chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID-19 case. Pt was sent to the ED for COVID 19 management. PT stated she has been coughing for 4-5 days with scant sputum production. Covid test was done on 8/18/21 at outside facility and results today were positive. She was sent to the ED and admitted on 8/21/21. Note: patient previously received Moderna Covid-19 vaccines on 4/12/21 & 5/10/21. Diagnosed and treated for Covid-19 infection. discharged 8/25/21.
Shallow breathing - stridor. Lost of consciousness. .3 mg EPI-PEN given Intramuscular (R) thigh by Dr. at 12:14pm.
Severe HA, fatigue starting two hours after Menactra vaccine. Lasted 24 hours. Relieved with Tylenol. Possibly myalgias, afebrile. Resolved by 6/26/2005. Did not seek medical care at time of symptoms.
Onset 12/17/15 at 16:30: (L) arm redness/swelling 9.5 cm x 10.5 cm; warm to touch, painful (rates "8"/10), complains of chills. Tympanic temperature 37.3 C, BP 124/78, pulse 131.
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours.  Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
This spontaneous report as received from nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in March 2016, (also reported as unspecified date last week) the patient was vaccinated with second dose of GARDASIL 9 (dosing details were not reported), intramuscularly. The patient was not using any medication concomitantly. On an unknown date in March 2016, 15 minutes after vaccination the patient fainted. The reporter stated that the patient had no issue after the first dose in the immunization series. The patient was still in the office and needed no follow up medical attention. The patient did not receive any treatment for the event. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. This is one of the two reports received from the same reporter (1604USA006593). Additional information has been requested.
Client received TDAP in left deltoid. Arm is tender to touch and swollen to the size of a small golf ball. Instructed client to alternate cool & warm compresses and take MOTRIN PRN for pain & swelling.
Some taste loss, muscle aches, weak stomach, fatigue,  headache,  general malaise,  sleepiness,
At the time of the vaccination the daughter was 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 20-APR-2021 contains non-significant information: Consumer reported denial for follow-up.
I developed severe preeclampsia at the time of delivery. Baby was born at 39 weeks and 2 days. She was 6#8oz.   This was my second pregnancy and I had no prior history of preeclampsia with my first pregnancy. my first was born on his due date.   In this pregnancy,  my blood pressure began going up in the last few days before she was born and after her birth it turned into severe preeclampsia.
Headache and temperature of 100.6, took Tylenol and Ibuprofen at usual time in evening, went to bed, was fine next morning
Moderna Covid-19 Vaccine EAU   I received my third shot of the Vaccine on Friday at about 4 PM.  ( 10/22/2021).  On Saturday morning about 9 AM I began to have chills, teeth chattering, and some head aches. At the time I was working in a boat yard and often on boats. I had a friend drive me home and I got home late morning. More headaches and continued chills and teeth chattering. I went to bed for the rest of the day and basically stayed in bed till this morning. I believe I am now OK but will take it easy today. The first two Moderna shots did not trouble me at all.  This came as a surprise.
Pt consented to Janssen vaccine on 7/22/2021. Pt filled out consent and indicated this was her first COVID-19 vaccine. Vaccine administered WNL. When documenting in NC CVMS it was then determined patient received Pfizer vaccine 2/2021. Called patient and she states yes she did take Pfizer and forgot to put that on her form or tell the nurse administering- she thought "she need to start her vaccines over because it had been so long"
He started experiencing pain all over his body. He could not eat. He said his bones were hurting. This was in February 2022 and in March of 2022 he finally went to the hospital. After some testing they informed him that he had metastasized cancer all over his chest, liver, lungs, spleen, practically all over his body. They could not do anything and suggested hospice. He was in hospice there in the hospital and was given morphine for the pain and he died within a day.
