chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; swine flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and swine influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the swine influenza was fatal. The reported cause of death was swine influenza.   It was unknown if the reporter considered the vaccination failure and swine influenza to be related to Influenza vaccine.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by the patient's brother. The patient received Flu shot and had swine flu. As per reporter, the patient died from this flu shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.; Reported Cause(s) of Death: Swine flu
Since receiving COVID-19 vaccines, has been having ongoing joint inflammation and swelling; After this Bivalent vaccine symptoms have become worse also include low grade headaches and started having muscle spasms and twitching; Has been seeing various doctors to find a diagnosis; Has a Neurology appointment next month.
extreme pain in left arm at injection site, fever of over 103 degrees, headache, stomach ache, numbness in right hand fingers and left hand fingers, chills and uncontrollable shivering
Pt noticed redness after vaccine, next morning about 16 hrs later redness and swelling about quarter size. Getting worse over next 24-36 hrs with size of redness 6 X 8 cm, warm, tender left deltoid.
fever 4 days, severe h/a, possible paresthesias 2 leg;adm to hosp 5MAY98 & readmitted 8JUN98;?MS like illness;some unsteady gait, slurred speech, ocular complaints;polymorphic slowing over rt central parietal region;cushingoid features;
This is a spontaneous report from a contactable Health Care Professional via a Pfizer sales representative. A 61-year-old male patient of an unspecified ethnicity received TRUMENBA, (lot M95612, expiry date Jul2017) 0.5 ml single, intramuscular in the left deltoid on 26May2016 09:30 for immunization.  At the time of vaccination patient had malignant paragangliom. The patient was immunocompromised.  Concomitant medication included MENACTRA administered on unknown date intramuscular in the right deltoid (lot U517AA) for immunization. On an unspecified date in Jun2016 the site where meningococcal group b rlp2086 was administered became enlarged, swollen, red and it hurt a lot and the patient (an electrician) had difficulty in working. The patient recovered from the reported events on an unspecified date in 2016. The reporter considered that the vaccine had a causal effect to the adverse event. Follow-up (16Sep2016): New information received from a  contactable Health Care Professional  includes vaccine administration information (date, route, site), outcome of the events, causality assessment. Follow up attempts completed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: Legacy paper report 2016364116 added as linked report number. Sender's Comments: Linked Report(s): 2016364116 Legacy paper report number.
Initial unsolicited report received from consumer (office staff) on 25-Jul-2018. This case was linked to 2018SA206644 and 2018SA206651 (same reporter). This case involves a four month old patient (gender not reported) who was vaccinated with 0.5 ml second dose of PENTACEL (Batch number: C5402AA, expiration date: 24 Jun 2018, was not reported) via intramuscular route in left leg on 25 Jul 2018. The patients medical history was not reported. Concomitant medications included PREVNAR 13 for Immunisation and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, the patient did not had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
There were no initial reactions within the first 13 hours of receiving the Moderna vaccine.  Time period:  11am - 12am. By midnight, I experienced uncontrolled shaking, the sensation of "exploding out of my skin", nausea, vomiting, and diarrhea. As I was vomiting, I blacked out and had a seizure.   As a result, I passed out and hit my head on the floor causing a concussion. To date (6/30/21), I am still dealing with the head injury and under the care of a neurologist to see if I have epilepsy. I have been out of work since May 19 and began medical disability on June 1, 2021.
fever of 99.9; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (fever of 99.9) and CHILLS (chills) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 013M208) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 99.9) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Jan-2022 for Chills and Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 99.9) outcome was unknown and CHILLS (chills) had resolved.            No concomitant products were reported.  The patient had little chills but it went away. She took a couple of Tylenol yesterday (18 Jan 2022) and on 19 Jan 2022 morning.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 62-year-old female patient who received SHINGRIX (batch number 4LH35, expiry date 11th September 2021) for prophylaxis. On 30th March 2019, the patient received SHINGRIX. On 31st March 2019, 1 days after receiving SHINGRIX, the patient experienced localized erythema, induration and local swelling. On an unknown date, the outcome of the localized erythema, induration and local swelling were not recovered/not resolved. It was unknown if the reporter considered the localized erythema, induration and local swelling to be related to SHINGRIX. Additional case details were reported as follows: On 30th March 2019 at 7:00 pm the patient received the vaccine in left arm. She woke up Sunday with a red, swollen oval shaped area less than an inch below the injection site. It was also hard to the touch. The patient returned to the pharmacy today as it had not resolved. It was 2 inches in circumference. The reporter gave permission to follow up.
