chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty walking; pain; belching; indigestion; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (difficulty walking), PAIN (pain), ERUCTATION (belching) and DYSPEPSIA (indigestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), ERUCTATION (belching) (seriousness criterion medically significant) and DYSPEPSIA (indigestion) (seriousness criterion medically significant). At the time of the report, GAIT DISTURBANCE (difficulty walking), PAIN (pain), ERUCTATION (belching) and DYSPEPSIA (indigestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that After the Moderna COVID vaccine the patient became sick from Jul-2021, and stated that the vaccine was totally disabled the patient's condition. No treatment medications were reported.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) events of Gait disturbance, Pain, Eructation and Dyspepsia that occurred in the context of a dose of mRNA-1273 Vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and exact onset date of the events was not available. No information on risk factors, medical history, concurrent conditions, detailed clinical course, relevant investigations, treatment received were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Loss of appetite; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever) 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 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 DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DECREASED APPETITE (Loss of appetite), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
W/in 12 hrs of receiving Engerix-B in lt deltoid, experienced pain in arms x 3 days, induration, hot, & swelling; Events resolved
pain in lt arm-swelling @ inj site;pt seen in ER;cool compresses to site;
Next day woke up at ~3am with; fever, hot and cold flashes, and weakness and fatigue. These symptoms persisted until end of the day 4/12.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Dizziness & possible metallic taste onset 3 minutes after administration. Lasted 20 minutes and resolved on own with eating per client statement. Client did not seek medical care.
Headache, explosive diarrhea, nausea & vomiting, fever, slept for 18 hours, body aches
2ND Maderna injection Friday, March 5, 2021. Slight loss of right-side facial function on Tuesday, March 9, 2021 at approximately 5:30 PM. Advancing loss of facial function on the right side of my face by Wednesday, March 10, 2021. By 6PM, Wednesday, March 10, 2021, my daughters showed concern about facial drooping on the right-side of my face. Daughter drove me to Medical Center ER. I was attended by ER Doctor. I was admitted to Medical Center, Wednesday, March 10, 2021 around 8PM. Admitting Physician, M.D. I was attended by J M.D. until my discharge from Medical Center Friday, March 12, 2021 at 6PM.
Lymph nodes on the back of neck were noted to be inflamed on  4/5/2017. The following morning at approximately 11 AM pt spiked a mild fever. Motrin was administered around 2:30 PM. The fever then spiked to 103.9 degrees around 10:30 PM. At that point we brought pt to the emergency room at Hospital. Urine samples were collected as well as blood. Vital signs were taken and the initial prognosis was noted to be viral. Children's Motrin and Children's Tylenol was recommended to be alternated approximately every 4 hours. Pt exhibited overall discomfort and was inconsolable over the next 2 days with fevers spiking up to 104 degrees. Appetite was non-existent with exception to nursing. Pt refused water and solids for the next 2  days. Pt was extremely lethargic and somewhat unresponsive during the height of her fever. Sunday showed signs of promise as pt started to show an appetite and began eating solid food at approximately 2:00 PM. She also accepted water. At this point pt still exhibited a mild fever that did not exceed 100.5 degrees. By Monday evening pt exhibited extreme pain, arching her back and crying incessantly. At approximately 3AM we noted a rash on most of pt's body and included white "pimples" in mouth.  Her last fever was Tuesday morning at 3 AM.  Motrin was used to bring the fever down.  Pt has remained "not herself" since composing this report.
Pt recvd 1 dose of Engerix-B & w/in the wk of administration, devel shingles; now over it, w/o reccurrence;
shortly p/vax pt devel marked mottling & cyanosis from waist down,cont screaming then noted progressive pallor of upper body & face,some grunting;
This spontaneous report was received from a certified medical assistant (CMA). It was reported that 13 improperly stored doses of PEDVAXHIB (dose, route, lot# not reported) had been administered to 13 patients on unspecified dates. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient was seen in office on 01/23/23 and received a tdap that expired on 01/21/23. Patient had no reaction just received a expired vaccine.
