chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated had some tingling in the right arm that traveled down to her hand after the 15 minute observation period. Patient was advised to be observed for an additional 15 minutes.   After the additional 15 minute observation period the patient stated that the tingling seemed to be resolving.  Patient was advised to monitor the adverse reaction and contact her physician if the tingling did not resolve or if other adverse reaction occur
pt recv vax 5JAN98 & 11JAN97 T102 w/rash c/o legs hurting, rt hand rt foot & ankle swollen;areas tender upon exam-limp;
"COVID Arm" 3 " diameter red blotch around injection site for 10 days.    Narrative:
Information has been received from a nurse referring to a patient of unknown age and gender. The patient did not have any pertinent medical history, or drug reactions/allergies. There was no concomitant medications administered. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, route, lot # and expiration date were not reported). On an unspecified date, while on M-M-R II the patient experienced a rash at the injection site. The outcome of injection site rash was reported as recovered. There was no lab diagnostics studies performed. The reporter's causality was not reported. Additional information has been requested.
Information has been received from a nurse concerning a 12 month old male with a drug allergy to CEFZIL who on 18-JUL-2007 was vaccinated with a 0.5ml subcutaneous dose of PROQUAD (Lot # 657536/0475U) in the right thigh. There was no concomitant medication. On 23-JUL-2007 the patient developed redness and vesicles around the injection site with fever. The rash spread over the body to the areas of the chest, arms, head and a couple of areas on the lower extremities. On 26-JUL-2007, the patient had a sample of the lesion and vesicle sent for VZV identification and the results showed that the specimen was inadequate, negative for B-Globin and there was no strain ID. Subsequently the patient recovered. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. Additional information has been requested.
Felt tired; ill; Nausea; diarrhea; Temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 11:00 (Lot number: FE3592) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "Control blood pressure" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: INFLUENZA, administration date 30Sep2021; PNEUMOCOCCAL VACCINE, administration date 30Sep2021; AMLODIPINE taken for blood pressure abnormal (ongoing); ALPRAZOLAM taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Left, Date: 31Mar2021, Time: 11:00), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Date: 10Mar2021, Time (24hrs): 10:30, Batch/Lot No: Fn6207, Route of administration: Intramuscular, Location of injection: Arm Right), administration date: 10Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 13Oct2021 03:00, outcome "recovered" (15Oct2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 13Oct2021 03:00, outcome "recovered" (15Oct2021), described as "diarrhea"; BODY TEMPERATURE (non-serious) with onset 13Oct2021, outcome "recovered" (15Oct2021), described as "Temperature"; FATIGUE (non-serious), outcome "recovered", described as "Felt tired"; ILLNESS (non-serious), outcome "recovered", described as "ill". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, diarrhoea, body temperature.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Woke day after booster with Diarrhea and nausea. Took temperature. Elevated temperature by 1 degree felt tired and ill for 2 days. Prior to and since the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a 13 month old female with reactive airways disease and a history of frequent ear infections, who on 27-NOV-2006 was vaccinated SC in the leg (also reported as thigh) with a first dose of Varivax (lot # 654610/1049F). Concomitant vaccination included a fourth dose of Prevnar (lot # B08681F) given IM in the leg (also reported as thigh) and a first dose of Fluzone (lot # U2220BB) given IM in the leg (also reported as thigh). Concomitant medication included loratadine (CLARITIN0. There was no illness at the time of vaccination. On approximately 09-DEC-2006 the patient was seen in the physician's office for an unspecified reason, on the same date as a 4 month old infant with active varicella. On 13-DEC-2006 (also reported as 11-DEC-2006) the patient came in to the office with less than one dozen spots of varicella crops and crusted lesions visible on her trunk, in her mouth and on her lips. The patient was fussy, had a decreased appetite and had a low temperature (also reported as afebrile). It was reported that there were a few lesions with a honey colored crust and a few with the classic tear drop shaped blisters. It was reported that there was an "active outbreak" in this country. The patient was noted to have a laceration to the top of her phrenulum. The patient was treated with amoxicillin (AMOXIL) for prophylaxis. It was reported that the patient and her sibling had not had any adverse events followed prior vaccination (previously reported as the patient has experienced soreness and fever after previous vaccination with DTaP. No labs tests were performed, just a physical exam by the physician. Subsequently, on an unspecified date the patient recovered. No further information was available. Additional information is not expected.
