chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt generally  bad; Sick enough systemically went to bed for 36 hours; substantial joint pain in hips, knees, hands; Headache; Slight nausea; Fatigue; VACCINATION SITE RASH; VACCINATION SITE ERYTHEMA; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache) and NAUSEA (Slight nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Low sodium diet (Low Na DASH), Mitral valve prolapse (mitral prolapse), Premature atrial contraction (PAC) and Hypertension (high BP).   On 17-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ibuprofen for treatment.  No concomitant medications were reported.   This case was linked to MOD-2021-014403.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Initial Additional-1 : AE outcome
Information has been received from a physician concerning a 65 year old female patient who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). On an unknown date, the patient developed zoster type rash at injection site after getting ZOSTAVAX (Merck). The patient sought unspecified medical attention. At the time of reporting, the patient had recovered. No further information is available.
Initial report was received 18 November 2008 from a health care professional.  A female patient (age and date of birth not reported) with an unknown medical history, had received a dose (administration, route and site not reported) of FLUZONE, lot number U2849AC on 07 November 2008 and an unspecified amount of time later, she developed a cardiac problem which required a stent.  The patient's recovery status was unknown and the reporter had no additional information to provide at the time of the report.  The reporter for this case is the same as case number 2008-03658.  Documents held by sender: None
This student received vaccines (Varicella, Hepatitis A, Flu Mist) on 03/15/2016 at 2:00 PM. The varicella vaccine was administered to the right upper outer arm subcutaneously by MA. No reactions noted 15 minutes after vaccine administration and the family went home. The next morning the mother noted swelling at the right outer arm where the varicella vaccine was given. Swelling and induration was noted at site throughout the day and the mother gave Ibuprofen suspension 2 tsp at 6pm and the following morning at 7am before returning to the clinic. The student arrived at the clinic today 2 days after the vaccine administration with noted swelling of the outer aspect of the right upper arm. The mother states that the swelling is less today that yesterday. Diphenhydramine (12.5mg/5ml) 2 tsp was given orally in the clinic. Ice was applied to the site. A prescription for diphenhydramine (12.5mg/5ml) sig 2 tsp po q 6 hours prn urticarial. Ibuprofen (100mg/5ml) sig.3 tsp po q 6 hours po q 6 hours prn T> 101 or pain. Appointment (recheck of site) scheduled for two days. No acute distress noted.
sore throat, t101, rash on arms & legs, h/a starting on 15MAy93 went to see MD on 16MAy93 was dx w/tonsillitis & was told it was a poss reaction to vax;
varivax received approx 8 hrslater edema and itching at site. Returned to clinic approx 18 hrs later with 3.5 x 3.5 cm warm, red, indurated itchy rather than tender
Pt felt faint, slumped onto father's shoulder. No injury from fall. Pt began vomiting and sweating post vaccine administration.
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 22 year old female with no medical history and no drug allergies, who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL. On 11-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient was approximately four or five weeks pregnant. The patient's last menstrual period was 24-DEC-2007 and her estimated delivery date was 29-SEP-2008. It was reported that the patient had not seen a physician but would be seeing a nurse practitioner. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information was received from the nurse practitioner regarding the outcome of the patient. It was reported that the patient had a primary cesarean section at 37+6/7 weeks secondary to an active outbreak of HSV (herpes simplex virus). The baby weight 2785 grams and had Apgar scores of 9&10. The reporter also stated the baby was fine without any problems. There were no reported complications for the mother or baby. Upon internal review, active outbreak of HSV (herpes simplex virus) was determined to be an other important event. No further information is available.
