chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented to Health Center. Client received Pfizer Booster . When vaccinator  was giving vaccination card back she noticed his first dose Janssen was received on 11/22/21. Client had come in one month early for his booster.  RN was notified of incident. Lead RN notified client that his dose doesn?t have to be repeated in two months per guidelines.  Client verbalized understanding. Client stated he was feeling fine and walked over to observation area with a steady gait. Lead RN informed client when to seek emergency care. Client verbalized understanding.
Excessive swelling of (L) arm, redness, tender to the touch. Lasted 3 days. Recommended antihistamine. Improved.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal allergies" (unspecified if ongoing), notes: Known allergies: Seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Generalized seizure 4 minutes~. Temp found to be 102 + In the ER. - Diagnosed with : Febrile Seizure.
approx 2-3 days p/vax both inj site had a rash around them then devel circular patches near sites;had hive like patches;
Given MMR vaccine. Approx an hour later patient began having red, raised, hot to touch area on skin where vaccine administered.  The next day pt. arm continued to be red and swollen. Pt reported to have used Benadryl by mouth 25mg. Stated alternating warm and cool compresses on and off.  Size of reaction was approx 6 inches by 3 inches in diameter.  Pt states no changes for several days.  Pt went to Urgent Care facility. She stated she was having tightness in her chest and felt it was her allergies.  She reported having fever/chills. Patient stated she did not take her temperature. She was having congestion as well.  She states on Sunday May 19th. She was at the urgent care and received a dose of Solu-Medrol IV and Levaquin. And also received an inhaler.  She reported on Monday May 20th that the right side of her neck was swollen and she felt it was her lymph nodes.  She stated her arm was no getting better and was not as red and hot feeling. She states she is returning to the Dr. on May 22nd.
Start: 6-12 hours after injection: Fever 102 degrees, dropped to 100 or less in 24 hours. Muscle aches, painful skin, headache.
This subject is a 76 year old male, who died at home of carcinoma of unknown primary origin while enrolled in RSV11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/31/02. The subject died of carcinoma of unknown primary origin on 8/8/03, 281 days post immunization. Death Certificate 8/17/03: The cause of death was carcinoma of unknown primary with ascites and pleural effusion. Approximately interval between onset and death: 5 months. Other significant conditions were COPD, anorexia/malnutrition. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested. A 15-day follow report received 10/23/2003 adds: Additional info received 10/09/2003. Death occurred at home. Upon researching recent history, 4 additional hospitalizations, SAE's found unreported to site with some medical history and relevance to this will be forthcoming. Reference hospitalization SAE of 7/17-7/23/03 as last medical info available. Pt released in stable condition in care of hospice on 7/23/03. No further data available other than Discharge Summary of 7/23/03. Diagnosis: Carcinoma of UNK primary with ascites and pleural effusion. Cross Reference SAE hospitalization for CHF symptoms 01/05/2003. Hospital Discharge Summary: 07/17-07/23/2003. The pt presented to the Emergency Dept with mental status changes after taking 0.5 mg of Ativan also with a concomitant increase in his Duragesic patch to 50 micrograms. He was admitted for evaluation and continued treatment of his mental status changes and also due to some increase in his shortness of breath and dysphagia type symptoms. A therapeutic paracentesis was performed x2. Due to his dysphagia, speech therapy was consulted for a swallowing evaluation. A barium swallow showed a normal swallowing mechanism. Computed tomographic scan showed air in the esophagus, which was consistent with some sort of mass lesion in the mediastinum, although this was not apparent on the computed tomographic scan done previously. An esophagogastroduodenoscopy was consistent with mild esophagitis, otherwise was WNL without strictures or other obstructions seen. The pt continued to be at his baseline during his hospital stay with no definite etiology of the globus sensation, his dysphagia and swallowing difficulties that the pt was having. He was given no apparent etiology from an esophagogastroduodenoscopy, barium swallow or computed tomographic scan. After discussing the risks and benefits of total parental nutrition and ventral line, the pt declined that therapy at this time. The pt's medications were changed to add Megace, Morphine Sulfate as needed and the pt was instructed to call his Primary Care Provider if his symptoms returned for a repeat therapeutic paracentesis as well as other interventions as needed. Additional info received and available in source file: Medication Record: 10/29/2002-07/24/2003. Death Certificate: 08/17/2003. Discharge Summary: 07/17-07/23/2003.
Pt. states that after receiving the 2nd dose of Moderna 08/22/2021, started experiencing symptoms that evening of burning sensation throughout the body, fatigue, numbness, weakness lasting 2 weeks. Primary visit referral for Neurologist. Prescribed Lyrica for nervous system. Pt. still experiencing symptoms.