another neurological side effect in another patient.; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "another neurological side effect in another patient.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200104466 same reporter/drug, different patient/AE;
flu like symtoms after booster shot, although it lasted for about 18 fours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE and ESTRADIOL for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication reported.   This case was linked to MOD-2021-336321 (Patient Link).
Information has been received from a physician concerning a 13 year old female with no history of drug reactions/allergies who on 25-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5 ml injection. On 27-AUG-2007, the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection. There was no concomitant medication. On approximately 31-AUG-2007, the patient experienced Bell's palsy. On 31-AUG-2007, the patient went to the emergency room (ER) because she could not close her eye and one side of her face felt heavy. There was no swelling involved. The physician did not specify which eye or which side was involved. The ER physician gave her eye drops to keep her eye moist and a type of ointment. The ER report obtained by the physician stated the patient's condition as Bell's palsy. The reporting physician saw the patient on 05-SEP-2007 at the office and she still could not close her eye and felt heaviness on the side of her face. At the time of reporting, the patient's Bell's palsy persisted. Additional information has been requested.
Noticed swelling, blisters, pain,and redness to lips and oral mucosa including gums. Felt pain in roots of teeth. Went to ENT, Received Amoxicillin 875mg BID x 14 days and Fluconazole 100mg as directed for 14 days. Also instructed to use Aquaphor lip repair balm as needed daily for irritation. Physician felt this could be a fungal or bacterial infection but was unsure of diagnosis. Treating prophylactically as above.
New onset atrial fibrillation.   Heart rate 170's irregularly irregular.  Rhythm confirmed 2 weeks later  with one episode of A-Fib recorded with a ZioPatch.  Echo, TSH, labwork all normal.  Had a 3rd short episode of A-Fib confired with a Mobile device about 6 weeks after the bivalent vaccine.  Since that time I don't believe I have had additional episodes of A-Fib.  Treatment has consisted of Eliquis and Flecainide as needed.
Sleeping after shot, rash break out which was thought to be dermatitis which was an extreme abnormal but rash that was persistent for months after these shots but was then ruled to be eczema after a visit in Urgent Care.
Extreme irritability, inconsolable X 8-10 hours beginning several hours after DTAP. Had a fine rash, diarrhea and some vomiting. Irritability persisted X 4 days. Fever X 36 hours.
103.7 fever evening of 3/27/2001 and became very silent and withdrawn.  11/1/2007 Evaluation for Autism 7/2/2002 received with DX of Autistic Disorder. 11/5/07 Vax info updated in VAERS database. 11/05/2007 MR received from PCP beginning 3/7/2001 to present.  Normal development noted at 3/7/2001 WCC.  Multiple sick visits.  Deviation of R eye/? strabismus noted 9/10/01. Opthomol eval for eye blinking and rubbing ? tic (Fam hx Tourette's). Receiving PT, OT and speech Tx 9/25/02.  DX Autism 9/9/2003  Per 60 day follow up: Around the same day/time/week he started exhibiting symptoms of autism. He has recovered from the high fever/lethargy, but not from the autism.  1/13/2010 Autism (moderate/severe).
Persistant arm soreness in left arm; muscle soreness on the back side of shoulder (not the site of injection) for 3 weeks now; painful to lift arm or bend arm behind back.
Immediately after vaccinations, injection sites were hot and red. This continued and about 3 days ago, a rash like streak appeared w/bumps and swelling. It does not hurt. Primary doctor suggested he put ice on it and notify him if this continues. Rash extended from injection site to elbow.
Vomiting-Saturday 3/17 x2 in AM. Diarrhea since Friday PM (denies blood in stool).
