chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated was having blurred vision and couldn't see.  Skin appeared pale, denied trouble breathing, no sign of swelling, rash, shortness of breath, cough.  Patient layed down on the floor, with feet elevated.  EMTs arrived, evaluated patient, patient began to feel better and was walking around okay.
functional neurological disorder; functional limb weakness; Postural Orthostatic Tachycardia ("POTS").; vision disorder; speech symptoms; functional movement disorder; central and vestibular abnormalities; central and vestibular abnormalities; Other Related Injuries; autoimmune disease; First dose on 14-AUG-2018 and second dose on 10-SEP-2019; Information was received from a lawyer regarding a case in litigation and refers to a 13 year old female patient. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, she had no autoimmune diseases and no autonomic issues. Information about historical drugs and concomitant medications were not reported.  On 14-AUG-2018 and 10-SEP-2019, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) respectively for prophylaxis (dose, route, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered).  On 10-SEP-2019 at the evening, she began falling out of her turns, later that week began to experience tremors and dizzy spells. As the months progressed, she was seen by multiple physicians for her complaints which now included: tunnel vision, headaches, tremors, dizziness, severe lethargy, anxiety, elevated heart rate and painful periods.  As a result of her post-Gardasil symptoms, the patient was unable to engage in normal activities that a normal young person could enjoy. Due to her unrelenting stomach aches, headaches, constant dizziness, tremors, fatigue, and extremely elevated heart rate, she now struggles in school and could not complete tasks she could before the Gardasil vaccine. Because it was so difficult for her to learn, her grades in school had suffered and that is affecting her ability to attend college.   On an unknown date she was diagnosed with functional neurological disorder (conversion disorder), nervous system disorder (medically significant), vestibular disorder (medically significant), functional movement disorder, functional speech symptoms, functional vision disorder, postural orthostatic tachycardia syndrome (POTS), functional muscular weakness, autoimmune disease and other related injuries (ill-defined disorder).      The outcome of conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-defined disorder was unknown.     The reporter considered conversion disorder, nervous system disorder, vestibular disorder, movement disorder, speech disorder, visual impairment, postural orthostatic tachycardia syndrome, muscular weakness, autoimmune disease and ill-define disorder to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).     It was reported that the events had resulted in her suffering from severe, serious, disabling and painful chronic Injuries.
Malaise; feverish; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Malaise) and PYREXIA (feverish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (feverish). At the time of the report, MALAISE (Malaise) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a nurse and refers to multiple unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N019924, expiration date 02-SEP-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA006172.
Pain in right shoulder radiate down arm swollen finger can't close hand extreme pain. Pain in both legs hard to walk.
The patient was administered GARDASIL 9, and was 5 weeks pregnant at the time of administration; This spontaneous prospective pregnancy report was received from a 29 year old female patient. The patient had no medical history, concurrent conditions, and historical drugs were not reported. The last menstrual period of  the patient was reported as 06-JAN-202 , and the patient became pregnant on 20-JAN-2020,   On 12-FEB-2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the arm muscle(strength, route, dose, frequency, lot # and expiration date were unknown) for prophylaxis, and was 5 weeks pregnant at the time of administration. The patient stated that was her first dose and only dose she received of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exposure during pregnancy).   Additionally, the patient stated that she was on the medroxyprogesterone acetate(DEPO-PROVERA) shot at the time, and did not know she was pregnant, and stated that she now takes unspecified "prenatal vitamins", but was not taking them when she received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). She stated that her due date was 12 -OCT-2020, the pregnancy outcome was pending. The patient did not seek for medical attention and no treatment was given for the adverse event.
8 year old male, no history of vaccinations per mother's report and no prior record with Public Health Center.  Patient received MMRV, TDap, Hep B & Polio vaccines at around 4:05pm. At 4:10pm, while in lobby with mother and 2 siblings for observation, client reported to mother that he was not feeling well. Nurses were notified and assessed client with the following symptoms: diaphoresis, pallor, does not respond to questions, disorientation and intermittently experienced loss of consciousness (approximately 60 seconds while being cradled by mother), no fall/injury observed or reported by mother. Client had patent airway and regular unlabored respirations, provided the following intervention: assess client's responsiveness (calling name), applied gentle sternal stimulation and applied cold compress to face and neck. Client regained consciousness but was still disoriented (VS: BP 92/64; HR: 74; RR: 20). EMS activated @4:14pm, arrived at 4:22pm, client was alert and oriented x4 at the time of paramedic assessment, client was able to communicate fully and was cleared by paramedics to leave clinic with no further treatment recommendations. Paramedics left clinic at 4:38 pm.  Mother stated client did not have lunch prior to vaccine administration. Client was provided with snacks (juice box) and tolerated it well. Client left clinic with mother and siblings @5:00pm with no further incidence.
