chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash developed at injection site; rash developed at the injection site and on the back of her legs/ rash was only on left side of her body; the PREDNISONE may have caused this reaction, since she had to take it so shortly after the ZOSTAVAX vaccination; hard, warm tender knot at the injection site; hard, warm tender knot at the injection site; hard, warm tender knot at the injection site; arm was tender; back pain; measles like rash; red mark on arm with injection; This spontaneous report as received from a consumer refers to a 67 year old female patient. There were no drug reactions/ allergies. Concomitant therapies included budesonide, formoterol fumarate (SYMBICORT).  On 19-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose and lot # unspecified) in the left arm to prevent shingles.  On 20-JUL-2014, about 24 hours after vaccination, the patient experienced hard, warm tender knot at the injection site. She stated that her arm was tender for about 2 weeks. On 28-JUL-2014, patient had to have a computed tomography (CAT) scan. On approximately 25-JUL-2014 (also reported as 3 days prior to CAT scan), she had to take prednisone. On 04-AUG-2014, the patient experienced rash developed at injection site and on the back of her legs. Rash was only on left side of her body. On an date in 2014, patient had back pain as well. The patient was concerned that prednisone could have caused this reaction, since she had to take this so shortly after zoster vaccine live (ZOSTAVAX) vaccination. No lab diagnostics were performed.   The outcome of events was unknown. The patient did not receive any treatment for the events. The patient did not seek medical attention. Product quality complaint was not involved. The reporter considered hard, warm tender knot at the injection site, arm was tender to be not related to prednisone. Causality of hard, warm tender knot at the injection site, arm was tender, rash developed at injection site and on the back of her legs with zoster vaccine live (ZOSTAVAX) was unknown.     Follow-up information was received on 20-OCT-2014 from the physician, refers to the male patient with allergy to ciprofloxacine (reported as Cipro) and contrast dye. The patient was seen by the physician on 11-AUG-2014 with healed punctate papula over left arm and left leg.  Follow-up information was received from currently the 74 years old female patient, via Pfizer, on 09-APR-2021. The patient reported that 24-FEB-2021 at 09:15, she received the first dose of coronavirus (COVID-19) vaccine (lot # EN6203) in the left arm; and on 20-MAR-2021 at 09:00, she received the second dose of that vaccine. She reported that she experienced a red mark on the arm with the first dose and measles like rash primary on arms and legs from the second injection. However, she reported that she experienced this similar reaction when she was vaccinated with zoster vaccine live (ZOSTAVAX) on 19-JUL-2014, that lasted over 44 days.  The causal assessment between the events and zoster vaccine live (ZOSTAVAX) was not provided.
This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL lot # L033347 and expiry date: 23-JUL-2017 (dose and route were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
6 hrs p/DTP/OPV/HIB pt appeared pale for 15 minutes responsive; Incident occurred rt p/a crying spell which lasted 5-10 minutes;
Tachycardia (HR of up to 135), High Blood pressure (up to 154/90), Chills/shivers.  Was monitored for a couple hours.  I was discharged a few hours later.
The first day had narcolepsy symptoms  would fall a sleep immediately,  lasted for week , random rashes and head aches was migraines, bad rash. Went to the hospital due to migraines.
dull headache after an hour, lasted 36 hours.  Body aches, chills, started 2/2/21 around 3 pm, still experiencing those
Reaction to pneumococcal shot (L) arm IM on 11-10-08.
Information has been received from a consumer concerning her 20 month old son who was vaccinated with MMR II. Secondary suspected vaccine included PNEUMOVAX 23 (manufacturer not reported). After receiving MMR II, the patient became quieter. After receiving PNEUMOVAX 23 (manufacturer unknown), the patient developed full blown autism. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Rash at injection site, red rash covering upper arm and had severe fatigue with some joint pain
There was an administration error today (8/11) .  Individual is under 18 years old.
