chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event note Information provided in this submission, is per a report received by Health Department from a submitting facility. Covid-19 vaccination information is provided by information from Immunization Registry. Moderna 12/16/2021 LOT Number 032H2lA; Moderna 01/19/2022 Lot Number: 04IJ21A PER REPORT: She was positive for COVID-19 on 9/20/2022 at her rehab facility. Patient admitted to Medical Center for the 1st stage of her operation on 10/31/2022 for an exploratory laparotomy, removal of infected prosthetic mesh, abdominal wall debridement, removal of prior infected mesh, small-bowel resection, and repair, noted to have hostile abdomen with extensive small-bowel mesh adhesions. On 11/3/2022 she was in persistent atrial fibrillation. Overnight on 11/3/2022 into 11/4/2022, she was noted to have abrupt change in the consistency of her subcutaneous abdominal drain. Patient was also in atrial fibrillation with rapid ventricular response and became hemodynamically unstable requiring vasopressor use and bedside resuscitation in the ICU.  Details were discussed with the family by the operating surgeons and the critical care team. Patient's family was clear about transitioning a comfort focused approach. Patient died on 11/4/2022 at 17:03. The submitted report noted Acute Hypoxic Respiratory failure to be a contributing cause of death. Health Department has no further information. If additional information is needed, contact the providers at Medical Center.
Patient presented to pharmacy with a diagnosis of shingles after receiving a second dose of Shingrix earlier that day.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
One hour after second dose,  started experiencing shortness of breath and broke out in hives. Couple hrs later had a fever along with body aches and vomiting.  Evening time experienced hallucinations and nightmares.
Soreness in the vaccinated arm, persistent swelling through course of week. Likely delayed allergic response.
This spontaneous report as received from a consumer (patients mother) via company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with her 3rd dose of GARDASIL. No concomitant medications were reported. On 20-FEB-2014, the patient fainted, and also the reporter questioned if this event could have had a seizure (medically significant) and the patient hit her head on the exam table and suffered a concussion during the event. The outcome of event the patient fainted, seizure and concussion was reported as recovering. Relation between the event and GARDASIL was unknown. Upon internal review event seizure was considered medically significant. Additional information has been requested.
Patient complaints of extended muscle pain in arm post vaccination for over 1 month. Patient states that it was difficult to hold arm above head and that the muscle pain lasted longer than usual.
Pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative reported that the pharmacist said that the patients were experiencing pain from vaccination.  The sales representative mentioned pharmacist would not like to receive acknowledgement letter. This case linked with US2019AMR127498, reported by same reporter.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.54. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021 and 16-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 50, 10 AM: 36, 42, 11 AM: 38, 44, 12 AM: 39, 44, 1PM: 43, 44, 2 PM: 44, 44, 3 PM: 44, 44, 4 PM: 42, 44 and 5 PM: 42, 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
8-29-08 No fever, muscle spasms per Dr. in ER and he felt normal.  Rash to trunk front and back, worse on the back.
Patient called two days later and stated her arm at injection site was "red,knotted, and feverish and she felt bad"- she called her md and she told her to  take tylenol and benadryl and come to office in afternoon if not better. I told her to go ahead to md and i would check back on her. I called her at 9pm on 10-17-19 and she said she was at ER and they were going to admit her for 2 days. Patient stated she had been given flu test and chest x ray and both were negative. Patient said she had fever of 103 degrees abd the er had given her a shot of morphine  for her pain. She said the er md said she had bacteria on her skin and the needle injection site pushed the bacteria into her system and she was infected . pharmacist did practice aseptic technique when administering vaccinations.
Patient was given a bivalent dose by accident when she should have been given a monovalent dose.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-NOV-2014 the patients were vaccinated with an improperly stored dose of (Merck) VARIVAX (strength, route of administration, dose and lot # were not reported). The reporter was not able to provide a cumulative time frame of these excursions, so the total time out of range was not know at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Customer on floor in lobby, staff reports passed out approx 5-10 secs and hit head. Customer recieved shot at 11:49. States was feeling lightheaded squatted down to put head between knees to gain focus. EMS called (red area on forehead LT side). Ice packs given. Refused EMS transport. Denies pain, no swelling or redness at site. Transport per family member.
pt recvd vax 13NOV95 & NOV95 pt devel a rash;no further details were provided;
I began feeling a little nauseous right after getting the injection. Over the course of the last 12 hours I've had increasing nausea and digestive problems. I feel fatigued, cold, and sore all over my body. The injection site is particularly painful. I've had a headache since shortly after receiving the shot and I still have it. I feel like vomiting.
The Patients parent put on the forms that patient is 5 years old. She is 4 years and 11 months.
