chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling a bit weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling a bit weak) and CHILLS (Chills) in a male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced ASTHENIA (Feeling a bit weak) and CHILLS (Chills). At the time of the report, ASTHENIA (Feeling a bit weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
soreness at the arm where the injection was; Chills; running a fever; do not feel well; leg hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Aug2021 (Lot number: EW0165) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "soreness at the arm where the injection was"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "running a fever"; MALAISE (non-serious) with onset Aug2021, outcome "unknown", described as "do not feel well"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "leg hurts". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated no other prior vaccination was administered.   No follow-up attempts are possible. No further information is expected
On February 25, the day after receiving the 2nd dose she developed a red mark at the injection site, arm soreness, and swelling of shoulder ( above injection site, near collarbone). Patient also reported flu like symptoms and states she felt like she got hit by a truck. Patient has been taking Tylenol to reduce the pain and noted slight improvement today (02/26/2020). Patient denies hx of stomach/intestinal bleeding or kidney issues, and was recommended to try ibuprofen or naproxen if Tylenol is not adequately relieving pain. Patient to follow-up in a few days to let us know if there has been improvement or resolution of adverse reactions and to contact primary care provider if not improving.
Initial unsolicited report received from a nurse (LPN) on 27-Oct-2016. This case involves a 94-year-old female patient who was vaccinated with FLUZONE HD (lot number: UI689AA, expiration date: 26-Apr-2017, dose in series, site of administration not reported) intramuscularly in left arm on 19-Oct-16. Illness at the time of vaccination was reported as unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy. Concomitant medication was not reported. On 20-Oct-2016, one day after the vaccination, patient had warm skin, headache, shaky and lethargic with a fever of 101F. Patient required ER/doctor visit. The patient's laboratory and corrective treatment were not reported. It was reported that all symptoms were resolved on 27-Oct-2016. (The outcome was also reported as not recovered). List of the documents held by sender: none.
On Thursday, 5/6/21, client was to receive her first dose of Pfizer COVID vaccine (LOT #: EW0167, exp: 8/2021) at approximately 10:30am. RN administered client's first dose in her left deltoid. Client was observed in the Observation Area for 15 minutes with no adverse effects and left vaccination site with a steady gait at approximately 10:50am. RN finished administering his 6 doses around 11:45am and returned his form." Another RN noticed a duplication in forms. Upon further assessment, another RN recognized that she had reconstituted the same Pfizer vial twice with 1.8ml of Normal Saline. Issue was elevated immediately to Clinical Lead who advised to call client back to receive the proper full dose. Client was called at 1:20pm. RN apologized and explained to client what happened. Client was understanding and verbalized agreement to come back at another time. VAERS completed on 4/7/21.
This case was reported by a physician and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject completed two full series of vaccinations with Engerix B at 1 ml.  An unspecified amount of time following completion of each series, the subject was found to not be responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Passed out next morning, went to ER, received 2 units of fluids, released with heart monitor for 48 hrs
Armpit swollen up to the size of a softball (assuming lymph node swelling); Achy pain yesterday; Sore, especially to the touch today; still swollen
rash; This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The doctor shared that the patient returned with a rash on the back of the neck after receiving a dose of Shingrix.  The reporter referred the patient to the dermatologist.
Patient spouse reports on evening of vaccine patient began with slight arm pain, vomiting, nausea, dizziness and chills have continued daily.
pt recvd vax & 7 days p/vax exp elevated liver function tests; pt was seen by MD;
Pain (left wrist to finger) / Achiness; Vomiting; Weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). On 10th October 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain, vomiting and weakness. On an unknown date, the outcome of the pain, vomiting and weakness were not recovered/not resolved.   It was unknown if the reporter considered the pain, vomiting and weakness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received vaccines on left arm. The patient experienced pain (left wrist to finger), vomiting, achiness and weakness. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. The outcome reported for all AES in the structured field of XML is "recovering" instead of "not resolved" (outcome uploaded in system).
Subsequent to receiving the second dose of Engerix B the pt experienced deep pain in the injection arm, nausea and lower back pain. No treatment was given. The most recent information received reports that her left arm still hurts, but her nausea and lower back pain have resolved.
