chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient who on 14-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#666855/0162Z). Subsequently, the patient developed classic chicken pox lesion within 4 to 7 days after receiving the VARIVAX (Merck). At the time of this report, the patient's outcome was unknown. Follow up information was received from a physician who was requesting a lot check on the above VARIVAX (Merck) (lot#666855/0162Z). This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Localized swelling and erythema at injection site of anterior left thigh. Also, localized itching. No systemic reactions noted. Varicella vaccination given approx 1430 on 16 July 12 itching began that evening and localized rash noticed in morning 17 July 12. Treatment- cold compress.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On an unknown date in 2014 (reported as a month or so ago) the patient experienced red, swollen, itching at the injection site. The outcome of the events of red, swollen, itching at the injection site was unknown. Relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
I occasionally would have palpitations and an irregular heartbeat. I have since been diagnosed with Afib presently and have taken the 4th and 5th dose. I am on a heart monitor now. I did have a tachycardia attack sometime in September 2021, after the 4th dose. But to be brief, my heart races and I get palpitations and dizzy spells. This all became much more pronounced after the 3rd dose, which is why I am reporting on the 3rd dose as the start. I also had the afib attack soon after the 5th dose. It seems that the vaccine might be triggering and flaring up any pre existing conditions. I did have palpitations before any of the COVID vaccines and before COVID but they were mild and very sporadic. Now they are much more pronounced now, which could be age, but it seems to be a pattern with the vaccines and my current attacks.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On 24-AUG-2016 or 25-AUG-2016, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L032182, expiry date: 25-AUG-2017) (route: subcutaneous) (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
pt was crying nonstop for days (more than 3) small sleep periods but very cranky; red rash on tummy; fever (high) over 103 x 3 days; APAP wouldn't bring fever down
Tinnitus ringing in the left ear almost immediately after the first shot and increased after the second.  Within 2 mths I started experiencing dizziness and ultimately vertigo attacks.  The symptoms continue today.
Patient received influenza and Zostavax vaccines on 10/22. the next day she began to feel tired, weak, and generally not well. Over time she noticed shortness of breath with mild exertion. On admission she denied any fever, nausea, vomiting, diarrhea, abdominal pain, chest pain, headache, or neck stiffness. During hospitalization she did present with low grade fever along with previously described symptoms. A large pericardial effusion was detected upon further testing.12/06/07-records received for DOS 11/7-11/14/07-  Developed diarrhea and stool leukocyte positive.Weak, low grade fever, malaise, dyspnea, atrial fibrillation. Impression: probably autoimmune phenomenon possible related to recent immunizations, Pericarditis. Per 60 day follow up: Atrial fibrillation developed during hospitalization related to acute pericarditis. Pt was discharged home 11/14/2007. Patient is still alive, had lab work 1/21/2008.
Extreme Chills and Fever; Severe Pain in Injection Site; Nausea; Dizziness; Trouble Catching Breath and Weakness
13Jun90 pt vax;  serology indicated non responder.  08Apr91 booster dose given - still non responder.
From initial information received on 27Aug04 from manf (HQWYE614423JUN04) from information received from a physician regarding an adverse event occurring. It was reported that a four month old female pt received an Acthib vaccination, lot number X0073, and Ipol vaccination, lot 40148, and a Tripedia vaccination, lot number 61258BA (lots provided for Ipol and Tripedia could not be confirmed as manf lot numbers and routes and sites of admin were not reported) on 22Jun04. The same day, the pt developed hives over upper body. The pt recovered from this event. From additional information received on 11Oct04 from the reporting physician, it was reported that the pt received the Acthib product IM in the left thigh; the Ipol product SC in the right thigh; and the Tripedia product IM in the right thigh. She also received a first dose of Prevnar, lot 495170, administered IM in the left thigh on 22Jun04. The pt developed hives on her left thigh within 15 minutes of receiving the vaccinations. The hives did not spread and slowly resolved over the next two to three hours. The pt did not experienced a reaction to a subsequent DPT injection given on 13Sep04. No treatment was needed for the hives and the pt recovered from these events. No further information is anticipated, this case is considered closed.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 20-Dec-2013. It was reported that the patient had administration of expired product. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
achy; flu like symptoms; fatigue; nausea; had no energy; feel crappy; they threw up; sore arm; headache; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, headache, achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  The patient's medical history was not provided. Concomitant medications reported were omeprazole 20 mg once a day, levothyroxin 50 mcg, lovastatin 20 mg for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event(s) sore arm, headache. On 21 Feb 2021, the patient experienced the event(s) achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 14 Jan 2021 the outcome of event(s), sore arm, headache was resolved. On21 Feb 2021 the outcome of event(s), they threw up was resolved. The outcome of event(s), achy, had flu-like symptoms, fatigue, nausea, had no energy, feel crappy was unknown.
