chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent were not reported. On 31-JUL-2015, the patient was vaccinated with M-M-R II, (lot number, dose and route were not reported). The pharmacist reported that the vaccine expiry date was on 12-JUL-2015, but it was properly stored. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Hospitalized with shortness of breath, oxygen saturation less than 80%, BP 220/123 on admission. Trialed BiPap but failed and was intubated. Extubated 11/9.
L upper arm with irregular shaped firm, red, warm area extending about 2 cm proximal to injection site, 3-4 cm laterally and up to 6 cm distal.
Client recieved J&J vaccination and arrived at obseravtion area. Client stated he was feeling faint and dizzy, Prior to passing out. Nurses and EMT beside client. Client was assisted gradually to the floor with legs elevated. Client Vital signs 101/62 99% O2 HR 69.  Dr educated patient to hydrate and to stay in observation area longer to be monitored.  Client states he has a fear of needels and has experinced fainting after recieving a vaccine in the past.  Client states he feels much better and no longer feeling faint.
chills; high temperature/fever 38 C; feeling tired; headache; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 26Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday 26Jan2021. He experienced chills, high temperature/fever 38 C, feeling tired, and headache the day after (27Jan2021). The patient took paracetamol (TYLENOL) to manage the symptoms. He asked if these are normal side effects and was looking for recommendations. The clinical outcome of chills, high temperature/fever 38 C, feeling tired, and headache was unknown.   Information about Lot/batch number requested.
Patient presented to emergency center for evaluation of right sided headache for 12 hours with episodic slurred speech day after 2nd dose of  COVID vaccine. Per notes slurred speech already resolved at time of ER visit.
I got the vaccine at 8:15 on a Wednesday. About 12 hours after receiving the vaccine in my left hip via IM injection, the injection was extremely painful and starting to get red. I went to work the next morning. By the evening of the 2nd day, I was very nauseated, felt warm (temperature 99.2), my outer hip was very painful. There was a firm lump and it was red. I tried to apply an ice pack--didn't help. I felt wiped out. I called in sick for work the next day. That night, I woke up and felt very warm. My temperature was 100.2. (My temp is usually 97.4). I felt like I had the flu. I was achy all over and had no energy or appetite. On Friday, I slept until 2pm because I felt too sick to move. I took medication for nausea, TYLENOL and MOTRIN about every 6 hours. The injection site continued to enlarge, but slightly less painful. On Saturday, the injection site on my hip was at least 4 inches in diameter of redness. Less lumpy, still tender. I was queasy all day Saturday until evening. Today-Sunday-day 5-I finally feel better. The injection site is still pink and sore but not painful.
I exp joint pain wrist, knees, hip, neck for 4 hours day after.
G62.9 NEUROPATHY 7/13/2023 CKD STAGE 3A (GFR 45-59)
Over a month after receiving my second dose of Pfizer, I had an episode of lightheadedness, dizziness, shakiness, and fatigue. I attributed it to dehydration and laid down and ate a snack, I began to feel better after 1-2 hours. A week later I had another lightheadedness incident that sent me back to bed (this one being slightly worse). I experience slight chest pain in my upper right chest muscle. It took me a day to recover from this spell. I constantly felt weak and as if I was about to faint. I went to the doctor two days later and got blood work done and measured my blood pressure. Everything came back normal. On Saturday June 19th, I had another near-fainting experience in a public setting. My hearing changed, I couldn't think straight, I was very shaky and weak, and I tried to drink a lot of water. Nothing helped so I went home and once I got in bed I was aggressively shaking. Since then I have been bed-ridden for the week, and unable to do normal activities such as go for walks, exercise, or go to work. I am going to visit a cardiologist tomorrow.