Initial information regarding an unsolicited valid non-serious case received on 03-Oct-2018 from a consumer. This case involves a 49 years old female patient who experienced flu symptoms, chills, body aches last night, general not feeling well and low grade fever (below 100.4 f), while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication(s), vaccination(s) and family history were not provided. On 01-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot U6263CA via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious chills (Chills) and body aches last night (General body pain) five hours following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious flu symptoms (influenza), general not feeling well (Feeling unwell) and low grade fever (below 100.4 f) (Fever) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests included no lab data. Final diagnosis was low grade fever (below 100.4 f), general not feeling well, body aches last night, chills and flu symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is unknown for all events. List of documents held by sender: none.
Chills; Nausea; Vomiting; Weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on 16Mar2021 at 10:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), lurasidone (LATUDA), bupropion (WELBUTRIN), dextroamphetamine-amphetamine (ADDERALL), valacyclovir (VALTREX) taken within last two weeks of vaccination for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Feb2021 at 10:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient experienced chills, nausea, vomiting and weakness on 17Mar2021, at 10:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, nausea, vomiting and weakness were recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information expected.
Patient complained of chills, sweating, aching, weakness starting 10 hours after immunization. Patient started feeling better today two days after immunization
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from literature: This report concerned a 36 year old female of an unspecified race and ethnicity. The objective of the study is to present in-depth characterization of transmission and immunity among vaccinated individuals in a household, revealing complex dynamics and unappreciated comorbidities, including autoimmunity to type 1 interferon in the presumptive index case. 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow up will be requested for this case. Age at time of vaccination 4 decade old. No concomitant medications were reported. The 5 individuals were live together in the same residence, where they ate, slept and socialized with one another in an un-masked setting. The individual number 6 lived separately but frequented the home of individuals of 5. Together, these individuals also attended weekly community events, such as religious services, together as 1 large group. Each individual was thus exposed to one another either through co-residence or frequent visitation. On 16-MAY-2021, the patient (individual number 2) had fever, cough, rhinorrhea and headache. On 19-MAY-2021, a covid-19 PCR test was performed which was positive (confirmed covid-19 infection) which leads to confirmed clinical vaccination failure. On 23-MAY-2021, a rapid antigen test was performed which was came as positive. On an unspecified date, anti-interferon (IFN)-a2 autoantibodies test was performed from the serum which was negative. The patient did not required care at a health facility and improved with self-monitoring at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. The authors emphasized that with household exposure to COVID-19, even fully vaccinated individuals with typical levels of neutralizing antibodies are at risk of infection. The data support the urgency for continued vaccination, boosters, and next generation vaccines that contain mutations known to confer immune escape potential. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000267919; Sender's Comments: V0: 20230136345- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Patient experienced hives on left arm approximately 6 minutes post-vaccination (patient also experienced this after vaccination with first dose)
Resident with chronic lower extremity edema and mild shortness of breath, resident has been receiving chemotherapy for treatment of stage 4 colon cancer with mets to the lymph nodes. Resident has been having large amounts of diarrhea and some nausea and emesis noted at times. On 12/17/2021 at 9:00pm nurse notes his O2 stats were below 80% on room air and his body temparature was 93.2 degrees ferenheit. They placed him on 2L of oxygen per nasal cannula and were only able to get his O2 stats up to 81% on 5L oxygen per nasal cannula. He continued to be hypothermic and was incontinent of multiple loose stools. Resident was very weak and agreed to be transported to the local hospital where he was treated for acute respiratory and acute kidney failure. He was discharged from this facility at 2230 on 12/17/2021. Facility was informed resident passed away the morning of 12/18/2021 at the hospital.
Child had vaccines 1/20/11 and seizure x 1 = 2 minute duration on 1/23/11. Resolved spontaneously and ER eval showed NL CBC, BMP and CT Scan head.
massive sweats; not been able to sleep; intense dreams; Redness; very inflamed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 046C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020 and Neurological symptoms NOS on 04-Jul-2020. Concurrent medical conditions included Type 1 diabetes mellitus (diabetic with major neuropathic reaction). Concomitant products included INSULIN for an unknown indication.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed). At the time of the report, HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient reports being on 2 types of insulin.  Patient reports after bug had sever rashes all over leg and arm left marks.   This case was linked to MOD-2021-337577 (Patient Link).
