chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced an epidose of syncope after adminstration of GARDASIL 9; This spontaneous report has been received from a Nurse Practitioner via a Company representative, referring to a 14 year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.    On an unknown date, the patinet was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 0.5 milliliter, intramusculary as vaccine series (strength, frequency, lot number and expiration date were not reported).         On an unknown date, after administration was complete the patient experienced an episode of syncope. The outcome of syncope was unknown. No product quality complaint (PQC) reported.      The causality assessment between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and syncope was not provided.   Upon internal review, syncope was determined to be medically significant.
Initial information was received 08 December 2008 from a consumer (patient's aunt). A 17 year old male patient with no medical conditions received an injection of "TDAP or DTaP" (manufacturer, lot number and date not reported). The patient went to the dentist two weeks after receiving the vaccine and was found to have a decreased heart rate of 29. The patient was hospitalized and awaiting pacemaker insertion. The patient had multiple tests and scans completed (specific tests and date of tests not reported). The patient was told by his pediatric cardiologist that his condition was congenital. The patient's recovery status was not reported. No further information was provided. List of Documents held by Sender: None.
Only symptom experienced during first ~36 hours after receiving vaccine was soreness near injection area of left arm.   A couple hours after falling as sleep the second night after vaccination shot (Sunday night), I woke up very cold / severe shivering. After several hours I managed to fall asleep for approximately another 1-2 hours. The next day I experienced fever, shivers, general body weakness/fatigue, and muscle aches/discomfort especially in both legs. These symptoms lasted throughout the day.  That night (Monday night), when I got into bed, I was strongly shivering. I managed to fall asleep for 1-2 hours, but woke up uncomfortably warm. I was unable to fall back asleep until 4-5 hours later. I woke up 1-2 hours later, with most of my body dripping with sweat, and the sheets rather damp.  Tuesday and Wednesday: Symptoms came and went, mostly feelings of fever, chills, general fatigue, lost appetite, and mild light headedness. Sleeping remained difficult, able to stay asleep for <4 hours each night.    As of today (Thursday), fever has subsided. Still generally feel fatigued, occasionally lightheaded.
tightness in chest, tightness in throat, hoarseness burining sensation in throat 50 IM Benadryl given in right arm
Large area of swelling, red, firm to touch and warm. 3" by 5" initially, increased to whole underside of left upper arm by morning.
Swelling began at the sight of the pneumonia injection (hip area) and continued for approximately 8 hours even after receiving an injection of Benadryl from a doctor.  Swelling ultimately was the size and shape of a football and raised approximately 1 inch.  The swelling lasted for 3 days.
Swelling at injection site noted 12/18/14. Continued to worsen throughout day. Swelling extended down to hand. Severe pain.
pt recv vax & 21APR99 PM lt leg had inc swelling & mom called MD on call 22APR98 seen in office 23APR99 lt leg 3cm larger than rt thigh, red, swollen, warm to touch;pt was placed on keflex, DPH;length of redness 18cm down, 15cm wide;
04/15/2021 I had a very weird sensation in back of throat, taste was rotten, sensation caused headache, made back of tongue tingle, felt unable to get enough air when breathing, felt tingly hot, arm started to tingle, felt chest pressure. I had urge to have bowel movement. I thought I was having heart attack, I went to ER Hospital, I was not having heart attack per testing, symptoms continue to this day. I am scheduled to see a neurologist in September.
breach of implied warranty; shingles; products liability - defective design; products liability - manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a elderly patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine by a pharmacist. The patient was treated by a healthcare provider for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: Injury to themselves; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the event was not recovered/not resolved. Causality assessments were related.
Noticed an enlarged, moveable(size of dime, 2cm?) lymph node on daughter's left side of neck with enlarged tonsils and possible adenoids.  Known side effect of mumps portion of MMR is enlarged lymph nodes (duration of this side effect is not listed). She is breathing heavy at night with mouth open breathing/snoring due to her enlarged tonsils.
Blurry vision, light-headed. BPs 87/62 (pulse 81), 114/82 (pulse 68). Patient was dehydrated - advised to hydrate before second vaccine dose.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 21.64 years.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. On 19-Apr-2021, the vaccine with batch number 007C21A was moved to fridge. On 27-Apr-2021, 8 vials were moved to the clinic. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 19-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.Temperature recordings were taken using a traceable temperature monitor at every hour.It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Painful, warm, reddened area around injection site 6 inch oval remains as of this form submission
Numbness/loss of feeling around nose, mouth, chin and neck beginning on evening of second dose. The following morning I had full body hives and still numbness/tingling in face and neck. Benadryl helped. Symptoms began about 6:15 pm on Thursday and we?re cleared up by 3:00 on Sunday.