Narrative: generalized erythema of upper arm same day; improving after 24 hours; serum reaction. Symptoms: ErythemaMultiform Treatment:
Adacel exposed to 52.6 degree Fahrenheit for seven days and were administered to the patient/ No AE; pregnant female patient received Adacel vaccine at 28 Weeks of gestation/ No AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA188909, 2020SA189059, 2020SA189112 and 2020SA189085 (same reporter).  This case involves a 24 years old pregnant female patient who on 09-Jul-2020 at 28 weeks of gestation received a 0.5 mL dose of  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left arm for prophylactic vaccination and that vaccine got exposed to 52.6 degree Fahrenheit for seven days (exposure during pregnancy and product storage error)  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The patient received Adacel vaccine at 28 Weeks of gestation.  The date of last menstrual period was reported as 25-Dec-2019.  The estimated due date is 30-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were given to the patient.   It was of actual medication error due to incorrect product storage. It was also a case of vaccine exposure during pregnancy.    Case details: It was reported that the excursion was for seven days and vaccine got exposed to 52.6 degrees Fahrenheit from 08-Jul-2020 to 15-Jul-2020 that was administered to five patients since the excursion. Reporter wanted to know about the possible side effects.  Laboratory details were not reported.  The patient had no adverse reactions at the time of report.   Additionally, at time of reporting, the outcome of the pregnancy was unknown.   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.
Left foot second toe became very painful, swollen, red, suspect it was second toe capsulitis.  Could not walk or put shoes on.  This has never happened to me before, perhaps coincidence but perhaps due to the vaccine.
This spontaneous report as received from a physician via a company representative refers to a female patient of unkonwn age who was a nurse in his office. On an unknown date the patient completed 3-dose HepB (manufacturer unknown) 10 MCG/ML series (lot#, frequency and route unspecified) on unspecified dates in the past but when she was tested for Hepatitis B antibody titer, result was negative. The patient received another series of 3-dose HepB (manufacturer unknown) 10 MCG/ML series (lot#, frequency and route unspecified) on unspecified dates and second titer for Hepatitis B antibody was done but her result was yet again negative. The patient sought medical attention and no treatment was given for the events. Physician could not confirm that Hepatitis B series nurse received was RECOMBIVAX HB. The outcome of the events was unknown. Additional information has been requested.
Localized swelling approximately 4 x 6 " in diameter associated with a temperature of 102. Fever lasted approximately 6 hours, swelling for a week.
Estimated 90% hearing loss and severe tinnitus of right ear 14 days after 1st injection of moderna covid19 vaccine.
Chills; temperature of 101; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, EN6202), via an unspecified route of administration on 02Mar2021 14:00 (at the age of 73-year-old) as single dose for covid-19 immunisation. Medical history included high blood pressure, gout, heart attack, heart problems; all via unspecified date and unknown if ongoing. On 03Mar2021 at around 3:00 in the morning, the patient started getting chills and temperature of 101. The patient did not receive any treatment in response to the event. Outcome of chills was not recovered, while outcome of temperature of 101 was unknown.  No follow-up attempts are possible. No further information is expected.
Developed whole body itching about ten hours after shots. Next morning, about 20 hours after shots, had sore joints, watery eyes, tightness in throat, feels shaky, tremorous.  Treated with Zyrtec 10mg. p.o. No pharyngeal  edema on exam. Lungs clear. Eyes watery. No rash noted.
Moderna Vaccine was administered after the beyond use date of 30 days at refrigerated temperature. Beyond Use date 10/01/2021
NOSE BLEED; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: dry eyes, knee osteoarthritis, and mobic allergy. The patient was previously treated with meloxicam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-NOV-2020 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid, chondroitin sulfate/citroflavonoid/glucosamine sulfate/manganese, ciclosporin, ergocalciferol, and hydrochlorothiazide. On DEC-2020, the patient experienced nose bleed. On 22-APR-2021, Laboratory data included: Platelet count (NR: not provided) 265. On 22-OCT-2021, Laboratory data included: Platelet count (NR: not provided) 239. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Went down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 20-AUG-2021. This report was non-serious. This case, involving the same patient is linked to 20211225951.