absence of heartbeat and estimated the embryo stopped growing at 7 weeks; had a very difficult time keeping her glucose levels; lightheaded; possible threatened miscarriage; persistent vertigo; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 11:00 (Lot Number: EN6204) as single dose for covid-19 immunisation, administered at the hospital. No other vaccine received in four weeks. Medical history included type 2 diabetes, fatty liver disease, high cholesterol, and known allergies: Pineapples and Zoloft. Concomitant medications included metformin; glipizide; escitalopram oxalate (LEXAPRO); and meclozine hydrochloride (MECLIZINE [MECLOZINE HYDROCHLORIDE]).  The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 03Feb2021. On 25Mar2021, 03:00 PM, patient sought treatment for persistent vertigo at a hospital and was given meclizine. On 03Apr2021, patient went to the emergency room to be assessed for a possible threatened miscarriage. They found her embryo sac and determined she was pregnant. She was released and told to go home. Patient is a type 2 diabetic and was ordered to go on insulin. On 05Apr2021, she had another threatened miscarriage and returned to the hospital. She was given an ultrasound and her due date changed from 10Nov2021 to 28Nov2021. Ultrasound discovered a heartbeat at 132 bpm. On 23Apr2021, at a routine ultrasound and OB visit, doctor discovered absence of heartbeat and estimated the embryo stopped growing at 7 weeks. She was electing for a D&C surgical procedure and requesting pathology testing to investigate the cause of death. She had a very difficult time keeping her glucose levels within the recommended pregnancy range of 90-150. She had persistent lightheaded still. Outcome of events vertigo, possible threatened miscarriage, and lightheaded was not recovered. The patient received treatment for vertigo and did not receive treatment for other events.
MODERNA COVID 19 VACCINE EUA PAIN TENDERNESS SWELLING/ FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS/ THEN CAME THE ALL OVER BODY RASH AND I STILL HAVE THIS
Fever, chills, cervical adenopathy and severe total body myalgias following 48 hrs after each vacc.
numbness/tingling in hands and feet specs in urine Water feeling in the left ear nervousness feeling in my body like jitters and I can see some twitching Back, abdominal, and  right side pain insomnia heartburn slight fever for one day Blood pressure elevated and slightly lower lip soreness diarrhea
Patient came to registration table and said tongue initially felt fat and tingly but was having no trouble breathing.  States she felt weird and was directed to sit in front row of chairs to observe and let us know if symptoms worsened or persisted.  As patient continued to be monitored she states she was becoming immediately fatigued and just wanted to take a nap and felt very weak.   Rapid response team was called to take patient to ER to be evaluated further.
soreness at injection site; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and headache. On an unknown date, the outcome of the injection site pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Aug-2022 Reporter's Comment:  The reporter was husband. The patient received the second dose of Shingrix vaccine on yesterday. The reporter stated that the patient was experiencing raised soreness at injection site and headache. The reporter want to know how long these adverse events would last. The reporter consent to follow up. Additional Supportive Information:  This case had been linked with US2022124934, reported by same reporter.; Sender's Comments:  US-GSK-US2022124934:Same reporter
Case number PHEH2014US003670 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown dale in  JAN 2014. No adverse event occurred to the patient following this  medication error. (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
itching; hives; inflammation of skin after scratching; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not reported) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included obesity.  The patient's concomitant medications were not reported.  Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 16March2021, after 24hrs of vaccination the patient experienced non-severe allergic reaction, such as itching, hives and inflammation of skin after scratching, lasted 4 days, stopped for two days, then reoccurred. Patient did not receive any treatment for the events. The clinical outcome of the events of itching, hives and inflammation of skin was not recovered at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Child suddenly started wheezing severely, coughing while trying to breathe, could not speak because he could not get sufficient air, became somewhat lethargic, temperature was taken: 101, and was retracting. We administered a breathing treatment of albuterol and a dose of ibuprofen, Oxygen levels eventually stabilized at 95 and fever reduced within hours, no recurrence.
Got the shot on 01-12-2011 - swelling - red - soreness - fevered - welted - itchy.
Beginning approximately one week after receiving the first dose of the COVID-19 vaccine by Pfizer I began to develop a rash on my legs and arms. This was treated with cortisone cream and aloe. After receiving the 2nd dose, the rash that has been receding and healing has come back to cover my arms, hands, and stomach and sides of my breasts starting about 4 days after receiving the 2nd dose. This is being treated again with cortisone, aloe, and now sensitive skin lotion by lubriderm.
