chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around August 2015, the patient was treated for shingles and zoster-related injuries. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021 at 8:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine). On 25-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non significant follow up appended
Severe mouth ucers began to develop, resulting in taking prescription ofValacyclovir HCL 1 Gram tablet, 2 tabs every 12 hrs orally 1 day, beginning 3.14.2021. No relief. Mouth ulcers remained and lips swollen and cracked. 3.18.2021 via telemedicine visit, Dr prescribed Lidocaine 2% Viscous soln 15 mL as needed every 3 hrs mouth/throat 5 days. Also Famciclovir 500 MG tab. 3 tabs by mouth ever day for 2 days. (To be used if no improvement  with Lidocaine solution) Did not use prescription  Significant improvement, but still sore up until approximately 4/04/21
Patient presented to the ED and was subsequently hospitalized with Sepsis without acute organ dysfunction within 6 weeks of receiving COVID vaccination.
After receiving MENACTRA, in process of receiving GARDASIL, child became extremely pale and experienced LOC x about 15 seconds, slumping into chair. Head protected thru out. Given liquids and observed for 1/2 hour. Mentating well, no dizziness when ambulating when discharged.
My vision is blurry and I am having double vision that is still ongoing ever since the vaccine. I went to the eye doctor and my vision had changed since the vaccination. I have bubbles in my urine. I also been having back pain that is still ongoing as of today. I went to the ER. They did CT scan, showed that I have a spot on my kidney that has doubled in sized. They also did blood work and EKG, normal result. I am seeing a kidney specialist and they are going to do surgery to freeze and a biopsy on April 12th.
Maculopapular discrete lesions on face trunk and arm started 2-3 days after his uneventful Td and MMR shot at clinic. Started from face and reached to trunk and head. Seen on day 11.
On August 10, 2014 I attended the second day of an annual two-day event. I elected to receive 3 vaccines approximately 30 minutes before the event ended on August 10th.  I indicated that I wanted to receive the meningococcal vaccine, the measle-mumps-rubella vaccine and the Pneumovax. I had written these three vaccines on the intake sheet. I was informed that they had run out of the Pneumovax but they had the pneumonia vaccine that was given to children and it would be OK to receive that one. I was given the patient information sheets for  1) Pneumococcal Conjugate Vaccine  (2/27/2013), MMR Vaccine (4/20/2012) and Meningococcal Vaccines (10/14/2011). The nurse administered all vaccinations. The MMR was administered subcutaneously into the Right upper arm and the meningococcal vaccine into the Right deltoid muscle. I asked that the third vaccination not be given the Left arm because I am Left-handed but the nurse insisted that she had to administer this vaccination into in my Left upper arm (deltoid muscle) and did so. I experienced muscle tenderness and achiness in the left arm initially for about two weeks during which there was mild pain when I attempted to raise my left arm straight up in the air. The muscle tenderness, achiness and inability to raise my left arm straight up in the air or place my left hand behind my back continued for another ten days which I attributed to time spent in a cool, damp environment.  After leaving the cool, damp environment the muscle tenderness and achiness progressed to severe pain with the slightest movement of my left arm in any direction. The severe pain lasted through the month of September, approximately 30 days. The muscle pain and achiness gradually resolved over the next three months and was completely gone by January 2015; however, the inability to raise the left arm straight up in the arm, lift objects with my left hand above shoulder level or place my left hand behind back persisted. It was at this time that I inquired at the local County Health Department information about the vaccines that I had been given in August 2014. At first, January 30, 2015, no information regarding the site of administration or lot numbers was available for any of the three vaccinations because the information had not been entered into the Statewide Immunization System. On February 5, 2015, a fax of the intake sheet revealed handwritten lot numbers for the "pneumonia" vaccine [Merck J010396], MMR [Merck J013316 ] and an illegible sticker for Menactra with a handwritten lot # [44681AA]. The faxed intake sheet indicated that ALL immunizations were given in the right deltoid. Three physicians, a family medicine (03-11-2015), an internal medicine (03-23-2015) and an orthopedic surgeon (04-02-2015) were seen for the left upper extremity problem. Their comments were consistent: unable to abduct beyond 90 degrees, decreased range of motion, adhesive capsulitis, respectively, and all agreed no pain was elicited on examination.  All recommended physical therapy.
Pt reported itching 26 mins after vaccine.  Evaluated by EMT and itching resolved.
Patient was given 3rd covid vaccination when she was not eligible yet. 2nd dose Moderna was received 4/21/21, patient checked yes to being immunocompromised even though she is not.
Sudden hearing loss in left ear, occurred within 24 hours after first COVID vaccine received. Not sure if conidence or if an adverse reaction. Treated by Dr and had two audiology test preformed. Currently wearing hearing aid's.
Patient presented to ED with severe headaches, found to have small subarachnoid hemorrhage.  Is currently being monitored in the ICU, no surgical intervention needed, but closely monitoring and treating her blood pressures.
