chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 06 November 2007 from a health care professional.  A 52-year-old female patient, with a history of allergic rhinitis and glaucoma, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number not reported, on 25 October 2007.  Immediately post-vaccination, the patient developed a sore, painful arm.  The patient was examined by a physician 11 days later and was experiencing an inflamed subacromial bursa.  Per the reporter, it appeared that the vaccination had been given very high, "possibly into the acromium process."  C-reactive protein was four times the normal limit.  At the time of this report, the patient had not recovered.  Follow-up information was received on 22 January 2008 from a health care professional.  After review of the case, it was decided to upgrade the case to serious due to the patient's persistent pain.  The lot number of Fluzone received by the patient was U24978A, expiration date 30 June 2008.  Laboratory test results (date not specified) included Sed rate (7), CBC differential (normal), CRP (4.1 to 3.7).  According to the reporter, the vaccination had likely been injected into the subacromial and subdeltoid bursa.  The patient was diagnosed with suspected subacromial bursal injection of Flu vaccine with sterile bursitis.  Corrective treatments included NSAIDs (not specified) and a follow-up consult with an orthopedic physician who administered a subacromial steroid injection.  The patient showed some improvement after the subacromial steroid injection but had not yet recovered from the event.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: tingling in arms - numbness in arms as well.  called 911 - they checked everything, gave the ok for patient to go home with someone picking him up.
None at the time of the vaccine.  Adverse reactions became apparent after the 2nd shot and obvious after the 3rd shot. Second shot was 2/17/2021 lot # EN6201, third shot was 11/4/21 lot # FH8028. by spring 2021 patient sufferings from wild blood pressure swings - 170/95 to 85/55 within the same days.  Multiple events of near passing out, averted only by sitting down, chronic headaches that did not respond to Medrol pac.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Hepatitis A vaccine, Hepatitis B vaccine and ARMOUR THYROID. On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th June 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 26th June 2018, the patient experienced headache and general body pain. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the headache and general body pain were recovered/resolved. The reporter considered the fatigue, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received 1st dose of Hepatitis A vaccine intramuscularly on the left arm, 4 weeks prior to receiving SHINGRIX and 1st dose of Hepatitis B vaccine intramuscularly on the right arm, 3 weeks prior to receiving SHINGRIX. The manufacturer of Hepatitis A and Hepatitis B vaccines were unknown. The patient received SHINGRIX on the left arm. The patient stated that the following day after receiving SHINGRIX, she experienced a headache and body aches. On the reporting date, she felt a bit better, however, she was still quite tired. The patient gave the contact details of the physician. She did not have physician's phone number at the time of the reporting.
This spontaneous report as received from a physician via company representative refers to a 50 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose number, route, lot number and expiry date unknown). On an unknown date in her 50's the patient developed autoimmune like reaction similar to rheumatoid arthritis after receiving ZOSTAVAX. The outcome of autoimmune like reaction similar to rheumatoid arthritis was unknown. No further information was provided. Additional information has been requested.
Headache, Sedation, Myalgia, Arthralgia,  shortness of breath with exertion, chills, and fatigue. pain and redness at the injection site. Narrative:  Other Relevant History:
Itchy/burning throat. After the first shot, thought it was allergies/coincidence.  Happened again after second shot. Both about 3 hours in. Along with runny nose and itchy eyes.  More pronounced than my seasonal allergies.
swelling & redness to inj site (12x7cm) occurring 24hr p/vax; tx w/DPH & Sytec;resolved rt arm;
Area around vaccination site on Left Upper arm was swollen and mildly painful from time of injection on 1/15/2021. On 1/22/2021, upon awakening my upper arm was very itchy, with a raised circular area at injection site that was hard, mildly painful, mildly reddened. (The area resembled an insect bite.) I didn't think much about it. On Saturday, the itching lessened but it was still swollen, tender and red. Today, 1/24/2021, my upper left arm has a reddened area is approximately 2 1/2 to 3". It is still swollen, quite red,  but not particularly painful. I do not have a fever or any other symptoms. My sister who is a retired nurse told me that I should report this development.
Unexplained unilateral, left lower extremity edema, hypertension, heart palpitations, PVCs
First came a report of a Low Level of White Blood Cells which required steroids.   On March 1, 2021, an ongoing weakness in legs was reported to Nurse Practioner. It was established that this was NOT Mysthenia Gravis. Physical Theraphy was suggested but only made it worse. Last week my leg completely lost any sense of strength to stand and I had to be helped to my seat. Numerous time I have not had the strength to move at all. At this point the condition is disabling   Physicians Comments: " You had antibodies because you had Covid even after 6 months".  The vaccine did not do you any good" (I cannot rule the fact that the vaccine is the cause of your leg weakness."   WE NEED GUIDANCE; NO KNOWS WHAT TO DO: Ambulatory and moderately active at the time vaccine was given; The condition is getting progressively worse. Would appreciate any guidance or help that the center can give us.
