chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 11-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Pt's was sweating, involuntary arm movements and eyes were fixated.  Did not recognize name or respond to voices or touch.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (STUFFY NOSE/CONGESTION); This spontaneous report received from a consumer concerned a 61-year-old male of unspecified ethnicity and race. The patient's height and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD) and High blood pressure (HBP). Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: unknown) 1 total, dose was not reported, administered on 06-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the patient experienced stuffy nose. On 26-JUN-2021, the patient tested positive for covid-19 antigen test (confirmed covid-19 infection, confirmed clinical vaccination failure). Next day, on 27-JUN-2021, to verify whether the previous result was correct, patient was tested again using a PCR test kit and result was positive again. On the same day, patient received Regeneron monoclonal antibodies. On 30-JUN-2021, at the time of reporting, patient still had some congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection (stuffy nose/congestion) and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700296-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
About 16 hrs after admin of FLUZONE'0910, (L) tight became very large, swollen, erythema, tender, hot - >10 cm induration.
1615-  complained of feeling nauseated, tingling fingers, BP-176/135, p-91, O2 sat- 98%,  patient with small amount clear emesis given Zofran 4 mg SL 1626- BP- 173/95, p-84, O2 sat- 96% 1644- p-77, BP-164/94, O 2 sat- 97%    Feeling better, no further nausea, no further dizziness Home with family members with instructions to seek immediate care if any shortness of breath, trouble swallowing,  swelling of lips, tongue or mouth
waiting in observation on a 30 minute wait time, reports change in voice, gravelly sensation in throat, clammy hands, not feeling right  reports similar reaction to contrast dye, no SOB no audible wheezing
Information has been received from a pharmacy tech concerning a pediatric patient who was vaccinated with a dose of MMR II. It was reported that at titer was drawn and the patient failed to seroconvert to mumps. No addition al information was provided. Unspecified medical attention was sought . Additional information has been requested.
Patient presented to ED on 02/09/2022 for chest pain and mild shortness of breath.  The patient tested positive for Covid-19 on 02/08/2022.  The patient required 2LNC in ED.  Ddimer elevated, and patient was admitted to rule out a PE.  Patient also presented with AMS.  The ED started the patient on a heparin qtt.  Patient expired on 02/23/2022.  Death diagnosis include Respiratory Failure, Covid-19 PNA, Failure to Thrive, AKI, NSTEMI with elevated troponin.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from other health care professional referring to a 16-month-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 17-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number 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, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported), and  pneumococcal vaccine conj 7v (crm197) (PREVENAR) (dose, route of administration, vaccination scheme frequency, anatomical location, indication, lot number, and expiration date were not reported). The administered doses of the vaccines experienced a temperature excursion at -10.5 degrees Celsius for 1 hour and 34 minutes. It was not mentioned if there was a data logger implied. There was no previous temperature excursion. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
Anxious to get 2nd dose; Not received 2nd dose yet; Swelling of the lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of the lips), ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced LIP SWELLING (Swelling of the lips). On an unknown date, the patient experienced ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet). On 18-Feb-2021, LIP SWELLING (Swelling of the lips) had resolved. At the time of the report, ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) 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.   Concomitant medications were not provided. Treatment information was not provided. Patient doctor had put patient on hold from taking the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received contains significant information. Added events anxiety and dose omission.
Fever; Chills; A spontaneous/solicited report was received from a consumer concerning a female patient and who experienced fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the shoulder for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient experienced fever and chills. Her temperature reached 101.7 degrees Fahrenheit. Treatment for the event included paracetamol; after taking paracetamol her temperature decreased to 100.6 degrees Fahrenheit, and her chills subsided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, fever, was considered not resolved. The event, chills, was considered resolved on 22 Dec 2020.   The reporter did not provide a causality assessment for the events, fever and chills, to study drug.; Reporter's Comments: Company Comment: This case concerns a consumer report of a female patient who experienced a listed events of fever and chills per EUA fact sheet. The events occurred 2 days after the first dose of vaccine administration.. Company causality assessed as possibly related.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in approximately 2015, reported as 1-2 years ago, the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date unknown) for prevention of shingles. On an unknown date, the physician stated that the patient complained of injection site reaction {unspecified date) of blistering, nausea, fever, and dizziness. The physician stated that the patient's symptoms seem to be "vague systemic symptoms" of nausea, fever, and dizziness. The physician stated also that it appeared to be an "immune complex hyper sensitivity type of reaction or serum sickness. No treatment information was given for this incident. The physician did not recall what else took place with the patient. No other information was provided on this matter. The outcome of the events was unknown. The causal relationship between ZOSTAVAX and the events was not provided. Upon internal review, "immune complex reaction" was determined to be medically significant.  Additional information has been requested.
Chills beginning after bedtime (about 10:30 PM), followed by sweats to about 3:00 AM. Fever of 100.5 deg F.  Symptoms treated at home with 650 mg aspirin. Fever and all other symptoms resolved themselves by 7:00 AM and did not recur.
