chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been 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's healthcare providers 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 25-AUG-2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-DEC-2016, the patient was treated by a healthcare provider 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 vaccine, 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 including 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 was considered to be not recovered. Additional information has been requested.
I first started showing symptom on the 4th of October, I was on a trip and when I returned, I tested on the 6 and it was negative. On the next day I tested again and, I was positive. I was having symptoms like a bad cold. I then went to a urgent care and was suggested to get an infusion since I was on a blood thinner. I was not showing any symptoms after 5 days of the infusion. On the 6th of January I had a third booster shot.
Patient developed rash on face with swelling.   Injection site was red and tender to touch.
Patient called states she has had extreme fatigue since shot 5 days ago.  She also gets nauseated everytime she tries to do any activity.  Also gets "clammy" and chills and has to sit down often.
Beginning Eight hours after vac, mild chills, moderate body aches, headache, nausea, moderate fatigue. Today (24 hrs after vac) chills resolved, moderate body aches continue, nausea mild, mild fatigue
Mild fever (to 101.4), reproduceable chest pain and some generalized arthalgias.  All resolved with Motrin.
Irritable several days post imm. jerky for 1 week post-ward. Two different MD's checked-both would not call these sx a true vaccine reaction.
Fever within 24 hours up to 102 rectally @ 6:30am on 12/19/19
Severe vertigo to the point I can?t get out of bed.  Reports of this are all over the internet yet no mention by company.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 1/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I30.9 ACUTE PERICARDITIS, UNSPECIFIED 4/11/2023 AUTOIMMUNE THYROIDITIS
This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, third patient in 2010-04837, fourth patient in 2010-04838 and fifth patient in 2010-04839. Initial report received from a health care professional on 07 September 2010. A 39-year-old female patient received on 04 August 2010 an injection (route and site not reported) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms, fever, chills and arm pain. The outcome was reported as recovered. Documents held by sender: None.
The night of 3/9/21  following the vaccination I had fever, chills, sweating, severe body aches and pains (all over) and nightmares Wednesday morning I was unable to go to work and remained in bed sleeping all but approximately 2 hours in the afternoon  because I was still in pain and had headache/fever/chills/muscle and joint pain. I also had no appetite. I was awake long enough to eat one bowl of cereal and a small apple sauce cup so that I could take more meds without upsetting my stomach. Wednesday night 3/10 my temperature was still at 99.3. I was still having body soreness and headaches (sinus). Thursday morning 3/11 I still had the headache and body soreness but no more fever. I was still feeling unwell but could at least get out of bed and function. By late Thursday most of the symptoms subsided and I started feeling better. Friday morning I was no longer having symptoms.  It was the initial symptoms Tuesday night and Wednesday that concerned me the most because it hit me so severely and fast. The pharmacist warned me of possible side effects that would require over the counter medication, but in my case that did not suffice. I was physically unable to do anything but sleep which is highly unusual for me, and my entire body was in more pain than I?ve ever experienced.
Rash: Red papules on B/L thighs in a circular area around where vaccines were administered. No fevers, no other rash.
Info has been received from a physician concerning a pediatric pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/13/05, the pt developed a mild case of breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report the outcome was unknown. Additional info has been requested.
Fever, NauseaVomiting, Chills, body aches (unspecified) Narrative:
That same evening, post vax, leg had swelling from knee to hip. No temperature, only fussy. No nodule at site. Injection in proper site.
Pt noticed slight swelling and tenderness under rt arm axillary area on Monday following immunization given 12/07/2002. General malaise throughout day.
At 3 hrs post-injection: Palpitations. At 4 hrs post/injection: dizziness and throat tightness. Took chewable Benadryl 25mg and throat tightness resolved. Since 2 days post-injection to present: anxiety, feeling ?wired?, racing heart, racing thoughts, insomnia.
