chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who, about three weeks ago, on approximately 15-MAR-2007, was vaccinated subcutaneously with her first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). On approximately 28-MAR-2007, two weeks after receiving the vaccination, the patient developed a rash that was vesicular on her cheek, back, stomach, legs and on the arm that she did not get the injection. There were "large areas of induration." The rash was not at the injection site. The number of lesions was not reported. Unspecified medical attention was sought. At the time of reporting, the patient was considered recovering. There was no product quality complaint. Follow up information was received from the physician, who reports that "it turned out not to be vaccine related."
Stammering speech, body tremors, involuntary hand/arm muscle movements. Memory loss, unable to work due to the above. Also anxiety from the above.
Fever (highest at 101.5 degrees F) x 12 hours - treated with TYLENOL.
The patient reports starting to feel unwell with cough, chest pain (when coughing), shortness of breath, and fatigue on approximately 10/7/21. He presented to the ED on 10/18/21 for evaluation. The patient was positive for COVID-19. The patient will be discharged home.
pt recv vax 18JUN96 & 8APR97 pt devel chickenpox;13APR97 pt recovered;f/u info reported that the case of chickenpox reported on 8APR97 turned out to be not chickenpox;
fever; excess chills; The upper arm is swollen all the way to underarm; tiredness; Stiff body /neck; upset stomach; upset stomach with nausea; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 2 days after receiving Shingrix, the patient experienced fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea. On an unknown date, the outcome of the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea were unknown.   It was unknown if the reporter considered the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and the upper arm was swollen all the way to underarm, excess chills, fever, tiredness, stiff body, neck, upset stomach with nausea.  The reporter wanted to know was this common two days after shot.
Her rihgt thigh is red and swollen. the red spot is bigger than a quarter size. Her left thigh is ok. We monitored the spot to see if it has gotten bigger. She has not had any fever
In addition to a very sore arm, at injection site: alternating feelings of being hot and cold throughout the night following injection. Tachycardia (110-120 bpm) throughout the night and into the next day. Two days following injection, extensive rash over most of body, lasting at least the entire day. (My report is being written on this third day, after consulting my PCP and being advised that I should go to the ER if any symptoms worsen.)
Pt received her vaccine on 10/21/2014 and developed pain her her clavicle on the same arm as vaccine was administered. seen in the ER on 10-29-14 and later by her PCP and was diagnosed with shingles. She believed she developed shingles from the flu vaccine. Unsure of time or date this occurred.
About 7 hours after vaccine, arm began getting very painful, nausea 9 hours after administration.  Could not move arm and hand and hand tingling.
Patient's leg was slightly warm to touch, red localized color and some swelling. No fever or breathing issues. 3/17/16 Dr spoke with patient's father. Swelling resolved completely few hours after injection.
No other adverse event reported; Temperature excursion on PROQUAD that was administered on 04/23/2021 to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) first time dose (route of administration was not reported), lot # T037957 rHA and expiration date 09-MAY-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.5 fahrenheit (°F) for 30 minutes on 22-APR-2021 and 6.0°F for 15 minutes on 23-APR-2021, for a total time out of range of 45 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2105USA003579:
pain & numbness lt arm from 21APR - 23APR93; pain down arm & across;
A report has been received from a Health Professional concerning an 18 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient experienced administration of expired FLUMIST QUADRIVALENT which started on 20-Dec-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Pt was irritable & cried & cried all day; Ambulance called but not taken to Hosp; Later seen in ER & died; MD states death had to do w/chambers of the heart & mixing of blood Death certificate states cardiac failure;
Developed fever within one hour after vaccination that persisted for greater than 72 hours.  Body aches present at the time and for several days after.  Left deltoid area of arm remained swollen for greater than 72 hours (injection site).   Nearly one week since vaccine administration and still have intermittent fever and body aches with chest tightness and cough.  Self treatment with occasional ibuprofen to help sleep.
Presented  to the ED  complaining of worsening O2 sats following positive COVID test on 12/22. Diarrhea,Cough, chest congestion, hypoxia. On admission, was found to have pneumonia due to COVID-19 and was treated with IV steroids-Decadron and Actemra and oxygen. Disposition: He will be discharged today to home.
had chills, fever and nausea with vomiting in middle of the night so badly it woke me up from my sleep.
Initial report received from a health care provider on 16 August 2007. Four patients had received a dose of Adacel, lot number C2771AA, expiration 02/Nov/2009 and developed large local reaction at the site of injection. One patient had been evaluated at an emergency room and was discharged with a diagnosis of cellulitis. The needle size routinely utilized by this facility for vaccine administration had been reported as 25 gauge, 5/8 inch. Patient identifiers and the date of administration, route and site of administration, Latency of adverse event onset, and prior tetanus vaccination histories had not been reported. No additional information had been reported.
