chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CT of the abdomen and pelvis ordered on 4/20/21 revealed thrombosis of the right hepatic vein with heterogeneous enhancement of the right lobe of the liver compatible with Budd-Chiari syndrome.
SITE OF INJECTION IS SWOLLEN WITH REDNESS AND PAIN ALSO THE ARM FEELS HOT.
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient got the booster shot found dead in the morning. No treatment medications were reported.  Company comment- This is a fatal spontaneous case concerning a male patient of unknown age, with medical condition of diabetes, who experienced the serious (death and medically significant) unexpected event of death. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported that patient got the booster shot and was found dead in the morning. The cause of death was not reported. It is unknown if an autopsy was performed. No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. Medical condition of diabetes remains as a contributory risk factor for the event. The benefit risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-692839 (E2B Linked Report).; Sender's Comments: This is a fatal spontaneous case concerning a male patient of unknown age, with medical condition of diabetes, who experienced the serious (death and medically significant) unexpected event of death. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported that patient got the booster shot and was found dead in the morning morning. The cause of death was not reported. It is unknown if an autopsy was performed. No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. Medical condition of diabetes remains as a contributory risk factor for the event. The benefit risk relationship of mRNA-1273.222 is not affected by this report. US-MODERNATX, INC.-MOD-2022-692839:Master; Reported Cause(s) of Death: Found dead
Felt pain in left arm as soon as shot was administered. About 30 minutes later felt sort of brain fog. Could not think of the word for air pump. Woke up at 6 AM the next day with severe ache at injection site. Left arm was stiff and unable to move. Went back to bed. Woke up an hour or two later. Arm was the same, felt the usual illness effects from prior pfizer shots (chills, fatigue etc). However, at some point I passed out and landed on the floor. I do not remember much before passing out. I grabbed an ice pack for my arm then woke up on the floor.  Luckily, I landed in such a way that I came away with minor bruises. My wife found me. She said I was completely devoid of color and covered in sweat. She kept asking me questions. It took great effort to respond at all. Eventually I was able to shuffle back to bed, where I stayed until 2pm.
Patient is a 74 year old female with PMH of asthma, depression, hypertension, hyperlipidemia, and morbid obesity who presented to the ED with chief complaint of of shortness and breathe. Patient states she has felt SOB for a couple of days and has been progressively worse. The patient did test positive for COVID. She states she is fully vaccinated and has no received a booster.   Upon arrival to the emergency department patient's blood pressure was 91/64, pulse was 100, respirations were 18 per minute, and the patient was saturating at 92% without a rebreather. The patient oxygen demands began to increase, and the patient was placed on 50 L of high flow nasal cannula.   Initial labs in the ED were remarkable for a hemoglobin of 11.1, MCV of 79, a potassium of 3, a creatinine of 1.24, and 0.4, phosphorus 1.9, pro calcitonin on 11.74, d-dimer of 5528.   CXR: Hazy opacifications of the right hemithorax, representing accommodation of airspace disease and small pleural effusion/atelectasis
Initial report received from a health care professional on 01 December 2008. A 43-year-old female patient who had stepped on a nail and who had a pre-existing cough, was inadvertently given a second dose of ADACEL, administered intramuscularly to the left deltoid on 25 November 2008 (lot number UF455BA; other lot number C3004). The patient had previously received a dose of ADACEL on 10 January 2007. On 27 November 2008, the patient experienced an orange-sized area of redness, swelling, warmth and itching that became worse in 28 November 2008. As of 01 December 2008, the symptoms had resolved. It was also reported that the patient's cough had worsened after the ADACEL vaccination. No fever or additional events were reported. Outcome of cough was not reported. Follow up information was received on 22 December 2008 from a health care professional. The reporter clarified the patient had a staple in her finger at the time of vaccination, previously reported as stepping on a nail. The reporter confirmed that the orange sized redness, swelling, warmth and itching were all symptoms at the injection site, the left deltoid. Treatment included ice and MOTRIN. Concomitant therapy included NORVASC, FLEXERIL and MOTRIN. The cough worsened on 26 November 2008 and then resolved by 28 November 2008. The patient did not seek medical attention. No other information was provided. Documents held by sender: None.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.            No relevant concomitant medications were reported. No adverse events were reported so treatment is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: unable to get in touch with patient, left voice mail, no new information available
I started getting nerve issues in my arm and neck and locked up muscles had to go to physical therapy  for several months and had to get dry needles also was on pain meds and muscle relaxants
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 200, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sore injection site; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 16:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 15Mar2021, the patient experienced sore injection site and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the event sore injection site and body aches was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Received vaccine 041409 fever low grade -> 101.8 from 041409 -> 042009. Anorexic, personality changes. Fever - no response to Tylenol or Motrin. 042109 - total body rash.
