chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse gave serum that had expired its 6hr since puncture time.  Time and Date were on the dose.  Education has been provided to nurse to pay attention to detail.  Patient will be called and scheduled to come in for another dose.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) had not resolved.      No concomitant medication details were provided. No treatment medication details were provided.  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.
adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Patient's daughter called and stated patient developed chills and vomiting after receiving 3 vaccinations. 104 degree fever. Came down with bronchitis.
MMR administered on 12/11/12. Following day seen in the office with temp of 100.8 and red cheeks. Rechecked 12/18/12; sx improved. 10 days after vaccine pt went to ER due to rash for 24 hrs. ER notes state patient left ER Against Medical Advice w/o notifying anyone.
First vaccine: sick with fever and body aches for 4 days, 2nd vaccin: sick with fever and extremely painful muscle cramps for 5 days and clogged ears there after which lead to sudden hearing loss in left ear one morning on waking up. Then Developed Tinnitus and Hyperacusis in same ear. These symptoms lead to chronic daily migraines, light orbs in both eyes, eye floaters in both eyes, and inability to read & write as well as  sensitivity to light.  Hospitalized for Hyponatremia
Patient fainted after administration of his vaccine.   It was only a few seconds and when he opened his eyes he stated he usually only faints after giving blood.   We held him the full 30 minutes for observation and he did not experience any other adverse reaction
Developed shingles of the RLE 2 weeks after receiving the 1st vaccine.   Developed PAC?s 1/6/21. Then later was diagnosed with atrial fibrillation 5/18/21. Saw Cardiologist.
throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.
A 58 year old male patient (RK) experienced inadequate antibody levels after prophylactic treatment with RabAvert. The patient received RabAvert on 10/03/2002, 10/10/2002, followed by a third injection 2 to 3 weeks later. On 05/01/2004, enzyme-linked immunosorbent (ELISA) testing was performed and showed inadequate antibody levels. On 06/15/2004 rapid fluorescent focus inhibition test (RFFIT) was performed and showed below acceptable levels. A booster shot was suggested due to the low post vaccination titers. The reporter stated that a booster would be obtained and follow up titers reported. Follow-up information received on 07/22/2004: The correct lot number for the RavAvert is #309011, expiration date 10/2005. The RFFIT result for this patient was 0.21U/ml. Follow-up information received 08/04/2004: The RFFIT test result was converted to dilution to compare to the CDC Advisory Committee on immunization Practices recommendation of an adequate rabies virus neutralizing antibody titer (greater or equal to a serum dilution of 1:5 resulting in complete neutralization of rabies virus in RFFIT). The first RFFIT neutralizing antibody dilution results were less than or equal to 1:11. The sample was retested to refine the values at the lower cut off. On 07/06/2004 the results of the RFFIT retesting was reported as less than or equal to 0.1 IU/ml or less then or equal to 1:5 dilution. According to the CDC Advisory Committee on Immunization Practices recommendations, the patient needed a booster dose of vaccine.
pain at time of injection, woke at 2:30am with pain/soreness surrounding injection site, followed over the next few hours with chills, low fever, headache, malaise, redness extended 2" from injection site still present 48 hours post injection
pt recv vax & 2 days p/vax pt exp an asthma attack & was treated w/pred for 5 days;an antibody titer 2wk p/vax was negative;no further details were provided;
Patient vaccinated at 0910, reported "feeling lightheaded and dizzy" around 0940. This RN assessed patient and took VS (O2sat: 100%, BP: 120/74 (RUA), RR: 16, HR: 67 bpm). Patient remained seated and was provided with water. Patient states she had not drank water at all this morning. Patient reported feeling better with no further adverse reactions and left observation room at 0949.
Rash, itching, swelling at injection site, general malaise, trouble breathing, fatigue
Pt had shortness of breath, and tightness in the chest that was unresponsive to their use of an albuterol inhaler (pt reported the inhaler was expired). The pt then went to the ER where they were given prednisone before being discharged.
Left arm joint pain 4 hours after shot. Chills. Nausea. Muscle aches. Headache. Fatigue. Stomach ache. Remaining started that night continuing now.
PAIN IN THE THIGHS BOTH SIDES; PAIN IN THE ARM AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced pain in the arm at the site of injection. On 13-JUN-2021, the subject experienced pain in the thighs both sides. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the arm at the site of injection on 13-JUN-2021, and had not recovered from pain in the thighs both sides. This report was non-serious.
several hours after the pt received the vaccine, he woke up from a nap, cried vigorously while in his mother's arms and then turned teal blue, as described by the mother, and limp. his parents called 911 for the paramedics and stimulated him so that when the paramedics arrived he was no longer dusky looking. he was brought to er where he had an ekg and a cxr done, both of which were normal. he was transferred to hospital on october 30, where he is presently admitted. in the er he had anisecoria and an intermittent murmur on exam, the rest of the exam was normal. The hospital discharge summary received on 1/16/04 confirms diagnosis of anisocoria. It also mentions ALTE (acute life-threatening event) due to DTaP.
