chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medications were not reported.   It was reported that the temperature for vaccines was never checked throughout the day. The reporter stated that the vaccines were above 46 degrees F (fahrenheit) after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-250558 (Patient Link).
This case was reported by a pharmacist (subject) and described the occurrence of tinnitus in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In 2012 the subject received a dose of BOOSTRIX (unknown details). In 2012, within months of vaccination with BOOSTRIX, the subject experienced tinnitus. The subject stated that she received BOOSTRIX "a few months ago" and has been experiencing "ringing in the ears/tinnitus". She described it as "not going away, there all the time and feels like bees buzzing in her head." The pharmacist attributes the adverse event to a BOOSTRIX vaccination [possibly related to BOOSTRIX vaccination]. At the time of reporting the event was unresolved.
patient states had small reaction to Gardasil vaccine with numbness and tingling, wanted to continue with covid 19 vaccine. she had vaccine and immediately after receiving vaccine stated with itching and tingling. Gave her 50mg Benadryl and still having numbness and tingling and states " Throat was closing up. Gave epi-pen and symptoms improved then transported to ER.
This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received PEDIARIX (batch number 372DT, expiry date July 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to PEDIARIX. Additional details information received: Inadvertent administration of PEDIARIX to an 18 months. INFANRIX was meant to be given.
MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING.  PATIENT DID NOT FAINT.  PATIENT DID VOMIT ONCE.  PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2  1303 VITALS: BP: 116/99 P: 96 SA02: 100%  PATIENT STATES THEY ARE FEELING BETTER.  GIVEN JUICE AND BANANA.  1312 VITALS: BP: 128/87 P: 74 SA02: 100%  PATIENTS COLOR HAS RETURNED TO NORMAL.  STATES THEY ARE FEELING MUCH BETTER.  ABLE TO STAND AND WALK WITHOUT DIZZINESS.   PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE.  PATIENT LEFT WITH HER WORKMATE.
warm to touch; itching; a welt on upper left shoulder; swelling on tatoo; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included birth control Treatment medication included Topical Antibiotics.  Company Comment: 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'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.
15 minutes after administering drove home began to have access thirst, Broke out in hives down the left side of my face and neck. Began to have anaphylaxis, throat tightening and tingling.
Patient received flu vaccine on 10/30/2014 and 12/3/2014.
reaction keeps growing outside the sharpie line; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 22nd June 2020, the patient received Bexsero. In June 2020, less than a week after receiving Bexsero, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Bexsero and experience reaction it was keeps growing outside the sharpe line. The reporter inquired it might need to urgent care.
Received vaccine on 05/21/2022. Adverse event began on 05/22/2022 with headache, muscle aches and a stiff neck that started on that evening. I also had nausea and vomiting. I had chills but I do not remember when those started. By Wednesday it was rally bad, I thought I would tough it out but it just kept getting worse. In them mean time, I had gone to see my acupuncture doctor on the 05/28/2022, the treatment did not help at all. My acupuncturist stated that my neck was putting out some heat so he felt it was really inflamed, so he just worked on pressure points, without result. I called my daughter at 04:30 in the morning on 05/30/2022 and she came and took me to the hospital emergency room. The ER did a CT scan that was unremarkable, gave narcotics, something for nausea and muscle relaxants. The medications made me loopy which I did not like at all. By the time I got home I was feeling bad.  I did not take the narcotics, and the muscle relaxants are getting less and less effective. I saw Dr. Rheumatologist on 06/01/2022 he gave me cortisone shot and 6 day course of prednisone. I have not noticed any difference yet.  He also did a lot of blood tests. The inflammatory markers were higher than the last time he did testing. One of the markers was 30 times higher than it had been back in November.
feeling feverish; shivering uncontrollably; shaking uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2022, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2022, 12 hrs after receiving Shingrix, the patient experienced fever, shivering and tremor. The patient was treated with paracetamol (Tylenol). On 28th January 2022, the outcome of the fever, shivering and tremor were recovered/resolved.   The reporter considered the fever, shivering and tremor to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly into unspecified arm and about 12 hours after the vaccination experienced felt feverish and shaking/shivering uncontrollably. The patient took her temperature and it was 102 degrees. She took Tylenol.  The patient took her temperature again 30 minutes later, and the fever had gone up to 104.2. All  above symptoms resolved that same day.  The patient felt fine on 29th January 2022. The patient did not want to provide her email address.  GlaxoSmithKline failed to ask for her date of birth or age. The patient did not have the paperwork which would have the lot number/expiration date of the Shingrix but she did provide the contact information for her doctor's office where she got the shot and the doctor's office should have that data on file. The reporter consented to follow-up.