Initial unsolicited report received from a consumer via other company (Pfizer) on 6 November 2015. Manufacturer reference number: 2015378589. This case is linked with case number 2015SA180840 (same reporter, different patients). This case involve a male (age not reported) patient who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, four days following the vaccination, the patient developed Flu. On an unspecified date, following the vaccination the patient also developed bacterial pneumonia. On 18 December 2014, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. List of documents held by sender: none.
I contacted  Covid 19 November 12 and a week later I was admitted to the hospital with acute lung failure. I was in the hospital for a week and was given antibiotic ,steroids' and plasma transfusion and on supplement oxygen. My Dr. at the time Dr. advised/scared me  to get the shot at 3 months out. After both shots. I got deathly sick and was in the bed for a week with both. I had a fever with both shots, nausea, joint pain, neuropathy  pain, burning all over my body and migraines. Now I have burning and pins and needles  all over my body, Heart racing, chest pains, fatigue, joint pain, nausea and what feels like inflammtion all over my body.
patient tested + for covid 1/30/22 and also 2-12-22 .  I have no other information except date of death as 3/20/22
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2021 as dose 3 (booster), single (Lot number: 301308A), in left arm, on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm and on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (09Jan2023) Negative; (13Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was administrated from 31Dec2022 to 05Jan2023 for treatment of COVID-19 via oral. The symptomatic with Covid symptoms occurred again on 09Jan2023 and tested negative, then tested positive for Covid on 13Jan2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5, and the reported events covid 19, vaccination failure cannot be excluded.
Patient's wife said that the patient's arm is still swollen and warm to the touch after 5 days.
Diagnosed with varicella, recevied Varivax 04/12/1996
Narrative: COVID infection following COVID vaccine series 01/04, Pfizer, dose #1 01/25, Pfizer, dose #2 07/03 pt cc: fatigue, loss of taste or smell, weight loss, no appetite, exposure: unknown 07/04 -08/12 pt symptoms continue 07/15 admit to ED (non Facility) LOS: 1 day 07/15 COVID swab, result; detected (non-Facility) 07/27 went to Walk in Clinic (non-Facility) 07/27 COVID swab, result: not detected (non-Facility) 08/12 COVID swab, result: detected
cellulitis; wrong route of; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a male patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, 2 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and intramuscular formulation administered by other route. The patient was treated with ibuprofen (Motrin) and antibiotics nos. On an unknown date, the outcome of the cellulitis was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a potential cellulitis after receiving Shingrix. The patient received Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient was treated with ice and Motrin, might have also received antibiotics (reporter was unsure).
I informed the person the injection was not given in the muscle. As soon as injected I felt as the medication was in the surrounding soft tissue, My arm was limp and swollen. I thought it would get better. However, I feel lumps/clots that extend down the left arm. The arm is weak and limp when picking up items. Pressing the lumps/clots is painful.
On January 22nd 2022. I started getting pretty bad nausea. I took Dramamine and tums thinking I had bad acid reflux. As the days went on my nausea became worse and it became clear something was very wrong. On January 26, 2022 my nausea and dizziness became worse and I felt overwhelmed. The ER at local Hospital ran a blood test and urine test and both came back normal. The doctor said it may be a reaction from the vaccine but was unsure and informed me to follow up with a primary doctor. I was given a prescription of Ondansetron 8mg. With this medication I was able to function again and I felt normal. When the medication wore off the extreme nausea would come back and it's very debilitating. I almost went back to the emergency room twice after that. Today January 28th at 9am I spoke to a doctor from local Primary medial care over a zoom appointment. He asked me several questions and concluded this was most likely because of Covid. He went on to say people who recovered from Covid experienced stomach issues and nausea/ vomiting. He believes the booster shot may have caused my body to think it was re-infected with Covid because of the booster. He said I received the booster shot too early and that I should have waited a month after my Covid symptoms went away before getting a booster shot. He gave me a prescription for more Ondansetron 8mg, 3 times a day every 8 hours. He said to continue the Prilosec and will check on me in 3 weeks. As of right now I cannot function without the Ondansetron. Without this medication I would not be able to eat or attend work.
