chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with allergy to penicillin. On 24-NOV-2014 (also reported as Monday) the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) at her primary healthcare providers office. Concomitant medication, laboratory tests and pertinent medical history was not specified by reporter. The pharmacist stated that the patient came into the pharmacy on approximately 26-NOV-2014 (also reported as today), stating that she was not feeling well (onset date was not specified by reporter), approximately in November 2014. The pharmacist also stated that the patient had a prescription for CIPRO and wondered if that would not interfere with her ZOSTAVAX vaccination. The outcome of not feeling well was reported as not recovered. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information is not expected, because the reporter didn't wish to be contacted.
Woke up the next day with Chills and Headache.  Got progressively worse over the day.  Fever 101º F, muscle aches and pains.
Had my second shot on 03/02/2021.  On the morning of 03/22/2021 started having pain in chest with deep breaths.  was put on an ekg monitor and that all came back negative.   Was diagnosed with inflammation of the heart with a diagnose of pleurisy .  Inflammation of the tissues that line the lungs and chest cavity.   Was sent home and prescribed anti-inflammatories or pain relivers every 4 hours until symptoms let up  along with rest.
Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage; doses administered after temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Had two temperature excursions in our freezer, One was 8 degrees F for 30 minutes. Two days later and the other was 11 degrees F for 90 minutes. Both were caused by an overnight power outage) and EXPIRED PRODUCT ADMINISTERED (doses administered after temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received added patient demographics.
Started developing discomfort in my right breast around the time of my 2nd covid vaccine shot. The discomfort getting progressively worse and also started to hurt. About 10 days later,  self-checked more carefully and discovered that an artery or vein that runs from the lower part of my breast (slightly to the right side of the nipple) all the way up to near my armpit tightens and hardens to form a cord like lineage when I move my right arm up and to the side.  The situation worsened overtime. About 20 days later, the cord runs down further and I felt small bumps near it on the bottom part. Now, The cord on the upper part seems to have softened, but it developed further down into abdomen area and it hurts.  The symptom also looks like the Mondor disease. My Dr. believes it is thrombophlebitis in thoracoepigastric vein.
Medical response called for patient counseling. Patient received the second dose of Pfizer today and only just received the first dose on April 23rd. Patient states that he looked at the back of his immunization card which said to come back on May 4th, 2021 for his second dose. Upon examination of the card, the date listed is May 14th, 2021 however, it was hard to see the 1 in 14 on the card and could've contributed to the confusion. The patient also has three accounts and the CORE member checking him in may not have noticed the date. The patient has no complaints, and no reaction to the vaccine. VS were not done. Patient was able to drive himself out of parking lot with follow up instructions.
A very bad Flare up of Eczema on right hand. Very unusual since I have my eczema under control.
COVID Vaccine Breakthrough Case Pfizer Dose 1 5/6/21 (ER8736) Pfizer Dose 2 6/4/21 (EW0164) COVID Positive 12/27/21  12/27/21: Patient is a 57 year old female with metastatic ductal carcinoma, Mets in bones, liver and pleural currently on monthly Faslodex injections and po Ibrance 100 mg every 4 weeks, she is followed by Cancer Center. Patient has been experiencing shortness of breath since September of this year. She was recently seen in ED for bilateral pleural effusions, thoracentesis was performed, however she did not have any improvement in her shortness of breath. She was scheduled for chemotherapy today but has been experiencing fevers since yesterday, TMAX 101.4. She endorses a cough with greenish mucous production. No chest pain. Denies loss of taste or smell. She has fatigue.  She denies any diarrhea, nausea or vomiting.  She has been fully vaccinated for COVID-19 but has yet to receive her booster.  Patient was recently started on Lasix by her Cancer Center secondary to pleural effusions.  She does admit to recent travel by plane.  On arrival to ED the patient was tachycardic 113 and temp 99.3.  She is noted to be hypoxic in ED and 2 L supplemental oxygen was applied with improvement oxygen saturations to 95%.  Laboratory findings were significant for hyponatremia 132. Hypokalemia 3.4.  Transaminitis ALT 65 in ALP 248. Hypocalcemia 8.6.  ProBNP 283. Leukopenia 4.80.  D-dimer 6.82.  CT chest no Regulatory Authority.  Rapid COVID positive.  Chest x-ray small right and moderate left pleural effusions.  Metastatic disease in both lungs, similar to prior.  Patient received acetaminophen, DuoNeb treatment, Solu-Medrol and potassium 40 mEq p.o. in ED.  12/29/21: A 57-year-old lady with generalized metastasis to the lung, liver and bones, presented with history of worsening shortness of breath.  The patient was noted to be positive for COVID-19 infection.  Images show extensive lung metastatic disease.  The patient was treated for hypoxia related to fluid overload and metastatic lung disease. Patient's condition has improved, was given a short course of empiric remdesivir, as well as dexamethasone and empiric antibiotic therapy.  The patient's condition has improved.  She has been advised to follow up with PCP in 2-3 weeks.
