chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Red streak from injection site on left arm towards lymph nodes in left arm pit. Swollen and sore lymph nodes in left arm pit. Tinnitus in right ear developed 14 hours later.
body aches; headaches; light fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills). At the time of the report, MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills) had not resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
On 01/29/2021 was feeling  Nausea, Chills and Diarrhea, fever 101.9, Patient states that she was not able to keep anything down and took medication for the fever. On Monday 02/01/2021 patient was feeling weak and tired and felt like she has fast racing heart rate. Patient is feeling a lot better now. Patient was advised if new symptoms or symptoms return to go into UC or ER or give our office a call back.
On arrival to pt's house, spoke with family about possible side effects of vaccine.  Pt stated she did have previous allergic reactions with anaphylaxis but spoke with PCP.  Pt agreeable to pfizer vaccine lot ew0185 to L arm.  Pt reported dizziness and nausea about 5 to 10 minutes after receiving vaccine.  Family got pt water and cold cloth.  About 10 minutes later pt reported chest heaviness.  This nurse drew up epinephrine but pt did not feel epi was needed just yet as she could still breath fine and opted to take inhaler with some relief instead.   Ten minutes later pt reported soar throat, hoarseness, and chest heaviness again.  While pt was talking with this nurse, she began to be unable to complete full sentences and was clearing her throat.  No cyanosis noted.   Pt stated "it's time" and this nurse agreed and administered 0.3mg of epinephrine into the pt's R thigh @ 1421.  911 was notified.  Vital signs were taken.  97% o2 on room air, heart rate 90, breaths per minute 18,  blood pressure 128/94. Pt experienced near immediate relief from symptoms.  Alert team remained to monitor pt and await EMS.  EMS arrived @ 1432.  Pt able to ambulate to ambulance with EMS to be checked out and taken to hospital for observation.
Mouth got an odd taste-dry- change in sensation which persists. Feeling that the end of the tongue is burnt but without pain or change in taste. Sensation is noticeable when doing little (like driving) but is forgotten about when busy.   Approximately 10-12 weeks after vaccination I started waking up in the night with tingling in the left arm (where injection was). This continued for several weeks and got worse- till pain was occurring in the left back arm (ulnar nerve pain). It progress to neck pain.  There is pain at the shoulder back neck to the armpit where the nerves go down the arm.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUL-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Extreme fatigue (rest, lasted 48 hours) Extreme muscle pain (Advil every four hours, lasted 24 hours) Extreme joint pain (Advil every four hours, lasted 18 hours) Fever (started 12 hours after shot and broke 4 hours after it started) Hot/cold flashes (lasted 36 hours)
A report was received from a Health professional regarding a patient who was accidently given last years flu vaccine in error.  There were no adverse events reported.  There was insufficient information to determine the reporter's causality assessment.
Arm was hurting; Huge red lump around the arm; when you touch, it was swollen; m It was hard rock about 2.5 inches in diameter; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter). At the time of the report, INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Within 12 hours - I had fever and chills, really bad headache; missed a day of work because I felt so crappy. That passed within 24 hours. I first noticed a lymph node  on right side of my neck within 2 days of the vaccine. I had a swollen lymph node on the right side of my neck - I can feel it - it was about the size of nickel and round. I went to see my doctor and they want me to go get an ultrasound. That happens this next week. It's about the size of a pea now. I have had a in person visit with doctor and televisit.
FEVER, REDNESS TO ALL 3 INJECTION SITES, SWOLLEN ABOUT 1 INCH HIGH AND 2 INCHES AROUND SITE, SITE VERY HOT AND SORE TO TOUCH.
Pt reported diffuse hives and hoarse voice approx. 10 minutes after injection. Pt also reported rapid heart rate and difficulty breathing. Pt appeared to wax and wane symptomatic to asymptomatic over about 15 minutes. At 15 minutes EMS was called to further assess and transport to ER. Total time from onset to EMS transport was approx. 30 minutes.
Minor rash on trunk of body and itching last two days. Lortadine 10 Mg every 24 hours last two days.
Patient received pfizer dose for patients 5 to 11 but patient is 12.  Patient turned twelve previously.
moderna vaccine given to a 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old). On 23-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old) had resolved.        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 medications provided. No treatment information provided.
I had inflammation around my eyes. It felt like a slight eye irritation. I also had a slight throat irritation and some fatigue.  Those symptoms lasted for about 2 days or less. I had a slight moment of feeling that again briefly but then the feeling didn't stick around. The symptoms showed up momentarily and they didn't stay. I am living with someone who is having symptoms of a sore throat and sinus issues so I could be either getting something from them or giving them something.
Pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of Hep B vax on 18AUG92 & w/in an hr following the vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; no further details were provided;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 6 (booster) , single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster) , single (Batch/Lot number: unknown), as dose 4 (booster) , single (Batch/Lot number: unknown) and as dose 5 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 06Sep2023 to 10Sep2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
It was the next morning I woke up with a severe excruciating headache and ten trigger fingers. It lasted for two weeks before I finally called my doctor and was referred to specialists first my Ophthalmologist, ENT, Neurologist, a hand surgeon and a Rheumatologist. The trigger fingers subsided to a few days a week as did the headaches.