Pain at sit of injection for 2 days . Low grade fever, fatigue for 2 days
Received expired Booster dose about 20 hours post puncture; Received expired Booster dose about 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that number of doses/vials was 1 vial / 2 doses. On 02-JUN-2022 the vial was initially stored in the refrigerator. On 23JUN2022 at 1:14PM the vial was first punctured. Vial did not undergone any temperature excursions. Post punctured the vial was stored in the refrigerator approximately for under 20 hours. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-596592.
Severe local reaction with redness, warmth, swelling of entire upper leg. Stiff in AM - hesitient to bear wt.
Woke up with a headache; Chills; Low grade fever; Start cough a little bit; This is spontaneous report received from a contactable consumer (patient) reported for himself that:  A 27-years-old male patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (Batch/Lot Number: ER8786) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 27 years). The patient past medical history included Blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first 1st dose of COVID-19 Vaccine via an unspecified route of administration, administered in Arm Left 08Apr2021(Batch/Lot Number: EW0150 as DOSE 1, SINGLE for covid-19 immunization. Consumer stated, I am having some side effects after taking the 2nd dose of Pfizer today I woke up with a headache, I got chills and I have low grade fever and I have start cough a little bit on an unspecified date. No treatment was received. The event outcome was unknown for all the events.  No follow-up attempts are needed. No further information is expected.
Appears to have had a vasovagal  response,  vomiting and syncope approx.  7pm same day of 2 vaccine.  Hit head causing head injury.
From waking up the next day, until waking up this morning (-2/22/19), have been unable to lift my left arm. Beginning around 10 am on 02/20, I began having chills and aches all over. By time I got home from work, I had and maintained a fever reaching up to just over 102 until about 4 pm on 02/21, when it finally returned to a normal range.
pt recv vax;devel redness, swelling,warmth and pruritus at inject site;
A little over a day, I went into AFIB, not sure if the Covid-19 shot caused this or not?
jaw was inflamed; Head ache in the eye region and back of the skull; Warm sensation at the site of the injection.; Inflammation at the site of the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm sensation at the site of the injection.), VACCINATION SITE INFLAMMATION (Inflammation at the site of the injection.), OSTEITIS (jaw was inflamed) and HEADACHE (Head ache in the eye region and back of the skull) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Warm sensation at the site of the injection.), VACCINATION SITE INFLAMMATION (Inflammation at the site of the injection.) and HEADACHE (Head ache in the eye region and back of the skull). On an unknown date, the patient experienced OSTEITIS (jaw was inflamed). On 21-Aug-2021, HEADACHE (Head ache in the eye region and back of the skull) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm sensation at the site of the injection.), VACCINATION SITE INFLAMMATION (Inflammation at the site of the injection.) and OSTEITIS (jaw was inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.
Patient received Tdap in at the (R) deltoid area - subsequently developed swelling, redness, pain and fever requiring emergency hospitalization.
Information has been received from a physician concerning a child who on an unknown date was vaccinated with a dose of PROQUAD (Oka/Merck upgrade process). Subsequently the patient experienced a febrile seizure. The patient sought unspecified medical attention. Upon internal review, febrile seizure was determined to be an other important medical event. No product quality complaint was involved. No further information is available.
pt relates swelling & pain to both knees & lt ankle upon awakening 1st day p/vax;
PUNCTURED VIAL ADMINISTERED AFTER HALF AN HOUR OF EXPIRATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. 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: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prevention of covid19. No concomitant medications were reported. On 20-AUG-2021, the patient experienced punctured vial administered after half an hour of expiration. On 20-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial administered after half an hour of expiration and off label use was not reported. This report was non-serious.
Swollen erythematous about 10cm area (R) posterior upper arm with induration & vesicles/blisters centrally.
Patient experienced lightheadedness, dizziness, nausea blurred vision and chest pain within 10 minutes of receiving second dose of Moderna vaccine. Blood pressure was 80/60 initially but rebounded in 10 minutes to 90/62, pulse regular and steady at 63 and 02 sat 99%. He was initially diaphoretic and pale. Patient monitored for 20 minutes, given food and water. After 20 minutes he returned to normal coloring , chest pain and all other symptoms completely gone. He was allowed to leave facility.
Patient received  2nd Moderna (Covid-19) dose under the age of 18. No adverse reactions/allergies were reported from the first dose.
