chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 08-MAR-2014 the patient was vaccinated with VARIVAX (dosing regimen unspecified). Other suspect therapies included on 08-MAR-2014 MMR II (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses of VARIVAX and MMR II on 08-MAR-2014, that were exposed to a supported temperature excursion. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
ANKYLOSING SPONDYLITIS FLARE UP; FLU LIKE SYMPTOMS FOR A COUPLE DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS FOR A COUPLE DAYS). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS FOR A COUPLE DAYS) outcome was unknown.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  Company comment: This spontaneous case concerns a 43-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis (AESI) an unknown time after the first, second and booster dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis (AESI) an unknown time after the first, second and booster dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
At 4:30 PM on 09/16/21 I began to feel short of breath and easily winded with some chest discomfort.  By about 5 PM I used my rescue inhaler.  Around 5:30 PM I called for a ride to the ER because chest pain was getting worse.  At the ER they ran a number of tests including blood work and EKGs.  Chest pain got worse while at the ER.  Fever spiked while in ER.  I was given Tylenol and ibuprofen.  Results came back from running blood work twice and there was no evidence of blood clot or heart attack.  EKG was performed twice and I was told it was normal.  I will follow up with my primary care provider on 09/20/21 for more information.  As of today (09/18/21), I continue to have some chest discomfort and tire extremely easily.  Breathing is still more labored also.
Shortness of breath, fever, chills, severe body aches, nausea, headache, weakness, fatigue.
About 12 hours after the vaccine, I experienced similar reactions as when I got my second covid vaccine. Headache and fatigue then upset stomach. Followed shortly by sever chills, fever and nausea. Then sever joint and bone pain. Was completely miserable overnight and then the following  day felt completely run down. The day after the vaccine I was very emotional and it seemed to be the reaction not any other reason.
no adverse effect; patient ws inadvertently administered a dose of PROQUAD that had been improperly stored; This spontaneous report was received from the vaccine coordinator and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On 24-SEP-2019, the patient was inadvertently vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030805, expiration date on 02-AUG-2020 (Strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent. No adverse effect reported.  The administered dose of vaccine experienced the temperature excursion of 27.1 degrees Fahrenheit 77 for 40 minutes. There was no previous temperature excursion reported. Data logger was involved.
Within four hours of getting the shot, I had a fever of 102, I was delirious, couldn?t walk straight, couldn?t think properly, and was having minor muscle convulsions.  Breathing became somewhat difficult. I became weak and my arm was extremely hot, swollen, red, and painful. This lasted through the night but was better when I woke up in the morning.  I did not report this to my doctor, as I did not see it as serious enough. It wasn?t until the horrific reaction to the second shot that I told my doctor and she said to report both shots to the CDC.
Tested positive for COVID-19 today; Tested positive for COVID-19 today; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An adult patient received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: EW0217) as dose 3 (booster), single, administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLOWMAX. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "Tested positive for COVID-19 today". The event "tested positive for covid-19 today" and "tested positive for covid-19 today" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: No other vaccine received in four weeks.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site lump. On 19th November 2018, the patient experienced fever. On 20th November 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site lump were unknown. It was unknown if the reporter considered the fever, pain in arm and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The reporter was a patient who received SHINGRIX and experienced low grade fever of 100.5 degrees F that resolved within 24 hours. The patient was experiencing sore arm and small knot at the injection site.
Patient came in with redness and soreness down her arm that was not near the injection site. It looked very similar to the reaction a different patient had with the same vaccine and lot number. It had been 2 days since administration and patient claimed she never had soreness like this following a vaccine.
Patient complained of burning, hot feeling running up his arm about 10 mins after receiving the IM vaccine. Also complained of  "plastic" smelling and taste in his mouth at the same time. Patient then complained left arm and hand were more swollen than right arm. (Difficult to tell because patient was "heavy set with large thick arms"). He stated no difficulty breathing. Offered him Benadryl 25mg and water, which he accepted. After 30 mins he said he felt better.
Kinrix given to 8 year old. With regard to the mistaken administration of the DTaP in a child older than age 6 years, the dose can be counted and does not need to be repeated with Td.
Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consumer, the patient.   A 77-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unknown route of administration on 09Mar2021 at 03:00 PM (at the age of 77-years) for COVID-19 immunisation. On 09Mar2021 at unknown time, the patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not provided) via an unknown route of administration for COVID-19 immunisation. Medical history includes osteoarthritis. The patient was allergic to darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient experienced nausea, severe fatigue, vertigo and sore arm on 09Mar2021 at 03:00 PM, which were intense for 24 hours then intermittent for 6 days. No therapeutic measures were taken as a result of these events. On an unknown date, the patient was recovered from the events nausea, severe fatigue, vertigo and sore arm. Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 67 years old female patient with hypothyroidism, high cholesterol and Gastrooesophageal reflux disease (GERD) and no drug reactions/allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # reported as "H009779", exp date: 27-MAR-2013) on 05-AUG-2012. No other co-suspects were reported. Concomitant medications included SYNTHROID, ZOCOR, PRILOSEC and omega-3 marine triglycerides ("fish oil"). On 05-AUG-2012 ("later that evening") the patient developed a red, hot area at the site of injection that was 3 inches in diameter. The patient came into pharmacy for medical attention. No treatment information was given for the events. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. Additional information is not expected.
