chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his voice has changed over the last several days; dizzy; He has been unable to walk normally but only shuffle; feeling sick; nauseous; vomited; chills; he did not eat with the exception of soda and ice pops until Sunday 17-Jan-2021; He had 3 nights of sweating during sleep; He has lost 7 lbs in the past week; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nauseous), VOMITING (vomited), CHILLS (chills) and DECREASED APPETITE (he did not eat with the exception of soda and ice pops until Sunday 17-Jan-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced WEIGHT DECREASED (He has lost 7 lbs in the past week). On 13-Jan-2021, the patient experienced MALAISE (feeling sick), NAUSEA (nauseous), VOMITING (vomited), CHILLS (chills), DECREASED APPETITE (he did not eat with the exception of soda and ice pops until Sunday 17-Jan-2021), NIGHT SWEATS (He had 3 nights of sweating during sleep) and GAIT DISTURBANCE (He has been unable to walk normally but only shuffle). On 19-Jan-2021, the patient experienced DIZZINESS (dizzy). On an unknown date, the patient experienced DYSPHONIA (his voice has changed over the last several days). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. On 16-Jan-2021, NIGHT SWEATS (He had 3 nights of sweating during sleep) had resolved. On 17-Jan-2021, NAUSEA (nauseous) and VOMITING (vomited) had resolved. On 19-Jan-2021, WEIGHT DECREASED (He has lost 7 lbs in the past week) had resolved. At the time of the report, MALAISE (feeling sick), CHILLS (chills), DECREASED APPETITE (he did not eat with the exception of soda and ice pops until Sunday 17-Jan-2021), DYSPHONIA (his voice has changed over the last several days), DIZZINESS (dizzy) and GAIT DISTURBANCE (He has been unable to walk normally but only shuffle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
This spontaneous report was received from a patient's mother who posted on a social media page regarding her daughter, of unknown age. The patient's pertinent medical history, concomitant medication and concurrent conditions were not reported. On an unknown date the patient was vaccinated with an unspecified HPV vaccine (either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown)). Three weeks after the vaccine, the patient developed severe autoimmune neutropenia. She had no white blood cells to fight bacterial infections. The reporter suggested that precautions may needed to be taken if one is susceptible to autoimmune disorders and research should be done before getting vaccinated. Outcome of neutropenia was not known. Causality assessment was not provided. Upon internal review autoimmune neutropenia was determined to be medically significant. Additional information is not expected since the patient's physician cannot be contacted.
3cm x 3cm rash L cheek slightly raised, some scaling 1cm x .2cm rash R cheek rashes upper eyelids bilateral  Rashes noted this morning; treated with .1% triamcinolone.  They are improving canker sore L upper lip appeared this evening
pt recv vax & immed p/vax pt devel a fever which led to stiffening of musculoskeletal system & aching body organs such as kidney, liver, etc;p/ 4 or 5 days devel into meningitis;pt hosp in critical condition;BP 195/165, T102;   Annual follow-up received on 11/27/2000 provided no additional data.
Palpitations that lasted 1 week, have improved but were occurring prior to the vaccines. Patient states palpitations increased after vaccine
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection hurting more, swelling at injection site and redness at the injection site. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced injection hurting more, swelling at injection site and redness at the injection site. The outcome for the events was not reported. No additional information was available at the time of this report.
9/10/21 tightness in chest began at 12pm. Shortness of breath very mild Friday night, 9/11/21 chest tightness increasing and more shortness of breath. 9/12/21 chest pain and tightness, short of breath and sharp pain under left shoulder blade began. 9/13/21 went to ER 8am at the advice of PCP. Diagnosed with acute pericarditis. Given aspirin, Solu-medrol, nebulizer treatment, labs drawn, chest xray and ekg performed. Covid swab (negative). Sent home with prescription for anti-inflammatories, inhaler and to rest and monitor vital signs and symptoms for worsening.
Swollen lymph nodes in same arm as injection site, near inability to move my arm without extreme pain, fever for 2 days even while taking ibuprofen, sweating, chills, aches in my whole body, tremendous arm pain at the time of injection and immediately following, tingling in hand continuing 2 days later, a lot of difficulty sleeping (even though I?m very tired), sharp pains and cramping in various places
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
LITTLE SORE ARM; LIGHT NAUSEA FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported 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 subject experienced little sore arm, and light nausea for a couple of days but still ate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little sore arm and light nausea for a couple of days but still ate was not reported. This report was non-serious.
1 day after vaccine developed redness and swelling at injection site. Was given BENADRYL. Next day redness and swelling worsened and 2 other raised spots developed on (L) forearm. Started on KEFLEX and Prednisone. More spots developed on (L) arm. Evaluated in ER for concern of cellulitis.
Client was having spots on the arm that the varicella vaccine was given that were spreading to face and shoulder.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted while walking down aisle with dad. She immediately regained consciousness. Although she was conscious, EMTs were called to assess vitals. She was cleared by the EMTs to go home. No injuries were sustained.
