chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of PEDVAX HIB (lot number M034187 and expiration date 17-MAY-2019, dose and route were not reported) for prophylaxis. The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested. Sender's Comments: US-009507513-1702USA003523: Original Case: 1702USA001003. US-009507513-1702USA001003:Original Case : 1702USA001003 US-009507513-1702USA003520:Original Case : 1702USA001003 US-009507513-1702USA003521:Original Case : 1702USA001003
Patient received the first dose on 18-jan-2022 and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 24-MAR-2022 Reporter's Comment: The pharmacist reported a patient received the first dose of Twinrix on 18th January 2022. The reporter consented to follow up. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
--- 12/29/2020 11:02 AM by NOT AUTHENTICATED--- 1809: Patient is a 54 year old female presents requesting vaccination for COVID-19. Patient's identity was verified utilizing two patient identifiers. Allergies reviewed and patient has no history of severe allergic reactions.  Patient reviewed vaccine information and given opportunity to ask questions: Yes Patient wants vaccine: Yes Pfizer-BioNTech COVID-19 vaccine # 1 in series administered, see Immunizations activity for vaccine details. Patient tolerated well and will remain for observation period to monitor.  1815: Patient is a 54 year old female COMPLAINED OF NO FEELING STRANGE, WITH TINGLING IN NECK ON BOTH SIDES. ADULT EMERGENCY WAS CALLED AND WATER WAS OFFERED TO PATIENT. RADIAL PULSE READ 110 BPM. SHE WAS TRANSFERRED TO HOSPITAL FOR EXTENSIVE OBSERVATION. NO APPOINTMENT WAS MADE FOR SECOND VACCINE.  1817:  Staff present and transported via w/c for eval. Pt. treated as noted below.  Triage Note: C/O feeling ? Strange?. Tingling in neck. Pulse:110  Upon arrival, (Triage Note) Member received COVID vaccine, and shortly thereafter began to experience SOB, tingling in bilateral hand and back of neck and head, and elevated heart rate. Feels like symptoms have improved. Pt speaking in complete sentences, in no acute distress.  Given Benadryl 25mg IV, Famotidine 40mg PO.  Improved, Observed.  D/C home at 2242.
p/about 5min of vax while pt standing fell down inthe office & had poss gen tonic clonic convuls lasting about 1min & was pale;
Onset of dizziness, confusion and tremulousness.  Patient claims he felt like "he had taken shots of tequilla". VSS, PE normal but for slow response times to direction and some uncooperativeness.  Was given Benadryl by mouth and patient fell asleep and then left the clinic at 13:50 - recovered.
This spontaneous report as received from a physician refers to a 11 year old female patient. The patient's medical history included syncope. There was no known drug allergies. On an unknown date in December 2017 (reported as two weeks ago), the patient was vaccinated with first dose of GARDASIL 9 (lot # N017833, Expiry date: 16-NOV-2019) for prophylaxis. There was no concomitant medications administered. There was no lab tests performed. On the same day after few minutes after GARDASIL 9 administration, the patient experienced "near syncope". It was reported that the patient was brought back into the room, laid down on bed and given a Popsicle while observed the patient for 15 minutes. The outcome of the event was unknown. There was no product quality complaint involved. The reporting physician did not provide the causality assessment for the event.
Headache, sick to stomach, tired, loss of appetite, body ached all over, felt chilled, swollen at injection sight these symptoms lasted for about 36 hours then on 5/21/2012. My arm started hurting more and a red, itchy rash started at injection site going down arm the area of the redness is about a 6 inch by 6 inch area. Was advised if it gets worse I should be seen.
Got hives on arm... spread to chest. Took a bunch of Benadryl. I was itchy for several days. Decided not to get the next shot, but when I went to a regular appt with my allergy doctor and told her, she said she could give me a steroid shot before the next one so I didn't get the hives again. I let them know when I went to take it (took it at the hospital) so they could keep a good eye on me. Went fine.
