chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEAD; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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. The reporter stated "Then go get all 50 of the boosters. A friends of mine's son dropped dead from it."  On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220207151.  Version created to amend previously reported information on 02-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events.  V0: 20220207255- COVID-19 VACCINE AD26.COV2.S- Dead. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
For the first 24 hours after vaccination, pt reports having 10 out of 10 pain in area where previous shingles had occurred approximately 3.5 months prior to vaccination. After 24 hours pain in that area was lower than before the vaccination was given. He reports his arm being swollen at injection site and a 5 inch "chord" of swelling running down arm from the injections site.
1.  03/21/21 extreme muscle and joint pain; could barely do anything (like walk or go up/down 3-4 steps, or stand). Using 1-10 for pain level, my pain level was about 4 or 5 for several days with gradual relief over next 3 weeks as long as I did nothing but sit and rest. As of 11/15/21 I still am experience notable muscle fatigue and soreness - i.e., when I cut the grass or walk short distances. 2.  left arm/shot site and surrounding area was very tender and ached with a pain level of about 2.  Pain and tingling still remains as of 11/15/21. 3.   experienced pain in lower back which lasted about 2 weeks. That pain returns periodically to this date.
From initial information received on 08/14/2004 from the patients mother regarding an adverse event occurring in the U.S.A., it was reported that a 17 month old male patient received his fourth dose of Daptacel administered on an unspecified date. The lot number, route, and site of administration were not reported. Sometime after the administration the patient developed blisters around the injection site. The patient's mother states she's not concerned as the event has resolved. The child was not seen by a physician. She has requested that the facility that administered the product not be contacted.
Autoimmune reaction resulting in destruction of pancreatic islet cells and insulin dependent diabetes.  Autoimmune reaction - GAD654 antibody positive
This case was reported by a physician and described the occurrence of fussiness in a 2-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Previous and /or concurrent vaccination included PEDVAXHIB; Merck; unknown; unknown given on 7 November 2008; PREVNAR; Wyeth Labs; unknown given on 7 November 2008. On 7 November 2008 at 16:15, the subject received 1st dose of HAVRIX (.5 ml, unknown, left thigh). On 7 November 2008, at the time of vaccination with HAVRIX, the subject experienced wrong vaccine administered. On 08 November 2008, 1 day after vaccination with HAVRIX, the subject experienced fussiness. Physician reported a 2-month old infant received HAVRIX instead of PEDIARIX. The physician stated that 24 hours after the HAVRIX, HIB and PREVNAR vaccinations were given the subject's parent contacted a pediatric infectious disease physician because the subject was experiencing fussiness. The reporting physician feels that the fussiness is not due to the HAVRIX. The physician is unsure if the subject's fussiness has resolved. The subject was expected in the office to received PEDIARIX. At the time of reporting the outcome of the events were unspecified. The physician considered the events were not related to vaccination with HAVRIX. Follow-up information was received on 05 December 2008, via healthcare professional who reported the subject received HAVRIX instead of PEDIARIX. Other than fussiness, the subject did not have any adverse reactions. The reporting healthcare professional considered the events possibly related to vaccination with HAVRIX but also stated the fussiness my have been related to ROTATEQ, HIB or PREVNAR, which the subject also received. The onset dates was on 08 November 2008 and resolved the same day.
The area by the injection was itching and there was a rash 2 X 4 inches in size. The itching was not severe but it was bothersome.  I applied hydrocortisone cream twice a day which helped a lot. I took a Benadryl on day 5.  By day 7 the rash was barely noticeable and the itching had decreased. By day 8, all effects were gone.
No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-MAR-2022, the patient was vaccinated with improperly doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, lot numbers 1741817 and u026664, expiration dates 30-JUL-2022 and 24-FEB-2023 respectively and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dosage form, lot number u026217, expiration date 02-NOV-2023 (routes of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccines underwnet a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. No previous temperature excursions were detected.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791:
Started having pain in my right arm immediatley after the shots, Went to the doctor a few weeks later once the pain did not go away. He ordered xrays , then on next appt. he sent me to an orthopedic specialist.  that doctor ordered MRI of the arm, it shows a contusion, but he disagrees that a contusion can be there that length of time. He tehn ordered a bone scan wich was normal. I am now being referred to a shoulder specialist, My orthopedic doctor had diagnosed me with either busitis or tendonitis , he is not sure , he also wanted to do exploratory surgery which I denied at this time. I was given cortizone shot to try to relieve the pain with no avail, in 9/2019.
