chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister 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 was selected adult as per vaccine indication. The patient received Shingrix at least a month ago and developed blisters on their chest and neck. The pharmacy intern did not have any other information.
no adverse event; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA W021491 12/14/2023 Temperature: 30F Time fr; This spontaneous report was received from a other health professional and refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 09-FEB-2023, the patient received improperly stored vaccine of hepatitis a vaccine, inactivated (VAQTA) lot # W021491, expiration date 14-DEC-2023 (dose, route, and anatomical location were not reported) for prophylaxis (product storage error).  Temperature exposed: 30F Time frame: 3 hours 15 minutes
pt hospitalized on 8/26/2021 for cellulitis and tested positive on admit (asymptomatic)
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 09-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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, pain and suffering, and other damages. Additional information has been requested.
Ear infection; Pain in ear; Inflammation in ear; A spontaneous report was received from a consumer concerning a 49-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in ear, inflammation in ear, and ear infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient began experiencing pain and inflammation in his ear and was treating for an ear infection. Treatment for the event included pseudoephedrine, loratadine, ibuprofen, diphenhydramine hydrochloride, and amoxicillin.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, pain in ear, inflammation in ear, and ear infection, were unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of ear infection and non-serious unexpected events of ear pain and inner ear inflammation. The event of ear infection, ear pain, inner ear inflammation occurred 9 days after mRNA-1273 (lot # unknown) administration. Treatment included pseudoephedrine, loratadine, ibuprofen, diphenhydramine hydrochloride, and amoxicillin. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
multiple itchy but non productive pustules manifested on 2nd and 3rd knuckles of both hands
Injection site became hot, red, itchy, and slightly swollen 2 weeks after the injection was administered..
Horrible headache; Body hurt; Chills; upset stomachupset stomach; Fever; appetite went away for three horrible days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Horrible headache), general body pain (Verbatim: Body hurt), chills (Verbatim: Chills), upset stomach (Verbatim: upset stomachupset stomach), fever (Verbatim: Fever) and decreased appetite (Verbatim: appetite went away for three horrible days). The outcome of the headache, general body pain, chills, upset stomach, fever and decreased appetite were resolved (duration 3 days).   It was unknown if the reporter considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   It was unknown if the company considered the headache, general body pain, chills, upset stomach, fever and decreased appetite to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The case was received from the patient interactive digital media. The reporter stated that the symptoms when they gave you the vaccine were horrible.  The patient had 3 terrible days with a horrible headache and his/her whole body hurt. The patient had horrible chills, upset stomach and fever and my appetite was gone for three days, that vaccine felt horrible. The follow-up could not be possible as no contact details were available.
Around 12/7/00, pt developed numbness then 1 week later, he developed weakness in extremities. Pt stated that he was told he has Guillain-Barre.
I received my vaccine while I was at work around 1400. Around midnight I woke up shivering and could not get warm. My heart rate was elevated but that could have been related to my anxiety. I layered clothing on and finally managed to sleep. Upon waking up around 6 the next morning, I had a temperature of 102, a sore throat, throbbing headache, and was vomiting. My arm was so sore and swollen that I could hardly touch it. After rest, Tylenol, and fluids, I felt better around 8 that evening.
The day after patient got his shots he was running a 102.0 fever.  I gave him Tylenol every four hours and by the next day he did not have a fever but he was still under the weather for that day.  So he was sick for about a total of 2 full days after the shots.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 3:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 69.55.  Concomitant products were not provided.  Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials was sent to clinic. Vaccine BUD dates was 29-Apr-2021.  Vial was stored on cooler 1, on 20-Mar-2021, Excursion duration At 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM: 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 traceable 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
approximately 53 hours after shot, developed fever of 101.5 which broke overnight. Noticed red raised rash at injection site about the same time. rash is in shape of the band-aid administered and was left on for 48 hours. Rash is still present on arm now in the 5th day after injection. Soreness in arm developed within 24 hours and persists now, as well, 5th day following. Soreness is a mild ache, noticeable when touched or when raising arm above head.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX "did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2013, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 03/03/21. Hospitalized from 08/10/21 - 08/14/21 (death). Below is copied from patients discharge (death) summary:   Hospital Course: Patient is an 84 year old man with a past medical history of Afib (on eliquis, metoprolol), HTN, HLD, MI admitted to the ICU for acute hypoxemic respiratory failure secondary to Covid-19 pneumonia. He presented to the ED after EMS was called for fall out of bed with generalized weakness, he denies hitting his head or LOC. He was satting 78% on EMS arrival and tachypneic, he had minimal improvement with NRB. In the ED he was found to be in Afib RVR to the 160s with hypotension, levophed was begun, he was cardioverted, and was begun on amiodarone infusion. The patient reports a 1 week history of generalized fatigue and shortness of breath without leg swelling or orthopnea. He was vaccinated in March with the Pfizer vaccine. He reports his cardiologist is at another facility and doesn't remember his medications offhand but knows he takes Eliquis BID.    8/11: TTE ordered, not yet performed. K+, Mg, phos low and repleted. On HFNC + NRB 60L/92% satting high 80s/low 90s. Currently on amio drip. No other acute events.   8/12 Patient elected to be DNR/DNI yesterday. Urine culture growing >100K Staph, started on Vanc/Cefepime while waiting sensitivity. Amio gtt changed to metoprolol. Patient endorsing soreness/back pain and states he uses Percocet and fentanyl patch outpatient. On HFNC + NRB 60L/95%, satting high 80s/low 90s past 24 hours. Echo performed shows EF 50-55%, impaired relaxation, moderately enlarged RV, moderately dilated LA, PASP 45 mm Hg.   8/13: Patient elected to rescind DNR/DNI 1 day ago. Became acutely agitated throughout the night and was removing HFNC stating that he "did not want to do this anymore". Started on precedex gtt and haldol prn for agitation. Pt w/ improved compliance w/ HFNC and able to maintain O2 saturation between 87-89%.    8/14: Patient now DNR/DNI, daughter at bedside while patient's wife was again admitted to the hospital. Decision made to pursue compassionate wean. Started on Morphine infusion for comfort and to prevent air hunger. O2 saturation continually downtrending.   Asystole at 1803, confirmed in 2 leads.  No signs of life.  Pronounced expired at 1803. Dr notified at 1806.