1) Just days after I received the Shingrix vaccine my left arm and shouldr area, the arm where they administered the vaccine began to look atrophied. In fact it still looks atrophioed today and even the left half of my face looks less plump than the right side of my face, (IT WAS NOT LIKE THAT BEFORE I RECEIEVED THE SHINGRIX VACCINE).  2) Also just days after receiving the Shingrix Vaccine my left arm and shoulder area began experienceing intermittent pain in diffferent parts of the arm and shoulder.  3)Now for AT LEAST 3 1/2 weeks I've been experiencing extreme pain in the same areas. on a scale of 1 to 10 the pain is a solid 8.5 and is making it difficult to complete everyday tasks. EXTREME PAIN happening dail
Pain, swelling in arm; "5" on scale of 10. Had to make visit next day, hospitalized 3 days Fever 102.7, chills, rigors, malaise. Sepsis. Pt. had acute myelogenous leukemia.  12/1/08 MR received for DOS9/22-27/2008 with D/C Dx:  Sepsis in an immune compromised pt.  Cellulitis of the R arm/forearm.  Immunocompromised, due to Acute Myelogenous Leukemia.  Chronic bronchiectasis.  AML with complex cytogenetics.  Pancytopenia.  Hyponatremia.  Chronic obstructive airways disease.  GERD.  Diastolic dysfunction. Pt presented with fevers, chills, rigors and redness, swelling and pain to the R arm which began w/in 24 hrs of receiving Pneumovax.  Tchycardic and febrile on admission with redness, swelling and warmth on the R arm. Tx with IV abx with improvement noted. Dx with possible pneumonia following CXR with LLL infiltrate. Will continue to receive IV abx as outpt.
Macular, papular rash on torso and bilateral arms that appeared 2 hours after receiving Influenza vaccine and a PPD.
Left upper arm aches/pains everyday, notice weakness in left arm, feel nerve pain constantly all day, every day.
Pt began feelin nausea and tightness in her throat. Wheezing noted upon auscultation.  Vitals: O2 sat of 99% on room air. B/P of 124/64, HR 90. Benadryl 50 mg given IM. Called Dr. at and was advised that pt would normally be observed for 5-6 hours. Pt to be sent to by family member in vehicle.
Mother and daughter had gone to site for vaccinations.  Vaccinator got the ok from Admin to give the next vaccination which was for the mother to receive who was fully registered, but the mother told the daughter for her to go first.  The vaccinator assumed because admin stated all clear that she was already register but she wasn't, the injection that was meant to be given to the mother was given to the daughter who was only 14.  Vaccinator states did not ask for the daughter dob. Med error, no adverse reactions noted and was observed for an hr.
This subject is a 70 year old male, who was admitted to the hospital due to abdominal pain while enrolled in a study. The last dose prior to the event was given on 5/28/04. The patient received either a foreign Td vaccine or Td vaccine (control product) (lot number not reported). The subject developed abdominal pain 30 days post-immunization and was admitted to the hospital the same day. He had a seven day history of epigastric and right upper quadrant pain and a two week history of weakness, nausea, vomiting, weight loss, diarrhea and anorexia. The initial CT scan done showed ascites and multiple lesions consistent with carcinomatosis. A cirrhotic liver was also noted, a thickened gall bladder, no diluted ducts and right hydronephrosis. Reportedly, the etiology of the cirrhosis was likely due to the hepatitis C. A chest x-rays showed an elevated right hemi-diaphragm and bilateral pleural effusion. Initial labs showed an abnormal ALT of 102, bilirubin of 1.8, alkaline phosphatase 168. Treatment given was not reported. He was discharged from the hospital three days later. The subject's recovery status was unknown at the time of this report. The abdominal pain was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: Fax covers, initial reporting form, history and physical, physical examination, lab reports, IND SAE fax reports and fax confirmation (12 pages). From additional information received on 7/7/04 it was reported that the patient died on 7/2/04. Patient developed abdominal pain on 6/24/04 changing the latency to 27 days post immunization. He was diagnosed with ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver and hydronephrosis. An ultrasound guided paracentesis which showed frank blood in the ascetic fluid compatible with a possible hematoma with probable rupture associated with a hemo-peritoneum. The subject underwent an MRI of the abdomen which did confirm ruptured hepatoma/hepatocellular carcinoma. The subject was discharged home with hospice care to follow up as an outpatient. The following medications were prescribed on discharge: Vicodin 2 tables orally every four hours for a pain scale less than 5.10. Use morphine sulfate liquid for breakthrough pain. A stool softener of Colace to be taken twice a day was prescribed for constipation. The ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver, hydronephrosis and death was reported by the investigator as unrelated to the study vaccine. The etiology of the cirrhosis was likely due to the hepatitis C. The question remains of the cause of the hepatic metastases. A CEA, PSA, and AFP will be checked. A phone call was made to the IR department for paracentesis for both diagnostic and therapeutic procedure. If this patient has symptoms, spironolactone 12.5mg daily should be started. No autopsy was done. Pt died at home.  Nurse follow up on 10/13/04 states: "Liver cancer, Hepatitis C, Cardiovascular arrest, ruptured hepatoma."
