chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was uncomfortable, crying, and basically inconsolable that night and into the morning. She didn't sleep well at all, with is unusual for her. She was running a low fever, but nothing too concerning. From then, until now, she has had a dry cough and random little bumps that pop up and go away. Then, on the 11th, she woke up with a large red bump on her right thigh, where her injection would have been, warm to the touch, and a knot underneath. I drew a circle around the spot, and the next morning it had only subsided a tiny bit. Advised by office to do cold compresses and massage, and if in 3 days it hasn't gotten better, to bring her in.
pt was given an expired vaccine due to local lot corordinator having incorrect manufactures expiration date listed on site
Immediately after administration of 1st dose Pfizer, patient experience complaints of palpitations and racing heart and "felt like a feeling of fear came over her." A&O x 4, reports Right foot numb but has also been seated in car waiting in line for > 1 hour.  Patient given water and gummies and reports heart racing  sensation improving. VITALS at 10:55 AM: HR 110 regular,   Denies feeling of SOB, dizziness, itching, difficulty swallowing.   At 11:13 AM, HR 88 and regular, BP 138/84, RR 20, O2 96%  Patient reports sensation of tachycardia resolved and right foot numbness resolving. She was able to ambulate without distress.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 19-NOV-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Presented with first time generalized tonic clonic seizure 11/23/22. Found in her bed with gurgling noises and shaking. Remained altered for over an hour with left gaze deviation and minimal responsiveness before slowly returning to baseline.
she had a a little soreness in her arm; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: FL9262) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "had reactions in the past to sulfa drugs " (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; SINGLE; Lot number: EL9367), administration date: 22Feb2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "she had a little soreness in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a a little soreness in her arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201262 Same product, patient, different AEs, different dose;
Severe joint pain, fever, fatigue.  In bed for two days. Felt affects for 3 more. Five total.  Astonished by severity of reaction.
The upper arm of my injection site started to itch, and develop a pink rash.  The first two days it enlarged to about 4"x4" and was very itchy.  It is now more like 8"x8",  splotchy with the outer pink splotches itchy, but less itchiness in the more clear central area which had been itchy earlier.  I'm currently in day 4.  Effects are a minor annoyance, but I thought you would want to have info to help gauge the frequency of this particular side effect. I was personally relieved to learn that others had encountered this side effect about a week after the injection, with previously no reaction to the vaccine.  I surprised me when it happened almost a week after my shot.
She had the shot on 27th and she just noticed this morning had a about 4 inches of red mark around.
Information has been received from a physician concerning a patient (gender and age unknown) who on an unknown date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown). Subsequently, on an unknown date the patient developed a rash. The outcome is unknown. It is unknown if patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Information was received from a registered nurse concerning a 16 year old patient of unknown gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was administered one dose of PROQUAD (lot # M021428, expiration date 29-OCT-2017) (route of administration not provided), reconstituted with sterile diluent (MSD) (lot number and expiration date unknown) at 16 years of age, which is outside the prescribing information. No adverse effects reported. No further information provided. Additional information has been requested.
Red, rough, burning rash on the inside of left arm, armpit, and left breast that started the night of the injection and spread larger over 24 hours. After taking Benadryl the spread stopped but turned into patchy, dry, almost hard skin. Still there 1.5 weeks later.
Fatigue and arm pain same day following shot (Monday 1:15pm). Next morning (Tuesday) fatigue rapidly progressed to fever and chills. Chills became increasingly intense around 10am-noon, had to bundle up and lay down, could not move, work, or do anything productive. Chills, fever, headache, muscle aches became so bad they were totally incapacitating from about noon to 3PM, probably would have made my spouse drive me to the ER if I wasn't expecting some sort of vaccine reaction like this. However, just as suddenly as these intense flu-like symptoms came on, they began to recede. Fever broke around 3PM, began to feel better, and by about 7PM I was feeling mostly normal, just tired + a headache. Next three days (Weds, Thurs, and Fri) felt a little fatigue and difficulty concentrating, nothing too terrible. But the flu symptoms the day after the injection were intense! and weirdly short-lived.
Areas 8" x 4" raised, itching, and hot skin hard to touch, after anthrax vac. 5th shot, has not had reaction to anthrax vaccination before.
Experienced uncontrollable shaking chills which woke me up around 2:30 am, around 9 hours after vaccination which lasted around 2 hours. I also had a fever of 100.7. After going back to sleep and waking up the shakes had stopped but still had a fever of 100.7 and sever body aches and a headache. The body aches persisted until around 5 pm. I think the fever abated around 3 pm. Felt very fatigued and tired through the evening and next day but no other side effects.
bronchitis; Now it's been 3 months (since first dose)Should I still get the second dose?; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get the second dose?) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get the second dose?). At the time of the report, BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get the second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
My legs and arms were itching.  I was get needle like pains in my legs and feet.  It felt like cold water in my feet some times.
This case was reported by a physician and described an 81 year old male pt who received Engerix-B and subsequently tested positive for hepatitis B surface antigen. On 4/16/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/24/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/28/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Case number PHEH2015US003157, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 12 year old patient of an unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 09 Feb 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Pt is 16yoa and received the Janssen vaccine at our clinic. Pt was asymptomatic, notification made to parents.