Following my second dose of the vaccine on 5/8/21 (Lot #EW0183) I had an irregularly long and heavy period for 3 months. This included extremely heavy bleeding (going through a pad + tampon every hour) for 11-15 days each month, with blood clots the size of my fist for 6-8 of those days each months. This is far heavier than my regular period that I've had for over a decade. I also had the Nexplanon implant at the time of vaccination and symptoms.
Chills (extreme) vertigo, nausea - started at 1030pm. Passed out- when I came to began vomitting - bile lasted approximately 4 hours. 1030 pm - began intense shaking - cold - I went to get Tylenol but found myself extremely dizzy and nauseous.  I took 4mg Zofran and 1000mg Tylenol & tried to make it back to bed. I passed out - my husband witnessed and said my legs simply collapsed, He was yelling my name and he said I moaned. He is 1 wk post op TKR so he was going to call 911. I came to and began vomiting thick yellow bile. By 2:30 I felt somewhat better. Today I am achq - my back & head hurt but I am still nauseous. Fever 99.0
The morning following the vax red whelps appeared on the upper half of the arm; pt recvd DPH & recovered in a couple of days;
Hives to face, ears and left arm. Treated with topical steroid and antihistamine. Decrease of hives noted.
Vaccinated with Moderna 2/8/21 Moderna 3/8/21  Patient seen in ED on 1/1/22 due fall admitted 1/1/22 to Hospital medical floor.  not known when patient was discharged from Hospital or when admitted to Facility. Patient positive for COVID-19  on 1/1/22 Noted on CXR that lungs demonstrated ?streaky opacities suggestive of scar atelectasis w/infectious/inflammatory process not entirely ruled out.? Labs and EKG and ECG  Received death abstract with date of death 1/18/22 at 00:46 at Facility  Cause of death stated on death abstract: COMPLICATIONS OF INFECTION WITH NOVEL CORONAVIRUS (COVID-19)
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 18-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J000433 exp: 10-APR-2014 (dose and route not provided). On 18-APR-2014, the patient received an expired dose of ZOSTAVAX. The outcome of the patient received an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Swollen  and painful lymph nodes in left arm pit, no treatment, swelling and pain resolved in two weeks
The second and third day was the worst, I had excruciating pain in my back, like a nerve pain, Tylenol did not help, it was almost in my jaw, I could not lay down or sit up or walk, It was just really bad nerve pain, I had a fever as well. The pain was in my back and my neck, and that is what made me contact my Dr. and she advised to to just give it a few days and it did, I would say it took like a week for it to et better again.
Information has been received from a physician via a company representative, concerning a 19 year old female who on 07 Feb 2007 was vaccinated with an 0.5 ml dose of Gardasil. By the evening of the same day, the patient developed a "rash from head to toe and itching." The patient has not recovered at the time of this report. The patient sought unspecified medical attention. Additional information has been requested.
a lot of pain in legs; he might had a blood clot; Numbness in leg; Arthritis/ arthritis in both legs; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-3920316-00 (Agency).  A 84 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "a lot of pain in legs"; THROMBOSIS (medically significant), outcome "unknown", described as "he might had a blood clot"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in leg"; ARTHRITIS (non-serious), outcome "not recovered", described as "Arthritis/ arthritis in both legs "; FATIGUE (non-serious), outcome "recovering", described as "Fatigue". The patient was hospitalized for pain in extremity (hospitalization duration: 3 day(s)). The events "a lot of pain in legs" and "numbness in leg" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: laboratory test: unknown results, notes: could not find out the cause or what was wrong. Therapeutic measures were taken as a result of pain in extremity. On 28Dec2021, he had to use pain killers over the counter to alleviate pain in left leg. The pain alternated. He had a walker and cane.   Causality for Humira with events (arthritis, fatigue, numbness in leg) per reporter was reported as reasonable possibility. The reporter considered "fatigue" not related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported fatigue and suspect drug BNT162B2  Based on the information currently available,The casual association between the reported other events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement.    In early June 2021,  the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation.  While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.
Around 8:30p.m. Saturday  March 6, 2021 I began to feel chills. I laid down around 9:30p.m to go to sleep. I woke up at 12:25a.m (Sunday March 7th, 2021) with a fever of 104.3 and was experiencing extreme neck and head pain. My hands hurt as if I had arthritis and couldn't make them feel better. I was very short of breath and dry coughing. I took Tylenol and tried to lay back down and was able to go back to sleep around 3:00a.m. I got up at 6:10am and my temp was 101.6. I took Ibuprofen at this point and by 9:30am my temp was 99.8. I was still experiencing a very bad headache and my neck and back were achy. I felt a lot better by about 11:00am, took a hot shower and laid down for a nap around 2:00pm Sunday. When I woke up around 3:15p.m I had spiked yet another fever of 102.0 and was having bad body aches again in my neck and head area and it continued to get worse though my back over the next hour. I was experiencing a dry cough again also but this time it was more constant. It took over 3 hours for my fever to go below 100.0 with alternating Tylenol and Ibuprofen. It finally broke around 7:00p.m. I had a lot of pain in my neck and head the rest of the night. I woke up Monday March 8th, 2021 with a moderate headache but it went away throughout the day. No fever returned Monday. The only time I experienced coughing and shortness of breath was while I had the fever.