The next day I had fatigue, headache, sore arm. The following day I felt ok but my left eye. Same side as shot became red an  d swollen.  Emer Room diagnosis is Chemosis of left conjunctiva
Nausea, vomiting, headache, muscle aches, chills, sore throat, dizziness.  Treated at home with Tylenol and rest.  Nausea and vomiting lasted approximately 12 hours, other symptoms still ongoing as of 11:00 AM next day post vaccination.
I was around someone who currently had COVID-19. Two days later I had a scratchy throat so I took a Home COVID-19 test and it came back Negative. The next day I tested Positive. I called my Dr. and spoke on the phone, didn't couldn't prescribe Paxlovid because it could react with my current medications so I was given  Monoclonal Antibodies. Started feeling better 2 days later. Then tested again, 5 days later and I tested negative
Pt called 10/1/14 to report headache and aching muscles in shoulder of vaccination, but no fever. His vaccination was around 9am 9/30/14 and onset of symptoms was around 3pm 9/30/14. Spoke with pt at 1:45pm 10/1/14 and he says symptoms have almost completely resolved. Pt requested his reaction be reported to the appropriate agency.
Rheumatoid arthritis flare up; Sacroiliac joints inflammation; Pain after pfizer covid-19 vaccine; Inflamation after pfizer covid-19 vaccine; This is a solicited report based on the information received by Pfizer from Regulatory Authority (MFR Control No. 21K-163-4114790-00) from the marketing program facilitated collect received from a contactable consumer (patient).  A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 06Aug2021 (Batch/Lot number was not reported) age at vaccination of 47-years-old, as single dose, dose 2 intramuscular on 27Aug2021 (Batch/Lot number was not reported) at vaccination of 47-years-old, as single dose, for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis.  The patient medical history and concomitant medications were not reported.   On unknown dates in 2021 (after pfizer covid-19 vaccine), the patient experienced non-serious sacroiliac joints inflammation, rheumatoid arthritis flare up, vaccination site pain and vaccination site inflammation. The patient was experienced inflammation in her sacroiliac joints every now and then. She had a flare up when she stopped to get the covid-19 vaccine with pain and inflammation. She received a steroid shot on her elbow and two week later in her shoulder. It was unknown if patient was enrolled in a covid-19 vaccine trial.  On an unknown date, rheumatoid arthritis flare up resolved, outcome of the event Joint inflammation was resolving while outcome of the events vaccination site pain and vaccination site inflammation was unknown.  Causality for Rinvoq (upadacitinib): The reporter's causality for the events of sacroiliac joints inflammation and rheumatoid arthritis flare up with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the events of vaccination site pain and vaccination site inflammation with Rinvoq (upadacitinib) was not provided.  The reporter's assessment of the causal relationship of all the events with the BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event (sacroiliac joints inflammation, rheumatoid arthritis flare up, vaccination site pain and vaccination site inflammation and the BNT162B2 cannot be excluded.  "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."
Fevers over 102 started after stopped taking continuous dosing of Tylenol (about 36 hours after vaccine), and persisted 2-3 , with chills, myalgias, and fatigue.   Headache every day for 7 days following vaccine, requiring treatment with naratryptan on 3-4 of those days. Symptoms similar to those experienced after dose 2 of Covid vaccine.
Patient experience violent hand tremor in both hands, starting at 7:15pm and lasting for 1 hour, until 8:15pm.  The hand tremor went away after 1 hour without treatment
Started the day after the second injection at about 5pm. Red Slightly raised, warm patch two inches below injection site measuring about 3 inches by 3 inches with an irregular shape and burning sensation.
Redness & swelling to right posterior upper arm started within 24 hours worsening next 24 hours. Red area approx 9 cm diameter soft, non-tender. Watchful waiting RTD if symptoms worsening. Pt dad stated that the tetanus shot was given in the fatty area.
PROVIDED DOSE NUMBER 1 DURING VACCINATION CLINIC AND DISCOVERED DURING RECORD REVIEW THAT RECIPIENT WAS 17 YEARS, 9 MONTHS OLD. NO ADVERSE EVENTS, TREATMENT, OUTCOMES REPORTED TO DATE.
Bad cough / hard and deep cough; Headache / slight headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough / hard and deep cough) and HEADACHE (Headache / slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache / slight headache). On 17-Feb-2021, the patient experienced COUGH (Bad cough / hard and deep cough). The patient was treated with PARACETAMOL (TYLENOL RAPID RELEASE GELS) for Headache, at an unspecified dose and frequency. At the time of the report, COUGH (Bad cough / hard and deep cough) and HEADACHE (Headache / slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Additional information received: The patient had declined further follow-up.