The evening of the day I received the vaccine, I developed severe pain and loss of mobility in my left arm. It has persisted to present and made sleeping very difficult. The first night, the pain was really extreme. I didn't even have to move the arm for it to hurt in several different places. It remains difficult to lift and use today, and I can't use the arm without pain. Something like putting a shirt on is now very difficult. The site is swollen and red (splotchy), and tender to the touch with some bruising. I don't have a fever when I check my temperature, but woke up having soaked everything with sweat. I've been sweating a lot, and feeling either hot or cold. I've taken one does of Tylenol for it, and then switched to ibuprofen (at least before bed, and sometimes when I wake up in the night, or during the day).
Patient tested positive for Covid-19 at Facility on 01/20/2022.  On 02/05/2022 the patient was found lying in bed with no response, no breathing or heart rate.
bronchitis; diagnosed with COVID after having been administered 2 doses of Pfizer Covid Vaccination; COVID; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (PIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 18Aug2021 at 18:00 (Batch/Lot Number: FC3181) (age at vaccination 48-year-old) as dose 2, single, dose 1 via an unspecified route of administration, administered in arm right on 28Jul2021 at 18:00 (Batch/Lot Number: FA6780) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was reported as none. The patient had diagnosed with covid after having been administered 2 doses of pfizer covid vaccination and covid on 03Oct2021 and bronchitis on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 SARs PCR Test sars-cov-2 test: positive for covid on 03Oct2021. Therapeutic measures included Z-Pak was taken for bronchitis. The patient was seen in an urgent care for this event bronchitis, but has not had any visit to the emergency room or hospitalization. The outcome of the event covid after having been administered 2 doses of pfizer covid vaccination and covid was not recovered and the outcome of bronchitis was unknown.
first dose 4 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 4 years ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19th July 2022 Reporter's Comments: The pharmacist reported that patient received Shingrix first dose  4 years back. The reporter consented to follow up via email. Additional supportive information: Till the reporting patient did not received second dose which led incomplete course of vaccination.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case involves a six-months old male patient who received only DTaP portion without ActHib portion of PENTACEL. The patient's past medical history, medical treatment(s), was not reported. Concomitant medications included ROTAVIRUS VACCINE and PREVNAR 13. It was case of actual medication error as inappropriate reconstitution technique. It was reported that the reporter did not mix the ActHib portion with the DTaP portion but gave the DTaP 0.5ml IM left thigh. No reported side effects at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. 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. List of documents held by sender: none.
Vaccine was given beyond use date. Vaccine was received in refrigerator on 01/11/2022  and kept in in appropriate temperature ( 2-8 Celsius). Vaccine was administered to patient 7 days past the 30 day time in refrigerator.
After receiving the COVID-19 vaccination the patient experienced the following adverse events itching and red blotchy skin upper mid chest, lower neck. tingling of the lips 1/6/21 approx 1310 patient began to report itching of right arm and tingling. Sx progressively developed redness itchiness, mid upper neckline, reported feeling swelling. VITAL SIGNS at 1324: BP 188/110, HR 81, 02 100% RA, RR 20,.During vital signs, patient reported swelling on her neck, she refused to be transported to ED by WC, walked to ED, a/ox3. Once patient checked in to ED, she began to report tingling of the upper lips. She was then checked into ED room, this RN remained at her side until she was taken to the back. VAERS documented. Patient advised 2nd contraindicated.
This spontaneous report was received from a medical assistant, via a company representative, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. Patient was reported as otherwise healthy. On an unknown date the patient was vaccinated with MMR II (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that patient was vaccinated with MMR II on an unknown date, had "low measles titers". The patient had not suffered any other adverse effects. At the time of the report the outcome was unknown. Additional information has been requested.
rash first seen on face @ 1PM;about 315PM mom noticed the extremities were covered w/erythematous macules 2-4mm in diameter;no fever, acting fine;
pt recvd vax 3OCT92 & w/in 24 hrs of vax pt devel generalized hives; pt was treated w/DPH;
This spontaneous report was received from a physician refers to a patient of unknown age and gender. Approximately on an unknown date in April 2012, the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date and route not reported) instead of ZOSTAVAX due to a human error. No adverse effect reported. Additional information has been requested.
Pt vaccinated with MMR experienced dizzy, migraine, fever & chills developed after reeiving vaccine. Headache persists 15OCT.
Headache, Myalgia, Arthralgia & Fever Narrative: Patient received 2nd dose of vaccine on 03/18/2021 at 945 AM. Symptoms began that afternoon/evening. Reported symptoms include fever/facial flushing, headaches, body aches, and joint pain. Reports use of Motrin 800mg x 1 dose helped with symptoms. Reports experienced similar symptoms after receipt of flu vaccine this year.
mom called stated pt woke up yesterday 28JUL92 w/fever >101 & very large knot on rt leg warm & cold compresses applied along w/APAP for fever; mom further stated pt unable to walk well on leg; c/o severe pain to this area; referred to MD;
At the time of the second vaccine I was 14 weeks and 5 days into my first pregnancy. The estimated date of delivery is July 08,2021.  The only side effect I experienced was soreness at the site of injection.