She got her vaccine, just pain on the arm itself, which she sees is normal.  She then felt that her body was heating up and got a really bad headache, and felt that was fine.  She started having some problems breathing.  Then she had a fever, but that did not come until after that reaction.  She then had bumps on her arm, hives on her arm, and the fever got higher and higher and she had to lye down.  She did fall asleep but she did take an Ibuprofen which her doctor said to take it.  By 3:00 AM she woke up with chest pain and could hear her heart pounding, and she could not get it to stop pounding for 2 days.  Her husband told her to go to the ER and called her doctor and she was informed that if it got worse to go to the ER.  She was sick for about 3-4 days and then the pounding has slowed down after the 3rd down and continually continues to slow down.  She has some pounding, but not as severe as she did have.  She is feeling much better now.    she still has a rash on her neck which developed 3 days after the vaccine, but it is still there.  Almost by her collarbone.  She was told to put neosporin on it and is going to see her if it does not go away by Monday.
inflammation around his heart; pericardial effusion; difficulty breading; severe weakness; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Feb2021 (Lot Number: EL9263) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 24Jan2021 (Lot: EL3247) for covid-19 immunisation. After two dose of vaccination, the patient developed inflammation around his heart. He had difficulty breading and had severe weakness. He was taken to the emergency on 13Apr2021 and given steroid treatment. He was taken again on 10May2021 and admitted with steroid treatment. On 14Jun2021, he was admitted again and they did a pericardial effusion. His symptoms have returned. Need some answers. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
lesions began appearing evening 11MAR by 12MAR had 50 lesions on trunk w/mild pruritis, no fever, URI sx, resolved by 18MAR; contracted chickenpox p/vax;
pt recvd vax & devel sl edema, itching, & redness @ inject site; pt was treated w/DPH;
Pale pink papules, a few scratched at site of immunization; itchy rash (local).
- AFTER THE 1ST DOSE: PT HAS BEEN EXPERIENCING LOSS OF TASTE AND REGAINING THE SENSE OF TASTE EVERY 2 WEEKS.  - AFTER THE 2ND DOSE: ABOUT A WEEK LATER, PT STARTED FEELING OF BLACKING OUT AND STATED DID NOT FULLY BLACK OUT BUT COULD NOT MOVE HIS BODY (UNSURE FOR HOW LONG). DURING THIS TIME, HE DEFACATED HIMSELF AS WELL; NEUROPAHTY (NERVE SHOOTING PAIN) ON LEFT LEG. FEELS LIKE IT FALLS ASLEEP THEN ON FIRE; VELCRO RIPPING FEELING FROM LEFT SIDE OF HEAD (ABOVE EAR) ABOUT 1 MONTH AFTER 2ND DOSE; WHEN HE GOT A CUT ON HIS LEG, IT FELT ITCHY INSTEAD OF PAIN; INDIGESTION FEELING ON THE LEG, NOT IN THE STOMACH. 3 DAYS OF INSOMNIA AFTER 2ND DOSE; HAIR LOSS AFTER 2ND DOSE.  PT CURRENTLY DOES NOT HAVE PCP. RECOMMENDED TO THE DOCTOR/URGENT CARE/HOSPITAL.
