chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.63. Concomitant products were not provided. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
The night/next day after vaccination patient stated her arm started to feel sore and a rash developed that was originally small. She reported to us on 11/2/19, six days later. Her rash was dark pink about 4-5 inches in diameter, with a red spot where the vaccine was injected .  She reports that it is firm, sore and warm to the touch. It itches as well. Has worsened since the original date of injection. She reports no other symptoms. She was advised to take Benadryl if needed and to see her doctor asap.
This spontaneous report was received from a physician who referred to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA005552: US-009507513-1709USA005553.
Pt recv vax on 1/30/99; on 1/31/99 pt exp swollen, inflamed nodule on right thigh
Approximately a few weeks after my 4th dose vaccination, I contracted COVID-19 and experienced the following symptoms: Sore throat, Headache, Congestion, Runny Nose, Fatigue. I took Tylenol, Dayquil and Nyquil for treatment. It did help to ease my symptoms and help me sleep better. I had a tele visit with my doctor and wasn't prescribed with anything and to let it run its course.
Mild joint stiffness in bilateral hand/ finger joints noted >2 weeks after initial dose, lasting a few seconds in the morning. Received 2nd dose 2/2021. A few days later noted to have warm inflamed joints  joints In bilateral hands primary fingers now lasting all day .Joints were not tender. This continued for several days , finally started scheduled NSAIDS For about 10 days with gradual improvement in symptoms. Currently still having mild stiffness occurring a few seconds in mornings.
Patient received a second flu shot for this year on 10/16/2022. No adverse event reported by patient.
Pain got worst on site of injection (right arm) at 9 pm (administered 2:30 pm 9/22/09), and by 12:00 AM patient cannot move her right arm anymore, went to ER and was given VICODIN. She was able to move her right arm a little bit this afternoon only 9/23/09 5:30pm), and still taking pain med. she will be seeing her MD in 48 hrs. Still in process, observing.
mixed menveo with diluant and not liquid part of menveo; mixed menveo with diluant and not liquid part of menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were provided as follows: The age at vaccination was not reported. Menveo was mixed with diluent and not liquid part of menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.. The reporter agreed to follow up. This case was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166884:same reporter US-GLAXOSMITHKLINE-US2021AMR166885:same reporter
Swelling of left armpit, blood clot in lower left lung, pneumonia, 15-3 blood marker at 102, but MRI and Cat scan can not find cancer. I will have one more CT scan and PET scan next week.. Breathing is getting worse.
Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time).    This case contained information for the 8th of 8 adult patients described by the reporter.  No concomitant medication was reported by reporter.  Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 02-Aug-2022.  No treatment medication was reported by reporter.
Patient was vaccinated at Vaccine Center at 11:57am for his Pfizer booster. He sat for 15 minutes and then left. Returned to Vaccination Center at 12:25pm because he had concerns about his symptoms. He said that he had similar symptoms with his previous covid19 vaccines. Patient stated that he had a tingly feeling from the site (left deltoid) of his injection to his fingers, stated he felt warm and a little nauseous. Patient had stated that he had visited his doctor prior to being vaccinated and was told that his BP pressure needed to be rechecked, but patient did not return to see his doctor yet. Checked patient?s vital signs and saw that his BP was 210/106 using automatic blood pressure. Other vital signs: 97.8F, SpO2 99%, HR 84. Tried to retake blood pressure on his other arm, but cuff read error. Asked patient if he knew what his regular blood pressure is and if he took any medications. Patient denied taking any blood pressure medication and that he didn?t know what his usual blood pressure was. While patient was with staff, he mentioned that both of arms started feeling tingly and he felt like he was losing sensation in both his arms and he had pain in his neck. He stated that felt like this when he had a previous covid19 infection. Called 911 at 1246 and let patient know that staff wants him to be checked out. While waiting patient was pleasant, responsive and talkative. Paramedics arrived and took vital signs : BP 210/120 , SpO2 100% on room air, HR 84, RR 18. Patient decided to go with paramedics to the emergency room at 1310.
