chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot #M042853, expiry date: 17-FEB-2019; lot # N004798, expiry date: 31-OCT-2019) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent (STERILE DILUENT) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000705:US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000709:
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006064: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Fever of 100F, chills, body ache and headache. Took 2 Tylenol every 4 hours. Felt better by 1:00pm 06/18/2021 but tired until next day.
This case was reported by a nurse and described the occurrence of limited range of motion in arm in a 30 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. On 08 November 2005 the subject received 1st dose of Fluarix in the right arm (lot AFLUA148AA). On 08 November 2005, less than one day after vaccination with Fluarix, the subject experienced limited range of motion in the right arm. At the time of initial reporting, 29 November 2005, the outcome of the event was not provided. The nurse considered the event to possibly be related to vaccination with Fluarix.
Large erythema noted l/thigh at injection site.  Area taut, tender, and warm to touch.  Given Rx for Prednisone per private physician.
I received my first COVID19 vaccination injection on March 30th, 2021. Four days later, on April 4th, I noticed that I had developed moderate bilateral tinnitus and it has persisted up to the time of this submission (April 13th, 2021). The intensity of the tinnitus has not wavered much, nor has the nature of the tinnitus in general. Occasionally, there have been additional phantom sounds heard, like a quiet fan-like wooshing, but ringing has been the overall dominant effect. Reading up what I could online, I have done what I can to mitigate the effects, but I have yet to experience any relief.
Lower back pain started at approx 4:30.  Muscle soreness through rest of body.  Then skin began to feel tingly most everywhere, not painful but more so sensitive to touch? I feel physically fatigued. When I move too fast my ears start to ring in and out for a few times before settling. Headache.
I got a booster shot. My first vaccines were in January. My only symptom so far is pain and tenderness at the injection site. I do not have any redness or noticeable swelling.
I just started feeling itchy around the beltline. I broke out in hives which is something I have not had before. And now still to this day and it still happens, so now I take some Zyrtec and it goes away. But the first 2 weeks were really bad. I had hives covering about 40-50% of my body. I didn't get a lot in my arms or face but mostly on my body and legs. Doctor told me to take the Zyrtec and a heartburn medication to reduce it.
On February 4, 2016 I received the hepatitis B vaccination series shot number one. Several days later I started to experience a headaches, mental distortion, fogginess, tingling and muscle weakness. The muscle weakness started in my arms then eventually moved down to my hands. A couple of days later I started having muscle weakness in my legs down to my feet. So much so that I felt uncomfortable walking by myself at times. I've always struggled with constipation and digestion issues (having UC) however during this time, the excessive bloating and constipation/pain became so unbearable that on February 8 I made an appointment to have an ultrasound of my abdomen. Results came back normal. I had made an additional three doctors appointments (1 phone/2 in office) in hopes of a diagnosis as my quality of living was declining. I was told by one of the Doctors that it was probably a tension headache or anxiety I was experiencing and that it had nothing to do with the hepatitis B vaccination. Though I was advised not to continue the last 2 shots in the series?
Soreness immediately after shot was given, increasing over the course of a month, decreased range of motion, weakness. Treatment: cortisone injection on 11/20/14, Dr.
Patient is a 60 y.o. female patient of, MD with history of diabetes mellitus type 2 on insulin, hypertension, hyperlipidemia who presented to Hospital with hyperglycemia, hypoxia and fever.  Patient was transferred from ED   Acute respiratory failure with hypoxia COVID-19 infection Date of onset of symptoms: 5/1/23 Symptoms present on admission: fever, sore throat, dry cough Date of covid positive test: 5/2/23 Vaccination status: vaccinated Imaging: CXR no acute focal infiltrate Oxygen requirements on admission: 2L NC Current oxygen requirements: Currently weaned to room air Infectious disease following Continue Decadron, remdesivir Stable for discharge home   Hyperglycemia Diabetes mellitus type 2 on insulin A1c 10.4 up from 10, 5 months ago Labs on admission with normal bicarb and anion gap with glucose 332 States she is taking Lantus 17 units nightly, Farxiga 10 mg daily and metformin 2000 mg nightly. Lantus 25 units nightly plus SSI.  Adjust as needed   AKI - resolved At OLH creatinine was 1.86 ->1.13 >1.17 baseline 1.11.3 Avoid nephrotoxic agents   Hypertension Takes amlodipine 5 mg nightly at home and hydrochlorothiazide 25 mg daily Continue amlodipine.  Resume hydrochlorothiazide
aproximately 10 minutes after vaccine taken, I developed problems with my vision.  I had double vision, and Kaleidoscopic vision with floaters in both eyes .  Lasted about 30 minutes.  Did not keep me from reading or walking.  no pain.