At 2300 - Dyspnea, chest pain, cough, left arm pain, temperature of 99 degrees F, collapsed at home, ambulance called
red, swollen, pain-shoulder to elbow starting approx 5 hrs p/vax; sx totally resolved w/in 48 hrs; no treatment necessary;
Since I was injected with the vaccine I have had problems with my heart, my kidneys -Where I have been missing work to be seen by a cardiologist and nephrologist.
I was diagnosed with shingles on my left thigh and across my left buttocks two weeks after dose one of the COVID-19 (Moderna) vaccine.  Itching, redness/bruising, burning skin, scaly bumps and marks, feeling of worms crawling underneath my skin, feeling of needles constantly sticking into my skin.  Unable to work, unable to sleep, unable to wear clothing, walked with a cane for a full week and was pushed in a wheelchair to my doctor's appointment.  Medications - lidocaine ointment, prednisone (5mg tablet), valacyclovir (HCL 1 gram tablet), gabapentin (300 mg capsules).  To date (as of 4/22/21) as I complete this report, I still have shocking sensations of pain running up and down my legs and scaly and crusty skin that has not healed from my shingles.
Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;) in a 55-year-old male patient who received Moderna COVID-19 Vaccine (batch nos. 037C21A, 024C21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety since 11-Jan-2018, GERD since 10-Nov-2017, Hypertension since 10-Nov-2017, Hyperlipidemia since 10-Nov-2017 and Myocardial infarction (myocardial infarction/CABGx2) since 11-Aug-2018. Concomitant products included ATORVASTATIN and FENOFIBRATE for Cholesterol, LOSARTAN and METOPROLOL SUCCINATE for Hypertension, ACETYLSALICYLIC ACID (ASPIRIN 81) for Myocardial infarction.   On 01-Apr-2021, the patient received first dose of Moderna COVID-19 Vaccine (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of Moderna COVID-19 Vaccine (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021 at 12:30 PM, received third dose of Moderna COVID-19 Vaccine (unknown route) dosage was changed to .25 milliliter. On 15-Nov-2021,  after starting Moderna COVID-19 Vaccine, the patient experienced PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;). On 15-Nov-2021, PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;) had resolved. Not Provided      For Moderna COVID-19 Vaccine (Intramuscular), the reporter did not provide any causality assessments.   COVID-19 vaccine - body site- Deltoid  No treatment medications were provided.  The booster dose vial should be used beyond 02-Dec-2022. The vial was stored in the refrigerator between two to eight degree Celsius. The patient reported no symptoms following the booster dose.   This case was linked to MOD-2021-387978 (Patient Link).
The evening of the shot and the next day, had myalgias and fatigue for 24 hours 5 days after the shot, had 1 week h/o of large hive like swelling near the vaccine site on my left arm 7 days after the shot, broke out in a find sandpaper like rash over my entire body but sparing my face.
Presented to hospital on 3/15 with c/o increasing shortness of breath and productive cough with O2 sat at 96% on RA. Had been feeling unwell x 2 weeks with nausea, vomiting, diarrhea and decreased PO intake. Admitted for Covid-19 pneumonia and COPD exacerbation. Started on dexamtheasone adn enoxaparin with elevated D-dimer. Began reuiring oxygen supplement and started on remdesevir, doxycycline and azxithromycin. Noted areas on chest swelling and ultrasound revealed a low denisty mass in the left axilliary chest wall region which could be hematoma versus abcess. On 3/23 noted patient had enlarged pupils and more lethargic. Code stroke caleed. Developed severe repsiratory distress and intubated. Stat heart echo showed normal fucntion. CTA thorax abdomen, pelvis showed hematoma without active extravasation. Requored some pressor's which improved some what with transfusion.  However, again needed escalation in pressor requirement with worsening reanl function and acidosis. Nephrology consutled for CRRT.  Labs showed evidence of DIC and C. difficile positive. Excelated to 4 pressors and broad-spectrum antibiotics and fidaxomicin for C. dificile. Continued with severe hypotension temporarily improved with bicarb pushes. Mutiple discussion with gamily and patient of critical illnes and decline. Decided on comfort care
Out of the three vaccinations I received that day this one hurt when injected and by the time I arrived home my arm was swollen, tender and red from my shoulder to halfway down my arm.  Each time I turned on the arm while sleeping for several nights the pain awakened me.  For about four days I had no energy or appetite.  After a routine class working with swords my arm started having shooting pain when I moved in certain ways.  I applied Cortisone cream for the itching and also took prescriptive Hydroxyzine and for pain I took Acetaminophen.  When symptoms lasted a week, I went back to talk with the pharmacist, and she recommended that I file this report.  Now, nine days out the symptoms are finally fading.