Patient stated that she started feeling cramps & bloating in June (received shingles vaccine on 8/27/08). Patient claims that symptoms began the Saturday after receiving the vaccine. Dr diagnosed patient w/shingles @ the ER. Patient was given pain medication & told that nothing else could be done. Since then she has followed-up w/her PCP who per patient performed an ultrasound on her abdomen & found nothing wrong w/her pain meds & laxatives were given for condition.
About 12 hours after recieving the vaccine, lots of pain in upper arm muscle and very sore to touch. Extreme fatigue and body aches with onset about 12-24 hours after receiving vaccine.
Ipsilateral axillary swelling and tenderness beginning 2 days after vaccine with notably increasing swelling and tenderness at 5 days post vaccine.  Continuing to monitor at home.
Information has been received from a registered nurse concerning a female patient who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient fainted. This is one of several reports from the same source. Additional information has been requested.
The following day p/vax pt was irritable & had a fever (102F); WBC count was 18,900 & pt was given Ceftriaxone; 2 days following vax mom reported that pt had stopped breathing twice during the prev noc; each episode of apnea lasted 10 sec
Fever, chills, body aches, sore throat, diarrhea, fatigue, continued swelling, redness, and pain at injection site
Sore joints, cough, chest heaviness, shortness of breath, sore arm. No fever. Reports that three other paeople in his unit experienced the same post-vaccination symptoms.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient and his mother presented about 30 minutes after receiveing vaccine stating he passed out in the car for about 15 seconds and fell on his way back into the store. He lied down for a while and said he was fine. Mother said do not call an ambulance, she would take him to the emergency department.
Patient had discomfort/pain in arm following flu vaccine.  After 11 days & still having pain, she went to her doctor and was told the vaccine was given too high in shoulder.  She was then given a cortisone shot.  After one month, patient said she is still experiences discomfort in her shoulder.
Loss of appetite, headache, nauseous, severe leg and hip pain (hard to walk), excessive sweating (I thought my dog peed in the bed at first), confusion.  Husband was close to taking me to ER
1st dose on April 7th resulted in untreatable migraine lasting more than 7 days. I also started noticing pain in my left arm, but did not seek treatment. This was not the same arm I received vaccination. 2nd dose resulted in immediate migraine and fatigue, but I had pre-treated so symptoms were tolerable. Normal pain at injection site and chills, but tolerable. On Sunday following the 2nd dose, I awoke to my heart racing, extreme palpitations, and chest pain. I had pain in the left arm as I had before, but it wouldn't subside and was much worse. I had stomach pains with extreme nausea, but I did not vomit. It felt as though someone had their hand wrapped around my esophagus, and it felt as though I couldn't breathe (shortness of breath). The migraine had gotten much worse, and no treatment would help. General sense of not feeling well. After several hours, my fiancé thought I was having a heart attack, and we went to urgent care. After only a quick check in, they sent me directly to ED where I spent the majority of the day. I saw my PCP the following day and my hormone specialist the following Thursday. I had to reduce my thyroid meds significantly to let heart palpitations subside. It's been more than 6 weeks since the 2nd dose. Palpitations have subsided for the most part. However, about 3 weeks ago, I started feeling numbness/tingling/pins and needles feeling in my fingers, hands, lower arms, feet, and calves. That comes and goes. I have had arm pain and muscle spasm in the same area of left arm where it started hurting after 1st and 2nd dose. Muscle spasms are not subsiding, and when they do, my arm is achy with shooting pain. Legs from hips down are now stiff, and I especially feel it when walking, particularly up/down stairs. Feeling/burning/acid reflux has gotten significantly worse with a constant burning/pain/stinging in throat.
2/19/09.  Local Reaction with continued erythema & induration at site.  2 Pruritic rash with small dark lesions on thighs on 2/21/09
Next day p/inject pt had pain develop in rt arm fr deltoid to wrist; No swelling @ site; No lump @ inject site, no fever; Pain in arm never left; Arm feels like it goes to sleep @ night; Was constant pain;