temperature excursion product administered to the patient with no reported adverse event; Initial information was received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA239960 (CLUSTER).  This case involves a 4 years old female patient who experienced temperature excursion product administered to the patient with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient had temperature excursion product administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, caller would like to find out if the vaccines involved in the previous excursion would need to be readministered.  She would like to find out if the vaccines involved in the previous excursion would need to be readministered. POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO Does extended stability data cover the excursion: NO And in case of negative advice: Was the product used by/ administered to the patient: YES This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023. ADACEL, MENQUADFI administered.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Within 2-5 minutes of receiving the vaccine, I began to feel dizzy.  I signaled for help while in my car  and help arrived. Within the next few minutes the severity seemed to go from ?0-100? and I began to feel a deep impending sense of doom and panic/fear. I also felt extremely tense in my muscles and felt itchy in the chest area. That continued for 15 minutes or so before subsiding slowly. Staff surrounded my car and were very supportive and great about the situation.   It was one of the most frightening experiences to date I have had. No EpiPen type intervention was done. Once the event was on the downswing I was kept for additional observation and release on my own accord.  Everyone there was great. I am reporting for my own records in case further testing reveals I have an allergy to this vaccine for employment purposes should the vaccine become mandated prior to me having alternative means of vaccination or allergy testing competed to determine if it was an true reaction or not so I can get vaccinated safely.
Received vaccine sept 14th. 4 days after sept 18th started to have severe palpitations and dizziness. Admitted to the hospital and Discharged on 20th .  The night of sept 20th rushed to ER for SOB,palpatation headache. Discharged. On sept 24th ambulance called for severe palpitations and blackout. Night of the Sept24th admitted to hospital for palpitations and dizziness.
This spontaneous report as received from a Physician refers to an unspecified number of patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number reported as: M0007764, expiration date on: 01-JUN-2019 for prophylaxis. The administered doses of the vaccine were exposed to a temperature excursions of 32 °F (degrees Fahrenheit) to 35°F (degrees Fahrenheit) for 123 hours and 31 °F (degrees Fahrenheit) for colder for 35 hours (coldest 26 °F). A digital data logger was involved. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA013063: US-009507513-1707USA013064.
felt crappy; had cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms) 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, the patient experienced MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms). At the time of the report, MALAISE (felt crappy) and NASOPHARYNGITIS (had cold symptoms) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-358069 (Patient Link).
A 2 month old presents to ER at 06:10 in full cardiopulmonary arrest. Two month immunization given the day before presentation to the ER.  Reported to MD. Per F/U 4/16/02: Pulmonary congestion and edema; focal pulmonary hemorrhage (history of vigorous cardiopulmonary resuscitation); no injuries demonstrated. The death therefore falls into the category of SIDS
PATIENT WAS VACCINATED WITH FLUMIST QUADRIVALENT AND REPORTED 4 DAYS LATER WITH A FEVER AND COUGH. PATIENT WAS TESTED AND IT CAME BACK POSITIVE FOR BOTH INFLUENZA A; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; POSITIVE FOR INFLUENZA B; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route, on an unknown date.     A Health Professional administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a (preferred term: Influenza A virus test positive). On an unknown date, the patient experienced positive for influenza b (preferred term: Influenza B virus test positive).     The outcome of the event(s) of patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a and positive for influenza b was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray   Product Role: Suspect
Extreme burning pain in arm at vaccine site since then extreme anxiety, depression, violent behavior involving visits to ER psych eval, psychologist and psychiatric appt. Turned my teen into a completely different person.  Refusing to attend school and associate with anyone outside of our home.
w/in 12 hrs p/vax, pt exp redness, induration & blistering; tx w/Medrol dose pack; seen in office; had 4cm of redness; 3mm of blistering @ inject site which was an improvement compared to prev day;
2/24.  Joint pain, headache, extreme fatigue & weakness in legs, chills & excessive night sweats Took 4 extra strength Tylenol over 12 hour period and stayed in bed all day. 2/25.  Extreme fatigue, chills, sweating, diarrhea & vomiting.   Took 2 extra strength Tylenol & tried eating a poached egg.  Vomited again.  Stayed in bed. 2/26.   Rash & itchiness at site of injection.  Applied ice packs.  Rested most of day.
