopathy. The patient was treated with hydrocodone, cefixime, and ibuprofen. The benefit-risk relationship of mRNA-1273 is not affected by this report.
UTI after second dose; A spontaneous report was received from healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI after second dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 03 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the second dose of vaccination, the patient developed UTI. Treatment included antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome for the event, UTI after second dose was unknown.; Reporter'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.
9/22/2020 9:33:04 AM > pt states he Recieved Shingles shot 3 days ago, dose 2/2, states no issues with first shot. Experiencing chicken pox like rash through out body, bilateral arms, wrist and up, and bilateral legs and neck. Denies itching. States it's not bothersome, just there. Noticed it today, did not see it yesterday. Took a BENEDRYL.
several hrs p/vax legs felt very weak (as if had been standing lal day & needed to sit down);sensation subsided by Friday AM;when woke up Thursday AM felt nauseated;vomited twice but by noon time felt fine
Right after the vaccine I had a fever for a few days, and the shoulder I had the shot in ached off and on for a few weeks. My joints were also very achy. This I was expecting. What I wasn't expecting was how it'd affect my menstrual cycle. Ever since the shot, my periods have been much further apart. The problem doesn't seem to be going away with time either. Prior to the vaccine I had, on average, 24 days between the start of one period and the start of the next. They were relatively predictable (I use a tracking app). Now though I'm going anywhere from 26 days to 30 days.
PT complained of numbness in the right arm at injection site. PT was attended by NP and once symptoms resolved was cleared.