Took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours; A spontaneous report was received from a physician on 03JUN2022. It described a male patient (unknown age) who "took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took his second dose 24 hours after the first dose instead of taking it every 48 hours.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took the second dose of Vivotif 24 hours after the first instead of taking every 48 hours (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Information has been received from a physician concerning a 18 month old female with no known drug allergies and no prior medical history who on 07/07/2001 was vaccinated with varicella vaccine. On that same date, the pt was vaccinated with MMR vaccinated in the opposite leg. On 07/10/2001, the pt's mother telephoned the physician's office complaining that the varicela vaccine injection site had become red, tender, swollen and hard. The pt was treated with a cool compress. On 07/17/2001, red bumps were noted at the injection site. On 07/18/2001, the pt's mother phoned the physician's office again with the same complaints. The pt was seen in the office on 07/20/2001 at which time the area around the varicella vaccination site on the anterior thigh was noted to be indurated, erythematous with 2-3 localized zoster-like vesicles. The pt was afebrile, no other systemic symptoms were noted and no lab testing was performed. On 08/06/2001, the pt was seen by the physician who noted that the pt had 3 papular lesions with surrounding erythema, no vesicles and that the lesions had a "look of drying out varicella lesions around the injection site." The pt did not received any treatment. Subsequently, the pt recovered. Additional info is not expected.
Initial unsolicited report received from a consumer on 01-Nov-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose and dose in series route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, after the vaccination, patient had been extremely sick and had been hospitalized (date not reported) and placed on a respiratory. It was also reported that after many doctors stated they did not know what was wrong with her a physical said she had a virus that he been embedded in a flu vaccine that attacked her kidney that caused the problems. Lab test and corrective treatment was not reported. Outcome of the events were not recovered. Documents held by sender: none. Sender's Comments: In this case the patient had been extremely sick due to flu virus which attacked her kidney and caused problems after vaccination with INFLUENZA vaccine MFR UNK). Time to onset is unknown. This is a poorly document case. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on the information available, a role of the vaccine cannot be assessed.
10/4/2022 Full range of motion of all extremities. No axillary LAD.  Erythema with mild warmth and moderate edema entire L upper arm, does not cross over shoulder or elbow joint but leads right up to both.   RUE 7.1in circumference, LUE 8.2in circumference Keflex 450mg BID X 7 days
Myocarditis; Information was received on 09JUL2021 in review of scientific literature.    This case describes an additional single patient identified during review of the entire registry who experienced myocarditis (PT: Myocarditis) after receiving a smallpox vaccine (date unknown).  This study was conducted to review a prospective outcomes registry of COVID-19 vaccinated patients who developed myocarditis for the 3-month period between 01FEB2017 to 30APR2017 and though 2021 and to also identify all patients with possible vaccine-associated myocarditis during the past 20 years.  One of the patients (age, 23-36 years), a member who developed myocarditis after COVID-19 vaccination also had history of documented (as per author) myocarditis approximately 4 years earlier after administration of smallpox vaccine.    Medical history and concomitant medications specific to this patient was not reported.   No additional information is available at the time of report.  Company Comment:  Myocarditis is a known complication that has been reported after ACAM2000 vaccination. However, due to the lack of information the causality cannot be properly assessed; therefore it is considered as "Not assessable". If the occurrence of myocarditis has been documented, it is possible that this case is duplicated. More information will be sought. Although there is no information, the case Is considered serious.; Sender's Comments: Myocarditis is a known complication that has been reported after ACAM2000 vaccination. However, due to the lack of information the causality cannot be properly assessed; therefore it is considered as "Not assessable". If the occurrence of myocarditis has been documented, it is possible that this case is duplicated. More information will be sought. Although there is no information, the case Is considered serious.
occasional flare up of ulcerative colitis; Fatigue; Vaginal dryness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358047-00.  A 64-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history included: "lichen sclerosus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "occasional flare up of ulcerative colitis"; FATIGUE (non-serious), outcome "unknown"; VULVOVAGINAL DRYNESS (non-serious), outcome "unknown", described as "Vaginal dryness". The action taken for adalimumab was unknown.  The reporter considered "occasional flare up of ulcerative colitis", "fatigue" and "vaginal dryness" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of colitis ulcerative, vulvovaginal dryness, fatigue is assessed as possibly related to the suspect drug "BNT162B2" based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient began to feel dizzy 1 minute or less after given first dose of Moderna.    She then became unresponsive. Called 911 .  Her mother  held her upright in chair until it was safe to move her to floor. And I cradled her to monitor that she still had a pulse and was breathing.  Continued to talk with her while waiting for ambulance to arrive.  She did not respond to verbal interaction, she did have a pulse and was breathing, however it was shallow.  Her eyes were open but unresponsive.  We moved her to the floor as soon as it was safe after about 10 minutes.  Once we moved her to the floor she became responsive once again.  gave her a bottle of water and at that time the EMT arrived.  They checked her out and she was able to answer their questions. They completed their care for her and left her to her mother's care.
Patient fainted, turned pale, made patient lie down, gave water. Patient fainted again, again we laid him down, water and took his blood pressure and pulse.
Before I even got out of bed on Oct. 7 at 4:00 am, I felt dizzy.  I tried to get ready for work that morning, but felt very "drunk" and knew it would not safe for me to drive to work, or to be at work.  So, I had to call off work.  I felt "drunk"  all day and laid on the couch all day and evening.  By the next morning (Oct. 8) I felt about 80% better, so I did go to work, but as the day went on, I felt slightly worse.  I felt basically normal by later that evening (Oct. 8).
Patient could feel the heat in her arm; Patient has swelling in the injection site; Patient has big red swollen arm patch, the size of an orange in arm of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 20-Nov-2022, 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. On 21-Nov-2022, the patient experienced VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: Positive.         Patient was taking concomitant medications but did not specify on what.