Normal ache in upper left arm on next day. Stronger than usual headache on next day - reduced to barely noticable by using Ibuprooen. At 7:00 pm - 27 hours after shot, high fever started, face was red - lasted for about 2 hours. Return home and return to normal
Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested.  12/18/07-records received for DOS 9/10-9/28/07- DC DX:  Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk.  PE: reflexes absent in both lower and upper extremities.  This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008.  Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007.  On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported.  On 14/SEP/2007, the patient was given  a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered.  It was unknown if the prescriptions wore taken by the patient.  On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed.  She presented to the emergency room, with Guillain Barre syndrome where she was examined.  On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome.  The patient had a magnetic resonance imaging performed that was being evaluated.  At the time of reporting, the patient had not recovered and was in the intensive care unit.  The reporting physician felt that the event was serious (Other Important Medical  Event) immediately life-threatening, required hospitalization, and was disabling.  A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release.  Additional information is not expected.
Began with dry cough and sore throat, progressed to pain in hands and feet, "lower left lung" pain, and finally diarrhea and vomiting. Patient stated illness lasted for days. Patient did not report illness at time of symptoms.
This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown demographics. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 12-DEC-2016, "three months off schedule", the patient was vaccinated with a third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Developed headache within an hour of receiving injection that lasted 2 days. Injection site swelled up and became painful and itchy, with the appearance of a hive. Felt exhausted, achey and lymph nodes in my left arm swelled up for 4 days. It has now been 6 days and while the injection site is not painful any longer, It still itches and is still a bit swollen. I did miss a day of work due to feeling ill.
This spontaneous report was received from a patient's mother regarding her 12 years old son via company representative. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-DEC-2016, the patient experienced nausea, headache and vomiting after receiving GARDASIL. The company representative could not confirm whether it was GARDASIL or GARDASIL 9. Outcome and causality of the events were not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Booster COVID given incorrectly, nurse gave 0.5 ml for booster instead of 0.25 to this patient
The pt developed redness and tenderness surrounding the vaccinia (primary rxn) vaccination site with lymphangitis spread to the axilla. Treated with 5 days of Levaquin 500mg/day.
Rash below injection site; redness, warm to the touch. Noticed 2/14/21. On 2/15/21, rash has grown in size towards bicep.
Had a temperature excursion recently where the temperature hit -12 C; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Had a temperature excursion recently where the temperature hit -12 C) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter stated that they had a temperature excursion recently where the temperature hit -12 C. They moved the vaccines to other location's freezer within 30 minutes in a cooler with some ice packs.
Night Sweats; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, 1 days after receiving Shingrix, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient stated the day after vaccination he experienced night sweats, and he was still experiencing night sweats. No further details were provided. The reporter consented to follow up.
Dizziness on head movement and unsteadiness. Brief episodes, but consistent. Wondering if this is a reported side effect, and if so, prognosis
Severe itching and hives only on the back of my leg and on the back of my right arm which lasted approximately three days. Treated with a steroid dose pack and Zyrtec.
numbness beginning on lt side-fingers arm-spread to rt side then both feet up to & above hips;
FELT CONFUSED AND OUT OF IT; ARM FELT LIKE FEVER IN IT; Fever; ARM VERY RED; RASH; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH) in an 88-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH). At the time of the report, CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up this morning with the rashes upper chest and neck; It feels like on fire; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient reported that the patient got second shot of covid-19 vaccine yesterday and on an unspecified date, the patient woke up this morning with the rashes on upper chest and neck. It felt like on fire and asked did the patient do anything or just ignore it. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High blood pressure, shortness of breath, dizziness, low-grade fever, and chest pain.
Per parent report:  Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl.  Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl.  Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21.  some improvement in fatigue, but experienced some brain fog.  Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction.  On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital.  Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause.  Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.