1/20 1:30pm: 2nd dose Moderna vaccine received  1/20 9:00pm: fatigue, malaise, chills, headache, body aches 1/20 10:00pm: brief 5 second hallucination upon waking up from sleep 1/21 3:30am: recommended dosage of Dayquil taken (this was the only time medication was taken) 1/21 5:30am: fainted and blacked out for 5-10 seconds after standing for 5-10 minutes (face flushed and started twitching, felt nauseous, managed to sit down on the ground first before blacking out.)  1/21 5:35am: stood back up, fainted and blacked out again for 5-10 seconds (was able to sit down again before blacking out. After regaining vision: started sweating, lips and hands were tingling, and vision was blurry.) 1/21 3:00pm: symptoms subsided and no additional fainting or blacking out occurred  Patient has never experienced adverse side effects to vaccines (including common vaccines as well as travel vaccines such as yellow fever, typhoid, first dose of COVID-19 vaccine, etc.) - only chills for 1 hour after an influenza vaccine one time.  Patient has no medical history of blacking out or fainting, even when taking Dayquil in the past.
ANXIETY; nausea; vomiting; STAGE 4 LIVER DISEASE; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (STAGE 4 LIVER DISEASE), ANXIETY (ANXIETY), NAUSEA (nausea) and VOMITING (vomiting) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIVER DISORDER (STAGE 4 LIVER DISEASE). On an unknown date, the patient experienced ANXIETY (ANXIETY), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with DULOXETINE for Anxiety, at a dose of 30 milligram twice a day. At the time of the report, LIVER DISORDER (STAGE 4 LIVER DISEASE) and ANXIETY (ANXIETY) outcome was unknown and NAUSEA (nausea) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: Possible stage 4 liver disease.         The patient had a possible stage 4 liver disease as revealed in a recent blood work. He had sore arm after first covid-19 vaccine and for the second had nausea and vomiting, then it went away like four hours.   The reporter's causality for the events of stage 4 liver disease, nausea after covid-19 vaccine and vomiting after covid-19 vaccine was not provided. The reporter's causality for the event of anxiety with skyrizi(risankizumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Moderna.  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.   This case was linked to MOD-2021-623082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow-up received included narrative updated.
approx 30min p/vax pt became nauseated, weak & sweaty;pale, weak pulses, bradycardia, irregular pulse, difficult to arouse w/weak verbal efforts;slow to respond to trendelenburg position;circumoral cyanosis prominent;
Patient experienced shortness of breath an hour after injection was administered on 3/15/2019.  She took a Benadryl and did not seek medical attention at the time of event.  We did not learn of her reaction until following up for Shingrix booster on 6/4/2019, and deferred to her physician on whether to proceed with booster.  She was told not to get the booster by her physician on 6/19/2019.
Patient given vaccination in left arm where she previously had a partial breast removed. Patient did not tell vaccinator not to administer in that arm. Patient still experiencing pain in vaccination arm.
Body aches, fever, diarrhea, chills? 4 days later broke out in sever hives!
Quite Severe:body aches, chills, fever, horrific headache, body aches, fatigue, nausea, vomiting profusely, arm pain in vaccinated arm. Some confusion and dizziness.
chest pain & chills.  PT presents with midsternal CP described as tightness with SOB and cough since this afternoon, reports receiving covid vaccine yesterday.  Patient is a 23 year old male who presents to ED with chills, body aches, dry cough after receiving the J&J COVID vaccine yesterday at 10:30am. No fever, no chest pain at this time. Denies significant PMH.
My documentation indicates that this 13 year old boy got Moderna vaccine dose #1 (0.5 ml, lot # 005C21A, left arm, intramuscular injection) as part of a drive-through mobile vaccine event.  Given I know well that children are able to receive only the Pfizer vaccine, I believe it likely that he received the Pfizer vaccine and that somehow my error was a mix-up in the documentation (perhaps an adult in the same car received Moderna and I mixed up the consents).
Vaccine given to a 16 year old. Discovered on 4/16/21 when child came back for the 2nd dose.
tenderness @ site w/swelling for 1st 3 days then swelling resolved but inc soreness extending down arm to elbow & up into shoulder;has cont since inj;pt will be treated for pain to f/u w/MD;
This case was reported by a pharmacist via call center representative and described the occurrence of rash aggravated in a 73-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Concurrent medical conditions included rash and shingles. On 4th December 2018, the patient received SHINGRIX. On 5th December 2018, 1 days after receiving SHINGRIX, the patient experienced rash aggravated, blister and spot pigmented. On an unknown date, the outcome of the rash aggravated and blister were not recovered/not resolved and the outcome of the spot pigmented was unknown. It was unknown if the reporter considered the rash aggravated, blister and spot pigmented to be related to SHINGRIX. Additional details were reported as follows: The patient had the rash before the SHINGRIX, but the rash got worse the day after receiving the vaccine and the patient was diagnosed with shingles by his doctor. The blisters looked like they had little black spots at the top, like the blood was not circulating. The reporter consented to follow up.
