chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exhibited all of the symptoms of serotonin toxicity; emotional ride on the weekend; possible drug interaction/patient on Prozac and Trazodone; This spontaneous case was reported by a physician and describes the occurrence of SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced exhibited all of the symptoms of serotonin toxicity, emotional ride on the weekend and possible drug interaction/patient on Prozac and Trazodone    The patient's past medical history included Blood pressure high (On blood pressure medication (stable)).  Concomitant products included TRAZODONE for Sleep disorder NOS, FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) (seriousness criterion medically significant), EMOTIONAL DISTRESS (emotional ride on the weekend) and DRUG INTERACTION (possible drug interaction/patient on Prozac and Trazodone). At the time of the report, SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) and DRUG INTERACTION (possible drug interaction/patient on Prozac and Trazodone) was resolving and EMOTIONAL DISTRESS (emotional ride on the weekend) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient took vaccine and then exhibited all of the symptoms of serotonin toxicity. Patient went to urgent care and "they had no clue." Patient hopes the message can be used to add to the research as serotonin syndrome is very serious.; Sender's Comments: There is not enough information to assess this case as treatment date and onset date of the events were not provided.  Description of symptoms for all reported events to enable adequate assessment is also lacking.
Starting at 10:30 p.m. I experienced severe, shaking chills, fever, random tingling, some joint aches and a headache. I took advil p.m. and tried to sleep, but really couldn't sleep much. By 7 a.m. the symptoms subsided accept for a mild headache. I went to my teaching job that afternoon and felt pretty good. Now two days later, I feel completely fine.
High fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever after 2nd dose) in a 62-year-old female patient 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. On an unknown date, the patient experienced PYREXIA (High fever after 2nd dose). At the time of the report, PYREXIA (High fever after 2nd dose) outcome was unknown.            Concomitant medication included blood pressure medication,diabetes medication and high cholesterol medication were reported. No treatment details were reported.   This case was linked to MOD-2022-462968 (Patient Link).
This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB (lot# M007762 expiry date: 07-DEC-2018, lot# M020101 expiry date: 07-MAR-2019). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from same reporter. Additional information has been requested.
slighty swollen sore arm with both vaccines; slighty swollen sore arm with both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Heart valve disorders (history of heart valves). Concurrent medical conditions included Overweight (slightly overweight).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines). At the time of the report, VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-337936 (Patient Link).
Redness 13x17cm swollen edges of redness whelped hive-like warm to touch Lt leg.
Herpes sine Herpete  involving C3 R side. I had the same thing 2 years ago documented by serology. I have had Shingrix vaccine. As this has occurred less than 2 weeks after 2nd vaccine dose I felt it should be reported
Patient developed a lump immediately after vaccination. then a few days later developed redness and itching within 48 hrs, persistent soreness. presents on day # 8 to clinic with worsening itchiness and painful, more swelling
Took two doses of Vivotif and then diagnosed with an infection (urinary tract infection); Spontaneous report received on 15JAN2020. Additional information received on 16JAN2020.  A nurse reported that an adult female consumer "took two doses of Vivotif and then diagnosed with an infection (urinary tract infection) (UTI)"(PT: Urinary tract infection). She was receiving Vivotif for immunisation. The consumer took two doses of Vivotif on an unknown date and then diagnosed with UTI on an unknown date. Action taken with Vivotif with respect to the reported event was unknown. The outcome of the reported event was unknown.  Treatment medication included an antibiotic for UTI, which was a "sulfa drug" but she could not confirm the drug. She did not know the start date of the antibiotic but it was reported that she was still taking antibiotic which would be completed on 20JAN2020.  Company Comment: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.
Patient says she has been getting muscle pain and slight fever for the past 2 weeks. She can't lift arm up sometimes and has pain up to the shoulder and neck. Injection site not swollen or infected.
pt exp large local react w/redness & rash at inject site. 4 hrs after vax local rx completely gone
Relative bradycardia approximately 80 bpm, central facial pallor without cyanosis, decreased awareness (not recognizing/acknowledging mother) but not unconscious. Occurred within minutes of final vaccine & lasted approximately 5 minutes. Recovered spontaneously. Received some O2 by mask. No rash, no airway changes.