March, hair loss; take shower and hair would come out lasted for about a month. April Joint pain, very sore, hands, wrist, elbows, knees, ankles and toes. Doctor put on a depomedro dose pack. Swelling in right ankle and foot and went away and returned after 2 weeks.
Initial unsolicited report received from a nurse on 31 Oct 2017. This case involves a five separate female patients (age reported as ranging from 30-90 year-old) who were vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose series and site of administration were not reported) intramuscularly on an unknown date. It was reported as all the patients were administered vaccine by physician. Patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, all the five patients experienced severe arm pain and arm pain was so severe that it was difficult for all the patients to move their arm. Relevant lab tests was not reported. It was reported as all the five patients received corrective treatment with TYLENOL but did not help reduce the pain, so they were given oxycodone. One patient received a DEPO-MEDROL (injection). As of 31 Oct 2017, the outcome of all the patients was reported as recovering. List of documents held by sender: none.
About 18 hrs after the injection trying to get out of the chair she fell . She felt weak all over.  Paramedics arrived and put her on the bed . It took several hrs to regain strength so that she could get up. Was not taken to ED to no specific treatment other then resting. Visit to physician to discuss further was not until 6/17/22. Of note she has labile BP and sometimes very low with weakness but low BP was not reported as part of this event. Reports also feeling generally weak the day after her second Moderna vaccine also with a fall but this was a more significant event. Was okay after the 1st and 3rd vaccinations. All were Moderna.
11 days post vaccination numerous papulovesicles, 2-4 mm size are present about the dorsal hands, favoring joint surfaces, similar appearing papulovesicles are also present about the palmar surfaces and extensor elbows. Few are also scattered about the extensor forearms. Areas mildly tender to palpate. Symptoms: Rash, other nonspecific skin eruption.
Blood pressure went up to 190/120; High grade fever of 102.7F; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) (seriousness criterion medically significant), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Feb-2021, HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: high (High) 190/120 mmHg.. On 13-Feb-2021, Body temperature: high (High) 102 degree Fahrenheit.. On 13-Feb-2021, Pulse abnormal: high (High) 116..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol.  Company Comment: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Additional information included specific side effects/events that the patient experienced.; Sender's Comments: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a pharmacist regarding a case in litigation concerning a young female relative (exact age unknown) of a healthcare worker who was vaccinated with a dose of MMR II several years ago. It was reported that the patient developed idiopathic thrombocytopenic purpura shortly after receiving the vaccine. The child subsequently developed an intracranial hemorrhage and "almost died". The patient sought unspecified medical attention. The child did fully recover. The reporter considered the adverse experiences to be life-threatening. Additional information has been requested.
The PT took the last capsule of the oral vaccine on 10/21/02 6 p.m. On 10/26/02 10 a.m., itching started and slowly increased. The itching was treated w/Benadryl (diphenydramine). By 10/27, there was a red macular rash over parts of chest, belly, groin and back which generalized over the next 2 days and therapy w/Medrol (methylprednisolone) was started. Itching and rash slowly decreased and were gone on 11/5/02. There was no fever, no headache, or GI symptoms, no sore throat. There was fatigue which probably was due to Benadryl. The PT is known to have a penicillin allergy.
Rash on arm at injection site, developed larger over first 3 days. Hot, painful, itchy. Beginning to subside on day 4.
Fever 100.0, chills, severe shaking, severe body aches, fatigue and vomiting. Took Tylenol and Motrin. Symptoms not quite resolved as of today.
Tinitus (ear ringing) on the same side as the injection (left ear); This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included albuterol (MANUFACTURER UNKNOWN) and ADVAIR for an unknown indication from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced tinnitus (ear ringing) on the same side as the injection (left ear) on 19Mar2021. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the tinnitus (ear ringing) on the same side as the injection (left ear) was not recovered.  No follow-up attempts are needed. No further information is expected.
