chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Tdap vaccine 2/18/08. on 2/22/08 noticed tenderness and swelling in (L) axilla area. PCP saw me the same day 2/22/08. Sx checked to warmth site to see if would resolve on its own. PCP called 2/25/08 due to more swelling in (L) axilla area. PCP started me on antibiotics for 7 days. Tenderness at site better, but swelling persists. After taking antibiotics I had a yeast infection which was treated with Monostat. On 3/19/08 tingling noticed on fingers (R). 3/21/08 noticed swelling, pain and tight feeling in (R) knee. Pain was in the back of knee down into top of calf muscle and Rt lateral area of knee cap down onto shin.
PATIENT DESCRIBES HAVING A RAPID HEART RATE WHEN GOING TO BED THE EVENING FOLLOWING VACCINATION AND SKIN WAS WARM TO TOUCH WITH NO NOTICABLE INCREASE IN BLOOD PRESSURE OR BODY TEMPURATE AFTER TESTING.
Patient was given Hepatitis A in right deltoid and Varivax in the Left Deltoid. Within 5 minutes pt developed spreading, pruritic rash on skin at left deltoid. No respiratory sxs noted.
expired Moderna vaccine administered to patient; Product was initially stored in the refrigerator on 05-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Product was initially stored in the refrigerator on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that vaccine was administered to patients from 06-APR-2022 to 09-Apr-2022. The vial was initially stored in refrigerator on 05-Apr-2022. It was reported that no temperature excursion occurred and patient reported no adverse events.   This case was linked to MOD-2022-539012, MOD-2022-539071, MOD-2022-537580 (Patient Link).
an expired dose of PENTACEL was given to a patient with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and consumer/non-healthcare professional via call center via the Regulatory Authority (Reference number- 00815089). This case involves a (unknown demographic)  patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ411AA, UJ385AA and expiry date: 12-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Caller wanted to know if the patient needs another dose."  At the time of reporting, 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.
Mild swelling and rash around injection site.  Persisting 1 week after administration.  Continued swelling and spreading of rash after 1 week.
Extreme sharp stabbing pain in injection area, sometimes accompanied by movement other times doing no activity at all. This has impaired my daily activity.
pt felt like he was going to pass out , then got very hot and started to sweat . He stated he hadn't slept much and had worked out earlier and my be dehydrated ... he was not sure this event was related to the vaccine ... these symptoms started about 10 minutes following the vaccine
Full-body rash that last for two weeks. Especially torso, upper arms, butt, behind the knees, eyelids, head, and neck. Itchy little dots that looked like measles.
I had woke and I had a bad cramp and then it turned into where my toes would spasm and went downward and I couldn't move them. It would happen for a couple day and then it moved to my fingers. I was getting them everywhere on both legs and both hands. They were very painful to the point I was getting sore. I was getting so many that I had to lay down and it got to the point that it wasn't sore it was just painful. I still get them not as often maybe 2 or 3 times a week. They last for a few seconds and it will release, they don't come as often and they don't last long.
Patient was scheduled to receive his second monovalent dose of the series.  He was given the bivalent instead.  Pt had no adverse effects.  Contact Pfizer and our medication safety officer.  Pfizer had no instructions except that the patient should not receive an additional bivalent booster.  Medication safety officer suggested that the patient be scheduled to obtain a second monovalent in 2-3 months.  Patient is scheduled to receive in Jan of 2023.
My daughter is on week 5 of ring shaped hives that all over her body: torso, legs, feet, hands, arms, face and ears. Given it was unkown at first, pediatrician, prescribed a round of oral liquid prednisone, 4ml twice a day for 3 days (9/20-9/22). This appeared to make the hives disappear after the last dose, but they came back and multiplied in less than 24 hrs later. We were told this was a rebound and she was placed back on prednisone this time once a day for 14 days. We saw no improvement this time, and by the end of the first of the 2nd round of prednisone, the pediatrician referred us to a dermatologist who confirmed (10/13) the itchy patches were hives, likely resulting from the vaccine.
PT IS RESIDENT OF HEALTH AND REHAB FACILITY.  PT WAS FOUND UNRESPONSIVE ON 9/5/21 BY NURSE.
