chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy 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.
phlebitis of the forearm starting at injection site tracking up to the mid arm; pain and erythema running as a linear cord along the course of a superficial vein
DVT diagnosed 7 days after vaccine.  Pt does have hx of DVT in past and was dx'd with COVID by NAAT at same time. Otherwise no risk factors.
Information has been received from a company representative concerning a patient who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced "an adverse event which was called in after hours". No further details were provided. No further information is available.
Information has been received from a registered nurse concerning a female (age not reported) who on 27-MAR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. On 29-MAR-2007 (2 days after vaccination) the patient developed hives on her chest, back and upper extremities. The patient sought unspecified medical attention. The registered nurse reported that the patient had used a tanning bed earlier on the same day as the reaction. On an unspecified date, the patient recovered. There was no product quality complaint involved. No further information is available.
Neck pain; Difficulty breathing; Fast heartbeat; Headache; Fever; Feeling unwell; Injection site swelling; Injection site redness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 11:30, the patient experienced difficulty breathing, fast heartbeat, headache, neck pain, fever, feeling unwell, nausea, injection site swelling and redness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of difficulty breathing, fast heartbeat, headache, neck pain, fever, feeling unwell, nausea, injection site swelling and redness were recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I received the vaccine on 2/1/21. I noticed a swollen red bump at injection site and small cluster of red swollen bumps about an inch below the injection site. No pain and no itchiness.
Case number PHEH2014US024980, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 26-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
He got his 3rd vaccine, he had arm soreness, achiness all over, very slight fever.   He went to his doctor for a pacemaker check and she informed him that he had A-fib which his cardiologist  told him it was due to the vaccine.  He did not prescribe any other medication other than what he was taking, and just wants to know why with taking the vaccines he goes into A-fib.  He was in A-fib for about a half hour and then went back into sinus rhythm.    He had his 2nd booster on 4/25/22 Moderna 005M21A.  He went to his cardiologist today for a pacemaker check, and again it showed that within 72 hours of that vaccine on 4/25/22 that he went into A-fib again, which was about 2 hours and then went into sinus rhythm.  He did have a history of A-fib back in 2015, but has had relatively few isolated instances since that time until he has had these 2 vaccines and within 72 hours of each.  He feels that this information needs to be documented as a possible AE.
Patient was given Moderna vaccine at another clinic at age 14. With Medical Director's approval, she came to clinic to receive 2nd Moderna vaccine. Parental consent received prior to vaccine administration.  Patient observed for 15 minutes in clinic and had no adverse reactions.
This female subject was enrolled in the study 112957 (HIB-097). On 21 July 2010 and 17 September 2010, she received the 1st and 2nd dose of HIBERIX, IM R thigh), PEDIARIX, IM L thigh, Wyeth's PREVNAR 13, IM L thigh or deltoid and ROTARIX, PO. On 17 November 2010, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13. This subject received HIBERIX lot number AHIBVC251A@ADO2VB363A. The subject's past medical history included gastroenteritis. On 20 November 2010, three days after the 3rd dose of HIBERIX, three days after 3rd dose of PEDIARIX, three days after the 3rd dose of PREVNAR 13, 64 days after the 2nd dose of ROTARIX, this five-month-old subject experienced seizure. The event was clinically significant (or requiring intervention). This seizure resolved with sequelae on 21 November 2010. On 25 December 2010, she experienced an other seizure. The event was clinically significant (or requiring intervention). This second seizure resolved with sequelae on 26 December 2010. The investigator considered that there was a reasonable possibility that the seizure may have been caused by HIBERIX, PEDIARIX, PREVNAR 13 and ROTARIX and that the events were possibly due to medical condition (gastroenteritis). Subsequent study vaccine administration was discontinued. The subject was withdrawn from the study due to the SAE. 30Dec2010 Electroencephalogram abnormal. Nov 17, 2010-Dose  3 of HIBERIX administered with concomitant vaccines PEDIARIX and PREVNAR 13. Nov 2010-Day 3 post vaccine-"Body jerking" first noted by parent awake and sleeping. Subject also diarrhea stool at each body jerking episode. Nov 21, 2010-Day 4 post vaccine-parent noted "body jerking" six times at two minutes intervals. Dec. 13, 2010-Clinic visit with MD for gastroenteritis and report of "glassy eyed" on 2 occasions. Dec. 30, 2010-EEG performed with outcome as follows: EEG tracing recorded in wake, sleep and drowsy was abnormal due to focal slowing and focal sharp wave activity. The tracing is suggestive of focal encephalopathy. Recommendation from Neurologist-clinical correlation and neuro imaging study. Jan 4 2011-Clinic visit with MD to discuss seizure and start of medications KEPPRA 10mg/kg bid. MRI ordered (apt pending) Neuro consult pending. Jan 4, 2011-Subject withdrawn from study per PI.