chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 50 year old male patient. The patient's medical history included depression and on an unknown date in February 2015 the patient had a foot injury due to fall. No drug allergies were reported. On 11-MAR-2015, the patient was vaccinated with ZOSTAVAX subcutaneously (lot number and expiry date was unknown) (dosing regimen and frequency was unknown). It was reported that the patient was taking concomitant medications (details unspecified). On 13-MAR-2015, the patient visited an unspecified spinal specialist due to fall he had in February 2015 and the spinal specialist diagnosed the patient as having bulging discs (disability) in his back due to the fall the patient had in February 2015. It was reported that the even tcaused the patient significant disability or incapacity and the patient had been out of wrok since February 2015. It was reported that the patient sought medical attention and visited a spinal specialist. The spinal specialist prescribed the patient an unspecified dose of an unspecified corticosteroid. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the event was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
has a problem with her teeth; This is a spontaneous report from a contactable consumer.  A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient said she got the first dose of the Pfizer COVID-19 Vaccine and was doing fantastic. She said she was now getting ready to get her second Pfizer COVID-19 Vaccine dose, but had a problem with her teeth and needs to take an antibiotic, and will need to see a dentist. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator:18-Oct-2021 No temperature excursion of product reported. No adverse events were reported.   No concomitant drug information was provided.
There is a bumpy painful rash at the injection site - rash seems to be fading as days go.
p/vax pt exp localized swelling @ inj site, a fever & arrhythmias;pt hosp;60 day follow-up received on 10/25/00 provided no additional data.
tested positive for COVID after getting the 1st dose PFIZER-BIONTECH COVID-19 VACCINE - Patient received the the 1st dose 21Feb2021 then tested positive for COVID 27Feb2021; This is a spontaneous report from a contactable consumer reporting for his wife (patient). A female patient of an unspecified age (age: 55; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included immunocompromised from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient tested positive for covid after getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE; the patient received the 1st dose on 21feb2021 then tested positive for covid on 27feb2021.The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 27Feb2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
pt recv vax & several hr later, devel redness & swelling @ the site of vax, nausea, h/a, chills & drowsiness;
Became Anemic, with hemoglobin going to 7, became very tired, sleepy, loss of appetite.
Developed scattered hives like rash approximately 24hr after administration of vaccines. No respiratory distress & otherwise nl exam when seen for f/u sent home with BENADRYL prn.
Headache, body ache, sensitive muscles, low-grade fever (99.2), fatigue, chills.
Syncope and vomiting. Patient was given FLU vaccine and felt ok afterward. Explained that she was afraid of needles but felt fine and prepared for the next shot. Patient was given second vaccine and stated that she did not feel well immediately afterward, after about 1 minutes the patient lost consciousness, she regained consciousness after 5-10 seconds and immediately started vomiting. Patient was alert and oriented within roughly 15 seconds from waking up.
Moderna dose was drawn up and administered after recommended 12-hour punctured Beyond Use Date but before recommended 24-hour room temperature unpunctured Beyond Use Date.
Patient tested positive for COVID-19 on Monday the week later (5APR2021); This is a spontaneous report from a contactable consumer (mother). A 28 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 01Apr2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. Patient (Son) received the first dose on a Thursday, 3 weeks ago (01Apr2021), and was scheduled to receive the second dose this Friday (23Apr2021). Patient tested positive for COVID-19 on Monday the week later (05Apr2021), but he was better now as reported. It was asked if patient can get the next dose. Seriousness reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Increased heart rate, rash on chest, arms and legs, redness on palms and face, tightening of chest. 50 Mg of benedryl X2 ( 4 hours apart) resolved issue
Patient complains that her body aches, felt like throat closing up for about 3-4 hrs, redness of chest & throat, eyes bloodshot & watery. She felt like this during the evening and she states she just slept through the symptoms.
Next morning after taking the shot everything on the right side he had trouble with. As the days go by he was in pain, he couldn't move his hands, and dragging his legs. He went back to the dr. and he put him on prednisone.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that no treatment was given on the patients. No concomitant medications were reported.
Family noted route post vaccination symptoms including fatigue, fever shortly after vaccination and within first 24 hours.  >24 hours patient began having increase in activity level, emotional lability, hyperactivity, flight of ideas, auditory and visual hallucinations, etc.
