chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 28-AUG-2012, the patient was inoculated with ZOSTAVAX by a physician for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-JAN-2016, the patient was treated by the same physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Fever, tenderness deltoid area x 1 mo. Given Toradol IM and Loddul x 10 d - XR - (L) shoulder abnormal - refer pt to ortho.
Approximately 24 hours after my second vaccination on Feb 11 2021 my husband noticed my urine was dark brown/red in color. I had severe fatigue, severe hip/joint pain, flank pain, chills and flu like symptoms. I started to feel better from chills/flu like symptoms Saturday Feb 13, however, still had significant pain in my hips, flank pain, and clear indication of blood in my urine. I call my medical provider and was advised to go to Emergency Department Saturday evening. Blood work and urine was collected and after reviewing labs the Emergency department concluded that I had an arthritic inflammatory response and neuritis.  I was sent home , told to drink lots of water and monitor symptoms. after about 10 days in bed and hydrating I was able to return to work/normal functioning.
Patient received anthrax vaccine in his right arm, over the tricep, on 9/24/04. That evening he noted tenderness surrounding the vaccination site. On the following morning, patient experienced generalized body aches (both muscle and joint pains), which he first attributed to playing basketball the previous evening. He also noted a moderate local reaction at the vaccination site - redness, some swelling, and tenderness. On 9/26/04, the local reaction increased; he noted increased redness, warmth, tenderness, pruritis, and edema surrounding the vaccination site. He denies axillary lymphadenopathy. He also noted systemic symptoms of low grade fever (about 99.5 degrees), fatigue, continued body aches, and generally not feeling well ("felt sick"). By 9/27/04, the local tenderness and edema decreased but the redness and warmth increased to approximately 4" surrounding the vaccination site.  Muscle and joint aches, fatigue, feeling "sick", and pain limiting motion lasted approximately 48 hours.  No further increase in local reaction following 9/27/04, but site remains red, warm and slightly tender. No self treatment initiated.
Moderna COVID-19 Vaccine EUA Lightheadedness, similar to effect of one or two alcoholic drinks.  Systolic BP 180.  No typical symptoms nor signs of allergy.  No treatment except to watch and wait. Systolic BP returned to normal (<150) in 15 minutes.   Lightheadedness fully resolved in less than 2 hours..
On 6-14/17 I was  given  a verbal order to give the patient a DTaP, Polio, Hib, PREVNAR 13 and Rotavirus. I got up from my desk where I had been entering vaccines, went to the refrigerator and grabbed the vaccines ordered. I came back to the lab area and asked another employee to assist me, which she had done in the past and again willingly. I have a system that I have used for years when giving vaccines to make it easier when documenting, so I know what vaccines I want to go together and where. Since that employee does not like to give the PREVNAR vaccine, I began drawing up the PREVNAR and Hib to go in one leg and she began drawing up the DTaP and Polio to go in the other.  In the midst of drawing up the vaccines, another employee stopped us in the middle and asked why we were giving four vaccines instead of PENTACEL and PREVNAR. I immediately realized and told her I was thinking PEDIARIX due to just seeing it on a patient's vaccine record and I knew I wasn't giving a Hep B so that is why I grabbed the four individual vaccines. I told her that you can administer several vaccines at one time, which is even noted on the CDC webpage. We talked about the individual vaccines again, but since they were already opened and drew up, if they were not used right then, they would have been wasted and thrown away. Nothing more was said. We went and administered the vaccines to the patient. I then finished rooming the rest of my patients for the day, making and returning patients calls, working on pre-cert/prior authorizations, faxing documents, as well as documenting the vaccines/injections given that day. On July 5th, it was brought to my attention that the DTaP I gave had expired on June 11, 2017. The provider researched the vaccine and afterwards I informed the patient's mom of the error. I told her that no harm would come to child for receiving the expired vaccine, but the dose would have to be repeated at his 9 month well child checkup. In the past six months, multiple vaccine errors have been made with different employees. The one lady that stopped me asking why I was giving so many vaccines was giving KINRIX to infants until our lead manager at the time noticed and told her not to do that anymore since it was only to be given to children 4-6 years olds. Since then our team lead is no longer there and this same employee took over being the vaccine coordinator. VFC and private vaccines was being tossed in together so on a few incidents private vaccines was given to VFC patients and vice versa. Multiple expired vaccines was in the refrigerator. Some vaccines were expired on the box, but written on box with expiration not expiring for another year. After my error, I went through and organized the vaccine refrigerator, so no other errors could be made.