Client was given a Men B vaccine but only 15 years of age and not yet 16 years of age to qualify for the  vaccine. Client had no reaction to the vaccine.
Nausea/vomiting more than 20 min after vaccine given. Pale/warm to touch. Now reports "feel dizzy" ate donuts for breakfast. Denies feeling nauseated now. Form sick room due to reports "dizzy" parent called - reports student "really nervous about getting shot". Student denies feeling anxious/nervous about getting shot. Left to class. Will reassess.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N012092 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage. Additional information has been requested.
Headache Grade 2. Improved with Ibuprofen. Lasted 24 hours.
pt recvd vax & exp soreness @ the site of inj (lt deltoid area) which progressed to shoulder & neck area & acorss to rt shoulder 2 dasy p/vax; h/a across nasal sinuses also reported during this time;sxs lasted 1 1/2wk
was found to be COVID positive with mild sore throat and some shortness of breath persisting after paracentesis but much improved and remains on room air, afebrile, no cough.
SORE BODY; SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore body, sore arm, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, sore body and tiredness was not reported. This report was non-serious.
Sick; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Headache, redness and swelling of right upper arm where vaccine administered; developed fever to 100.4 degrees F on 09/21/2014. Treated with aspirin, Tylenol, Advil and fluids.
in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event; 20-staff members and 7-Residents received expired doses, with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-health care Regulatory Authority (RA) number: 00842648.  This case is linked to cases US-SA-2021SA370183(CLUSTER), US-SA-2021SA369806, US-SA-2021SA371632, US-SA-2021SA369738, US-SA-2021SA370183, US-SA-2021SA369789, US-SA-2021SA369738, 2021SA371630, 2021SA369738, 2021SA370209 and 2021SA369789 (CLUSTER).  This case involves a 89 years old female patient who experienced in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event administered an expired dose of  INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number:  UJ507AC and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  At time of reporting, the outcome of the event was reported as unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module Regulatory Authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a nurse referring to a 61 year old male. The patient's medical history and concomitant medications were not reported. On 10-OCT-2017 the patient was vaccinated with a first dose of M-M-R II (lot # M048368, expiration date: 08-DEC-2018, strength, dosage and schedule were not reported) together with a sterile diluent (MERCK STERILE DILUENT) (lot# and date of expiration was not reported) subcutaneous for prophylaxis. Subsequently, on 07-NOV-2017 patient received a second dose of the same vaccine. It was reported that the patient had been taking an unspecified dose of etanercept (ENBREL) for rheumatoid arthritis. The causal relationship between M-M-R II together with a sterile diluent (MERCK STERILE DILUENT) and rheumatoid arthritis was not provided. Upon internal review rheumatoid arthritis was determined to be a medically significant event.
Twenty-five minutes after vaccination pt complained of redness at site, slight itching. Examine sight, no local swelling. Local irritation. Gave pt ice pack, re-examined pt before I left pt was fine.
12/12/2021 Vaccination / Booster 12/15/2021 I noticed that my skin became hyper itchy over all extremities. I would scratch, within 10 seconds, it was like I was writing on myself. I can write a word and it will be on there 20 minutes later. Every night, its worse at night and stressed, I would break out in hives all over face and neck; itchy. I took pictures and I still have. The hives really started a month after the vaccination. I was perfectly healthy but within a couple days of having the booster, I have been having this issue to presently.  Dr. diagnosed with Hyperdermagraphia  / 'skin writing disease' *doctor gave me referral to allergist
Left arm is in so much pain; I can barely move it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it). At the time of the report, PAIN IN EXTREMITY (Left arm is in so much pain) and MOBILITY DECREASED (I can barely move it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
The pt received injection on her left deltroid on 10/08/2001. Injection was immediately painful and deltoid area swelled up. Now she has decreased range of motion on her arm and she can't swing toward back or twist to hook her buckle seat belt. Arm is weak and she can't reach arm above her head. It's very painful at night and it aches all the time. Also, laying down causes more pain.
Fever, clear running nose, ear infection on right side not there previously...also had very white/pale skin, vomiting... by 7 PM she was not responding, rolling her eyes and looking to the left.  We figured she was tired so we went to bed.  Woke up at 6:10 AM 01/15/10 she was having a Grand Mal Seizure that lasted somewhere between 6 to 8 minutes.  We rushed her to the doctor's office.  The Doctor requested a spinal tap at the hospital to rule out potentially fatal bacterial meningitis... we refused.  We were certain it was due to the vaccine.
STROKE LIKE SYMPTOMS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate account) concerned a male of unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received 2 doses with covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number and expiry date were not reported), dose was not reported (dose number in series 1), for covid-19 prophylaxis. It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer (dose number in series 1). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). 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 in 2022, the patient experienced stroke like symptoms (dose number in series 2). It was reported as "my husband had stroke like symptoms after his 3rd shot this year". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke like symptoms and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221145286-Stroke like symptoms. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 301L20A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal pain since 03-Feb-2021.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
At 4:00am I woke up with my heart beating very hard and fast. I put on my Apple Watch and checked my heart rate. It was 149. I was also in A Fin. I went to the ER for a correction. I?ve never had A Fib before but I have always been slightly high blood pressure.