chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/13/2022 10-year-old male without significant past medical or surgical history presenting for evaluation of 6 days of fever, nausea/vomiting and decreased p.o. intake, diffuse abdominal pain, headache, fatigue, and migratory rash. Patient reportedly COVID-positive 12/6/2021, received initial COVID-vaccine in late November. Patient denying any chest pain, cough, or shortness of breath. Constellation of symptoms is concerning for Kawasaki versus MIS-C. Exam notable for diffuse rash with palmar involvement and early bullae/vesicles, straw berry tongue. There is no conjunctival injection, no perineal involvement. No focal neurologic deficits, diffuse abdominal tenderness without focality. Vital signs are stable hough notable for mild hypotension.  Laboratory studies overall consistent with MISC (elevations in ESR/CRP, ferritin, etc. with elevations in troponin and BNP consistent with myocarditis. Electrolyte abnormalities including hyponatremia, hypokalemia, hypocalcemia consistent with inadequate oral intake and diarrhea.  Hospital course: MIS-C associated with COVID-19, S/p CTX x2, negative blood cultures, S/p IVIG 1/14, Solumedrol 1/14-1/15, Transitioned to PO Prednisolone 1/16 Lovenox switched to ASA 1/1  Acute respiratory failure with hypoxia, Required HFNC on arrival to PICU, Stable on RA day of d/c.  Myocarditis,  LVEF 45-50% on 1/14  Discharge: Pt tolerating regular diet well. No N/V. Pt denies any pain. Rash to BLE and bilateral hands/arms improved. Follow up with PMD in one week, Rheumotology in one week, Cardiology in one month
Received tetanus shot 3/23/03, at hospital emergency room for gash in leg. Next day, red blotch and hardness appeared on arm and very itchy. Palpitations and difficulty breathing increased, red blotch and hardness spread; itch worsened. Made appt. for 5/26. MD said never take Tetracyclin again - bad reaction. Prescribed Benadryl for itch. Stopped after one day because I couldn't stay awake. Palpitations and breathing bad.
Narrative:  This is a 41 y/o mail with pmhx sig for HTN, HLD and obesity. He initially had chest pain similar to this back in September a few days after his second COVID vaccine. The pain went away after several days. However for the past 2 weeks, he had noticed a recurrence of his symptoms associated with vomiting. His CXR back in September showed a normal cardiac silhouette; however repeat CXR here shows cardiomegaly. EKG with sinus tachycardia and TW inversions in the inferior/lateral leads. His symptoms appeared to suggest gastrointestinal initially. Primary team started treatment for pericarditis. EKG with inferior/lateral TWI's, which could be consistent with stage III. Echocardiogram now with LVEF < 20% with severe LV dilation, which has never been diagnosed previously. RHC obtained 10/28 with severely low cardiac index (1.8), elevated PCW 33, elevated RA pressure 20. Coronary angiogram was normal on 10/28. CMR was obtained to define etiology did not show evidence of pericardial enhancement or late gadolinium enhancement to suggest scar or myocarditis. Biventricular failure noted on MRI. # Non-ischemic cardiomyopathy with low cardiac output # Biventricular heart failure # Concern for previous myocarditis possibly 2/2 to COVID vaccine--------------------------------------------------------------------------------------------------------------------------------------------------------On admission, the patient reported burning chest pain that occured following the 2nd dose of the Pfizer COVID vaccine which he recieved on Sep. 13th. His was intermittent in nature and resolved spontaneously after 5 days, but recurred on Oct. 12 and persisted until his admission to MC. He was found to have pericardial fluid on CTPE in the ED concerning for possible post-vaccination pericarditis/myocarditis, and the patient was started on Ibuprofen for treatment. It was later discovered by ECHO that the patient's EF was noted to be ~ 20-25% consistent with new heart failure. The only identifiable risk factor for the patient's clinical condition was recent administration of the COVID vaccine.
Rheumatoid arthritis flare up in finger; BODYACHES; Headache; tiredness; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer. A contactable consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; upadacitinib (RINVOQ) oral from an unspecified date at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 via intramuscular on an unspecified date for COVID-19 immunisation. The patient had flare in finger after BNT162B2 lasted three days and caused her headache, tiredness, body aches on an unspecified date. The action taken in response to the events for upadacitinib was unknown. The outcome of events was recovered.    The reporter's causality for the events of body aches, headache and rheumatoid arthritis flare up in finger with upadacitinib was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the current limited available information and the drug-event plausible association, a possible contributory role of the suspect product BNT162B2 to the development of events of rheumatoid arthritis flare up, body aches, headache and pain cannot be totally excluded/assessed.  Moreover, case assessment for causal association is confounded due to presence of co-suspect product upadacitinib (RINVOQ). The case will be reassessed if additional information becomes available. 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 Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a male patient of unknown age, who received double dose of PNEUMOVAX 23 on 28-AUG-2012. The patient received a 0.5 ml dose of PNEUMOVAX 23 intramuscularly (lot # not reported) in one arm and in error (no product confusion) was given another 0.5 ml dose of PNEUMOVAX 23 in the other arm. No adverse event reported. Additional information is not expected.
