chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 21 year old female patient with no medical history and no allergies who on 08-NOV-2006 and 10-JAN-2007, was vaccinated with a first(Lot# 653978/0955F) and second dose of GARDASIL (Lot# 655619/1427F). There was no concomitant medication. It was reported that the patient received the vaccine while she was pregnant. No adverse side effects were reported as a result of this. Unspecified medical attention was sought. Laboratory diagnostic studies performed was prenatal blood work. On 20-NOV-2007, the patient gave birth to a normal live born infant female. The infant weighed 7 pounds and 10 ounces. There were no congenital anomalies and no complications or abnormalities. It is unknown if the products of conception were examined. There were no complications during pregnancy or labor and delivery. It was also reported that in 2006 to the present, the patient was placed on (VALTREX), 500 mg as needed for genital herpes and on 06-SEP-2007, the patient was placed on (RHOGRAM), "full strength" for RH negative. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe Abdominal pain. CT scan and ultrasound revealed inflamed lymph nodes in abdominal cavity. Pain medicine prescribed. Pain is still present today, 04/25/21
Pt given PROQUAD subc. in R arm at approx 330. Pt immediately developed a 5x5 cm area of redness, warmth and itching. Pt was given BENADRYL and asked to wait in office for about 20 minutes. No further symptoms developed and itching is beginning to resolve.
Wrong Route of Administration; redness at injection site; tenderness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K1T3C2 ?, expiry date 5th December 2021) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 4th September 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2019, the patient experienced injection site erythema and injection site tenderness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site erythema and injection site tenderness were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The reported batch number was not available in sales data sheet, hence it was captured as  K1T3C2 ?. The pharmacist reported that a 66 year old female received the initial dose of Shingrix subcutaneously and experienced redness and tenderness at the injection site, which led to intramuscular formulation administered by other route.  The patient took Tylenol and the redness and tenderness had resolved.
Continued aching - 3 weeks after TDAP injection. Pain at (L) arm injection site radiates to (L) neck down to (L) wrist. Warm to touch. Pain in (L) shoulder joint & (L) elbow. Afebrile.
Flu injection given. 5 minutes later pt. passed out. Pt was moved to exam table with elevated legs and observed for 15 minutes. Pt. exam by Dr. was normal. Pt. walked to parent vehicle without any problem.
Date of Vaccines: #1 on 1/4/21, #2 on 1/29/21 Adverse event: On 1/5/21 had nasal congestion, rhinorrhea, allergy flareup. On 1/30/21 for 1 week had fatigue, chest pain, then had shingles at Left chest starting 2/4/21. Took Zyrtec for symptoms and is on Valacyclovir for shingles
Dose administered was one hour and 30 minutes past the expiration time from time of diluting the vaccine.  We will contact Pfizer for further guidance.
Shortness of Breath      Pt arrived via local EMS for difficulty in breathing. EMS unable to obtain initial pulse ox on room air, placed NRB 15L en route.        HPI:   This is a 82y.o. female with significant past medical history of HTN, paroxysmal atrial fib, obesity, and recent COVID admission at a local Hospital that presented to the hospital with chief complaint of shortness of breath. Patient was reportedly diagnosed with COVID-19 infection on 1/2/22, at which time she completed steroid therapy. She was noticed yesterday by her daughter to have increased labored breathing and she phoned EMS.    In the ED, patient normotensive, afebrile, stable SPO2 on nasal cannula. CT head negative for acute process. CXR with bibasilar atelectasis. D-dimer > 10k. EKG with SVT S/P adenosine with cardioversion to NSR. She has been admitted for further evaluation and management with cardiology and nephrology consultations.    Patient seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
sick; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration, at the age of 53-year-old, on 13Sep2021, as dose number unknown, single for COVID-19 immunization. The patient medical history includes systemic lupous erythematous, organ for system involvement unspecified. The patient concomitant medications were not reported. On an unspecified date in 2021,the patient experienced sick. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Rash. Treatment: methylprednisolone 124 mg IVP MG once, diphenhydramine 50 mg IVP MG once.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. The patient received the first dose of ZOSTAVAX on an unspecified date of November 2014, then received the second dose on an unspecified date of March 2015 (dose, route and lot# were unspecified). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 31-AUG-2017, the patient was vaccinated with PROQUAD and VARIVAX for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). On 31-AUG-2017, the patient experienced overdose. No adverse effects were reported.