A week after my vaccine injection I noticed that a red spot had developed at the injection site.  It is raised and feels hard but it doesn't hurt or itch. It is round and about 1 inch in diameter.
Face flushed, c/o itchiness on face ant throat lethargic, weak, vomited x 3 10 min after given injection 420. 430 pm Epinephrine 1 1000, nd given SW rt. Benadryl tsp given 440pm. bp 96/56, BP 80/42 HR 84, HR 100 Pulse 02 100%, 430. pulse oz 96%, 4:45pm.
Approx. 10 minutes after receiving HPV #1, youth felt dizzy while sitting down in lab and having blood work drawn. Then, felt dizzy and rolled head and stated he was dizzy. Blood sugar immediately taken via finger stick and glucometer was 56. No food since yesterday 12/18/15 t.c. to mother. No further sx.
My arm got sore after I received the shot.  It really had stayed a little sore from the time I got the first shot.  It is still sore, four months later.  I started physical therapy on it about a month ago, because it kept bothering me when I would try to use it.  It is not severely sore, but I feel it if I try to use my arms more vigorously when I walk.  It is frequently sore at night.  I feel it when I try to turn over in bed.  I get a minor shooting pain when I lean on it.  I had rotator cuff problems a few years ago, that were 99.999 % under control after physical therapy and not bothering me.  From the time I have received the first short in February 2021 and definitely since I received the second shot on March 15, 2021, it has been bothering me again, particularly when I try to use it with a little more weight, pressure or motion.  It cycles between me thinking it is improving and then getting worse again.
Headaches, Lymph nodes in the throat area, tired, and joint pain in the wrist area.
Pt received HPV9 along with Tdap and MCV4 at age 11 yrs on 9/28/17. 1-2 months later, he complained of hearing voices and hurt himself, depressed. Admitted to hospital on 6/18/18 for suicide attempt. No prior h/o mental problems.
First Hepatitis A dose administered Feb. 24, 2022 but at a pediatric dose.  Also administered Feb. 24th was a DTAP booster.   Doctor called to say initial Hep A dose was incorrect, please come in for another shot.   On  Friday, 4/1/2022 I received a second, adult dose for Hepatitis A.    Mfg. unknown by me for Hepatitis A vaccine.  Over the weekend (April 2 -3 felt fatigued, similar to other times I have received vaccines).  April 4, 2022 experienced fast onset of significant inflammation in both eyes.  Vision very clouded, eye pain; diagnosed as Uveitis by eye doctor.  Indicated it was likely caused by the vaccine.  Immediately started steroid drops and dilating drops.  Steroid drops once an hour for several days, then several times a day for over a month.
Patient said diarrhea started 3 to 4 hours after first dose and lasted 3 to 4 hours off and on. (She said the same thing happens after a flu shot for her.)
Attendee reported dizzyness 15 minutes post vaccination when standing up and walking. Returned to cot, then chair with gradual resolution of symptoms. Attendee reported history of hypertension/anxiety at 20 minute mark and medication history.  Symptoms resolved with stable thought slightly elevated blood pressure and Attendee ambulated home with sister and without assistance.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K0102155, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient was immunized and within 20 minutes of inject felt arm go numb and painful down to finger tips. Patient has been seen by 2 different providers, Dr and PA-C, to report injury.  Patient has also been seen by chiropractor, for continued pain and has requires 2 therapeutic massages to reduce the pain. Patient came back to the pharmacy today report left arm is still in pain from the immunization.
This spontaneous report was received from a 52-year old male pharmacist, who refers to himself. The patient's pertinent medical history included community acquired pneumonia from sinus infection at the age of 13 years old. The patient's drug reactions and allergies included allergy to FLUARIX QUADRIVALENT, sulfamethoxazole (+) trimethoprim (BACTRIM DS) and hydrocodone. The patient's concomitant therapies included montelukast sodium (SINGULAIR), walsartan, sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), atorvastatin, indomethacin, fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and daily aspirin. On 05-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose, lot # and expiration date were not provided) due to history of community acquired pneumonia at age 13. On 06-JUL-2018, the patient's temperature rose to 103.1 degrees Fahrenheit and he had a sizable red reaction an injection site. The patient went to see general practitioner and was prescribed cephalexon. On approximately 13-JUL-2018 (reported as a week later), the patient went to allergist who suggested that the patient might have had an allergic reaction to inactive ingredients as he also received SHINGRIX in approximately 2017 (reported as past year), and had no adverse reactions. The outcome of the events was reported as recovered on an unknown date in July 2018. The relatedness between the events and PNEUMOVAX 23 was not reported.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K005881 with expiry date 04-JAN-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient states numbness to her entire face top of her face to her chin for 4 hours that began 45 minutes after having the Moderna vaccine.
