chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning a 22 month old white male pt who was vaccinated with a 1st, 2nd, 3rd and 4th dose of Haemophilus b conjugate vaccine on 7/1/94, 9/2/94, 11/8/94 and 9/26/95, respectively. The pt developed septic arthritis due to "vaccine failure." From joint fluid the serotype was positive for Haemophilus influenza B. The pt's experiences were considered "other important medical events." Outcome was indicated as "yes". No further information is expected.
Due to the pandemic, hasn't received her second dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 or early 2020). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, due to the pandemic, the patient did not receive 2nd dose of Shingrix, which led to social problem . The reporter did not consent to follow up. This case was linked with case US2021254883, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254883:same reporter, other patient
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 168 doses/vials were given for LOT 048C21A. It was unknown when the vial was stored in refrigerator.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Shakiness; Feverish feeling; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 023M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for Diabetes.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Shakiness and Pyrexia, at an unspecified dose and frequency. At the time of the report, TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Updated Outcome of Events to Recoverd and Reporter declined to further Follow Up.
Woke up with leg pain the next morning with swelling of his thigh, inability to bend leg, and fever.  09/18/2008 MR received for DOS 9/12-13/2008 with DX:  Left Leg Cellulitis.  Pt awoke the day after vax with c/o leg pain and being unable to bend knee. Leg swelling noted and low grade fever.  On PE L thigh edema, non-pitting and warmth noted. No erythema.
Information has been received from a registered nurse concerning a female patient in her sixties with fibromyalgia, myalgia, and osteoarthritis and a history of multiple outbreaks of herpes zoster who on approximately 26-APR-2007 or 27-APR-2007 was vaccinated with a dose of Zostavax. Concomitant medication included hydrocodone bitartrate as needed. The nurse reported that 48 hours after vaccination, on approximately 28-APR-2007, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
7 days after injection, awoke with 1 small hive.  My arm was hot and red.  Throughout the day, the area developed more hives, became painful, itched and hives had spread to a 2x5 inch area.  Today 1/16, hives cover a 4x5 inch area, is still hot, painful and itches. I am taking Allegra, AM, Bendaryl, PM and putting cortisone on the hives
Narrative: Myalgia, paresthesia, fasciculations; Otherwise healthy female who developed paresthesia/fasciculations  on day 2 after vaccine. Has been evaluated by neurologist Dr. at Health facility in state and had EMG/testing. At this time she is currently taking prednisone and symptoms have not resolved.
Night of what I can only describe as head to toe nerve pain making it impossible to sleep in any position. Followed by a general sense of fatigue to the point where walking was the max exercise I could do 3 days after the injection. Woke up during the night on day 4 with flu-like symptoms.  Went to work and came home mid afternoon and slept for two hours. Later that evening started to shiver.  Shivering  accompanied by fever of 103 continued.  Advil brought fever down to almost normal but shivering and flu-like symptoms persisted.  Tested negative for flu and mono.  Went to the ER on  10/31 and diagnosed with viral meningitis.
Patient should have received 30 mcg dose of Pfizer BioNTech vaccine. 10 mcg dose of Pfizer BioNTech was administered. Patient and guardians were immediately informed of the administration error. Clinician and Operations Chief educated patient and guardians that re-administration was not indicated, per CDC guidelines.
bad reactions that were extremely unpleasant; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (bad reactions that were extremely unpleasant) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (bad reactions that were extremely unpleasant). At the time of the report, IMMUNISATION REACTION (bad reactions that were extremely unpleasant) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Received full dose instead of 0.25 mL; She has been very ill last night; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (She has been very ill last night) and ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL). In January 2022, the patient experienced ILLNESS (She has been very ill last night). On 14-Jan-2022, ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL) had resolved. At the time of the report, ILLNESS (She has been very ill last night) outcome was unknown.        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.
had positive home test for COVID on 24Jun2022; had positive home test for COVID on 24Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 16Apr2021 as dose 2, single (Lot number: FW0151), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 18Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus II" (unspecified if ongoing), notes: diabetes mellitus II; "Hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. The patient's concomitant medications were not reported. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin", notes: Known allergies: Metformin; Januvia, reaction(s): "Known allergies: Januvia", notes: Known allergies: Januvia; Lipitor, reaction(s): "Known allergies: Januvia", notes: Known allergies: lipitor. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "had positive home test for COVID on 24Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (29Jun2022) with no symptoms, notes: tested clear on June 29Jun2022 with no symptoms (home test.); (30Jun2022) with no symptoms, notes: tested clear on 30Jun20222 with no symptoms (home test); (03Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had positive home test for COVID on 24Jun2022. started paxlovid on 24Jun2022 (two doses on start date). Finished Course on 28Jun2022. tested clear on 29Jun2022 with no symptoms (home test.) tested clear on 30Jun2022 with no symptoms (home test). woke ups Sunday 03Jul2022 with stuffy/runny nose and scratchy throat. feeling woozily in the head. took home test. Positive for COVID. Patient received other medications within two weeks of vaccination were reported as Levothyroxine 0.125 mg, started on 01Jun2022; losartan 100mg, started on 01Jun2022; metoprolol succinate 50 mg, started on 01Jun2022; hydrochlorothiazide 25 mg, started on 01Jun2022; Allerfex, started on 01Jun2022 with lot number: 1kr0449; Meloxicam, started on 01Jun2022; Tylenol 500 xrta strength started on 01Jun2022.
Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03171, and 2012-03172. A 76-year-old female patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Four weeks after vaccination, the patient developed "paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers;" and she also had loss of balance. Her motor symptoms were noted as "loss of dexterity and dysphagia." Neurological exam noted "generalized weakness (graded 4/5). Decreased pinprick, joint position, and vibration in both lower extremities; unsteady upon stance and gait. Deep tendon reflexes 1+ in both upper extremities; absent patellar and ankle reflexes." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 78 mg/dl. Electrodiagnostic testing on Week 7: was "highly suggestive of Acute inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed as having Guillain-Barre syndrome with "acute motor sensory axonal neuropathy (AMSAN)." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient experienced improved sensation but had "slow improvement of weakness and dysphagia on week after the course of IVIG." The patient resumed her "base line level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
The patient had COVID disease in October, 2020.  The evening after getting the COVID Vaccine, the patient experienced extreme confusion and was thinking that he needed to go somewhere and was unable to put his thoughts into words correctly. Since then the confusion has improved, but he is still experiencing some confusion and loss of time.  The patient has also experienced involuntary muscle movements since his COVID diagnosis.  These involuntary muscle movements worsened after he received the vaccine and they are now starting to improve. RN
C/O L chest pain, tightness/squeezing, SOB, fatigue, insomnia beginning s/p dinner on 10/30/21. Patient came to local Health Center for previously-scheduled PrEP MSM appointment with PCP. An EKG revealed slight ST elevation; troponin labs could not be done d/t policy, so patient was advised to go to alternate Medical Center for a cardiac workup.  Diagnosed at TMC with ST Segment elevation and multiple leads consistent with pericarditis.
Patient's arm began to get red and swell a few hours after vaccine was administered. She took Benadryl and applied cold compress. Pharmacist checked back in with her in a few hours and patient's symptoms were better but still present. When contacted two days later she was still having symptoms. She did not wish to get medical care, but will continue to take Benadryl and ibuprofen. Will seek medical if necessary.
Patient was given a Bivalent Pfizer 6mo - 4 yrs vaccine as the 2nd dose in the primary series instead of the Monovalent Pfizer 6mo-4yrs. Tolerated well, no contact from parents regarding any kind of reaction.
did not receive second dose of Moderna Covid-19 vaccine; intense itching for about six weeks/A little bit itchy/Whole body itchy at times; minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine), PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (did not receive second dose of Moderna Covid-19 vaccine), PRURITUS (intense itching for about six weeks/A little bit itchy/Whole body itchy at times) and RASH (minor rashes/Rash once in a while on the skin/Small rashes that appear on different parts of the body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided. No treatment information given.
On 5/8/12 started vomiting, headache, dizziness, diarrhea, shaking, fever, seen in office 5/9/12.
No adverse effects; Nurse called regarding MMR II. Nurse reported expired vaccine was administered to a patient. Patient is not reporting signs or symptoms of adverse effects. Expiration date for lot # U017524 was 06/03/2023. Permission to contact HCP was granted. No ad; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 30-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U017524, expiration date 03-JUN-2023 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
pt recv vax & exp rash on body, crankiness, congestion & runny nose;
Nothing happened initially the first couple of weeks, but then I noticed leg pain and swelling. I am a nurse and work 12 hour shifts and I was working 6-7 days a week at that point. I thought that it was fatigue but it got to the point where it was the normal deep vein thrombosis pain in the back of my legs, so I had another nurse check my pulse and the Doctor there sent me for an ultrasound and that's when we discovered it. He sent me to ER to get injection of Enoxaparin and to do a CT of chest to make sure I didn't have a pulmonary embolism and I was sent home on Eliquis for 3 months and then was seen by hematology. Hematologist did the work up with the blood work to determine any other reason for the DVT and there was no reason and only found that I was anemic and iron deficient.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in 2016, reported as after 28-MAR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot #L051099, expiry date 17-JUN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The nurse reported that the doses of the vaccine were stored in the shipping container for 5 days and exposed to unknown temperature (date unspecified). The reporter stated that the excursion, which was outside of the 1 day shipping allowance, occurred due to a late delivery of the vaccine order, and that specific details of the excursion could not be provided by the nurse. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a currently 5 years old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On 09-MAR-2012, the patient was vaccinated with M-M-R II injection, lot # reported as 0400A (dose, route of administration, anatomical location and expiry date were not specified). Other suspect therapies included VARIVAX injection, lot # reported as 0469AA (dose, route of administration, anatomical location and expiry date were not provided) administered on the same day. On an unknown date in 2016 (reported as "recently"), the patient experienced upper respiratory tract infection. The patient sought medical attention and visited the physician's office. During the visit, the patient was prescribed 5 course day of prednisone (manufacturer unknown). No lab diagnostics studies were performed. The outcome of the event and the causality assessment were not provided. Additional information has been requested.
urticaria, chronic. comes and goes. ongoing for > 6 mo necessitating almost daily allergy medication
Cold like symptoms; runny nose; scratchy throat; cough that is on and off; close contact with someone who tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat), COUGH (cough that is on and off) and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19). At the time of the report, NASOPHARYNGITIS (Cold like symptoms), RHINORRHOEA (runny nose), THROAT IRRITATION (scratchy throat) and COUGH (cough that is on and off) had not resolved and EXPOSURE TO SARS-COV-2 (close contact with someone who tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         No concomitant medication was provided by the reporter.  No treatment information was provided.  Patient would like to know if he should go ahead to receive the booster shot tomorrow.
Intussusception - surgery.  5/18/07 Received medical records from hospital which reveal patient experienced nausea, bilious vomiting & decreased oral intake for 2 days & 1 episode of blood stool   Admitted 2/13/07-2/14/07.   Taken to OR for exp laparotomy, mechanical reduction of IS.  Progressed well postoperatively & d/c to home w/PCP & clinic f/u. FINAL DX: Intussusception, surgically reduced.