10/10/11 To Occup Health with hx receiving flu vaccine on 10/6/11 and immediately had pain in elbow and down to palm (rt. side). Developed cherry red at site - started taking BENADRYL 2 tablespoon on Sunday x2 and again Mom used cortisone cream. Area of redness today measures 90mm wide and is pale pink in appearance. Denied pain.
Received VARIVAX on 11-9-10, on 11-16-10 pt presented with vesicular rash on extremities, trunk, face & scalp. Some vesicles were large with erythematous base - 15 days later, sibling with similar rash.
Redness  Soreness Headache  Fever Chills Tired Aches
COVID-19 TEST POSITIVE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 06-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Within 30 minutes to about 1 hour after receiving the vaccine, I mentioned to my boyfriend that it was so strange that I was having trouble breathing, I wasn't aware that this was a known reaction. When I come in contact with gluten from cross-contamination I take Benadryl, as the breathing was becoming labored, my stomach became distended and my fingers became swollen. As soon as my fingers started swelling up I took 2 servings of Benadryl and within 30 minutes my breathing was improving and my joints had marked improvement from pain within 3 days. I continued taking Benadryl for the next three days. I basically feel like the vaccine put me into a flare, which I had been concerned about as my joints do swell up from time to time. The lack of breathing was scary, it felt like being at 10,000 ft in altitude without adjusting. I was also light headed and confused and tired for those three days but only had expected pain at the injection site. I am still feeling a little confusion which is typical for me in a flare up, so I'm hoping that goes away soon.
pt recv vax 1030AM has been crying high pitch loud not usual cry since then;it is 2PM when mom called;
Rash on both elbows, both knees, top of hand and itchy, rash on left shoulder.
low grade fever (99) 4-5cm induration w/large area of erythema extending from deltoid to elbow, painful treated w/APAP
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 16-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
A company representative reported that a pt received Prevnar and subsequently, developed a red spot at the injection site. The pt recovered. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
Pt went to ER on morning of 8/29/2021 with chest pain and diagnosed with ST elevation myocardial infarction
Pt has swelling, slight warm to the touch, 5 cm by 10 cm, painful when touched. Pt received MMR and varicella vaccines 7/30 2014.
Perioral & labial rash, irritability, malaise, decreased appetite, blisters on feet, mild diffused rash on legs.
received first dose April 6th and tested positive for Covid-19.; This is a spontaneous report from a Pfizer sponsored program COVAX US support via contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 06Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's first vaccination was on 06Apr2021 and immediately on the same day, the patient was tested positive for COVID-19. She was supposed to receive second dose on 04May2021 however she was required to quarantine tile 03May2021. She wanted to know if she should still receive the vaccine or what was the protocol for testing positive after receiving the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient returned to Pharmacy 10/26/19 3 days after vaccine administered with bruise from shoulder to elbow. Patient stated contacted cardiologist about size of bruise and patient says office didn't seemed concerned and she checks her INR at home for Warfarin. Patient doesn't get medication from pharmacy, unaware at time pt was on warfarin. Staff Pharmacist referred pt to walk into MD site and have them visually see the size of bruise to re-verify if they should act.
(L) deltoid area - red - warm - swelling 8 x 8.5 cm.
The patient reports immediate hot sensation from her toes up her body.  Left arm was tingly and pulsating.  Extreme nausea.  The neck stay she developed fever and aching.  Every few days she developed a new symptom for 2 weeks including diarrhea and cough.  She return to work after 3 weeks but was still experiencing ?brain fog?, extreme fatigue and muscle aching.  She was still experiencing these symptoms when I saw her on July 17, 2021.
This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 19-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
When I was ill, my Covid test came back negative after being fully vaccinated with both of the first two shots. But i lost taste and smell. I was sicker than I have ever been. I felt drunk. Unable to do anything for two weeks and now I have extreme bloating and gasiness I never had before. My taste and smell are sowly returning. I believe it was a breakthrough infection. I am concerned that the test did not detect it properly.
Reddness at the injection site ( oval shape 7cmx4cm) became noticeable after 10-11 days. Maybe a little bit earlier but I notice only few days ago). Increasing very slowly for 3 days which I notices. Still continues.
Six to 8 hours post second vax, noted stiffness in entire left arm and hand lasting about 20 minutes (opposite arm from shot). Four days post vax, tingling and discomfort in lymph node and difficulty performing intricate tasks with hands because fingers and hands would stiffen up and hurt to the point, pt would have to stop what he was doing. Also painful red spot on arm about 3 inches in diameter where injection was received which lasted about 2 weeks. Ten days post vax, left ankle began swelling and becoming stiff. This continued for a week and then right ankle began doing the same. Both ankles stiff and swollen for the next 2 weeks or so. Tingling feeling in ankles remained and an arthritic like soreness came and went in the bones in pt's feet. Also noted knee soreness and stiffness and the same in hands and wrists. It has now been nine weeks since second vax and pt is still experiencing problems in joints, primarily feet and ankles. Swelling, inflammation, and stiffness lasting for days at a time. Feet sore in the morning. Constant tingling sensation in inside of ankles.