Heart palpitations beginning 10 days post injection.  I had a similar response following the 2nd dose in series early in the year.  Symptoms have resolved at this time.
Fever, Aches, Chills, Fatigue have been ongoing since approximately 8 hours after the I had the vaccine.  I had the corona virus in July 2020 and I feel like I did when I had the virus only worse!  I am now going on day 3 and am still feeling these adverse affects and am wondering how long I can expect them to last.  When I had the virus in July 2020, I was sick for 3 weeks.  Will I be sick for 3 weeks with these vaccine side affects?  I am taking tylenol and ibuprofen but they are not helping much.  Taking Vitamin D and Zinc supplements and trying to drink lots of water.  I haven't yet contacted my doctor thinking these side affects will go away soon but I am getting concerned.
About 24 hours later I developed paralyzing panic and headaches. I could not sleep more than a couple hours a night at that point. This lasted for about 3 weeks. It finally went away as I got the second dose. I developed the panic again for a day and it went away. Then my period came and it was much more painful and heavy than normal. And I have the paralyzing panic and sleeplessness again. It clears but it?s happening with every period now. I?m having incredibly painful cramping and inability to function. I am not able to sleep due to feeling so incredibly wired. Having headaches surrounding my period still. I?m having the same symptoms around the time I ovulate as well.   I?m not sure how long this will last but hoping it isn?t permanent
Stinging at the injection site; This case was reported by a pharmacist via sales rep and described the occurrence of injection site stinging in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site stinging. On an unknown date, the outcome of the injection site stinging was unknown.   It was unknown if the reporter considered the injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced Injection site stinging. No further details reported.
Adverse Event: Vasovagal syncope 2- 3 minutes after injection  , treatment:  supine , legs raise, ice back of head , water Outcomes: after 911 evaluation by EMT patient left the pharmacy
4 hour course: 03/23/08 (onset). Office visit: 04/08/08. 4/11/08 Starting to feel better. Symptoms: fatigue; Generalized myalgias, chest discomfort, low grade fever, jaw (muscle) pain.
10 hours after the vaccine: fever, chills, body ache, diarrhea, abdominal cramps, light headedness. Treatment: electrolytes and paracetamol. Symptoms resolved after 24hours  9 days after the vaccination: headache, fatigue Treatment: ibuprofen  10days  after vaccination: fever 100.8, chills, body ache, skin sensitivity, fatigue, & mild headache.  Treatment: Paracetamol
Swelling and rash around injection site (lower deltoid), fever, flu-like symptoms, 105 degree fever. Tx with CIPRO in hospital (11/22/12) and had follow-up with PCP (11/24/12).
A nurse reported that a 38-year-old female was administered her first dose of RECOMBIVAX HB vaccine, 10 mcg on 27SEP95. There was no concomitant medication. On 29SEP95, the patient experiencd flu0like symptoms which included nausea, vomiting, a fever of 101 degrees F, and headache. She also developed jaundice and liver tenderness and was hosptialized. Therapy COMPAZINE was initiated for treatment. At the time of the report, the patient was still being treated. Additional details are being requested.
Tingling feeling in the left index finger; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling feeling in the left index finger) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PARAESTHESIA (Tingling feeling in the left index finger). At the time of the report, PARAESTHESIA (Tingling feeling in the left index finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD-2021-091434, MOD-2021-091434 (Patient Link).
Hub of syringe was loose and < about 0.5 mL of ZOSTAVAX leaked out. DId not re-dose as got most of vaccine injected.
Information has been received from a physician concerning a 9 year old male allergic to ibuprofen who at "one year of age", in approximately 1999, was vaccinated with a first dose of VARIVAX and did not have any symptoms. On 14-AUG-2007, 8 years between doses, the patient was vaccinated with a second subcutaneous dose of VARIVAX (Lot # 657796/0842U). There was no concomitant medication. Shortly after vaccination, the child had an anaphylactic reaction. The patient was treated with epinephrine and BENADRYL and was sent to the emergency room. At the time of the report, the patient was recovering. No product quality complaint was involved. The event of anaphylactic reaction was considered to be an other important medical event and life threatening by the investigator. Additional information has been requested. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from a healthcare professional who reported that the patient, with no prior history of medical conditions, or allergies (previously reported as allergy to ibuprofen), developed anaphylaxis, with wheezing and "feeling unwell". The patient was not experiencing any illness at the time of vaccination. There were no lab diagnostic studies performed. The patient recovered on an undisclosed date. No further information is expected.
Vomiting, unconsciencious, convulsions. Transported by ambulance to  Hospital. Hospitalized for 5 days. CAT scan, EEG,
Mother reported at md office that child developed cold symptoms within 24 hours after receiving flu mist. URI sx started first then a cough a day or so later. Sx worsened 2 days before office visit which was 11/18. Fever onset the pm before office visit on 11/18. Inhalers were started as soon as cough started. There is no mention of wheezing or asthma attack on the md office documentation.
