chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported.; received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.      On 12-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020; strength, dose, frequency and route, were not provided) for prophylaxis. (product storage error). Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added to the case since the office did not know which lot was given to which patient. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported. It was stated that the vaccines were exposed to a temperature between -14 to -10 Celsius degrees (-9.74 Celsius). Time frame was unknown. A digital data logger was involved. No previous temperature excursion was reported.
The following evening after my 2nd shot I developed a red rash at and extending below the injection site, plus my arm began aching slightly.  The aching subsided quickly but the rash worsened and persisted for the next several days through Sat. 3/22/21.  (Note that 8 days after my 1st shot I  experienced a delayed rash and reported such on VAERS form E-number 337765 on 3/6/21.)  After the 2nd shot the rash appeared within 36 hours at approximately the same site, but was much larger. While the 1st shot rash was more rectangular with an irregular outline, the 2nd shot was a larger oval.  Vestiges of this 2nd oval rash persist today, noticeably after a hot shower or vigorous exercise.
Flu symptoms: Cold chills, sweaty, body aches, no appetite, painful enough to not sleep, extremely tired, headache, no nausea.
Administration Error: 14y/o patient inadvertently received Pfizer vaccine at mass vaccination event. Tolerated vaccination well without side effects or significant reaction.
Information has been received from a registered nurse referring to unknown number of unspecified patients. The patients' medical history, concurrent condition and concomitant medication were unknown. On 05-AUG-2016 and 08-AUG-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose and frequency unknown, lot # L048854, expiration date: 31-AUG-2017). Vaccines were stored in 53.4F for two hours. There was no previous temperature excursion. This report is for data logger. No adverse event was reported. Additional information has been requested.
ACUTE ON CHRONIC RESPIRATORY FAILURE 3/27/2023 INTERSTITIAL LUNG DISEASE ACUTE ON CHRONIC RESPIRATORY FAILURE 3/27/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE ACUTE ON CHRONIC RESPIRATORY FAILURE 3/27/2023 PERICARDIAL EFFUSION
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid started on 13Feb2023 and stopped on 18Feb2023. Known allergies: None.   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.
Chills starting about 7 hours after injection of vaccine until the end of next day, fever, body ache, injected arm sore, pain behind eyes
mom states pt began to run slight T on evening vax given, by early next am T to 103 & rash over body /w exception of hands, face & diaper area
Information has been received from a physician concerning a male with irritable bowel who was vaccinated on 11-FEB-2008 with varicella virus vaccine live (Oka/Merck) second dose. The doctor reported that a child received a second dose of varicella virus vaccine and immediately experienced a large raised area, like a white bubble at the injection site. The physician feels that it was administered intradermally rather than subcutaneously. The patient was treated with ice as needed and will be seen in the office on 13-FEB-2008. The patient was vaccinated with the first dose at one year of age. It was reported that the patient had not improved. Additional information has been requested.
5/30/2022- Presents to Ed, weakness, confusion, slurred speech. Ct head- on acute intracranial hemorrhage. Covid + test. Incidental finding. CXR- mp focal infiltrates. Ordered Bebtelovimab.  Not a candidate for tPA due to low NIH score and thrombectomy d/t lack of arterial target. Ordered ASA, plavix. Pt refused anticoagulation s/t past GI bleding with Xarelto.  6/1/2022- Maintaining 02 sat.  VSS 6/2/022- MRI brain negative. Stable on RA. D/C to home with stroke team and cardio f/u.
Patient was given Gardasil and fainted about 30 sec. after it was given. It was difficult to wake her up and she had incontinence of urine and was very startled when she did awake. We had her lay on the table and drink some orange juice before she was able to leave the office.
erythema, tenderness, swelling, hematoma and warmth at injection site; headache and fever; all symptoms x 48h
Patient was given two doses of the Shingrix vaccine. One in each arm. She experienced flu like symptoms for a few days.
Vaccine given 9/11/13 - Rt deltoid. Pain, weakness onset 9/14. Seen in emergency dept. 9/23. Seen by health center 10/4 -> brachial neuritis.
I tested positive for Covid-19 on March 2, 2023. I experienced sore throat; nasal congestion; ear congestion; chills; fatigue. I was prescribed PAXLOVID for my symptoms.
many months of chemo; surgery; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 13 days after receiving Shingrix, the patient experienced surgery. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). Shingrix was discontinued. On an unknown date, the outcome of the cancer and surgery were unknown.   It was unknown if the reporter considered the cancer and surgery to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The patient got the first dose of Shingrix and she had a surgery on 15th May 2020 and she had many months of chemo due to the surgery which she started in July 2019 and ended in November.  She was advised by her doctor to not get the second dose of Shingrix.  The reporter did not consent to follow-up.
