chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning afemale patient, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced expired FLUMIST QUADRIVALENT administration. The outcome od the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report was received via voicemail from a field representative who learned of this adverse event from a nurse practitioner referring to a 17 year old patient of an unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "a couple of years ago"), the patient died from  an unspecified cause It was unknown if an autopsy was performed or not. The causality assessment was not provided at the time of the report.; Reported Cause(s) of Death: on an unspecified date a couple years ago, the patient died from an unspecified cause.
Pt recvd vax & about 1 1/2 hrs later exp sneezing, watery eyes, sore throat & tired; pt still tired, sneezing went away;
Discharge Provider: DO Primary Care Provider : DO  Admission Date: 9/23/2022 Discharge Date: 09/30/2022  PRESENTING PROBLEM: Bilateral pneumonia   HOSPITAL COURSE: The patient is a 70-year-old female with a history of diabetes mellitus type 2, essential hypertension, dyslipidemia, GERD with moderate hiatal hernia, who presented with chest pain on 09/23.  Patient reports that she did have COVID pneumonia in August of 2022. Patient did have a cough and shortness of breath at that time which resolved.  Patient subsequently had developed urinary retention, and had been diagnosed with a urinary tract infection and began Macrobid as an outpatient on 09/20.  The patient noted improvement in her ability to void, but noted left-sided chest pain, under her left breast, worse with deep inspiration, and also radiating to her left shoulder.  Because of her symptoms she came to the emergency room.  CT scan of the chest showed no evidence of PE but did show evidence of left lower lobe pneumonia and moderate loculated effusion on the left side.  The patient was also noted again to be positive for COVID.  It was felt the patient likely had secondary bacterial community-acquired pneumonia, possibly leading to parapneumonic effusion versus empyema.  The patient was started on Rocephin and azithromycin.  With antibiotics the patient's leukocytosis improved.  Blood cultures obtained at the time of admission showed no growth. IR was consulted for thoracentesis which was performed on 9/26/22, showing transudative pleural effusion. Pulm consulted recommended IR consult for possible pleural drain. IR repeated CT chest that showed very small pleural effusion and IR did not recommend pleural drain. Pulm recommended completion of 3 weeks of antibiotics total with Augmentin, also recommended repeat CXR in two weeks with PCP.     As mentioned previously, the patient had noted dysuria and had been diagnosed with a urinary tract infections an outpatient.  Urine culture grew pansensitive E coli.  Macrobid was discontinued at the time of admission.  The patient was treated with Rocephin for pneumonia, also covering any urinary pathogens, with patient being asymptomatic during her hospital stay.   Patient was also noted to have a 1.3 cm right kidney lesion on CT scan of the abdomen pelvis.  This was solid, being suspicious for renal cell carcinoma.  Urology consulted, Given its small size recommended that she follow up with Urology as outpatient, with patient previously seeing Dr.
Severe headache over 12 hrs, vomiting started at 3 AM lasting several hours, hot/cold chills starting about 1 am for 18 hrs
Swelling of left lower lip (6 hours after vaccine given) and Right upper lip (Next morning)
Possibly after my first vaccine of 04/1999 but definitely after my second vaccine I developed arthritic symptoms in my fingers, feet, elbows, hips, neck shoulders, spine, wrist and knees. I also became anemic.
About 45 minutes after the injection, I started itching.  It began on my feet and then spread to my waist area and then hands.  My face was very flushed and I felt warm.  The person in charge had my blood pressure checked and gave me two Benadryl caps and told me not to play anymore tennis that day and wait another 30 minutes to be checked again. I did so and then went home---took a cool shower and ate lunch. Soon after I began to have chills and period of warmth (no temp)and an a general ache all over felling.  I called my doctor and was told that the Benadryl was a good remedy and I took some more and 2 Tylenol caps and took a nap---I was red from head to toe and itched all over the rest of the day.  The next morning, the red was starting to fade and the itching gradually subsided. By the following day I was almost completly normal except for a little itching.
I had a sore arm for about a day after receiving the vaccine.  On 03/14/2023, I felt a dizzy and nauseated. I went to an urgent care center, and I got a prescription for Meclizine, and I felt so much better.  As of today, I am feeling better with no more issues.
Sore, red spot 1.5" to 2" across upper arm, lasted 3 days and soreness lasted 6 days.
pt recv vax 21OCT97 & the next day pt exp a large local rxn in the lt deltoid that appeared as a lemon sized lump, red, warm & indurated;pt was described as crying in pain;greater than 10 yr since last Td;
received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days; received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Feb2022 (Batch/Lot number: unknown, Expiration Date: 14Feb2022) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days".  Additional information: Caller is in purchasing working for a health care facility calling regarding the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine and the expiration. Caller states that some undiluted vaccine vials were in the fridge past the 31 days which was on 14Feb2022. Caller states the vaccine was accidentally administered to a total of 6 patients, 3 patients on 15Feb2022 and 3 patients on 16Feb2022. Caller states the vaccines were stored undiluted in a refrigerator at around 4 to 5 degrees C. Caller would like some information. Caller states he does not have any additional information as he was only told to obtain this information. Caller states to contact the number (Phone number withheld) at a later time to obtain additional information, which would be the person who will be handling the paperwork. A total of 6 patients have received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days allowable time in the refrigerator.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER.