Patient reports low grade fever on day of admin. Presented to pharmacy with hard, red injection site that was warm to touch. Site surrounded by large swollen area of light red skin approx. 8" in diameter.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA291015 (10 year old patient). This case involves a 7 years old male patient who received a pediatric dose 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259NA and expiration date 30-Jun-2019) via intramuscular route in the left deltoid on 13-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient experienced any adverse event. 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  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. List of documents held by sender: none.
sore arm; achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1989 and Diabetes since 2010. Concomitant products included ATENOLOL for Blood pressure high, GLIPIZIDE for Diabetes, METFORMIN for Prediabetes, HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication.   On 05-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to MOD-2021-317919 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Patient Demographics Added. Medical History Added. Concomitant Medications Information Added.
no adverse event; Improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse referring to 12-month-old patient of unknown gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patient involved was not reported.  On 13-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number: W002601 (expiration date: 24-JAN-2024) for prophylaxis (strength, route, dose or units were not provided).   The storage characteristics were the following: Temperature: -11.8C Time frame: 1 Hour 45 Minutes 0 Seconds Previous temperature excursion?: No  No adverse effects were reported.
Patient of 5 years had previously received 2 pfizer primary series and patient's parents were adamant in requesting Moderna vaccine as booster. Pt received Moderna as a booster, when patient should have received 3rd dose of pfizer. No adverse reactions seen in patient.
patient had a dizzy spell right after vaccination, fell and hit his head against  the pharmacy counter. patient was asked to sit and rest for about half an hour and was fine after
SIX DAYS AFTER VACCINATION SEIZURES (INFANTILE SPASMS) BEGAN; CLUSTERS OF SEIZURES RANGING FROM 20 TO 60 SPASMS IN APPROXIMATELY 5 TO 7 MINUTES (SOMETIMES LESS); SIEZURES HAVE CONTINUED TO PRESENT STILL AVERAGING APPROXIMATELY 30 A DAY (SOME DAYS MORE, SOME DAYS LESS); EACH SEIZURE LASTS APPROXIMATELY 2 - 3 SECONDS WITH A TIGHTING OF THE BODY WITH ARMS FLARING OUTWARD, EYES ROLLING UP/BACK; SOMETIMES GROANING SOUNDS AND CRYING; FULL BODY JERKS FORWARD WITH HEAD JERKING DOWNWARD; SEIZURES COME IN QUICK SUCCESSION (ONE IMMEDIATELY AFTER THE OTHER) HENCE "CLUSTERS"; TREATMENT: ACTH INJECTIONS (INTRAMUSCULAR) FOR 6 1/2 WEEKS (DR. STOPPED MEDICINE DUE TO ADVERSE SIDE EFFECTS); NO MEDICINE GIVEN FOR APPROXIMATELY 10 WEEKS--SEIZURES APPEARED TO BE DEMINISHING, BUT AROUND THE 8TH WEEK OF BEING OFF OF ALL MEDICINES, SIEZURES INCREASED AGAIN IN FREQUENCY AND INTENSITY; STARTED ZONEGRAN BY MOUTH FOR 3 1/2 WEEKS WITH NO SIGN OF IMPROVEMENT; CURRENTLY ON NATURAL MEDICINES. 60 Day follow up information indicates patient has not recovered from the event. Still having over 100 seizures a day. Each seizure lasts about 2-3 seconds-some less and some are stronger than others. Seizures have caused delays in development. Physicially could be dangerous due to falling/hitting head while/after having a seizure.
She was laying down with the patient taking a nap this afternoon when she was awakened by, what she described as a gurgling noise.  She turned to find the patient with eyes rolled up and both upper extremities shaking.  She called 9-1-1 and the patient was transported via ambulance to Hospital.  The EMS stated that they gave the patient rectal Valium, and they did not notice any seizure activity en route to the hospital.  In the emergency room, the patient was described as being postictal, but then began to have generalized tonic clonic activity.  She received Ativan with no result.  She then received a dose of Valium and continued to have seizure activities, so the patient was given a neuromuscular blockade and was intubated at that time.  She was then loaded with 20 mg/kg of fosphenytoin.
pt recv vax & devel an inj site rxn characterized by swelling & redness;the redness extended to the foreamr;pt also exp nausea, chills, backache;
Headaches, vomiting, diahrrea, shortness of breath. Asthma reacted - went to ED on 11/8/09.  12/02/09 ED notes for DOS 11/10/09 DX: Cough  Pt c/o worsening cough, headache, runny nose for 3 days, body pain. On examination the skin was warm and dry, tachycardia, productive cough, vomiting and diarrhea. tx: albuterol, prednisone, chlorapheniramine-hydrocodone. Pt improved and discharged home.