Fatigue began 02/04/21 and lasted approximately 24 hours. Hives began 02/05/21 and continue as of 02/08/2021, currently using Benedryl, Cholecystitis began 02/07/2021 with bloated feeling and abdominal pain behind belly button and off to the right side of abdomen pain is beginning to ease off as of 02/08/2021.
Patient had Tdap and GARDASIL then stood up. Was helping sister get shots then felt lightheaded and fainted.
soreness; flu; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age started to receive BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date, as a single dose for COVIF-19 immunization. Medical history was not reported.  Concomitant medications included pravastatin , 1 tablet once a day.  The patient reported that she got the first dose of the vaccine and experienced soreness and flu but is okay. She was about Pravastatin and if it will interference with the COVID vaccine. The clinical outcome of the events was recovered.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given 2 doses of polio accidently. Patient had a fever the next day, which subsided same day.
Patient contacted pharmacy complaining of a rash in her left forehead moving towards the back of her scalp that is painful.
The night after my vaccination my 2 middle fingers started to numb (Right fingers) and it was very unusual for me and I couldn't lift my right arm. These both lasted for about 4-5 months until I had to go to the Doctor's office and was advised that my wrist needed surgery and I had to have physical therapy for my right arm to recover. It took me a couple of months to fully get back to normal.
fever 101 ºF; in bed for 5 days; taste of metal in their mouth; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included PRIDINOL HCL (PRIDINOL HCL 300 mg ER) for Back pain, CLONAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), DULOXETINE (DULOXETINE 60 mg) and AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth). At the time of the report, PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-046906 (Patient Link).
Immediately after the vaccination nothing, but 2 hours later I became aware of a ringing sensation in both of my ears. This is still ongoing to this day. I let a week go by and it was still there, I reported it to my doctor through a video chat. My doctor suggested to let it go and see what happens and contact him after I had my second vaccine and 2 weeks after that. I got back in touch with him and told him it hadn't gone away. He examined me and referred me to an audiologist. Audiologist had seen similar symptoms in other patients.  It wasn't affecting the way I hold my conversations, I can watch TV, it does not get in the way. The audiologist stated there was a possibility it could disappear or never go away.
10/19 top swollen left eyelid 10/20 swollen cheeks/tingling lips/weird sensation in mouth10/21 left lower eyelid swollen 10/22 entire eyelids swollen
This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a rash. Patient stated, "I have a rash and it's now 5 weeks. My dermatologist has got me on a program of steroids (unspecified steroids). I am wondering if there is any advice that you have or someone to give me that is the right program to be on?" Patient also stated, "It is from the COVID-19 vaccine. It happened after my first shot. I went to my dermatologist and my general practitioner and they said well it's a rash; go take the second shot because that is more important and we can resolve the rash. Well that was 5 weeks ago, now I want to know how get these things clean down." The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Pain in arm, fatigue, headache, joint pain, muscle pain, diarrhea, stomach ache, nausea, chills.
I woke up with severe shoulder/joint pain and weakness plus popping and cracking burning as well, in both arms left and right.  Plus joint pain in hips. Still having. the same weakness and pain as of  today on 2/23/2021.
Pt. given Hep A VFC, instead of Hep B, VFC. She had already received 2 Hep A 's.
Administered 11/12/13 patient was 6 then is 7 now. INFANRIX given RD IM. VARIVAX RA SQ. Normal redness VARIVAX 4 inches down from where DTAP administer red/purple and swollen.
she is older than 45 years old; No additional AE reported; This spontaneous report was received from a female patient of an unknown exact age (older than 45-year-old), who reported on herself. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient who was older than 45-year-old, was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), for prophylaxis (dose, lot #, expiration date, route and site of administration were not reported). No additional adverse event was reported.