"Moderna COVID 19 Vaccine EUA"   At time I thought it was the start of a panic attack but now looking back, it might have been an allergic reaction.  Felt like a sting going up my arm, over my shoulder into my back.  Felt a little dizzy but it went away with sitting for 15 min.  When I got home I then realized my heart was fluttering but it went away within an hour.  6pm got chills and very tired.  Didn't sleep much and took tylenol in am to help with pain in arm, headache, burning eyes, chills and nausea.  I was still very tired and stayed in bed all day Sunday.  Today, I feel better with taking Tylenol but still nausea and headache and a little dizzy.   I now have a rash on my arm near injection site.
Dizziness during post vaccination; symptoms resovled and pt was d/c from vax site
A male reported that he received an injection of 1996-97 formula influenza virus vaccine in 1996. Immediately following vaccination, the patient developed severe hives from scalp to soles of feet. The patient was administered an injection of Benadryl and recovered. This event is considered medically important (OMIC).
Information has been received from a physician concerning an adult male patient with no pertinent medical history and none sensitive skin band-aid cause redness who in early January 2011, was vaccinated with an adult dose of VARIVAX (Merck) (668296/0858Z). There was no concomitant medication. On approximately 21-JAN-2011 ("1-2 weeks ago"), the patient developed a red, non vesicular, non itchy rash at the injection site and at the area below the injection site. The physician mentioned that the patient complained that the area below the injection site felt hot and itchy for the past few days. The physician stated that on 04-FEB-2011, the patient came to receive the second dose of VARIVAX (Merck), and the area below the injection site was red, and it looked like a localized skin allergic reaction. The second dose of VARIVAX (Merck) was not given to the patient. There was no lab diagnostics studies performed. At the time of the report, the outcomes were unknown. The patient via saw physician to seek medical attention. Follow up information has been received from a health professional reported that on 04-JAN-2011, the patient received subcutaneously the first dose of VARIVAX (Merck) (668296/0858Z). On 11-JAN-2011, the patient developed itch hive about one week with the initial injection. At the time of the report, the patient had recovered from his adverse events. The patient did not seek medical attention. Additional information has been requested.
No additional AE information; Caller is an office manager that reported a temperature excursion for VARlVAX and MMR II. / Caller stated during that time the vaccines were administered; This spontaneous report was received from an office manager, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in 2021, the patient was vaccinate with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter, as prophylaxis(formulation, strength, vaccination scheme frequency, anatomical site of vaccination and route of administration were not reported, lot number T027111, which has been verified to be valid, expiration date reported and validated as 07-FEB-2022). The vaccine administered, experienced a temperature excursion of -10 degrees Celsius (C) for a time frame of 1 hour and 15 minutes. There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.
41 YO F C/O HEADACHE IMMEDIATELY POST VACCINATION FOLLOWED BY A TINGLING SENSATION ON THE LEFT SIDE OF HER FACE. PT WAITED AN EXTRA FIFTEN MINUTES. WITH CLOSE OBSERVATION, THE HEADACHE STOPPED AND THE TINGLING FEELING STARTED TO RESOLVE. PT MENTIONED THAT SHE HAD NOT EATEN LUNCH, BUT PLANNED TO EAT ASAP. VS @2:20 BP 101/60 PULSE 70 REPEAT HR 77 @ 2:22 SpO2 99% PT DID NOT APPEAR TO BE IN ACUTE DISTRESS. PT WAS INSTRUCTED BY DR TO CONTINUE MONITORING FOR ANY SYMPTOM CHANGES AT HOME AND TO F/U WITH HER PCP ESPECIALLY IF HER SYMPTOMS WORSENED. PT LEFT THE OBSERVATION AREA IN STABLE CONDITION.
mom describes inconsolable crying throughout noc p/shots given says definitely >3hr;negative high pitched cry no high fever;positive redness & soreness @ site;
first dose of MENACTRA at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case a patient of an unknown age and gender and reported that patient received first dose of Menactra at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event, and it involved vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE,  wit an unknown formulation and strength, 1 dosage form (DF) once, ( lot number  and expiry date: not reported) via unknown route in unknown administration site for immunization. The patient received the same vaccine with an unknown formulation, strength, dose frequency, route, indication, batch number and expiry date). The information regarding batch number has been requested  The reporter stated that she has given a patient first dose of Menactra at 11 years old and has given the second dose at 5 weeks before the patient turned 16 with  no reported adverse event (inappropriate schedule of product administration) (latency: unknown)  The reporter  to know if she can give another dose as the school required the vaccine before school admission   Action taken : not applicable.  Outcome: 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 VI of the Good Pharmacovigilance 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.