Information has been received from a physician concerning a female patient with obesity and sulfonamide allergy who "last week" on approximately 07-FEB-2011 was vaccinated with a first dose of GARDASIL (Lot # not reported). The physician reported that the patient, after receiving her first dose of GARDASIL last weekend, experienced an allergic reaction. Patient had a sulfur allergy and presented with similar symptoms. Patient's primary care physician listened to her chest and reported a breathing difficulty indicative of an allergic reaction. No treatment was given for adverse event. There were no laboratory tests or diagnostic studies performed. It was reported that "the patient will not continue the dose series". At the time of the report, the patient had recovered (date unknown). The patient sought unspecified medical attention. Additional information has been requested.
Provider administered 0.3 cc of the pfizer covid vaccine for 5-11 yo patients. CDC web site reviewed and noted that pt will not need additional vaccines at this time. No need to repeat, no need to monitor. This writer called the  Immunization Dept. and instructed on how to document the vaccine so that it is clear that pt got 0.3 cc of 5-11 yo strength. APRN who ordered vaccine informed,  parent informed via phone, facility event report completed.  Facility had both COVID vaccine solutions side by side on a table. Day of even the clip boards with forms and solution switched from who they were normally placed and this writer did not notice until the end of the shift.  As a result the vials are now placed in 2 separate spaces in the med room to minimize the error occurring again.
Pt began to feel very dizzy at 1044  approx. 4 min after first dose pfizer vaccine  then pt began to feel nauseated zofran 4 mg given with no  relief  pt began feeling chest pressure MD  notified EKG x2 performed pt has no relief of symptoms per provider pt will go via ambulance to nearest ED for further evaluation.  Pt was A&Ox4 at time of departure family notified of pt condition all nursing notes completed per policy.
This spontaneous report was received from a pharmacist referring to a 60 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt presented with a history of skin eruptions, seemingly associated with varicella,  over the past 24 to 36 hours. Pt had prodrome  consisting of headache, nausea and temperature elevation.  It was reported that pts pruritus was low in intensity. Physician felt the pts symptoms were indicative of a low grade manifestation of varicella.
6 days post vaccine patient presents to clinic with Left side facial paralysis,  left blurred vision, and left ear pain. Bells Palsy.
A few days after receiving the vaccine I began to experience tinnitus. While it has varied in intensity it has remained with me to this date.
Case number PHEH2014US019857 is an initial spontaneous report received from a pharmacist on 01 Oct 2014. This report refers to and adult male patient who was in his 40 to 50s. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 24 Sep 2014. On 28 Sep 3014, he experienced pain and soreness in his arm. The event outcome was unknown. The seriousness and causality were not reported.
Patient stated she had "Vertigo Attack" on 07/01/2021. Suspects it was caused by vaccine.
Parent reported on 12/15/10 at 10:00AM that pt. was transported via ambulance around 2:30AM due to seizure activity to Medical Center. Pt. had a temperature of 101.6. Followed up with Dr.: pt. pediatrician on 12/15/10 afternoon. Parent states pt. Dx. with ear infection and congestion. Parent states pediatrician feels like seizure activity was related to fever and not the vaccines.
Patient was vaccinated Moderna 3/18/201 and 4/17/2021  3/11/22 patient was seen in the ED after being found on the floor at his home. Patient had been discharged on 3/1/22  Patient was admitted to ICU on 3/11/22  Patient died 3/12/2022 at 23:19  Cause of Death per WEB REPORT was stated as  Acute Hypoxic Respiratory Failure secondary to Cardiogenic and Distributive Shock. Secondary Contributing Diagnoses: Acute kidney injury, A. fib RVR, anion gap metabolic acidosis, hypertension, combined systolic and diastolic CHF, nontraumatic rhabdomyolysis, COVID 19 infection
Initial misuse report received from a healthcare professional on 27 JUNE 2013. It was reported that one dose of IMOVAX was administered into the gluteal area. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
Extreme fatigue, joint pain, headache, low grade fevers,  chills, sore red lump the size of a golf ball at injection site
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 44-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). On 7th October 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 7th October 2015, 2 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were recovering/resolving. The reporter considered the injection site erythema, injection site itching and injection site warmth to be probably related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: This case was not previously reported to anyone. The patient received FLULAVAL QUADRIVALENT vaccine in her right deltoid. Same day, approximately 2 hours after vaccination, the patient experienced a warm and redness of 9 by 9 cm of area with itching below the injection site. No additional details were available.