chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 1-year-old female patient who received ENGERIX B (batch number 7FN99, expiry date 4th April 2016). Co-suspect products included PEDIARIX (batch number NK947, expiry date 5th September 2016). On an unknown date, the patient received ENGERIX B (intramuscular) .5 ml and PEDIARIX (intramuscular) .5 ml. On an unknown date, an unknown time after receiving ENGERIX B and PEDIARIX, the patient experienced inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered were unknown. Additional information: Nurse reported giving PEDIARIX with ENGERIX-B instead of PENTACEL which led to maladministrations inappropriate schedule of vaccine administered, accidental overdose and wrong vaccine administered. No adverse event reported.
This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with dose 1, .65 ZOSTAVAX on 31-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012 the patient experienced injection site reaction, 4 days after onset of therapy. No treatment information was reported. The outcome of injection site reaction was reported as not recovered/not resolved. The relatedness for injection site reaction is unknown for ZOSTAVAX. The pharmacist called to report a patient experienced an injection site reaction that was raised in the area, painful and a developing rash that radiated down her arm after receiving ZOSTAVAX on 10/31/2012. No further information is available.
Pt received flu vaccination, sat down on bench outside of pharmacy waiting for her sister and mother to receive the vaccines and passed out within 1-2 minutes of receiving the vaccine. Patient woke up after less than 10 seconds, laid on the bench for 2-3 minutes then sat up without any other complications.  We offered her water and support, but Mother was with the patient and supported her. Patient rested while the other 2 received their flu shots. She sat for another 5 minutes and stood up and walked under her own power without assistance.
left arm soreness, progressively lost ability to move arm, lasted 4 days. Symptoms of severe pain, limited mobility and numbness occurred in right arm 5 weeks later. Went to family physician, treated with methylprednisolone p.o.;improvement within 5 days after treatment initiated. No lab or testing done.
given vax 18DEC95 pt w/temp 102.5 (ax), very irritable, uncomfortable w/in 4-6hrs post vax;sxs persisted x 24hrs;mom stated pt much improved 3PM 19DEC95
Initially had severe shaking that lasted several days which resolved but on 2/28 developed very severe shaking again that lasted for 3 hr and on 3/1 developed chest pain.  Presented to ER w/ CP and diagnosed w/ MI.
This spontaneous report was received from a physician refers to a 19 year old male patient. Concurrent conditions, medical history and allergies were not reported. The reporter indicated that the patient was scheduled to receive M-M-R II and VARIVAX (Merck) but instead, on 27-FEB-2015, the patient was concomitantly vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous, (frequency, route, anatomical location, lot number and expiration date were not reported) and a dose of VARIVAX (Merck), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). No adverse effects were noted. It was reported that the patient did not seek medical attention. Additional information has been requested.
3 months after vax she has had an aggressive outbreak of serious MRSA. SHE HAS NEVER HAD MRSA BEFORE. She now has an allergy to antibiotics when she has NEVER had an allergy to ANY MEDICATION.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Mild fever (99.1-99.5), body aches, chill started about 12 hours after receiving injection. Treated with alternating doses of acetaminophen and ibuprofen.  Was tired the next day. The symptoms started to dissipate after 24 hours and were gone after 30 hours.
I developed shingles shortly after receiving the vaccine, that lasted for 3 months. I now developed low blood pressure that I now need to take medication for, and I also developed a rash (longstanding) around my neck and back that came out of no where.
The patient was given Pfizer pediatric vaccine undiluted which resulted in patient receiving double the dose than intended. The patient was contacted three times for follow up but we could not get a hold of them.  The patient never called back to report any side effects. Therefore, no side effects were reported from the patient end.
Patient is a 86 y.o. female patient of Private MD with a history of breast cancer hypertension was hospitalized in local hospital with cough shortness of breath and found to have COVID-19 infection.  She was treated with remdesivir and IV antibiotics she underlying severe emphysema and a CAT scan did show that she has evidence of right lung mass with hilar and mediastinal lymphadenopathy.  I suspect primary lung cancer.  She does have a history of breast cancer antiemetics but she does need a lung biopsy and I spoke to the patient examined her interviewed her give a copy of the CAT scan I also spoke to alternate Dr. who is his primary care physician also spoke to primary Dr. and the patient renal biopsy but the patient right now does not want to get anything done that she discussed with the family members.  Her white count is normal she has mild anemia basic metabolic panel fine was unremarkable.  I reviewed the medication.  She had renal failure which got better by stopping the lisinopril HCTZ and she is currently being treated supportively with the steroids antibiotic and she is taken off the oxygen.  She has finished 3 days of remdesivir currently not on oxygen and she is doing better overall she is pleasant cooperative in stable condition and she is being discharged home in stable condition to her home with the isolation for 10 days total and she will be referred to her primary care physician and alternate Dr. regarding a lung biopsy if she is willing to     Acute COVID-19 She had COVID-19 with respiratory infection with hypoxia needing remdesivir and steroids, antibiotics, supportive care, nebulizers, and will need oxygen and hydration.  Her blood pressure is low.  She has generalized body ache and malaise.  We expect her to get better.  We will check the labs every day and give her DVT prophylaxis.  3/22/23: She is responding remdesivir steroid and has been getting better and has gotten stronger she is not on oxygen no fever and chills labs were reviewed.  She does have a mass in the lung which needs further evaluation. 3/23/23:   She has COVID-19 infection she is improving now.  She has been off the oxygen lungs are sounding better she has no fever her labs were reviewed and they are unremarkable she is getting better and being discharged home and may need isolation for 10 days total.