Reported palpitations which is a feeling of a single strong heart beat w/ associated catching of his breath and feeling of startle and mild anxiety which started w/ other post COVID vaccine symptoms of f/c, fatigue, and body aches. Other symptoms resolved but not startle symptoms and pt now also having cough and nasal congestion. Normal exam other than congestion. EKG NSR w/ no feeling of the startle while here and no CP or SOB. CXR normal. Full lab eval also normal including neg CRP, Trop, BNP, and D dimer. CBC and CMP also normal. TSH mildly elevated but normal T4 so likely c/w pt's prior minor thyroid abn but unlikely to be source of current symptoms. Given normal exam and w/u do not feel myocarditis, pericarditis, or clots or other significant process associated w/ current symptoms. Pt retested for COVID since not fully immune prior to symptom onset.
chills, night sweats Narrative:   chills, fever, nights sweats, general aches/myalgia for 3 days. Pt had covid-19 in December 2020
Experienced symptoms of Tinnitus several months after receiving both vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Dec2020 15:45 (Lot number: EL3247) as dose 1, single and administered in arm left (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 15May2021, outcome "not recovered", described as "Experienced symptoms of Tinnitus several months after receiving both vaccine". The event "experienced symptoms of tinnitus several months after receiving both vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications the patient received within 2 weeks of vaccination. Experienced symptoms of Tinnitus several months after receiving both vaccine. No other cause. Reported to provider. Patient was not covid prior vaccination and did not test for covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
Patient developed a 102.1 fever at around 6:30 am on 07/08/2022. She was tired throughout the day, slept more than she typically does, and did not eat much at meals.
Patient's arm started involuntarily shaking about 17 hours after vaccine administration.  Patient states it continued for an hour then gradually subsided.  She would also like to report severe headache beginning at the same time.
MD recv phone call from parent 6:05, 29JUL97 3-4" indurated & gross swelling of rt thigh w/rt thigh larger than lt & pt refusing to move;t102;
This case was reported by a physician via sales rep and described the occurrence of hepatitis acute in a 67-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced hepatitis acute (serious criteria GSK medically significant), influenza-like symptoms, headache, general body pain and feeling unwell. On 17th May 2018, the patient experienced liver function test increased. On an unknown date, the outcome of the hepatitis acute, influenza-like symptoms, feeling unwell and liver function test increased were unknown and the outcome of the headache and general body pain were recovering/resolving. It was unknown if the reporter considered the hepatitis acute, influenza-like symptoms, headache, general body pain, feeling unwell and liver function test increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On the next day, the patient developed flu like symptoms which included headache and body aches. The reporter reported that the patient had symptoms for 3 to 4 days. These symptoms were improving. On the 5th day, after vaccination with the dose of SHINGRIX, the patient felt worse. At the time of reporting, after 2 weeks the patient was still not feeling well. The reporter stated that blood work was done with results which included Aspartate aminotransferase (AST) 400, absolute lymphocyte counts (ALC) 540, Potassium 406, platelets 94 and inflammation marker of 53 and reporter diagnosed acute hepatitis. Blood work showed elevated liver function tests, Aspartate aminotransferase (AST) 400 and alanine aminotransferase (ALT) 590. The call center representative noted that he was not able to confirm and clarify these lab values with the reporter. On 17th May 2018, 14 days after vaccination, the patient went to the emergency room, and was tested for liver function test (LFT's) which were found to be 800. The patient was screened for hepatitis A infection, which was found to be negative. The physician reported that the patient was sent home and referred to follow up with his physician on 21st May 2018. The vaccination date could be 3rd May 2018 or 4th May 2018, however, no clarification could be obtained.
There was an excursion from the freezer; There was an excursion from the freezer/administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not know how to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients.Concomitant medications were not reported. Treatment information was not reported.
6 MO was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2019, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 2019, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 2-Sep-2022 Reporter's Comments: The nurse reported that going back through old records from 3 years ago and noted that a 6 month old patient was administered a dose of Kinrix. The vaccine administration facility was the same as primary reporter. The reporter give consent to follow up. Additional Supportive Information: The reporter stated 6-month-old patient was administered a dose of Kinrix which led to inappropriate age at vaccine administration.
Information has been received from a pharmacist concerning a 65 year old white female who on 20-AUG-2007 was vaccinated subcutaneously in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot# 658207/0883U). On 28-SEP-2007 the patient developed a lump on her right arm (unknown location of the lump on the arm). On 28-SEP-2007 the patient sought medical attention at the pharmacy. The patient's outcome is unknown. Follow up information received from the pharmacist indicated that the lump has persisted. Additional information has been requested.
