chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.95 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, and 35 degree Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Jan-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (E2B Linked Report).; Sender's Comments:  MOD-2022-566976:Master Case(Same Reporter)
Narrative: COVID POSITIVE AFTR COVID VACCINATION SERIES 02/10 COVID vaccine dose #1 03/03 COVID vaccine dose #2 04/28 symptoms started with sneezing and allergy symptoms, 1 day of dizziness (4/29) that resolved  same day 05/04 COVID screening positive due to report of myalgia, rhinorrhea, dizziness, sore throat and close exposure to known positive 05/05 c/o continued runny nose, myalgia, congestion 05/06 c/o ongoing myalgia, rhinorrhea (nearly resolved) 05/07 c/o chills, moderate/dry/scratchy throat, diarrhea x4, ongoing fatigue, nausea, rhinorrhea, dry heaves, no fever, O2 sat WNL; rx'd tessalon perles and robittussin DM 05/08 c/o continued cough and diarrhea, ongoing rib pain from coughin, dyspnea when coughing 05/09 c/o continued dry cough improved with robitussin, diarrhea, fatigue, myalgia (rib pain due to coughing); no dyspnea or vomiting 05/10 states dry cough is improving, quarantine ended
My son lost eye contact, speech and responsiveness to those around him following his 1 year vaccinations. MMR, varicella, pneumococcal. He has immune deficiency and encephalitis.
had the first dose of the Pfizer Covid-19 vaccine on 08Mar2021 and on (10Mar2021) they are both tested Covid-19 Positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non-healthcare professional reported similar events for two patients (Wife and Husband). This is 1st of two reports. A female patient of an unspecified age received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number: not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she was tested positive for covid-19 on 10Mar2021, after the first dose on 08Mar2021. Patient wanted to know if it was safe to take the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on 10Mar2021. Reporter assessed case seriousness as no. Outcome of the event was unknown.  Follow-up (25Mar2021): This follow-up consists of no new safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325997 Same reporter/product/event, different patient
Received flu vaccine 8:55 am 11/29/05 began breaking out with red rash on neck down  upper chest with itching and burning on 8:00 pm 11/30/05.
This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex aggravated in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included herpes simplex. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced herpes simplex aggravated. The patient was treated with Valacyclovir. On an unknown date, the outcome of the herpes simplex aggravated was unknown. It was unknown if the reporter considered the herpes simplex aggravated to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got SHINGRIX dose and the next day started valacyclovir for a suspect flair of herpes simplex. The patient took 2 doses before stopping. The patient reporter was asking what was your (GSK) recommendation. The reporter consented to follow up.
Patient had swelling and redness from injection site (RAT) to right ankle. Observed patient for 30 mins, at the end of 30 mins swelling subsided and skin color returned to normal.
Throat felt tight with blood pressure and pulse elevated about 15 minutes after giving vaccine. 30 mins after vaccine was given blood pressure and pulse still elevated.  45mins after vaccine was given throat was no longer tight but patient reported lower gums felt swollen. No swelling visable. Blood pressure and pulse remained elevated. Approximately 1 hour after vaccine was administered the patient reported that her gums no longer felt swollen but her blood pressure and pulse remained elevated although had decreased some since initial readings. Decision was made for her to go to the emergency department. Called the patient later in the afternoon on 1/13. She was still in the emergency room. Her blood pressure was still elevated and they were planning on giving her an intravenous medication to try to lower it.
Patient is fully vaccinated and boosted 11/10/2021.  The patient is a 78y.o. female with a PMHx of coronary artery disease with PCI, diastolic CHF, A. fib, diabetes and sleep apnea who presents with a complaint of Chest Pain and Shortness of Breath. Patient is COVID-positive, diagnosed approximately 5 days ago. Troponin negative. On eliquis.  On Room air, no indications for ABX/Steroids at discharge. CT chest:  No definite central pulmonary embolus, evaluation of the segmental and subsegmental pulmonary arteries is limited secondary to bolus timing. CXR: Correlate for mild congestive change. No focal consolidation. Discharged to home.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding to the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the vaccine M-M-R II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The M-M-R II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012479, 1405USA012481, 1405USA012482 and 1405USA004216). Additional information has been requested.
Swelling of tongue; Shortness of breath; Chest tightness; Tingling lips; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported that the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EL9264) on an unspecified date via an unspecified route of administration in right arm and for covid-19 immunization. The patient medical history included breast cancer and concomitant medication was not reported. The patient took blood work in the emergency room (further not clarified). On an unspecified date the patient had swelling of the tongue, then back shortness of breath, chest tightness and tingling in my lips. The patient also reported that she did not being admitted, she had been to the emergency room throughout night, they gave me medicine in the emergency room two shots of epinephrine and one shot of Benadryl and then they gave two things, they did the blood work and then they gave me something similar to Pepcid for the reflux but it was not Pepcid. The outcome for the events were unknown.