No adverse event; Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: BBIBP-CORV on 02-Oct-2021, BBIBP-CORV on 04-Nov-2021 and BBIBP-CORV on 03-Feb-2022. Past adverse reactions to the above products included No adverse event with BBIBP-CORV, BBIBP-CORV and BBIBP-CORV.    On 13-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.).    The patient received historical vaccines in a foreign country. The patient did not report any adverse reactions to the Covid-19 (Vero).  No concomitant medications was reported.  No treatment medications was reported.
Two to three weeks after that I had pain in my left knee/The pain got continually worse that I saw my Orthopedic surgeon; Had a 24 hour fever after my booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Had a 24 hour fever after my booster) and ARTHRALGIA (Two to three weeks after that I had pain in my left knee/The pain got continually worse that I saw my Orthopedic surgeon) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Had a 24 hour fever after my booster) and ARTHRALGIA (Two to three weeks after that I had pain in my left knee/The pain got continually worse that I saw my Orthopedic surgeon). At the time of the report, PYREXIA (Had a 24 hour fever after my booster) had resolved and ARTHRALGIA (Two to three weeks after that I had pain in my left knee/The pain got continually worse that I saw my Orthopedic surgeon) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Right arm warm to touch; Right arm itchy; Right arm rash; Right arm swollen; Right arm redness of 2-4 inches; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash) and VACCINATION SITE SWELLING (Right arm swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) and LEVOTHYROXINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PRURITUS (Right arm itchy) had resolved and VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Extreme leg pain for approximately 2 weeks that still hasn't resolved at time of report. Pain has subsided some but knees continue to be very bothersome. Cyclobenzaprine was tried for 6 days.  At time of report diclofenac gel has been prescribed and will begin that treatment today.
Rash ended up on mouth; Painful rash on jaw./ Rash ended up on neck/ Rash began on sides of face; Itchy rash on jaw./ Rash ended up on neck/ Rash began on sides of face; Itchy rash on jaw./ Rash ended up on neck/ Rash began on sides of face; This is a spontaneous case from a contactable consumer(patient) reported that. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection), dose 1 via an unspecified route of administration on 13Apr2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 17 years).The patient medical history was reported as none. The patient had no allergies to medications, food or other products.The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 21:00, the patient experienced painful and itchy rash on jaw. It began on sides of face and had ended up on neck and mouth.Therapeutic measures were taken as a result of events and included treatment with Benadryl and topical Benadryl. It was reported that rash was not lessened by Benadryl. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful and itchy rash on jaw which began on sides of face and had ended up on neck and mouth was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 20 minutes post vax, the pt developed 4 small welts on the left elbow, and itching between his shoulder blades. On 10/16/00, the pt received 50 mg of diphenhydramine orally for prophylaxis 40 minutes prior to the 2nd RabAvert vax. Additional info received on 03/22/2001. The diagnosis provided by the ER was documented as an allergic reaction to the rabies shot.
HERPES SIMPLEX VIRUS; SHINGLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced herpes simplex virus and shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the herpes simplex virus and shingles was not reported. This report was non-serious.
Patient began having headaches and was having falls at home despite never having balance issues before.  She hit her head once on 2/28.  She was admitted then on 3/10 with severe headache, nausea and vomiting.   3/10: Head CT showed vasogenic edema in right frontal with mass effect.   3/10:  MRI head showed a mass in right frontal lobe extending into right temporal lobe, right insula, right basal ganglia, right thalamus and right cerebral peduncle and laterally across midline with expansion of corpus collosum into left frontal horn.  10mm midline shift and subfalcine herniation.   3/11:  Brain biopsy:  suspect for Glioblastoma tumor.   3/11:  CT chest/abdomen/pelvis:  2 small lung nodules measuring 5mm in RUL and 3mm in LLL.
This case was reported by a nurse to a sales representative and described the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. on an unspecified date in June 2006, the subject received a dose of Infanrix (lot number and dose number were not reported) at an unspecified site of administration. On an unspecified date on or before 27 June 2006 after vaccination with Infanrix, the subject experienced limb swelling and redness. The outcome of the events was unknown.