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case considered of 3rd patient out of 16 patients. Concomitant product use was not provided by the reporter. Patient received additional booster. It has been reported that 26 patients received bivalent vaccines from 2 different Bivalent lot numbers on 09-Jan-2023 they were lot numbers: 061F22A and AS7170B. For all 26 patients vaccine cards lot number has been written as AS7170B.  For 16 patients Vaccination Cards reflected the wrong lot numbers. Additionally, it has been reported that all patients received the correct vaccine and bivalent dose and the error only involved in documentation. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:master case
Pt recv vax & within 24 hr devel cellulitis from elbow to wrist of injected arm. Tx w/antibiotic. This is 1 of 2 pts from this site to devel cellulitis after vax w/this lot #.   See comments
Received shots at 15:30 and 10 minutes later, became dizzy, diaphoretic and light-headed, color was pale-green. Treated the vasovagal response but didn't improve well so was taken to hospital.
rash, tendeness, and itching in arm where shot was administerd about 10 days after shot was given; rash and itching subsided after 5-6 days
ZOSTAVAX given 2-11. H.Z.=symptom - Rt C.N. 5 - 1st branch vesicles onset 2-20. Rt trigeminal 1 distribution.
Diagnosed with Autoimmune hepatitis, I have since had normal enzyme numbers after getting treated with predisone. I still have to have lab work once a month to monitor numbers.
patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. The vial was initially stored in the refrigerator on 04-Nov-2021.Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021.The vial did not undergo any temperature excursions. HCP stated, no adverse event occurred as result of this misadministration, patients were monitored. No treatment information details were reported..
Dizziness; Hunched over; Vomiting; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 09Jun2021 at 01:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient had been tested for COVID-19 since the vaccination. On 09Jun2021 at 01:00, the patient experienced dizziness, hunching over, vomiting and refused medical transport. Therapeutic measures were taken as a result of events and included treatment with first aid and vitals (unspecified). The clinical outcome of the events dizziness, hunched over and vomiting were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
A cat scan was taken  to ck my bladder. It was neg for any problem however it showed a large cyst on my left ovary . I followed up with my Gynogoligist Dr he ordered a pelvic ultrasound and confirmed large cyst on left ovary not there at my recent internal pelvic exam and pap test. He reccomended I see a gynogologist oncologist to ck for cancer of ovary. Dr. at Hospital. He sugested blood work for Braca Gene it was very slightly elevated but not enough to be concerned he did a 6 month follow up of pelvic ultra sound size was 6.2 mil he said he would follow up in 6 months if size grew to 9 mil would consider removal unless i had symptoms like stomach pain or pressure then call him and a decision would be made as to next step . Since i was. Post menopausal for many many years it seemed starange that this cyst had suddenly appeared everything shrinks older you get .i am still doing follow ups and have a pelvic ultra sound sceduled for Wed 12/14/2022
Pt did not devel "protective titers" p/3 injections of Engerix-B; "plan to revax pt; Reporter states the non protective titers can possibly be disabling and/or life threatening "if person contracts Hepatitis";
9AM pt was ill when arriving @ sitters; 10NOV92 nausea & elevated temp; vomited APAP given; t102; given small amounts of fluids; retaining liquids;
Pt with Hx RAD episodes as infant, resolved. Pt deemed FLUMIST candidate of received dose 10/23/08. Pt had subsequently developed URI/LRI with reactive airway component (11/24/08) and begun on inhaled. Bagonist. Prescribed albuterol 11/24/2008
pt recv vax 16JUL96 & a few hr later pt devel chest pain, stomach cramping & h/a, t99.4 in MD ofc 17JUL;no prior illness;no cough, congestion, diarrhea, or vomiting;had 1 hive on cheek;exam neg on 17JUL;
Had fever, nausea, mild erythema and swelling of left arm. Dehydrated. Reported tot he ED 8/20/08.