This spontaneous report was received from a nurse refers female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL injection, (lot number, route and expiration date were not provided) for prevention of HPV. The nurse reported that on an unknown date in June 2014, the patient experienced small red bumps. At the time of the report, the patient outcome was not provided. This is one of several reports received from the same source. Additional information has been requested.
still have a sinus infection; still got paa flu; Initial information received on 24-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves Adult and unknown gender patient who still have a sinus infection and still got paa flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious still have a sinus infection (sinusitis) and still got paa flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown.
Gradual onset of swelling of right arm with decreased ROM (significant) for 24-36 hours. 4x5 inch area of redness at inject site right arm. Additional symptoms include swelling of stomach, hives on scalp, nausea, fever, pressure behind eyes, HA, pain in joints. Treated with Tylenol and Benadryl. Improved but not recovered.
Extreme period pains and excessive bleeding every month since my 2nd dose. Clots also occur more in my periods post vaccination.
This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 22 year old female patient. On 10-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). On 12-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). The patient was administered a dose of GARDASIL while she was pregnant, the patient is 4 months pregnant at the time of the report. The patient LMP was calculated as 12-OCT-2012, the estimated date of conception as 26-OCT-2012 and the estimated delivery date as 02-AUG-2013. On 12-FEB-2013, the patient was administrated the third dose of GARDASIL (dose, route and lot not reported. The patient was receiving obstetrical care by an unspecified provider. Additional information is not expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of VAQTA experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.
paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Patient reports she was late to dose due to infection and reaction to COVID vaccine. No additional information provided. Patient does not consent to be contacted.
Approximately two minutes after injection of vaccines Mom noticed and questioned to nurse about bilateral lower extremity redness. Nurse called Dr. back to room immediately. Doctor diagnosed as an apparent vassal motor reaction with moderate facial pallor. Baby taken out of infant seat and laid flat on table. Face pallor occurred after he was taken out of infant seat and lasted less than one minute. Doctor observed continuously for ten minutes. Lips remained pink, heat steady normal rate though not recorded by doctor. Legs normalized feet first in estimated five minutes.
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE FIRST VACCINE, PFIZER, WAS ADMINISTERED 1/18/2021 AND THE SECOND VACCINE, JANSSEN, WAS ADMINISTERED 4/9/2021. TREATMENT AND OUTCOME UNKNOWN. ALSO UNKNOWN IS IF SYMPTOMS WERE EXPERIENCED.
Headache along with some numbness; Headache along with some numbness; Tingling in her arm; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her (daughter). A 21-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 03Apr2019 15:00 at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient which was a nursing student was given the vaccine around 3:00 pm on 03Apr2019, 3-4 hours later she developed a headache along with some numbness and tingling in her arm. The parent took her to ER. They treated her for headache at ER and sent her home. Patient was feeling better approximately 1-2 days later. Outcome of the events was recovering.
I got GBS on 8/29/02. Diagnosed as GBS in hospital. Now in a rental assisted living home. Hope to be walking soon. Follow up 01/20/05: Still under on going medical care, has not recovered. I' good as I can be. I fell good, no aches or pains. The only thing to complain about I gues is that I can't make the right knee do what its supposed to do. I can't get either leg to pull up like their supposed to do. Neith leg hurts, I just can't lift both of them as far or as high as I should. The left one is nealy normal but not so for the right. I can't get either leg to lift up as far as it should in a single step. On I can get the left on up pretty good but the right one is hard. Also, I can't get them up on the second step very easily. I guess I could get it up a second step but boy what a task. My back is ok, arms ok, breathing ok and talking seems to be ok. I am having soem trouble with my eyes. My right eye might as well be blind as I can only see everything as a blear. Stuff just wont focus in the right eye. The left eye is pretty much ok. I need my old glasses to make out stuff, but I can read the newspaper with my glasses in the left eye if I'm careful and try hard. In the right eye I'm having troube, it just doesn't focus good. Rougly speaking however it's functioning pretty well. I have to have drops in bother eyes to see fairly well. When I look at airplanes in the sky, there are two airplaines separated by a bit of space. I guess that's double vision. I can make a airplane disappear however by blocking the vision to the right eye!!! Lets see you do that!! I am walking down and back 150 foot corridor with my walker all by myself. I can get in and out of the car without any help, but I'm not sure how much more I can do. Information from Discharge summary states respiratory failure, ataxia, infection, dyspnea, weak, eye disorder and venous thrombophlebitis. Medical records state sepsis, constipation, bells palsy, abnormal thinking, pneumonia.  msv
PATIENT STARTED HAVE SHAKES AND SHIVERS AND ELEVATED TEMPERATURE THE SAME NIGHT. ALSO SOME SWELLING UNDER THE ARM. PATIENT DAD SAME SYMPTOMS UPON PREVIOUS ADMINISTRATION AND SYMPTOMS SUBSIDED IN A COUPLE OF DAYS. TOLD PATIENT THAT IF SYMPTOMS GET WORSE, THEY NEED TO SEEK MEDICAL ATTENTION.