got the shingles 3 days later; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and got the shingles 3 days later. The patient would not get the Covid vaccine. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR202770, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202770:Same reporter
pt recvd vax; 29nov95 devel rash of 60 lesions & fever, & slept all day;
25 Y/O MALE WITH C/O LYMPH NODE ENLARGEMENT AND PAIN POST ANTHRAX INJECTION X 4 DAYS.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 17 months old infant patient of unknown gender. On 16-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
About 48 hours after receiving the vaccine, patient reported arm tingling (pins and needles), shoulder pain, and discomfort.  A muscle relaxer helped with the discomfort for about an hour, but nothing else seems to help.  It is now 24 days later and he reports his should feels much worse, "like it is about to explode".  He went to the ER last night and they ruled out infection.  The shoulder pain wakes him up at night.
My adverse reaction started on April 16 with an intense headache in the front of my head. I went to my doctors office and they sent me to the ER where gave me a shot, sent me home which knocked me out and I slept for two days. I was tested for Covid 19 at the ER and it was negative. Recently I was in the hospital (May 23 - May 26) for my blood pressure dropping to 90/60. I had been in contact with someone who was Covid 19 positive and they thought I had Covid but I was negative. Also on 04/13/22 I received the Hepatitis A and B vaccine. I tested positive for Covid 19 on 01/20/21 and was hospitalized for 10 days.
Information has been received from a licensed practical nurse (L.P.N.) concerning an a 24 year old female who on 03-AUG-2010 was vaccinated with 0.5 ml a dose of VARIVAX (Merck) (lot # 667291/0753Z, dose and route of injection unspecified, expiration date: 20-MAY-2012). The reported stated that approximately "8-10" days later (approximately on 11-AUG-2010) the patient developed small lesions on the upper trunk and face, and had a "fever". Patient was initially given antibiotics for a diagnosis of folliculitis. The physician made a diagnosis of chicken pox. At the time of reporting, the patient recovered from chicken pox in August 2010. Additional information is not expected.
patient's spouse reported that patient was acting confused on 4/20, states usually happens when she gets a UTI, CT chest/abdomen/pelvis concerning for urinary tract infection, patient admitted and currently admitted at the time of this report
back pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Mother) that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation and acetylsalicylic acid (BABY ASPIRIN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) daily (Everyday) for blood pressure abnormal. Medical history included drug hypersensitivity (allergic to penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced back pain. The patient has back pain which she said was unrelated to the vaccine. The reporter wanted to know if it was safe for the patient to take painkillers like Aspirin. The patient also takes a baby aspirin everyday for her BP. Someone told the patient not to take this medicine. The reporter wanted to know if it is okay to take it. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: The causal association between the event  back pain and the suspect vaccine is assessed as related . The case will be reassessed once new information is available.
Patient was given 0.5 ml of vaccine. She took the vaccine well but 10 seconds later patient complained that she did not feel well. She then lost consciousness and fell right of the chair. She awoke 30 seconds later with no memory of the event.
Skin lesion for 5 days on right face near nasolabia fold; pustule. Itching -2mm pustule with minimal amount of erythematous base.