Case number PHEH2012US014959 is an initial spontaneous report received from a nurse on 26 Jul 2012: This report refers to a patient of unknown gender and age group. This patient was vaccinated with MENVEO (batch number: M11051 and expiry date: Mar 2014) on an undetermined date. After vaccination this patient experienced firm swelling on the arm, the arm was warm, red and swollen. These events were treated with unspecified steroids, TYLENOL along with MOTRIN and ice. No further information about causality and outcome of the events was reported.
This is an instance of breakthrough COVID-19 after which death occurred. The individual received a mixed regimen of COVID-19 vaccine, having received 1 dose of the Jansen product on 03/10/2021 and 1 dose of Pfizer on 04/19/2022.  The individual tested positive for COVID-19 on 05/11/2022 at the facility at which they were a resident. I see no indication they were hospitalized for this illness. They experienced complications of respiratory arrest, and pneumonia aspiration. They died on 05/15/2022.
AFTER RECEIVEING THE HEPLISAV-B VACCINE PT WENT TO THE FRONT DESK TO SCHEDULE FOR HIS SECOND DOSE. AT THAT TIME THE PATIENT CONFIRMED HIS NEXT APPOINTMENT AND THEN SLOWLY WENT DOWN TO THE FLOOR AND PASSED OUT FOR A BRIEF SECOND. TWO OF OUR MALE EMPLOYEES AND OCC HEALTH NURSE ASSISTED PATIENT IN GETTING TO A CHAIR. PATIENTS LEGS WERE ELEVATED AT THAT TIME, COLD PACK WAS GIVEN TO PATIENT AS HE WAS NOTICABLY SWEATING, VITALS WERE TAKE AND ALL WITHIN RANGE. PATIENT WAS MONITORED FOR 20 MINUTES BEFORE PATIENT FELT OKAY TO LEAVE.
Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains non-significant information.; Reporter's Comments: N/A
morning fatigue - bedrest, recovered by mid-afternoon  neck rash, watery eyes - began a week after first shot. took loratadine this morning, now neck not itchy, eyes not watery.  also had covid arm a week after first shot - went away in 3 days.
Extreme soreness at injection site (right arm) no redness was visible. As the evening progressed this developed into extreme weakness in the right arm, almost complete inability to lift the arm. This then developed into overall body soreness in all joints but especially lower back, neck and knees along with fever and headache. Basically extreme flu like symptoms with the extreme soreness and weakness of the right arm.
On 1/8/98, the pt developed varicella and sought unspecified medical attention. No further information is available.
Shortly after going home after the vaccination pt developed joint and muscle pain of the right arm and shoulder blade area. She was advised to contact her physician and pain medication was offered.
CDC reports: 6yr old developed fever to 104, nausea, vomiting & coughing following DTP/OPV immun, sx lasted 1 day. Pt also dx as having early ear infection. MD told parent that illnes due to DTP "because she recovered quickly".
Mom stated that /w last DTP in '88 pt had T 104 (R)that noc & she was giving APAP.Mom called ER-Told her to put pt in tepid H20 & inc APAP.Pt T broke 1 hr later.Not reported until today when coming in for 15 mos injections.DTP not given
Patient experienced erythema surrounding local injection site that presented approximately one day after vaccine was given (vaccine administered on 9/4).  Patient came in to pharmacy on 9/8 to make pharmacist aware.  At that time, there was still redness on left deltoid.  It was not worse from the initial onset.  It appeared to be slowly healing.
FEVER, MYALGIAS, HEADACHE, MALAIASE, SORENESS AT THE SITE - FLU LIKE SYMPTOMS.
event occurred @ flu clinic pt c/o blurred vision, head throbbing, nausea & fainted 2 times, sustaining small abrasion over lt eyebrow 105PM;
staff found the expiration date on the PENTACEL confusing and caused them to administer the PENTACEL after it had expired with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp. number: 01521982.  This case involves patient of unspecified demographics to whom as staff found the expiration date on the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] confusing and caused them to administer the Pentacel after it had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection at dose 0.5ml once (lot: UJ648AAA, expiry date: 25-Feb-2023) via unknown route in unknown administration site for immunization, staff found the expiration date on the Pentacel confusing and caused them to administer the Pentacel after it had expired with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.   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 the 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.
This case is a part of a cluster of 5 cases and is linked with 2012-10398, 2012-10466, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A female patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
IG bottle expired on 8/26/19.  Informed patient. Called manufacturer  and they also did a report. Patient informed she should repeat. She decided not to at this time and stated she will call if she changes her mind.