Information has been received from a registered nurse (RN) concerning an elementary aged child who was vaccinated with a dose of Varivax. The RN reported that in February 2006, the patient breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
4 hrs after receiving TWINRIX, pt states she started feeling weak, having body aches and joint pain, nausea and dizzy and difficulty breathing. Pt states started having "behavioral changes" - states crying and angry @ the same time, symptoms persist till the next day - seek medical attention - Dr visit this morning and was given meclizine. Pt claimed having the same reaction with last TWINRIX but thought it was a reaction from flu vaccine -  claimed it took 2 wks for her to recover.11/03/2009
Second dose of Pfizer-BioNTech vaccine administered. Patient became slightly aloof as his mom noticed a change in his facial expression and a slight disconnected look in his eyes. Mom asked if patient was ok, to which he stated "yes" and attempted to stand up, but became lightheaded and vision became "dark" and patient fell over into mom's arms. Patient laid on floor for approx 10 minutes before attempting to sit up again, but again became dizzy and weak and vision became "dark" so patient laid down once again. EMS arrived shortly after and tended to patient. Given a bottle of water in the meantime, and patient stated he was nervous and had a fear of needles.
Left arm stiff. Unable to lift past shoulder height without assistance. Pain on passive ROM post TDAP (x2 days).
Mother reports he got his vaccine, he reported that he didn't do that good.  He complained of tiredness.  He just didn't feel right, and that something wasn't right with him.  He felt like his stamina was down, he was very athletic and felt that he was not doing his normal routine.  He went to work as usual, that morning he told his mother that "they want to kill us all".  He went to work, thought that he was going to be OK.  He came home for lunch, he ate lunch and went to work and then he came back within 5 minutes and said that he did not feel good.  He collapsed on the floor and she called 9-1-1, they resuscitated him and taken to the hospital and he died.    He did not have any history of heart disease prior to the vaccine.  He had routine blood work and had no issues other than some high blood pressure.    In January of 2021 he did have COVID which did not require hospitalization and recovered at home without any issues.  They had cough, exhaustion and fatigue.  He recovered fully and was back to his baseline and back to work without any problems prior to the vaccine.  He saw the doctor for his COVID who told him he was OK to go back to work.  He was a very active, athletic and ran in all the marathons and eat healthy foods.
12 hours vaccination, pt reported experience a throat, hand/feet swelling, SOB, body aches, fever 100.6F
Information has been received from a physician concerning his son who was tested for and diagnosed with a peanut allergy on an unspecified date in approximately the year 2000. The son had been immunized with several unspecified vaccines on unspecified dates in the 1990s. It was not known whether or not the son received MMR II. The patient had sought unspecified medical attention. At the time of report, the outcome was unknown. Additional information has been requested.
Patient fainted in chair after receiving vaccines. Nurse helped patient to ground, laying with knees bent. (Pt awake at this time) patient pale in color, alert and oriented x 4. Vital signs stable. Patient helped to chair after 5 minutes. Crackers and juice provided.
