chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs or PQCs reported; temperature excursion for VARIVAX/ temperature: 9 degrees C to 25 degrees C (14.5C) for 2 hours/ product was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 26-MAY-2022, the varicella virus vaccine live (oka/merck) (VARIVAX), lot # T027305, expiry date reported as 31-AUG-2022, but upon internal validation established as 12-AUG-2022, experienced a temperature excursion of 9 degrees C to 25 degrees C (14.5 degrees C) for 2 hours. It was also stored in -14 degrees C up to -10 degrees C (-11.49 degrees C) for 2 hours.  On 27-MAY-2022 the patient was vaccinated with 1 dose of above mentioned improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route and site of administration were not reported) for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaints (PQCs) were reported (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006055:
Information has been received from a certified medical assistant concerning a 26 year old female patient with penicillin, amoxicillin allergy and (PERCOCET) allergy who on 27-MAR-2009 was vaccinated with a dose of GARDASIL (lot# 659655/0940X). On 28-MAR-2009 the patient experienced a rash on both her arms lasting about 24 hours after vaccination with GARDASIL. She also experienced dizziness and migraines that lasted for a few weeks after vaccination. The patient sought medical attention via telephone call. Additional information has been requested.
pt recv vax 13MAY96 & Tuesday AM pt c/o site sore & sm red area;12:30 c/o diarrhea, vomiting & cough, ?fever, warm wed AM temp 100;wed AM t100;wed eve temp 101;thurs t101 seen in MD office red area 5x2inches w/1" induration
Varicella 8 yr after administration of Varivax. 2-29-04 vesicles started on face and chest. 3-5-04 approx. 15 crusted or semi crusted vesicles.
MYOCARDITIS SEVERE W/ HEART ANEURYSM    SEVERE CHEST PAIN LASTING SEVERAL HOURS  WAS NEG FOR HEART ATTACK WAS HOSPITALIZED FOR SEVERE CHEST PAIN  AFTER SEVERAL DAYS OF HOSPITALIZATION WAS DX W/ MYOCARDITIS AND HEART ANEURYSM  WITH NO PREVIOUS HEART HISTORY
Partial Dose given. Vaccinator injected vaccine in right arm. However, vaccine leaked from syringe and down participant's arm. Vaccinator determined participant did not receive complete dose #2. Participant okay with getting revaccinated in left arm. Vaccinator clarified that when removing syringe, needle separated from syringe and remained in arm briefly. Vaccinator placed BD brand syringe and needle into sharps container immediately.   Participant had no pain or adverse events after vaccination
Patient received 'steroid' injection from allergist and 3 days later received 1st dose of Pfizer COVID-19 vaccine, then 3 days later received another 'steroid' injection. Patient then developed headache associated with fever and chills for 1 day. The patient travelled at which time his symptoms came back now with nausea, vomiting and diarrhea. Patient also noted to have erythema and itchiness for 3 days prior to coming to the hospital. Patient has a rash on left arm, as well as bilateral lower extremities. Patient was admitted for septic shock with an AKI. Patient received IV fluids, Levophed, vasopressin, IV Fentanyl, IV antibiotics, and IV steroids. Patient is now off of vasopressors and is improving.
NOSE BLEED; BODY ACHES; CHILLS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and severe headache on 09-APR-2021, and had not recovered from nose bleed. This report was non-serious.
Swollen legs, could no longer walk, low platlet levels, needed a blood transfusion, cognitive decline, kidney failure, death
I received the first dose of Moderna vaccine Jan 26th 2021, On Feb 2nd, I developed what I thought was hives. I went to two doctors; the first being prompt care, the second being an emergency room doctor. My rash has been present for fives day today (Feb 6th), with no sign of healing. This rash is bliserous. It is on my face, arms, hands, wrists and a few splotches here and there on my torso and hips. I am currently taking steroids, they are not helping. This rash is absolutely miserable and unlike anything I have ever experienced .
mainly noted flushing of skin mainly on both forearm- slightly  itching/ sensitive sensation - no hives , no edema noted - no other s/s of any breathing or swelling in oral mucosal area - remained alert no other stress -- recommended Benadryl OTC  and pt was fine with recommendation and will contact to see pcp if any other worsening issues -- mainly want to know how to manage his second vaccination - what advise to give - recommend him to take Benadryl prior to next vaccine , or is he safe to get his second vaccination?
I woke up with body aches( muscles) and could not get back to sleep because of it. For the next 22 hours I experienced these aches( all over) and could not find the feeling of comfort either staying still or doing stuff. I didn't take anything for them, as I wanted the vaccine to create antibodies to its fullest potential. Finally, I was able to find periods of comfort so I could fall asleep the next night. They were gone when I woke, and I was left with a minor headache.
