chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, chills and fatigue Narrative:  missed one day of work
9 days after injection, swelling, redness, itching and heat at injection site. All symptoms increased in the next 24 hours. Swelling advanced to elbow and rash spread across upper arm from front to back. Center of rash became mottled and peeled. No pain but constant and unappeasable itching.
Swelling redness and spreading redness. Steroid given in clinic. Advised OTC BENADRYL and PEPCID at home. If not improved advised to come back to clinic.
This spontaneous report as received from a registered nurse refers to a 10 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with MMR II (therapy type: rHA, batch number: J00584, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unreported temperature excursion (temperature range: 45F, time frame: 24h). This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported very high fever and flu symptoms like muscle, which are expected with SHINGRIX, but she also sufferred arrhythmias and has been in the hospital for several days. She informed me after she was discharged. She also had a high dose flu shot on the same day.
Dizziness; Lightheadedness; Rash; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), DIZZINESS (Lightheadedness), RASH (Rash) and HEADACHE (Headaches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), DIZZINESS (Lightheadedness), RASH (Rash) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Dizziness), DIZZINESS (Lightheadedness) and HEADACHE (Headaches) had not resolved and RASH (Rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications received by the patient include Ondansetron and meclizine.
1446: patient was vaccinated w/ Pfizer (Peds)  1502: patient had a syncopal episode while in mother chair with mother   patient was given juice and observed for 45 minutes  1545: patient left in stable condition. Parents were educated to monitor for s/sx of anaphylactic reactions such as: SOB, cough, difficulty breathing, swelling of the throat, flushing of the face, if any occur to go the nearest ED, parents verbalized understanding.
Overnight on 1/13 into 1/14 patient woke up feeling unwell and had a fever and a very sore arm where the vaccine was given.  The site of administration is red, burning, tender, and warm to the touch.  No more fever today.
Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 12th September 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The reporter believed that the vaccine might have been given in patient's upper left arm because he was right-handed. The patient experienced soreness at the injection site and did not experience any other adverse events. The soreness had resolved, but initially lasted for about 2 days. The reporter gave permission to follow-up with their health care professional. The reporter was unable to provide health care professional's email/fax at the time of report. This case had been linked with US2020229458, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229458:same reporter
neuropathy flared up; My feet started hurting; Had Numb fingers; Also since the Vaccine my Tinnitus has flared up.; nerve pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EL1685) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (non-serious) with onset 08Jan2021, outcome "not recovered", described as "neuropathy flared up"; PAIN IN EXTREMITY (non-serious) with onset 08Jan2021, outcome "not recovered", described as "My feet started hurting"; HYPOAESTHESIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Had Numb fingers"; TINNITUS (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Also since the Vaccine my Tinnitus has flared up."; NEURALGIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "nerve pain". The events "neuropathy flared up", "my feet started hurting", "had numb fingers", "also since the vaccine my tinnitus has flared up." and "nerve pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Other; negative, notes: Nasal Swab; negative, notes: Nasal Swab; negative, notes: Unknown. Therapeutic measures were not taken as a result of neuropathy peripheral, pain in extremity, hypoaesthesia, tinnitus, neuralgia.  Additional information: Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient had no known allergies. Patient received second dose bnt162b2, administered in arm left, administration date 254Jan2021 (Lot number: EJ1284) as dose 2, single for covid-19 immunisation.   Follow-up attempts were completed. No further information was expected.
13.5 X 13.75 cm2 area of erythema and swelling surround vaccine puncture, non-tender, no fever, no wounds
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a consumer via a company representative concerned a 32 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included exposure to delta variant covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got very sick with fever, aches, head congestion, fatigue, general feeling of illness (suspected clinical vaccination failure, suspected covid-19 infection), and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and brain fog was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000186646.; Sender's Comments: V0: 20210742468-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Painful left arm; Big red patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful left arm) and VACCINATION SITE ERYTHEMA (Big red patch at injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red patch at injection site). On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (Painful left arm). At the time of the report, VACCINATION SITE PAIN (Painful left arm) and VACCINATION SITE ERYTHEMA (Big red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication include birth control. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received and contains no new information. But initial case was submitted without concomitant medication so it becomes significant.