Diffuse lacey rash, Severe vasoconstriction of fingers with digit ischemia resulting in complete necrosis of the 3rd digit on right hand
local reaction at shot site with redness and induration that grew during the day on 3/25/21, larger on right leg than left.
Hospitalized (1.21 - 1.27.22); COVID-19 positive (1.20.22); Fully vaccinated (no booster) Date of Admission: 1/21/2022, Hospital Day: 7 Date of Discharge: 1/27/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 [U07.1] HOSPITAL COURSE: The patient is a 54 yo woman with ESRD on HD with recent repair of bleeding pseudoaneurysm AV fistula, diastolic HF, hypertension, vascular dementia, hx of CVA with residual left sided weakness who presented to ED with lethargy, confusion and generalized weakness. Over the 3 days PTA patient had been feeling down and weaker with decreased appetite. She vomitted at HD on 1/20 and was subsequently found to be COVID positive. On day of admission, she was difficult to awaken from sleep and did have fecal incontinence. She did become more alert and was alert and oriented by the time she was seen in ED. Vitals were WNL at admission. Labs showed Cr consistent with ESRD but otherwise no abnormalities. Nephrology was consulted for HD needs. She had no oxygen needs. Her home diuretics were held in the setting of dehydration.  Her stay was remarkable for spontaneous recovery, hemodialysis and discharge home 1/27/22 with improvement of her oral intake. Care was discussed with her significant other per patient request and questions and concerns addressed.
Cellulitis of left lower limb. Cephalexin prescribed: 125mg/5mL. Q12 hrs for 7 days. BACTROBAN ointment 2% 1 application to left leg TID for 14 days.
Client reported chest pressure ("heavy chest") after receiving first dose of Pfizer COVID-19 vaccine. She did not take any medications and it resolved after two days. Vital signs were WNL and clinical team approved to administer 2nd dose. Client was educated on COVID-19 vaccine side-effects and encouraged to report side-effects on V-SAFE.
This case is linked to case number 2012-08522 (mother case). Initial report received from a healthcare professional on 06 September 2013. An infant, whose gender, weight and height were not reported was exposed to ADACEL vaccine via transplacental route (lot number unknown) on 12 September 2012. The baby's personal and family history was not reported. The baby had intrauterine growth retardation (IUGR). Other diagnosis included fever and glucose problems. No laboratory tests and corrective treatment were reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.
01/23/22 presents to ED for "Shortness of breath". PMHx of "metastatic colon cancer with liver mets" "HTN, GERD, and anemia"
1 hour after receiving the vaccine I developed the same headache I had when I was diagnosed with COVID on November 27th 2020. The next morning I felt the same headache treatable with over the counter medication (Tylenol). Around 1030am I began to feel fatigued at work. This worsened followed by an increased headache and dizziness. I left work early. Once I got home and took my temperature (tympanic) it was 100.3 at 130pm. Next symptom happened within the next half hour and it was pain in both thigh muscles. The pain felt how muscles would feel the day after a hard workout. This muscle pain began to effect all the muscles in my body. This worsened to joint pain even in my fingers. The fatigue was very severe. I went to sleep around 230pm and slept and off until 3-23-21. I was barely able to walk on 3-23-21. I was not able to perform any daily tasks. I contacted my primary car physician. She advised me to rest and if my symptoms did not improve my the next day to consider getting a test for COVID. I did go to an urgent on 3-24-21 for a rapid COVID test which was negative. I returned to work on 3-25-21 not feeling completely back to normal but much better.
Significant bladder discomfort. (Same thing occurred with shot #2) Discomfort lasted for approx 36 hours.  Secondary to that was fatigue and injection site soreness.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) .  On an unspecified date (reported as "subsequent to inoculation"), the pt was treated at a medical office by a healthcare for shingles and was hospitalized on an unknown date. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for this injuries; significant medical and related expenses as a result of this injuries, including but no limited to medical losses and costs included care for hospitalizations, physical care, monitoring, treatment, medications and supplies; diminished of quality and capacity for the enjoyment of life, increase risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continued to suffer such losses, and damages in the future.   At the reporting time, the pt had not recovered from the event and the causality assessment was considered as related.
body aches; sore arm at injecti on site; swollen lymph nodes under arms on the side booster was received (left ); tender lymph nodes under arms on the side booster was received (left ); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MYALGIA (body aches), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )). In November 2021, MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injecti on site) had not resolved and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )) was resolving.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Symptoms started about 4-6 hours after receiving of booster. Body aches lasted about 48 hours; lymph nodes still swollen and tender, started to decrease and arm still slightly sore.
After 20 mins (I had already arrived to my car) my throat started to feel tight, I could breathe normally but the sensation of tightening was happening accompanied by very warm rushing sensation in my neck and ears. I also experienced numbness near my neck. My heart rate also elevated significantly range between 88-106. (After the tightening sensation began I started to panic a little which certainly contributed to the heart rate elevation), The provider monitored me to make sure that no breathing issues were present and I took two chewable Benadryl.  I stayed at the clinic until one hour had passed and returned home. The provider called me later to check on my status. I want to emphasize that i was not at all nervous or anxious about receiving the shot but I very stupidly had alcohol in my system.