This is a spontaneous report from a Pfizer sponsored program COVAX US Support.  A contactable consumer (Patient's wife) reported for her husband that a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 22Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history included diabetes mellitus from 2004 to an unknown date Verbatim: diabetes, hypertension from 2003 to an unknown date Verbatim: Blood pressure high. Concomitant medications included metformin (METFORMIN NDC: 65862-0010-05, LOT: MTSC20156a, EXP: discard by April 2022) 1000mg a day by mouth taken for diabetes mellitus from 2004 to an unspecified stop date for almost 20 years since approximately 2004; Humalog Kwikpen insulin lispro (INSULIN LISPRO, Manufacturer: Lilly, NDC: 0002-8799-01, LOT: D255549C, EXP: June 2023) 3mL(caller says he has been taking this two days), taken for diabetes mellitus from May 2021 to an unspecified stop date; amlodipine (AMLODIPINE) taken for blood pressure measurement for 10 years, start and stop date were not reported; glipizide (GLIPIZIDE, Manufacturer: Apotex Corporation) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL, Manufacturer: Lupin) taken for blood pressure measurement, start and stop date were not reported; apixaban (ELIQUIS, Manufacturer: Bristol-Meyers, NDC: Unknown, LOT: ABQ4087S, EXP: April 2023) taken as a blood thinner, start and stop date were not reported; dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning (blood glucose increased) (medically significant) on 23Apr2021. The caller says that her husband's blood sugars have been high since the next day after the shot, and have not been better. The patient underwent lab tests and procedures which included blood glucose increased: 382 on 06May2021, blood glucose increased: 298 on 06May2021. Therapeutic measures were taken as a result of high blood sugars after first dose of vaccine/high blood sugars of 300-350/waking up with blood sugars from 300-400, his sugar right now is 298/blood sugar was 382 when he woke up this morning. His normal blood sugar is 160. The clinical outcome of high blood sugars was unknown. The reporter seriousness for high blood sugars after first dose of vaccine was unknown. Information about lot/batch number has been requested.
This spontaneous report was received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD, lot # M033216, expiration date 09-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was 10.6 F for 98 hours 51 minutes. No digital data logger was involved and no previous excursions were performed. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Persistent clogged milk ducts while breastfeeding. I was pregnant at the time I was vaccinated and my son was born 08/04/2021. About three weeks after that I started getting clogged ducts in my breasts, and have consistently had two to three a week on average since then, in both breasts and on all sides. Treatment includes behavioral changes to minimize pressure on the ducts, and 3,000-4,000 mg of sunflower lecithin a day, however this treatment has not proved effective in preventing clogs. I continue to breastfeed exclusively.
1800 Chills started. 2100 fever 100.8, hr 115, slight sob resp 28, spo2 96, achy, lost appetite  Next day  fever 100.5, resp 32, spo2 93, very achy,  head ache,  sob walking around house,  bad reflux heartburn  Day 3 fever 99.5,  resp 28, spo2 93, same symptoms  Day 4 normal temp, resp 26, spo2 95, same symptoms,  now with loose stool Gradually improved but stayed very fatigued.    Day
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received, Dose information updated(Booster dose)
Customer was sleepy, not respond to husband call, breathing was ok, later she opened her eye talked some words to husband. 911 was called, took her to hospital.
Severe chills, vomiting (approximately 4 times over several hours starting around midnight the day after vaccination), mild fatigue for several days after.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of ZOSTAVAX (lot# reported as M032651 with expiration date: 15-JUN-2017) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Case previously recorded as MA2009-4199. Initial case report received from a health case professional via MedCom on 10 NOV 2009. A 3 year-old male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 100813) i.m on 04 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007859.
Painful, swollen lymph nodes on right upper arm and underarm. Started approximately 3 hours after vaccine. Persisting until present.  Tiredness Pain at injection site
w/in 1hr of vax pt fell over-arched back, eyes rolled back apparent sz;parent called to report & said it lasted 15sec;parent instructed to also call family MD & report incident;
Sluggish; It felt like a bully at school.; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy NOS.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included medications for Blood pressure and unspecified allergy.   This case was linked to MOD-2021-209019, MOD-2021-209019 (Patient Link).
Modern a COVID-19 Vaccine EUA Chills, body aches, fever high of 101.1 Fahrenheit, fatigue, diarrhea, joint pain, headache, injection site soreness. Chills and body aches began around 10:48 on and symptoms progressively worsened throughout night.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310464, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, 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
Chills on Dec 15 and 16. Vaginal yeast infection on Dec. 18.
02/01/2021 I had vertigo all of a sudden, so bad I had to get on the floor. I was taken to the ER Hospital. Antivert and Zophran, medrodose pack of steroids'.  It went away and came back from time to time over, it lasted for about three months.
First covid vaccination at 0800. Twelve hours later around 1930, I began to have uncontrollable shivering that lasted for approximately 8 hours. Then intermittent shivering for a few more hours. Low grade temperature in the morning 99.5.  Headache,  generalized body aches, severe fatigue and nausea began 24 hours after vaccination. I tested postive for covid in January of 2021 with symptoms starting appoximately January 11. Covid symptoms at that time were mild, mostly fatigue, mild dry cough, some shivering and I lost my sense of smell which still hasn't returned.
On 7/6/00, pt went to ER for allergic reaction; possible cellulitis vs abscess.
