chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of fainting in a 30-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MENACTRA (non-gsk); manufacturer unspecified;unknown given on 12 June 2009; IPOL (non-gsk); manufacturer unspecified;unknown given on 12 June 2009; TYPHIM (non-gsk); manufacturer unspecified;unknown given on 12 June 2009. On 12 June 2009 at 15:00 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 12 June 2009, within 5 minutes after vaccination with TWINRIX, the subject experienced fainting, pallor, did not feel right (unspecified) and dizziness. The other vaccinations were given a little later on 12 June 2009 with no complications. The fainting resolved within five minutes, paleness, not feeling right and dizziness resolved within 30 minutes after vaccination. The pharmacist considered the events were clinically significant (or requiring intervention). On 12 June 2009, the events were resolved.
Information had been received on 07-MAR-2017 from a nurse who reported that a female patient received the first dose of VARIVAX (dosage not reported, unknown lot/expiry date) on 06-MAR-2002, at the age of 11 months, 22 days, sooner than the indicated minimum of 12 months. Nurse reported that the second dose of VARIVAX (dosage not reported, unknown lot/expiry date) was received on 10-MAY-2007. No adverse effects reported. No additional information provided.  Additional information has been requested.
Bradycardia , stay, bluing of the lips, spontaneous breathing, lethargic, watery stools, uncontrollable crying, apnea, changes in blood flow on right side of the brain hospitalized for a week until symptoms resolved
19 y/o fully immunized female with history of anxiety presents for dizziness and nausea x 2 hours.  Received COVID vaccine at 14:30.  At 16:30 went from sitting to standing, felt dizzy and nauseous.  No syncope.  No palpitations.  Similar reaction to influenza vaccine.  No intervention required to previous vaccination.  No history of anaphylaxis.  BP 125/88, pulse 88, RR 18, 02 95%, temp 37.3.
On 10/30/2021 in the evening, fever (it was not very high), muscle aches, joint pain, headaches, and fatigue. I took Ibuprofen every 6 hours and Tylenol every 6 hours. My symptoms lasted 2 1/2 days.
Dizziness (vertigo) and  moderately severe fatigue beginning approximately 10 minutes after influenza immunization. More severe by suppertime. Could not stand. Severe the following day. Gradually improved. Immunized Oct. 9,2006. Mild residual symptoms Oct. 14.
2 weeks after 2nd dose of Moderna vaccine, i developed moderate to severe lower back pain which made it difficult to stand erect. prior to vaccination, I ran 3 miles 2-3 times per week. It is now difficult to walk over a half mile.  4 weeks post vaccine I started to develop generalized muscle fasciculations and generalized spontaneous muscle cramping.. Through extensive testing and examination at the neurology department at  Hospital i was given a diagnosis of Amyotrophic Lateral Sclerosis, ALS.  Muscle fasciculations and muscle cramping have continued to get worse.
Second dose not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose two-three years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it had been greater than 6 months after 1st dose of Shingrix vaccine and the 2nd dose not given till the time of reporting, which led to incomplete course of vaccination. The reporter unable to provide exact data, any adverse event information. The reporter gave consent for safety team to follow up. GSK note- Regarding discrepancy about 2nd dose date, a follow up was done but had no reply.
Initial unsolicited report received from a pharmacist on 21 Oct 2016. This case involves six patients (gender and age not reported) who were vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patients had developed tennis ball size red swollen local reactions on the arm. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. The patient's pertinent medical history, drug reactions and allergies were not reported. On 16-MAR-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # M018436 with an expiration date 13-APR-2018 for prophylaxis (douse, route of administration and anatomical location were not reported). The sterile diluent used to reconstitute the vaccine was not improperly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours. There was not previous temperature excursion. A digital data logger was involved.
p/vax swelling began on upper arm;swelling had reached to near wrist;swelling was quite severe;went to ER;recommended ice packs & massage & elevation;swelling less gradually over 2 days;told to use DPH;
Muscle weakness in leg calves, joint pain, and still have a slight swelling at ejection site
Woke up with extremely sharp pain in stomach. 20 minutes later, dry heaving. Went to sleep after. Woke up 3 hours later feeling fine.
Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   Concomitant products included WARFARIN SODIUM (COUMADIN), HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (ALDACTONE 50 HCT) and LOSARTAN POTASSIUM (COZARIL) for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) had resolved.      No treatment information was provided. The patient had nose bleeding 5 times after the first dose and twice she had to go to the emergency. She had the 2nd dose also without any repeat of nose bleeding or other issues. The patient was fine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: the outcome of the event was updated.
Patient presented with mother to receive second dose in meningitis vaccine series. Due to error of miscommunication via provider patient was provided with dose of Menveo vaccination. Upon further conversation it was discovered patient previously completed this series and the desired vaccination was Meningitis B. Patient and guardian informed of incorrect vaccine administered. No symptoms reported at that time.
Area in left armpit started to feel sore about 24 hours after the vaccination. Armpit area swollen, and tender to the touch morning of April 16, 2021. Tenderness has extended out of the armpit area and up towards collarbone as has swelling. Afternoon of April 16, 2021. Onset of migraine like headache around 1 PM on April 16, 2021.  Headache feels worse when sitting down..