Immunizations team administering Pfizer and Moderna vaccine boosters.  Patient presented with screening form and request for Pfizer booster. Patient was screened and approved for booster.  Patient was administered Moderna instead of Pfizer booster.
Lichen Planus developed 2 weeks after the shingrix first vaccination, It has continued to worsen into the summer. I has spread over most of the body. Patient is being treated by primary care doctor.
Patient called service on 10-10-15 at 0821. Reported to Dr., questionable local reaction to flu vaccine (pain down spine, up neck, and shoulder blades). Applied heating pad to back and right shoulder blade, took TYLENOL as instructed by Doctor - little to no relief. Was advised to see the doctor in office. No appointment to date.
fever-coughing-runny nose, swelling under eye;fever devel 1NOV96;pt still active playing advised father to notify PMD of sx;
Pt to ED 7/30 for fever and positive COVID home test. COVID+ 7/30, rx remdesivir, to stop decadron. 7/31 Pt A&Ox4 with mild situational confusion, on 2 L nasal cannula. 8/1 no acute issues overnight. Pt denies chest pain, shortness of breath, abd pain, no fever or chills. 8/3 No SOB noted, pleasant mood, appetite fair, drinking well. No cough noted. Condition appears stable. Pt discharged.
I got an itchy rash on my right leg within the first 15 minutes, staff at the site tried to get me to belief it was from anxiety. The redness subsided though bumps remained when they let me go home. I also felt a bit "detached" on the drive home and really had to concentrate on my driving. Once home, I still felt odd but went about my day. About four hours later, I realized I was scratching my stomach and chest while watching TV. Upon raising my shirt, I saw a bright red rash on the top part of my belly that extended underneath both breasts and to the area directly over my heart, and up my left side into my left armpit. All of these areas were very itchy. I put Hydrocortisone cream on them, which helped reduce the itching quite quickly. I then took half a Benadryl tablet. When I awoke the next morning, the areas that had been bright red now had dark red dots but did not itch. However, I had lines of a bright red, itchy rash on both thighs near my groin. I again applied Hydrocortisone cream and took Benadryl, which helped abate the symptoms. Lymph nodes in my left armpit were quite sore as well, so I took ibuprofen.
3JUL96 pt comes to clinic arm lt was red, hot, swollen measuring 6cm x 5cm;c/o some soreness;APAP had been helping w/the discomfort;
After the 2nd immunization (MENACTRA), the patient fainted while sitting in the chair. I gently moved pt to laying on the floor and patient woke up a few seconds later. I provided an ice pack for pt's forehead and he layed on the floor calmly for a few minutes. I observed pt until he said he felt ok. He sat upright for several minutes before leaving.
Arm extremely hurt; Could not sleep; Nauseous/ Queasy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm extremely hurt), INSOMNIA (Could not sleep) and NAUSEA (Nauseous/ Queasy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm extremely hurt), INSOMNIA (Could not sleep) and NAUSEA (Nauseous/ Queasy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Arm extremely hurt), INSOMNIA (Could not sleep) and NAUSEA (Nauseous/ Queasy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Includes Acetaminophen.
Left leg swollen at injection site. Area quarter to 50 cent piece size on 11/30/06. By 12/01/2006 area enlarged and child complained of standing on right leg. Pt seen in ER.
Initial symptoms were as expected and quite intense - strong fever, chills, headache, and nausea starting 6 hours after injection and lasting for 24-48 hours.  Lingering side-effect has been headaches. Dull general headaches at least 4 days a week that last much of the day and are cause to disengage from normal activity. I HAVE NEVER HAD REGULAR HEADACHES IN MY LIFE AND HAVE NEVER HAD A MIGRAINE. This is ONGOING TODAY (July 12).