pt recv vax 14OCT96 & was jerking;pt was asleep & both arms were jerking perfectly symmetrical;attempted to awaken pt because pt was sleeping soundly;jerking cont;flexed & rigid;began to cry;
Information has been received from a physician concerning a female who was vaccinated with 3 doses of GARDASIL IM, and was tested positive for HPV. Prior to the vaccination, the patient was negative against HPV. The physician reported that the vaccines failed to protect the patient against HPV. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies. Patient was neither diagnosed nor tested positive for COVID.  The patient's past medical history included Coronary arterial stent insertion. Concurrent medical conditions included Blood pressure high and COPD.   On 07-Jun-2022 at 4:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022 at 3:00 AM, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN on 08-Jun-2022 for Chills, at a dose of 800 mg 1 tab. At the time of the report, CHILLS (Chills) had not resolved.      No concomitant medications were reported. It was reported that, the patient received his 1st dose of COVID 19 vaccine on Feb 2021, 2nd dose on Mar 2021, 1st booster dose on unknown date from unknown manufacturer. On the day of reporting, early morning 08 Jun-2022 at around 03am patient woke up with chills. the patient wanted to know if chills was a reaction to the booster dose.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.  Treatment information not provided.      This case was linked to MOD-2021-090212.
Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4:18 pm. Started with O2 treatment at 3 ml flow rate, notified site lead immediately. Under site lead supervision, attempted to take VS : HR 90 irregular, RR 40 irregular, unable to take BP due to equipment malfunction. No T due to no thermometer in observation room.  Patient is diaphoretic  states SOB, dizziness. Denies Chest pain. No N/V.  At around 4:20 pm, one dose ( 0.3 ml) of epi-pen adult was administered left lateral thigh and called Emergency service ambulance per protocol. At 4:30 pm, EMS ambulance and police were arrived. Detailed patient care information was provided and handed over the care to the team. At 4:40 pm, patient left with emergency ambulance team.
Three days after receiving Dtapacel pt developed redness, swelling and tenderness to R arm at inj site. Treated with Zithromax and Ibuprofen.
Vaccinator pushed needle into patient's right deltoid. Vaccinator pushed plunger and vaccine solution came out around the base of the needle. Needle was a vanish point that could not be tightened or loosened. Unable to determine amount given to patient; another dose was given in the opposite deltoid without incident.
Woke up with sore throat and a runny nose. I used a home test about 12 hours after those symptoms and the test was negative. I tested again due to still feeling poorly so I tested again about 12 hours after the first test and that was positive. Saturday afternoon I did have a virtual visit with urgent care due to not having a spleen and I was worried. I had also recently had been treated for Gout with Prednisone and I was worried that I was going to have a harsh response to having Covid so I wanted to get be on Paxlovid to treat the Covid symptoms. I do think had I not been on the prednisone I would have not had any Corvid symptoms.
multiple seizures; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (multiple seizures) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epileptic seizure.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SEIZURE (multiple seizures) (seriousness criterion medically significant) and PYREXIA (fever). At the time of the report, SEIZURE (multiple seizures) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient fainted after 4 vaccines were administered. Patient gained consciousness. 911 was called and patient was taken to ER.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history,  concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Very sore left arm starting on the morning after inoculation. I have severe pain when raising my left arm to take off and put on clothes, and reach out to do anything at all like wash or style my hair, routine housework, put on or take off a coat. It has been 6 1/2 weeks now, with some small decrease in pain in just the last few days. I had pain 2 years ago from a flu shot, but it only lasted about 5 days. I will not get another flu shot until my research determines that you have fixed this problem. It is bad medicine to inflict pain for ADL's on aging people in the name of health care. I would rather have the full use of my arm. I will be watching and reaching out to others about this issue, and plan to not have another "treatment" which is so debilitating.
I have been having really severe migraines with auras, vomitting, numbness and tingling on my left side.
