chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-APR-2009, the patient's healthcare provider administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 29-APR-2013, the patient was treated by the patient's healthcare providers at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Nearly completely numb and tingling arm (of injection) for two days. Fever for two days. Anxiety. Mild headache for two weeks after and lingering headaches as of the date of this form submission (november 2021).
dry mouth , shiver and difficulty breathing  and tightness in arms complained (05.10 pm)by patient within 15 minutes of administration( 450pm) . Patient was laid down on floor with raised legs and cold packs applied to face and hands.  Bp monitored and benadryl given ( 5.15 pm) . patient was still breathing .  BP was high. next 10 minutes patient was feeling better. was seated with elevated legs. Drank water and Ems was called . Bp was at 178/112 pulse 83 Per EMS possibly syncope or initial reaction to the shot.
Vaccine: 1/23/2021 around 1445 - by the evening fatigue muscle aches and injection site swelling 1/24/2021 around 0245 restless and woke from soreness in left arm and headache 1/24/2021 around 1200 nausea, dizzy, fatigue worsened, brain fog 1/24/2021 around 1900 low grade fever 99.1 1/25/2021 fever subsides - body ache and brain fog continue  1/26/2021 less brain fog, body aches
Pt. past away unexpectedly on 5/25/2023,  the cause was ruled a heart attack. This was reported to us by a friend, after she found his vaccination information from 5/13/2023 and saw that cardiac events are a potential adverse effect for the vaccine.
Had 2 recent Covid breakthrough cases where the 2 individuals had received Pfizer vaccine.; Had 2 recent Covid breakthrough cases where the 2 individuals had received Pfizer vaccine.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patient. This is second of the 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 2, SINGLE, via an unspecified route of administration and via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. It was unknown if patient received other vaccine in four weeks. On an unknown specified date, the patient was tested positive for COVID and had drug ineffective. It was unknown if the patient received treatment for the events. The outcome of events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375616 same reporter, drug and event, different patient
DTaP vaccine given 07/16/2003.  Patient seen on 07/18/2003 and 07/19/2003 2 hours high arm swelling, redness warmth of upper arm.
Dose administered on 8/29/23.  mom contacted our office reporting hematochezia x 3 on 8/30/23.  no vomiting, mild fussiness.  Had three subsequent normal stools, but then had another episode of hematochezia 8/31/23.
Information has been received from a registered nurse concerning a patient who on 4/24/00 was vaccinated with a dose of varicella virus vaccine live (lot # 632366/1458J). Subsequently, on 6/13/03, the patient developed chicken pox. The patient was not seen in the office because he was out of town. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chicken pox (WAES0409USA00600, 0409USA01045, 0409USA01046, 0409USA01047, 0409USA01048, 0409USA01049, 0409USA01050, 0409USA01051, 0409USA01052, 0409USA01053, 0409USA01054, 0409USA01055, 0409USA01056, 0409USA01057, 0409USA01058, 0409USA01059, 0409USA01060, 0409USA01061, 0409USA01062, 0409USA01063, 0409USA01064, 0409USA01065, 0409USA01066, 0409USA01067, 0409USA01068, 0409USA01069, 0409USA01070, 0409USA01071, 0409USA01072, and 0409USA01073). No further information is expected.
Adverse event happened on 1/13/21 - headache, fatigue, loss of appetite
Administration Error. Patient was at drive through COVID Clinic for his second dose Moderna Vaccine. He had Been through the checklist station and was at the Administration Station. A Pfizer dose was administered to the patient instead of a second dose of Moderna.
PREVNAR 13 given on 10/10/14 - Came to office on Oct 16 - Arm red and hot to touch - Redness measures 16 cm x 24 cm.
Fever, chills, muscle aches, joint pain, fatigue - all only lasted 24 hours
developed a twitch in the face; This case was reported by a pharmacist via call center representative and described the occurrence of twitching facial in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix. In January 2020, 14 days after receiving Shingrix, the patient experienced twitching facial. In February 2020, the outcome of the twitching facial was recovered/resolved.   It was unknown if the reporter considered the twitching facial to be related to Shingrix.  Additional information was received as follows: The patient developed a twitch in the face that lasted for 10 days intermittently (near dimple area). The batch number of Shingrix was reported as 24k27, however upon review of sales data sheet it was corrected to 24KZ7. The reporter consented for follow up.