Pt. states received Phizer 1st dose 03/08/2021, sore arm, headache, and fatigue. Received 2nd Phizer shot 03/31/2021 and within a week started the fatigued, nauseous, heart palpations, stomach issues, tremors through the body, mood swings, issue with right eye (Cotton Wool Spots), weight lost, heat intolerance, weakness. Diagnosed with Graves Disease, 6 weeks of treatment. Beta-blockers prescribed. Most of the thyroid symptoms have went away, anti-thyroid medications have resolved underlining issues.
I week after the second dose around lunch time, I started feeling numbness in my face. I went home and took my mask off and had facial drooping on my right side and the numbness on the left side. I went to the Dr. and diagnosed me with Bals Palsy and gave me prednisone, and lasted about a month.
Narrative: COVID infection following COVID vaccine series 03/16, Moderna , dose #1 04/13, Moderna , dose #2 08/30 pt cc: cough, rhinorrhea, sore throat, fatigue, dyspnea exposure: unknown 08/31 COVID swab, result: detected
Red, hot, swollen area left deltoid s/p TRUMENBA (Men-B) vaccine. Ice. BENADRYL.
Information was received on 15-FEB-2019 by a lawyer regarding a case in litigation, concerning a female patient, history not provided. In 2009 at age 71 the patient was prescribed and administered ZOSTAVAX by a health care provider at a medical center. On an unknown date the patient was treated by a health care provider at a medical center for shingles. Outcome was not provided. Additional information has been requested.
30SEP98 red, warm, puffy rt arm upper;dx cellulitis 30SEP98;
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand) and VACCINATION SITE HAEMORRHAGE (Bleed a little after injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMINS [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), NODULE (Knot on arm that has not gone down), VACCINATION SITE REACTION (COVID  arm), ERYTHEMA (Redness size of the palm of her hand), VACCINATION SITE HAEMORRHAGE (Bleed a little after injection), PYREXIA (Fever), VACCINATION SITE PAIN (Arm very sore/ sore to the touch/ hurting), VACCINATION SITE ERYTHEMA (Arm red), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High) Unknown.         Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-072928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072928:first dose
Patient received Tetanus/Diphtheria 0.5 ml IM was given 8/14 in Left Deltoid; Manufacturer: Sanofi Pasteur, Lot Number: U6021AA Exp: 27JUL20). Patient sent message on site to physician describing symptoms as follows "I basically had flu-like symptoms, to include chills (severe, couldn't sleep), fever (didn't check it often, but it was 101 at one point), very low energy, body was aching all over, no appetite (not even thirsty), and I felt "high". As expected, arm was a little sore too. Symptoms started 11 hours after I got the shot (about 10:30pm). I couldn't work or barely do anything. Today, I still have chills on and off and I have a slight headache." ADR entered.
This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns a 77 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported. Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-26 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
1-19-06 Evening of immunization-erythema, warmth of rt arm.  T-100.1 degrees.  1-21-06: Rash on arms/legs would come and ago.  1-29-06: 3 papules-one each on chest, back and injection site.  Disappeared in 2 days. From 1-9-06 to 2-4-06 temp ranged from 100-104 degrees. 2-5-06 Questionable febrile seizure. Seen in urgent care.  Diagnosis was pneumonia.  Mom gave non-aspirin product for fever.
EVER SINCE GETTING THE BOOSTER (MODERNA FELT FATIGUED, AND BOUTS OF BRONCHITIS.
