chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death (dose number in series 2). The reporter stated that, "My ex and his brother both died from getting the jnj booster". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220327268.; Sender's Comments: V0:20220327356-COVID-19 VACCINE AD26.COV2.S-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Fever, extreme chills, nausea, diarrhea, loss of arm strength, bad soreness around injection site, minor rash
Wheezing, asthma - like symptoms, pressure in upper lungs.  Feeling out of breath.  (To Doctor on 11/20/09 : SYMBACORT & PROTIC inhalers).
BUD date excursion. BUD was 4-7-23 and vaccine administered 4-22-23.
patient died right after receiving the vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via agency (Reference number- 00324247) and transmitted to Sanofi on 20-Oct-2020.  This case is linked to case 2020SA297516 and 2020SA298004 (same reporter).  This case involves male patient (demographics unknown) who died right after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died right after receiving the INFLUENZA VACCINE. The event of death was also assessed as medically significant.  The reporter asked about side effects, efficacy, and the difference between fluzone quadrivalent and fluzone high-dose quadrivalent. Also stated her friend (only described as 87 years old) was convinced that a flu vaccine killed her parents because they died right after receiving them.   No laboratory data was provided.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient who died right after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
This spontaneous report was received from a healthcare worker, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, injection, lot # L042258, expiry date 18-AUG-2018, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Pain in joints; elbow and shoulder; persistent ache; tender to touch at times with stiffness. Continued complaints but no worsening. There were 3 Lymerix given starting with 1st on 4/29/99, 2nd on 6/1/99 and 3rd on 5/1/00.
fever spiking to 101.8 orally, chills and aches lasting 4 days
After patient was given the HPV vaccination:  Pt had vasovagal response, noted to periorbital area with pallor appearance, with slight muscle twitching to face, no stop with breathing  - Patient then was talking and coherent  - BP rechecked: 118/78
On 5/16, I started to get a sore throat. when I woke up on 5/17, I also had fever, achiness, and congestion so I took an at home covid test which was positive. I called my doctor right away and was prescribed antibiotics and a steroid. My symptoms have been getting progressively better. The only symptom I am really still suffering from is the raspy throat.
This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021.  She stated she had a fever of 102.  Her body ached all over from head to toe.  She had dizziness with an intermittant rash.  She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia.  Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021.  She did state about 1.5 years ago she experienced tachycardia and hypertension but not since.  She did not get any new medications upon her visit to the emergency room.  She was going to try to see her physician today if possible on 1/12/2021.
After receiving Moderna booster, patient developed a large, hard, itchy, welt that was inflamed and sore. Patient had not experienced any similar reaction to previous doses and is concerned that the administration of the vaccine was improperly performed. Patient was seen by her physician and given a course of an antibiotic to treat possible cellulitis.
I had flu shot on Oct 1, shot was given very high on shoulder-later that day could not move arm up and out-pain began and mobility/strength decreased (unable to get shirt off and on/comb hair, etc)-let Dr. know and saw office Oct 4-impression bursitis and advised to take anti-inflammatory, warm/cold compress, light movement w/ no weight workouts for two weeks; did not resolve so visited Orthopedic on Thursday 10/18-diagnosed w/ rotator cuff tendon injury "tendinitis"-PT, anti-inflammatory shot and home exercises ordered to try to resolve this injury.
J96.00 ACUTE RESPIRATORY FAILURE 12/13/2021 FEVER
I had not menstruated since December of 2020. I started menstruating, after having a week and a half of severe fatigue after my second dose. Flow is very heavy (over an ounce a day).
15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left arm became super tender, I woke up with significant joint pain in my right knee. I almost couldn't walk, it was chronic pain when I tried to walk. It lasted about 24 hours and went away.  I did inform  my OB.
Severe pain and burning at injection site at time of injection. At 6pm severe pain in left arm and left shoulder; left arm numbness; left hand severely cold;
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated started next day, reddness, used coritsone and the spot began to grow, now is red and hot to touch, but no longer painful. Thinks it may be celluilitis and is going to check with primary MD as follow up.