PATIENT HAD A RED SWELLING, HOT TO TOUCH AT THE INJECTION SITE AND AROUND THE AREA OF VACCINATION.  PATIENT SAID IT WAS EXTREMELY SORE AND IT WAS STILL RED WHEN THE PATIENT CAME INTO THE PHARMACY TO SHOW US.
missed their 2nd dose of IMOVAX RABIES for pre-exposure prophylaxis. They missed Day 07 and has come in at Day 10 with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who missed their 2nd dose of imovax rabies for pre-exposure prophylaxis. they missed day 07 and has come in at day 10 with no reported adverse event.  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 of suspect RABIES (HDC) VACCINE, Powder and solvent for suspension for injection via unknown route in unknown administration site for pre-exposure prophylaxis (strength, dose, batch number and expiry date: unknown) and missed their 2nd dose of imovax rabies for pre-exposure prophylaxis. they missed day 07 and has come in at day 10 with no reported adverse event (product dose omission issue) (unknown latency).   Information on the batch number was requested  Action taken: not applicable.  Outcome was Unknown for the event (product dose omission issue).   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.
Onset of tremor right hand and arm for 20 minutes.  Recurrent until present in right arm, then developed tremor in left arm/hand and left leg.  No nausea, dizziness, headache.  No weakness, numbness. Did have some 'tingling' in right arm/hand.
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe
This spontaneous case reported by a consumer, describes the occurrence of chills, pyrexia (low-grade fever (99.7)), headache, nausea (nausea led to vomiting that lasted until 4 am) and vomiting (nausea led to vomiting that lasted until 4 am) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jan 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 21, 2021, patient experienced chills, pyrexia (low-grade fever (99.7)), headache, nausea (nausea led to vomiting that lasted until 4 am), vomiting (nausea led to vomiting that lasted until 4 am) and diarrhea (little bit diarrhea). On Jan 24, 2021, patient experienced dizziness and tremor (shakiness). The patient was treated with ibuprofen for headache, at a dose of 200. On Jan 22, 2021, diarrhea (little bit diarrhea) resolved. On Jan 23, 2021, chills, pyrexia (low-grade fever (99.7)), headache, nausea (nausea led to vomiting that lasted until 4 am) and vomiting (nausea led to vomiting that lasted until 4 am) resolved. On Jan 24, 2021, dizziness and tremor (shakiness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No relevant concomitant medications reported.
This spontaneous report as received from the company representative who was reported by a health care worker refers to a male patient of unknown age. No demographics were provided for the patient and the physician. No medical history was reported. ON an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX injection. (lot number, dose, strength, frequency and route was not specified). No concomitant medications were reported. On an unknown date, the patient experienced rash at the injection sit4e and torso after receiving (Oka/Merck) VARIVAX. The patient sought for the medical attention and visited the office on unspecified date. The action taken of the suspect drug with respect to event was not reported. The outcome of injection site rash and rash was unknown. The causality was not reported. No product quality complaint (PQC) was filed. The reported events were not considered as cancer. No further adverse event (AE) information was provided by the reporter. Additional information has been requested.
Rotateq administered 2/15/07. Hematochezia began 2/18/07. Vomiting and abd pain 2/20/07. Air contrast enema negative on 2/21/07. Child better on Alimentum.
Non arteritic ischemic optic neuropathy in one eye; swelling/joint inflammation in one hand. Started several days after 2nd Pfizer Covid-19 vaccination.
Arm pain at injection site, chills and back pain. Patient took Tylenol and Ibuprofen and was better within 24 hours
1 hr post/vax, I had tightness in my chest & difficulty breathing, dizziness & a local rxn of swelling & redness. I was Rx'd w/Bendaryl & to see an Allergist. On all 5 injections I have had, I had stinging sensation & rxns are getting worse
Nothing was identified until 6/2/22 as reported previously. Trace blood was found in urine.
foggy head; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy head) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN B [VITAMIN B NOS] for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 08-Mar-2021, the patient experienced FEELING ABNORMAL (foggy head). On 08-Mar-2021, FEELING ABNORMAL (foggy head) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Concomitant medications was not reported.  Treatment for the events was not provided Consent given.
This spontaneous report was received from a registered nurse refers to an infant of an unknown age who on 01-FEB-2013, was vaccinated with a dose of ROTATEQ (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that within 30 seconds of administration on 01-FEB-2013, the infant regurgitated the dose of ROTATEQ. No adverse effects were reported. The relatedness for within 30 seconds of administration the infant regurgitated the dose of ROTATEQ was unknown for ROTATEQ. Additional information has been requested.