About 6 hours after vaccination, I spiked a fever, reaching 101.9 (maybe higher, but 101.9 was the highest reading taken) and I had an overnight resting heart rate average of 96. My normal overnight resting heart rate average is 56. I also had a migraine-intensity headache. I understand that milder versions of these things are expected, but because they were more extreme, I wanted to report them.
pulmonary emboli; pleural effusion; chest tightness; shortness of breath; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: EW0178) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EW0191, Intramuscular, in right arm), administration date: 06Aug2021, when the patient was 43 years old, for Covid-19 immunization. No other vaccine was given in four weeks.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 11Nov2021, outcome "unknown", described as "pulmonary emboli"; PLEURAL EFFUSION (non-serious) with onset 11Nov2021, outcome "unknown", described as "pleural effusion"; CHEST DISCOMFORT (non-serious) with onset 30Oct2021, outcome "unknown", described as "chest tightness"; DYSPNOEA (non-serious) with onset 30Oct2021, outcome "unknown", described as "shortness of breath"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizziness". The events "pulmonary emboli", "pleural effusion", "chest tightness", "shortness of breath" and "dizziness" were evaluated at the physician office visit and emergency room visit on 11Nov2021. The patient has since been experiencing dizziness/ lag since discharged from hospital to the time of report. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness.; Sender's Comments: Based on the available information in the case provided, the causal association between the events pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I had original injection on 03/05/2021, 2nd injection 04/02/2021, and the booster 01/04/2022. I was told on 10/21/22 that I possibly have Lupus, an auto immune disease.  I have never had a hint of anything auto immune before now and I believe this is due to the vaccine.
This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient were vaccinated with improperly stored doses of ROTATEQ lot # R012957 with expiration date of 11-JUN-2019 (indication, strength, dose, and frequency were not provided). For prophylaxis. Other suspect therapies included LIQUID PEDVAXHIB, VAQTA and RECOMBIVAX HB. The vaccines were exposed to a temperature range between 32 degree F to 35 degree F (32.5 degree F), during a time frame of 4 hours, which was called by a data logger. No previous temperature excursions were reported.
Initial unsolicited report received from a Physician on 10 February 2016. This Case Linked with 2016SA027336 (same reporter). This case involves a 75-year-old male patient who was vaccinated with an intramuscular dose of Fluzone (batch number UI430AA (invalid lot number), expiration date, dose, dose in series was not reported) in left deltoid on 28 October 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 29 October 2015, one day following the vaccination, the patient experienced an erythematous area at the injection site on left deltoid. The redness was lessened at the end of the day. It returned the next day and could not be relieved. The redness spread down the arm into the elbow and the elbow joint was sore.The elbow and the bicep were sore. The arm was still sore and it interfered with his sleep. It was reported that patient received many previous doses. Patient required emergency room or doctor visit. Lab data and corrective treatments were not reported. The patient was not recovered from events. List of documents held by sender: none.
chills, increase in spasticity x 1 day Narrative: pt with history of quadriplegic due to MVA with history of spasticity living in our residential care facility.
AROUND 9:30 PM I  BECAME VERY WEAK AND FEVERISH.  I HAD CHILLS AND I COULD NOT EAT OR DRINK.  I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM.  I THREW UP TWO DIFFERENT TIMES.  THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE.  THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS.  I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE.  ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN.  I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER.  BOTH OF FEET FLARED UP AND HURT ALL THE TIME.
Son had low grade fever (under 100).  Son had rash (bumps over trunk area).  Son was irritable.
MILD SHORTNESS OF BREATH; BODY ACHES; CHILLS; SORE THROAT; RIGHT ARM SORENESS; NAUSEA; FATIGUE; FEVER; MIGRAINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included acid reflux, and migraine.  The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 31-MAY-2021) dose was not reported, administered on 09-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced right arm soreness. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F. On an unspecified date, the subject experienced mild shortness of breath. Treatment medications (dates unspecified) included: botulinum toxin type a, sumatriptan, and topiramate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, right arm soreness, body aches, chills, fever, sore throat, nausea, and fatigue, and the outcome of mild shortness of breath was not reported. 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.
LARGE RED WELT SURROUNDING INJECTION SITE.  APPROXIMATELY 4 INCHES IN DIAMETER.  Warm to touch.  Rather hard/firm. First felt approximately 12 hours after injection.
When vaccine was being given the patient jerked their leg and vaccine administrator saw some of the ProQuad vaccine leak out of the syringe onto the table. Situation discussed with parents and parents aware that patient will need to repeat this ProQuad vaccine.
Telephone call from parent stating redness and swelling at injection site of DTAP and HAV.  10/29/2003: telephone call from mother stating swelling and redness is gone.
Pt. developed blisters on both hands/ palms that spread to feet and around mouth . Pt also c/o sore throat and temp.
Congestion in head, Fever over 100.3 for over 3 days Cough, headache Fatigue brain fog nasal sinus congestion, lingering sinusitis.
Arm sore after first COVID Vaccination; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm sore after first COVID Vaccination) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after first COVID Vaccination). At the time of the report, PAIN IN EXTREMITY (Arm sore after first COVID Vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.