Information has been received from a 19 year old female with no drug allergy who in January 2008 was vaccinated with the first dose of GARDASIL. She stated she had all 3 doses. On 15-JAN-2009 the patient was told she had papilloma viral infection. No medical attention was sought. At the time of reporting, the patient's HPV infection persisted. No further information is available.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 23-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1611USA004113.
Diaphoresis, flushing, weakness, nauseated. Vasovagal. Recovered within 5-10 minutes.
Initial symptoms 3/30/18 in the evening: Nausea, vomiting, mild fever. Next morning 3/31/2018: Worsening symptoms, blood pressure drop to 70/30, anaphylaxis.
Pt states blistery, itchy rash over arms and on face, head and neck that persisted for a week or two.  Lightheadedness also continues to persist (1/8/2016).  MD had no explanation and wasn't sure if it was related to the vaccination or coincidental.
On 4/15/2021, I fell to the floor, lost complete feeling in my right side of my body, could barely walk, tingling in legs, extreme muscle pain and muscle spasm in both calve muscles in legs, chest pain. Went to ER , they had me stay over night in case I had a silent stroke since I showed all the signs of a possible stroke. Received CTC and MRI scans the following morning. Had leg pain for months following adverse event. Was discharged with minimal communication, just basic discharge for "Adverse drug reaction" no follow up from doctors or providers.  No blood clot was found in scans. Developed dizziness and vertigo as an on going side effect I am still dealing with today as of May 2022, on almost a weekly basis following my reaction last April. Following my adverse reaction less than 30 days later on 6/23/2021 I had an infection in my uterus , was treated with an antibiotic, no STD or any other sexual transmitted dieseases were found,  and I am curious to know if this could be related to my vaccination as it has been stated publicly women have experienced harsh side effects in their uteruses and ovaries following their vaccinations. Leg swelling and pain is now minimal but still happens from time to time, as well as pain in my left arm near my vaccination spot was distributed.
This spontaneous report as received from a pharmacist refers to an 86 years old male patient. None pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose reported as 1 vial, subcutaneously, lot # K010969, expiration date 07-NOV-2015). On approximately 22-SEP-2015 (reported as about 2 weeks ago), the patient started getting a rash that was itchy. The pharmacist reported that the patient returned to the pharmacy on 06-OCT-2015, with a "big rash", later described as being the size of a quarter on both arms. The rash was red, raised and itchy and was not localized at the injection site. The patient sought medical attention - he visited the pharmacy. None lab diagnostics studies were performed and the patient received the treatment with an unspecified hydrocortisone cream. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
INADVERTENTLY ADMINISTERED PFIZER FOR AGES 5-11 YRS.  NO ADVERSE EVENTS NOTED WHILE IN CLINIC. I CALLED CLIENTS FATHER 24 HOURS LATER, NO ADVERSE EVENTS NOTED
Two weeks after booster vaccine developed a rash on lower right leg warm to touch , itching  and swelling. Was seen at  urgent care. Was given Solumedrol IM and put on a Solumedrol dose pack.  Finished 11/29/2021.  As of 12/17/2021 Redness of leg still persists.
whole arm fr elbow to shoulder erythematous, hot to touch & tender, included axilla lymph swelling & fever 99.6; tx w/ATB; routine booster for school 8-10yrs since last vax
Information has been received from a physician concerning a female who on Oct 18 2005 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (upgrade process) (lot 651812/0769R. Ten days following vaccination, On Oct 28 2005, the patient experienced a measles like rash and a fever. Additional information has been requested.