Pt recv vax on 11/6/98; on same day pt exp fever (102.4); tx=Advil
Pediatric dosegiven to an adult; Pediatric dosegiven to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   On 16th February 2023, the patient received the 2nd dose of Engerix B pediatric. On 16th February 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comments: The medical assistant reported that the adult patient received pediatric second dose of Engerix B. The reporter consented to follow up by email.  Additional Supportive Information: The adult patient received pediatric second dose of Engerix B, which led to underdose and adult use of a child product.
ED Discharged  8/7/2021 (4 hours)  COVID-19 Elevated d-dimer COUGH
hearing loss in left ear; Extremely loud tinnitus; Dangerous rise in blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Sulfa" (unspecified if ongoing), notes: Known allergies Sulfa. Concomitant medication(s) included: LOSARTAN; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 2, location: Right arm), administration date: 05Mar2021, for COVID-19 immunization; BNT162b2 (Dose 1, Location: Right arm), administration date: 10Feb2021, for COVID-19 immunization. Facility type vaccine: Pharmacy or drug store.  The following information was reported: BLOOD PRESSURE INCREASED (disability) with onset 09Oct2021, outcome "not recovered", described as "Dangerous rise in blood pressure"; TINNITUS (disability) with onset 09Oct2021, outcome "not recovered", described as "Extremely loud tinnitus"; DEAFNESS UNILATERAL (disability, medically significant) with onset 09Oct2021, outcome "not recovered", described as "hearing loss in left ear". The events "hearing loss in left ear", "extremely loud tinnitus" and "dangerous rise in blood pressure" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure increased: Rise, notes: Dangerous rise in blood pressure caused me to increase BP meds. Therapeutic measures were taken as a result of deafness unilateral, tinnitus, blood pressure increased (Blood pressure meds twice daily and hearing aid). No Covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per LVN patient was nervous and shaking some prior to the vaccine. LVN offered patient to decline or return another date. Patient reported he has to get it for the University. Immediately after the vaccine which was given at 0950, patient reported nausea.  LVN notified RN. 0958 Patient sitting up in chair with an emesis bucket.  Patient is pale and has light tremors, and reports nausea. Vital sigs taken Pulse 91, respirations 20, blood pressure 91/54, and 02 sat 100%.  Patient reports he is thirsty. Reports he ate a bagel and had coffee this morning. Gave patient sips of water. Had patient take a few deep breaths. 1003 Assisted to gurney. Vital signs rechecked and ice pack applied to back of head and neck. Pulse 65, blood pressure 110/74, 02 100%. Patient reports he is feeling better. Patient transported with LVN and RN via gurney to nurse treatment room per protocol. Report given to LVN ad RN.  Patient is stable.
Did not have an immediate reaction to injection. 8 days after injection. started to have discomfort, swelling, temperature  went up to 100.3 that lasted for a couple of hrs and then went away. slept real good and woke up and not long after waking up my arm started feel very uncomfortable and swelling, turning red and a little itchy. and took a little Acedimidafin and now its back to normal.
At 9::00pm I felt chilled ,and achy and went to bed because I started to shake U.N. controllably.  I took Tylenol at about 10:00pm and in about10 minutes the shaking stopped.  Soon after I was able to take off extra pjs and covers. When I went to the bathroom at sometime around 7:00 am I felt hungry as I stood up and fainted.  I fell on my back and was out for less than a minute.  I was checked out by paramedics.  My blood pressure was 119/49.  They told me to drink Gatorade and water from being dehydrated.  I had already started drinking before this.  They got me in bed.  I ate, rested and got through the day.feeling stronger. The next day felt stronger and stronger.
Delayed menstrual cycle from 28 days to 44 days Caused acne on my face and my back  Caused bloating
adverse experience; revaccinated; Temperature excursion involving, PEDVAX HIB; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 2-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U003873, expiration date: 15-APR-2023, which have been verified to be valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) in left thigh (strength, exact dose, dose # and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2201USA000582:
He describes pain in Left anterior axillary fold, and some tingling down into the elbow. There was no erythema, induration, increased warmth, swelling, or other injection site reactions. There were no motor or sensory deficits in L arm or shoulder. There was no epitrochlear, supraclavicular, or axillary adenopathy.
during billing adjudication to third party it was flagged as being already received.  Confirmed through local database they previously received at local Pharmacy on 9/9/22.
Developed tremors, shortness of breath, and facial urticaria approx. 1 hr after vaccines given. Mother gave PROAIR at home, and symptoms resolved within about 1 hour. He returned to my office 3 hours after vaccines given and had returned to baseline.
drowsiness; chills; body aches; burning sensation of the skin; shortness of breath; extreme fatigue; anxiety; confusion; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 14May2021 09:30 as dose 2, single for covid-19 immunisation (at the age of 41 years). Medical history included covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 14May2021 20:00 patient experienced drowsiness, chills, body aches, burning sensation of the skin. Days 2 through 4 - shortness of breath, extreme fatigue, anxiety and confusion. The treatment was not received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Developed a 4"x2" red, warm, lump around DTaP site within 24 hours of vaccine.