big old red circles; itching; burning; This case was reported by a consumer via  interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced localized erythema, localized itching and burning sensation. On an unknown date, the outcome of the localized erythema, localized itching and burning sensation were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized itching and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine had a reaction both times big old red circles itching and burning. The follow up would not be possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR186892, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186892:Same reporter
Information has been received from a registered nurse concerning a 26 year old female with an allergy to penicillin and no medical history who in 1992 was vaccinated with the first and second doses of varicella virus vaccine live. Concomitant therapy included iron tablets. In March 1992, the patient had a negative titer. No lot numbers were available. No additional information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sore at injection site, 2chrs after shot slept 3 hrs than 2 hrs later another 2 hrs, light headednes,
Second dose of RabAvert delayed several days after day 7; Case reference number US-BN-2022-000216 is a spontaneous case report initially received from a health care professional via regulatory authority (reference number USBAV22-0079) on 01-Mar-2022 and concerns a 29-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 19-Feb-2022, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at an unknown dose, route or site of administration, for pre-exposure prophylaxis (PrEP).  As reported, the RabAvert was unavailable to obtain through the vendor and the patient could not receive the second dose on day 7 (explicitly coded as 'Incomplete course of vaccination'). The reporter asked if the second dose could be delayed for several days and if the RabAvert could be interchanged with Imovax, which was available.  At the time of this report, it was unknown whether the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: A 29-year-old female patient could not receive the second dose of RabAvert for pre-exposure prophylaxis (PrEP) on day 7, because the RabAvert was unavailable to obtain through the vendor, as reported, which is considered as incomplete course of vaccination. No associated adverse events have been reported with the reported medication error. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: A 29-year-old female patient could not receive the second dose of RabAvert for pre-exposure prophylaxis (PrEP) on day 7, because the RabAvert was unavailable to obtain through the vendor, as reported, which is considered as incomplete course of vaccination. No associated adverse events have been reported with the reported medication error. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
A report has been received from a Health Professional concerning a 9 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 18-NOV-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A (lot no. CK2009) which started on 24-NOV-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
This spontaneous report from a contactable nurse and a contactable physician via a Pfizer Sales Representative. A 39-year-old (race unknown) female patient received PREVNANR 13 injection intramuscularly in the right arm at 0.5 ml single on unknown date. Relevant medical history included neutropenia, asthma and allergy to unspecified  diphtheria vaccines all since an unknown duration. Relevant concomitant medications included unspecified vaccines on 24Sep2013 on left arm influenza. On 24Sep2013, the patient experienced local reaction at the injection site, pain at the injection site, severe swelling at the injection site and redness at the injection site while on PREVNAR 13. Relevant laboratory data was unknown. Therapeutic measure taken in response to the events was CUBICIN intravenously on an unknown date in Sep2013 at an unknown dose and frequency. Clinical outcome of the events was unknown at the time of report. Follow-up (05Nov2013): New information received from the contactable physician includes: This physician confirmed the occurrence of the events. Follow-up (20NOV2013): Follow-up attempts completed. No further information expected.
1/6 Red, swollen, warm, itchy at inj site L arm  Narrative:
patient described injection site as red, swollen and hot. Also stated that she noticed her lymph node in under her arm was swollen. it has been 4 days since the vaccine.
Migraine headache, neck muscles sore, upset stomach, malaise lasting through night into next day.