Left thigh swollen and tender. Blisters on thigh (8x10 cm) erythematous, swollen, tender.
Patient recieved 0.5ml dose of AFLURIA vaccine on 19 oct 2010.  102 temp 7pm at 19 oct 2010
I did not have an adverse reaction to the vaccine. On 12/02/2022, I started not feeling well with body aches, tired, cough and respiratory issues. On 12/06/2022, I test positive for COVID-19 with a home test. I contacted my doctor and got the prescription for PAXLOVID. I tolerated the medication, but it did leave a nasty taste in my mouth. As of today, I continue to have congestion and a cough.
Extreme Sore Deltoid (1st sign progressed over day).  The following symptoms started around 9 pm and increased through the night:  severe headache, nausea, malaise, other joint pain - especially joints of previous injuries (lifetime), chills, hot flashes, tiredness - though inability to sleep. I needed to take Tylenol through the night which did help with headache.  The symptoms were significantly decreased by 6 pm that day (Feb 24th).
w/in 15 mins of inject pt fainted while mom was checking out @ billing desk; uneventful recovery; nl BP; had sore achy inject site w/erythema & tenderness 2x5 for 2 days; mom said had fever day p/inject;
Pt was scheduled for a booster shot with Health District today.  When I reviewed vaccination history, I saw that pt had first dose of primary series on 11/17/2021, and second dose of primary series 14 days later on 12/1/21.  I established that the 12/1/21 dose was an invalid dose.   Pt's mother close to have an appropriate second dose of primary series today and will have booster dose in five months. Pt's mother reports that on 12/2/21, the day after the invalid dose,  the patient felt "slugglish and tired" all day and hade one episode of vomiting.  She felt "normal" on 12/3/21 and had no other symptoms.
green stools; difficulty breathing; nausea; headache; dizzeyness; loss of appetite; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: paa156051), dose 1 via an unspecified route of administration, in Arm Left, on 27Jan2021 12:30pm as single dose for covid-19 immunisation. Vacination facility was Other. Medical history included High blood pressure, Low potassium and High cholesterol. The patient had no allergies. Concomitant medication's included Lisinopril, potassium and simvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient previously reported her adverse events but forgot to add that on 29Jan2021 at 06:00pm she have had green stools since the vaccine along with the 3 episodes of difficulty breathing, nausea headache dizzeyness and loss of appetite this was from wed of injection until friday 9 days later. The patient was terrified of receiving the second dose because these symptoms happened on the 3rd day and later. If she does not take the second dose what are my chances of surviving the virus if she should come down with it. She tried calling and was on hold for 4 hours and no one picked up. Events resulted in emergency room. The patient underwent lab tests and procedures after vaccination which included COVID-19 (sars-cov-2) test: negative on 05Feb2021. Patient did not received any treatment for the events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sometimes incredibly hard bowel movement after booster; Sometimes just gas after booster; Gets up in the middle of the night going to the bathroom after booster; reaggravated the stomach/Gut function is unpredictable after booster; Goes to the bathroom 8-20 times a day after booster; Sometimes severe diarrhea after booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster) and FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (20 years ago.) and Stomach discomfort (little stomach issue).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster). At the time of the report, ABDOMINAL DISCOMFORT (Sometimes incredibly hard bowel movement after booster), FLATULENCE (Sometimes just gas after booster), SLEEP DISORDER (Gets up in the middle of the night going to the bathroom after booster), ABDOMINAL DISCOMFORT (reaggravated the stomach/Gut function is unpredictable after booster), FREQUENT BOWEL MOVEMENTS (Goes to the bathroom 8-20 times a day after booster) and DIARRHOEA (Sometimes severe diarrhea after booster) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that after receiving the booster his stomach was reaggravated and he had to go to the bathroom 8-20 times a day, there was no blood but he sometimes had incredibly hard bowel movement, sometimes severe diarrhea and sometimes just gas. He had to get up in the middle of the night to go to the bathroom and his gut function was unpredictable.   This case was linked to MOD-2022-452386 (Patient Link).