Assessment Left leg cellulitis (L03.116). Impression well appearing afebrile 4 yo F with cellulitis of L leg at vaccination site  skin with erythema, edema, and warmth that is ttp on anterior and medial L thigh.   we will treat with Cephalexin TID for 7 days Other care and return precautions discussed. Patient Plan Cellulitis treatment: Keflex 3 times per day for 7 days Improvement should begin within 24-72 hours on antibiotics. Take ibuprofen 7-8 ml up to 3 times per day as needed for pain or irritation. Follow up if redness spreading after 24 hours on antibiotics, if an area of pus develops or grows, there is increasing pain in the area or in involved lymph nodes, or if you develop new fevers.
Pt had previously received Janssen COVID-19 vaccine. Pt reported on consent form that he had no previous COVID-19 vaccines. The Immunization Registry reports a Janssen vaccine on 3/14/21.
Migraine immediately after vaccine, along with nausea and site pain. Extreme muscle pain, fatigue, and nausea starting approximately 10 hours after injections and lasting for about 24 hours. 46 hours after vaccine, very light headed and tingling in hands.  Site pain has continued for 48 hours.
Pt developed edema and pain to LLE from knee down to ankle on 4/9/21. Describes skin tightness and redness.. No fever, but with chills. Given crutches to avoid weightbearing on left leg. Pt is being worked up for potential blood clot, US Left venous duplex.  Pending results for exams, Sent to emergency room on 4/13/21 by reporting nurse.
pt recvd vax 7AUG92 & 45 mins p/vax exp h/a, stiff arm & diaphoresis; treated w/fluids & rest;
started with chills, body ache and fever.  Severe fever/body aches as night progressed.  24 hours after shot she is couch bound with less severe symptoms but still very sick.
5 minutes after 2nd Moderna COVID-19 vaccination experienced episode of dizziness, nausea and diaphoresis.  Resolved in 15 minutes.
No adverse event was experienced by patient.  First COVID vaccination was received by patient on January 11th 2021, and second dose was given 23 days later February 3rd 2021, 1 day outside the allotted minimum of 24 days between vaccinations.  Vaccine Administration Error
Breakthrough case admission after 2 vaccines Pfizer 4/14/21 Lot# Ew0162;  Pfizer 5/5/21 Lot# Ew0164
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 03-NOV_2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a dose of Johnson & Johnson vaccine on 4-12-21 and patient has reported a severe headache. She has a history of migraines and she has taken her migraine medication and it has not worked on the migraine.
Large, warm rash (10-15 cm) on shoulder near injection site, states throat felt funny but airway was not compromised. Prednisone 10 mg. Rx given by Dr.
Rapid heartbeat at erratic times, along with sweating, chest pain, headaches, tinnitus
Bells Palsy onset with R sided facial droop, Given prednisone and valtrex,  Outcome TBD
Moderate soreness at injection site; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK 5730), via an unspecified route of administration on 19Dec2020 08:15 at 35 years old at left arm at single dose for covid-19 immunization. Facility type vaccine was doctor's office/urgent care. NO other vaccine in four weeks. Medical history included migraine. No known allergies. Concomitant medication included sumatriptan succinate (IMITREX) 100 mg PRN (As needed) for migraines, ethinylestradiol, norgestimate (SPRINTEC) 28 day. The patient experienced moderate soreness at injection site only for 2 days on an unspecified date. No Covid prior vaccination and covid was not tested post vaccination. The outcome of the event was recovered.
MMRV inadvertently given to a 16 year old.   Patient experienced no adverse events or side effects.
?Covid Arm? rash 7 days later.  Itchy hard hive like
initial vertigo and joint aches in hands. On 5/21, strong joint aches in hands began in evening, continued, decreasing in frequency through 5/31, still present but less constant. Joint ache similar to fever.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: peg allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Dizziness, Headache, Fatigue, Weakness, Muscle ache Narrative:
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with VAQTA (lot #: L023232, expiry date: 25-FEB-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process.  Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration.
15 year old had first dose of HPV vaccine and walking out of clinic she felt faint, nurse saw it and made her lay down. She had ringing in the ears, tingling and clammy hands, headache and has impaired vision and felt like she was going to die. The next day she still has headache and vision issues.
