chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via consumer via phone via Agency number: 00775098.    This case is linked to cases 2021SA311330, 2021SA312326, 2021SA314197 and 2021SA314182 (same reporter)  This case involved 4-year-old female patient was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
30cm wheal to Left thigh with redness, induration, and warm to touch.  Patient unconsolable.
I suffered extreme pain in the arm where vaccine given that radiate to the shoulder and then the neck area.  All became sore to the touch and the neck pain hendered daily activity.  The neck pain resulted in a trip to mu chiropractor today for adjustment.  The arm is still sore to the touch.  I also suffered from mild aches which I had been advised about.  I did have fluxuations ffrom hot to cold.  Mostly on the cold side. I also had to use my albutoral inhaler to ellivate the tightness in my chest
DIZZINESS; HEADACHE ON LEFT SIDE OF FACE; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced headache on left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and headache on left side of face. This report was non-serious.
Child was given adult dose of Pfizer Covid-19 vaccine; Instead of 0.2ml he received 0.3ml. No immediate reactions or side effects. After waiting 30 minutes, still no reactions and child went home with his mother symptom free. Will call next day to check on child.
Case number PHEH2013US011178 is an initial spontaneous report received from a consumer on 17 May 2013. This case refers to a 28-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) intramuscularly in his right arm on 14 May 2013. On the same day in the evening, he developed injection site swelling, lightheadedness and dizziness. In the morning of 15 May 2013, the injection site was sore, had a knot at the site, and was red and swollen. The final outcome was reported as unknown. No other information was available at the time of this report.
Within 24 hours of vaccination, patient experienced fever, nausea, and headache. This lasted for approximately 36-48 hours. Patient returned to symptom free state at approximately 48 hours from time of vaccination.
Information has been received on 15-FEB-2019 from a lawyer regarding a case in litigation concerning a 75 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2015 the patient was administered the ZOSTAVAX vaccine by a healthcare professional. In March 2017, the patient was treated by a nurse practitioner for shingles as a result of vaccination with ZOSTAVAX. Additional information has been requested.
HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt brought to ED with fever and malaise, BS was in the 50s at home; In ESRD, on hemodialysis; after dialysis pt did not feel well; EMS called; diagnosed with UTI, positive for COVID; acute hypoxic respiratory failure secondary to COVID pneumonia; pt's condition continued to decline; palliative care consulted; family decided to dc dialysis; pt passed away in the hospital
vaccine was administered outside of storage recommendations. patient returned on 6/6/21 to re-vaccinate
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; titer result was 4.0 indicating a low pos response;
adverse reactions occurred on the arm that received the shot  within 24 hrs I began feeling some intermittent "tingly" sensations, and most alarming was the immense underarm pain (pain to the touch -9/10 scale) that ensued. It felt like my underarm was swollen and highly sensitized.    I had a virtual call with my PCP and was advised to go in for a follow-up  evaluation  within a few days.  Swelling and pain subsided with 2 weeks of start  in addition, my first period following the shot was atypical- far more excruciatingly painful cramps than usual (I only noted because I was in the middle of  my workday and the cramps literally had me scrunched  down to the ground in seconds)
Swelling, redness and warm to touch. Left upper arm. Ibuprofen 800mg TID and Benadryl 25mg PRN
Pt recvd 4 doses of Engerix-B, 11 wks p/1st booster does; 2nd booster dose was given 6APR92; f/u titer will be drawn 10 wks later;
Several hours after getting a vaccine i experienced sharp abdominal pain, back pain and cramps. Severe headache and then more abdominal pain/ cramps. Around 10:00 pm i started to bleed vaginally.  My period was not supposed to be before August 11th-12th but I started to bleed on the day i got the vaccine.  I was bleeding for four  weeks straight .  After that i had a break for ten days and started yo bleed for another two weeks. I now have my period every two weeks with severe pain and back ache and nausea.  This is in addition of having flu like symptoms for four days following the vaccination. My life is ruined now, i am low in iron and miserable
No additional adverse events reported; Nurse reports the administration of expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse, referring to an unknown age and gender patient, Information about the patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were unknown.  On 18-JUNE-2021 an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) at a dose of 0.5 milliliter (route of administration, vaccination scheme and anatomical location were not provided; lot number S029542 has been verified to be a valid lot number, expiration date reported and established as 10-JUN-2021), as prophylaxis. No additional adverse event was reported).  No Additional adverse event was reported.  This case was considered as non-valid case due to lack of patient's identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient reported dizziness with flushing and rapid heart rate. VS 97.1 68 20 118/80. Resolved after 15 minutes. Patient also reported she just drank rapidly a double expresso coffee.