Very heavy menstrual bleeding x2 periods following vaccine.  Additional light bleeding one week after second heavy menstrual cycle and again light bleeding one week after that.
Grand mal seizure x 2 10-11 hours after vaccine administration.  Patient admitted to hospital. 9/22/08-records received for DOS 6/19/08-DC DX: Seizure disorder. Presented with disorientation, posturing, jaw clenching and foaming of mouth, eyes rolling back. Unresponsive after episode with subsequent clonic seizure and post ictal state. Responsive to painful stimuli but would go in and out of post ictal state.
A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/08/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee was inadvertently received Fluvirin on 10/15/03. On 10/15/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting, the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.
Infant received PEDIARIX on 5/29/12 1632. Noticed temp increase at 5/30/12 0800, 99.9 degrees F. Acetaminophen given at 0929 & 1415, temp lower by 0930 to 99.6 degrees F - at 1100, 98.8 degrees F. No other increase in temp but PREVNAR injection given on 5/30/12 at 1530. At 0147 on 5/31/12 starts to have desaturations. By 0735 on 5/31/12 starts having bradycardic episodes with apnea & periodic breathing till 0815 when placed on SiPAP from HFNC. Started on caffeine able to come off SiPAP on 6/1/12. Still on caffeine now.
Approximately one month after second dose of Pfizer injection patient began to have shoulder joint pain, progressing to hand and then opposite shoulder. Has persisted greater than 3 months. New onset/diagnosis rheumatoid arthritis, connective tissue disorder.  Patient states he has had similar pain and swelling in joints in the past that resolves quickly, however states this pain and swelling is severe and persistent now three months
Pt had onset of pain at (R) shoulder vaccination site @ 12/11 of PM -exam c/w localized reaction at lateral aspect of deltoid no sign of infection or isotonic reaction.
Pt developed increasing rash several hours after injection and fever spiked at night to 102.
occipital lobe stroke; postherpetic neuralgia; vision problems and balance issues; vision problems and balance issues; herpes zoster; This initial spontaneous report was received from a lawyer on 08-JAN-2021, regarding a case in litigation and refers to a currently 72-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 28-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and dosage regimen information was not provided) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient was treated for a provider for the following injuries: herpes zoster, postherpetic neuralgia, occipital lobe stroke, vision problems and balance issues.  At the time of the report, the outcome of cerebrovascular accident, herpes zoster, balance disorder, visual impairment and post herpetic neuralgia was unknown. The reporter considered that herpes zoster, postherpetic neuralgia, occipital lobe stroke, vision problems and balance issues were related to zoster vaccine live (ZOSTAVAX).  Upon internal review, occipital lobe stroke was considered to be medically significant.
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED.  Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
Immediately after receiving the moderna vaccine I felt a warm feeling in my arm and immediately in my chest and my heart rate increased immediately and I felt a little dizzy. After abt 5-10min my heartrate slowed down. EMS was on site and performed bp check and Ekg which he says were both textbook and normal. My hear rate at that point was at 100bpm.
Pt recieved a subdose of vaccine (amount unknown) due to vanish point syringe malfunction that engaged prematurely while injecting. A second full dose was administered, pt tolerated injection well with no adverse outcomes.
Got the Pneumococcal PPV 23 vaccine on March 6, 2013. On March 7 the pain became worse and redness is worse. That night pain was very intense whole body hurt. Had chills, fever, headache, nausea, dizziness, and muscle weakness. Came in to see doctor on March 8 going to take meds for pain & swelling.
Patient reports tongue swelling/tingling the day after receiving the vaccine. Patient reports that her tongue swelled/tingled for about 2-3 days after receiving the vaccine, but has fully improved 4 days after receiving the vaccine. Patient used hydrogen peroxide mouth gargle but otherwise did not take any other medication to relieve the swelling. The patient also reports her bottom lip was swollen for one day but that improved and was resolved the next day. Patient is advised to take prophylactic Benadryl before receiving her next dose.
swelling at injection site, about the size of a tennis ball, no progression of swelling throughout the day, able to use arm normally.
felt hot, flushed face and felt itchy. Hives on hands. Rash on face and torso.
Headache, Sedation Arthralgia, Fever, FEELING SO WEAK COULD BARELY WALK TO BATHROOM FROM BED Narrative:
raised red cirlular area about 1 1/2" diameter @ inject site; treated w/Durcef; next day swelling gone, area resolving;
Chills, Fever, Muscles Pains, Fatigue, Loss of bladder control, loss of appetite
Initial unsolicited report received from a health care professional via other company (Pfizer) on 08 July 2016. Manufacturer report number: 2016269330 This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to influenza vaccine split (not specified). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
fatigue accompanied by painful cough, wheezing, difficulty producing sputum, sneezing, eye tearing, sinus headache. Symptoms abated after approximately 72 hours.