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
Developed sores on bottom side and top of tongue. Tongue turned white and is sore. Hurts when eating. Gums also swollen and some bleeding. Developed a week after 3rd shot was given. Using mouthwash but not getting any better.
Injection site pain and swelling.  Pt states that she was anot able to use the arm d/t the pain.
Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 01-SEP-2015 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician for a rash that was diagnosed as shingles. The patient has been prescribed Acyclovir to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Case was vaccinated x2 but not boosted for Covid as of March 2021. He was hospitalized for and died of Covid in February 2022. Hospitalized at: Hospital. Case was admitted to hospital overtly for melena, but was found to have Covid pneumonia and acute respiratory failure due to said pneumonia. He was intubated for respiratory failure, but due to complexity of medical issues, and poor response to ventilation, was transitioned to comfort care, and died 2/2/22 of respiratory and heart failure.
Initial report received from health care professional on 08 November 2013. Over 30 out of 50 patients whose age, gender, medical history and concomitant medications were not reported, got FLUZONE ID (Lot # UT4719AA) intradermally are complaining of redness at the site and knots at the injection sites 1 week later. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none.
Patient said she felt like she developed the flu from the flu shot, she had fever, chills, aches, fatigue. I told her it is not a live vaccine so you don't develop the flu from the shot, but she wanted me to report it. She is feeling a bit better 4 days after the shot, just a bit tired.
On the first day, I got my vaccine. They said stay for 15 minutes, I fell asleep for an hour 1 and 15 minutes. Then I woke up and felt weak and fatigue. Then next I feel asleep. I slept for 2 days. I woke up and still was fatigued. I keep taking naps through the days. I did not feel well. I see my doctor, the did blood work. Now I only slept for about 3 hours a night. I went to the ER. They did blood work also. They did a urine sample, CT scan, EKG and X-ray. They diagnosis me with general muscle weakness post vaccination.
8/2/07 TC from client c/o sore LVE 1 day post administration 7/18/07. 7/18/07 c/o Temp 101.6-N & V Reddness and rash at injection site. Traveling during side effects. Has no further side effects at this time
Developed pain ("mild") in L arm, which pt initially discounted as a normal reaction to a vaccination. Noticed that area was red, swollen. Cellulitis measured diameter, 11 inches (compared to 10 inches on right).
contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19 2-3 weeks after receiving their third PFZ vaccine". Clinical course: In the recorded interaction from Jul2022, a Patient contracted COVID-19, 2-3 weeks after receiving their third Pfizer vaccine. Patient's partner said that they got COVID like two or three weeks later. They didn't have it for like two and a half years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300126914 same reporter/drug/event, different patient;
Moderna COVID-19 Vaccine EUA was received at 13:45 on 1/13/21 at Medical Center on right shoulder. Right arm started to  be tender the next day 1/14/21. Motrin 600mg was taken orally and symptoms subsided. Fever, headache and general malaise continued to next day 1/15/21. Right shoulder and arm became more painful on 1/15/21 with hardness at injection site and swelling of lymph node under right axillary. Tenderness extending from outside upper right shoulder to right armpit area and right chest area.
No reaction day1. Day 2 swelling and redness size of dime. Day 3-6 no reaction. Day 7 pm red, swollen , itchy red spot size a little larger than golf ball and slight headache .  This lasted 5 days with red area 31/2? wide and feeling tired and slight headache.  Days 12and 13 all symptoms vanish.  This morning, 2/05/2021 my arm is again 3? area red, itchy, slight headache and fatigue.  I hear that this called Covid arm and seems to affect about  .06 % of those who have had the Moderna vaccine.  I thought I should report this because my husband who had the same injection had no symptoms at all...not even redness at the site.
I had swelling and pain in the left armpit and swelling of the lymph nodes..   with both doses of the vaccine.  I felt faint about 30 minutes after the first dose as well.   The second dose seemed to be going okay even though there was much more pain at the injection site.  But the armpit and lymph node issue has become much worse after the second dose.  Painful to touch today into the left pectoral region the sometimes travels into the rib cage.  Soreness in the left elbow and left index finger.   All of this has been occurring since April 29th and it is still happening May 20th.
Blistering, redness, swelling, warmth to site. Augmentin.
This spontaneous report as received from a nurse's aide refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ oral solution (strength, dose, lot# and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.