Large Peach Size round circle around shot area with swelling, pain, headache, fever and tired all the time.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "bone cancer" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
numbness on side of arm, sharp pain on same side running down arm, sore elbow that is warm to touch. Took percocet  and aleve from previous surgery to aleviate pain
Face flushed for the first two days, then severe red itchy rash on arms, thighs and knees and under breasts and sides of stomach.
pt recv vax & w/in 24hr post vax & exp numbness around lips & felt like passing out;resolved w/o treatment;
Patient received PNEUMOVAX vaccine.  Arm became swollen, warm to touch, down into chest few hours after receiving injection.  Went to ER around 11:00 PM.
patient developed a rash following the COVID vaccine.  was mild after first vaccine  and then severe after second vaccine  severe on neck  and trunk.  had papules blisters crusting burning..
Given PNEUMOVAX vaccine Lot#1175F exp  12/1/08 MERCK and FLUZONE vaccine Lot#U2768AA exp 6/30609 9.5cc of each) in left deltoid, the influenza vaccine placed in upper Deltoid and PNEUMOVAX lower. A different alcohol wipe, syringe, needle were used to prepare vaccine. Separate wipe for each area on her left Deltoid- 10/6/08 10/7/08 eve T 101 degree, left arm sore and red saw PMD 10/9-swelling 2 cm- redness, heat. Put on AVALON x 5 days improvement 10/11 and complete resolution  10/13/08
Hearing loss; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 08-MAR-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date (reported as "shortly after"), the pt suffered hearing loss (deafness). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered serious, severe, progressive, permanent and incurable personal injuries that caused physical limitations (physical impairment) not presented prior vaccination; the pt also suffered significant conscious pain, suffering, mental anguish, loss of enjoyment of life and emotional distress due to his physical limitations and seriousness of his condition. As a further proximate result, the pt has suffered significant medical expenses, the loss of accumulations and other economic and non-economic damages.  The causality was reported as related and the event was considered to be disabling.  Upon internal review, the pt's deafness was determined to be a medically significant event.  Additional information has been requested.
pt recv vax 1030AM hives noted @ 530PM-lasted until 1030PM;
Influenza vaccine administered on 11/28/2003 at 3:30 pm.  Patient developed spreading erythema, induration, pain and warmth at intramuscular injection site (left anterior thigh)first noticed on 11/29/2003 at 9:30 am.  Oral Augumentin started on 11/29/2003 at 11:30 pm.
The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. He decided to delay getting the bivalent booster in January after the holidays.
Pt was hospitalized for a prosthetic joint infection and developed cough, tachypnea, and fever.  Tested positive for COVID
Pt recvd 2 doses of Engerix-B & devel pain in elbow a few days later; exact time of onset unk; pain radiates up & down arm when moves arm;
Patient had general malaise unknown cause. Onsite EMS was called vitals BP 180/98 HR 80  100% O2. Patient refused evaluation/care  and released against medical advise.
4 cm area of erythema with "quarter" sized swelling in right arm surrounding injection site. 2x3cm area of erythema with "dime" sized swelling in left arm surrounding injection site. Diphenhydramine 4.6ml given orally. Swelling in left arm resolved, but unchanged in right arm 10-15 minutes later.
t103 @ 2AM following shots;no appetite-mom giving APAP q4 hr-temp 101 @ 1230PM next day;
SLEPT FOR 4 DAYS ABOUT 20 HOURS A DAY 100-101 FEVER COULDNT EAT ONLY DRINK VERY TIRED AND SLEPT ALL THE TIME  DRANK LOTS OF LIQUID TOOK ASPIRIN
Myalgia, Arthralgia, fatigue Narrative:  loss 1 day work   Other Relevant History:
His whole right side is sore; Feels like he had flu; Drowsy every morning; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like he had flu), SOMNOLENCE (Drowsy every morning), NAUSEA (Nauseated) and ARTHRALGIA (His whole right side is sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder discomfort.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like he had flu), SOMNOLENCE (Drowsy every morning) and NAUSEA (Nauseated). On an unknown date, the patient experienced ARTHRALGIA (His whole right side is sore). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like he had flu), SOMNOLENCE (Drowsy every morning), NAUSEA (Nauseated) and ARTHRALGIA (His whole right side is sore) outcome was unknown.            No concomitant medications were reported.   The patient reported having an issue with his shoulder before having the dose and  was unsure if it is due to the vaccine or previous shoulder issue.  The patient did not use any treatment for the events.