The place of the vaccine can weep at times; The place of the vaccine is still a little red; The place of the vaccine itches; 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 VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches). At the time of the report, VACCINATION SITE DISCHARGE (The place of the vaccine can weep at times), VACCINATION SITE ERYTHEMA (The place of the vaccine is still a little red) and VACCINATION SITE PRURITUS (The place of the vaccine itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Patient felt numbness in throat, no difficulty breathing or swelling. Waited for an hour, no worsening but still felt numbness.
This spontaneous report was received from a 59 year old female patient with antihistamine allergy, who was reporting on herself. The patient had no pertinent medical history. In 2008 (reported as "8 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were not provided), however the patient was not sure if it was indeed ZOSTAVAX vaccine. Concomitant therapies included acyclovir. On unknown dates, the patient has broken out at least three times since the vaccine was given. No treatment for the event was given and no lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as the patient did not wish her physician to be contacted.
Felt inebriated; Increased libido; Fatigue towards sundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 10:45 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLLAGEN; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. Past drug history included: Amoxicillin, reaction(s): "allergies: amoxicillin". The following information was reported: FEELING DRUNK (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Felt inebriated"; LIBIDO INCREASED (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Increased libido"; FATIGUE (non-serious) with onset 04Jan2022 12:15, outcome "not recovered", described as "Fatigue towards sundown". The events "felt inebriated", "increased libido" and "fatigue towards sundown" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling drunk, libido increased, fatigue.  Additional information : No other vaccine in four weeks of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other medications in two weeks: multivitamin. Device Date was noted as 22Jan2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax DEC95 & was noted to have elevated liver enzymes on a routine blood draw in approx APR96;subsequent hepatitis screen was negative;pt is not symptomatic
In general did not feel good; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient had no adverse reactions or side effects from first dose. The patient received his first Moderna COVID-19 vaccine booster dose on 02-Nov-2021, lot number 01721A, expiration date was not provided. Patient received his booster dose in his right arm shoulder deltoid muscle. The patient reported no adverse reactions or side effects.
Arthralgia PAIN AND NUMBNESS IN LEGS Narrative:  ARTHRALGIA, PAIN AND NUMBNESS IN LEGS LASTED TWO WEEKS AND REQUIRED A VISIT TO ED AND PCM
Arm pain; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), first dose on an unspecified date and second dose on 08Apr2021 via an unspecified route of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain on an unspecified date and took Tylenol (2x500mg) after the first dose. It was sore for two days. She had arm pain again after the second dose and took Tylenol (2x500mg) twice daily for the event after the second dose. Caller stated she was never told about not taking Tylenol after getting the COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itchy rash that looks like measles. Daughter had only been up about an hour when she started complaining that she was itchy. I looked at her and saw the rash. I called her doctor where she got the shot but she isn't open on Fridays. They recommended urgent care clinic. We went and they checked her for strep because her tonsils were also swollen and it was negative. They gave me a script for CLARITIN and a steroid. Told me to come back if it got worse.
Within a few days stiffness and swelling in left knee and leg; stiffness and soreness in both shoulders, stiffness in hips, stiffness in hands, particularly left. After about 3 weeks, swelling of right foot.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 17-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1708USA001768: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
Pt developed white spots on left arm below the immunization site.  Pt felt a little itchy.  25 mg of Benadryl given with no change in spots.  Pt reported being a little less itchy.  No trouble breathing or swallowing.  No obvious swelling.
VOMITING, DIARRHEA WITHIN 15 MINUTES OF VACCINE. ABOUT 30 MINUTES AFTER VACCINE BLOODY STOOLS OCCURRED...2 FULL DIAPERS OF BLOOD.
This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, RECOMBIVAX HB underwent an excursion and the excursion was supported. On an unspecified dates, unspecified number of patients were administered with post excursion supported RECOMBIVAX HB (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects had been reported by any patients. This is one of the several reports from the same reporter. Additional information has been requested.