Patient received Moderna COVID vaccine on 2/26/21, 3/26/21, 10/27/21, 4/28/22, and Moderna Bivalent COVID vaccine on 10/29/22. On 3/4/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COPD exacerbation and COVID infection/bronchitis. As of today (3/9/23), patient is still admitted in the med/surg unit.
10.11.23 - pt presents to clinic for puncture wound on foot from 9.29.13 and was having redness and pain. Temp was 37.5 C. Pt received TDap at clinic approx @ 9am. Pt left clinic  and within 20 min was feeling extremely warm and had severe headache . Patient went home to rest and fever elevated to 102F per mother. Mother gave ibuprofen and dose of Cephalexin 250mg by mouth at approx 12:20 pm. Mother took patient to ER @12:50pm. Upon arrival to ER, Temp was 39.1C HR 132 Resp 30. Tylenol 450mg given at 1330 by ER staff.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date the patient was vaccinated with VARIVAX lot # N014368 for prophylaxis, which was exposed to temperature excursion of 15 to 46 (28) degrees Fahrenheit for 45 minutes. There were no previous temperature excursions. Data logger was involved. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. The pharmacist confirmed that the DILUENT (unknown lot#/exp. date) used to reconstitute the VARIVAX was properly stored. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009239:
This spontaneous report as received from a physician, as part of a ZOSTAVAX marketing research program conducted by marketing agency, refers to a patient of unknown age and gender. Medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a single dose of ZOSTAVAX (dose, route, lot# and expiration date were no reported). On an unknown date, the patient experienced shingles. The patient got shingles a few weeks after getting the vaccine. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX. The reporter considered the event of shingles to be other medical event. (Also reported that it was unknown by reporter if the case was serious). This is one of several reports from the same source. Additional information is not expected.
On 10/30/99, pt broke out in hives & rash all over body. Took Benadryl and improved by next day. On 11/2/99, pt at ball game, & eyes started to swell. Started Benadryl again & improved. No further episodes.
Pt came in about 15 minutes after receiving shots complaining of shortness of breath and tightness in his chest. O2 @ 10 LPN per non-rebreather mask was placed and an IV of NS @ 150ml/hr with an 18g IV was started. 911 was notified. MD gave 0.3cc epinephrine IV. SOB.
Severe nausea, violent vomiting, fever of 100.2, weakness, exhaustion.
Bloody Stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody Stool) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure), Anxiety, Depression and Asthma (Allergies).   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced HAEMATOCHEZIA (Bloody Stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Bloody Stool) outcome was unknown.            Concomitant product was not provided by the reporter. On 23-Jul-2021, Patient had blood stool. Consumer did not take any medications to alleviate the possible adverse events. Treatment information was not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2/26/21 patient found unresponsive, deceased in her home; suspected OD; autopsy done - COD: complications of chronic substance abuse, COVID 19 (positive test at Center) and underweight body habitus; PCP unknown.
Felt tired; Had Cold Chills; Retching; As injecting, could taste it in tongue; Felt weak; Covid; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, chills, retching, taste altered, weakness and covid-19. On an unknown date, the outcome of the tiredness, chills, retching, taste altered, weakness and covid-19 were unknown.   It was unknown if the reporter considered the tiredness, chills, retching, taste altered, weakness and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The patient did not provide date of vaccine.  The customer reported that as they were injecting into her arm, she could taste it in her tongue.  The patient reported while driving home immediately she started retching, and felt weak, tired and had cold chills.  The patient reported it turned out she had Covid and did not know it when she got the Shingrix vaccine.  Not all information was available.  The customer declined to provide demographics or additional information for the adverse event report (lot/expiry date, injection site date when vaccine was provided). The permission for consent to follow-up was denied.
Vaccine given at approx 1pm, at approx 1:05 pt complains of numbness and tingling in lips. Denies difficulty breathing, no itching, no rash, BP 138/92 Dr. notified - Monitor and complete forms. While monitoring pt complains of feeling "sugar drop" and hands shaking. Wife gives food and drink, after eating pt states he feels much better - adds it was not vaccine, but his sugar dropping.