Hallucinations; Feeling I was about to die; Felt my vision closing in; Paralyzed; My brain couldn't follow the tv program; Couldn't remember how to do simple tasks; An electric vibration sensation; Distinct tastes and smells; Distinct tastes and smells; Couldn't breathe; Couldn't speak or communicate; Confused; electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:00 (Batch/Lot Number: EN6203) as dose 2, single (at the age of 76 years) for covid-19 immunization. The patient's medical history included hypertension and chronic obstructive pulmonary disease (COPD) on an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of COMIRNATY on 02Feb2021 at 09:00AM in the right arm (lot:EL9265) at the age of 76 years for Covid-19 immunisation. On 23Feb2021 18:00, the patient experienced hallucinations, feeling I was about to die, felt my vision closing in, paralyzed, my brain couldn't follow the tv program, couldn't remember how to do simple tasks, an electric vibration sensation, electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder, distinct tastes and smells, couldn't breathe, couldn't speak or communicate, and confused. The events were further reported as, around 6 pm the evening of the second dose the first event happened, followed by three more the next day. Patient's brain couldn't follow the tv program. He couldn't remember how to do simple tasks. He was having hallucinations, and couldn't distinguish between them and reality. The next day he had three or four experiences of an electric vibration sensation traveling up his left leg, into his arm, then the entering left side of his brain and through it to the right, then seemed to dissipate into his right shoulder. During that time he experienced several distinct tastes and smells all at once, and had the feeling he was about to die. He couldn't breathe, felt his vision closing in, and was completely paralyzed. He couldn't speak or communicate and was confused all day. Two weeks later, he thought it was going to happen again, and had to sit down suddenly. After this, He saw his doctor and they did scans and couldn't find anything. Patient was put on blood thinners. The patient underwent lab tests and procedures which included brain scan and sonogram in Feb2021 with unknown results. The outcome for all the events was recovered with sequelae in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
6days p/vax pt devel fever. 23oct pt began to breakout w/few pustules vesicles on face. pt also exp loss of appetite, irritability, & lethargy. MD dx pt w/varicella
swelling w/itching @ vax site; started w/welts all over body, general malaise & a fluttering sensation in chest; MD says serum sickness;
PATIENT FEEL SHAKING AND PASSED OUT FOR FEW SECONDS,   FACE AND LIPS GOR PALE. CAME BACK NORMAL AFTER HAVING SOME WATER. CALLED 911 AND EMR SERVICE CAME IN 4 MINS ,WHO CHECKED HIM, FOUND ALL PULSE , BLOOD PRESSURE NORMAL ON ARRIVAL. HE WAS FEELING OKAY BY THEN AND REFUSED TREATMENT FURTHER AND REFUSED TO GO HOSPITAL
pt recv vax 10FEB97 & w/in 1 wk pt exp muscle aches & scratchy throat;sx resolved w/o any prescription meds;
45 Min after shot given Covid Arm Developed 12 -13 Hours after Numbness developed in both arms and hands 17 hours after Joint swelling occurred ( Hands, Knee's )
Patient is a 56 y.o. male patient of DO with history of alcoholic liver cirrhosis, alcohol withdrawal, gastric varices status post banding, iron deficiency anemia, presented on 1/15/2023 with weakness, lightheadedness, fever/chills was admitted to the ICU for septic shock on 1/16/2023 initially requiring pressors. HMS consulted by MD  for transfer of care from ICU to intermediate unit. IR re-consulted for paracentesis today; had 8750 cc of fluid drained. 75g of albumin infusion given   Discharge Diagnoses: Sepsis due to R LE cellulitis Unclear etiology, likely septic shock from RLE cellulitis Or suspected hepatorenal syndrome/COVID infection VSS, BP improved, AF, on 2L NC. AAOX3 Required levophed on adm 1/16, quickly taken off On Midodrine 15 mg TID and octreotide 100 mcg TID VIR c/s for paracentesis 1/17 and removal of 9 liters, no SBP. 100g of albumin given Had repeat paracentesis today with removal of 8750L; 75g of albumin infusion given ID on board; received IV Ancef and completed 7 days of therapy  AKI-improved Adm Cr: 1.4>1.2.GFR:58>70.(Baseline Cr: 0.7-0.9, GFR: >90) Probable cause(s): suspected hepatorenal syndrome/sepsis Avoid nephrotoxic agents including NSAIDs Lasix and aldactone restarted 01/20 Nephrology on board; recommendation appreciated   Covid-19 Virus Infection Date of onset of symptoms: on adm (1/16) Symptoms present on admission:  cough and generalized fatigue on adm (1/16) Date of covid positive test: 1/15/23 Vaccination status: vaccinated Imaging: CXR (1/15/23) Moderate-sized right-sided pleural effusion appears increased.  Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: Dexamethasone and remdesivir started due to hypoxia, which has resolved Consultants following: N/A Anticipated special isolation end date: 1/25/23 ID on board, complete 10 days of Dexa. Remdesivir completed   Alcoholic Liver cirrhosis w/ ascites  Alcohol abuse MELD NA 21 on 1/17/23 Seen by Hepatology 10/14/22 --rec torsemide 20 mg TID.  Noncompliant, patient continues to use alcohol on a weekly basis Overdue for Surveillance EGD (last EGD: 5/2021 S/P banding) Diagnostic paracentesis 1/15/23 (-) SBP or culture growth Therapeutic paracentesis 1/17/23 S/P 9L and 1/23/23 8750L removed.  Albumin given after each session as described above Counseled to quit ETOH use; Lim it acetaminophen < 2 g daily F/u RUQ US w/ dopplers-Cirrhotic liver morphology no masses, Splenomegaly. AFP at 1.3 GI consulted, cont midodrine, 2gm diet Follow up GI as OP