Information has been received from a certified medical assistant concerning a 49 year old female with PENICILLIN and SULFONAMIDE allergies and a history of splenectomy who on an unspecified date was vaccinated with a first dose of PNEUMOVAX.  (Lot # not reported).  On 08-OCT-2008, the patient was vaccinated IM into the right arm with a second dose of 0.5 mL of PNEUMOVAX.  (lot #659778/0024X given is for MMR).  Concomitant therapy included influenza virus vaccine (unspecified) into the left arm, and hormonal contraceptives (unspecified).  The medical assistant reported that on 10-OCT-2008 the patient was seen in the office and was diagnosed with cellulitis of her right arm at the injection site.  At the time of the report, the cellulitis of her right arm at the injection site had not resolved.  Additional information has been requested.
Patient states they were unable to lift or raise arm after the vaccine with pain, swelling, and bruising of the arm. She went to her regular MD at facility, who she alleges stated the vaccine possibly hit a nerve or was given too high.
RARE BLOOD CLOT; LOW PLATELETS; This spontaneous report received from a consumer concerned about 50 years old female. The reporter obtained the information from news/media. 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: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unknown date in APR-2021 after vaccination, the patient experienced severe headache, abdominal pain, leg pain and shortness of breath. The patient developed a rare blood clot and low platelets on an unspecified date in APR-2021, within two weeks of receiving JANSSEN COVID-19 vaccine. The patient was hospitalized on an unspecified date in APR-2021. On APR-2021, the patient died from blood clot. The reporter was not sure whether the events was related to the vaccination. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of rare blood clot on APR-2021, and had not recovered from low platelets. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This female patient in her 50s was reported to have developed a rare blood clot and low platelets within two weeks of receiving JANSSEN COVID-19 vaccine.  On an unspecified date, symptoms reported were severe headache, abdominal pain, leg pain and shortness of breath.  The patient was hospitalized on an unspecified date and subsequently died from blood clot.  It was not known if autopsy was performed.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.; Reported Cause(s) of Death: BLOOD CLOT
Patient experienced welt , warm area of vaccine and large reaction on injection sit the following morning after the vaccine was given. She was started on a daily dose of Allegra in the am Pecid around lunch time and Xyzal at night symptoms started to get worse around the fourth day after injection her local reaction increased in size it became about the size of a large orange it became a welt and was very hot to touch. She was applying cold compress as instructed and started applying one percent hydrocortisone cream with no relief. Throughout the following week she noticed when she forgot to take her antistamine at night she could not stop coughing and was sneezing and clearing her throat and the vaccine area had become extremely itchy and had flared up in size and warmness she took flonase nasal spray, 40mg of prednisone and took xyzal to help with the symptoms. She immediately reported the reaction to MD this am.
Spiked a fever, began vomiting, & shaking.  Feet turned blue & turned gray around mouth for over half an hour.
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
1/3/21: Supraclavicular lymph node swelling on right side, side of vaccine 5 days after the 1st vaccine. 1/14/21: Went to PCP 16 days after 1st vaccine, 11 days from the first onset of event. Supraclavicular lymph node swelling has now persisted for 7 weeks since first vaccine.
chills (developed in the evening, appx 9pm); unexpected amount of swelling at injection site (swelling almost covered entire area from shoulder to elbow on the outside of the arm, lasted appx 24 hrs); fevered skin at injection site (appx 24 hrs starting at 9pm); severe headache (appx 24 hrs starting at 9pm); nausea (appx 12 hrs starting at 9pm) and vomiting (3am-4am); diarrhea (appx 24 hrs starting at 9pm); night sweats (1am-10am, weakness (appx 24 hrs starting at 9pm); fatigue (appx 24 hrs starting at 9pm); allergy-type symptoms: itchy, watery eyes, sinus congestion and pressure, sore throat (appx 12 hrs starting 2/5 at 10am)
Patient received 4 year old vaccines. Over the next 3 days, developed worsening redness and swelling at vaccine injection site. Patient seen in clinic on 7/19/2018 and was diagnosed with R thigh cellulitis. He was prescribed cephalexin. He showed improvement in symptoms by follow-up the next day 7/20/2018.
This case was reported by a consumer via call center representative and described of sickness in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Influenza vaccine (unspecified season) and got sick. The patient was asking if the shot used to prevent infections more that just the lungs also other parts like nose, ear and throat. Also asking whether the side effects included a cold right after vaccination.
Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-OCT-2007 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot # 658488/1264U). There was no concomitant medication. On 18-OCT-2007, within hours of vaccination, the patient developed hives all over her body. Subsequently, several days later, the patient recovered from hives all over her body without any treatment. Additional information has been requested.
This spontaneous report as received from a male physician of unknown age refers to himself via company representative. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number not provided) for prevention for shingles. On an unknown date, the patient experienced rash at the injection site and cold sore on his lip. The physician treated himself with acyclovir (unspecified dose/frequency and manufacturer). The outcome of rash at the injection site and cold sore on his lip was reported as recovered/resolved. Additional information is not expected.
started at least 4 hours later welt at injection site that got to the size of a half dollar.