Patient turned 12 and vaccine was administered on 11/15/2021 at the pediatric dose. Full dose will be administered in 21 days
Patient was vaccinated about 3 days before conceiving, patient's mother reported a miscarriage to pharmacy that occurred about 6 weeks after receiving vaccine.
Child with one sibling broke out same day with greater than 50 pox. On 08/10/04 and taken to ER. Diagnosed with chickenpox possible. Treated with Caladryl and Benadryl.
AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1/2.  ON SECOND DAY, AWOKE WITH SLIGHT HEADACHE AND SEVERE LEFT NECK PAIN, UNABLE TO MOVE HEAD FROM SIDE TO SIDE.  FELT NAUSEAUS ON AND OFF ALL DAY. THE NEXT MORNING BEFORE WAKING, I COULD FEEL THE PAIN MOVING FROM THE LEFT TO THE RIGHT SIDE BEHIND MY NECK, FROM EAR TO EAR. THIS IS CONTINUING ON DAY 4 WITH NO RELIEF. CALLED MY PROVIDERS' OFFICE WHERE NURSE TOLD ME SHE HAD THE VERY SAME THING THAT LASTED 2 WEEKS, NECK PAIN PLUS FATIGUE. I HAVE NOT FOUND ANY INFORMATION RE. THIS SYMPTOM ONLINE.
Pt has cellulitis near injection site on right arm. Dr visit treated. Patient is doing well as of 9/11/2017.
I was feeling fine/normal prior to vaccine injection on 4/26/21.  In the middle of the night on 4/27 I woke up due to severe pain in my right ankle, right knee and right hip.  It was a full blown Rheumatoid Arthritis flair up.  I couldn't walk, required crutches to move from room to room.  Right knee was swollen.  Right foot became numb which has not happened to me with previous flair ups.  Blood pressure was taken and running high.  Called on line doctor and she recommended going to ER.  I sent my Rheumotolgist doctor an email.  I have yet to hear back.  Symptoms began subsiding around 3pm on 4/27.  I am able to walk now without crutches.  Swelling has subsided in right knee.  Right foot is still
Time- about half hour after receiving vaccine. Symptoms - tongue got numb, itched all over my body. Took benadryl when I got home. Called my doctor but they never called back. 1/29/21 morning - took a Zyrtec and that helped a lot. Still kind of itchy but symptoms are lessening.
Info has been received from a health professional concerning a 21 month old Hispanic and white female, with no medical history and no allergies, who on 9/23/04, was vaccinated with a 1st SC dose in the right arm of varicella virus vaccine live. Concomitant vaccine, administered on the same day, included a 1st SC dose in the left arm of MMRII. It was noted that there was no illness at the time of vaccination and no adverse events following prior vaccination. On 3/30/05, the pt experienced a rash on her trunk, consisting of 7 lesions that were described as pleomorphic and itchy. It was noted to be a mild case. The pt was prescribed, by the doctor, symptomatic care consisting of Benadryl and Motrin. There were no lab or diagnostic tests performed. Subsequently, the pt recovered. Additional info is not expected.
Reportedly immediately following the vaccination the pt developed local hives and erythema at site of injection. Pt recovered from this experience.
2 days after vaccine had a symmetrical rash on my upper torso. Followed the path of my lymph nodes. Rash lasted for 3 days. Elevated heart rate averaging 90-110 BPM. Heart palpitations.  Neck stiffness for 30-60 days after vaccine. Dec 28th rash came back with exact same symptoms. Continue to have neck stiffness and brain fog since vaccine.