soreness of arm; headache; steroid pills for 7 days due to infection; This is a spontaneous report received from a female consumer (patient), reported for herself.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. on an unspecified date Patient called to request for cancellation of the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE schedule on 03/18/21 She received the 1st dose last 02/28/21 and had minor side effects like soreness of arm and headache. She was not sure if she has reported this to DSU but she was able to speak with 2 different people with Pfizer Due to long wait, she requested for callback from us and called the pharmacy to cancel the appointment She was advised by the pharmacist to cancel the 2nd dose appointment as she will have steroid pills for 7 days due to infection and wait until the steroid medication is done 2nd dose will be scheduled within 42 days after the 1st dose. Therapeutic measures were taken as a result of steroid pills for 7 days due to infection (infection). Outcome of event infection was unknown, for the events   pain in extremity, headache was recovered on unspecified date.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Redness and warmth at the site of vaccine, swollen left axillary lymph node.
Developed rash on face, chest, arms, back and tongue approx 10 days post small pox vaccination.  Rash is erythematous, maculopapular and nonitchy.  Slight headache also.
softball size swelling, redness,  tenderness to right arm.   The swelling occurred  1 week after my injection.
approx. 20 minutes after injection experienced episode of dizziness. 14 hours after injection woke up at 4:00am with severe headache, body aches, chills, low grade fever 100.4, nausea and vomiting. Took Tylenol every 8 hrs. Symptoms subsided after 18 hours.
Received flu vaccine 10:30am noticed itching 10 mins after then hot and aching after 30 minutes. Returned to health dept 11:15am referred to MD.
ENTIRE UPPER LIP STARTED TO SWELL AND FEEL NUMB, AND LOWER LIP SLIGHTLY SWELLED IN CENTER OF LOWER LIP AND FELT NUMB
pt recvd flu vax & devel a baseball sized welt @ the site of inject; redness was followed by pruritus; reaction  persisted 4-5 days;
Patient husband is reporting that the patient has red, blotchy, spots all over her left arm.
At her visit on 2/10/21 she was found to have a left supraclavicular lymph node that was swollen. She received her first Moderna injection on 2/5. She has not called VAERS. 2/15/21 Since then she developed pain, redness, and swelling to the left arm at the injection site. She reports she has a history of delayed responses (ex. bee-stings). The pain in her arm causes her to have pain at night. She has tried to ice the area without relief from pain. Pain radiates from left deltoid to neck
On 12/21/2022, I had a mild case of chest pain which I thought was just gas. I took TUMS and PEPCID and it subsided within the hour. I didn't have the chest pain again until 12/28/2022 and that occurred in the evening. The same thing happened but the pain persisted. When I took a deep breath, it was very painful. Thursday, I was fine, then Friday it happened again and the chest pain was radiating to my right shoulder. I thought something more was going on, so on the 12/31/2022 I went to the urgent care. I went first thing in the morning and the doctor there ran some tests. The D-dimer indicated some blood clot activity. He immediately put me on XARELTO twice a day. He did a chest x-ray but was unable to do a CT scan. They did the CT scan with contrast on 01/03/2023 and that test came back that I had blood clots in both lungs. They continued me XARELTO 15 mg in the morning and evening. I was scheduled to see my PCP the following week for follow up. On Saturday 01/07/2023, I had the chest pains again and went back to the ER. They did more blood tests to see if there was a heart attack and they also did an x-ray. They noted it was a little bit of pleurisy because of the blood clots. They kept me on the blood thinner. The physician thought maybe this could have been due to recent travel. I saw my PCP and she has now ordered an ultrasound of both legs and I have that on 02/20/2023. I've continued on XARELTO. I started 15 mg in the morning and evening for the first 21 days. Now I've gone down to 20mg per day.
Fast heart rate; rash/ redness - chest, neck, face; feeling hot; feeling dizzy; feeling lump in throat; feeling stomach nausea
After 24 hours, developed fever 101.5 and bulging fontanelle. Seen at ER. Seen in my office about 72 hours later and found to be completely recovered.
Flu shot 10/28/11 - Several days later pain in shoulder at shot site. Pain radiated to her fingers & also caused swelling of the elbow, developed arm & hand weakness. Symptoms slowly improving 1 month later.
Chills, fever 102.4, metal taste in mouth, horrible headache, joint ache, L arm very sore.