patient reports feeling lightheaded, nervous, anxious, fingers tingly and stomach feels funny.  Patient reports same reaction after 1st dose.  Benadryl given at 1:29pm.  At 1:40pm, patient reports a sense of relief.
Vasovagal syncope approximately 2 minutes afterwards while still at doctor's office. Hit head on floor. No loss of consciousness. Had nausea/vomiting afterwards. Neuro exam normal. Observed for a period of time afterwards and given signs/symptoms which would warrant reevaluation.
Developed noticeable diminished hearing on 12/6/11-12/7/11 that progressed to near total hearing loss. (Hx: hearing loss on (L); deaf on (R)). Treated by Dr (ENT) Prednisone, Acyclovir.
Received vaccine in (L) upper arm, on 6/14 pain started Tues. night. Redness & swelling noted Wed.
He added the pain in from top of the shoulder to elbow and not going away; He is having hard time sleeping because of constant pain; 1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain; At the injection site, 1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He added the pain in from top of the shoulder to elbow and not going away), INSOMNIA (He is having hard time sleeping because of constant pain), NECK PAIN (1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain) and VACCINATION SITE PAIN (At the injection site, 1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 020B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Broken bones (Patient fell off the roof and had broken multiple bone about 30 years ago). Concomitant products included MELATONIN and ALLOPURINOL for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He added the pain in from top of the shoulder to elbow and not going away), INSOMNIA (He is having hard time sleeping because of constant pain), NECK PAIN (1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain) and VACCINATION SITE PAIN (At the injection site, 1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (He added the pain in from top of the shoulder to elbow and not going away), INSOMNIA (He is having hard time sleeping because of constant pain), NECK PAIN (1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain) and VACCINATION SITE PAIN (At the injection site, 1 inch below the injection site to the shoulder and kind of bit on in the neck, he has extreme pain.) had not resolved.            It was reported that it has been close to 6 weeks, and he is having hard time sleeping because of constant pain. Patient had consulted HCP who advised him to take ibuprofen. The medication worked for 1 day and it stopped working after that.  Patient stated when in motion the pain was not there, but when he relaxes, he had been having the issue.   This case was linked to MOD-2022-468066, MOD-2022-467651 (Patient Link).
Information has been received from a physician concerning a 9 year old female who on 14-JUN-1999 was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 630037/0290J). Concomitant therapy included a SC first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 644644/1080M). There was no illness at the time of vaccination. It was reported that on 29-JUL-2007 the patient experienced a breakthrough of varicella with 200 lesions 2 weeks after patient's sibling had experienced a breakthrough. At the time of report the patient had recovered and it was also stated as "on going". Additional information has been requested.
9/22/23 - swelling in testicles, sharp pain in stomach and lower back. Last 72+ hours.  9/24/23 - went in to be seem at Urgent Care, prescribed antibiotic as precaution. Dx with epididymitis. Has older sibling who was dx with HSP when he was about 6. Pt wasn't aware of this at time of vaccination, but found out later.
This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that patient always got the flu if patient got a flu shot. Since patient has stopped getting a flu shot, patient has not had any form of flu. Go figure. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information available on the batch number for this case.
Sore throat, 98.8 fever, nasal congestion, chills, runny nose.  Resolved within 10 days.