Patient received booster vaccine on 1/18/22 (1 month too soon).  2nd dose was given on 9/14/21.
Swollen red hot rash covering most of my arm where the shot was given  from elbow to shoulder which has lasted for 5 days. It started 2 weeks after the injection was given. Also a persistent headache and uncomfortable aching in that area. It is going away slowly now.
This spontaneous report was received from a registered nurse via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, the patient was vaccinated with a total of 4 doses of GARDASIL (dose, indication, route of administration, lot# and expiration date were not reported). Concomitant therapy was not provided. No adverse symptoms were reported. Additional information has been requested.
Patient given immunizations despite low grade fever (101.4). Same day, high fever (103), prolonged seizure. Admitted to hospital overnight.
Patient presented to the pharmacy to receive her 2nd dose of the COVID-19 vaccine. Patient was unknown to pharmacy staff and did not have a vaccination card from her 1st dose but patient reported receiving the Pfizer vaccine as her 1st dose which she received elsewhere. Upon entering vaccination data into the registry it was discovered that the patient  received a Moderna COVID-19 vaccine as her 1st dose. This information was communicated to the patient and patient received a new vaccination card detailing both doses. Patient has reported no adverse events to date.
Post vaccine leg swollen at injection site, spot, rash appeared itching body, no fever. On 1/29 F/U treatment given by Dr.
pt recv vax & 2-3min later devel SOB, resp diff;HR 96, Resp 26 & audible wheezing w/inspiration;pt breathless, skin pale, cool & dry;BP 138/84;HR 108;BP 138/82, HR 106;pt instructed to be seen in ER or PMD for return of sx;
Vaccine location: Right buttocks; Started feeling moderate to severe vertigo; This is a spontaneous report from a contactable nurse (patient). A 48 years old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via intramuscular route, administered in the gluteus medius right (right buttock) on 26May2021 at 12:00 (at the age of 48-year-old) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included depression, anxiety and IV iodine allergy. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) 150 mg and escitalopram oxalate (LEXAPRO) 20 mg; both since unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via an unspecified route of administration on unknown date as a dose 1, single for COVID-19 immunization. On 26May2021 at 16:00, the patient experienced feeling moderate to severe vertigo in afternoon and better the next day but the vertigo was still there, although it was somewhat less severe, and this was upon her second dose of the vaccine. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event moderate to severe vertigo was recovering.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
New onset polymorphic ventricular tachycardia, multiple episodes of ventricular tachycardia requiring multiple ER visits and hospital overnight stays and ultimately AICD placement.   Persistent episodes of ventricular tachycardia with AICD firing requiring multiple ER visits and initiation of amiodarone.   Recurrent hypotension and syncope requiring AICD placement and midodrine .
left hand was paralyzed; muscles got real weak, hands real weak then could feel it in legs,but not as bad as arms; nauseous; A spontaneous report was received concerning a 70 year old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced monoplegia, muscle weakness and nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 01 Feb 2021, prior to the onset of events, the patient received his first of two planned dose of mRNA-1273, (batch number 013L20A), intramuscularly into his left arm for prophylaxis of Covid-19 infection.  The patient received his first dose of mRNA-1273 at the hospital which is 3 hours away from his home.  While driving home, the patient's "muscles got real weak". His left hand was "like paralyzed". "He couldn't move his fingers". Then if he moved his wrist down, his wrist would "lock up".  He had his hands on the steering wheel, he could tell they were "real weak and wanted to fall".  Then he could "feel it in his legs, and they weren't as bad as his arms". He had his foot on the accelerator and was "worried". He was "real nauseous".  It was "real scary", and he was "praying a lot".   The symptoms lasted about 4 hours in total. Two hours while driving home and two hours after arriving home. He stated he had no other reaction. No medical tests or treatment were reported.    Action taken with mRNA-1273 in response to the event was not provided.  The events, monoplegia, muscle weakness and nausea, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Fever, irritable, wet cough, clear and white runny nose, ear pain.  Patient was examined by Dr. in office.  Treated with Motrin and Tylenol.  Auralgan to both ears.
