chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in back of neck; Tingling in her extremities; Tingling in her fingers; Tingling in her toes; Pain in her shoulders; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes, Hypothyroidism, Blood pressure high, Breast cancer, Ovarian cancer and Brain cancer metastatic. Concomitant products included METFORMIN, PRAVASTATIN, LEVOTHYROXINE, LISINOPRIL, CYCLOBENZAPRINE and GABAPENTIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, NECK PAIN (Pain in back of neck), ARTHRALGIA (Pain in her shoulders) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
approx. 20 hours after flu shot my daughter has temperature of 99.3, headache, back ache and arm ache(where shot given)  Given Motrin but still having symptoms
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 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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 25.41. No concomitant medications were reported.  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. Temperature recordings were taken using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  On 07-Jan-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 34, 11 AM: 36, 12 PM: 37, 1PM: 38, 2 PM: 38, 3 PM: 40 and 4 PM: 40.  On 07-Jan-2021, Excursion time was 09 AM and 10 AM, temperature were 34, 34 respectively and total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021, 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  No treatment medications were reported.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 78-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Approx 16 hours post-vaccination (6:00 am): Severe headache over forehead, chills, pain in all joints except the feet, aching in all muscles, fatigue and mild confusion/dizziness, temperature of 100.2 which increased over the course of 2 hours to 102.4 and maintained that temperature for approximately 8 hours before declining to 'normal' over the course of 4 hours.  No loss of appetite, but slept much of 24 hours.  The following morning (40 hours post-vaccination), most side-effects were gone except slight confusion and the brief return of acute headache if I coughed or sneezed.
After an hour of my Infliximab treatment I began to have difficulty breathing, started itching and became light- headed. In 10 years I had never had a reaction to my Infliximab. Treatment was stopped and begun again after symptoms cleared in about 10 minutes . Symptoms then returned. Treatment wAs again stopped and Benadryl was given as was IV steroids. When symptoms cleared treatment was again started and completed. I weigh 135 lbs and receive  500 ml of Inflximab every 5 weeks.
3 to 5 min p/vax pt became catatonic, posturing, diaphoretic;tx w/smelling salts & recovered;
Pt reported side effect of heart racing, SOB, arm pain and headache. Pt stated that it started the day after getting the vaccine. However all the other symptoms have gone except the SOB and heart racing. I advised the pt to go to the emergency room or to her Dr. office. pt voiced understanding.
Tongue, roof of mouth, inside of cheeks, uvula, and back of throat went numb about 20 minutes after vaccination. It's currently 11pm and the numbness is still present in all areas.  (mild nausea, mild headache, mild chills, moderate arm pain present but I'm not concerned about those since they're published side effects)
Injection site: pain, tenderness and swelling General side effects: fatigue, muscle pain, joint pain, nausea
48-72 hours after injection patient started to notice a rash around injections site. Patient also has pain and muscle cramping below site of injection.
Initial itching around the collarbone progressing up the neck. while in route to ED she started complaining of a scratchy throat. Seen in ED. no further information provided
Heart palpitations; Left arm was very sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She also takes blood pressure medication and thyroid medication.  No concomitants medication were provided.   This case was linked to MOD-2021-365231 (Patient Link).
I was fine up until this morning. My rid eye lid was a little sore. Went in bathroom and a pus-like substance was in the corner of my eye
Patient was put to bed as normal the night of the vaccination.  A few hours after going to sleep, he began flailing and screaming,  became inconsolable,   yet I was unable to fully wake him.  Once he would get calm, the episode would reoccur every 10-30 minutes the remainder of the night.  This became the "norm" for the next approximately 1.5 years until he stopped receiving this vaccination.  His sleep would slowly improve until the next DTaP vaccination, and the cycle would restart. The rest of his DTap schedule is as follows: #3- 7/9/14 #4- 6/25/15  Approximately 6 months after the last vaccination on 6/25/15, Patient stopped having these "night terror"-like events and was sleeping well through the night.  He has not had any other similar sleeping issue since then.