Extreme lethargy and weight loss.  I would get in bed when I got off of work and sleep 14 hours EVERY DAY. This lasted almost 4 months and while not as bad, I still experience bouts of lethargy. It was hard to do my job.  I had confusion and general mental fogginess.  I lost 25 lbs in 3 months as I had no appetite.
Patient received Zostavax on 4/28/08 in left arm.  On 4/29/08, patient developed rash.  Rash first developed in the left innter arm by the elbow bend, and later developed on the left abdomen to a lesser degree.  The area on the arm was seeping.  Patient denied pain. Rash only developed on the left side.  Patient was advised to use calamine lotion to the rash.  Patient stated the calamine did not seem to help, and that the reaction "needed to run its course".  States it took several weeks to resolve.
The patient received the Janssen vaccine at 10:30, approximately 10 minutes later, around 10:40, the patient was feeling lightheaded with clammy, sweaty, and pale skin.  The onset of syncope occurred at 10:41, heart rate was 102 BPM, O2 Sat 98%. The patient was put into a supine position with both legs elevated on a chair. The total syncope time was approximately 30 seconds. At 10:43, her HR was 79 BPM, O2 sat 98%,  alert and oriented. The patine remained supine for another 5 minutes and stayed for another 5 minutes in a sitting position, had some fluid and snack before leaving, the last HR was 81 BPM, O2 Sat 97%.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M043424 with expiration date of 06-JUN-2018, lot # M029681 with expiration date of 22-JAN-2018 and lot # M039060 with expiration date of 22-MAY-2018 (doses, route of administration and anatomical location were not provided). No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002131: US-009507513-1704USA009410: US-009507513-1704USA009408.
maculopapular rash for 5 days;onset 21JUL98;sl fever first 2 days;
24 hours after getting the vaccine I started feeling sleepy and groggy. 48 hours after the vaccine I felt very groggy and off balance, like I was half asleep or had been drugged with a sedative. I also had low energy and exerting myself (with long walks, etc) made me feel wiped out and exhausted . After one week I started to feel better, but still felt slightly groggy and off balance, like I was drugged with a mild sedative. Now on July 1 -- one full month since getting the vaccine -- I still feel slightly groggy and off balance, no matter how much sleep or rest I get. I also still have lower than normal energy and muscle soreness. The grogginess and off balance is most noticeable when walking or moving my head quickly.
Sunburn like rash on shoulders & posterior portion of upper arms; itching inside of ears, arms & rear of hands; burning sensation in the nose; rhinitis, watery eyes, under the skin bumps; appeared 4 hrs p/flu vax & lasted approx 1 1/2 hr;
PT was accidentally given a pediatric dose of Pfizer Covid Vaccine instead of receiving the Moderna Booster.  PT and Child were seated in the same room, both syringes were given to me instead of me retrieving the shots myself.  In haste I grabbed the wrong syringe and administered the pediatric dose.
Difficulty catching breathe since Friday after second vaccine. Worse when laying down. Also complained dry cough, shortness of breathe and fever.
Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced severe menstrual bleeding and cramps, very significant change in mood, depression on an unspecified date. It was reported that depression symptoms when she have never had an issue before. She did not seek medical attention. No treatment  was received for the events. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101418500 same reporter/drug, different patients.
immediatley p/recvd flu vax @ 1PM on 24OCT91, pain, pt had difficulty sleeping because of the pain & on 27OCT91 stopped aching but was still sore; nausea, 4-5 red spots, itch, pain under lt heart, shingles;