Pt woke up morning after vaccination with h/a, nausea, temp 101 and swelling at site. Pt. stated she was fine when she called on 7/20/12.
Severe chills Extreme headache  General feeling unwell Achy & tired Swollen (lymph node) in left armpit-size of baseball-2 days after injection. Slowly decreased in size over the following 5 days after vaccination.
This spontaneous prospective pregnancy report was received from a 38 year old female patient, reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies, and was not taking any concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. On 09-JUN-2017 the patient was vaccinated with M-M-R II for prophylaxis (route of administration reported as injections, dose reported as "two injections"; lot number and expiration date were not reported) (maternal exposure during pregnancy). On approximately 30-JUN-2017, reported as "3 weeks after June 9", the patient experienced spotting and cramping. The patient had two outpatient visits to a medical center where she was administered unspecified intravenous medications and an ultrasound on unknown dates and for an unspecified reason (also reported as treatment given for adverse event: yes). No product quality complaint was filed. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. The outcome of haemorrhage in pregnancy and dysmenorrhoea were reported as not recovered/not resolved. The outcome of exposure during pregnancy was unknown. The reporter did not assess the causal relationship between M-M-R II and the events haemorrhage in pregnancy and dysmenorrhoea  Upon internal review the event haemorrhage in pregnancy was considered to be medically significant.
Pt recvd 3 doses of Engerix-B Hep B surface antibody titer was borderline-subtherapeutic; was advised to recvd 4th dose & be retested;
My ankles became swollen, became so bad that I could not walk. Eventually swelling decreased by 1/3/2021/
Delayed reaction 8 days later large round patch at injection site, hot to touch and burning, itching.  Progressively getting worse . Seeking Treatment now.
Initial report was received from a healthcare professional on 23 November 2011. A 12-year-old male patient had received an Intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3947BA) in left deltoid on 22 September 2011. On 15 October 2011, the patient developed a reddening to his hands progressing to the skin peeling and a rash on the hands. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Patient came on 3-11-21 doesn't have his moderna vaccination card. One of our nurses administered the 2nd shot before checking his 1st shot. Information through registry site said hec recieved his 1st shot 2-23-21 but he said it was on 2-11-21. So the patient received his 2nd dose 16 days early, he was monitored for 45 mins. Moderna was contacted and they  confirmed that his 2nd dose is administed less than 20 days. Patient was conseled and sent home. Patient to be monitored and followed up by one of our staff.
Day 1-5: Lethargy Irritability  Decreased poop and urine output   Decreased eating Vomiting and spitting up frequently  Day 5-10 Constipation When pooped, it was green with mucus Low urine output Scream crying bouts off and on for more than 3 hours Bouts of irritability Bringing Legs to chest  Holding hands to ears Crying when have pee diapers (never was an issue before)  Days 10-30+ Poop has changed to every 2-3 days with heavy grunting and is thicker and darker than before and other  normal exclusively breastfed baby  urine output is high.. baby cry?s with wet diapers when before vaccine baby ignored wet diapers Occasional random scream crying. Inconsolable crying when in infant car seat which was never an issue before vaccines.
This spontaneous report as received from a pharmacist to a patient of unknown age and unknown gender. The patient was vaccinated with ZOSTAVAX (lot number, route, site, dose not reported) on an unknown date. No other co-suspects or concomitant medications were reported. The patient received ZOSTAVAX and two weeks later developed a rash. No treatment information was reported. It was unspecified if the patient had sought medical attention. The outcome of rash was unknown. Additional information is not expected.