pt recv vax & became unresponsive, skin color dusky, unresponsive to stimulus;called 911;crying;pt taken to hosp by parents for further observation;
Mom statees pt had immunizations 18MAY92 & began 19MAY92 having a high pitched cry that lasted thru 20MAY92;
Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious) with onset Dec2020, outcome "unknown", described as "Tachycardia".  Additional information: 1 hour after administration, she experienced tachycardia and never got a second dose. Caller wanted to know if she could get another vaccine (Moderna) as her second dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
30-45mins past last shot fever inc-went up to 104.7 had unusual high pitched crying >3 hrs; started w/croup that noc; seen by MD next day; OK p/about 1 wk;
Symptoms progressively worsened over 4 weeks until they became unbearable: severe diarrhea, abdominal cramping/pain, nausea, and headache within half hour of eating any solid food.  Went to the ER where labs were drawn, medication administered, and referred to see primary care doctor. Primary care doctor ordered a standard stool test that came back negative. An ultrasound of the gallbladder was also ordered which came back normal. A Certified Nutrition Specialist recommended aleo-mediterranean diet, probiotic, NAC, vitamin D3, Phosphatidyl-choline, fish oil, borage oil, oregano oil, B vitamins, zinc, magnesium, vitamin C, pancreatic enzyme, curcumin, DIM.  Symptoms subsided within 1 week.
General malaise started about 18:00 with complaints of headache, nausea, pain and tenderness at injection site; redness/erythema at site; warm and mild swelling. Fever of 102.5F at 04:00 on 1/14/03 and night sweats. On MD visit on 1/14/03, MD recommended not to have Hep-B #2 or #3.
It started three days after the first dose of the vaccine. I had a metallic taste in my mouth which lasted five weeks. It was there all the time. I was thirsty and trying to get rid of it all the time. It did not go away until after I got the second dose of the vaccine. It went away about a week after getting the second dose. It just went away suddenly.
Patient developed cellulitis in her deltoid after receiving the MMR and Pneumococcal vaccine in the same arm.
Redness, itching and hives at injection site. Right deltoid area. Donor denied any other signs or symptoms. Donor advised to follow up with medical attention if symptoms worsen.
pt recv vax & exp a mild case of chickenpox w/a few papules noted on arm & chest;pt also devel some hives @ the inj site;pt seen by MD who prescribed DPh  for itch & APAP for fever;
2/4/2021 12:00 Noon- After receiving his first COVID vaccine, he began to experience throat swelling with tremors.  The vaccination station administered Epi and brought him to the ED for further evaluation.  At 12:27, patient was feeling improved and left ED. The ED physician offered steroids and he did not want anything prescribed.  He was instructed to return if symptoms worsen or do not improve.  After he left the ED, he called his PCP and stated that the ED was no help and they had tried the CDC and Health department with no luck.  Patient informed his PCP that he is experiencing elevated BP, dry sore throat, and dizziness to the point of passing out.  The conversation between the patient and provider are ongoing at this time.
Patient developed fever of 102.2 and a rash which started under the Band-Aids which had been placed on her thighs over the vaccine administration sites, Then subsequently developed a red, "angry" confluent rash across her chest and under a tape at an IV site on her left arm. Pt had fever for 5 days, firmly generalized rash, chapped lips with redness, conjunctival inflammation, generalized edema of hands and feet, echocardiogram showed mild ectasia of the left coronary artery. 05/29/07-records received for DOS 5/5-5/14/2007. DC DX Kawasaki's Disease. Anemia that was stable. Last CBC showed a normalized white count of 13600. H&H 7.8 and 23.5. Platelets 643000. Differential normal. 2 days after vaccination developed fever 102.2, rash. Seen in hospital on 5/5/07 for febrile illness and possible sepsis. During hospitalization developed rash, angry, confluent rash across chest and under tape from her left arm. Conjunctival inflammation. Crying, would not feed. NG tube placed. Transferred due to development of pancytopenia.  Received IVIG.
Severe dizziness 2 hours after injection. I was driving and had to pull over to let my husband drive. It lasted about 3 minutes. I also had a 101.2 fever and headache 24 hours later that improved with Tylenol, diarrhea 48 hours later.