A 57-year-old male consumer reported that he received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date in December 2003 and developed a runny nose, stuffy nose, impaired sense of smell and impaired sense of taste. Medical History: The patient has no known drug allergies. He has a history of seasonal allergies, however, the reported indicated that he was asymptomatic prior to the Flumist vaccination. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. The product was administered approximately three weeks prior to 30-Dec-2003. Concomitant Therapy: Concomitant therapy included Atenolol. Event Details: On a unspecified date in December 2003, a male patient developed a runny nose, stuffy nose, impaired sense of smell, and impaired sense of taste after receiving a dose of Flumist. He stated he "could taste the Flumist in his mouth right away" after vaccination. The patient indicated that the runny nose, stuffy nose, impaired sense of smell and impaired sense of taste occurred almost immediately after administration. He also noticed that his sense of smell and taste was affected in "sensing fragrances associated with certain foods." Treatment included over-the counter antihistamines and Sudafed, however, the patient stated that his runny nose and congestion were not relieved with the use of these products. The patient described his nostrils as "sometimes very dry and sometimes very wet." As of 30-Dec-2003, the reported adverse events persist. The reported indicated he was in the process of contacting his physician regarding the adverse events. No additional information was available at the time of this report.
Fever, diarrhea, sore throat, along with redness, swelling and tenderness at the injection site. Pt put on Zyrtec 10mg PO x 7 days. Still has redness and tender.
HIVES,  ITCHING ON THE BACK, BACK OF ARMS, UPPER CHEST, AND SHOULDERS.  MOSTLY ON THE BACK.  BEGAN APPROX 6 HRS AFTER THE INJECTION.  HAVE APPLIED BENEDRYL (EXTRA STRENGTH) THROUGHOUT THE DAY APPROX EVERY 3-4 HOURS FOR SOME TEMPORARY RELIEF
Received MMR vaccine 5/6/03 and developed generalized urticaria about 6-8 hours later with headache and malaise.
Received report on 10/22/12 from pt re: this Rx to her vaccines. We did not see her & she says she fully recovered. Sxs included fever, generalized body aches & fatigue & localized swelling at inj site. She was seen in out-of-state ER & tx'd with antibiotic. We do not have the ER report.
Information was received on 24-JUL-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 29-SEP-2008 at a medical center 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 strain of herpes zoster. On or about 05-MAR-2011, the patient was treated at a medical center for a blistering vesicular outbreak, which 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.
hot, red and lumpy, tender to the touch, about 6 inches in diameter, lasting five days.
New onset occasional PVCs confirmed via EKG, up to 3 per minute sporadically
Patient had severe itching over body for 3 days after vaccination but did not break out in hives. She took Zyrtec and the itching went away.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Negative; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received Paxlovid as a Treatment of COVID-19 from 05Oct2022 to 09Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2D AFTER VACCINE BEGAN HAVING PAIN IN LOWER ARM THEN DEVELOPED WEAKNESS OF BILATERAL HANDS WITH STIFFNESS AND MINOR PAIN.  LATER DEVELOPED FULLNESS SENSATION IN THROAT.  NO RASH.  NO FEVER.  DID NOT DEVELOP REDNESS AT SITE OF INJECTION
Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities.  Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein.  As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
At approx 11:15AM on 09/12/2005 gave Td, lot U1341AA exp 10/25/06. Pt had syncope then generalized seizure.
Information has been received from a registered nurse, concerning 4 patients, who on unknown dates were vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported). It was reported that, in September 2012 ("last week") the patients experienced injection site reactions. At the time of the report, the patient's outcome was unknown. This is one of the several reports from the same reporter. The other linked reports included case # 1209USA008631, 1209USA008632 and 1208USA002950. Additional information has been requested.
Patient stated was feeling okay after receiving shot about 8:45 pm. Patient went to sleep and woke up around 2 am due to itching. Patient stated was itching, noticed a little swelling around eyelid and felt as if her tongue were slightly swollen. Patient took a Claritin reditab and went back to sleep. About an hour later patient stated felt like she had something in her throat. Stated trying coughing and was not able to get it out so contacted family member in the home and then went to ER. At ER received IV Benadryl, steroid and Pepcid. Swelling receded and when doctor came to see at 8 am most of swelling had resolved.
MIGRAINE HEADACHE; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cat hair allergy. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805016, and batch number: 1805016 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced migraine headache. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 13-MAR-2021, and was recovering from migraine headache. This report was non-serious.
