chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ocular abnormalities; Peripheral vision; kaleidoscopic vision for 2 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No concomitant medications were taken by patient.  The patient's past medical history included Migraine since an unknown date. Concurrent medical conditions included Diabetes and High cholesterol.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 21-Feb-2021, METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) had resolved. At the time of the report, VISUAL IMPAIRMENT (ocular abnormalities) and VISUAL FIELD DEFECT (Peripheral vision) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) A blood work was made and he discovered he is diabetic and has high cholesterol levels. On an unknown date, Magnetic resonance imaging: (Inconclusive) Negative. On an unknown date, Ultrasound Doppler: (Inconclusive) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller's husband received the 1st dose on 27Jan2021 and on 07Feb2021 he had ocular abnormalities, kaleidoscopic vision for 2 weeks, he lost some of his peripheral vision, doctorsmade MRI, vascular testing, everything turned out negative now he's symptom-free. He has a history of migraine. A blood work was  made and he discovered he is diabetic and has high cholesterol levels, so he was put on medication for cholesterol and folic acid which he wasn't taking at the moment of the 1st dose   This case was linked to MOD-2021-056249, MOD-2021-056249 (Patient Link).
Muscle pain in left arm, left back, and left breast. Has left hand weakness, runny nose, dizziness, weakness, and drop things from left hand.
Anaphylactic reaction; Throat started to close up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001166 (Novavax).  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose number unknown, Single). The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; THROAT TIGHTNESS (medically significant), outcome "unknown", described as "Throat started to close up".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296723 same reporter/patient/drug, different dose/AE;
Moderna COVID-19 Vaccine EUA. Vaccine recipient received vaccine on 1/19/2021. On 1/10/2021 reported fever, headache, chills, aches/pain, and fatigue. She self-managed at home. She reported that she developed a tinnitus (high pitch, intermittent buzzing) for 10 days. She does not have a history of tinnitus. She reports that her she self-managed at home and her symptoms resolved.
Patient received the vaccine on 7/27/21 and symptoms began on 7/31/21. It started with swelling in her hands which would travel up her forearms. The swelling would go away after a few days but then swelling in a different body part would occur a couple of days later. Eventually, her lips and ears got swollen. Today, there is still residual swelling in her ears.
Vaccine administered  24 hours after vial puncture; A spontaneous report was received on 1 Feb 2021, from a Healthcare Professional Dear concerning a 21-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccine administered 24 hours after vial puncture.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the event(s) vaccine administered 24 hours after vial puncture.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), vaccine administered  24 hours after vial puncture was resolved; Reporter's Comments: This report refers to a case of  Expired Product Administered  for mRNA-1273, (lot number not provided) with no associated AEs.
Body temperature increase to 102.5 degrees Fahrenheit. Shaking, fever, and severe fatigue and sweat all over body.
I became extremely dizzy and passed out, hitting my head on my bathroom sink. I was unconscious for about three to five minutes. I had a huge bruise on my forehead and needed to be checked for a concussion, which luckily I did not have.
The day after shots, started out itching on both shoulders, then both arms. Two days after shots, bumps appreared on forearms with itching. The itching spread to my hand, also with bumps forming. Now forearms and hands itch with bumps.
Red cheeks, chills, relentless zapping shocks on right side of head, sweats......(02-17-2021)went to the ER crying from head zapping pain, given 2 shots of morphine, had a ct scan on head, they took blood, gave me a covid test which was negative,  released me  with prescriptions for Ibuprofen 800mg and Tramadol 50mg.  Meds controlled pain for two days, zapping went away, but redness at injection site persists.