When elevated bilateral arms and head shook like chills approximately 8 seconds. Six episodes. None observed today.
August 11th - J&J covid vaccine  August 25th - not feeling well late evening better next morning, bilateral legs hurt, slight numbness in arms, legs and lips August 26th - not feeling well again late evening, bilateral legs hurt more than on the 25th, numbness in arms, legs and lips. Took 3 Tylenol for pain to sleep  August 27th - continue symptoms from the prior day  August 28th - bilateral leg pain sufficient not to be able to sleep. Went to Emergency room. Doctor ran blood test and ultrasound of bilateral legs. Doctor stated no acute reason for bilateral leg pain  August 29th - felt fair, still have pain and numbness in bilateral legs and arms  August 30th - Called in sick at work. Went to another ER and took Emergency room blood test records. ER doctor performed lower back CT scan, prescribed steroid pills, tramadol, and steroid injection  August 31st - Went to spine doctor, discussed treatments including physical therapy and steroid injection, felt fair, unable to sleep due to continue bilateral leg numbness and pain  September 1st - Went to another ER - ER doctor reviewed medical records, prescribed muscle relaxant Flexeril - medication did not help and did not sleep well September 2nd - went to Medical Center and discussed treatment, had minor back adjustment, started taking steroid pills  September 3rd - Went to Neurologist - saw Dr. and was diagnosed with Guillain-Barre and treatment to follow with findings of impaired walking and left foot drop and ataxia  September 4th - could walk with difficulty  September 5th - went to assigned hospital per Dr. since not able to walk by myself - received first dose of IVIG at 11 pm - plan for IVIG treatment for total of 5 days  September 6th - walking with walker and second round of IVIG at 2137
Raised bulge at injection site. Red streak extending to elbow and forearm, ending close to the wrist. Reaction was described as painful and swollen. Symptoms began the day of the injection and subsided 5 days later (5/15/18).
This is a spontaneous report from a contactable physician. A 58-year-old female patient of an unspecified ethnicity started to receive pneumococcal 13-val conj vac (dipht crm197 protein) at single dose for immunisation, mupirocin at an unspecified dose for an unspecified indication, both via an unspecified route of administration on an unspecified date. Medical history included drug hypersensitivity. The patient's concomitant medications were not reported. The patient experienced allergy to pneumococcal vaccine and mupirocin on an unspecified date with outcome of unknown.
On day following vaccine administration, patient developed painless localized red lump on right arm (site of influenza vaccine). No itching or systemic symptoms. Typical of localized vaccine reaction.
The Patient had a Moderna booster shot on 11/29/21. His previous doses were on 3/1/21 and 3/29/21.  Shortly thereafter he the patient started complaining of fatigue and shortness of breath. He had an echo in office on 12/20/21, he was found to have severe pericardial effusion with tamponade features, normal ejection fraction and valvular function. (He had a previous echocardiogram in 7/2020 that had no effusion and an angiogram in 9/2020). He was admitted to a local hospital for outpatient pericardial Window which was performed on 12/28/21 by the cardiovascular surgeon. The pericardial effusion was serosangiouous, showed no malignancy or granulomata and was consistent with chronic pericarditis. The patient has no known autoimmune diseases and his thyroid function is normal. He was discharged on 12/31, His surgery was complicated by atrial fibrillation and he was discharged on amiodarone. He was re-admitted on 1/3/22 with left arm thrombophlebitis and cellulitis. He was started on vancomycin and upon receiving his second dose rapidly deteriorated and coded. He was resuscitated and responded to epinephrine and steroids. Presumptive cause of code was anaphylaxis to vancomycin. Trans-esophogeal echo showed no additional pericardiac effusion, normal cardiac function for age and did not support pulmonary embolism.  He recovered over the next few days and was discharged on 1/7/22. He has done well since.
Inflammation a few days after vaccination. Diagnosed with vasculitis. Hospitalized for two days with pelvic and joint pain. Blister on abdomen. Bilat. swollen lumps above patellas.  9/3/09 Hospital records received DOS 8/24/09 to 8/26/09 and 9/2/09 to 9/3/09. Assessment: Intractable myalgias and arthralgias. Acute leg nodules. Anthrax (vaccine) reaction. Patient presents with diffuse body aches. Right calf and leg pain. Nodularity to legs. Moderate discomfort. Upper extremity pain. Abdominal pain.  9/30/09 ED records received DOS 8/24/09. Assessment: Intractable myalgias and arthralgias. Patient sent to ED by PCP. Patient presents with diffuse body aches. Right calf and leg pain. Right calf fullness. Admitted for 23 hour observation.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced cried for 2 hours. The patient received a dose on an unspecified date. The patient experienced cried for 2 hours. The patient recovered. No additional information was available at the time of this report.
Pt received flu shot on 9-22-14 - presented back to pharmacy on first of Oct. Stating arm was still in a lot of pain and unable to raise his arm. He was advised to see MD. He went, got a pain medicine, and is currently undergoing physical therapy twice weekly.