chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 71 yo female with a history of PE, previously on anticoagulation (stopped due to GI bleed,) DM, HTN, HLD, seizure disorder, depression, who presented to the ED complaining of syncope this AM. Patient was walking her dog when she felt dizzy (lightheaded) and lost consciousness. She fell on her face. The patient is tested positive on 7/23/21. However, she denies SOB, cough, nausea/vomiting, abdominal pain, diarrhea, loss of sense of taste or smell. Patient is fully vaccinated with Pfizer (first dose 4/6/21 Lot: ER8737, second dose 4/27/21 EW0171.) She not been diagnosed with COVID before.  She was found to have PE, no right heart strain on CTA chest,  and COVID positivity 7/23/21.  No hypoxic respiratory failure.
Moderna Covid-19 Vaccine EUA 2/13 to 2/14    sore arm at injection site         treated with Tylenol 2/19   sore at injection site, raised area near site 2/20    red around injection site, low grade fever, headache   Treated with alternating Tylenol and Alleve  , ice pack applied to site 2/21   red around injection site, low grade fever, headache      Treated with alternating Tylenol and Alleve
loss of teeth; pain; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (loss of teeth) and PAIN (pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH LOSS (loss of teeth) and PAIN (pain). At the time of the report, TOOTH LOSS (loss of teeth) and PAIN (pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
irritability p/shot;next shot given was DT & pt also reported irritability p/this shot as well;
Information has been received from a physician concerning a 3.5 year old female child with perinatally acquired human immunodeficiency virus and a history of human immunodeficiency virus encephalitis and developmental delays who on 06/05/2001 was vaccinated with varicella vaccine. Concomitant therapy included anti-retrovirals. On 06/24/2001, the pt presented to the hospital with 12-18 vesicular lesions. It was noted that the pt was afebrile. Follow-up info was received and indicated that the physician felt that "she will send the child home with the plan to have the mother contact her if the rash should become more severe." Additionally, it was indicated that the child has been very stable with a CD4 count of 28%. It was noted that the physician would not obtain a specimen at this time for VZV analysis. Additional info has been requested.
BODY ACHES; NARCOLEPSY; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the patient was sleepy (could not stay awake) and had body ache the next day (only lasted 24 hours). The patient's narcolepsy had not improved and had stayed the same.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-MAR-2021, and had not recovered from narcolepsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210328585-Covid-19 vaccine ad26.cov2.s-Narcolepsy. 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.
Within a couple of hours after being given on 1/3, my arm began to throb and ache. It continued to get worse, and I expected some soreness getting the injection. However, within a day or so, I could barely move my arm, could not lift it. Went back to the clinic on 1/8, was told to take Ibuprofen, use warm or cold compresses, all things I was already doing. I asked for some pain medicine, told I could not have any pain medicine, and was given FLEXERIL and Gabapentin. Neither really did much to help the pain I was having in my arm. This pain, making it hard to work, I was in intense training for a new job; my husband is disabled and I have to do all of the daily tasks at home, including getting groceries, which became increasingly difficult. This pain made it difficult to work, hard to sleep. On my own, I began going to physical therapy on 2/2/18 which was the best help I received in this whole entire experience. Most of the pain seems to focus on the front of my arm, in the biceps area, making it hard to move and lift. I waited a month to get an apt with an orthopedic physician on 2/5/18 who didn't really think it was too bad, and recommended a steroid shot. I realize I do have some arthritis, but had never had any problems with this arm or shoulder. I did get the shot and it did help, for about a month or so. The ortho doc would not give any pain med, advised to go back to PCP. The steroid shot really helped but seemed to wear off after a month or so, and the pain continues. Back to my clinic on 3/26, and had to have a long discussion about why I could not have any pain medication, should go to a Pain Clinic, and was finally given Tramadol 50mg. Thus far, this injection being given in the wrong place has been very expensive: three clinic visits, an ortho visit, eight-PT visits, MRI, and venous study. And now it has been three months since the injection. The pain has gradually subsided, but continues to be constricting in my life.   And since it was January when this happened, all of the costs were applied to my deductible, out of pocket, just to get some relief. And there has been little.
Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Patient fainted after vaccine administration. Bumped head; cleaned area; Band-Aid provided. Patient refused EMT service. Friend drove him home.
24 hours after shot tiredness, chills,fever, pain at injection site for 48 hours.   Today, I woke up this morning with a light pink rash, about the size of my fist, around the injection site. I had the shot 12 days ago.
Patient called on 7/3 reporting that he had redness/soreness and some hives on his right arm around the Hep A injection site. Pt was counseled to take BENADRYL and keep and eye on it and call us back if symptoms continued. Pt called back 7/5/18 reporting that hives had spread to his back and BENADRYL was not helping. Patient was counceled about any over the counter products (soap, heat rash, food changes, etc.) that could contribute to hives. Pt was also instructed to see his physician since hives were spreading and asked to call back the pharmacy with an update.
I have a positive ANA.  My auto immune system acts up.  I had a elevated heartbeat.  I had fatigue and was out of breath.  I went to my doctors about it.  They did Echo exam and a stress test.  Last week they did a Nuchal cardiac stress test.  I have an appointment on Thursday to find out the results.
Patient was an adolescent and was given an adult dose of Hep A.  No adverse reaction.
Pt's mother called in pm on 03/15/2002 which she described as chicken pox, a few chicken pox began on vaginal area. A few had crusted over. Advised calamine and Benedryl. Pt returned on 03/18/2002 with a confirmed diagnosis of varicella.
3APR97 day p/vax pt recv lt leg @ inj site, devel redness & pus drainage;no fever;dx cellulitis;tx w/ATB:
Flu-like symptoms for ~12 hours, followed by muscle weakness that became progressively worse over the course of a week.  It got to the point where I could barely grip anything and had difficulty moving about.
A Pfizer covid vaccine was administered as a second dose when her initial covid vaccine was a Moderna covid vaccine.
Fever, Chills and shaking, Muscle Aches, Swollen Joints, Nausea/vomiting, fatigue, weakness and lethargy, GI issues, headaches, changes in taste
Pt recvd vax & following 2nd dose of vax pt felt very anxious & became agitated; No further details were provided;
FAINTED AFTER GETTING VACCINE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNWON) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fainted after getting vaccine, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and fainted after getting vaccine was not reported. The reporter considered the causality between JNJ-78436735, and faint and flu like symptoms as possible. Company causality between JNJ-78436735, and faint and flu like symptoms was possible. The batch number was not reported and has been requested. This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 12-Mar-2021 following information was updated and incorporated into case narrative: Patient demographic details (patient initials and sex) and other identification numbers was added.; Sender's Comments: V1 Follow up information updates Patient demographic details (patient initials and sex) and other identification numbers. This updated information does not alter prior casuality assessment of reported events. Flu-like symptoms and fainted. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
This spontaneous report was received from a healthcare worker/clinical manager refers to a 11 year old patient. Patient medical history and historical conditions were not reported. On 12-JUL-2013, the patient was vaccinated with GARDASIL (lot # H021608 and expiration date was 13-AUG-2015) first dose, 0.5 ml, once, intramuscular and second dose on 07-JUL-2014 (lot # J012212 and expiration date was 18-FEB-2016) (dose, frequency were not reported). Concomitant therapy was not reported. No PQC was involved. On an unknown date, approximately in 2014 the patient experienced incorrect schedule. No adverse effect was reported. The outcome of incorrect schedule and no adverse effect was unknown. The reporter considered events to be not related to GARDASIL. Additional information has been requested.
large sore spot; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 2nd dose of Shingrix. On 21st May 2019, 5 days after receiving Shingrix, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was unknown.   It was unknown if the reporter considered the painful rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine in the arm. The patient had Shingrix and noticed a large sore spot on buttock 2-3 days ago the day of reporting. The reporter asked could that be a reaction and what should we do for it.
inconsolable screaming & crying for 6 days.  Infant Tylenol was administered, with some, but little effect.