SICKNESS WITHIN 4 HOUR; OTHER SYMPTOMS; FLU; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced sickness within 4 hour, other symptoms, flu, and fever. Treatment medications (dates unspecified) included: ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickness within 4 hour, fever, other symptoms and flu was not reported. This report was non-serious.
Patient, a 44 year old female received Moderna vaccine in L deltoid on 1/5/2021. On 1/6/2021, pt reported to vaccine clinic at 1130 with c/o racing heart and nausea. VS obtained. EMS called and patient transported to ER. Macular rash noted on chest per ER report. During time at ER, pt given IV fluids and PO Tylenol 1,000mg. Pt discharged home in stable condition with recommended follow up with PCP.
Spiked a temp of 102.9 throughout the night. Administered Tylenol. Temp would drop to 101.4. Has previous history of high fever and seizure after 2 month shots. Infant very fussy. Mother was going to have infant evaluated in ER.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, strength and dosage unspecified) orally, which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sudden Tinnitus and difficulty hearing that began the day after taking the second Moderna dose. A specialist doctor indicated that the cause may be the vaccine and there are no underlying infections or inflammations that may have caused this.
Patient comes to health  clinic with complains of right arm redness.  Patient had a 4cm diameter, erythematous, slightly indurated, warm lesion on right arm where her vaccination was injected.  This appeared 1 day after and has been growing.  She reports that her arm was not wiped with alcohol prior to injection
Per patient; itching almost immediately followed by chills, knot at injection site, swelling at injections site, redness, shortness of breath, racing heart.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:30 as dose 1, single (Lot number: EN6199), in right arm, on 31Mar2021 at 13:30 as dose 2, single (Lot number: ER8733), in right arm, on 14Aug2021 at 14:30 as dose 3 (booster), single (Lot number: EWo180), in right arm and on 18Jan2022 at 14:00 as dose 4 (booster), single (Lot number: FJ5682), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol and Triglycerides" (unspecified if ongoing); "High cholesterol and Triglycerides" (unspecified if ongoing); "Diabetes Mellitus type 2" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 12Apr2018, stop date: 21Mar2023; PREDNISONE, start date: 14Sep2016, stop date: 21Mar2023. Past drug history included: Bactrim ds, reaction(s): "Known allergies: Sulfa meds (Bactrim DS)". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (lot number: 662523) from 21Mar2023 to 26Mar2023.
8 hours after receiving vaccine I began to shake and get super cold. A pounding headache began. Legs were crampy. This continued through the night but was better in the morning.
A spontaneous non-serious report of administration of expired product was received from a nurse concerning a twelve year-old male subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
KINRIX was administered to four month old.  No adverse side effects reported or noted as of 7/1/21.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to DTPa vaccine. Additional details were provided as follows: This case was posted by a patient on a facebook page big bad cough. In 2018, the patient was forced to receive Tdap vaccine and had been sick all week.
I had a previous underlying condition of Myocolonus. 12 hours after the vaccination I started have massive mycolonic contraction on the entire left side of my body. They were strong enough to shake the twin bed and I was unable to walk without collapsing. I was taken to the ER. I was given 15 mg of Valium to control the tremors which did not fully subside until the following morning. The incident was reported to both my primary doctor as well as my neurologist. It is typical for me to have a myolonic reaction when my body is under stress, but I had not had a reaction that severe in over 5 years. It happened extremely fast 1 week later my chiropractor said that it had given me minor whiplash.
Initial report received from the parent of consumer who is a nurse on 30 July 2010. A 15-year-old female patient who had no concurrent illnesses, had received a first left arm injection of MENACTRA (lot number U3464AA) on 22 July 2010. That night after vaccination, the patient's left arm was sore, swollen and warm to touch. The patient also had a headache that lasted 24 hours. No diagnostic test or laboratory data were reported. Per the reporter, the patient had a reaction (description not reported) to BOOSTRIX at age 12 years. The patient has no known allergies or medical conditions. Concomitant medication included vitamin supplement. Recovery status was not reported. Documents held by sender: None.
