chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster ophthalmicus; Information has been received on from a lawyer and a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 12-FEB-2012, the pt was inoculated, by a healthcare provider, with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date (reported as "subsequent to inoculation"), the pt was treated by a healthcare provider for herpes zoster ophthalmicus. As a direct and proximate result of the Zoster Vaccine Live (ZOSTAVAX) the pt suffered ongoing injuries including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the reporting time, the outcome of the event was not recovered and the causality was related.  Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
LOCALIZED AREA REDNESS, SWELLING 3 X 5 1/2 IN AREA
About 8 hours after the shot extreme fatigue set in. And anywhere between 10-12 hours an extreme fever that included prolific sweats and chill throughout the night. This is in addition to muscle ache and a headache in multiple spots of my head. Even to this morning I have a little part in the back of my head that?ll feel uncomfortable from time to time
2 hours after shot, hands were itchy...Minor 6 hours after sot, no change 8 hours after shot,  hands were very itchy and feet were beginning to itch.  Groin are began to itch 12 hours after shot, itchiness was almost unbearable.  The more I rubbed or even touched, the worse it got.  Rash on inside of legs in groin area raided and itchy.   Applied a topical hydrocortisone cream.  Seemed to give a little relief...long enough for me to settle down and not rub. 18 hours after the shot, hands were very swollen.  Could not make a half fist.  Very sensitive to heat..  Continued to apply Cortizone-10 for temporary relief 21 hours after shot, went to Urgent Care.  Received a shot of a steroid and a Benadryl Capsule.   25 hours after shot, hands are still swollen.  Developed red blotches on the palms of my hands, Some are perfectly cylindrical about 1 CM in diameter.  Groin area still blotchy and raised.  Does not itch  as much as hands.     Waiting for relief......
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 30-AUG-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Given immunizations on 11/12/03 around 11 am. Baby seemed ok during day slightly fussy was given Tylenol. She woke up around midnight screaming. When mom picked her up she felt hot T 102.3 R-Tylenol given. Had temp thru night also had jerking of arms legs thru night. Pt had sepsis work up at hosp. ER-neg.
Bad reaction to second maternal,  after about 12 hours. Chills, muscle aches, both very severe, like a bad flu, but no fever.  Keep in mind, I had covid19 in September 2020, and first vaccine in January 2021
Soreness at injection site on upper left arm, still exists 4/17/17 with lump.
Could not move upper arm and extreme muscle pain - took acetaminophen Extremely fatigued....slept a lot the day after Small headache - took acetaminophen Bowels (unusually soft and frequent) and intestinal gas have been an issue (still)
FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination.  Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Patient stated he had severe muscular pain and sensitivity at left shoulder. Symptoms started 2 weeks after receiving flu shot on 9/30/2015.
Sore throat; fever 101; muscle aches; lethargy; This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 as dose 1, single (age at vaccination 54-year-old) for covid-19 immunisation. Medical history included Mild asthma from an unknown date, covid-19 from an unknown date (Prior to vaccination, the patient diagnosed with COVID-19), Shrimp allergy from an unknown date. The patient's concomitant medications were not reported. 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. The patient was not pregnant at the time of vaccination. On 11Feb2021 06:00, the patient experienced sore throat, fever 101, muscle aches, lethargy. The patient underwent lab tests and procedures which included body temperature: 101 on 11Feb2021 (fever 101). Therapeutic measures were taken as a result of events includes Tylenol. The outcome for all events was recovering.  Follow-up attempts are completed. No further information is expected.
Per father, no adverse event reported. Patient at the time was 15 and guidelines only included patients 16+ for booster. On 1/5/22, guidelines changed to include patients 12+ for Pfizer booster shot.
Headache that progressed in intensity for several days following the vaccination event.  Seizure/altered state of consciousness. Child's functioning was significantly affected for several days due to intense headaches.  He had to miss school and his testing for a week. After seizure event, the headaches ceased but he was left groggy, fatigued and depressed.  He stayed home to rest for several days.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, four improperly stored doses of (Oka/Merck) VARIVAX (injection, lot#, dose, route and dose number were not provided) were administered to patients after the temperature excursion which occurred on 05-DEC-2014. No adverse events were reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 56-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concurrent medical conditions included asthma. Concomitant products included amlodipine, Losartan, monteukast sodium, Rosuvastation, carvedilol, fluconazole, esomeprazole, LINZESS, NORCO, PROVIGIL, Dicyclomine and tizanidine. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced blister, skin discoloration and skin peeling. On an unknown date, the outcome of the blister, skin discoloration and skin peeling were recovering/resolving. The reporter considered the blister, skin discoloration and skin peeling to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The pharmacist reported that the patient developed 3 fluid filled blisters on her arm after receiving SHINGRIX. The patient was seen at the pharmacy on 27th April 2018 and the blisters were no longer filled with fluid, but there was peeling and discolored skin where they had been.
This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck), Lot # K006132, expiration date: 29-APR-16, via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient was administered an improperly stored dose of VARIVAX. There were no reported adverse events and no need for revaccination. The outcome of the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported is unknown. The reporter considered the patient was administered an improperly stored dose of VARIVAX and no adverse events were reported to be not related to VARIVAX (Merck). This is one of several reports received from the same reporter. Additional information is not expected.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data).  Patient was revaccinated 6/2/22 at our pharmacy.
Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (dose, route, lot# were not reported). No adverse effects reported. this is one of several reports received from the same reporter. Additional information has been requested.
no antigen, adjuvant-only used; Administration of adjuvant-only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The reporter reported administering Shingrix adjuvant only (no antigen) to patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (no antigen) to patient , inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193690:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022AMR194824:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193680:Same reporter
Vomiting on 10/3 with 102 fever, seen by PMD with normal labs.  Dosing with Ibuprofen and cold packs to continue. 10/4 Temp to 104, swelling at site with redness and pain, unable to bear weight.  Phone call to ID 10/4 and 10/5.  10/5 continuation and came to ER 10/6, admitted, with high WBC and CRP and respiratory distress.  Influenza neg, CXR bronchitis.  11/2/2009 records from 10/6-10/10/2009 and Infectious Disease Consult 10/15/2009.Dx RAD  Patient admitted with c/o's nausea, vomiting, fever,pain, swelling and redness rt thigh(inj site)  Tx: O2, Resp tx's , steroids, IV ABX.  Labs: Mycoplasma titer, Chlamydia, Diptheria/Tetanus AB, Influenza, Blood cultures:  Negative, CBC: WBC 23.6,  CRP 25, ESR 92 all High, Strep test neg Dx studies: CXR perivascular bronchial marking  ICD-9 codes: 682.6, 276.2, 999.5, 518.0, 238.71, 493.00, 799.02, 288.62, 564.00, 472.0
Swelling, warmth and redness to left deltoid 3x3cm indurate. Treatment ice to site, bactroban, Keflex
Systemic: Dizziness / Lightheadness-Severe, Additional Details: Patient became dizzy on standing after vaccination, patient was placed in supine position and quickly returned to baseline with symptoms resolved  AAOx3, normal heart and lung sounds, normal vital signs. Patient was observed for 30 minutes without any further reaction or side effects.
pt recvd the DTP/HIB/OPV on 23OCT92 that evening had an episode of paleness w/being limp which lasted 1 hr; it resolved w/o tx;
sudden sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   Around 30-OCT-2015, the pt. was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).   Shortly after receiving zoster vaccine live (ZOSTAVAX), pt. suffered sudden sensorineural hearing loss (Deafness neurosensory) (date unspecified).  As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was unknown. The event were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review sensorineural hearing loss (Deafness neurosensory) was considered to be medically significant.  Suffered sudden sensorineural hearing loss (Deafness neurosensory) was considered to be disabling by the reporter.
I don't think I had an adverse event for the vaccinations, per se.   I got covid in July, 2022.  I traveled to another country at the end of June.  On the return flight from on 6/28/22.  I think I was exposed.  But I live in a state, where covid is common.  On 7/3/22 I had flu like symptoms and was PCR positive.  I took paxlovid, per my family physician, and recovered quickly. I was PCR negative on 7/11/22. But I became antigen positive again on 7/22/22 and had a mild fever and cough for a couple of days.  I was antigen negative by 7/29/22.  It took some weeks for the cough to go away but this is common when I get a cold or the flu.
A moderna vaccine dose 1 was given after experiencing a temperature excursion. Patient was given vaccine by immunizing technician, was monitored for reaction, patient was fine and left. After patient left facility it was noticed the vial that was drawn up was punctured OVER 12 hours prior and thus was expired.
This spontaneous report was received from a nurse via field representative refers to a 15 year old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-JAN-2018, the patient was vaccinated with first dose of  GARDASIL 9) (strength, dose, lot # and expiration date were not reported), via intramuscular route for prophylaxis. On 30-JUN-2018, the patient was vaccinated with second dose of GARDASIL 9. On 30-JUN-2018, the patient developed a 'weird rash' (not clarified further) and had since been seen by an unknown dermatologist and an unknown infectious disease specialist on unknown dates (sought medical attention), where she received treatment (unknown). It was unknown whether any lab diagnostics/studies were performed. Outcome of rash was unknown. The reporter's causality assessment was not reported. There was no product quality complaint (PQC) reported.
This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (manufacturer unknown), for immunization. The patient developed a rash (rash all over her body), with outcome of unknown. Additional information: A coworker has a rash all over her body. The reporter did not have additional details. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient reported nervousness/anxiety prior to shot. Started feeling nauseous and sweating after the shot. Two compression packs were used to try and cool the patient. Patient ended up throwing up. Vitals were taken with a reading of 130/78    Temp 97.7  89 BPM. Patient was cleared
Pt states that "throat started closing immediately after vaccine given".  Difficulty breathing for about 24 hours.  Reports same reaction after 1st vaccine on 08/01/03 but did not think it was from vaccine.  No medical treatment sought.  Did not report reaction to health department previously.
swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient).  A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that "48 hours" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.
right arm lateral to injection site; 2 dime size erythematous raised areas, mild warmth to touch, and tender. Treatment: Keflex 500mg BID for 7 days, topical OTC hydrocortisone cream and ICE as needed. Spoke with childs mother on 7/28/08 she stated much better no redness, warmth to touch, fever or pain, only a small "pea" size knot.
Information has been received from a 63 year old female patient who was on 17-DEC-2008 vaccinated with the first dose of GARDASIL 0.5 ML on bum. The patient experienced muscle pain, dizziness and rash at the injection after getting the second dose of GARDASIL on 18-FEB-2009. Concomitant therapy included Raloxifene hydrochloride, Sumatriptan, Paroxetine hydrochloride, Omeprazole (MSD), vitamin D6, Aspirin, Omega-3 marine triglycerides and Calcium. The patient had not recovered at the time of reporting. It's not reported that the patient sought any medical attention. Additional information has been requested.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a six-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.