17AUG93 tc from mom pt recvd vax 16AUG93 & had fever 103 & rash on face & body-face swelled up;
This spontaneous case reported by a consumer, describes the occurrence of vomiting in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included decreased hearing. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 22, 2021, patient experienced vomiting. At the time of the report, vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant product use or treatment medications reported.
On Friday I received the current flu vaccine. Later in the day my face was hot and over the weekend the skin on my face was very dry and my face had some mild puffiness. Nothing serious, in fact I am not completely sure the puffiness is from the vaccine. But I thought I would report it as that is the only cause of the facial dryness and puffiness that I can think of as a cause.
The day after I recieved the Moderna COVID-19 vaccine i started getting itchy hives on my body. Some are small bumps, and some are groups of bumps. They appeared on both arms, both legs, and my body.
Lot of pain; This spontaneous case was reported by an other and describes the occurrence of PAIN (Lot of pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced PAIN (Lot of pain). At the time of the report, PAIN (Lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   Treatment for the event not provided.
Fever and Rash over arms, legs, tommy, back, feet and hands. 24 hours duration. He got the Rash 8 days after vaccination. Treated with Benadryl only.
Inappropriate schedule of dose; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore left arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of dose). At the time of the report, VACCINATION SITE PAIN (sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of dose) outcome was unknown.
I received the polio vaccine at two years old. In a two week time period I came down with the polio virus. I wore a brace and used crutches until 2005. I now use a power chair, some of the time. In August of this year, I was diagnosed with Post-Polio Syndrome. Record received from treating facility given by pt. reporter, which is a Consult for a Sleep Study. Brief medical notes received from diagnosing MD, as patient had not been seen since 1995 prior to the 08/08/2006 visit.  Initial assessment in 1995 was for post-polio syndrome.  Visit of 8/8/2006 reports increased problems of lower extremity weakness and overall fatigue.  Endurance and strength have declined. PE: DTRs are 1-2+ and even, cranial nerves intact, normal strength in upper extremities and normal sensation in the lower extremities. Left sided paresis in the quads and significant atrophy here.  Pt. has a tremor in the tongue and right upper extremity. Ritalin prescribed for fatigue. OV 10/17/2006 reveals no new significant problems. Ritalin was helpful with activity level and ability to concentrate. No other records available. At onset of Polio I became paralized in left leg.  I have had to wear a long leg brace and to walk on crutches.  I have had to have over at least fourteen seperate operations to correct muscles over- various problems in leg.  I was unable to have my two children natural.  I had to have c-sections with both children.  In 2006 the Polio virus became active once again.  I now have progressive brain damage, Post-Polio syndrome, chronic fatique, a leaky heart valve, sleep apnia, muscle atrophy, tremors in tongue and hands, acid reflux, A.D.D.  I have scoliocise from one leg being longer than the other because of Polio.  I have carpal tunnel syndrome from walking on crutches since the age of five.  All this can be verified by my Polio Doctor. The long leg brace I wear breakes all the time.  Medicade will only pay for a new brace every five years.  To verify just how often I have to get this brace fixed or maintaine.  Having Polio is a pain in the ass!   I will have to have spine surgery I may not live through.  If I pass during my spine surgery Polio will have claimed another person. Follow-up: Infantile Paralysis Poliomyelitis or Acute Flaccid Paralysis ---10/1963. Brain damage---10/1963. Progressive brain damage--6/13/06. Post-Polio Sydrome--6/13/06. Chronic Fatigue--6/13/06. Carpal Tunnel Sydrome--6/29/06.
Three or four days later diarrhea started; Colour is blackish (possibly blood); A spontaneous report was received from a consumer concerning herself, a 96-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea three or four days later and the color was blackish (possibly blood) / faeces discoloration.  The patient's medical history was not provided. Concomitant product use was not provided.  On 27 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Jan 2021, the patient experienced diarrhea and the color was blackish (possibly blood). The patient reports that the diarrhea has continued and she was concerned about the second dose of vaccine that was scheduled on 24 Feb 2021.  Treatment information, included that the patient have not taken any medications.  Action taken with mRNA-1273 in response to the events was not reported.   The event, diarrhea was not resolved at the time of report and the outcome of the event, color was blackish (possibly blood) was unknown.
Intense flu-like symptoms starting with chills and after 2 hours, fever lasting another 2 hours
The patient had an adverse event reaction at some point; Initial information received on 08-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who had an adverse event reaction at some point, while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had an adverse event reaction at some point (adverse event) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
This vaccine was given 1 day past the BUD (6/23/22).  Moderna was contacted and the lot was analyzed.  Per Moderna this lot was still active and the patient did not need to be revaccinated.
pt recvd vax 6AUG92 & the next day devel achiness all over & tiredness; progressed over the next 2 to 3 days into moderate throbbing daytime pain & severe noc time pain; pain was noted to be in hips & knees;