Patient was injected with COVID-19 vaccine twice during her initial visit for vaccination. Patient was monitored for 30 minutes for any reaction and then released.
Body Aches; Vomited; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache). At the time of the report, MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
5 y/o received Dtap in the right arm and arm is now is swollen, red and warm to the touch. Pt has also been running a fever. The day after receiving the vaccine pt was unable to move his right arm.
Pulsatile tinnitus: noticed after first shot, then faded somewhat before the second dos, when it returned strongly. It has faded over time to be almost imperceptible now. There seem to be triggers: exercise (heart-rate elevation), alcohol (red wine), and stress (work).
Patient given a Hepatitis A  and Hepatitis B vaccine that was not needed. No signs or symptoms of an adverse reaction.
extreme fatigue, sever body aches and pain.  extreme cold and shivering, fevor, severe cold sweats. severe headache, dizzyness, unable to focus on activities.  Passed out and fell twice.  Nausea, lack of appetite.  Eating or drinking water caused more nausea.  Trouble with equilibrium.   Trouble sleeping. Severe cough, and runny nose.   Trouble seeing clearly.   In a nutshell, worst Flu I have ever had multiplied 5 times worse. Going on 6 days with NO sign of improvement.  Slept and rested as much as possible during the 6 days.  Ibuprofen and or Tylenol does NOTHING to ease the symptoms.   I WILL NOT be taking the second dose.  And I will NOT recommend Shingrix to anyone I know.
Fever broke,sweating; Head is congested; Feels like I've been run over by a truck/Hurt everywhere; Moderately decent fever; Pain in head/Head pounding; Sweat chills; Extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Fever broke,sweating), NASAL CONGESTION (Head is congested), MYALGIA (Feels like I've been run over by a truck/Hurt everywhere), PYREXIA (Moderately decent fever) and HEADACHE (Pain in head/Head pounding) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced HYPERHIDROSIS (Fever broke,sweating), NASAL CONGESTION (Head is congested), MYALGIA (Feels like I've been run over by a truck/Hurt everywhere), PYREXIA (Moderately decent fever), HEADACHE (Pain in head/Head pounding), CHILLS (Sweat chills) and NAUSEA (Extremely nauseous). At the time of the report, HYPERHIDROSIS (Fever broke,sweating), NASAL CONGESTION (Head is congested), MYALGIA (Feels like I've been run over by a truck/Hurt everywhere), PYREXIA (Moderately decent fever), HEADACHE (Pain in head/Head pounding), CHILLS (Sweat chills) and NAUSEA (Extremely nauseous) outcome was unknown.  Treatment for the event included acetaminophen.  There are no concomitant medication.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Pain and swelling at injection site. Chills, nervousness, tingling sensation in hands.
About 10 days after injection developed two circular rash es on right arm near injection site.  Rash is itchy , red, swollen and burns. About 2-3 inches in diameter.  It resembles a poison ivy rash.  No other symptoms but rash has not resolved 5 days since noticing it.
15 hrs. after vaccine, red, blotchy itchy rash on face, around mouth.
Patient received CV19 booster, Phizer  booster on 12/29/2021.  Healthy, 36 year old male, active runner with no CV health history.  Suffered acute MI in Sept 2022 resulting in cardiomyopathy.
Lymphoma; Lump in her cheek described as cyst, but not hard, but soft fluidly on face; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, B COMPLEX + ENERGY, VITAMIN E NOS and CALCIUM for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Tired). On 09-May-2021, the patient experienced CYST (Lump in her cheek described as cyst, but not hard, but soft fluidly on face). On an unknown date, the patient experienced LYMPHOMA (Lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma), CYST (Lump in her cheek described as cyst, but not hard, but soft fluidly on face) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: Very limited information regarding this event (lymphoma) has been provided at this time. Details regarding diagnostics and treatment is required for further evaluation. Based on the current available information and temporal association between the use of the product and the start date of the event (fatigue), a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event (lymphoma) has been provided at this time. Details regarding diagnostics and treatment is required for further evaluation. Based on the current available information and temporal association between the use of the product and the start date of the event (fatigue), a causal relationship cannot be excluded.
medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5-month-old female patient who experienced medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA418088.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-Sep-2022, the patient received suspect Pentacel (VERO) Vaccine at dose 0.5 ml once (lot: U7311AA, 09-Sep-2022) via intramuscular route in the right thigh for prophylactic vaccination.  On 15-SEP-2022, the medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event (single component of a two-component product administered)(Product preparation error) at same day latency following the administration of Pentacel (VERO).  Action taken: Not applicable for both events.  At time of reporting, the outcome was Unknown for both event.  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.
