chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEG PARALYSIS; SEVERE HEADACHE; This spontaneous report received from a patient via other manufacturer (Moderna) concerned an elderly of unspecified sex, age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and concurrent conditions included: genetically immunocompromized, and allergies to dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, first dose, 1 total administered on 08-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 08-APR-2021, the patient experienced leg paralysis, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg paralysis, and severe headache on 18-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230619846- leg paralysis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the  Causality is considered indeterminate. The company causality is considered unassessable.
Had shot, then got shingles/suspected vaccination failure; Them, Shingles/have had them for 2 weeks already; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a shot for them before but he/she got shingles. The patient have had them for 2 weeks already, very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Approximately on November 3rd, I started feeling much sicker with really bad body aches and congested. I had headache, jaw ache and toothache. I was really tired and had to take a few days off of work. I was able to return but had to take more time of due to exhaustion. I slept for 4 days which is unlike me. My hair and clothes were wet due to sweat. I had nausea with no vomiting and diarrhea. I went in to see the doctor on November 10th, 2022, and I was diagnosed with a virus, but it was not the flu or COVID-19. I was told to take ibuprofen for the pain. I returned to work yesterday and I am feeling better since yesterday. I am still congested, and I am a little tired. I also have a headache, but I also had a concussion in October that could be a factor. When I had a metabolic panel completed it showed a slight elevation in blood pressure which is abnormal for me. The doctor said it was from the virus.
My arm was sore, kind of heavy on 2/10/2021 in the evening.  My arm was still sore the next morning (2/11/2021). It hurt to lift above my head. I happened to look in the mirror and I had a red mark where I received the vaccine. It is about an inch in diameter with the center not red. It does not feel warm to the touch and I don't have a fever.
Hives 1 cm 5 minutes after vaccine and redness around about 5 cm diameter. Benadryl 12.5 mg PO given.
BLOOD VESSELS POPPED IN ARMS AND HANDS; SWELLING IN HANDS AND ARM; NECK PAIN; ACHE; KNEES WERE STIFF; RED RASH ON ARMS, NECK AND FACE; JOINT PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included sprained knee, and concurrent conditions included heart disease, type 1 diabetes mellitus, type 2 diabetes mellitus, alcohol use, non-smoker, and tetracycline allergy. The patient experienced drug allergy when treated with codeine, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 12:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced blood vessels popped in arms and hands. On 21-MAR-2021, the subject experienced peripheral swelling. On 21-MAR-2021, the subject experienced neck pain. On 21-MAR-2021, the subject experienced ache. On 21-MAR-2021, the subject experienced knees were stiff. On 21-MAR-2021, the subject experienced red rash on arms, neck and face. On 21-MAR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red rash on arms, neck and face, peripheral swelling, blood vessels popped in arms and hands, neck pain, joint pain, ache, and knees were stiff. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Approx. 2 hours, post vax, sweats, chills, nausea. Developed hyperglycemia (pt is diabetic). In 2 days, pain through upper arm and in 3 days, noted erythema and pain at injection site.
Pt.'s Husband states that after the Pt. received the 1st dose of Phizer 09/17/2021, started experiencing symptoms 09/17/2021 of fatigue, and stomach pains. (History of Liver Disease) ER visit 09/18/2021 blood work done (Ammonia elevated), confusion started 09/20/2021 difficulty speaking. 09/24/2021 Diagnosed with Brain bleed, scheduled procedure to relieve the pressure. Pt. fell into a Coma. Currently still Hospitalized with no improvements.
Sick in bed.  Fever, Weak, Headache for about a week.  Skin was blotchy. and arm was swallen, and painful
This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (SHINGRIX) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received only the diluent part of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other details were reporter at the time of reporting. The reporter consented to follow up.
This is the second in the series of shots for Shingles.  The first shot that I got a few months ago caused mild chills and slight fever.  Although I was told by the pharmacy that this shot would cause minimal side effects, I have had mush more severe muscle pains and aches, fever, chills, sweats, and sever tiredness.  I should note that when I got the first shot a few months ago, I have had a complication in my groin where lymph nodes have been highly active and the pain was so bad that I had to get one removed. I went to three different specialists and they could not figure out the source of the problem and I am very concerned. What is disturbing about the side effects from this shot is that my groin pain has just started back up intensely and it is hard not to think that it was caused by something in this vaccine.  What is in this vaccine that is causing this pain? Is there some additive that is contributing to my pain and am I going to have long medical issues because of taking this vaccine?
Pt recv vax on 11/11/98; on 11/12/98 pt exp sore throat, drainage, cough & sweats
3pm upper arm muscle spasms, 5pm muscle spasm in neck L side then sharp pain to L shoulder and lower head all L side. 6pm tingling L hand and muscle spasm to L thigh. Swelling L hand. 6:30pm hive L arm. Arm hurts/hand swollen as of 9/4/02.