Developed hives/welts along arms, back and neck (waist up).  Continues to take Benadryl.  Has not spoken to his doctor.
Vaccinations delivered on-site to facility. After receiving 1st dose vaccine, recipient had severe reaction from what the FNP believed was from the vaccine. Reaction symptoms reported were altered mental status, lethergy, confusion, diarrhea with frank blood in stool and body aches.
It was reported that a 56 year old male pt received a Fluzone UNSP '99-'00 vaccination on 10/14/99. Reportedly, on 10/31/99, the pt developed paresthesia from sole of left foot with gradual increase to left leg, left side of body and left arm to the forearm. The paresthesia has faded in the same pattern it progressed. No right side involvement, pt's reflexes were normal. Pt also developed paresthesia below right ankle at this time and is fading. The doctor has not confirmed dx with spinal tap or nerve conduction studies due to symptoms resolving at this time. No additional information was provided from correspondence returned on 12/17/99.
Liver injury.   On 8/16 went to the ER due to dehydration from side effects of the vaccine. Liver enzymes were elevated.  Went back to the ER on 8/24 due to a headache with acute confusion, liver enzymes were even higher. Went to my PCP on 8/27 as a follow up and liver enzymes were even higher. Still waiting on other lab results to see if levels are due to illness.
None known. Reported since Fluviron vaccine given 0.25 ml (and not FDA approved) in 4 year old although studied.
This spontaneous report was received from a medical assistant concerning an unspecified amount of patients. The reporter stated that on an unknown date the patients were vaccinated with improperly stored VAQTA (dose, dosage schedule, route, lot number and expiry date not provided). There was no concomitant medication reported. No adverse effects were reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Fever Reports on 1/20 - feeling tired, lethargic, "hot & cold" at the same time, T 100.9F x 2 days. All symptoms resolved in day 3. Narrative:
hives; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and a sales representative.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Jun2022 as dose 1, single (Lot number: ER2622) at the age of 16 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 13Jun2022, outcome "unknown", described as "hives".  Additional information: Physician asked if there is any data on pre-medicating with Benadryl for patients who have had mild reactions (hives).
This spontaneous report as received from a male consumer refers to a female patient (his wife) of unknown age. The patient's medical history and current conditions are not reported. On an unknown date the patient was vaccinated with ZOSTAVAX of unknown strength and dose. Concomitant medications were not reported. On an unknown date, the patient's husband stated that ZOSTAVAX vaccine was not effective, and the patient was suffering from shingles and that the unspecified treatments for the conditions were ineffective in controlling her pain also reported that the patient was experiencing neuropathy in her head and stated that she cannot take the pain. The outcome of the events were unknown. Additional information has been requested.
Welt at injection site that turned to a yellow bruise.  Red rash that reached down arm almost to the elbow.
Patient was given MMRV (instead of MMR) and varicella. Patient received extra dose of varicella. Treatment per Dr. is to medicate with TYLENOL and monitor for fever. Update: Called mother 4/12/18 - no observed fever, mom medicating w/TYLENOL. Patient napping at time of call. Perhaps some increased fussiness, decreased appetite, and increased sleepiness. Pt now stable, eating, drinking, voiding.
Hives appeared within 6 hours of vaccine admin.  Responded to BENADRYL liquid but continued to recur for 48-72h.  1 episode of tightness in chest.  Local reaction also with redness with "bumps".
fever 106-cried then became very lethargic then in 2mo period seemed regressed in growth & devel;no attends LIU;had been referred to growth & devel clinic d/t walking on toes-balance issues a/vax;t106, fretufl then lethargic;
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX "about a month ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported the patient "broke out in a rash in the shoulder blade area the day after getting" ZOSTAVAX. The patient admitted to having pain in that area prior to getting the injection and the doctor believes the patient had shingles prior to receiving ZOSTAVAX. Treatment information was unspecified. The outcome of shingles is recovered/resolved. Additional information has been requested.
This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 8 doses of RECOMBIVAX HB (lot number M031574 with expiration date of 11-NOV-2018, and lot number M037248 with expiration date of 21-FEB-2019), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for RECOMBIVAX HB was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1703USA006474: US-009507513-1703USA006475: US-009507513-1703USA006476.
Pain in my left shoulder and arm woke me up and kept me awake all night.  I took two Ibuprofen at 1:30 AM but they didn't seem to help.  This morning I was unable to perform ordinary functions due to pain and weakness.  I took two more Ibuprofen at 7:00 AM with no noticeable improvement.