A female patient with no previous vaccine reactions, who, in April or May of 2000, was vaccinated with a 3rd dose of hepatitis B vaccine recombinant. Within one month of the 3rd vaccination, the child was diagnosed with a bowel obstruction and the mother reported that the child never returned to "normal". In June of 2000 the child was diagnosed with Coxsackie Virus. At the end  of June 2001 the child had muscle weakness and a rash. On 08/15/2001, the patient was diagnosed with dermatomyositis. The patient's mother felt that the dermatomyositis was related to therapy with hepatitis B vaccine recombinant and, as a result, does not want her other children to receive the vaccine. Unspecified medical attention was sought. It was reported that the child is doing better and is expected to recover. Follow up information from a physician indicated that the hepatitis b vaccine recombinant was given one year before the patient got sick and "it was not the RECOMBIVAX HB". Upon internal review, the patient's experience was considered an other important medical event. (OMIC)
medication error due to the administration of an expired product,with no reported adverse event; Initial information  received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 40 years old female patient who experienced medication error due to the administration of an expired product DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] ,with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Oct-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiry 17-Oct-22) (expired product administered, latency same day) (dose, formulation and strength: unknown) via intramuscular route in the left deltoid for immunization.   Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown for the event medication error due to the administration of an expired product,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No Treatment medication was provided.
Body body aches; Body discomfort; Pain in armpit; Extreme tiredness; Fever; Headache; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17May2021 (age at the time of vaccination 24-years-old, patient was not pregnant at the time of vaccination), as DOSE 2, SINGLE for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication included birth control medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme tiredness, body aches, fever, headache, pain in armpit, pain in arm and body discomfort on 18May2021. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events was recovering at the time of this report.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
3 days of fever 102.5-101.8 , chills, muscle pains, injection site ,took Tylenol  and advil
sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
3days p/vax pt devel fever 101-102f. by 24mar fever persisted & pt devel papular rash. by 27mar fever 103f. 28mar broke out w/a macular, raised, indurated rash on torso w/small pin-point lesions. became clumsy, bumping into things, falling
Significant swelling in the underarm lymph nodes and red rash interior right side of underarm
Severe rash on legs, back, arms and chest; headaches at times severe; occasional tightness in chest and pain, unreasonably elevated elevated heart rate after minimal exercise.  Has been going on for 4 weeks not and all symptoms are still present.
Vaccine given about 11:00 AM - noted onset of redness, warmth, pain about 10:00 PM - Seen 8/21; area of redness, warmth. No vesicles about 10 cm diameter assoc. with nausea, fatigue. Denies SOB, dysphagia, other systemic sx. Tx - Ice, continue allergy - f/u if worse.
Pt began with minor aches and pains 6-8 hrs post injection. 3 days later, she had fever of 102 deg F with upper abdominal and gastric pains with belching. No features, no change in BM. She c/o some discomfort over "liver." 5 days post injection, she stayed in bed with same discomfort and chills and mild fever. She did not take temp. She spoke with a nurse practitioner who was uncertain if reaction due to injection or other problems. 1wk and 2 days later she still has upper abdomen and gastric and has discomfort. She will consult with nurse practitioner tomorrow.
3 months after dose received, shingles occurred in my left arm. I had received a shingles vaccine in 2013 and had not been exposed to anyone with the herpes virus recently. Although I don't know if there is any relationship to the COVID vaccine, I'm erring on the side of caution by reporting this.
Within an hour after the injection 09/17: exhaustion. Night of the injection 09/17: chills and hot flashes (on and off throughout the evening), loss of appetite, unable to sleep due to discomfort,  severe migraine, and arm soreness. Next Day 09/18: mild fever, chills on and off throughout the day, extreme fatigue, loss of appetite, exhaustion,  continuous mild headache, and extreme muscle soreness at injection site. Second day 09/19: extreme exhaustion, continued mild headache ongoing since 09/17, and increased muscle soreness at injection sight.  Severe flu like symptoms subsided within 48 hours of injection. Continues to experience extreme soreness in arm at injection site, mild headache, and fatigue 48 hours after vaccine.    Treatment: Unable to alleviate headache symptoms with OTC medication despite trying different treatments: excedrin, tylenol, or ibuprofen. Took nyquil and daytime flu medicine as appropriate, which provided no immediate relief; experienced continued headache, chills, and fever on and off throughout 48 hour period.
Severe low blood sugar after injection. Ate every 10 to 15 minutes. Would not increase. Lasted for 3 1/2 hours.  Off and on since. Lasts  2 to 3 hours at a time
EXTREME dizziness and nausea.  Heart palpitations and chills. And one of the worst headaches of my life. I called the nurse line and they had me go to the hospital. I received the vaccine on Saturday evening.  Symptoms started Monday morning and increased in severity throughout the day until they were unbearable Monday evening.