death Narrative:  71 yo male who passed away on 1/29/2021, medical cause of death "cholangiocarcinoma, interval between onset and death 14 months. Since patient passed away within 42 days of the covid19 vaccine administration, we are required to complete a report to VAERS. Vaccine (Pfizer) was administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Synopsis- 1/23 71 yo male presented to ED with upper GI bleed. PMH: DM, HTN, cholangiocarcinoma of biliary tract requiring recurrent paracentesis, COPD, perigastric and lower esophageal varices (not on beta blockers due to bradycardia). Pt has had 2 episodes of coffee ground emesis. Lactic 2.6, ammonia 52. Rec'd protonix, octreotide, and ceftriaxone in ED. Family has been previously encouraged to speak to palliative care but has never been willing to. GI consulted. 1/24 EGD completed. No signs of active bleed. MDs recommending hospice. CT + for small bowel ileus. 1/26 Requires placement of NG tube to suction. Palliative care consulted. 1/27 Paracentesis completed. 4100mls removed. 1/28 Pt changed to palliative status. 1/29 Pt passed away.
FEVER OF 110 DEGREE; FELT BAD (FELT LIKE DEATH); This spontaneous report received from a consumer concerned a male 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: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 26-MAR-2021, reporter stated that the patient "felt bad" felt like death. Reporter also stated that patient had a fever of 110 degrees and wanted to know could give patient aspirin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 110 degree, and felt bad (felt like death). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210353896-covid-19 vaccine ad26.cov2.s-fever of 110 degrees. 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.
pt recv vax 27AUG98 & 31AUG98 pt presented w/facial paralysis;it was reported that pt was able to close lt eye w/great difficulty;2OCT98 pt was seen again by treating MD & did not look like had improved a measurable amount;
This case was reported by a physician via a regional medical scientist and described the occurrence of endotoxemia in a child subject of unspecified gender who was vaccinated with Hepatitis A vaccine (unk manufacturer). On an unspecified date, the subject received 1st dose of Hepatitis A vaccine (unknown details). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced endotoxemia. The physician reported that the subject received a monovalent Hepatitis A vaccine in the past and became endotoxic. No further information is available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
a tender lump above collarbone on left side; swollen lymph node(s) near the collar bone; a tender lump above collarbone on left side; After examining the site of the lump, it appeared to be swollen when compared to my collarbone on the right side.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), vitamin b12 nos (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D), all from unknown  dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:00, 2 days after receiving the second dose of vaccine, the patient experienced a tender lump above the collarbone on the left side, the lump was not immediately visible, but the patient could feel it with her fingers and move it around. After examining the site of the lump, it appeared to be swollen when compared to her collarbone on the right side. The lump on the left side was the same side where patient received the vaccine.  After researched by the patient, it appeared that the tender lump might be a swollen lymph node(s) near her collar bone related to the Pfizer vaccine.  It had been present for 5 days, but appeared to be reducing in size and sensitivity as time went on. The patient contacted her primary care provider who had instructed her to monitor the lump and follow up in person after a few weeks if it had not subsided. The patient did not know if that was an adverse event, but wanted to report the symptoms what she was experiencing and submitted a report. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events tender lump above collarbone on left side, swollen lump and swollen lymph node(s) near the collarbone was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 40-year-old female patient who received Fluarix Quadrivalent 2017-2018 season for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2017-2018 season, the patient experienced rash and injection site itching. The patient was treated with Medrol. On an unknown date, the outcome of the rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the rash and injection site itching to be related to Fluarix Quadrivalent 2017-2018 season. Additional information received as follows: The patient experienced itching at the injection site and rash. She had to took Medrol the year bofore reporting date for the reaction she had, and it took 8 weeks for it to completely resolve. No further details were provided. The reporter gave consent to follow up. This has been linked to the case US2018204728, reported for the same patient.
p/vax pt exp swelling & tenderness lt jaw area; fever to 102.4
Heart palpitations, lasting over 10 hours within 24 hours of injection each time.  First dosage caused an ambulance trip to ER at hospital as it happened twice within 72 hours of injection; once within 24 hours and once 72 hours later.  I did not go to hospital after 2nd injection even though my heart rate was over 140 bpm for 10 hours within 24 hours of injection.  I had an appointment with a cardiologist,  a few days later.
Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nauseous) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe Rash similar to measles rash- no fever, itching, or pain.