Lightheaded, dizziness, anxiety; BP 125/86; HR 109; SpO2 98, Temp 37.1
Extreme fatigue within 20 minutes of vaccinations, headaches, inflammation and pain in joints with ongoing flare ups that have continued up to now (6 months), muscle pain for 7 days, sporadic bone pain in left arm and both legs, fatigue continues, frequent headaches, tingling and loss of feeling in feet at times, chest pain a few times, extreme vitamin d deficiency, elevated blood sugar
Arm Swelling, Red and hot from shoulder to elbow. Rash on left arm, lower back, and right thigh.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case is reported for patient 8 out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (death and medically significant) event of Neoplasm malignant. Latency is unknown but it was reported that the patient developed cancer, with fatal outcome after the administration of mRNA-1273.222 vaccine.  No further information was available in the report. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.     This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Information has been received from a registered nurse concerning a child who between 1998-2003 was vaccinated with a dose of varicella virus vaccine live. The nurse noted that the child had been vaccinated and then came down with shingles. The child was in the first grade and has been kept out of school. No other information was given. Unspecified medical attention was sought. There was no product quality complaint. The reporter also identified 14 other patients. Additional information has been requested.
This spontaneous report was received from a physician via a consumer refers to 5 patients of unknown age and gender. Approximately on an unknown date in 2007 (reported as 7 years ago) the patients were vaccinated with ZOSTAVAX (strength, dose number, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. On an unknown date the patients developed shingles. The physician wanted to know if there should be a booster dose of ZOSTAVAX, given to the patients after a certain period of time. The outcome of shingles was unknown. The causality of the event was not provided. This case is linked to case # 1404USA004983 via the same reporter link. Additional information has been requested.
The night of the vaccine, 10/30/2021, I had severe back pain up and down my spine, starting at 8:00 PM. That night also started fatigue muscle pain, joint pain that never stopped. The following week, I  got a doctor's appointment. I went to the doctor crying about it because nothing was working. He prescribed Celebrex for the muscle pain. I only took one pill the day I got it and the next day and I did not take it after that. It did help with the joint pain. And tizanidine, I only took one night. The underlying fatigue, joint pain and muscle pain I just dealt with it until 11/23/2021 when the hives hit. I thought it was going to go away, full body hives. By Thursday night, I had a telehealth appointment. They prescribed prednisone, Zyrtec and on Friday. I had another telehealth appointment with my doctor. To continue the prednisone, continue the Zyrtec, and add Pepcid and get an allergy appointment. I had an allergy appointment on 12/06/2021. They told me to get off all the antihistamines prior to taking the allergy test. Now I am on Singulair, Allegra Zyrtec and Pepcid. When I don't have to take medication, then I will call that recovered from my adverse events. Diagnosis: Spontaneous idiopathic urticaria.
Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days before increased, Could hardly move, shortness of breath , had to stop constantly to get down the slopes to condo,  very weak, laid down on bed, had chills and sweats off and on, felt achy all over - could hardly move around - in other words had symptoms of Covid 19 slept overnight. The next morning was much better although still a bit tired.  It was very scary but I realized that it was a reaction to the vaccination.
Patient stated that she developed a fever, extreme back/arm pain, swelling in her arm and shoulder/back area, redness down arm and into the shoulder/back area, and vomiting.
Fever 01.6, dry cough, severe myalgia left axillae, left pectoralis, radiating into left neck.
Debilitating joint pain, joint aches, that began within one hour and a half after injection was given. Pain resulted in loss of sleep for several days. Self treatment with Tylenol accomplished no relief. Visited Urgent Care on 11/16 and was seen by Dr. Blood tests were done. The doctor prescribed 600 mg ibuprofen 3 x daily which resulted in some relief. Advised to follow up in two days with primary care doctor who diagnosed arthralgia, and unspecified anemia. Pain still exists at this date. Blood tests to follow to determine further treatment.
Influenza vaccine administered on 11/13/15. Guillain-Barre Syndrome began Dec. 1st 2015. Hospitalized x 2 12/6-12/8 and 12/10 - present.
Hands/fingers became swollen and itchy lead to bumps on my head and then hives all over my body