At around 4 am when he came to bed, he lay down and started convulsing. It was like he had an extreme chill but his body was so tensed up and he could not control his muscles or his breathing. He kept convulsing and was unable to control it for about 20 minutes. He asked if he was having a seizure but he was cognitively aware with no trouble speaking and so I told him it was not. His muscles hurt but I assume that was from the prolonged tensing of them. Later that afternoon he complained that his whole body was sore- arm, back, etc. He also has a headache and sore throat. Things to note- he has been running low on sleep (about 3-4 hours a night) for about 5 days leading up to the vaccine date.
This spontaneous report was received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The nurse reported improperly stored vaccines ROTATEQ (dose and lot number were not reported), which were exposed to 18.3 Celsius degrees for 86 hours and 16 minutes. Nurse did not know if any of these improperly stored vaccines were administered. Improperly stored ROTATEQ may have been administered to unspecified patients on unspecified dates. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Significant hives and urticaria at injection site (up and down the same side) on left arm. Noticeable joint and back pain began 6 hours post injection. Noticeable fatigue.
Rash developed one week after vaccine given. Left lower deltoid SC.  Rash was at injection site. Pt complained of itching at site also. Advised to use Benadryl if needed.  Seen on 05/17/04 and filled out this form.
Parent states that child's Left arm is bright red and swollen a half inch round in diameter.  Arm is tender to touch. Child ran fever Saturday and Sunday.  Mom states that she has been giving her Tylenol.  Parent contated child's doctor and informed her to bring Hayley in if arm size increases.  Instructed her to use cold compresses.
Leaking from the vial stopper of FLUVIRIN lot #89685 after withdrawing second dose. Vial was discarded and 8 doses were wasted.
Suspected vaccination failure; My patient / got shingles; This case was reported by a other health professional via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows The age at vaccination was not reported. The reporter stated that, after receiving Shingrxi, the patient got singles. The reporter asked if the patient needed a booster. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received from a health care professional concerning a 26 month old male patient who on 16-JUN-2008 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 659339/1516U) subcutaneously. Concomitant vaccine given on the same day included the fourth dose of PREVENAR (Lot # C57538) intramuscularly. There were no illnesses at time of vaccination. It was reported that on 19-JUL-2009 the patient experienced pruritic lesions, 20-30 of different sizes and different stages and firm papular lesions, there was no fever. It was reported that the patient recovered on 27-JUL-2009. No further information is available.
The pt experienced a febrile episode with a variable fever lasting 3 days occurring 1 day post vax. The pt was treated with anti - pyretics.
Patient first reactions were within the first 3 days of extreme fatigue, shortness of breath, palpitations, and extreme headache of migraine magnitude. Leg pain, heaviness to legs, difficulty to walk was a week after vaccine. Easy bruising and swelling 2 1/2 weeks after vaccine. Palpitations never went away.
patient received expired TENIVAC vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00383301) and transmitted to Sanofi 07-Dec-2020.   This case involves patient (unknown demographics) who received 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number not reported and expiry date: 23-Oct-2020 via an unknown route at an unknown administration site) (expired product administered) on 03-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Pharmacist wants to know if there will be any side effects or if the patient needs revaccination.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Swollen arm and  swelling in armpit area size tennis ball. Tylenol. Day 3 and 4 post vaccine
Sore, achy body, headache, fever of 101.3 on 10/03/2012 @ 930pm.  Took Tylenol and Aleve relieved fever and aches.  Felt better by 7 am on 10/04/2012.
Information has been received from a physician concerning a 33 year old female patient with sarcoidosis and some allergies, who on 12/7/04 was vaccinated into the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649979/0531P). Concomitant medication include fluticasone propionate (+) salmeterol xinafoate. On the morning of 12/9/04, the patient experienced right arm swelling and redness at the injection site. It was reported that her temperature was 98.4. Unspecified medical attention was sought. She was treated with ice. On 12/15/04, the patient recovered. No product quality complaint was involved. Redness at the injection site and right arm swelling were considered to be other important medical events (OMIC). Additional information is not expected. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649979/0531P) and experienced adverse events (WAES0502USA00445). This is an amended report. The adverse event terms of redness at the injection site and right arm swelling have been changed to other important medical events both in the data field and the narrative.
Patient has bilateral hives on arms  24 hours after injection and hives on the abdomen 24-to 48 hours after vaccine. Patient applied Benadryl cream to the hives and it cleared up with in 24 hours of applying cream ever few hours.
The pt became fussy, experienced increased sleeping the same day of the vax. The pt also experienced urticaria increasing over the next 24 hours.
Pt fainted after receiving covid vaccine dose 2. we held her up. no fall. sat with her until she felt better and no longer dizzy. pt was able to drive home herself after some rest