Information has been received from a consumer concerning her 4 year old daughter with food allergies, environmental allergies, a penicillin allergy, eczema and asthma who on 10-NOV-2006 was vaccinated SC with a 0.5 ml dose of Varivax (product circular # 7999915). Concomitant therapy included montelukast sodium. Subsequently, "2 1/2 to 3 weeks after the shot", on approximately 28-NOV-2006 the patient developed "itching and rashes all over her body." Unspecified medical attention was sought. There were no labs performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Very painful muscle about 4 hours after injection. I felt slightly nauseous and I could barely move my arm. It felt like a serious sprain. The pain slowly subsided over 3 full days.
Headache, Myalgia, Arthralgia, Fever, Fatigue, chills, injection site pain and swelling, tenderness and swelling of thelocal lymph nodes on the injection side,  Narrative:
Hard knot under skin at injection site, skin red about 3 inches diameter around injection site, some itching, turning into a slightly lumpy red rash after a few days with a few very small pimple-like pustules, now a week later, most of this has subsided.
Pt recvd 1 dose of Engerix-B FEB92 & was discovered to be in the 1st trimester of pregnancy p/receiving the 1st dose of vax; no further info concerning this clinical exp is available @ this time;
Received half dose Moderna  Booster instead of the first dose; Received half dose Moderna  Booster instead of the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose). On 14-Dec-2021, UNDERDOSE (Received half dose Moderna  Booster instead of the first dose) and PRODUCT ADMINISTRATION ERROR (Received half dose Moderna  Booster instead of the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received half dose Moderna COVID-19 booster vaccine instead of the first dose. No concomitant medications were reported. No treatment medications were reported.
SHIVERING; SLIGHT NAUSEA; FATIGUE; ACHY; FELT COLDER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 01-APR-2021 16:55 for prophylactic vaccination. The batch number was not reported and has been requested.    No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced felt colder. On 02-APR-2021, the subject experienced slight nausea. On 02-APR-2021, the subject experienced fatigue. On 02-APR-2021 05:00, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivering, fatigue, achy, slight nausea and felt colder was not reported. This report was non-serious.
INITIALLY 1 HR POST INJECTION: SORE ARM 6 HOURS POST INJECTIONFEVER 100f, SEVERE BODY ACHES, CHILLS, SORE THROAT NASAL DRAINAGE, EXTREME FATIGUE DIZZY WHEN UP, HEADACHE "FEELS LIKE WHEN I HAD THE FLU" TREATING WITH REST, HYDRATION, TYLENOL CALLED IN SICK TO WORK - STAYING HOME AND TREATING SYMPTOMATICALLY
pt recv vax 10:40 & cried;pt was still crying when lt clinic about 5 mins later;2:45 mom called & stated pt was unconsolable, had only stopped crying a min or two;would not take bottle;mom gave APAP around 11AM;3:30 pt OK
1st shot of Moderna 3/15/21 and reaction was extreme sore arm, almost immobile for 2 days. Then fine. First shot hurt during injection perhaps too deep into muscle. Second dose I couldn't even tell she injected it. 2nd shot of Moderna 4/12/21 and flu like symptoms for about 12 hours. Then after about a month numbness starting in lower left leg, then also in left forearm, then in left side of face. This condition continues. Dr. has NOT determined professionally this was due to the COVID vaccine but there are suspicions because other possibilities like a brain tumor or Multiple Sclerosis have been eliminated and I have no previous issues of spinal or nerve problems, no health conditions that put me at risk for stroke.