Rash on chest and arms , hive like and extremely itchy started in day 9 and is continuing through day  33
Tramadol for pain; Alprazolam pre procedural; Expired M-M-R II (expiration 21-JUN-2021); On 25-JUN-2021 the patient received a third dose of M-M-R II; This spontaneous report as received from a registered nurse and refers to a 28 year old female patient. The patient's concurrent conditions included hidradenitis, obesity, vitamin d deficiency, vitamin b12 deficiency and menstruation irregular. Her concomitant therapies included lidocaine patch. Her medical history was not reported.  On 09-APR-1994, the patient received a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis. On 09-JUN-1997, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis. On 25-JUN-2021 the patient received a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S018594 (expiration date reported as 21-JUN-2021, but upon internal validation, established as 17-JUN-2021), albumin status rHA,subcutaneously in the left upper arm, for prophylaxis.      On an unreported date, the patient experienced an unspecified event and, due to that, she underwent an unspecified procedure, that was treated with alprazolam 0.25 milligram, 3 tablets, prior the procedure, on 30-JUN-2021. Besides, on an unreported date, the patient experienced pain (unspecified) that was treated with tramadol, 50 milligram orally, as needed, administered since 08-JUL-2021. In addition, the reporter stated that the involved vaccine was not available for return and evaluation, as it was disposed after injection. Also, the reporter stated that the patient's titer would be measured in order to determine the vaccine's efficacy (results not yet available).  At the reporting time, the outcome of the events was not reported. The reporter did not provide a causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
This spontaneous report has been received from a pharmacist refers to a 57 year old female patient with allergy to morphine. The patient had no medical history to be reported. On 11-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route of administration were not provided) lot # N019348, expiration date 18-FEB-2019, for prophylaxis. Concomitant therapies included atorvastatin, loratadine (CLARITIN), lisinopril, citalopram hydrobromide (CELEXA), atomoxetine hydrochloride (STRATTERA), bupropion hydrochloride, levothyroxine sodium and alendronate sodium (FOSAMAX). The reporter stated that on an unspecified date in 2017, soon after the vaccination with PNEUMOVAX 23, the patient experienced swelling (peripheral swelling) and a red rash on her arm (rash erythematous). Additionally, it was reported that the patient visited her primary physician on an unspecified date for the rash. The outcome of peripheral swelling, rash and rash erythematous was reported as recovered. At the time of this report, the causality between the events and PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1711USA001303: US-009507513-1711USA001291:
01/12/22 presents to Birth Center Triage for "elevated BP".  PMHx of "Anemia"
Rash, UrticariaPruritus, rashes chest, both arms, chills Narrative:  Other Relevant History:
accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;
No additional AE reported; a 25 year old patient was inadvertently administered a dose of PROQUAD; Patient was to receive mmr, but received mmrv; This spontaneous report was received from a nurse, referring to a 25-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-JUN-2021, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (albumin status of rHA (recombinant Human albumin), 1 time dose, strength, vaccination scheme, route of administration were not provided, anatomical site of vaccination: right deltoid, lot # U002535, expiration date 24-JUL-2022, lot # T028139, expiration date 15-FEB-2022) for  prophylaxis instead of included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (product administered to patient of inappropriate age and product dispensing issue). The patient was notified and reported no adverse event.
Initial report received on 17 February 2009 from another manufacturer as part of a study for which Sanofi Pasteur is not a sponsor. "The patient is a 10 year old female patient in the fifth grade. She reports having lots of trouble controlling her temper. She was arguing with her mother and grandmother and did not believe them when they said that they couldn't go to church because their ride was sick and could not drive them and so the patient threw a fit, barricaded herself in her room and broke a lot of mirrors and windows. The patient also hit her grandmother repeatedly and scratched her mother drawing blood. They report that the patient has been having fits and tantrums every week and it has been escalating. The patient has been hitting walls, getting very argumentative, they do report that the patient gets bullied a lot at school and she is made fun of because of how she looks and pushed into walls. As a result, the patient has tried to have friendship with teachers. She used to be on the honor roll, but she is failing all the classes this year. They report that ADHD is improved on CONCERTA, but again her school performance has worsened quite a bit. The patient lives with her mother and 6 year old brother. The patient's parents divorced when the patient was 6 and then the mother remarried and just divorced the step dad year ago, the patient apparently is very resentful about this and blames her mother and says that she should remarry any guy. They do report that the stepfather was very strict and punished the patient with a belt leaving red marks, but no bruises and the patient was never sexually abused. The patient was admitted to a child psychiatry unit from November 12 to November 19, 2008. Final diagnosis: Behavioral problems with mood and anxiety disorders." Past medical history included ADHD and asthma. The patient was taking CONCERTA, Clonidine, RISPERDAL and ZOLOFT. The patient had received FLUZONE on 03 October 2008. The date of the SAE was reported as 12 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number: 2009-00622.
Patient was inadvertently given Fluzone HD instead of Fluzone Quad, age 61 is not eligible for Fluzone HD
On 3rd day after injection I started have severe vomiting,, severe direaherrea, then came the freezing, following  with the fever of 1-08.  My stomach was rolling and I was as weak as a kitten.  I couldn't hold down anything by mouth and no suppositories would work -- my body passed them out with bowel movements..  When the nausea lifted I took ondanstron nauseau  pill and pepto bismol.  Next bowel I took another dose of peptol bismol.  Then the 3rd bowel movement I started taking antidiaherreal pills -- two to three doses.  These pills could not be taken until Mon (Oct 4th) because I couldn't hold anything down by mouth or bowels.  It is middle ofo the afternoon on Mon, Oct 4, and I am finally feeling almost like myself.  My stomach is still rolling some though.  I really don't know if these are definitely symptoms from the shot as I went to facility this weekend and could have got a stomach bug or a viral infection.
Post vax, last series of vaccines, the pt had crying episodes for 3-4 hours.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K010215,expiration date 05-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011947: US-009507513-1611USA011948: US-009507513-1611USA011949.
