chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around July 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, shortly after receiving receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
pt recvd vax&4hrs later felt itchy;devel flu-like szs that included nausea,h/a,malaise, & dizziness;exp numbness all over & numbness @ inj site;18MAR95 pt awoke w/small red hives on arms, face & trunk;pt to ER 19MAR95 w/itching blotches
Pain in upper right arm beginning day of vaccine and continuing for three days General tiredness beginning day of vaccine an continuing for three days Systemic inflammation, edema, swelling of legs and hands beginning later in the day of vaccine and lasting several days. (I have never experienced anything liked that) Skin lesions on right side similar to chicken pox: ankle, knee, buttock, back, breast, arm, wrist  (all on the right side of body) appearing Tuesday - Thursday (few days after vaccine) and lasting a couple days About 20 red spots (petechaie?) on abdomen that looked like a pin prick that did not blanche to touch.  Spots appeared on Tuesday (day after vaccine) and are almost gone after two weeks.
day of vaccine, nerve pain in shoulder , hips , back and thumbs for 4 hours, then subsided after taking an aleve  location of shot is swollen till today
Large swollen circle on arm showing up 12 days post first dose. Soreness, itching, swelling. Also shortness of breath.
Headache weakness, lost of taste Narrative:  Informed employee to go get COVID tested since employee reported loss of taste, headache, muscle aches, and weakness. Employee understood and stated that she would.
Child was accidentally given Bexsero instead of TDAP.  Suffered no adverse effect other than discomf from injection. Mom was councilled by Provider concerning pt receiving vaccine sooner than recommended for her. TDaP will be given @ next visit. Told Mom she will not need to get second Bexsero until older. Mom verbalized understanding of this.
Case number PHEH2012US018706, is an initial spontaneous report received from a consumer on 21 Sep 2012 with a follow up information received on 24 Sep 2012: This report refers to a female patient whose age was not reported. She was vaccinated with influenza vaccine (unknown manufacturer and batch number) on an unknown date. On an unspecified date she died following a flu shot. Cause of death was not reported. Causality assessment was not reported. No further information was provided. Follow up information received on 24 Sep 2012: Gender of the patient was updated.
On 1/24/2022 I developed symptoms and the next day tested positive for a breakthrough COVID case.  Symptoms included sinus congestion and drainage, sore throat, cough, headache, felt weak.  On 1/28/22 I received monoclonal antibody infusion.  I was also prescribed antibiotics.  I took over the counter decongestant, Tylenol, and advil.  I did not have a fever, I did not lose sense of taste or smell, and I did not have breathing difficulty.  I did go to the ER on on day 10 for a battery of tests and all turned out fine.  As of 2/5/22 I tested negative for COVID with my home test.  In addition, in mid March, I began experiencing a low heart rate (as low as 35 few a few seconds).  I have never had any heart issues in the past, and I wonder if this is an after affect of COVID.  I am currently undergoing tests and am wearing a monitor to determine how to resolve this.
Patient with sneezing, diffuse hives, hypotension and hypoxia 30 minutes after receiving vaccines.  Treated with epinephrine and benadryl and observed in hospital overnight. Discharge Summary received on 1/26/2005 states pt experience anaphylaxis and acidosis. Follow up 02/04/05: anaphylactic shock with metabolic acidosis.
Flublok vaccine was given to a seven year old patient, no AE; Initial information was received on 23-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a seven years old patient (gender not reported) who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1942 and expiry date 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, past medical treatment, vaccination and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration..  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date; Received expired 1st booster dose 8 days after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 1st booster dose 8 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (The unpunctured vaccine vial was stored in the refrigerator for 38 days and administered to this patient 8 days after the 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter thinks that the patient is in his 60's but not 100 percent sure. No concomitant medications was reported.  Patient received the expired first booster dose of Moderna COVID-19 vaccine.  30-days use by date was reached on 17 May 2022. Vial did not undergo any temperature excursions.  No treatment was reported.
Patient stated that on the morning of 9/24/20 wit a burning sensation in her left axilla, arm, clavicle on neck. On 9/25 she reported that her left clavicle and side of her neck still had the burning sensation.
This spontaneous report was received from a patient's mother regarding her approximately 15 month old daughter with asthma. On 13-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# reported as 017011 Expiry 24-SEP-2014). Concomitant therapies included albuterol. On an unknown date in 2013, the patient developed shingles after receiving VARIVAX. It was unspecified if the patient sought medical attention. The outcome of shingles was reported as not recovered. Additional information has been requested.