By 3 PM on the day of the injections I experienced severe fatigue, the following two days I had muscle aches, headache and shooting pains in my joints. I had chills, dizziness and no appetite.  The shots were given Tuesday AM. Wednesday I could not have driven a car, Thursday I improved slightly but did not feel that it would be safe to operate a car. On Friday I returned to the doctor's office and saw a Dr. who suspected an allergic reaction. I have continued to improve and feel normal again one week following the injections.
This spontaneous report concerning an unspecified number of patients of an unknown gender and age was received from a registered nurse. The patients' concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of PROQUAD lot # L045675 expiration date 09-MAY-2017, lot # M004893 expiration date 26-JUL-2017 or lot L050908 expiration date 14-JUN-2017 (strength, dose and frequency were not provided) subcutaneously. There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
A non-serious, spontaneous report of "daughter got H1N1 and now she is sick" has been received from a physician concerning a 15-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose H1N1, Intranasal in Oct-2009. On an unknown date the patient became very sick. Neither outcome nor causality has been reported for this event.
After the vaccine my next INR  international normalized ratio check was low. This caused the heart doctor to raise the dose of warfarin and come back in 2 weeks. At that visit it was okay, and two weeks later they had to raise the medicine dosage again. It has been raised 4 times since the vaccine. I have been on this medication for 20 years and have never experienced this until after the vaccine. My finger tips and toe tips did not feel right, even on my medication. I am on 12.5 mg daily 7 days of week of Warfarin. The maximum dosage is 15.
T103, shaking episode, pale color w/bluish lips; lasted <1 min; Hypotonia & hyporesponsive;
2FE93 c/o fever since 31JAN93, ears hurting, runny nose, P160, c/o fever, vomiting; 3MAR93, twitching, jerking, restless, jerky; crying; t102.4ax, vomited, twitched, inconsolable crying, swelling of leg;
severe (continuous) debilitating  vertigo that lasted 14 days with lingering on and off dizziness up to 30 days ; attempt to treat with meclizine but did not work. eventually resolved (after 30 days) on its own; wooziness still recur to this date - unknown if there is permanent damage - tests are being done
Information has been received from a Mental Health Therapist concerning a male child of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates as a child, the patient was vaccinated with M-M-R II for prophylaxis(dose, frequency, route of administration, lot number and expiration date were not reported). The Mental Health Therapist reported the patient would have experienced unspecified side effects (adverse event) At the reporting time, the outcome of the unspecified side effects was unknown. The reporter considered that the the side effects were related to the therapy with M-M-R II as reported that the side effects were "from the M-M-R II vaccination". Additional information has been requested.
Had one seizure, no fever during or before seizure, but developed fever afterwards. Had difficulty breathing, intubated and ventilated for about 36  hours. ?Had pneumonia.
Nausea and vomiting approximately 8 hours after injection lasting less than 12 hours. General malaise lasting approximately 24 hours.
On 11/21/96, pt recv'd Fluogen vax. In Dec '96, he dvlped cough, nasal congestion, & nausea. Dxed on 12/17/96 w/ Guillain-Barre syndrome.Pt was hospitalized & tx w/ plasmapheresis.He was discharged w/ weakness & balance problems.
Delayed (7 days) injection site erythema, swelling and diagnosed as cellulitis. Treated with Doxycycline.
sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 03-MAY-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from and was diagnosed with sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of sensorineural hearing loss was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of sensorineural hearing loss to be disability.  Upon internal review, the event of sensorineural hearing loss was determined to be medically significant.
Pt Received PCV-13 vaccine on 2/14/17 to L deltoid and has been having throbbing pain ever since. Pt also having limited range of motion to L shoulder.
Patient has a history involving fear of neeedles and experienced a near syncopal episoide.  Patient laid down and felt better.  Refused transport to the hospital.
rash on extremities and trunk, occurred 1 day after vaccine, resolved with Benadryl, no other symptoms
The morning after receiving the shot I had pain at the injection site, fatigue, chills, fever, body aches, and fever of 101.1 degrees.  It lasted through the night until the following morning at 9:00 am.