small red rash about 2.5/3? wide and about 1.5? long, with a little swelling/raises, no pain, warm surface, and very lightly itching
Intense heat through body after vaccine Tremors, borderline convulsions Fever 103 Blacked out 24 hrs after vaccine Headache Tylenol could not relieve  Body pain especially in legs and back Unable to lay down Shaking chills lasting 36 hrs Burning sensation in right eye Nausea Stomach cramps
I woke up at around 4:30 am with a pounding heart beat. I could clearly hear every beat in my ears. For some moments, my heart rate was changing a little bit between faster and slower rates. I drank water and went back to bed to see if it would go away with more sleep. At around 8am, I got up and my heart beats were not so intense. However, after I got on my feet for a few minutes, my heart beats became more intense and it felt like I could not get enough air, even though I was breathing heavily. I also had a headache, body aches, and some mild chest discomfort. I laid back down, and the symptoms quieted down again. At around 10am I took 2 ibuprofen pills. I spent most of my time from 8 am on lying down around noon. After that, the symptoms had improved significantly. I still feel a little bit of chest discomfort, but it is very mild. My heart beats are mostly back to normal, and I feel less out of breath.
About 2 hours after receiving the second dose, I started feeling extreme burning pain in my muscles, throughout my whole body. It started in my shoulders and neck. I had a severe headache. There was a couple of weeks before I contacted my doctor. My swelling increased and he gave me Naprosyn and a water pill. The swelling and the pain in my muscles did not subside. I saw my doctor 3 weeks ago and he told me to wait it out. He told me to continue to take the medication that he prescribed me. I have had Hashimoto's disease since 2016 and I have had Raynaud's since 2018. As of today, I am still having really bad muscle aches throughout my body. I spoke with my endocrinologist and I have an appointment with him on 06/21 to have testing done to see if this has affected my thyroid.
Breakthrough case. Chest congestion, stuffy nose, sinus swollen, cough, fatigue, dizziness, occasional headaches. Took a home test on 06/30/2022 and tested positive. Still has Covid. Messaged Dr. through health portal. Wondered if I should take PAXLOVID, but my Dr. advised against it and wanted me to rest and quarantine. A Cardiologist from the patient portal contacted me and recommended me to keep watch on my Blood Oxygen levels and if it got below 88, to head to the ER. Still testing positive for COVID on 07/11/2022.
14 days after the booster, developed full body itchy  hives (scalp to toes).  7 days later still have itchy hives despite taking 25 mg of Benedryl almost every night.
Swelling, redness, warmth to (L) arm area where vaccine was given. Advised ice, Ibuprofen and BENADRYL. Swelling extended from shoulder to elbow-local hypersensitivity reaction.
pt recvd vax & w/in 30mins post vax exp diff breathing,chest pain,& nauseated;sx resolved w/o treatment;
Fourteen hours after receiving vaccine, I was awakened by severe chills, headache, and muscle pain.  Throughout the next 2 days, I experienced extreme fatigue, having to sleep for 3-4 hours at a time in the afternoons.  Chills ended after the first day, but head and muscle aches continued into the second day.  Also, I experienced nasal congestion during this time.  Of note:  My doctor and I suspect that I had undiagnosed COVID during the last week of March and first week of April, 2020.  There were not enough tests at the time, and I did not need to go to the hospital.  I was ill for 2 weeks with the same symptoms as above plus cough and sinus infection.  Dr. prescribed Azythromycin and over the counter meds for cough and headache.  I did not feel better until the entire round of antibiotic was finished.
p/vax that evening felt lt armpit tender & swollen;no swelling, tenderness, redness @ site;upon exam no obvious localized or mult adenopathies;c/o tenderness w/palpation & sensation of enlargement;
Recieved 4 shots on 4/12/11, on 4/13/11 call rcieved that right arm was red and sore.  On 4/16/11 patient seen in office and diagnosed with Right arm cellulitis at the Dtap site.  Treated with antibiotic.
The day after receiving the vaccine, I started to run a low grade fever. I figured it was normal after the vaccine, but I continued to have a low grade fever, during the afternoon and evening, every day for 6-8 weeks. I was tested for strep and COVID, by a doctor, but the tests came back negative. I was told to take Tylenol as needed for my fever.