Information has been received from a physician concerning an approximately 11 week old health male, with no history of vomiting or fever and no family history of bleeding disorder, who on 6/5/2006 was vaccinated with a 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 652964/0145F). Concomitant vaccine included a dose of diphtheria toxoid  (+) pertussis acellular 5 component vaccine (+) tetanus toxoid (Daptacel), a dose of polio virus vaccine inactivated IPOL, a dose of Hib conj hepatitis B vaccine and a dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). There were no other concomitant medications. It was reported that the patient was seen in the office on 7/5/06 with 2 week history, beginning on approximately 6/15/2006, of gross bloody stools. It was noted that the baby was breast fed with no changes in the mothers diet. It was also noted that the infant was acting fine with no distress, alert, with no fever. Stool cultures were negative, hemocult was positive, and stools showed 1+ white blood cells in smear. It was reported that the infant was nursing well,m and appeared to have occasional slight upset stomach but no vomiting. It was noted that the infant continued to thrive. At the time of the report some improvement was noted but blood was still visible in the stools, and was considered to be not recovered. No treatment was required thus far. It was reported that the patient was scheduled for an evaluation with a gastroenterologist. No product quality complaint was involved. No other information was provided. Follow up information from a physician indicated that the patients mother reported that the child was mildly irritable, in July 2006, but was nothing to be concerned about. There was no vomiting no fever, and no decreased urination. As of 7/7/06 the stools were still bloody. On 7/10/06 the patients mother indicated to the physician that the stools were still with occasional blood. The outcome was reported as recovering. Gross blood stool was considered to be an other important medical event (OMIC). Additional information has been requested.
When I got the first dose of vaccine,  immediately my throat was closing,  I felt like a light choking,  I couldn't swallow my saliva, it went on and off for at least 10 minutes
#1-Sleepwalking Events. 1/17, 3/27 & 5/31. NEVER had such episodes in lifetime. Incurred significant injury to face, teeth and neck. Received CT scans, EKG, observation and blood testing at Kaiser ACC. Will have sleep study later this month #2-Panniculitis. Developed a very aggressive episode 1/27. Impaired mobility due to pain & swelling despite numerous courses of oral steroids, site injections, ointments and daily wearing prescribed support hose.  The condition keeps going from bad to worse and is being resolved #3-Mysterious Rash. Developed an unexplained, irritating, raw rash that my doctor determined was not caused by an infection and was resist
No adverse event; Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date).    Concomitant Medication use information was not provided by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19.   called because they reported that they had accidentally administered a patient a dose of the Moderna Covid 19 vaccine after the 30 Use by date. It was patient's first primary dose.  Treatment Medication use information was not provided by reporter.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, less than a day after receiving MENVEO, the patient experienced injection site erythema, injection site irritation, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site irritation, injection site pain and injection site warmth were recovered/resolved. The reporter considered the injection site erythema, injection site irritation, injection site pain and injection site warmth to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the unknown male patient experienced injection arm redness, warmth, irritation and pain after receiving MENVEO vaccination. This case had been linked with US2016146452, reported by the same reporter.
Presents to the emergency room with weakness and increased confusion, +/- flank pain.  Started on ceftriaxone 2 g IV for suspected UTI, urine culture has since returned mixed contaminants only. Patient treated and is discharged in satisfactory condition. ED visit adn hospital admission within 6 weeks of receiving the COVID vaccine.