It was reported in a published literature article that a previously immunized 5 year old female developed skin lesions consistent with varicella and aseptic meningitis. The patient was vaccinated with varicella virus vaccine live and eighteen months after vaccination, the patient presented to the emergency room with a five day history of fever, headache, and rash. The rash began on her face and spread to the trunk. The rash was described as pruritic and painful and the lesions were raised. Her headache was diffuse and it would wake her from her sleep. She had not experienced vomiting or ataxia. She was started on penicillin a few days before presentation for presumed group A streptococcal pharyngitis. The culture was subsequently negative and the penicillin was discontinued. There were no known sick contacts or exposures to varicella and her immunizations were up to date. On admission, her temperature was 40.3C, pulse was 148/min, blood pressure was 109/80 and she was awake and responsive. There were vesicles on the soft palate and her neck was supple. A positive Brudzinski and negative Kerning's sign were elicited. The skin had diffuse papules, vesicles and scabbed lesions. Her serum electrolytes, hemoglobin and platelet count were normal. Her white blood cell count was 45000 cells/mm with 50% neutrophils, 26% lymphocytes, 12% monocytes and 7% reactive lymphocytes. There were 168 red blood cells/mm, the protein was 133 mg/dl, and the glucose was 46 mg/dl with concurrent serum glucose of 86 mg/dl. The gram stain was negative for bacteria. The child was started on acyclovir for presumed VZV meningitis and vancomycin and ceftriaxone for possible partially treated bacterial meningitis. Her skin lesions were positive for VZV by direct immunofluorescence antibody, and the CSF was positive for VZV by polymerase chain reaction. The CSF PCR for herpes simplex virus types 1 and 2 were negative. Serum immunoglobulin and lymphocyte subsets were normal. She completed a 10 day course of acyclovir in the hospital. The patient made an uneventful recovery and was discharged from the hospital without medications. A follow up hearing evaluation six weeks later demonstrated mild to moderate sensorineural hearing loss from 500 to 100 Hz on the right side and normal hearing on the left. Tympanometric testing was normal. Two years later, hearing was normal and she was doing well. No further information is available.
Mother states patient has fever of 104F. The pediatrician did blood work and the results are pending.
Rash, UrticariaPruritus, Redness, slightly tender and warm Narrative:
pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body aches and headache.  Pt states she has intermittent dizziness.
102 fever, body ache, Diarrhea, nausea, head ache.
Pt was given GARDASIL and ADACEL 100m /office approximately 10 minutes after injection, was found outside the building by police. Had syncope.
No known adverse event to date. ADMINISTRATION ERROR, GIVEN 6MO-4YR DOSE INSTEAD OF THE 5-11 YR COVID VACCINE.
Information has been received from a nurse concerning a 47 month old patient who on 06-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot# 663710/0219Y). The nurse mentioned that on 22-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 3 year old female patient with precocious sexual development and puberty diagnosed early and wheezing and no illness at time of vaccination on 06-JUL-2009, was vaccinated SQ in the left leg with the first dose of VARIVAX (Merck) (lot# 663710/0219Y). The nurse reported that the patient went to the clinic for a rash. The mother stated that the day after initial rash visit (the patient was diagnosed with scarlet fever). The patient developed multiple vesicles and pustules, localized on genitals, arms and legs. The provider described "multiple scabs on genital, arms and legs". The patient was diagnosed with varicella. The patient did not have any testing done. On 13-JUN-2012, the patient recovered from varicella. A lot check has been initiated. Additional information has been requested.
Pt developed numbness/tingling in all of her toes on her L foot 3 days following vaccination. She was evaluated by 2 providers as symptoms persisted until 11/16/21
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old, female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies and the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 10/JUL/2021 patient tested positive for COVID after starting with symptoms on 05/JUL/2021. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745821-covid-19 vaccine ad26.cov2.s -Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "56 YO female with h/o ESRD, CHF, DM2, OSA, HTN, admitted with generalized weakness and multiple falls due to COVID-19 infection and missed HD. She was found to have COVID without significant respiratory symptoms and potassium of 6.5 on arrival. Nephrology was consulted and she underwent HD on arrival. Potassium remained somewhat elevated following initial dialysis session and she was treated with lokelma with improvement. A second HD session was performed prior to discharge.    She was treated with symptomatic management for COVID with improvement in symptoms. Therapy evaluated and she was appropriate for home with assist, or considered SNF placement. Patient adamantly refused SNF, but was willing to accept home health PT. Discharged home in good condition with home health PT."
From first night, localized swelling, redness. Second day redness gone, but still slight swelling, then incredibly painful arm starting in second day, could not lift over my head without wincing pain. Pain was completely gone in 60 hours from injection.
Arm sore and itchy Friday 9/3/21     Arm sore, itchy, swollen, hard and hot to the touch on Saturday 9/4/21 Arm back to normal 9/7/21
Hospitalization for status epilepticus and associated respiratory failure. Febrile to 106.9.
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.   Reporter did not allow further contact
1) arm  joint pain (not strong) for both dose 1 and dose 2 2) swollen lymph nodes under armpit (left side). For dose 1, I did not feel the pain until one week after I took the shot. It took fours days to disappear. For dose 2, I felt stronger pain at the same place (left armpit) at the night when I took dose 2 shot (4/14/2021). Now 4/16/2021, I am feeling better and predict that it would be gone in days.