Got the vaccine and was fine, on the 2nd day 3/12/21 she got so weak, was freezing, her legs and feet were cold.  She turned the AC off and the temp in the house was 82 and she was still cold, had a headache and felt so bad.  She took her temperature and it was 101.6, she felt nauseous.  She had eaten a protein bar at 11:00 AM on then at 1:00 PM had the above symptoms.  She continued to drink water and kept it down, took her temp about 2 hours later and it was 100.4.  About 4 hours later she continued drinking water, and her temp had dropped to 99._.  She was so weak that she could hardly get off the bed to go to the bathroom and urinated on herself trying to get up out of the bed.  After her fever went down she was able to get up.  Her husband was almost total care and she was not able to take care of him.  She went to sleep and woke up at 3:00 AM and felt so much better, and ate some crackers and took some Tylenol for the headache and felt like she was OK.  She did not eat anything on Friday and on Saturday ate lightly.   The vaccine area is warm to touch, sore and swollen but not much.
Pt with Varivax on 1/29/03 on 2/13/03 broke out with varicella on neck scalp upper chest and back.
Violent shaking chills, 104 fever, vomiting, body aches. All of these symptoms lasted over 48 hours.
Pts daughter called, pt received Pfizer vaccine on 1/6/2020 and 6 days after pt developed a mild rash around her mouth.  Pt tried Benadryl 25 mg and applied tropical Aquaphor on rash but did not get better.  But few days ago the rash had got worst. Pt also feels like there is some kind of swelling and tightness. Per daughter, no white discoloration or puss.  The rash is only on the outside of the mouth and not inside. No other symptoms besides the rash (no shortness of breath, dizziness, or difficulty speaking...)  Rx Benadryl 25 mg tid and send Prednisone 20 mg od and Famotidine 40 mg od, and Hydrocordozone topical 2-3 times a day
Vaccines were administered following a temperature excursion; No adverse event/ there were no adverse reactions; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), unknown dose, lot # T016195, expiration date reported as 11-MAY-2022, but upon internal validation established as 11-JUN-2022 (dose number and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event). No product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2109USA001290: US-009507513-2110USA003605: US-009507513-2110USA003601: US-009507513-2110USA003604: US-009507513-2110USA003603: US-009507513-2110USA003602:
This spontaneous report as received from a other health professional refers to an approximately 15 year old patient. On 11-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Immediately after injection she felt a tingling down her arm. She also noticed pain at injection site.  The pain intensified and patient is still complaining of arm pain that has no radiated to her neck and shoulder area.
11AUG93 pt recvd vax & 12AUG93 malaise, feverish, fatigue through noc; 13AUG AM achey, h/a (APAP given) which helped h/a; This occurred not of 14AUG, 15AUG; oral ulcers began 13AUG;
6/28/21 A 26y/o female client  10:25 A client was given the following vaccines; Hepatitis A- Lot #G99R expiration date    in the right deltoid;   Hepislav B- Lot # 934599 expiration date    in the right deltoid:  and Johnson & Johnson  Janssen COVID vaccine Lot # 202A21 expiration date 08/07/2021 in the left deltoid. 10:30A During routine observation noted client color was pale, skin warm and dry. Client initially states she is ?okay?. After questioning client again this time Client admits  she feels ?dizzy?. Client denies any difficulty breathing and B/P 112/70 with a heart rate 76; pulse was strong and regular. 10:35A Client now c/o a ?dry mouth and dry throat?. Client given a minute sip of water was able to swallow without difficulty.  Client continue to deny any difficulty breathing or swallowing so couple of minutes later client tried another minute sip of water, but this time had some difficulty swallow. Now client admits she is having ?pain in my throat? and ?chest pains? in the left side. Epi pen -Lot #G201104X expiration date 02/2022 was given in client?s upper left thigh without problems; repeat B/P 118/68 and 911 was summoned by nurse 10:40AM Paramedics arrived ? reported to Paramedics epi pen was given.  10:47AM Client B/P per Paramedics 107/73, heart rate 72; Paramedics report client will be transported to the Hospital ED for evaluation. 3:50PM Noted client was back. Client reports she is feeling ?okay?. Client states she was ?discharged from ED at 13:22? (1:22PM) with the diagnosis of ?allergic reaction?. Client resumed her routine scheduled chores and continue to report she feels ?okay?. RN CCM
Information regarding Flumist nasal solution was received from a consumer regarding her 10 year old son who experienced gagging, eyes watered, awful taste, runny nose, stuffy nose, coughing and feeling tired. At 10 years of age, the patient received a dose on 11/7/03. The patient's concurrent illness includes seasonal allergy. Indication for Flumist was immunization. Product was administered on 11/7/03. Dose regimen was 0.5mL 1 time per day (IN). Concomitant therapy included Claritin. The patient experienced gagging, eyes watered, and awful taste on 11/7/03. He developed a runny nose, stuffy nose, coughing, and feeling tired on 11/8/03. At the date of this report, his runny nose persisted. No additional information was available at the time of this report.