Patient received PNEUMOVAX 23 vaccine in her left deltoid muscle at her place of employment on 04/09/2007. She experienced swelling and pain in the few hours following the injection. The next day she awakened to find her left arm between her shoulder and elbow with the following: erythema, swelling, induration, warmth, and pain. The patient phoned the office of her internist and was advised to taken an antihistamine and apply over-the-counter hydrocortisone cream. The symptoms gradually subsided over a several day period.
TRAUMA SURGERY PROGRESS NOTE              Hospital Day(s): 31   Injuries:  (s/p MVC on 6/9/23; Repatriated from Medical Center on 6/10/2023) ? Traumatic pons SAH ? Left occipital condyle fracture ? Possible B ICA, vert artery dissection ? C1 ring fracture ? C-spine epidural hematoma ? L humerus fx x2 - displaced distal midshaft, nondisplaced proximal midshaft      Other Diagnoses: ? Bilateral true vocal fold paresis ? Vertical diplopia 2/2 CN 4 palsy ? Central cord syndrome, left upper extremity weakness ? Respiratory Failure ? Dysphagia ? Possible Pneumonia ? Covid 19 disease   Operations & Procedures: ? 6/9:     Endotracheal intubation ? 6/12:   Cranio-cervical (C5) fusion ? 6/13:   Left humerus ORIF ? 6/17:   Perc Trach ? 6/21:   Percutaneous gastrostomy    Transfusions: ? 6/12 1 u PRBC   Summary / Hospital Course: Patient is an 18 Y old Female status post motor vehicle collision who was initially taken to Medical Center for initial trauma evaluation and care on 6/9/2023. Pt was an  unrestrained passenger.  After a thorough trauma evaluation, the patient was taken to ICU for traumatic SAH and C1 fx.  While at Medical Center pt immediately intubated for GCS 3. Per NB ED documentation, deformity noted to Left arm, abrasions to L buttock, Right  knee, and bilateral hands. There was question of possible seizure activity, for which pt was administered 2mg ativan. Posterior long arm and sugar tong splint placed on LUE.  Transfer was requested for a higher level of care and she was transferred late on 6/10/23 and admitted to the ICU.   Immediately upon arrival, appropriate CTs and MRIs were obtained.  She was kept in very strict spine immobilization and Neurosurgery was consulted.  She has remained very sedated overnight to avoid any movement.   6/11:  Ortho consult.  Continue splint until ORIF after Cspine stabilized.  Continue deep sedation today.  Family counseled by NS.  EN started via OGT. 6/12:  Cranio-cervical fusion performed.  To ICU intubated.  Per RN, 2/5 motor RLE, 1/5 LLE, No movement BUE. 6/13:  Left humerus ORIF.  Moving BLEs; no BUE motor. 6/14 on steroids for central cord syndrome.  Vasopressors available but not needed for MAP therapy
Patient's husband reported that patient noticed on 6/4/2021 bumps and itchy rash on her stomach , side of torso, and back (not as prominent on back). Bumps and rash have grown in size and seem pustule and "zit-like".  Patient will continue to monitor rash size and temperature. If any drastic changes in  temperature or rash size/status, patient will seek medical attention.
Tdap 0.5 cc IM, R deltoid. Hard/painful w/swelling. Erythema 50cm x 30cm. No SOB. Wheeze. Airway open.
Painful vaginal ulcerations (Lipschutz ulcers) which began  2 days after second Covid vaccine.  Had fever and fatigue 24 hours after receiving vaccine which resolved then developed vaginal ulcerations. Ulcerations very painful. Presented with pain and dysuria.  Was treated with Ibuprofen and topical lidocaine
Patient reported pain and soreness in left arm, with it spreading to her leg and shoulders/neck. She said it was painful and it kept hurting until the next day 7/13/16. She came in to the pharmacy to be evaluated and there was  2-3 inches area of redness/puffiness about 1-2 inches below the injection site. Arm skin and injection site was normal otherwise, besides the red/swollen area.
HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine) 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 an unknown date, 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 NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine). At the time of the report, NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Just over 48 hours after the vaccine, I got a sunburn-like rash on both triceps that hurt and have a burning sensation. The rash and burning sensation remain.
Information has been received from a nurse practitioner concerning an 18 year old female with allergies to CECLOR, cephalexin (manufacturer unknown), gentamicin eye drops (manufacturer unknown), penicillin (manufacturer unknown), ZITHROMAX and with ADVIL caused asthma who on 22-AUG-1995 was vaccinated SC with the first 0.5ml dose of VARIVAX (Merck) and on 03-AUG-2009 was vaccinated SC with the second 0.5ml dose of VARIVAX (Merck) (Lot# 664712/0799Y). Concomitant therapies included OCELLA and ALLEGRA. The patient also was vaccinated with DTP vaccine (manufacturer unknown) on the same visit but different site. On 04-AUG-2009 the patient developed a red raised area the size of softball at the site of injection. The patient had sought unknown medical attention. At the time of report the patient's status was not recovered. This is one of several reports from the same source. Additional information has been requested.
I periodically started hearing humming in my ears for a few days then on Friday 4/16/2021 at night it started again and has not gone away, my ears were also hurting me I went to the Urgent Care Saturday 4/17/2021 and found out I have inflammation in both ears, I was given a prescription for ear drops Hydrocortison-Acetic Acid Soln, 3 drops 4 times daily.  I have not lost my hearing it is good so I'm assuming it is not Tinnitus.
3wk p/vax broke out w/rash;raised red, blistered scabbed over p/5 days;total of 10;
tinnitus/Ringing in ears; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 18May2021 14:00 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypothyroidism (from many years) , tinnitus from an unknown date (might have been noticing it from time to time in last 10 years). The patient had no family medical history. The patient did not have history of all previous immunization with the vaccine considered as suspect. The patient did not administered additional vaccines on same date of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for hypothyroidism, start and and ongoing. On Saturday 22May2021, he had ringing on his ears. He wanted to know if that was from the vaccine or not. At the time that it happened, he was pressure washing and he was not sure if the loud noise contributed to his tinnitus. He has a history 10 years ago of tinnitus. The pressure washer was very loud. Then he started to wonder. He had pressured washed before and never had it before. Caller stated that he still had the ringing. It was not as bad as it was at first. The patient stated he did not do anything but try to stay away from loud noises. The outcome of the event was improving.  Follow up attempts are needed. Further information has been requested.
Reporter indicates pt experienced a "failure to achieve antibody titers /p 3 doses of 20 mcg ea of Engerix B".
DIFFICULTY BREATHING; FAST HEART BEAT; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced difficulty breathing. On 10-APR-2021, the subject experienced fast heart beat. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, fast heart beat, dizziness, and weakness. This report was non-serious.
Janssen COVID-19 Vaccine EUA Bilateral Bell?s Palsy April 28th- I lost taste and my tongue felt burnt and had a coating on it.  April 29th- Morning, I noticed my top lip was off-center. Later that evening, I felt numbness around my lip and mouth. April 30th- Lost muscle function on left side of face, including around left eye. Went to Urgent Care, they diagnosed as Bell?s Palsy and prescribed a high dose steroid and antiviral medication. May 2nd- Called doctor because right eye was twitching and muscles were feeling very tight. They thought it was my eye over compensating  May 4th- Lost muscle function on right side of face. Went to Urgent Care to be re-evaluated. They suggested I go to the ER. Went to ER, bloodwork, CT scan and MRI all came back normal. They believe it is bilateral Bell?s Palsy
pt recvd vax on 6APR93  had mild conjunctivitis rt eye dx'd good hlth; @ sitter AM 9APR found white, not breathing code blue unsuccessful; suspected SIDS but 72hrs w/in vax;