Pt received 1st dose Pfizer COVID vaccine 12/18/20. On 12/21/20 pt presented to Urgent Care with headache, hypertensive, nausea/vomiting, shortness of breath, myalgia, fatigue, cough. COVID, Flu A/B, and RSV PCR all negative, CXR negative. Per provider note, potential side effects 2/2 COVID vaccine administration. Pt received compazine, toradol, zofran. Pt did not receive epi, no ED visit.
pt recvd vax; devel fever, watery eyes, malaise, myalgia & weakness; was tx w/ apap;
1/19/00, pt w/heavy feeling in jaw, mostly L/side, stated jaw felt so tense. C/o tongue feeling thick. No fever. Pt was seen by PMD & told sx's probably caused by new B/P meds & not caused by vax. PMD Rx'd Claritin & stopped Prinivil.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2017, the patient was vaccinated with one improperly stored dose of ZOSTAVAX (lot #: N013274, expiration date 04-JUL-2018; dose and route of administration were not reported) for prophylaxis. The sterile diluent (lot # M006117 and expiration date: 24-AUG-2018) used did not undergo a temperature excursion. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported.
influenza vaccine expired in June was administered to a baby with no reported adverse event; Initial information received on 14-Sep-2021 regarding an unsolicited valid non-serious case from physician and consumer/ non healthcare professional via Media Information (under reference 00767922).  This case involves a 9 months old male patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 13-Sep-2021, the patient received a 0.5 mL dose of suspect FLUZONE QIV (total, lot UT700BA and expiration date: 30-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "HCP (health care professional) states influenza vaccine expired in June was administered to a baby and would like recommendations on what to do."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 10/27/15, 16 month old F was brought to clinic for well child check. During visit, pt received immnizations for hepatitis B, MMR and varicella combined and pneumococcal conjugate vaccine 13-valent. Immunizations were administered without incident and pt was dischaged in stable conditoin. On 10/28, pt's mother called clinic and reported that after injections, pt developed a fever to 102 degrees and diarrhea. LPN advised that these were labeled possible side effects. MD notified and documented "It is possible that this infant is developing early symptoms of varicella, as she has been exposed. Recommend supportive care, patient may see us or her regular pediatrician if worsening or persistent concerns." Event reported to VAERS.
Several hours after getting the shot I started to get dizzy and my motor function slowed way down. I got migraines and breathing problems, and four months later nothing has gone away, the symptoms are permanent it seems. I can feel my heart palpitating and though I'm starting to adapt to living with these problems it's definitely something I regret doing and won't be getting any more of these untested injections.
The first COVID-19 case my heart was spiking on Thursday; then on Friday my heart rate consistently was spiking to the 120's 130's. I was really really tired. It was mild and I spent the weekend resting. I had a worse reaction with the Jansen vaccine than I did with COVID-19. I didn't have issues breathing or anything like that and recovered relatively quickly. My heart has taken a toll, it's not right. The second COVID-19 case my husband came down with it and my exposure to him was a lot and was admitted to the hospital with TIA. The week prior I had developed a full-on body rash. I was negative the first time they tested me with the antigen. Then on Tuesday the June 7th I was still negative but symptomatic. Coughing, throwing up, tired and not feeling well, by Friday my body was exhausted and completely wiped out. I was taken to the hospital on the June 10th where I was diagnosed with COVID-19. I still had cough but no respiratory issues; and I had brain fog and my heart rate continued to spike to the 140s while sedentary. Another issue I've been having is that ever since the vaccine I've had highly irregular period. And two weeks after the previous dose and it went for 7 days.
pt recv vax 17OCT95 & 4MAR98 pt devel chickenpox 10-12 lesions on trunk, forearms & neck;
6 days after injection i developed redness and swelling of the injection site. It became very hard upon palpation. The area was hot to touch and continued to spread. The area has been marked with a sharpie and the redness continues to spread. It is Saturday so I have to wait until Monday for my primary care office to open for further treatment. Currently I am utilizing oral benadryl, benadryl cream, cold compresses, and ibuprofen.
bilat dorsal hand/wrist synovitis without active arthritis pain or redness. started 2 hours after vaccine. persists.