Patient reported 2 clusters of blister on his low back and mid back. Starting 1 - 2 days after his SHingrix vaccine,. Patient reported this happened after first vaccine also, but he did not associate it with the vaccine. The blisters resolved after the first vaccine and he has not had them again until now after his second dose.
Presented on 1/28/2022 with inferior STEMI s/p PCI, DKA, and Covid-PNA.  Hospital course complicated by acute hypoxic respiratory failure 2/2 PNA, volume overload, and new onset atrial fib.  On admission to CC the patient was intubated and sedated.  Patient tested positive for Covid on 1/28/22.  Patient was not a candidate for Remdisivir because of being intubated.  Patient was treated with steroids.  For PNA he was started on antibiotics, and diuresis for volume overload and was extubated.  Patient was transferred to step down and started on Remdesivir per ID.  Patient with inferior STEMI who underwent emergent PCI/DES to the RCA, then developed VF arrest with inability to achieve ROSC.
Paresthesia on the right side of the body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Paresthesia on the right side of the body) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Concurrent medical conditions included MS (MS involved only Optic Nerve. Did not have any other symptoms except the optic Nerve problem .) since 2012.    On 19-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PARAESTHESIA (Paresthesia on the right side of the body). At the time of the report, PARAESTHESIA (Paresthesia on the right side of the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications taken by the patient.  Patient did not had any another symptoms until patient received the Moderna vaccine.  Patient experienced the event less than 24 hours after vaccination.  No treatment medications were reported.
Presented to emergency department with complaints of passing out and black stool on 3/28/21. Was found to be COVID-19 positive during screening for admission. Did not have symptoms and was not treated for COVID-19 infection. Patient stated he had prior COVID-19 infection in December 2020. Patient was admitted for 4 days for treatment of acute upper GI bleed and anemia.
Shingrix given without mixing the vaccine; Shingrix given without mixing the vaccine; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date : 17-NOV-2022 Reporter's Comment:  The reporter did not have patient's initials, gender and date of birth. the reporter stated that Shingrix was given without mixing the vaccine to two different patients. Only the adjuvant part was received by patient. The reporter consented to follow up.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR172088:Same reporter. Patient 1
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, but the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
The patient had no knowledge or record of having received the vaccine and at the time of uploading the information, he had already received the vaccine.
The patient skin became blotchy, red, with rash around the area of administration. It was about the side of a silver dollar. Waited 15 min to see if patients rash would spread or other side effect would occur. It faded as quickly as it started. No other side effects had occurred. Skin was back to normal within time frame. Provider confirmed this.
Headache Narrative: Employee states: After first dose: Fatigue/weakness and swollen lymph nodes under left arm. This has leasted approx. 3 weeks. After second dose: She completed the vaccine monitoring at 09:34am. She noted a faint headache around 11:20 that increased on a scale of 1-10 to a 6. Also she experienced arm soreness and stiffness with motion noted noted to begin around noon and progressed to throbbing in upper arm. She took Tylenol prior to vaccination and around noon which did not affect headache but helped some with arm.
patient reports tingling sensation to the lips tongue. IM Benadryl 50  mg given at the vaccine site.  patient sent to Emergency room for  further evaulation
Syncope, dizziness. BP 55/30 (pulse 56). Final BP 111/54, 100% O2 sat.
This spontaneous report as received from a female consumer reporting on herself who on an unknown date was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that she experienced a rash several years ago, on an unspecified date, after receiving ZOSTAVAX. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced a rash several years ago was unknown for ZOSTAVAX. Additional information is not expected.
Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies who on 28-JUL-2010, was vaccinated IM in the right deltoid with the first 0.5 ml dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included Tdap in the right upper arm given on the same day at a separate location. The physician reported that on 29-JUL-2010, one day after the administration of her first dose of GARDASIL the patient developed redness, swelling and discomfort of the right hand. The symptoms worsened to include exquisite pain in the right fingertips and palm and the patient was evaluated at local emergency room. A sedimentation rate test was performed, the result was normal and the patient was prescribed a 4 day course of unspecified steroid medication. The patient was then evaluated by an unspecified orthopedist. On an unspecified date, the symptoms initially improved but returned when the course of steroids was completed. On 02-AUG-2010, the patient was seen in the office, the physician ordered a complete blood count, sedimentation rate, and rheumatoid factor. The results were pending. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with no pre-existing conditions, no birth defects and no medical conditions who on 28-JUL-2010 was vaccinated into the right arm with a dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included vaccination into the right arm with a dose of BOOSTRIX (Lot# AC52B05DA) and into the left arm with a dose of MENACTRA (Lot# U3697AV) both on 28-JUL-2010. No illness at time of vaccination. In the morning of 29-JUL-2010, when the patient woke up, she experienced pain, swelling of right distal arm-wrist, fingertips, palm. Tingling. Redness of fingertips. Orthopedic physician diagnosed Reflex sympathetic dystrophy. The patient's outcome was unknown. A magnetic resonance imaging (MRI) and a X-ray were performed on an unspecified date (no results provided). No further information is available.