For 3-4 days following the 2nd dose of Pfizer vax I experienced almost non-stop munchies. Munchies as in canabis type. I could not find a full button on my appetite. It clearly effected my metabolism in some way. Then about 2 1/2 weeks later, my left wrist, where I have mild carpel tunnel grew a ganglion cyst ( confirmed with chiropractor ) It's still there.  I got the shot in my left arm. I've had carpel tunnel for over 30 years, and never had a ganglion cyst anywhere on my body in my life. Since then I have gained at least 10 lbs and feel like I could sleep for hours.  My mood is fine, but my head thinks my pillow is a standing invitation.
aches in legs; I walk and it is painful; Patient is sitting and her back just hurts/back (lower backache).; like having the flu; irritable; it is painful/Patient said that everything hurts; Cranky; ached all over; aches in hips; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).) and INFLUENZA LIKE ILLNESS (like having the flu) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included MONTELUKAST, HYDROXYZINE, DEXLANSOPRAZOLE (DEXILANT) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (aches in hips), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over). On an unknown date, the patient experienced PAIN IN EXTREMITY (aches in legs). At the time of the report, ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-404332 (Patient Link).
Client began to complain of feeling dizzy and experiencing tunnel vision right after receiving the vaccine. Ice pack was applied to back of client's neck. About 5min after receiving the shot the client stated he thought he was going to pass out. 2 RN's walked client to a safe place to lie down. Client began to pass out while walking and was carefully lowered to the floor. Total time unconscious was about 30 seconds. Client began talking though mumbled. About 3 min later client stated he was feeling better. Another 3 min and client moved from laying on the ground to sitting in a chair. He stated he was less dizzy but his arms felt tingly. Client eating crackers and drinking water. Vitals remained stable throughout incident. Client was released to personal vehicle at 1:41pm, walked out of building on his own, gait was steady. Educated pt to request to lie down for 2nd vaccine.
Patient was brought to clinic by ambulance for an unwitnessed syncopal event with LOC for unknown period of time. He reported no memory of event. No post-ictal confusion when found. Upon arrival in clinic, patient reported headache, mild confusion, bilateral facial numbness across cheeks and forehead, pressure behind eyes, light sensitivity, and nausea with eye movement. Time between receiving vaccine and event possibly 2 hours.  Following assessment in clinic, patient was referred to emergency department for further evaluation.
Woke up at 6 am on January 15th feeling extremely fatigued (more than normal). Around 10:30 am I began feeling extremely flushed (no fever although my temperature was elevated for my normal temp - usually 97.6 and it was 98.7) and nauseated. My whole body started to ache around 11 am and I had a hard time staying awake. When I left work around 4:00 pm I went home and slept for the rest of the day and until 11:30 pm that night. I got up and had a snack and then went back to bed. Slept all day January 16th due to a horrible headache and fatigue. Woke up feeling a bit better Sunday although I still had a headache and some fatigue. Monday I was doing better. Later in the day on Monday, January 18th my right eye started hurting and feeling irritated. Then on Tuesday, it started getting a little pink. On Friday I had a puffy red eye. I saw a doctor online on Saturday, January 23rd and I was given eye drops for conjunctivitis.
elevated temperature the day after; This is a spontaneous report from a contactable consumer communicated to medical information team. A 72-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on 02Feb2021 (at the age of 72-year-old), as 1st dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021 (day after the vaccination), the patient had experienced elevated temperature. No ongoing side effects were reported. The patient was asking if it is ok to take Tylenol as she saw in the TV that Tylenol may diminish the effectiveness of the vaccine. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
After 2 days went into AFIB That was April the 9th and I am still in it I was admitted to the hospital no help I went to my Cardiologist and he did a Cardio Conversion helped two day now I am going to be put in the Hospital again and Having an Ablation
Severe arm pain starting 10 hrs after vaccine. Severe chills, followed by sweating, vomiting, restlessness and could not sleep. Black stools following two days.