PT  C/O "funny taste" in mouth and tingly tongue.  States had similar reaction to the 1st dose but did not tell anyone. feeling isolated to midline of tongue, no N/V/D  Given PO Benadryl 50mg @1655, denies swelling or SOB. house PA to observation to examine pt.
pt exp severe stinging & burning @ inject site over a long period of time following vax w/MMR; No further details were provided;
Massive headache 7/10 take came on after I woke up from a 5hr nap after I got my vaccine I am also feeling tired. My arm is feeling a bit sore (esp if I raise it) but not worried about that. My headache really hurts more then my usual post covid headaches which I've recently gotten under control I took sumatriptan to see if it will help. Will eat and probably go back to sleep. (it's 3pm for reference)
ADMITTED TO FACILITY 9/29/21 AFTER FALLS AT HOME. RECEIVED J&J VACCINE FROM PHARMACY ON 10/1/21. ON 10/4, STAFF PRESENT IN ROOM, RESIDENT BECAME DIAPHORETIC, PALE, AND UNRESPONSIVE. 911 CALLED, RESIDENT  EXPIRED MOMENTS LATER.
Information has been received from a physician concerning a female who on 24Oct05 was vaccinated with IM with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (650302/1039P). It was reported that the pt's first dose of pneumococcal 23 polysaccharide vaccine was administered 5-10 yrs ago. On 25Oct05 the pt was diagnosed with cellulitis in her arm. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
pt recv vax 17OCT96 & 28SEP97 pt devel chickenpox consisting of 15 to 20 lesions;
Left upper arm with moderate swelling and mild redness and warmth also tender to palpate no respiratory sx's
Our Son is typically a happy person and enjoys everything around him and everyone enjoys him, he usually helps with everything involving his care. He uses an IPAD for communication, he understands most direction given if it is something he has learned. Since receiving the second dose of the Moderna vaccination our Son has shown bouts of rage, a rash between his shoulder blades and on his left hip area, both rashes come and go and both rashes are the same type and size. He is typically active; however, the energy level is through the roof, what we mean by through the roof, it is so very extreme that he cannot settle down for anything, he normally sits on our couch and watches a movie but he cannot sit for even 2 minutes without trying to throw himself off the couch.  It is typical for him to sleep through the night, but now he cannot sleep more then 3 or 4 hours and he does not go back to sleep, he cries which is not typical.
No adverse reaction occurred.  Patient received Moderna vaccines 1 and 2,  and then Pfizer booster.  Reporting as instructed.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in 2013 (reported within the past few weeks), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiry, route, dose not reported) by a local (unspecified) pharmacist. On an unknown date in 2013 (reported as within the past few weeks), the patient had severely elevated bilirubin levels and was diagnosed with symptoms of liver failure after taking PNEUMOVAX 23. Patient sought medical attention (unspecified). The outcome of liver failure and severely elevated bilirubin levels was unknown. Upon internal review the event liver failure was considered to be medically significant. Additional information has been requested.
2OCT96 830PM t103 ax-t105 R taken by mom using a mercury thermometer-tx by parents w/sponge baths & alternated doses of APAP & Pediaprofen-mom called ER but did not take pt in;mom gave breathing tx of proventil;temp by 6AM was 99 R;
Cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, 4 hrs after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The pharmacist reported that the patient developed a cold sore approximately 4 hours after receiving dose 2 of Shingrix series. The patient took Valtrex to treat the cold sore. The reporter gave permission to follow up. In the sheet outcome of event reported as RECOVERING/RESOLVING, but in database it was mentioned as not recovered/not resolved so outcome kept as reported in database.
Patient received vaccine on 10/6/15-around noon developed severe pain from shoulder to hand and swelling around the injection site since 10/8/15 morning.
Moderna COVID-19 Vaccine EUA  About one week after first dose, very red, hot, circular patch of skin at the injection site, very itchy.  This lasted about 48 hours.
Achy, tired.  on nights 7&8  3-4 hours of chills where I couldn't get warm.  On day 9 I had a mass the size of a hard boiled egg in my right groin.  On day 10 it opened and a lot of blood and blood clots came out twice that day, once the next and only blood and liquid that night and the following day.  It's the size of a pea now.  It was painful and I was told to use hot compresses and if it didn't go down in a week to see a doctor or go to the ER. I had waves of exhaustion on days 4-9.
PATIENT EXPERIENCED POLYURIA (EVERY 15 MINUTES) FOR A COUPLE DAYS. URINE WAS DISCOLORED, PER PATIENT IT WAS "BROWNISH AND DARK COLORED". PATIENT WAS EXTREMELY FATIGUED WITH SEVERE BACK AND KIDNEY PAIN. SHE COULD NOT GET OUT OF BED FOR A COUPLE DAYS, THEN IT PROGRESSIVELY GOT BETTER. I SUSPECT AN IMMUNE-MEDIATED CYSTITIS OR KIDNEY INFFLAMATION. I RECOMMENDED THAT THE PATIENT NOT RECEIVE THE SECOND DOSE IN THE SERIES, SINCE SHE IS AN OTHERWISE HEALTHY ADULT WHO HAS RECOVERED FROM COVID TWICE BEFORE RECEIVING THE FIRST DOSE.
Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) 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 (Received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 27.2 (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.
pt recv vax 10OCT95 & devel redness & warmth to the inj site;no tx necessary;pt recovered;
This case was reported by a physician via sales rep and described the occurrence of myalgia in a 75-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included giant cell arteritis. Concomitant products included prednisone. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced myalgia, arthralgia and malaise. The patient was treated with MEDROL Injection. On an unknown date, the outcome of the myalgia, arthralgia and malaise were unknown. It was unknown if the reporter considered the myalgia, arthralgia and malaise to be related to SHINGRIX. Additional details reported as follows: The patient experienced severe events following administration of SHINGRIX in the week of 10th August 2018. The patient developed severe myalgia, arthralgia and malaise following administration of SHINGRIX in that week. The patient was treated with intramuscular DEPO MEDROL injection but not sure of outcome till the time of reporting since this just happened in the week of reporting. This case has been linked with US2018GSK145191, reported by same reporter.
Fever to 101.0 starting late in day of vaccination, lasting 48 hours. General myalgia 48 hours.  No other obvious cause for symptoms.
chills; tiredness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery and Pacemaker insertion (cardiac) since an unknown date.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting). At the time of the report, CHILLS (chills), FATIGUE (tiredness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
About a day and a half after receiving vaccination, I developed a headache and extreme fatigue. I also had some body aches.
reported to office by pts mom in APR t105 w/in 48 hrs of administration, nausea & vomiting;
Patient was intended to get the Infuenza vaccination and nurse gave an ADACEL. The patients age (5) is less than the recommended age to receive an ADACEL injection. Pt did leave the facility before the error was noticed. The physician was notified. The patient's parent was notified and they returned to clinic and received the Influenza vaccine. No adverse reaction was noted. No adverse reaction has been reported to date.
Reports 103.0 T, severe chills, shaking, shoulder blade pain. She was afraid shoulder pain could be a cardiac sign, called PCP who told her to get to ED.  ED told her the hi-dose flu shot was perhaps too much for her system, as she reports reacting strongly to any medication. They suggested she ask for the regular strengh flu sho next year.
Breakthrough case admission after 2 vaccines Pfizer 2/18/21 Lot# EL8267;  Pfizer 3/12/21 Lot# EN6200
On Tuesday 11/16, in the evening, face swelling, nose running, itchy red spots appeared on arms and legs. Wednesday 11/17, woke up approx 4:30 AM with swollen/reddish hands and upper arms, hives on upper legs/hips, waist, below and above armpits. Went to dr in mid morning. Got rx for prednisone and was told to keep taking Zyrtec and Benadryl and bought calamine spray and cortisone cream and ice gel packs. Hives continued to fade and reappear and spread up sides. Hives became more prominent after scratching and could see scratch ?lines?. Thursday 11/18, no change in hives/swelling. I got dizzy and light headed and passed out in the afternoon. EMTs came and said it was prob a combination of prednisone, too much Benadryl, too many clothes, nor enough water. Hives in my side continued to be really bad and covered most of my torso. Friday 11/19,  hives moving up to upper body and back. Dermatologist and pcp say wait it out. Friday PM hand swelling starting to go down. **side note,  another working theory is this may be an allergic reaction to fabric softener. We've rehashed everything that was possibly washed with it and so far no acute reaction to any clothes/sheets/towels.
Case number PHEH2013US024034 is an initial spontaneous report received from a pharmacist on 14 Nov 2013. This report refers to a 25-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 22 Oct 2013. On the same day after vaccination, she had a sore arm from the injection site and 9 inches down the arm. The pain was worsened when the arm was raised and was tender. She denied of any redness and swelling. She had been taking EXCEDRIN for pain relief and had not sought any medical care. Outcome of the event was unknown. No seriousness and causality was reported for the events.
Patient was 15 years old at the time of vaccination - which is not approved at this time. Patient is doing fine with no adverse reactions.
fatigue (2 days), arm soreness (5 days), fever (2 days) ... treatment - water (hydration), Tylenol,
Sore arm. Unable to lift arm up over 45 degree angle.  Lasted approximately 48 hours.
Elevated sores (about 8 in number)  resembling chigger bites with eruptions of yellow pus.   Also fatigue
This spontaneous report concerning a female patient of an unknown age was received from the patient herself via company representative. Concurrent conditions an medical history were not provided. On unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot and expiration date were not reported). There were no concomitant medications reported. On 01-JUN-2016, the patient experienced herpes zoster, reported as "the shot made her break out on her arm, had fever (result and units were not reported). On 12-JUN-2016, the patient broke out in shingles (herpes zoster) and itching. At the time of the report, the outcome of herpes zoster was no recovered (also reported as "still feels ill now") and the outcome of fever was unknown. The reporter considered herpes zoster and fever to be related to Zoster Vaccine Live (manufacturer unknown). Additional information has been requested.