Patient received vaccine and said he felt fine, was surprised by this because he usually faints when getting blood drawn and around needles. Was talking to pharmacist and wife for 2 minutes post shot and then leaned over slowly and fell sideways. The pharmacist caught his head but he had passed out and his body was stiff. Patient was breathing fine and "Woke" up 10 seconds later. He did not know what happened and where he was temporarily. Patient said he felt fine but became clammy and light headed 2 minutes after that incident. He drank water and sat on the floor for 20 more minutes per the pharmacist's request and then felt fine.
Urinary tract infection; She didn't know who she was or what she was doing for 3 days; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6201; expiry: 30Jun2021), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 59-years-old) as single dose for covid-19 immunisation. The vaccine was not administered at a military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient had no medical history, no concomitant medications and no investigation assessment. The patient experienced urinary tract infection in Mar2021 which was considered serious due to hospitalization from Mar2021 to Mar2021 for 5 days. She was diagnosed with a urinary tract infection. She didn't know who she was or what she was doing for 3 days. She was then kept an additional two days. The patient was supposed to go back on 12Mar2021 to receive the second dose. She was in the hospital at that time and did not receive the second dose. She was asking if she needed to start over since it was past the time for her to get the second dose. The event urinary tract infection required an emergency room visit. The outcome of the event urinary tract infection was recovered on 22Mar2021 while for disorientation was unknown.
1. Multiple large swollen lymph nodes along collarbone, ribs and underarm on the left side (visible and painful with & without touch). They continued to grow notably larger for 2 weeks, started to decrease in size in the middle of 3rd week and are still swollen 3.5 weeks after the shot. 2. Toes became very swollen, some were black & blue, some red & inflamed. Blister-like bumps developed and toes have been very painful (felt like on fire, bruised, burning & deeply sore) and intermittently extremely itchy. Varying intensity and continue to have these symptoms 3. Chills without fever occurred approx. 24 hours after the shot and lasted approx. 30 hours. This occurred again a week later for approx the same length
Two weeks after vaccine developed a large open sore on chest below the breast area. My dermatologist had it biopsied and it came back benign. Was given Triamcinolone Acetonide Cream. The sore is still there and moist feeling. A few weeks later, the same sores developed on my back. Was diagnosed as Bullous pemphigoid rash. Am taking Doxycycline and Prednisone.
On 8/18/2018 at around 6:15pm patient received FLUZONE QUADRIVALENT into her left deltoid, overnight she developed dime size burning hives on her lower abdomen, lower hands, and at inner thighs, she noticed this in the early morning, she also took 25mg BENADRYL tablet at 9 pm for sleep.
Extreme pain at time of injection. I have had flu shots every year for more than 20 years and it never has hurt this much.
Information has been received from a newspaper article concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. A few minutes post vaccination, the patient walked about 50 steps then went into what the patient's mother believed to be a seizure. The patient's eyes rolled back in her head, she stiffened up and had clonic jerks. The patient was placed on a stretcher and rushed to the emergency room. The physician's at the emergency room told the patient's mother that the patient experienced vasovagal syncope because "the patient was scared from the shot." Additional information is not expected.
Information has been received from a physician concerning a 12-month-old caucasian male patient with no known pre-existing allergies or medical conditions who on 20-SEP-1999 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 616452/0386D) IM in the left arm. On 23-SEP-1996, the patient developed a fever up to 105f. The patient sought unspecified medical attention. Follow-up information from a physician indicated that on 30-SEP-1996, the patient recovered.
warts on his groin and bilateral knees; This spontaneous report was received from a consumer, via a nurse (also reported as customer) and a company representative, concerning her son, a 12 year old male patient. Information regarding the pertinent medical history, drug reactions/allergies and concomitant medications was not reported.  The date of the first dose was unknown. On 18-AUG-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020255, expiration date not reported, but upon internal validation stablished as 09-DEC-2021) (dose, route of administration, and anatomical location were not reported) for prophylaxis.    On an unspecified date in 2020 (the exact date was not known), the patient developed warts on his groin and bilateral knees. Medical attention was sought, and an appointment with a dermatologist to assess the warts was scheduled for the patient. The outcome of the event was unknown.  No causality assessment was provide combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
mom states pt had a sz; 10 days following vax exp leg shaking in sleep; pt observed to have sz activity while sleeping; pt awakes & then very tired; family observed this behavior 2 x more;