A little fatigue feeling in early evening.  Slight deltoid soreness.  Next morning had slight fever 99.7.  Generalized tiredness.  Feeling like my body was glowing.  Fever continued into evening.  99.4 in late evening.  On 5/10 at about 4:30 am woke up in full body sweat.  Felt better overall a few hours later.  Went for a 2 to 3 mile walk and was ok.   On 5/11 I woke up sweaty again at 5:30 am.  Felt ok during the day.  That was the main extent of my reactions.
I first experienced a headache ~20 minutes after vaccination (11:15 AM). It faded, and I  felt generally unwell and tired throughout the afternoon. Around 10:30 PM, I experienced serious chills and generally felt like I had a fever. These symptoms worsened into the night, as did the fever (measured at 102 degrees F, possibly higher at the peak). I also experienced a headache, mild nausea, joint (knee) pain, although some symptoms may have been due to dehydration. Despite being very tired, I was unable to really fall asleep. At around 6 AM the fever finally dropped substantially, and as of 8:30 AM is currently only 99.4 degrees. I am still experiencing a bit of a headache as well, but the other symptoms are gone.
I received the vaccine at 4:10 and at 4:55 my lips and my left arm went numb. 2 hours later at 6:55 I had full on numbness and I noticed that the side effects started to subside. I called the pharmacy to let them know. An hour later or so, around 8pm, everything was gone and I was fine. The whole incident lasted about 3 hours.
Received immunizations Varivax & Hep A #2 in L delt.  Following a.m. had fever & arm swelling with redness L injection site.  Symptoms stable until 24 hrs after injection, developed lip tingling & throat tightness with pain & arm.  This occurred after a nap.  He was given Benadryl & presented to office with resolution of symptoms.  Exam was normal except for erythema around injection.  Some residual h/a.  Was prescribed Albuterol inhaler although no wheeze on exam.  Completely resolved 12/17/07.
PATIENT STATES THAT HER LEFT ARM STARTED GETTING RED AND WARM/HOT LATER IN THE DAY SHE RECEIVED VACCINE. THIS IS FOUR DAYS LATER AND STILL HAS THE SAME EFFECT.
Developed fever as high as 104 degrees axillary. Broke out in rash (parent described as lacy looking). 24 hrs later on trunk and extremities. Rash faded after 72 hrs,
1st dose 12/29/20 2nd dose 1/18/21-symptoms of feeling feverish started 1/19/21 abut 5am with headache, sore throat, and feeling sluggish.
Fever (T 101) 1 week after receiving 12 mos IZ. Fever resolved after 1 day, followed by rash 2-3 days later. Suspect viral exanthem but given timing of symptoms & IZs, VAERS completed.
menquadfi was given to a 2 month old with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 9 weeks old/ (2-month-old) female patient who was given meningococcaL A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance); and rotavirus vaccine live oral 1v (Rotarix) for Prophylactic vaccination.  On 07-Aug-2023, the 2 month old patient received a standard dose of 0.5 ml of suspect meningococcaL A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U7595AA, expiry date- 11-MAR-2025) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, Caller says a medical assistant gave MENQUADFI to a 2 month old and she wants to know what to look for or if they need to do anything.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Pt recv vax on 5/10/96; approx 7 hr post vax pt exp "lifeless" activity & sleeping through feedings] x6-7 days
Large circular area, red, raised, warm with moderate pain throughout arm and axilla going on 3 days now.
This spontaneous report was received from a 32 years old, female healthcare student reporting on herself with no pertinent medical history and no drug reactions or allergies. On 11-MAR-2014 the patient was vaccinated with a dose of VARIVAX, (subcutaneous, dose not reported). Concomitant therapies included an unspecified multivitamin. On 21-MAR-2014, the patient experienced fever of 101 F, nausea, vomiting, diarrhea, chills, a rash and 4 vesicles. The vesicles were on the injection site, neck, lower right back and on the left knee. It was reported the patient is recovering. No treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by going to see a nurse. Additional information has been requested.
Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain.  Fatigue onset 4/10/21, symptoms worsened 4/13/21.