10:30 am - Writer/Nurse responding to code blue in Front room. Crash Cart brought to location. Provider, MA, and Vaccine nurse present on seen. Pt sitting on chair verbally reporting all needs. Visible signs of pallor to face, lips and hands. Initial VS obtained by MA with Vitals Machine. Pt reports having Hx of feeling light-headed, blurry vision, and nauseous after getting injections or blood draws. VS: BP- 57/27, P ? 30, RR ? 18, SpO2- 99% @ RA, T ? 96.8 otic temp Administer O2 2 L/m via NC per Provider verbal order EMS called per Provider order BS obtain by MA per Provider verbal order, 100 mg/dl 10:40 am ? Vaccination nurse manual BP ? 82/60.  VS: P- 51, RR ? 16, SpO2 ? 99% @ 2 L/m via NC No visible signs of pallor to Pt?s face, lips, and hands. Pt communicating all needs, no s/s or c/o physical distress. Pt reports feeling better, no c/o blurry vision or light-headedness. Vaccination nurse reports Pt denied any issues with vaccination when initially asked. Pt agrees with vaccination nurse in failure to report history when asked by Vaccination nurse. Pt states she will remember to report Hx next time she is asked.  10:45 am EMS arrived on seen, report given by Vaccination nurse, Eval/assessment concluding with EMS Writer/nurse return to Nurse station, crash cart returned to station
Headache, body aches, stomachache, fever (99.7-100.8, chills).
The night of my vaccination, I had a lot of pain in my right bicep into the front part of my shoulder, which was difficult to move. Days 2-4 after the pain and movement improved but my arm became red in a mottled like pattern and swollen. By Day 5 post vaccine, the redness and pain have mostly resolved.
LETHARGY, FEVER, EXCESSIVE SLEEPINESS, DIFFICULT TO WAKE TO FEED SYMPTOMS LASTED FOR 4 DAYS. FUSSINESS, OFF AND ON BLANK STARE LASTED FOR 8 DAYS.
A report has been received from a Pharmacist concerning a 17 year old, male subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent (intranasal) started on an unknown date. The patient use expired FLUMIST QUADRIVALENT administered. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
GOT PRETTY SICK; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced got pretty sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got pretty sick was not reported. This report was non-serious.
PT RECEIVED VACCINATION 2 DAYS PRIOR TO RASH ONSET AT OUTSIDE FACILITY, WAS THE SECOND DOSE OF PFIZER VACICNATION. BROKE OUT IN HIVES THE SECOND DOSE. FIRST DOSE HAD NO REACTION.
2 weeks after vaccination with yellow fever & IPV patient began to have hives in random places on her body, also experienced swelling of her lip. Saw GP, took ZYRTEC & given tapering pack of steroids which she has not taken as of 8/7/12 still having hives in random places. (thighs, etc).
Immediate itching at the side.  Today a lump/redness and worsened itching at the injection site.
Next morning woke up with 103 temperature, chills, muscle aches, slight dizziness.  No headache or nausea
When I got the vaccine, my arm was very sore.  It remained sore when I returned 14 days later and I told NP  that the pain had not subsided. I explained that my arm hurt terribly with the range of motion.  Therefore, she injected my Hep B in my right arm instead of my left, which was closes to her.  She said she would do that due to me having pain in my left arm.  She said that it should have only hurt for a couple of days and not this long. However, I just received my medical records, because I wanted to verify if it was documented or not and IT WAS NOT.  I called the customer service department of pharmacy to have my medical records amended, because I am very well aware of all medical professionals are supposed to document subjective and objective information and it was not documented.  I can only assume that it is because she is the same person who gave me the flu shot that caused the issue.  My arm is weaker due to the pain. I was on hold for 25 min, so I discontinued the call.
Pt recv vax on 1/27/98; 1-2 hr post vax pt exp tinnitus, red/raised/ pruritic rash on upper arms &trunk; tx=hot showers
This spontaneous report as received from an office manager refers to a 23 year old patient of an unknown gender. On 06-MAR-2014, the patient was vaccinated with a dose of properly stored VARIVAX (Merck) (lot # 0418AE), 0.5 ml, subcutaneously that had expired on 27-FEB-2014. No adverse events were reported. Additional information has been requested.
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State was notified
Pt reported 2-3 days after Td vaccination R deltoid, site became reddened, swollen, itching 2 1//2" diameter. Has resolved gradually.
MILD SIDE EFFECTS AFTER THE SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced mild side effects after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects after the shot was not reported. This report was non-serious.