Delivered Male infant 8/23/2021 at 39w3d without complications developed s/s of COVID 8/21, was tested at time of delivery and tested positive for COVID.  Hospitalization is for delivery of baby, not COVID issues.
Chest tightness/pain, headache, body aches, rash,  fever and chills
Patient returned 5/3/10 with red itchy raised area 4 x 2.5 inches on left thigh. Treated with BENADRYL 12.5 mg tid prn.
Patient was 15 when vaccine was administered (authorized for 18 and older). No known adverse reactions.
Breakthrough case admission after 2 vaccines Moderna 2/15/21 lot# 015M20A;  Moderna 3/15/21 lot# 038K20A
Sore arm down to her elbow; Painful to lift her arm; Severe tremors; Diarrhea; Couldn't eat; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025020A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting and Iodine allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASCORBIC ACID (VIT C) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat). On 21-Jan-2021, LIMB DISCOMFORT (Painful to lift her arm) had resolved. On 22-Jan-2021, TREMOR (Severe tremors) had resolved. On 23-Jan-2021, DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm down to her elbow) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included pills for high cholesterol, high blood pressure and something for stomach acid.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Nausea is consistent with the product known safety profile.
Patient felt lightheaded immediately after dose. She moved to a waiting area under observation. she reported feeling hot, and anxious. She was provided cool cloths for her head, a water bottle, juice and a nutrigrain bar. She sat upright for about 6 minutes, then reclined with her head and feet at the same level. She reported continued anxiety and feeling hot. No rashes or skin involvement was observed. After 10 minutes supine,  she sat up on her own. She reported feeling better, but elected to stay under observation. At 12:24pm she stood up and reported feeling well enough to leave the clinic.
Patient  didn't get the second dose; lymph nodes swelled all over his body; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelled all over his body) and PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LYMPHADENOPATHY (lymph nodes swelled all over his body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose). At the time of the report, LYMPHADENOPATHY (lymph nodes swelled all over his body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
HIT BY TRUCK; EYEBLUR; BODY ACHES; HOT AND COLD FLUSHES; DIZZINESS; SUPER SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hit by truck, eyeblur, body aches, hot and cold flushes, dizziness, and super sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super sore arm, and the outcome of hit by truck, eyeblur, body aches, hot and cold flushes and dizziness was not reported. This report was non-serious.
I received my second dose of COVID19 vaccine in my left shoulder at approximately 3:50 PM.  I expected my shoulder to be sore as typical with previous vaccines I have received.  After dinner my should was very very sore and painful, but in a different way than I had experienced before.  The pain feels like it is in the joint rather than in the muscle.  The pain will subside if I keep my shoulder immobile and take Tylenol.  If I use my arm/shoulder the pain returns and worsens with use.  My range of motion is limited and becomes worse with use.   I will wait until the end of the weekend and seek medical treatment if this does not resolve.
Men B dose  #1   was ordered in  chart by  physician.  Nurse inadvertently gave Menactra instead.  When she realized the error she then gave patient the Men B that was originally ordered.  Nurse informed  charge  nurse and physician of  error.  Physician informed  patient and parent that an extra dose of Menactra was inadvertently given.  Patient was observed in clinic and no adverse effectes were reported.  Paitent and parent instructed if any  symptoms oor  side effects develop to seek immediate medical attention.
Patient c/o light headedness after injections; had syncope followed by seizure for approximately 30 seconds.
Side pain; Soreness / of the arm/ leg pain; degenerative hip woresning; Redness of the arm; Increase in temperature; Tiredness; This case was reported by a consumer and described the occurrence of pain localized in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer and degenerative joint disease. Concomitant products included Flu unspecified (Influenza vaccine) and pneumococcal vaccine (Pneumonia Vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease. On an unknown date, the outcome of the pain localized, pain in arm and degenerative joint disease were unknown and the outcome of the erythema of extremities, high temperature and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at the end of October at around 2pm. The patient experienced side and leg pain on opposite sides two weeks after receiving the 1st dose of the Shingrix vaccine.  The patient also reported experiencing soreness and redness of the arm, an increase in temperature, and tiredness. The soreness and redness of the arm, increased temperature, and tiredness started at 9pm on the day of receiving the vaccine.  The patient stated that these lasted for two days. The patient was told by her doctor that the side pain could be from her degenerative hip, but they were unsure about the leg pain. She has already gotten the pneumonia and flu vaccines along with the 1st dose of the Shingrix vaccine, but at different times. The reporter did not consent to follow up.