Pt developed cellulitis to 14cm x 9cm area on left arm treated with Keflex symptoms resolved.
CDC reports: 4 yo child developed fever to 104 x3 days, then fever 102 x 3 more days. Also had rash (face, neck, arms) & hives following DTP/OPV/MMR immun. Duration of illness 10 days. Pt had possible viral infection.
Sore throat; nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), intramuscular on the right arm on 15Dec2020 17:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were none. On 15Dec2020 19:30, the patient experienced sore throat and nausea. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he felt extremely nauseous and looked very pale. His blood pressure was checked and measured 120/66, he said he was starting to feel warm but did not have any chest tightness, difficulty breathing, or swelling. After about 2 more minutes he said he was starting to feel better and then after 5 more minutes his blood pressure was 120/81, and he was starting to show more color to his face. He said he felt fine to leave. In hind-sight he stated that he has fainted in the past after seeing his wife receive a previous immunization as well.
PATIENT SAID HE HAD SWELLING IN FEET, KNEES, HANDS, NECK, PALATE (UPPER PART OF MOUTH)
got a red, itchy, and swollen l rash where I got the shot.    pregnant: 13 weeks
7 days p/MMR devel severe t101.4, facial rash; fever resolved 3day; had febrile sz requiring ER visit;
On 6-21-2022  when I woke up was very dizzy.   Went to work at 6 am and got very dizzy and feeling nauseous.  Started throwing up.  Left work thinking it was a virus.  Next day work up tried to go to work same thing happened.  Called doctors office and they set up a virtual visit.  When speaking to doctor he said could be vertigo.  I didn't think to tell him that I had just gotten the 4th moderna  shot and first shingles shot a week earlier.  On Thursday still very dizzy went to Urgent care where they did ct scan, ekg, and sugar level to rule stuff out.  The outcome was that I have vertigo which I didn't think to tell them about the shots.  When picking up prescription meclizine 25 mg , they suggested that I let you know about what happen.  Don't know if that caused it but just to let you know.
Site: Swelling at Injection Site-Medium, Systemic: MUSCLE SPASMS-Medium
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2013, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 26-MAY-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
it was rpt by MD concerning pt vax & subsequently exp a varicella-like rash w/less than 50 lesions, fatigue & arthralgia
Information has been received from a physician concerning a 26 year old female who on 08-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # not provided).  On 17-JUL-2007 the patient received the second dose of Gardasil (Lot # not provided).  On 18-JUL-2007 the patient experienced severe itching an a large rash.  The patient sought unspecified medical attention.  The physician reported that the patient did not have any problems after the first dose.  The physician stated that she was "not sure" that the patient will receive a third dose of the vaccine.  Additional information has been requested.
Pfizer booster dose was administered approximately 12:35 pm and patient began to feel unwell approximately 10 minutes later. Patient felt like she may have a syncopal episode but ultimately did not.  She experienced diaphoresis, pale skin, and sensitivity to light. No signs/symptoms of anaphylaxis were identified. EMS was called upon request by patient for evaluation.  Pharmacist stayed with the patient until EMS arrived and upon evaluation the patient seemed to be feeling somewhat better and refused transport to hospital.  Patient left pharmacy with husband approximately 30-40 minutes after vaccination.
We are all Dtaped. Aka vaccinated/Suspected vaccination failure; Whooped; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whopping cough were not provided. The patient received Dtap and had whopping cough. No further information was provided. This case linked with US2020AMR227439, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227439:reporter's case
After administration of Hep B on 6/5/14 patient reported about 30 minutes she felt like her throat was swollen and it hurt to swallow. Patient stated sensation lasted about 2 hours and resolved on its own.
red rashes on my forearms and chest; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. The patient did not receive any other medications within two weeks of COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19, since the vaccination. On 25Ma2021 at 16:30, the patient had experienced red rashes on his body especially on forearms and chest on the day after vaccination. He did not notice this until the next day of vaccination. Prominently those red rashes occurred multiple times during the day. They remained prominent for 30 to 40 minutes after which they had subsided. He also noticed that they also occurred after he ate something, but he did not change anything as far as his food was concerned. He had the same food that he was had before getting vaccinated. There were no changes in food. The patient did not receive any treatment for the adverse event. Adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event red rash was resolved with lasting effects on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Per doctor orders: warm compresses and Tylenol and waiting to see if instructions are going to work if not the next step will be to give Benadryl