Patient did not like the oral vaccine before administering all of the vaccine - she projectile vomited quite a lot of formula vomiting continued next morning.
Pain at injection site.  Swelling , redness on inner arm "way lower than the injection site".  Warmth, itching.
15NOV91 began having episodes of leg weakness; not felt to be prob in vax; change in sensation of lower extremties; gait disorder; shaking, shivering, spasms, twitch, swollen like feeling;
Chills/shaking, sweating, body aches, blinding headache- 11 hours after shot Fever 24 hours after shot
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or about 13-JUN-2012, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at a pharmacy 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 or shingles. On or about 09-MAY-2013, she was treated at a hospital, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, she had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Pt. received ZOSTAVAX in left upper arm on 6/29/16 at 8:00 pm. On the evening of 6/30/16 redness and pain developed at injection site. Redness and pain continued through 7/1/16 and pt. came to pharmacy in the afternoon of 7/1/16 to report.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Heart Attack-Severe, Additional Details: Patient suffered a massive myocardial infarction 12 hours post vaccination. She was hospitalized and received stent. Patient was in remarkably good health and had no issues prior to vaccine.
Diarrhea, fever (Tmax 101.6), body aches, headache
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain) and fatigue in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history information reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient experienced pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees). The patient was treated with ibuprofen at a dose of 1 dosage form. At the time of the report, pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular, the reporter did not provide any causality assessments or concomitant medication use.
pt recv vax 7MAY96 & 30MAY96 pt devel a painful, blistering rash on scalp, which MD thought was a typical shingles-type rash;the reporter was unsure if the pt exp was r/t vax w/varicella vaccine;no further details were provided;
Permanent eye damage on the effected side due to the Bell; Bells palsy; Facial paralysis; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE INJURY (medically significant), outcome "not recovered", described as "Permanent eye damage on the effected side due to the Bell"; BELL'S PALSY (medically significant), outcome "not recovered", described as "Bells palsy"; FACIAL PARALYSIS (medically significant), outcome "not recovered", described as "Facial paralysis"; PAIN (non-serious), outcome "unknown", described as "Pain".  Clinical course: The patient has received the first dose of the Pfizer COVID-19 vaccine on 03Apr2021 and the second dose on 30Apr2021 and shortly after was diagnosed with Bell's palsy. The patient had lived with Bell's palsy/ facial paralysis for the past 11 months it causes pain and the patient had received permanent eye damage on the effected side due to the Bell's palsy. The patient was wanted to reach out to see if Pfizer offered any sort of compensation for the medical troubles, thank you so much.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
I woke up in horrible pain all over my body and couldn't straighten my fingers for approximately 2 hours. It took me 3 hours to get the strength to get off couch to pee. Felt as I was being beaten in my lower back, hips and legs. Also, hurt in my neck and eyes were painful. My face and eyes were also swollen. It also felt as if a hot ice pick was being stabbed in the sides of my hips, back and thighs. I hurt all over my body, including a headache. I had hoped to die. I have had 3 children and one was a natural birth and I have never experienced so much pain and exhaustion together.  Took Tylenol and Turmeric and didn't get any relief. The injection sight was very swollen and was painful, could but lay on my left side. I was down for 3 days with the 3rd day finally able to take shower and dress.  I had diarrhea the 2nd day.  The sides of my hips hurt to touch for weeks and are still sore. I have had a lot of breathing difficulties and asthma flares. I related the asthma issues to having a new dog but now I wonder if it was due to vaccines?? I have rehomed the dog and asthma isn't getting any better. I had to miss a day of work after the 1st vaccine due to flu-like symptoms and was prepared to have a reaction to the 2nd. However, I was not prepared the  severity of a reaction I had.
pt recvd vax & had inc t 103; emesis; h/a; no rxn at site; tx w/ apap, tigan supp & motrin;
The vaccine was not reconstituted so the DTAP/IPV portion of the vaccine was given without any Hib.  No side effects were noted at the time of vaccination.  Patient was well appearing.
Very sore at injection site this morning.  Took extended relief Tylenol 650mg.    Starting to have numb feeling and some tingling in fingers after morning of typing.  Going to a break from the keyboard and put some ice on the injection spot.  Remove watch.
Extreme diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea). At the time of the report, DIARRHOEA (Extreme diarrhea) outcome was unknown.            No concomitant medication nor treatment provided.
Abdominal Pain- child is unable to sit forward on his own.  Needs assistance getting in and out of a car. Very faint pink mark on skin in same area.  Pain is just above the belt line.