Subsequent to receiving third dose of Lymerix, the pt experienced generalized muscle aching. A doctor or ER visit was required. As of 09/10/2000 the outcome of the event is ongoing.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-NOV-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
5 hrs post vax pt became fussy, crying intermittantly, t103, mom was giving APAP; ER called 4AM temps till 103, pt listless & had not nursed or eaten since mid-afternoon; pt cried off & on & was listless all noc;
On 10/24/01 at 11:30, child was brought to ER having a seizure. Temperature was 101F and Advil was given. Seen RN in office for F/U on 10/25/01. Questionable viral illness/reaction to immunization.
Fever controlled w/acetaminophen. 10/2/99, fever to 102. While in highchair for lunchtime feed, pt developed "blank stare, then arms & legs shook". Episode lasted 1 min & occurred again at baby sitters. Mom picked pt up at 4pm, pt nml.
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The receptionist advised that, her granddaughter also got the flu even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 1 of the 3 cases reported by the same reporter.
This spontaneous report was received from an other health professional (certified medical assistant) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 25-FEB-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ lot number K004773, expiration date 22-FEB-2016, orally (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
vaccine given one day after BUD. Pfizer contacted and said excursions up to 2 days are reasonable as long as vaccine was stored appropriately. Vaccine was stored correctly
Follow-up info received from the physician on 10/23/02 provided serotype. A physician reported that a 6 month old male received his third dose of Prevnar on 7/16/02. Concomitant therapy included Act-Hib, Tripedia, IPOL and Recombivax-HB. On 9/15/02, at 8 months of age, he developed a fever. On 9/17/02, he was seen by the physician; he had a one week history of a cold and presented with vomiting, diarrhea, and a fever of 103.5 deg F. He was treated with acetaminophen. On the morning of 9/18/02, he was found unresponsive. He was taken to the ER and admitted to the ICU. His temperature ranged from 102.2 to 104 deg F. A white blood cell count was 2000. A spinal tap revealed open pressure, blew tube and stopped at 40cm, turbid fluid, protein 250, glucose 20, 8 white blood cells. A blood cultures and cerebrospinal fluid culture revealed Streptococcus pneumoniae serotype 19A. Serotype results are pending. Later that same day, he died.
Patient up to date on COVID vaccines who fell and admitted for femur fracture with COVID detected PCR.  No hypoxia noted during stay.
temperature excursion with AE; No adverse event; vaccines were administered to 26 patients; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE).    No concomitant medication were reported.  It was reported that Lost power the next day in the middle of the day at 12:00 PM. All the vaccine were placed into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment information was provided by the reporter.  This case is of Patient 26 out of 26 Patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
VACCINEE RECVD FIRST DOSE OF ENGERIX-B ON 2-20-90. ON 2-28-90 PT HAD ONSET OF FEVER AND NAUSEA. TOOK ASPIRIN FOR FEVER. RESOLVED 24 HRS;NAUSEA PERSISTED 5 DAYS.3-3-90 FELT HUNGOVER. WEAK FEELING SEV DAYS.3-10-90 FELT FINE.PT WON'T GET 2ND V
I received a Tetanus and Diphtheria shot on 7/19/06. 20 mins later my head started hurting as time went on I had a migraine that lasted 5 days as well as stiff neck that still is ongoing.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medicine were reported.  It was unknown patient was ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to one month before and about chronic or long standing health conditions. It was unknow if patient took prescription, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.  It was reported that patient was inadvertently administered doses of the monovalent vaccines for which expiration date was 13-Jul-2022.  No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received wherein reporter details, dosage information, expiration date, batch number and I narrative information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
Pt vomited after dinner at 6PM. Red blotchy rash all over body, no fever. Pt seemed fine next AM, no rash, acting fine, eating & drinking fine. At 11AM dad noticed rash on chest, no fever, rash different from previous night, not blotchy.
pt reported feeling hot and lightheaded - 3-5 minutes later, she became unresponsive - I administered one dose of epinephrine, she came to about 3 seconds later, and stayed stable until the EMTs arrived.
woke up with chest pains admitted to emergency room diagnosed with pericarditis chest pains continue to present time