Brain shocks (as though I stopped taking my antidepressant), tingling arm,  itching arm, headache, severe arm pain, fatigue
Initial and follow-up information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 18 year old female with no previous pregnancy, who on 31-JUL-2007, was vaccinated IM in the left deltoid with the first dose of GARDASIL (658222/0927U). On 11-OCT-2007, the patient was vaccinated IM in the right deltoid with the second dose of GARDASIL (658488/1264U). On 07-JAN-2008, the medical assistant reported that the patient called the office last week stating that she took a home urine pregnancy test, which was positive. The patient sought unspecified medical attention. the medical assistant reported in follow up that on 11-JAN-2008, ultrasound was performed and the result was negative. On approximately 22-APR-2008, the patient developed urinary tract infection. On 22-APR-2008, the patient was treated with nitrofurantoin (MACROBID), 100 mg, twice a day. The outcome of urinary tract infection was unknown. On 02-AUG-2008, the patient delivered a normal, healthy female baby at 39 week gestation. The baby's weight was 7.8 pounds; length was 20.5 inches and Apgar was 8/9. Additional information is not expected.
fever/chill, extreme fatigue, body aches, headache, near syncope, nausea
HEAT BLISTERS; SWOLLEN GLANDS; LEFT SIDE OF FACE ENLARGED/SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included neck tumor, and concurrent conditions included non-hodgkins lymphoma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: hydrocortisone. On 08-APR-2021, the subject experienced swollen glands. On 08-APR-2021, the subject experienced left side of face enlarged/swollen. On 10-APR-2021, the subject experienced heat blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen glands, and left side of face enlarged/swollen, and had not recovered from heat blisters. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
tinnitus in both ears. occurs all day every day.  some days louder than others.  Does not subside.  Louder now than in December.
4 month / received the first dose / April 2021 / second dose has not been administered yet; Rotarix + administration out of recommended; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number ZY5YH, expiry date 7th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   In April 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. In April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose. The medical assistant reported that a patient of 4 month age received the 1st dose of Rotarix, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Rotarix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Area turned red and hot to the touch. Area became itchy. The area became harder, measuring 30mm and hot to the touch.
Asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma). At the time of the report, ASTHMA (Asthma) outcome was unknown.            No concomitant medications provided. No treatment details were reported.
Red painful hot hard swelling in site on injection that spanned entire upper arm. Swelling continued to spread and enlarge over the next 24 hours. Gave Benadryl as per Dr.s instructions.  Applied ice to bring down swelling.
Patient experience low blood pressure 2 days after 2nd shingrix vaccination; visited emergency room until stabilized. No inference made as to SHINGRIX being the cause, and probably related to patient's adrenal gland issues, Addison's disease. Patient has experience several episodes of low bp  prior to vaccination with SHINGRIX.
Pt c/o musle and joint aches, (R) mild leg rash and swelling after a dose of VIVOTIF (oral typhoid). Resolved after cessation.
8 day later of the vaccination 1/7/2021 in the morning my upper left arm was swollen, itchy, & red. I also had tingling around my lips & my right hand on my finger tips lasted 1 day on & off. The swollen on my arm lasted about 2 days in a half. I also seen my doctor the same day on 1/7/2021 & she prescribed me medication.
had the shot, 1 year later had shingles/ suspected vaccination failure; shingles in both eyes; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that the patient had the shingles shot, 1 year later the patient had shingles in both eyes, it was been 4 years, still fighting it off and on. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, and laboratory confirmation of shingles was not reported.
Covid-19 breakthrough. 1st vaccine received on 01/22/2021. 73 y/o PMHx HTN, COPD, HLD, Laryngeal CA s/p radiation presents to ED with AMS x1 week per patients wife who called EMS. No HX of dementia. Room air sats 95%, dropped to 84% and placed on O2 at 3L NC.  CXR- no active pulmonary Dz. Afebrile. Started on IV ABX.
pt recv vax 10AM & devel T104 A;pt taken to ER;mom reports that t105 & child had been crying almost cont;many test were taken but mom does not know results;MD stated pt had sl ear infect;irritable, did not want to be touched, clenched fist
19JUN92 255PM mom called nurse to advise that son was crying non-stop since vax were recvd; advised by RN to notify MD; mom called MD rx advil & watch pt; crying lasted 6 hrs duration mom states rt leg reddness went away next day;
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated intramuscularly with lot # (667445/0993Z exp date 05-JAN-2012), 0.5 ml dose of PNEUMOVAX 23 on 31-AUG-2012. No adverse effect was reported. Additional information has been requested.
Several minutes after getting the shot, my chest started to feel tight and I needed to use my rescue inhaler.  I stayed at the Clinic until 30 minutes had been up. When I arrived home I needed to use my Albuterol Nebulizer Solution, and started to get slightly itchy. My chest didn't start to feel better until after 2am, and the next day I noticed my arm at the injection site was swollen and slightly red.  It is still red to this day and it feels achy all the way to my wrist.
Patient and patient's mother came into the clinic for her one year well child check up. The alert was printed as usual and vaccines were given it stated she was due for. When going to input her vaccines into the chart, it showed vaccines from 12/09/2022 that never transferred over to alert. Historical Immunizations were input into system showing that Pentacel and PCV13 were given when they weren't due.
Fatigue, pain, nausea, trouble breathing, swollen face and neck, trouble concentrating, fever, brain fog/can't think