DEVELOPED SNEEZING, FATIGUE, HEADACHE, AND STOMACH PAIN IN THE PM OF 11/06/09. 11/07/2009-SEVERE FATIGUE, BODY ACHES HEADACHE, CHEST AND NASAL CONGESTION, & COUGHING DEVELOPED THROUGHOUT THE DAY.  TEMPERATURE OF 101 BY LATE NIGHT. LATE PM 11/07 (OR VERY EARLY AM 11/08/2009) WENT TO EMERGENCY ROOM AND DIAGNOSED WITH H1N1.  TREATED IN ER WITH FIRST DOSE OF TAMIFLU, IBUPROFEN, BENADRYL, AND A BREATHING TREATMENT WITH OXYGEN. DISCHARGED HOME EARLY AM 11/08/2009 WITH TREATMENT INCLUDING TAMIFLU, IBUPROFEN, AND USE OF ALBUTEROL AEROSOL/INHALER.  ALSO USED OTC NASAL DECONGESTANT, AND COUGH MEDICINE WITH EXPECTORANT. STARTED FEELING BETTER ON 11/15/2009, BUT STILL EXPERIENCING LOW-GRADE FEVER, HEADACHE, FATIGUE AND CHEST/NASAL CONGESTION WITH COUGHING. 11/18/2009 ED records for 10/8/2009, patient with c/o's body aches, fever, non-productive cough and diarrhea. Tx: Tamiflu, Albuterol inhaler. Labs/Dx studies: None noted PMH: None allergies: cats and latex
This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown. No Follow-up attempts are possible. No further information is expected.
Mild Itching of fingers and injection site 10 minutes after injection. Moderate itching of hands, feet, and neck area. throughout rest of evening. 3AM no more itching, nausea, felt feverish, ( highest temp 99.9) arm very sore took Tylenol every 4 hours. Thurs AM, hot and cold chills throughout the day, entire arm very sore, hands and feet red, hot, swollen, arthritis very painful, Tylenol helpful. Slept most of day and night, felt like I had not slept in days. Friday symptoms persist but beginning to subside.. as of 5:18 PM symptoms light and tolerable. Swelling in hands and feet almost normal, not as tired, body temp fine, only very slight headache occuring.
Sore and pin in arm of vaccination site for 7 days; Swollen  lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days; Sore throat; tired; Inappropriate schedule of vaccine administration; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 03Jul2021 at 23:30 as dose 1 single and second dose (Lot number- Pfizer Evvo198 RX5449) via an unspecified route of administration in upper left arm on 03Jul2021 as dose 2 single for COVID-19 immunization. Patient's age at vaccination was 52-year-old). Medical history included Graves' disease, allergic to peanuts, Clidomiocin. Patient previously took Tapazol, Aspartame and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), amitriptyline. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 05Jul2021, patient experienced sore and pin in arm of vaccination site for 7 days, swollen lymph nodes in arm pit and neck (lymphadenopathy) under vaccination arm for more than 14 days, sore throat and tired for a week. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.
pt recvd vax; began fever nite of inject; next nite fever went to 104 & eyes were rolling in head; taken to hosp;
11-13-2005 to 11-19-2005 Hospital admission. Diagnosis:  Idiopathic Thrombocytopenic Purpura  Symptoms: Dense cutaneous petechiae on feet & ankles. Large bullous hemorrhages on buccal mucosa.  Occasional petechiae on face, wrists and back. Symptoms were first noticed in the morning of 11-12-2005.  Treatment: ER  11-13-2005   Blood Test, 3:30 PM  Platelet Low 4,000,  Received: Steroid IV  2 - Chest x-ray's            Blood Test, 5:51 PM Platelet Low 2,000,  11-14-2005 Blood Test, 6:25 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:            Protonix 40 mg/once daily IV- Rho(D) Immune Globulin       250ml over 30 minutes:        Ultra Sound-spleen, liver, 11-15-2005 Blood Test, 12:35 PM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11-16-2005 Blood Test, 5:00 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily             IV-Platelets Volume 250   (Donor P72919) 11-17-2005 Blood Test, 6:00 AM Platelet Low 1,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily       Bone Marrow Biopsy 11-18-2005  Received: IVIG, 1000ml, 100grams         Blood Test, 4:29 AM Platelet Low 4,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11-19-2005  Blood Test, 4:00 AM  Platelet Low 60,000,       Received: Prednisone 100mg/day:     Protonix 40 mg/once daily 11/21/05 Blood Work, Platelet  241,000  12/09/05 Blood Work, Platelet 283,000        12/20/05 Blood Work, Platelet 280,000
Service member received Moderna for the first series of COVID-19 vaccination followed by Pfizer for the second series, administered at pharmacy.
Multiple herpes (HSV2) outbreaks within the month following injection. Had been outbreak free for 6+ months prior to vaccination.