Oct. 18 - evening - started noticing a little postnasal drip; thought it was nothing.  Oct. 19 - throughout the day noticed a little more postnasal drip; Oct. 20 - started feeling tired and "rundown"; slight headache and cough  Oct. 21 - headache, cough, 100.5 fever - went to PCP clinic - negative flu; negative Covid test; treated for sinus infection with Cefdinir, Prednisone pack; Virtussin cough syrup; Oct. 27 - dizziness, fatigue, felt like I might pass out - went to nurse's station at work; blood pressure was monitored and was rising at rest, so school nurse called paramedics; they checked me out and said I could go to ER or to PCP; I chose PCP. At PCP, they monitored my blood pressure and gave me Clonidine. BP fell, and I went home with instructions to go to ER if symptoms got bad again. Suspect reaction to prednisone ; retested for covid - negative; bloodwork drawn - normal Oct. 28 - went to ER in the night with excruciating headache and rising BP ( both much better by the time I got there); CT scan and EKG normal; follow up with PCP
ROTATEQ administered today prior to tbe nurse knowing tbere was a temperature excursion; 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 02-NOV-2020, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.2 milliliter, oral, lot number 1684163, expiration date 26-JUN-2021 for prophylaxis.   The vaccine had a temperature excursion of 12.8 degrees Celsius (C) for 3 hours. There were no previous temperature excursions.
Patient had sore arm since immediately after injection, developed area of redness and swelling approx 1 1/2 inches across and hard, swollen upper arm area. Taking naproxen and BENADRYL currently, will consult MD if gets worse.
Two patients received vaccine that had been punctured 24 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine that had been punctured 24 hours ago) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine that had been punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine that had been punctured 24 hours ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
I was fine after the shot, but, that night I started to get ill. I felt like I came down with something. I recall going to the hospital to have a chest X-ray. I think I was sick for 3 days. After that time I seemed fine, but sort of weak.
12 hours after getting 2nd dose i felt like I had the worst case of the flu. This lasted for close to 48 hours. Shortly after, it felt like I had a needle stuck in my arm. This lasted for weeks and then turned into I tense pain in my upper arm that happened when lying down, sleeping. I still have the pain 7 months later.
Pt. reported arm swelling. Neighbor was a doctor; recommended treatment. Pt. subsequently saw Dr. who prescribed Doxycycline 100mg for cellulitis.
Started with extreme pain in right shoulder injection site. Urinated about every hour, fever of 99.8, extremely nauseous, excruciating headache, rigors throughout my body, teeth chattering, dizziness, weak, muscle aches. Could not get any relief from Tylenol or aspercreme. I did not sleep all night on 4/08/2021 until 7am 4/09/2021.  The extreme shoulder pain lasted for 3 days. For 2 days I felt very weak and dizzy with a slight fever of 98. Since my symptoms went away after 3 days I did not contact a Dr. My son stayed with me in case of an emergency.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2017 at 16:10, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Priorix administered on same day as Proquad; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-month-old female patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   Co-suspect products included PROQUAD for prophylaxis.   On 15-SEP-2023, the patient received Priorix and PROQUAD. On 15-SEP-2023, an unknown time after receiving Priorix, the patient experienced overdose (Verbatim: Priorix administered on same day as Proquad).  The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Sep-2023 A Medical Assistant called to inform that a patient received a dose of Priorix, and on the same day also was administered a dose of Proquad which led to overdose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
It was discovered after the vaccine was administered that it was expired.  The vaccine was labeled with the expiration date 5/17/2023, but when we looked it up online, the expiration date was 3/31/2023.  The patient was observed for 15 minutes and dismissed in stable condition.  We attempted to speak with his mother over the phone the evening of the incident, but she did not answer the phone.  We spoke with her this morning, and she reported that he is doing fine.  His only symptom is fatigue.  He will be evaluated by a doctor tomorrow.
Information has been received from a pharmacist concerning a female patient in her 20's who was vaccinated with three doses of VARIVAX (Merck) (lot# not reported) respectively in 1995, in 2003 and in 2004. It was reported that the patient did not seroconvert. Titer was negative on two occasions: after the second dose in 2003 and in 2005. No adverse effects were reported. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patent was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.