A non-serious spontaneous report of fever, cough, sore throat and runny nose has been received from a consumer concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 26-Sep-2011. The patient developed a runny nose a couple of hours after FLUMIST administration on 26-Sep-2011. On the same night, he developed a fever of 103 degrees F. On 28-Sep-2011, the fever was 101 degrees F and the patient had a cough and sore throat. The patient was not taken to the doctor for the symptoms. The outcome of all the events were unknown.
Patient received J&J COVID vaccine between 7.00pm and 7.10pm. I requested patient to remain in the store for 15 mins. Patient was anxious even before administration.Patient came back to pharmacy drop off at about 7.20/7.22pm stating she was not feeling good. She was flushed, her face was pale, patient was alert and communicating. She was really dizzy, so I had her lay on the floor. Requested my technician to get get wet towels and wiped patient's face. Within 3-4 mins she was feeling much better. But still dizzy. Had her take a few sips of Gatorade and remain laying on the floor for about 45 mins
This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender who on an unknown date in March 2012 received their first dose of GARDASIL; the second dose in June 2013 and the third dose in November 2013. No adverse events were reported. Additional information has been requested.
Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who felt really sick; similar to gastrointestinal abdominal pain, discomfort and nauseous, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUBLOK QIV lot QFAA1829, expiry date via unknown route in unknown administration site. On an unknown date, the patient felt really sick; similar to gastrointestinal abdominal pain and discomfort and nauseous (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was nauseous and felt really sick; similar to gastrointestinal abdominal pain and discomfort. It was not reported if the patient received a corrective treatment. The Event outcome was not reported. List of documents held by sender: none.
Case number PHHY2012US013581 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a neonate whose mother was vaccinated with H1N1 (manufacturer and batch number: unknown) at an unknown gestational period between 01 Oct 2009 to 28 Feb 2010. She had a preterm delivery (see linked case: PHHY2012US013562) on unspecified date and gave birth to this child. The neonate died approximately one month after delivery (reason unspecified). The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with 2009 H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcome.
PAIN IN EXTREMITY. Information has been received from an emergency medical technician concerning a patient, age late 30s to 40s, who during the week of 29-DEC-2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot #644694/1048M). Within five minutes post vaccination on approximately 29-DEC-2003, the patient experienced a shooting pain in the arm, which was described as a site reaction. Unspecified medical attention was sought, but treatment was not required. The pain lasted for 30 minutes and then resolved. A product quality complaint was not involved. The reporter also mentioned another patient who had an experience post vaccination with hepatitis B virus vaccine rHBsAg (yeast) (Lot #644694/1048M) (WAES 0401USA00543). Additional information has been requested. Follow up report received 03/16/2005: Unspecified medical attention was sought, but treatment was not required and laboratory testes were not performed.  On 01/10/2004, the patient recovered.  Additional information is not expected.
Suspected Vaccination failure; now both of them have shingles.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were received as follows:  This case is reported via chat. The reporter clients parent's got the shingles caccine and at the time of reporting, both of them have shingles.  The reporter asked, should I worry about client getting it from them. The male patint was mentally handicapped and has seizure disorder. The reporter don't know, how long ago the patient got the vaccine. The reporter was not a group home provider and do not hold a medical license of any kind. The reporter wasnted to know if need to worry about him having been in contact with them. This case was linked with US2020AMR044963, reported by the same reporter.
Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL vaccine (yeast). On an unknown date the patient's mother said that her daughter developed a growth or some type of warts. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested.
ischaemic stroke; A spontaneous report was received from a  other health care professional  concerning a female patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced ischemic stroke.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications were not reported.  On unknown date , the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscular for prophylaxis of COVID-19 infection.  Additional information was requested.  On Unknown date the patient experienced events ischemic stroke.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events ischemic stroke was unknown.  Causality was not provided by the reporter.; Reporter's Comments: This case concerns a female of unknown age with a serious unexpected event of ischaemic stroke.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes not reported. Based on 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.