Patient noticed swelling at the site of injection and swelling, redness, and itching along the lateral aspect of the left arm just above the elbow.  Patient took Benadryl and the rection diminished, but remained reddened and slightly edematous until 22 Mar 0900, when he reported to the clinic.
Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some foggy thinking.  this is day 10 headache duller now but other symptoms present
Headache, nausea, pulse - 76. Sat down, had a snack.
She said initially she felt pain and a bad taste in her mouth. Then, she felt faint and had mild seizure activity. I sent for the nurse and  she came to analyze her vitals. Her respiratory rate was normal at 20, but her pulse dropped to 40. She was still responsive and able to communicate. We called 911 and administered an Epipen. She was transported to the hospital.
Pt recvd vax 14JUL92 & 16JUL92 devel nausea, weakness, chills, fever, ear pain, body aches, tenderness in rt upper quadrant, stiff neck;
2nd dose 10/2/2020, has not received third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix with an associated reaction of no adverse event (1st dose of Twinrix vaccine was received on 4th September 2020, batch number 3Y7NL and expiry date 24-MAY-2022) and Twinrix with an associated reaction of no adverse event (2nd dose the of Twinrix vaccine received on 2nd October 2020, batch number 3Y7NL and expiry date 24-MAY-2022).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable for this report. The patient also received first and second dose of twinrix but third dose was not received till the time of reporting, which led to incomplete course of vaccination. This case has been linked to the case US2021208799,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208799:same reporter
Urticaria, pruritus. Ibuprofen 800 mg TID, hydroxyzine 25 mg TID.
When I got the shot I felt a cold sensation moving down my arm and an immediate shooting pain in my elbow.  I waited 15 mins and left the faculty. About 6 hours after receiving the first dose I started feeling weird.  Light Nausea, similar to the feeling of being on a ship and feeling constant queasiness in the background.  What came after was more concerning. I started feeling cloudy in my head and could not put my words together.  I did, but it took effort. The top of my head started tingling. My chest started feeling tight (feeling similar to having a panic attack) so much so that I felt the need to roll down the window in my car and get air.  When I came home I lay down and went to sleep early. The next day I felt better. My main symptoms were tingling on my head (where a baseball cap would cover the head) numbness in my tongue, tailbone pain, nausea, joint pain, and generally feeling cloudy.  I am feeling better now but not completely back to normal.
This spontaneous case, was initially received on 17-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (doesn't know which arm), batch number: 195223, expiry date: Apr-2018). On 13-Oct-2017, 10 days, after vaccination, the patient had hyperpigmentation around the injection site. It was reported by the nurse that, she was not the one who administered the vaccine. The outcome of the event was not reported. The reporter considered this case as non-serious. Significant case correction received with 17-OCT-2017: Event causality changed from not reported to related. Narrative amend accordingly. Non-significant case correction received with 17-OCT-2017: The case comment was corrected.
pt recvd vax;w/in 30 mins devel rash on body & face;no diff breathing,alert responsive;PMD notified;seen per MD & sent home as per mom;
Patient states he had fever and chills beginning the night he had the vaccine and lasting through 7/9/08.
Information has been received from a physician concerning a 12 year old male who in March 1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and received a second dose in August 2005. In August 2007, the child was sent home from school with chicken pox and had more than 100 lesions all over his body. No fever was reported. Subsequently, the patient recovered from chicken pox. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
This spontaneous report as received from a physician refers to a 16 year old female patient. The patient's pertinent medical history was not reported. She was allergic to cats and dogs. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 (dose, route and lot number were not reported). No concomitant medications were reported. On 18-SEP-2016, the patient felt shaky (nervousness) and had joint swelling. She sought medical attention. No treatment was given for the events and there were no lab tests performed. There was no intervention to prevent serious criteria. On 21-SEP-2016 (reported as "today"), the patient returned to the office still feeling shaky however ankle swelling was resolved. The physician stated that she was his partners patient and he did not know her much. The outcome of nervousness was reported as not recovered/not resolved. The outcome of joint swelling was reported as recovered/resolved. The causal relationship between the drug and the events was not reported. There was no product complaint involved. Additional information has been requested.