No adverse effects reported; improperly stored doses of VARIVAX and PROQUAD; This spontaneous report was received from an administrator referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-MAR-2019 or 31-MAR-2019 or 02-APR-2019 or 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot# R023736 with expiration date on 20-AUG-2020 or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot numbers R008697 and R000551, for prophylaxis (dose and routes of administration). The administered doses of the vaccines experienced temperature excursion -12.85 degrees Celsius for 15 minutes. There was no adverse effect reported.  This call was because of a data logger and there was not previous temperature excursion.   No product quality complaint was involved.   Lot number R008697 and R000551 are invalid lot numbers for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) .  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1904USA004742:Original Case : 1904USA003556 US-009507513-1904USA004743:Original Case : 1904USA003556 US-009507513-1904USA004744:Original Case : 1904USA003556 US-009507513-1904USA004739:Original Case : 1904USA003556
Area @ inject site - hot, bruised, hard; - Systemic - flu-like sx re: "feel bad", aching.
Ptosis left eye developed about 48 hours after vaccine, mild progressed to very noticeable currently improving
EYESIGHT WAS TOTALLY BLURRED (BOTH EYES SHE COULD NOT SEE) AND FAILED A DRIVING RENEWAL TEST DUE TO THIS; BOTH LEGS CRAMPED ALL THE TIME; PAINFUL BONE SPUR ON THE LEFT FOOT (SOMETHING HARD ON THE TOP OF HER FOOT AND IT WAS PAINFUL); This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced both legs cramped all the time. On 01-AUG-2021, the patient experienced painful bone spur on the left foot (something hard on the top of her foot and it was painful). On 12-AUG-2021, the patient experienced eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this, and had not recovered from both legs cramped all the time, and painful bone spur on the left foot (something hard on the top of her foot and it was painful). This report was non-serious.
Moderna vaccine given 1/8/21, lot #011L20A; PFIZER vaccine given 5/11/21, lot #EW0161; PFIZER vaccine given 6/14/21, lot #Ew0187; pt presents from SNF with c/o somnolence; tested positive for COVID 5 days prior to coming to ED; admitted to hosp; COVID positive; severe sepsis; acute on chronic RF with Hypoxia related to COVID; O2 supplementation; experienced cardiac arrest with PEA rhythm; ACLS performed with ROSC; pt transitioned to comfort measures and she passed away in the hospital
Per patient, after he received 1st dose of Covid Vaccine on 9/2 he started experiencing pain on left shoulder to fingers tips 5/10, difficulty breathing, chest pressure, and chest pain 4/10 same day. Denied any trauma to chest. C/O lightheadedness, dizziness, and headache. Patient declined to present to emergency room.
First dose (07/30/21) gave some muscle pain around my whole body and also crippled my hands specifically my right hand from being used. Muscles in right hand gave me extreme pain and discomfort when I tried to use them to lift or do anything even something like a computer mouse.   Second dose (09/17/21) gave me a lot more pain, the night of the second dose I felt super cold and was shivering so hard and for so long I started getting really bad cramps all over my body and had to massage them to relieve the pain. This shivering and feeling cold lasted a few hours and basically until the morning. It was around 72 degrees in my room and I had two heavy winter blankets on me but never felt warm. The next day my body was hurting all over I assumed from the soreness from shivering but then the next day and the next day and to this day the pain is still here. My right hand is still painful to use when I have to use a computer mouse and I have to take breaks to let my hand rest. This is only after weeks of physical therapy to regain some functionality of my hand without excruciating pain.
injection site had a blue spot and it was sore to touch but today it is not sore; injection site had a blue spot and it was sore to touch but today it is not sore; Fever; Lethargic; injection site is real red; Injection site itching; Injection site swelling; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiration date was not reported), dose 2 intramuscular on 05Feb2021 09:40 (age at vaccination 80 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing moderate stage 3 kidney disease (Verbatim: moderate stage 3 kidney disease) diagnosed a year ago, blood pressure (Why was the patient taking Concomitant Products Lisinopril (Verbatim): stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys). Concomitant medications included lisinopril (LISINOPRIL) taken for stage 3 kidney disease, moderate, so if her blood pressure goes up it does not damage kidneys.The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) on 15Jan2021 09:45am (age at vaccination 80 years) Intramuscular injection in left shoulder for covid19 immunization. On Feb2021 the patient experienced injection site is real red, injection site itching, injection site swelling, fever (duration of reaction -4day), lethargic, on an unspecified date the injection site had a blue spot, and it was sore to touch but today it is not sore. Patient reported, the only thing beside a vitamin that she takes is lisinopril. She has not been to the doctor for this. Advised to contact hcp. The first dose didn't bother her. Patient not visited Emergency Room nor Physician Office. The patient underwent lab tests and procedures which included body temperature was 100 point something on 06Feb2021. Patient received treatment for injection site is real red, injection site itching, injection site swelling. last night she put cortisone cream on it thinking it would help. The outcome of event fever, Vaccination site pain recovered, and lethargy was recovering. Vaccination site discoloration was unknown, Rest of all event was not recovered.  Follow-up attempts completed. No further information expected.