4:00am 4/28/21 - mild fever, chills, malaise/fatigue throughout the day.  Moderate diffuse upper left arm pain.  Treatment with acetaminophen as directed on package.  Fever/chills and malaise resolved by 4/29/21; arm pain reduced to mild and less diffuse.  7:30am 4/29/21 - pronounced left axillary lymphadenopathy  12pm 5/3/2021 - left axillary lymphadenopathy substantively resolved
I was bitten by a bat on July 21, 2018. I was able to capture it and took it to the local Wildlife Center where a form was filled out regarding the animal. Despite info being provided on the intake form regarding the bite, the bat was let go by the local Wildlife Center. It should have been killed and tested for rabies. Because of the condition of the bat was unknown, I had to undergo rabies vaccination (using RABAVERT), which is supposed be a series of the initial rig plus 5 doses, which were administered by the ER at Hospital. The ER failed to read the manufacturers instructions, not once but on 3 subsequent inoculations all of which were administered by different medical staff. In one instance a shot was incorrectly placed in my gluteal muscle which is one of the main areas where you should NOT get the vaccine since there is too much fatty tissue and it can result in the vaccine being rendered ineffective. As a result, I had to start the series over again, and again, there were protocol errors. I have become extremely ill, with fever and chills, blurred vision, slurred speech, burning pain at the injection sites, nausea, narcolepsy, colitis, forgetfulness, and frequent falling due to muscle weakness and dizziness. An infectious disease specialist was called in as well as the CDC and they all decided I just needed more shots, which enhanced my adverse reaction to the vaccine. To date I have been given 15 shots, 2 of which were the initial introduction of weakened rabies virus into my system. My body has no easy way to get rid of the excess vaccine and I have been told I have been overdosed. I have no idea if antibodies have been forming as expected or not because the protocol was not followed. Neither the hospital, the Dept. of Health, nor the CDC have any idea if the shots were effective and no one can guarantee I do not have an active rabies strain in my body, likely due to their incompetence. A titer to test for antibodies should have been done at 14 days, and it was only done this week, almost a month later. I am more sick than I have ever been in my life, I cannot shake this, I have been sleeping most of the time for the past 3 weeks. I have lost 22 lbs. I have no strength and my muscle tone is suffering. In addition, during one visit to the ER, I went hypoxic with my O2 at 80. I called the vaccine manufacturer, Novartis, and they have no idea how to deal with this. There is no protocol to deal with an overdose of this vaccine. Their comment "we just make it, we don't administer it". The CDC advised that if I was not deathly ill and hospitalized they wouldn't get involved. There has been confirmed rabies in bats within a 50 mile radius of my home. Do I have rabies? Will I develop rabies at some time in the future? No one seems to know, and none of the medical professionals who treated me seemed to have any idea what they were doing.
A nurse reported that a 32 year old female received Flu Shield '00-'01 on 12/4/00. On 12/5/00, she developed a red and swollen arm and was seen by her rheumatologist. A dx of infection at the injection site was made. The pt was prescribed an antibiotic.
child born to HBV positive mother, despite receiving HBIg and 3 doses HBV vaccine, child tested HBs Ag positive on 3/22/2002
This spontaneous report was received from a physician and refers to a 54 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Patient reports sore arm, chills, vomiting appx. 4 hours after vaccine administered.
14 mo male had MMR and varicella immunization 11/21/05. 11/29/05 had fever 101.9 degrees and minimal seizure . W/U and exams at the time was not revealing a source of infection. ? ear infection, Rocephin was given IM. Parents have continued to monitor temperature every time the diaper is changed. In the evening pt has 100.4-101.4 temp. No other symptoms. No crying, appetite good, normal BM, playing normally, gaining wt. No vomiting, diarrhea, pulling ears, or cough. Fever non specific. Rash could represent modified measles infection from the immunization. No evidence of encephalitis at present. CDC description of fever from measles is short deviation (2-3 day), varicella has also been described as producing a fever. Pt not toxic and the rash may be from any number of wild viruses in the community. Teething may give febrile reaction. Parents continue to be concerned so will give Zithromax for possible occult infection. Without more than occasional  fever would not advocate spinal fluid analysis, blood cult or repeat blood w/u.
. PATIENT WAS SITTING ON THE CHAIR AFTER THE VACCINE AND  STARTED COMPLAINING  SHORTNESS OF BREATH FEW MINUTES AFTER THE VACCINE . PATIENT'S FACE TURNED RED AND WAS ASKED IF SHE WAS FEELING OK. SHE DENIED WHEN ASKED TO CALL THE AMBULANCE. PATIENT STARTED FEELING BETTER AFTER FEW MINUTES. PATIENT WAS ASKED TO SIT IN THE OBSERVATION AREA FOR 30 MINUTES WHERE PHARMACIST KEPT AN EYE OF HER FOR THE  ENTIRE TIME SHE WAS THERE.