Patient stated that she received all three vaccines on 10/13/23 the next day she had a high fever, extremely sore arm, redness and rash near injection site, and is developing a cough.
Pt was administered 2 Typhoid VI vaccines. No signs/symptoms of reaction noted. Pt was told to report reaction ASAP.
Initial report was received 01 November 2010 and 02 November 2010 from two consumers, one consumer is the patient's sister-in-law, and the other consumer is the patient's wife. An 85-year-old male patient had received an injection of FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number, route and site of administration not reported) and an injection of PNEUMOVAX (manufacturer MERCK, lot number, route and site of administration not reported) on 20 October 2010 and two to three days post vaccination, the patient experienced a "funny feeling in his legs and arm". On 28 October 2010, he was unable to move his legs and it progressed to where he had no use of his upper and lower extremities and he could not walk. He also experienced chills, vomiting and a fever; the patient's wife thought the fever had been 101. He went to the emergency department (ED) and by the time he was admitted to the ED, he was able to move his legs. Laboratory results noted elevated liver enzymes and elevated WBCs. The ED physician felt the patient had some type of infection (not specified if viral or bacterial). The patient was given unspecified antibiotics as corrective treatment admitted on 28 October 2010. On 31 October 2010, the patient's WBCs were back to normal and he had use of both upper and lower extremities. The patient was discharged on LEVAQUIN on 31 October 2010 (date of discharge also reported as 30 October 2010). According to the reporter (the patient's wife), she inquired if the events were related to the vaccines her husband had received. She was informed by the ED physician and nurse that the event was not vaccine related. The patient was scheduled to see his attending physician on 06 November 2010. At the time of the report, the patient's recovery status was not reported. The reporter for this case is the same as case number 2010-06290. Documents held by sender: None.
FEELING SLIGHTLY IRRITABLE; BEGINNING TO GROW A  THIRD TESTICLE; This spontaneous report received from a patient concerned a male of unspecified age. 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, expiry: UNKNOWN) dose, start therapy date were not reported 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 MAR-2021, the subject experienced feeling slightly irritable. On MAR-2021, the subject experienced beginning to grow a third testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling slightly irritable and beginning to grow a third testicle was not reported. This report was non-serious.
Information has been received from a physician concerning a patient who on 09-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the zoster vaccine live (Oka/Merck) was inadvertently stored in the varicella virus vaccine live (Oka/Merck) (MSD) storage area of the vaccine refrigerator. There were no adverse symptoms. The event occurred as a result of human error. The bottle was "not seen properly" as stated by the physician. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician felt it was simply a case of human error. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up confirmed that there was one female 5 year old patient. No additional information is expected.
Vaccines were stored in the fridge since 21Dec2022; no AEs were reported.; HCP stated 4 patients were administered with doses BUD on 23Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated 4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (no AEs were reported.) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No known conditions were reported.  Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated 4 patients were administered with doses BUD on 23Jan2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (no AEs were reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated 4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (no AEs were reported.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no AEs were reported.) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated 4 patients were administered with doses BUD on 23Jan2023) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 21Dec2022).    No concomitant medications were reported. HCP stated 4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022. For patient number 2 no AEs were reported. No treatment medications were reported.
Pt rcv'd Tdap on 6/15/15, that night she woke and arm had a knot at injec site. The next morning area red, warm and painful to touch, hurts to move arm up and down.
Patient stated that she had intense abdominal pain and cramping lasting for 5 days (at time of report patient was still experiencing).  Patient reports no diarrhea or vomiting and was unable to work.
Patient experienced red bumps over majority of body. Pt stated that bumps were itchy.   Bumps left small pustules which left scabs a few days after presentation.   Pt followed protocol and was seen in the ER over the weekend.  No actions taken by ER, followed up with PCM 17 Jun 2019.  Symptoms resolved and pt was not instructed to take any additional medications.  Possible unknown skin condition cited as cause for reaction.  Pt denied any history of skin conditions during screening for Smallpox vaccine.  Member given permanent exemption from future Smallpox vaccines.
PT STATES THAT SHE STARTED TO SEE RASH BEFORE BED,PT WAS ITCHING BODY ALL NIGHT , SO SHE MADE AN APPT. AT APPT PT STATES THAT SHE GOT SHOTS YERSTERDAY AND ALSO STATRTED TO COOK ORGANIC FOOD AT THE BEGINING OF THE WEEK.  THE SHOT THAT THE PT RECIEVED ; HEP A & B
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M003011, expiry date 15-NOV-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PWC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID breakthrough. Patient came in for delivery of baby and was tested for COVID as part of routine testing process. She did not have any symptoms. The baby was delivered on 3/25/22 at 39 weeks 1 day.