Hospitalized (10.30.21);  COVID-19 (10.30.21);  fully vaccinated  Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 10/30/2021 Discharge Date: 11/1/2021 PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 virus infection [U07.1] COVID-19 [U07.1] HOSPITAL COURSE: Patient presented to the emergency department on 10/30/2021 with complaints of worsening shortness of breath and cough.  He was fully vaccinated for COVID-19.  During emergency department course, it was noted that his oxygen levels were 88% and he was placed on 2 L via nasal cannula and was given IV Decadron.  X-ray was without infiltrate.  He was admitted for hypoxia with COVID-19. During hospitalization, Decadron was continued, remdesivir given the and supplemental oxygen continued.  Inflammatory markers were followed and improved.  Home Xarelto for history of DVT and PE was continued. Early this morning, he was easily weaned to room air.  States that he feels much better and is requesting discharge home.  With able to ambulate without significant hypoxia.  We discussed continued quarantine, and need for self-monitoring and return to the emergency department immediately if he becomes short of breath or begins to feel increasingly ill.  Is being discharged with personal pulse oximetry monitor.  Is to return to the emergency department if pulse oximetry readings are 89% or lower for 5 minutes or longer.  Patient is stable for discharge home to self-care at this time.  He is agreeable with the plan care.  All questions and concerns were addressed.  Please see discharge instructions for further information
Mom reports child had dose of MENVEO last week and has had head and neck discomfort since; afebrile. Appt here to evaluate.
Weakness developing to extreme weakness and fatigue to respiratory diff and collapsing lung, diff walking and partial paralysis of hands, neuropathic pain.
My arm was swollen I had a knot in my arm the size of an apple. About 10 days after my vaccination my skin started to itch. When I woke up I scratched my back and I saw this stuff on my finger. My skin was itching the day before. I thought I was bit by something. I grabbed a mirror and saw blisters on my skin. The spots and redness kept spreading. It covered the right side of my body. The itching was from my back to my stomach. My husband states that it was getting out of control and he took me to urgent care.  When I got to urgent care the doctor stated that I had shingles.
Initial normal injection site swelling subsided after day 3  On day 8 a large swollen hard lump returned surrounded by 3 red blotches and actively painful and swollen Day 9 blotches had combined to form one large red patch and swelling and stiffness remain
My X husband got the Shingles Vaccine and got them in his eyes / Suspected Vaccination Failure; My X husband got the Shingles Vaccine and got them in his eyes; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's wife. The patient got the Shingles vaccine and got them in his eye. Now he has to go once a month to get an injection in his eye. The follow up was not required. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
A spontaneous report was received on 18JUN2015 from a licensed practical nurse who reported unspecified patients may have received improperly stored (Oka/Merck) VARIVAX, exposed to -10C for 20 minutes. No adverse effects were reported. No further information was provided. Additional information is not expected.
The morning after, I woke to the most excruciating pain. My hip joints, lower back and legs were causing me so much pain I could not find a position lie in to ease the pain. My left arm hurt so much and my strength was zapped, I could hardly get out of bed. It took me at least 10-15 minutes to get it done.  When I finally got up, my legs could barely keep me up. I got to the kitchen because I was very dry but couldn?t lift my water jug. Then I felt like I was going to vomit and that caused additional pain. I had fever and headache.  The extreme pain lasted over 5 hours. A friend wanted me to go to the ER but I couldn?t bare the pain of sitting in a car. I finally took 2 Tylenol pm just so I could sleep.  When I woke, 3 hours later, he extreme pain had subsided enough that I could get around very slowly. A family member came and stayed with me.
Fever then chills; trouble breathing; lethargic; loss of appetite; trouble sleeping.  After 10 days, had medical appointment with medical doctor; tested for flu and Covid which were both negative; sent to local hospital for blood work and chest x-ray; after doctor reviewed blood work results and chest x-ray, was asked to return to the local hospital for CTA scan; CTA scan revealed micro pulmonary embolism and fluid on the lungs; with rooms available I was asked to remain overnight in the ER; remained in ER overnight on heparin IV; when no in-patient room at the hospital, I was sent home with a prescription of 10mg (2xdaily) of Eliquis; after 1 week of 10mg (2xdaily) of Eliquis, prescription was reduced to 5mg (2xdaily).
I was sick for two days after receiving the vaccine with a fever. I began not feeling well on 03/06/2022 with a cough and a fever. I visited with a family member who was symptomatic but did not know she had COVID-19. I took a COVID-19 test on 03/06/2022 and it was negative. I went to an urgent care center on 03/07/2022 and had a rapid test which was negative. I had a PCR test on 03/10/2022, I got the results early morning on 03/11/2022 and I was positive COVID-19. I was very sick with a cough and fever. Prior to the positive COVID-19 test, I was treated for an infection with steroids, cough medicine and an antibiotic. Since having COVID-19 I have gained 35 pounds, I feel fatigued, and I have joint and muscle aches.