itching on different parts of her body; short of breath; wheezing; right arm had swelling; congested; nose started running; eye turned red; like coming up with a cold; eye itched; warm sensation; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body) and DYSPNOEA (short of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HCL for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FEELING HOT (warm sensation) and DIZZINESS (dizzy). On 02-Feb-2021, the patient experienced EYE PRURITUS (eye itched), NASOPHARYNGITIS (like coming up with a cold) and OCULAR HYPERAEMIA (eye turned red). On an unknown date, the patient experienced PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested) and RHINORRHOEA (nose started running). At the time of the report, FEELING HOT (warm sensation), DIZZINESS (dizzy), EYE PRURITUS (eye itched), PRURITUS (itching on different parts of her body), DYSPNOEA (short of breath), WHEEZING (wheezing), PERIPHERAL SWELLING (right arm had swelling), NASAL CONGESTION (congested), NASOPHARYNGITIS (like coming up with a cold), RHINORRHOEA (nose started running) and OCULAR HYPERAEMIA (eye turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to cases 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156. This case involves a patient (age 8-17 year old and gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT and reported that given the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT/no AE and administered FLUZONE HD to patients 8-17 years old/no AE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ043AB and expiry date: 22-May-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong product administered, overdose and inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
arm is swollen and red---approx 5-6 inches wide---patient states that there is some heat in the area.   Recommended to contact doctor to discuss issues, possibly cellulitis.  Recommended trying ibuprofen and possibly benadryl at night
A single large wart came up on each of his index fingers. They are very sore and are located at the first knuckle on each finger. I took him back to the Dr. on Oct. 3 to have them treated. It is hard for him to play basketball, and hold his pencil to write in class.
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-FEB-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23, time of frame was 35.5 hours at a temperature of 27F (strength, dose, and frequency were not provided) lot # L040181 and expiration date 18-AUG-2018 and lot # L040178 expiration date 18-AUG-2018. Concomitant therapies were not provided. The nurse did not report adverse symptoms. The nurse was not able to provide the lot # and expiration dates for the PNEUMOVAX 23 was administered to the patient. This is one of several reports received from the same source. Additional information has been requested.
chills all day; body aches; no appetite; extreme fatigued; No energy; Slept a good part of day/still groggy; Dose number= 4; Dose number= 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2022 02:30 (Batch/Lot number: unknown) at the age of 74 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "Bronchiectasis" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone", notes: Known allergies: Oxycodone. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 3 (BOOSTER), Anatomical location: Left Arm), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious) all with onset 19Mar2022 02:30, outcome "unknown" and all described as "Dose number= 4"; CHILLS (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "chills all day"; PAIN (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "body aches"; DECREASED APPETITE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "no appetite"; FATIGUE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "extreme fatigued"; ASTHENIA (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "No energy"; SOMNOLENCE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "Slept a good part of day/still groggy". Therapeutic measures were not taken as a result of chills, pain, decreased appetite, fatigue, asthenia, somnolence.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2010, the patient was vaccinated with live ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2013, the patient was treated at a Dermatology office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
administered from vials which had been more than 6 hours post initial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 4 dosage form. On 11-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, 4 Moderna COVID-19 vaccine doses were administered from vials which had been more than 6 hours post initial puncture.  Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.   This case was linked to MOD21-028125 (E2B Linked Report).; Sender's Comments:  MOD21-028125:4 expired vaccines administered, no patient identifiers.
(L) thigh swollen, hot to touch, redness, crying cool compress and Tylenol with positive effect