Flu shot was received from clinic on the afternoon of 10/21/2003. Upon arising the next morning, the pt had a headache, had decreased ROM in arm where shot was administered, pain, erythema, and edema around site of injection. This was reported to be worse than other flu shots that had been received in the past.
felt dizzy , like of balance dizzy; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired) in an 82-year-old patient of an unknown 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired). At the time of the report, DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter. Upon in internal review on 04-Aug-2021, the age was corrected to 82 years   This case was linked to MOD-2021-054609 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received on 15-07-2021 contain non significant information
This morning mom noticed erythematous wheals at the right deltoid (the site of injection) and perioral area. He also had a fever, nausea and vomited once this morning. On examination, he had nasal congestion and clear rhinorrhea in addition to the rash described above. Both of his sisters also had fever and sore throat but no rash. He and his sisters were diagnosed with viral upper respiratory infections
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY
(L) arm warm to touch 7-19-2012 AM gave MOTRIN 7-18-2012 for discomfort. (Received 2 injections) - possible reaction to band-aid.
Patient received 2nd dose Moderna vaccine at 21 days instead of recommended 28 days.  Patient thought she had received her first dose on 1/13/21, but in reality had received it on 1/20/21.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored M-M-R II (lot # L029266; expiry date: 04-AUG-2017) (route: subcutaneous). The vaccine was stored at a temperature of -136.6 degrees C for 48 hours. There was no previous temperature excursion. Data logger excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
back pain on her left side; breath; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain on her left side) and HYPERVENTILATION (breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced BACK PAIN (back pain on her left side) and HYPERVENTILATION (breath). At the time of the report, BACK PAIN (back pain on her left side) and HYPERVENTILATION (breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
PATIENT CAME IN 9/13/07 FOR 8YR PE AND VACCINES.  NO RECENT OR CURRENT ILLNESS AT THE TIME.  DURING ADMINISTRATION OF VACCINES, PATIENT APPARENTLY STRUGGLED AND MOVED. THE FOLLOWING DAY, PATIENT DEVELOPED REDNESS AND SWELLING OF THE RIGHT ARM AT THE VACCINE SITE.  PATIENT WAS SEEN IN DOCTOR'S OFFICE FOR F/U ON 9/17/07 AND MOM STATED THAT REACTION SITE WAS IMPROVING.  UPON EXAM, RIGHT MID DELTOID HAD APPROX. 4 CM OF REDNESS, WITH SOME SWELLING AND TENDERNES.  MOM WAS INSTRUCTED TO PROVIDE SUPPORTIVE CARE AND TO F/U WITHIN 3 DAYS IF NO IMPROVEMENT SEEN.
Was given the Moderna vaccine (1st dose) on 1/29/21. She fell out of her wheel chair early the next am on 1/30/21 and hit her head.  She subsequently fell again out of her wheel chair on Sunday evening 1/31/21  and hit her head a 2nd time. I was notified of her fall but was not allowed to physically go in to the facility to assess my Mom's status post the fall secondary to Covid restrictions in place at the time.  I noted she was not able to focus on the camera and visually track to the right/right side neglect.  The nurse practitioner for the facility assessed her the following Tuesday and sent her by ambulance to the emergency room to be assessed as she noted the same issues as I did on physical exam.  CT scan was done to assess for bleeding in the brain but an MRI was not performed to completely r/o CVA/clot She has since had significantly reduced vision/blindness along  with reduce cognition and physical impairment since these falls.  Questionable whether she had a stroke post vaccine but only CT was performed. She was lethargic and limited responsiveness in the ER.  See fall report at facility and notes
Reconstituted vaccine with .8mL sodium chloride instead of 1.8mL. No reaction noted.
Patient gave inaccurate DOB prior to being vaccinated. Consent signed with inaccurate information. Came back to the registration table approximately 10 minutes after the vaccine was administered and acknowledged error and asked to correct the record.  Patient did not have any symptoms following vaccination.  We asked her to wait in observation for an additional 15 minutes, no adverse reaction noted.