PER MOM:  RASH, PAIN, ITCHY, AND RASH ON ARMS LEGS AND STOMACH X5 DAYS
Pt exp nausea, vomiting, diarrhea 1 wk p/Influenza vax; On f/u, reporter stated pt had gastrointestinal virus that was not related to vax;
Massive headache on top of head starting 1200 on Saturday 08/28/2021; Advil and Tylenol made it bearable round the clock; 08/29/2021 Sunday morning woke up with eyes swollen and face; by 1100 face was red and itchy; Urgent care closed due to COVID; Fastmed not taking anyone; went to online clinc; took Benadryl and Steriods per care.  Breathing not affected; but face red swollen and itchy.  Affected cheeks; eyelids; nose for swelling and redness.
17DEC91 mom presented in clinic @ 415PM 17DEC91 stating pt crying since 1230 PM today; unable to console, gave APAP; pt crying continuously; no edema/redness @ inject site; dx pertussis rxn;
Subdural hematoma Retinal Hemorrhage  required surgical evacuation , and in October 2020 a  ventriculoventricular shunt  Evaluation for non-accidental trauma, child services involved
Pt came to pharmacy to get flu shot and shingles shot. He was unsure if he had received the shingrix. Upon 1st glance in his profile, I saw no apparent evidence of his receiving the vaccination. So I administered it. Upon looking further in his profile, I did see he had received both doses in 4/18 and 6/18. I was unable to reach patient to inform him. I had to leave message to call pharmacy back.
SWOLLEN UPPER RIGHT ARM AND  REDNESS.. PAIN ON THE ARMPITS ( LYMPNODES)  ALL THE WAY TO SHOULDER..
Had a stroke on May 12, 2021. Found unresponsive while at work, while at work and sent to ER at Hospital. Hospital sent him to Hospital, due to Stroke on the same day. On 5-15-21 sent to Acute Rehabilitation. Still in Rehab doing PT, OT and speech therapy. Many test completed and unknown to how stroke happened. Health prior to vaccine was healthy with no concerns.
Chest tightness, chest pressure, left chest side pain, shortness of breath, lump in throat, dry mouth
2/27/23  I woke up with a sore throat.  I then became cold, clammy and lightheaded.  I did not feel like I was with it.  I began feeling a tightness in my chest and a headache that was unbelievable. I took a Tylenol. I went to Urgent Care and tested positive for COVID. I was prescribed Paxlovid and began taking it that day. I continued with a cough for two weeks.  I took 2 at home COVID tests that were positive and then one that was negative.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received flu vaccine and were flu positive. The reporter observed that they got better faster and were not as sick. The reporter agreed to be contacted for follow up. This case was considered, as suspected vaccination failure case since the details regarding time to onset for target disease was unknown at the time of reporting. This case has been linked with case US2019AMR044915, reported by the same reporter. Lab Comments: On an unknown date, the patients were positive for flu.
patient felt nauseas early in morning, dry heaves, then passed out 2nd time , low blood pressure during event.  ER visit then 4 days in hospital
Rash x 2 days/varicella with Varivax vaccine 5/11/95.
red, blotchiness on patient's chest, neck, face, and at the injection site - did not have bumps - did not itch - felt hot to the touch - appeared after taking a shower - later it felt difficult to breathe (easy to talk but felt constricted in taking a deep breath) - patient took inhaler at that time - called  hotline and spoke to a nurse practioner - she advised to take a Benadryl and notice if the blotchiness spread to other areas of the body or if breathing became more difficult - patient took Benadryl (2 doses about 6 hours a part) - the red, blotchiness did not subside but it did not get worse - patient felt fatigued the next day (Monday) and felt hot/flushed for most of the day  - the symptoms continued to decrease throughout the day on Monday but patient felt itchy on Monday night - symptoms were almost gone on Tuesday - patient took 2 Benadryl on Monday night and Tuesday night - bumps and itchiness appeared at the injection site on Tuesday night