I woke up from almost like a pop in my brain and fluid started pouring down my throat and I started choking.  I woke up and was able to spit some of it out. It was clear and also tinged with blood. It stopped once I stood up. I immediately thought my brain was leaking.  I told my daughter about this the next day.  My balance was off and I had a weird flapping in my head for the next few days.  As well as a headache.  A few days after I heard about the blood clots. I am not 100% sure if it was from the shot but it was literally hours from when I received it. It was very scary.
After my J&J vaccine I experienced fatigue and was very tired. On 04-21-2021 I had incredible abdomen pain that caused me to become very nauseous. I went to see a doctor who prescribed anti nausea medication. I could not eat for about 10 days due to my nausea. Then after taking the anti nausea medications my symptoms started to go away.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild
Per discussion with wife, patient experienced worsening shortness of breath after each Moderna vaccine.  The patient has history of inhalers used for COPD, but the patient's wife stated that he has had difficulty moving from room to room without becoming short of breath, which did not happen before the vaccines.
No adverse reaction, patient was given FLUCELVAX and he is under 18 years old.
mom states pt screamed all noc & had fever over 104 even when given APAP; pt running fever & irritable 24 hrs post vax;
Fever began Saturday night 5/29, 102 degrees, would only come down a degree with infant Motrin.  Fever lasted 3 days (Saturday, Sunday, Monday) Tuesday morning (6/1), fever broke and woke up with a rash, head to toe of little red spots.  Spots were all over face, arms, hands, torso, legs and feet.  Took her to doctor's office.
Patient states she had high fever (102) for 3 days and her joints are swollen ,  she can't make a fist,  her knee joints are sore and don't support her weight when she crouches
site lt arm erythematous, hot to touch; 3 days post vax; dx'd w/cellulitis; rx w/Kelfex; local compresses
Patient experienced pain and redness at injection site the afternoon after shot was administered. Later in the evening there was pain on movement. Swelling and redness (about a 4 inch blotch) moved down the arm a little from injection site over the next day or two. Patient took ibuprofen for the pain and diphenhydramine for the slight itch that also developed. As off 1/25/18 around 6 PM patient states that rash is fading and pain is gone but still itches a little.
From primary care note written by Dr. on 10/7/22, " Here for new medical evaluation of  Hallucinations. She says no complaints till having Flucelvax and Bivalent Covid vaccintaions thurs 9/29/22. Within about 15 in she sqw a disembodied face (male), smiling, no auditory communications and non-threatening. Had another similar vision 15-20 min later while using hwe computer,this time smiling faces, shortly after getting a group picture of her family from her son ('some to me all who are heavy laden' was playng in the background while picture was playing, and son verified he sent the pic.).  Since 9/29 she has daily visions of a 'still picture' hallucination, smiling and non-threatinig, self limited. No headaches, no nightmares. No Hx of mental illness or stress. She lives alone, but has been staying with her daughter for additional safety, her daughter does the driving.       She was seen at ER, at Hospital 9/30, and had normal studies including non-contrast head CT, Lab studies, telemetry. She is scheduled to see NeuroScience Wed 10/12/22. She has been working as scheduled, and has no problems with memory cognition, walking or interacting. She continues to see the images, even during todays visit, she does not have sleep interruptions or nightmares / strange dreams.   Hallucinations, temporally on the day of mixed vaccinations, but NO systemic symptoms to suggest a reaction, and no clinical encephalopathy, nor  Local reactions (rash, induration).  She is concerned about the hallucinations, but NOT afraid of them, and there is no homicidal or suicidal ideation.  NO evidence to clearly correlate this with her vaccination Agree with NeuroScience consultation. May work in meantime, but avoid operating machinery."
UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT INJECTION SITE; WEAK; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pineapple allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAY-2021, the subject experienced total body aches. On 19-MAY-2021, the subject experienced can't sleep. On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced unwell. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced left arm is sore at injection site. On 19-MAY-2021, the subject experienced weak. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced uncomfortable. On 20-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unwell, dizzy, nausea, can't sleep, chills, uncomfortable, left arm is sore at injection site, total body aches, weak, and fatigue. This report was non-serious.
Severe vomiting, dry heaving, chills, sweating significant improvement by morning on 9/13.
the reaction is unknown, however the patient received multiple doses of a COVID vaccine in a short time. When we called the patient to schedule on 12/10/21, she only mentioned she received two doses of Moderna in Jan and Feb 2021. We scheduled her for a dose of Pfizer on 12/13/21.   After the patient received the dose of Pfizer and left, a staff member brought to my attention that she had an orange banner under immunization that showed she recently had two doses of Moderna on 12/2/21 and 12/9/21. She was scheduled on 12/10/21, by a Program assistant and her note states patient received 2 doses of Moderna on 1/19/2021 and 2/18/21. There is no note mentioning the patient just received a dose on Moderna the day before on 12/9/21! I pulled in the same two doses during chart review on 12/10/21 at 4:45pm. The recent doses in December were not shown in her chart yet possibly do to a lag in information.  I also don?t believe these doses were present on her COVID vaccine card either.