chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; product storage error; This spontaneous report was received from a healthcare professional referring to a 1 year old patient of unspecified gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022315, expiring on 30-JUN-2022, 0.5 milliliter for prophylaxis (route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039319, expiring on 04-DEC-2021, for prophylaxis (dose, route and site of administration were not reported)      The administered doses of the vaccines experienced a temperature excursion of -1.6 degrees Celsius for 1 hours and 36 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
My daughter received a GARDASIL 9 vaccine on September 12, 2016 and has not had her period since that time. She was 15 at the time the vaccine was administered and had been having regular menses since she began at the age of 11.
Awoke with vertigo.  Symptoms: dizziness, nausea, headache.   Saw PCP, was diagnosed with vestibular neuronitis.  Received short course of Meclizine to help with dizziness.
Discolored arm; Yellowand purple bruise mark; Head cold; Felt different; More tired than usual; Muscle ache; Hurt when she was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different) and FATIGUE (More tired than usual) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated). At the time of the report, VACCINATION SITE DISCOLOURATION (Discolored arm), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated) outcome was unknown and VACCINATION SITE BRUISING (Yellowand purple bruise mark) was resolving. Not Provided          The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
I received a high-dose flu shot on September 27, 2017, on the left arm. The next morning there was some soreness of the arm, at the site of the flu shot. Then later I discovered three small pimple-size hives around the site of the injection. At this time, I feel normal (except for a very small lingering cold) and fine.
Mouth pain, enlarges tongue, tongue ulcer or canker sore, body aches, chills
Initial unsolicited report received from a nurse on 14-Sep-2018. This case involves a 15 months old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE lot UI796AAA via unknown route in the left thigh on unknown date. The patient's medical history and concomitant medications were not reported. Concomitant medications included PREVNAR for Immunisation; and DAPTACEL for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown whether any adverse event reported. 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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Began with extreme pain, throbbing and burning at site of injection and diffuse pain throughout my shoulder. Pain continued with stiffness in neck since then. Went back to the clinic and they prescribed a steroid pack for 6 days to calm the area. Still having difficulty lifting the shoulder.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, historical conditions, concomitant therapies, and allergies were not reported.  On unspecified multiples dates, the multiple patients were vaccinated with varicella virus (OKA/MERCK) live attenuated [MRC-5 cells] (VARIVAX) (lot no. W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024) (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after a temperature excursion (Product storage error). The administered dose of the vaccine experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. There was no previous temperature excursion. No additional adverse event (AE) reported.    This report was classified as non-valid due to the lack of patient's identifiers and as it concern to multiple patients.  Follow-up information has been received from a nurse on 08-FEB-2023.   This spontaneous report has been received from a nurse, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.  Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA004610: US-009507513-2302USA004609: US-009507513-2302USA004606: US-009507513-2302USA004607:
swollen, erythematous lt arm area 7x6cm;tightness in throat, dizziness, induration on lt arm 4.5 x 5cm;
Patient said she feels dizzy after vaccines sometimes. After administration she was walked to a chair in our waiting are and at that time was fine.  After about 5 minutes she fainted in the chair and appeared to have a seizure. We called 911 and we were able to get her to talk to us but she appeared to go in and out of it. After the paramedics arrived she became better and better. She was able to walk out of the store with her mom and appeared fine. We spoke with her dad later that evening and she was doing well.
Reaction started two days later in the morning. Initially it showed up "as a large mosquito bite". Then more appeared, eventually totaling approximately 15 total. The center of the "lesion" had a "little bubble" in the center of it and when it broke open, a sticky exudate came out. They were extremely itchy. She was treated with a course of Prednisone starting the following Wednesday. That's when the itching stopped.  She still has lesions that have not completely gone away yet.
chest congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (chest congestion) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest congestion). At the time of the report, CHEST DISCOMFORT (chest congestion) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had chest congestion for a week after getting the booster. Treatment information was not provided.