Temperature  was 101,temperature was recorded 101.8; arm tender; little swelling on neck; woke up feeling bad; had stomach upset; felt nauseous; vomited; felt chilled and shivering significantly; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up feeling bad), TENDERNESS (arm tender), SWELLING (little swelling on neck), NAUSEA (felt nauseous) and VOMITING (vomited) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity. Concomitant products included IRON for Iron supplementation.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (woke up feeling bad), NAUSEA (felt nauseous), VOMITING (vomited), CHILLS (felt chilled and shivering significantly) and ABDOMINAL DISCOMFORT (had stomach upset). On an unknown date, the patient experienced TENDERNESS (arm tender) and SWELLING (little swelling on neck). The patient was treated with PARACETAMOL (TYLENOL) on 20-Jan-2021 for Adverse event, at a dose of UNK dosage form and IBUPROFEN on 20-Jan-2021 for Adverse event, at a dose of UNK dosage form (on empty stomach). At the time of the report, FEELING ABNORMAL (woke up feeling bad), TENDERNESS (arm tender), SWELLING (little swelling on neck), NAUSEA (felt nauseous), VOMITING (vomited), CHILLS (felt chilled and shivering significantly) and ABDOMINAL DISCOMFORT (had stomach upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 99.1 f (High) 99.1 F. On 20-Jan-2021, Body temperature: 101 f (High) Around 4 PM , 101.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dizziness, fatigue, nausea, muscle aches, stuffy/runny nose, chest congestion, yellow and green mucous, headaches, chills, sweats, diarrhea followed my stomach pain and constipation, stiff lower back with tingling sensation, concentration and vision problems, etc.  I was advised by Army staff that it is impossible to have a bad reaction to the flu vaccine other than immediate anaphylaxis.  Was given mucinex and discharged.  Explained previous complications with same symptoms shortly after flu vaccines, and was told that it was still impossible.  Medical staff would not report ANY complications with the flu vaccine.  And they attempted to administer the H1N1 vaccine while I was still dangerously sick from the seasonal.
Symptoms after vaccination 3/3/2022.  1. 2 days after the vaccine, I had vertigo. I went to the company's medical service. 2. Then I started having symptoms of a racing heart 3. Tremors in the hands 4. After a week, I went to the emergency room, I couldn't feel my legs from the knee down 5. Spine problem on LL-L5 and L5-S1. 6. Whole body imbalance 7. Rarely filled feet 9. hooked on the body 10. Numbness in the tissues from the knee down 11. dental arch movement 12. biting your tongue 123 does not hold anything in hand light objects 13, symptoms of dementia 14. bump into furniture, notion of space 15. Stuffed legs on the right    Currently: no arlegia medication. With the medication I get muscle pain, knee, stiff nec
started experiencing lower leg pain; uncle pain in the back and front; uncle pain in the back and front; Can hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (started experiencing lower leg pain), ARTHRALGIA (uncle pain in the back and front), PAIN (uncle pain in the back and front) and GAIT DISTURBANCE (Can hardly walk) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PARACETAMOL (TYLENOL) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (started experiencing lower leg pain), ARTHRALGIA (uncle pain in the back and front), PAIN (uncle pain in the back and front) and GAIT DISTURBANCE (Can hardly walk). At the time of the report, PAIN IN EXTREMITY (started experiencing lower leg pain), ARTHRALGIA (uncle pain in the back and front), PAIN (uncle pain in the back and front) and GAIT DISTURBANCE (Can hardly walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol. Concomitant medications also included Blood pressure medications.
Information has been received from a RN concerning a 50 year old male with a codeine allergy who on 01/16/2001 was exposed to varicella virus vaccine live via secondary transmission from his one year old granddaughter who on 01/15/2001 was vaccinated subcutaneously in the upper right thigh with 0.5 milliliters of varicella virus vaccine live (lot# 636572/0929K). It was reported that the granddaughter had 'no reaction to the vaccine'. On 01/16/2001, the child urinated on her grandfather's leg and on 01/16/2001 he had developed shingles in the same area. The rash was described as a blistery and painful vesicular rash that was scattered on his right thigh. It was reported there were numerous lesions that were scabbed over. The rash was diagnosed as herpes zoster approximately 2 weeks after the rash occurred. He was afebrile. The nurse reported in a FOLLOW- UP that the grandfather was coming into his granddaughter's pediatrician's office on 02/13/01 to have a specimen collected. It was indicated that the grandfather had chicken pox at age nine, but no recent exposure to varicella or herpes zoster. It was noted that the grandfather was on no medication when the rash occurred, but it is now on an antidepressant. The grandfathewr has recovered. FOLLOW-UP information indicated that the "shingles specimen" was betaglobulin positive and the presence of wild type VZV was identified.
Having a problem with my oxygen level, it has had my level from 2 litters to 4/It has had my level from 2 litters to 4; This spontaneous case was reported by a patient and describes the occurrence of OXYGEN SATURATION DECREASED (Having a problem with my oxygen level, it has had my level from 2 litters to 4/It has had my level from 2 litters to 4) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Having a problem with my oxygen level, it has had my level from 2 litters to 4/It has had my level from 2 litters to 4). At the time of the report, OXYGEN SATURATION DECREASED (Having a problem with my oxygen level, it has had my level from 2 litters to 4/It has had my level from 2 litters to 4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Patient was treated by increasing the oxygen level.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Reporter information, patient demographics, vaccine information, and treatment were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.