Patient was administered A Pfizer Orange Cap Pediatric dose, Not A Pfizer Gray Cap 12+
metallic taste in mouth; This is spontaneous report received from a contactable consumer. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration on left arm on 03Feb2021,15:45 at single dose for COVD-19 immunization. The patient medical history included High blood pressure, Allergies: Raw Eggs. Concomitant medication included hydrochlorothiazide taken; verapamil; biotin, calcium pantothenate, chromic chloride, cholecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide (CENTRUM VITAMINTS). The patient previously took prednisone, metoprolol, lisinopril, losartan and all had Allerges. No Covid prior vaccination and no Covid tested post vaccination. It was reported that, the patient experienced metallic taste in mouth on an unspecified date in 2021. The outcome of the event was reported as recovered on 2021.
she has half a millimeter bump; RASH ON HANDS AND FEET; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS BULLOUS (she has half a millimeter bump) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hand, foot and mouth disease (about three years ago).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (she has half a millimeter bump) (seriousness criterion medically significant) and RASH (RASH ON HANDS AND FEET). At the time of the report, DERMATITIS BULLOUS (she has half a millimeter bump) and RASH (RASH ON HANDS AND FEET) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. Based on 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.; Sender's Comments: This case concerns a 46-year-old female with serious unexpected events of dermatitis bullous and rash. Event on set 11 days after first dose mRNA-1273. Based on 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.
Patient states severe pain immediately upon injection. Trouble moving and using arm. Pain has subsided over time last 6 days but pain is still significant.
I had the vaccine on 12/21/2004 at 9:00 a.m. and on my way home at 4:30 p.m.I experienced headache, dizziness, weakness and by the time I arrived home at 5:30 I was pale and had a fever of 102 degrees. I called my doctor and he told me to take tylenol.
Information has been received from a physician concerning an 18 month old female with no pre-existing allergies, birth defects, or medical conditions who in the P.M. of 12-Mar-2007, received a subcutaneous first dose in her right thigh of PROQUAD (lot #656307/1391).  It was reported that she had no illness at the time of the vaccination and had not experienced any adverse events from previous vaccinations.  It was reported that on 22-Sep-2007, she developed vesicles and blister cluster erupted to her right thigh inner aspect.  On 28-Sep-2007, she presented to the physician for evaluation.  The doctor reported that the vesicles and blister cluster were tender to touch and looked like classic shingles.  Diagnostics obtained on 28-Sep-2007, included varicella-zoster virus culture (positive) and a superficial wound culture of the right inner thigh (negative).  It was reported that as of 04-Oct-2007, she had recovered with all drying lesions.  A product quality complaint was not reported.  No further information was available.  Additional information is not expected.
Began to have an earache and lower jaw ache around 10:30 AM on  06/02 while at work.  Symptom's of decreased ability to blink, smell, taste, talk, and pronounced facial droop by 3:30 pm.  1/2 face including tongue numb with full right side of face completely paralyzed by 6 pm.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild
On 11/3/2021 it was discovered the vaccine administered on 10/22/2021 had been stored in the freezer longer than the recommended 14 days. Patient did not have an adverse event.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at this time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for liver steatosis, vitamin d3 deficiency, essential htn, alcohol abuse, cannabis use, hyperlipidemia, neoplasm of uncertain behavior of lung, tobacco use, hx of homeless. Per note 4/15, wife reported that patient found in his camper 4/3/2021. Patient had been drinking and climbed into bed and fell. No further no notation on cause of death.
The following morning noted injection site swollen and hot. Hard knot at site about the size of my palm. By the end of the first day entire upper arm swollen, hot ant tight down to elbow. On the second morning swelling had progressed to my wrist. Watch band normally in fourth hole now was in sixth. Arm was very swollen, skin was hot, over 100 degrees, the arm was hard to the touch. No pain. At this point I did a tele-med check-in with my insurance provider. They recommended I seek care if it got any worse.   Swelling started to subside on the third day. Upper arm first and then forearm. On the fourth day I spoke with my local clinic to keep them in the loop. Now, one week post vaccination, mostly gone but wrist is still a little swollen.
Evening after shot and day after shot developed hives where pneumonia shot was given and all down arm to elbow.  Also tremendous soreness in arm and feeling like I had a virus.
BURSITIS (BRUISES / PAIN IN SHOULDER); TENDONITIS; TEAR IN ROTATOR CUFF; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced bursitis (bruises / pain in shoulder),  tendonitis and  tear in rotator cuff.  Laboratory data included: MRI (NR: not provided) Bursitis, Tendinitis, and a tear in rotator cuff. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tear in rotator cuff, and the outcome of bursitis (bruises / pain in shoulder) and tendonitis was unknown. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Redness and pain at injection site, fever, generalized arthralgias, rash heat/burning sensation at (R) axilla, stomach pain, fatigue, low appetite.