Sebaceous cyst that grew in the glands next to the armpit; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Sebaceous cyst that grew in the glands next to the armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CYST (Sebaceous cyst that grew in the glands next to the armpit). At the time of the report, CYST (Sebaceous cyst that grew in the glands next to the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event include shot of steroids.
abdomen cramps, abdominal pain, joints ache, muscles ache, body aches, high cholesterol, blood pressure: spikes and drops, acne, agitation, allergic reaction, allergies, alpha intrusion, Amblyopia, Amnesia, anal fissure, bursitis, Cachexia, Anaphylac, Anorexia, Anxiety, Cardiovascular dis, chills, cellulitis, chills fever, appetite loss, arm; hot to touch, arrhythmia, cold and flu like symptoms, concentration difficulty, concentration loss, concentration trouble, neurological confusion, asthma, blackouts, passing out, dizzy upon standing, falling down, dizzy spells, vertigo and dizziness, coordination problems, cough, cramps leg, balance problems, bladder problems, bloating, blood pressure high, numbness and tingling arms legs, paresthesia, photophobia, pain lower back, pain legs, pain shoulder hips, pain chest, pain groin, pain back, pain knees, pruritus, rash, macular papular rash, pustular rash, gout like pain in right foot, body pain, rectal bleeding, shortness of breath, exertion, stomach pain, bone and joint pain, muscle and joint pain, respiratory problems, satellite lesion (usually refers to rash), arthritis pain, ear pain, chemical sensitivity, shaking (tremors), sinusitis, cysts developed, itching, eczema, neck pain, burning sensation on skin, skin discoloration, Charlie horse, pallor, palpitations, paralysis that lasted for one day on one side of her body, pustule sores on scalp, urinary retention, Uveitis, straie, insomnia, sleeping problems, unable to comprehend words, vertigo, feel not refreshed upon waking up, shifting sleep patterns, unable to sleep flat with out medication, poor tolerance for bright lights, tunnel vision, vision problems, photophobia, blurred, speech disorder, stomach problems, voice alteration, walking difficulty, weakness, weight gain, stupor, strength loss, stomatitis aphthous, suicide attempt, weight gain, sweating, inappropriately hot, joints welling, glands swollen, lump in neck below ear behind jaw line, syncope, tachycardia, loss of taste, tendon disorder, testicular failure, shrunken testicles, thinking abnormality, thirst increased, throat swelling and closing, Tinnitus, tiredness, tremors, twitching or jerking. 7/5/07-records received:Seen in clinic for DX: epididymal tumor. asthma unspecified. hypertension. gout. mixed hyperlipidemia. hydrocele. diverticulosos of sigmoid. external and internal hemorrhoids. low back pain. impaired fasting glucose. intervertebral disc disorders. osteoarthritis. overweight.
I started having syncope and near-syncope episodes in June 2021. And this was intermittent, random, unprovoked and just happened. Wasn't sure if it was blood pressure, heart or seizures. I was worked up by Cardiology and they had me wear a heart monitor at the end of august because this thing went in overdrive at the end of July. They stopped me from driving because they weren't sure what was causing me to pass out. After a report in August, I was immediately hospitalized because I was having runs of ventricular fibrillation and ventricular tachycardia. Max heart rate was 387bpm. I was in ICU cardiac arrest - mind you I am a very healthy person.  No body knows what's going on, my diagnosis is idiopathic ventricular fibrillation.
pt recv vax 17OCT95 & the evening pt exp sharp pain like bursitis;pt could not use arm 3 days;tx w/Ibuprofen did not help;
intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contactable physician. A 38-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at left arm on 06Jan2021 14:00 at single dose for COVID-19 immunization. Patient had Covid prior vaccination. There were no concomitant medications. No other medications in two weeks. No other vaccine in four weeks. On 07Jan2021, The patient experienced fever and body ache for the first 2 days. On the 3rd day (19Jan2021) experienced intense chest pain and nasal congestion. she needed to go to Emergency Room where she stayed for 4 hours, and performed Thorax CT. No treatment received. The outcome of events was recovering.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 31-OCT-2014, administered at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 22-APR-2015, the patient was treated at a medical center, for a painful outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Started with  a headache on  Wednesday  lasting till late Saturday night. On Friday was running a low grade fever. On Sunday i was dizzy.