Fever, shaking, little headache, dizziness, very large and painful lump on arm bigger than a golf ball on night 1, swollen welts on night 2, large spread out welts and rash on day 3. I'm still on day 3. Very painful red and hot rash.
Initial report was received from a health care professional on 11 January 2012. A 20-year-old male patient had received an intramuscular injection of MENACTRA, sanofi pasteur Inc. lot number U4028AH on 10 January 2012 and that evening he experienced headache, body aches, sweaty, chills and loss of energy. The symptoms still persisted at the time of the report. The patient denied any illness at the time of vaccination, taking any concomitant medications and any past medical history. The patient had an allergy to peanuts. The patient denied any adverse events to previous vaccinations. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
-Urticaria hours after vaccines DECADRON and BENADRYL - Then 2 days later urticaria and wheezing seen again in ER Prednisone, ZYRTEC, ZANTAC and Albuterol.
I got lip filler 1 month after second vaccine shot and it dissolved in 2 months. The last 5 years it takes over a year to dissolve.
Last seen normal 9pm on 4/14; on 4/15 patient had altered mental status, fever (105.3 F), and hypoglycemia.  Presented as a sepsis-like picture. Patient required D10% infusion for hypoglycemia.  Diagnostics did not reveal any source of infection (CTA negative for PE and pneumonia, CT abd/pelvis negative, head CT negative, urinalysis unremarkable, chem port site did not appear infected).   Troponin was elevated (up to 10.8) with bedside echo showing EF=35% with severe apical wall hypokinesia (previous echo was 60%); EKG was similar to baseline. Patient went to cath lab; coronary vessels were not occluded.
Arm soreness; It expired the day before its administration; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old male patient received BNT162b2 (BNT162B2), administration date, on 24Mar2022 as dose 2, single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 6 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: 16:05, Anatomical site: Right Deltoid, Route: Intramuscular, Batch/Lot : FL8094), administration date: 28Feb2022, when the patient was 6-year-old, for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 24Mar2022, outcome "unknown", described as "It expired the day before its administration"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  Additional information: Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval). Dose administered past the expiration/beyond-use date. Vaccination facility type: Doctor's Office/Urgent Care. patient had no Prior Vaccinations and no Concomitant Drugs and the patient's Medical History: None No Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia were None. Error due to miscalculation from Vacc. Arrival Patient notified no adverse reactions only normal side effects arm soreness. Vaccine vial expiration date Sep2021, from arrival to 6 week period expiration 23Mar2022  Follow-up attempts are completed. No further information is expected.  Follow-up (15Apr2022): This is a follow-up spontaneous report received from the same contactable Consumer. This Consumer reported in response to HCP letter sent via follow-up letter which included that:  Updated Information: Historical vaccine added, Primary reporter's occupation updated, Dose description Updated, Dose number, Route of administration, Anatomical location added, Vaccination facility Name, Address, City, State, Postal code, Phone number added, Event medically confirmed updated.  Follow-up attempts are completed. No further information is expected.
Patient experienced redness  and soreness in arm that extended down the arm and up into the neck.
pt recv vax 28MAY98 & devel hives onset more than 48hr p/vax;tx w/pred & hydroxyzine;generalized hives, face, neck, chest, legs, between fingers;seen by MD;
Patient received three Moderna COVID-19 vaccines since 4/9/2021.  During a routine lab draw, patient's WBC count was found to be critically elevated at 74.0.  Bone marrow biopsy revealed Lambda Plasma Cell Leukemia.
Had  Covid vaccine booster and flu shot in November of 2021. Had common cold in January 2022, then strep throat infection 2/7/22. Developed Psoriasis rash all over my body in February, something which I?ve never had before. Has been progressively worse, not better. Also had positive ANA in march and exacerbated thyroid problems. Increase in inflammation overall, chronic pain issues, etc. But this rash is very unusual and psoriasis does not run in my family and was not pre existing.
About a week and a half after 1st vaccine pt had a pain in her knee that eventually spread up and down to ankle and thigh area.  On 3/21 she went to urgent care and was referred to the emergency room because she was also having a pain in her chest.  She had a stress test, EKG, chest xray, and Doppler and was diagnosed with a large DVT in the thigh and a small clot near the ankle.  She was given Lovenox injections inpatient for 3 days and sent home on  Xarelto 15/20mg starter pack and Aspirin 81mg.  She was also started on metoprolol tartrate 25mg and atorvastatin 40mg.  She saw her PCP 4/6 and sees a cardiologist and hematologist within the next couple of weeks for follow-up.