Hives (moderate) on back, legs, chest, torso and sides for past 36 hours.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CRACKLY EARS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height and weight were not reported. The patient's concurrent conditions included drug allergy (Ibuprofen). The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029 and expiry: unknown) dose was not reported, (dose number in series 1) 01 in total administered on 16-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient additionally received non-company suspect vaccine included: Pfizer covid-19 vaccine (bnt 162) (suspension for injection, intramuscular, batch number: FJ8762 and expiry: unknown) dose was not reported, (dose number in series 2) administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient had suspected covid-19 infection (cough, head congestion/clogged head, sinus pain and runny nose) and had suspected clinical vaccination failure (dose number in series 1). On 11-JAN-2022, the following vaccination with Pfizer covid-19 vaccine the patient experienced crackly ears (dose number in series 2).  On 12-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from crackly ears (dose number in series 2), and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported (dose number in series 1). This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213204.; Sender's Comments: V0:20220126728-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Child and mom arrive at clinic this AM, 9:00AM with complaint of redness and itching.  Rash appearance to left thigh, mom stated started late Friday afternoon after shots were given - mom stated measure to quarter size on Friday, - now approximately 7cm.
Received Expired Vaccine (>12 hours in room temperature); little sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) and VACCINATION SITE PAIN (little sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) and VACCINATION SITE PAIN (little sore arm). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine (>12 hours in room temperature)) had resolved. At the time of the report, VACCINATION SITE PAIN (little sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-138841 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow Up- 2nd reporter details updated and 2nd dose date; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138841:
sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient).   A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation.  Medical history included hypersensitivity to Penicillin. The patient did not receive "any other vaccines" within 4 weeks prior to the COVID vaccine.  The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown.  The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date.  Since the vaccination, the patient has been tested for COVID-19 however, no results were reported.  Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.
no adverse event; RECOMBIVAX was given after a termperature excursion; This spontaneous report was received from a registered nurse referring to one patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 15-DEC-2020, the patient was vaccinated with an improperly stored dose of  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, lot # R028528 expiring on 04-JUN-2021 for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   The administered dose of the vaccine experienced a temperature excursion of 10 degrees Celsius for 1 hours and 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
injection site pain; tiredness; feeling unwell; swollen lymph nodes; sore throat; My tonsil stones have returned; my normal with this thermometer has been about 97.4, and today my temperature was 99.1; I am a little sick; cough; This is a spontaneous report from a contactable 24-year-old Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264, administration time-11:30 AM, vaccine location-Left arm, dose number-1), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history included anxiety, low vitamin D and eczema. Concomitant medications were not reported. On 30Jan2021, the patient experienced injection site pain, tiredness, feeling unwell, swollen lymph nodes, cough, sore throat, tonsil stones have returned, my normal with this thermometer has been about 97.4, and today my temperature was 99.1 and little sick. The patient laboratory details included temperature on 30Jan2021 with 99.1 (my normal with this thermometer has been about 97.4, and today my temperature was 99.1). The patient did not take the treatment for the adverse event. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Vaccine was diluted with the sterile water instead of Normal saline. Manufacturer was called and told to not repeat dose of vaccine. Pt reports no adverse effects post-vaccination.
bump came back a week after; Injection site was swollen; injection site bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site bump), VACCINATION SITE MASS (bump came back a week after) and VACCINATION SITE SWELLING (Injection site was swollen) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE MASS (injection site bump) and VACCINATION SITE SWELLING (Injection site was swollen). On 16-Jan-2021, the patient experienced VACCINATION SITE MASS (bump came back a week after). On 11-Jan-2021, VACCINATION SITE MASS (injection site bump) had resolved with sequelae, VACCINATION SITE SWELLING (Injection site was swollen) had resolved. At the time of the report, VACCINATION SITE MASS (bump came back a week after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Face began to itch; raised rash on face/circumoral; No swelling at or around injection site.