SkinRash Rash at vaccine site ( Lef deltoid) @ 2inch diameter Narrative:
Mom states that the first day patient c/o of arm hurting and was "grabbing" her arm.  Mom gave her tylenol for discomfort and applied ice pack that seemed to help.  About day 3 mom stated arm was "beet red" from the sight of the injection about down to her elbow.  Her arm hurt for about a week after the injection.  When I spoke with mom today she stated her arm doesn't hurt anymore and there is about an  area of 1 inch on her arm around the injection site that is still red.  Mom stated that her arm also looked swollen.
ABOUT AN HOUR AFTER SHOT BECAME NAUSEATED, DIZZY... DEVELOPED A FEVER... DIZZINESS PROGRESSED AND BECAME WORSE AS DAY WENT BY. VOMITING BEGAN, HEADACHES, SEVERE CHEST PRESSURE AND PAIN, BODY ACHES AND DIZZINESS/SYNCOPY WORSENED. WENT TO ER AT AROUND 8:45 P.M.
numbness and tingling in left side of face five minutes after vaccination numbness and tingling began to spread to other appendages (both forearms, calves, fingers and feet) as well as both sides of the face over the next couple of months numbness and tingling would be in random places and at random times throughout the day  treatment included testing for MS and stroke at local GP  treatment included taking Vitamin D and testing for Lyme and testing blood for other levels treatment then was Xrays and physical therapy to see if the symptoms could be solved or if there was a physical correlation  treatment was relayed to an Ortho and patient was prescribed a steroid  (2/2/2021) and the symptoms have mainly gone away  patient still sometimes has issues in both sides of the face and occasionally forearms
No adverse event after administering Moderna 0.25 ml booster. Patient had first and second doses of Pfizer. Pt presented with parent for booster on 2/24/22. Pt was age 12.3 when booster was administered.
Itchy, bumpy, reddish swelling on left arm, site of the injection. Appeared at 8PM, 7 days after initial injection.
Information has been received from a physician concerning a 16 year old female student with no pertinent medical history and no known drug allergies who on 24-AUG-2009 was vaccinated IM with the second dose of GARDASIL (Lot# 661766/0652X). The patient also vaccinated with HAVRIX, RECOMBIVAX (Lot#663283/1601X) and VARIVAX (Merck) (Lot#664325/0663Y) on 24-AUG-2009. On 24-AUG-2009 after vaccination the second dose of GARDASIL the patient became pale, limp and started to black out. The patient had sought unknown medical attention via telephone. There were no lab diagnostic studies performed. She was administered oxygen (manufacturer unknown) and fully recovered. Follow-up information received from a physician concerning a 16 year old female patient with no pre-existing allergies, birth defects or medical conditions and with no illness at time of vaccination who was vaccinated with GARDASIL (Lot# 661766/0652X) at right deltoid at 16:12pm on 24-AUG-2009. On 24-AUG-2009 the patient was also vaccinated with HAVRIX (Lot#AHAV113311AA) at left deltoid at 16:11pm, RECOMBIVAX (Lot# 663283/1601X) (thimerosal free) at left deltoid at 16:12pm and VARIVAX (Merck) (Lot # 664325/0663Y) at right LUA at 4:13pm. On 24-AUG-2009 after the vaccines were administered the patient went limp at the arms. Per patient, everything went "black". The patient was sitting at the time, was placed in a lying position with lower extremities elevated. Oxygen mask was administered. All vital signal remained within normal limits, respiratory rate 16, pulse 70-80's, blood pressure 98/64 and pulse oximetry 100%. The patient was observed for 30 minutes, and was discharged home in stable condition. On 25-AUG-2009 the patient was recovered. No further information is available.
fever, severe aches, hard to walk or move; Had same reaction on the 1st injection in Feb. Lasted 2 days - 3rd day it was gone.
felt like her previous allergic reaction; swelling of her throat; tightness/ felt like someone was squeezing her throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling of her throat), THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat) and HYPERSENSITIVITY (felt like her previous allergic reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PHARYNGEAL SWELLING (swelling of her throat) and THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat). On an unknown date, the patient experienced HYPERSENSITIVITY (felt like her previous allergic reaction). At the time of the report, PHARYNGEAL SWELLING (swelling of her throat), THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat) and HYPERSENSITIVITY (felt like her previous allergic reaction) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Per Dr. note on 7/9/2020:  vaccines done on 7/2 (right leg was Hib) - redness at injection site starting yesterday and slightly worsening today.  no fever, no significant pain.  acting well.
Presented to the ED with chest pain found to have elevated troponins and diffuse ST elevation on EKG consistent with myopericarditis
pt recv vax & devel a horrible itching rash on upper extremities & legs which appeared to look like an eczema;dx w/gianotti Crosti synd or  papular acrodermatitis;itching;