When she went to bed she noticed arm hurt really bad, and she had a big bump at the injection site, that was pink in color and warm to the touch. A hardened area, aprox 2 inches in diameter.
feel tired; muscle aches; This is a spontaneous report received from a contactable 74-year-old male consumer (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 28Mar2021 (at the age of 74-year-old male) as a single dose for COVID-19 immunization about 10 days ago. The patients past medical history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) for COVID-19 immunization on 08Mar2021. The concomitant medications was not reported. On an unspecified date, the patient experienced feel tired, fatigue, muscle aches which was still continuing ten days after vaccination. The patient told he got some after effects from the vaccine and was asking about how long he could expect to have a typical number or range of days and how long side effects last. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 22-NOV-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (albumin status rHA) lot # N001488, expiration date 12-JUL-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine had been reconstituted with properly stored sterile diluent (MRK). The vaccine experienced a temperature excursion of 23.2 degrees Fahrenheit for 8 hours. There were no previous temperature excursion reported. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA006828: US-009507513-1801USA002138: US-009507513-1801USA002139.
This spontaneous report as received from a certified medical assistant refers to six patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, three patients were vaccinated with improperly stored doses of ROTATEQ oral solution, orally, lot # L013206, expiration date 29-JAN-2017 (dose was not reported), two patients were vaccinated with improperly stored doses of ROTATEQ oral solution, orally, lot # L026067, expiration date 06-APR-2017 (dose was not reported), and one patient was vaccinated with improperly stored dose of ROTATEQ oral solution, orally, lot # L035508, expiration date 12-MAY-2017 (dose was not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes, with previous excursion 46.8F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Pt devel nausea, vomiting & weakness following immun; next day lt arm (vax site) was red & tender;
Shaking of lower extremities every 30 seconds. Full body shaking the next day. Doctor at ER diagnosed condition as stress related without additional neurological testing. 12/7/2009 MR from ED visit 11/17/2009, patient with involuntary jerky movements of extremities, worse on the left, with head tilt, shoulder shrugs, facial movements, it was noted that patient was seen at another facility on 11/16/2009 with same sx and treated with Benadryl and Ativan with inital resolution of sx which have now returned, Neuro consult noted brisk reflexes, tx'd with Ativan 12/7/2009 Pediatric neuro OP notes for 12/3/2009, impression psychogenic tic started on Risperdal and f/up in 1 month
Was unaware I was pregnant at time of first injection/vaccine. At anatomy scan discovered baby had liquid in brain, double cleft lip and cleft palate. Was referred to fetal health. Went the following week and had MRI, echocardiogram, high tech ultrasound, bloodwork. Discovered in addition to above baby did not have a brain cerebellum or corpus collosum. It would be very likely baby would need breathing machine and g tube it?s entire life, would not be mobile, have any motor function, not able to communicate or possibly process thoughts.  Due date was 12-16-2021. Had D&E on 8-10-2021.
Information has been received from a physician concerning a 12 year old female with asthma and Advair allergy who on 10/11/06 was vaccinated with HVP vaccine. Concomitant therapy that day included varicella virus vaccine and influenza vaccine. On 10/11/06 the pt experienced numbing at injection site and around arm. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.
Sudden extreme blurry vision in one eye which eventually spread to both eyes and has ebbed and flowed continually since.
Pt. has lingering pain and stiffness almost 30 days after receiving flu shot. Cannot sleep on that arm either.
Ate lunch, piece of apple, 1/2 hour later noticed itchy - throat and roof of mouth, back of throat.  Went on fire call - patient felt hot, lips swelled and developed hives on lips and neck, back and chest.  EMS transported to ED.  Pt. was given 50 mg Benadryl IM and 1/2 hour later given steroids and Pepcid IV push. Hives abated around four hours.  Patient did not have any respiratory distress.
Patient stated her right arm was still hurting. Patient said it hurt in the shoulder joint and she was having trouble raising her right arm. Patient stated she had trouble fastening her seatbelt, getting dressed, and cleaning off her table. The patient told me all of this on 12/05/2012.  Patient stated she had not seen a physician and a friend who was a nurse told her a nerve may have been hit during administration of the vaccine. I advised her to see her MD to see if the pain could be caused by anything else.
itchy, hives all over head (not face), chest, back, legs, arms for 3 days. responded fairly well to benadryl. resolved completely.