Patient received a DTAP and Mantoux on 09-06-2007 at approximately 1:30 p.m. Within 1 hour she states that she became dizzy, her hands began to sweat, her face was flushed. Within 1 1/2 hour she began to vomit, 4 times over next 3 hours. She was nauseated through the night, but was fine by morning.
Afternoon of injection-pt developed fever (101). Then arm soreness and redness. TX-ice, NSAIDS.
death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient has a PMH significant for T2DM, CAD, hyperlipidemia, Parkinson's disease, HTN, Diffuse interstitial Pulmonary fibrosis. No cause of death listed or any notation. Patient deceased on 4/10/202. 2nd dose of Pfizer given 3/13
8:30 on 4/8/21 got a temp of 102, weak, tired, nausea, shaking, lost my breat milk and dried up
PT STATES ABOUT 8 HOURS AFTER VACCINE PT EXPERIENCED FEVER, MUSCLE WEAKNESS/TROUBLE WALKING, JOINT PAIN OF THE WRIST, ANKLE, AND KNEES. SKIN CRAWLING, TREMBLING. SYMPTOMS LASTED UNTIL 3AM. PT TOOK MOTRIN 600MG ONCE AT ABOUT 2AM AND WOKE UP  FEELING FINE. TODAY 8/22 PT HAS SLIGHT SORENESS AND NO OTHER SYMPTOMS. NO REDNESS, NO SWELLING, NOT HOT TO THE TOUCH, NO BRUSING. PT STATES HE HAS A PRIOR HISTORY OF BEING DIAGNOSED WITH EPSTEIN-BARR VIRUS AS A CHILD.
it was scabbing over; itchy at injection site; blotchy rash at injection site; the injection site was burning; arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore), SCAB (it was scabbing over), RASH ERYTHEMATOUS (blotchy rash at injection site), VACCINATION SITE PAIN (the injection site was burning) and VACCINATION SITE PRURITUS (itchy at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore). On 01-Apr-2021, the patient experienced RASH ERYTHEMATOUS (blotchy rash at injection site) and VACCINATION SITE PAIN (the injection site was burning). On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site). On 05-Apr-2021, the patient experienced SCAB (it was scabbing over). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 02-Apr-2021, PAIN IN EXTREMITY (arm was really sore) had resolved. At the time of the report, SCAB (it was scabbing over) had not resolved and RASH ERYTHEMATOUS (blotchy rash at injection site), VACCINATION SITE PAIN (the injection site was burning) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
5min or less extreme headache on L side, vertigo, confusion, anxiety.  Only lasted 5 min or so.  Headache lingered for about 30min
she has a bump, which is red and hot on her right arm at the injection site.; she has a bump, which is red and hot on her right arm at the injection site; she has a bump, which is red and hot on her right arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 609F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site). At the time of the report, VACCINATION SITE MASS (she has a bump, which is red and hot on her right arm at the injection site.), VACCINATION SITE WARMTH (she has a bump, which is red and hot on her right arm at the injection site) and VACCINATION SITE ERYTHEMA (she has a bump, which is red and hot on her right arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported.
INCORRECT STORAGE OF VACCINE (VACCINE WAS REFROZEN); OUT OF SPECIFICATION PRODUCT USE (ADMINISTRATION OF REFROZEN VACCINE); This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On 01-JUN-2021, the patient experienced out of specification product use (administration of refrozen vaccine). On an unspecified date, the patient experienced incorrect storage of vaccine (vaccine was refrozen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (vaccine was refrozen) and out of specification product use (administration of refrozen vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537532, 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297 and 20220538573.
Five days post vaccines pt developed macular/papular rash on posterior neck at 7 days post vaccine rash noted at axillary region & had Temp 99-100.
I have 2 sores that my doctor called Carbunkle. He drained one of them it was very painful and he sent it for culture. It's taking so long to heal, it's been over a year and I'm still healing. There may be a 3rd one developing and I'm applying antibiotic to see if that helps. The sores are on my lower right back where my belt and kidney interact. It's not affecting my kidney.
Patient states his left arm is still painful from when  got flu shot on 10/10/2019. Says a knot has since developed from injection site.