It was reported that a 57 year old female patient was vaccinated with Fluzone on 11/4/02. The patient reported to the nurse that she developed chest pain and chest tightness on 11/5/02. The symptoms resolved without physician evaluation.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 30-AUG-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2015 and 13-FEB-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 13-DEC-2015, the patient was treated by another physician for ongoing and worsening symptoms of shingles, and the new diagnosis of secondary infections caused by shingles in the ear. The patient was prescribed LEVAQUIN, prednisone, and acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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. Upon internal review, secondary infections caused by shingles in the ear was determined to be medically significant. Additional information has been requested.
rash quarter size by site of injection; headache; flu like symptoms; a lot of phlegm; coughing and congestion; coughing and congestion; feeling fatigue; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion) and FATIGUE (feeling fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE RASH (rash quarter size by site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever), VACCINATION SITE RASH (rash quarter size by site of injection) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were not reported. Treatment medication like TYLENOL was included.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX (subcutaneous). In July 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional reported that another pharmacist at their pharmacy vaccinated the patient with SHINGRIX by subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccine administration. The reporter did not have any patient information at the time of reporting, since the vaccine was administered by the other pharmacist, who no longer worked at the facility at the time of reporting. The healthcare professional stated she would need to look up the patient. In July 2018, the healthcare professional called the patient, and stated about the occurred medication error, where the patient stated that only injection site pain was experienced and no other side effects were reported.
Rash really bad (reaction); This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-DEC-2022 Reporter's comments: The case was reported via interactive digital media. The patient got the shot for shingle and she had got a reaction and got the rash really bad. Additional supportive information:  Follow up would not possible, as no contact details were available.
this morning the patient came in to get the bivalent Moderna administered but I administered the regular Moderna instead of the bivalent Moderna
had autoimmune anemia / hemoglobin was lower than 8 / Hematocrit was 9.3; physical rash over her entire body; fever of 103; was sick; low hematocrit; first dose of Shingrix in June 2019.  She never received the second dose; low hemoglobin; night sweats; hives with heat; hives with heat; This case was reported by a consumer via call center representative and described the occurrence of autoimmune anemia in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for rash and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Tylenol at an unknown dose and frequency and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced autoimmune anemia (serious criteria GSK medically significant), night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased, hematocrit decreased and incomplete course of vaccination. The action taken with Tylenol was unknown. In November 2019, the outcome of the hematocrit decreased was recovered/resolved. On an unknown date, the outcome of the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness and hemoglobin decreased were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased and hematocrit decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 69 or 70 years. The patient received 2nd dose of vaccine in her right arm. The patient never received the second dose due to the side effects she experienced, which led to incomplete course of vaccination. The patient was sick, had a fever of 103 for more than one week. She had a physical rash over her entire body and she took Tylenol. She had hives with heat that lasted for 8 days. She had night sweats for 2 weeks. Her doctor drew blood and it was determined with hemoglobin that she had autoimmune anemia. Her hemoglobin was lower than 8 which resolved after 6 months. Her Hematocrit was 9.3 which resolved in late November 2019.  The patient was unsure if the physical rash she experienced was related to the Shingrix or the Tylenol.  All of the patient's side effects had resolved till the time of reporting. It was unknown if the reporter considered the Tylenol to be related to reported events. The reporter consented to follow up
Pt. developed few pinks macules at site 8.9.04, seen 8.10.04; injection site slightly crusted, and quadriceps swollen and tender. (Swelling and tenderness had developed 8.5.04) Initially (8.9.04)appeared to be slightly impetiginized, but by 8.11.04 area around injection site erythematous, with 2 target lesions---clearly urticarial.  Swelling and rash gone by 8.15.04
Around 5-6PM shoulder at injection site became very sore and a little bit of feeling faint off and on.  About 9:pm shoulder still very sore and hard to move arm without pain. around midnight woke up with chills and shaking. Got warm and about an hour later woke up in a deep sweat and felt like I was going to vomit. Sat up in a chair and in about 30 minutes felt better but still pain in shoulder. Woke about 6AM and felt dizzy, pain in shoulder and faint. Stayed in bed all day on 4/18 until about 1:30 and had a fever of 99.8. About 4:30 PM. Was able to get up and move around a bit, ate then back to bed. Felt better the next morning 4/19/18 but still pain in the shoulder injection site.  Took some Tylenol for the pain. On 4/21 the shoulder pain began to subside and only tender on 2/22.
pt recv vax & 5 days post vax exp herpes around the mouth;pt presented @ ER w/ a BP of 150/102;sx were present as of 17JAN96;
Awoke approx. 16 hrs after injection with swollen hands and hives behind legs. No SOB/no wheeze. Resolved with BENADRYL use.