Patient called 11-28-08 and said her arm was still sore from vaccine. Pain is like that of a sore muscle.
diagnosed with COVID; felt worse than normal / body felt strange; Did not had any energy; a bit more tired than usual; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 037C21A, 007B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2022, the patient experienced COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. On 30-Jul-2022, COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual) had resolved.            No concomitant medications were provided by the reporter.  It was reported that symptoms lasted for about 5 days and took Paxlovid to treat COVID.  Company Comment: This spontaneous case concerns a 78-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of feeling abnormal, asthenia and other expected event approximately 3 months after 4th. dose of  mRNA-1273 vaccine. The patient was treated with PAXLOVID for 5 days. At the time of the report, the events had resolved. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   Reporter did not allow further contact; Sender's Comments: Company Comment: This spontaneous case concerns a 78-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of feeling abnormal, asthenia and other expected event approximately 3 months after 4th. dose of  mRNA-1273 vaccine. The patient was treated with PAXLOVID for 5 days. At the time of the report, the events had resolved. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
horribly ill/Felt very sick; started with dry heaves; feeling of weakness; Had to get to bed right away; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder disease and COPD. Concomitant products included BUDESONIDE, MOMETASONE FUROATE (ASMANEX), METOPROLOL, FUROSEMIDE, CLOPIDOGREL, METOLAZONE, POTASSIUM, MONTELUKAST, SIMVASTATIN and ALPRAZOLAM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away). At the time of the report, ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-043746, MOD-2021-034069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant
Pt had pain, swelling and redness to the right shoulder/arm with streaks going down his arm after receiving anthrax vaccine (#16).  He experienced fever/chills, headaches, and abdominal pains/nausea over the last 2-3 days.  Pt was seen by physician and immunization clinic staff and treated with steroids MEDROL dose pack), antihistamines (Zantac and Zyrtec), and Motrin.
armpit pain and headache, last night got chills; headache; chills; was very exhausted; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (armpit pain and headache, last night got chills), HEADACHE (headache), CHILLS (chills) and FATIGUE (was very exhausted) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced CHILLS (chills) and FATIGUE (was very exhausted). On an unknown date, the patient experienced AXILLARY PAIN (armpit pain and headache, last night got chills) and HEADACHE (headache). At the time of the report, AXILLARY PAIN (armpit pain and headache, last night got chills), HEADACHE (headache), CHILLS (chills) and FATIGUE (was very exhausted) 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.   Concominant medications were not reported.  Treatment information was not provided.
Got the shot from a nurse, which hurt a fair amount, but didn't think much of it. Shot site sore as expected initially, but then got increasingly worse that evening, to the point of severe pain which kept me awake all night, and had difficulty moving and lifting arm (literally hard to move, not only because it hurt). Also, there has been swelling in the upper right arm muscle, which is causing the muscle to not function properly. Although the swelling improved a little bit (helped by massage from an OT 10 days after injection), it continued even three weeks later and caused pain in other areas of the shoulder and arm due to having to compensate. Now it is a month later and it is more improved in terms of swelling, but not 100% because muscle still tired sometimes (while filling this in!).
Immediate redness at injection site with 3mm wheal. By 15 minutes, erythema was palm size and local swelling started. Within 4 hours large local swelling at site, child not bearing weight. Swelling worsened over course of 24 hours despite ibuprofen ATC and ZYRTEC twice daily. No systemic symptoms. Similar reaction in 2019 from a preservative free influenza vaccine given by PCP.
At approx. 1339, pt reported fogginess and dizziness.  Airway, and breathing were clear. Vitals were 130/90 BP, 90 BPM (strong), 99% O2 room air, and 14 RR. Pt reported only having orange juice at 1200. Pt was asked to drink water and stay for  further observation  for 15 minutes. Pt reassessed at 1355. Vitals were 120/80, 85 BPM regular,  RR 12 and 99% O2 room air.  Pt stated she felt better and left  facility with steady gait  and unlabored breathing at 1400.