chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, (dosing details and route of administration unknown) (lot # L024265 with expiry date 01-JUL-2017; lot # M004063 with expiry date 25-JAN-2018; lot # L041457 with expiry date 22-OCT-2017; Lot# M040624 with expiry date 03-OCT-2018) for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of M-M-R II experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
Brain fog/grogginess for the 1st 2 weeks.  Unable to function cognitively at baseline for at least 2 weeks.  That is improving now. Increased fatigue, increased orthostatic intolerance and general weakness for the 1st 2 weeks.  Reporting today due to persistent tinnitus since vaccine #1.  I don't know exactly what day it started, but it is relentless and ongoing.
Has had a metallic taste since the day after the second vaccine (11/8). Symptoms have persisted through today (11/18). Everything he eats tastes like metal except for an apple. He states it is all foods, but not drinks.
Vasovagal syncope with fall and head contusion. Refused transport to ER.
On 6/17, patient contacted clinic about a dermatomal painful rash on trunk that developed over past 48 hours. She recalls a small skin lesion present at the time she received vaccines on 6/15. Going to primary care physician for evaluation for possible herpes zoster.
Pain at site of injection that went up the side of her neck and down the right side of her right arm and had nausea in the evening of day of injection. Next morning 5/9/15 at 5:00 am sweating and nausea and fell down and hit head. Went to Emergency Department.
Exposed to Covid-19 positive person on 1/19/22. Symptoms of sore throat and slight headache on 1/23, tested 1/24 with a negative rapid but positive PCR.
Narrative: 74y.o. MALE with a h/o 74 yo male: History of Alzheimer's, Parkinson's, dementia, iron deficiency anemia, polycythemia, diabetes neuropathy, hypertension, degenerative disc disease. Brought in by daughter on 8/10/2021 to ER dept. Over the last 6months, patient has been deteriorating with progression of disease, recently has been falling, more difficult to walk without assistance, more weak, and more confused. Patient lives with daughter and son-in-law. However, daughter has just been hospitalized with COVID and has been in quarantine, and son-in-law recently hurt back and is unable to care for patient. Neither are able to help pt perform ADL's, and they desire long-term placement at the skilled nursing facility. Daughter states pt has been been having darker urine from baseline recently, a non-productive cough, and has long-term left-sided weakness. On evaluation by medicine team, pt was not oriented to self, location, situation, and time/date. Pt is Covid+ and is fully covid vaccinated. Pt received vaccines on 1/20/21 & 2/19/2021. Pt was admitted and treated for covid infection with the following PLAN: - continue ceftriaxone 1g x5 days (8/9-8/13) - continue azithromycin 500 x3 days (8/10-8/12) - albuterol PRN, guiafenisin PRN Pt was covid positive after had been fully vaccinated. Pt was treated during this admission & discharged to nursing home placement on 9/2/2021.
Developed widespread itchy rash on torso/buttocks/back which lasted one month. Denies any blisters or anaphylaxis.
Approx 11 hours post injection: Low fever (99.0) Persistent shivering Headache  24 hours post injection: fever (99.9) Body aches Headache Fatigue
ER visit for acute headache - treated and released. 4 days later ED to hospital, Pneumonia of right lower lobe due to infectious organism - started on rocephin/azithromycin. Patient completed his 3-day azithromycin course on 05/28 and received 3 doses of rocephin, will discharge patient with 7 days of Augmentin. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
5 days of severe migraine headache, photophobia, nausea tinnitus and fatigue.  Vaginal bleeding also began within several hours of receiving vaccine.  I am on Mirena and usually do  not get a period.  These symptoms have happened every single time after all of my vaccines, but thought it was coincidental.  Now that pattern emerged, pretty certain it's related to vaccine.
Redness and warmth at injection site.  Fever, Swollen axillary lymph node on side of injection.  Patient was given 5 day coarse of Prednisone and asked to take Benadryl as needed.
Shaking chills, 102 temp, myalgias. Treated with Tylenol and ASA. Lasted about 24 hrs with fatigue lasting 48 hrs. Pneumocoocal vaccine received at same time with site pain persisting 3 days.
stayed to sick for a month with my first one and last one; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media.  This case involved an adult patient of an unknown age and gender who reported stayed to sick for a month with my first one and last one (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient experienced stayed to sick for a month with first one and last one (illness). For seven years if the patient got a cold. The patient had to take antibiotics to get rid of just a cold.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
sinus pressure headache; right side migraine; soreness at inject site; Slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 11:45 (Lot number: EL 3247) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SINUS HEADACHE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "sinus pressure headache"; MIGRAINE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "right side migraine"; VACCINATION SITE PAIN (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "soreness at inject site"; FATIGUE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "Slight fatigue". Therapeutic measures were not taken as a result of sinus headache, vaccination site pain, fatigue. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that 20 hours after injection, began as sinus pressure headache that turned into a right-side migraine. Patient do have migraines but this one was unaffected by Advil which was typically very effective. Headache remained until 10pm 10Mar2021 at which time it ceased rather abruptly. Also had soreness at inject site for approximately the same amount of time. Slight fatigue which subsided once headache ended. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
body aches; joint pain; fever in bed for a few days; flu; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient (age unknown) who experienced body aches (pain), joint pain (arthralgia), fever in bed for a few days (pyrexia) and flu (influenza like illness), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included granuloma annulare and Thyroid disorder. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Alpha gal Allergy.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious body aches (pain), joint pain (arthralgia), fever in bed for a few days (pyrexia) and flu (influenza like illness) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was flu, fever in bed for a few days, joint pain and body aches.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported was not reported for joint pain, fever in bed for a few days, flu and body aches.  Information on the batch number was requested.  List of documents held by sender: none.
Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) vomiting, tachycardic, and febrile with increased home oxygen use. Denies chest pain. Found to have positive blood cultures and diagnosed with NSTEMI, underwent heart catheterization and found to have severe ostial RCA stenosis, and admitted for medical management of CAD and antimicrobials. Patient discharged medically stable to home.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date).    No concomitant medication was provided.  The BUD of the vaccine was provided was 8Sep2022.   Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow up received contains non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Allergic reaction, difficulty breathing, tightness in airways, redness, coughing, heart pounding, eyes red. Itchiness, burning where shot administered.
Pt. received varicella in Right Arm SQ and Hep A Right Deltoid on 8/14, developed erythema on back of R arm on 8/15, 4.5cmx4.5cm in area where varicella was given.
Facial swelling, hives, numbness of face and mouth, increased heart rate, stomach cramps.
Neuropathy; Shingles; Permanent nerve damage; I will NEVER take the second shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), nerve damage (Verbatim: Permanent nerve damage) and incomplete course of vaccination (Verbatim: I will NEVER take the second shingles shot). The outcome of the neuropathy and nerve damage were not resolved and the outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the neuropathy, shingles and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the neuropathy, shingles and nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 The case was received from the patient's sister/brother interactive digital media. The patient went to physician and stated that when he/she got them and she looked at me with a puzzled look on her face and said she was not sure what he/she had.  She gave me nothing.  The patient suffered with shingles about 8 times, with no medicine at all.  Now patient had neuropathy and had permanent nerve damage.  The patient stated that he/she took the stupid shingles shot and felt like he/she had shingles for 6 months after the shot.  The patient told physician that he/she would never take the second shingles shot. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine administered at 10;25am; at 10:32, the individual began experiencing swelling of the throat and tongue while seated in the observation area. Vital signs were checked and were withinnormal limits; she remained alert and oriented. A Code White was called; she had already taken Prednisone  po from own supply since she has a history of an autoimmune disorder.  The Code Team transported the individual to the ED via w/c for further observation.
High Fever  103 bad headace cold sweats chills inbed for 72 hr
Onset 8/24/08 vomiting 9 PM. Seen at hospital where intussusception dx'ed by abd ultrasound, failed enema reduction. Transferred to another hospital where laparoscopy was done - enlarged mesenteric node was resected. 9/10/08-hospital records received for DOS 8/25-8/27/08-DC DX: Intussusception status post reduction. Dissection of large mesenteric lymph node. Laparoscopic resection of enlarged lymph node. At initial hospital, saline enema failed to reduce intussusception. Vomiting began on evening prior to admission, some blood in stools.
Full body aches, fever, chills, chest pain, shortness of breath, headache, nausea
Onset 7/9/02 low-grade temp, itching, rash and blisters. 1st reported to office 7/11/02 and child referred to an urgent care ctr for evaluation. MD out of office until 7/22/02. TX: Tylenol for temp, Aveeno/Oatmeal baths for rash and itching cont. Zyrtec as prescribed per urgent care. Symptoms improving. Per urgent care note: One week ago, MMR/Chicken pox vaccine. Now with rash to arms/legs X 1 wk. Worse today. Pulls at left ear. Exam of skin: A few 1mm raised red lesions to arms/legs. No blisters. Hands/feet: no blisters. DX: Rash (NOS). F/U with FMD. OTC Cortaid cream PRN itching.
This spontaneous report as received from a physician assistant concerning a patient of unknown age who on an unspecified date was vaccinated with a dose of PNEUMOVAX23 (dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that on an unknown date the patient had experienced an adverse effect after administration of PNEUMOVAX23 was evaluated at the urgent care clinic over the weekend. No treatment information was reported. The outcome of adverse effect was unknown. The relatedness for adverse effect was unknown for PNEUMOVAX23. Additional information has been requested.
Exaggerated local reaction. Pain and swelling to L deltoid area extending down to elbow. Nodule palpated at injection site. Site warm to touch.
RASHES DEVELOPED FROM THE LEFT SHOULDER THROUGH OUT THE WHOLE BODY, LASTED FOR MORE THAN 5 DAYS. DIDN'T TAKE ANYTHING FOR IT AND DIDN'T GO SEE A DOCTOR FOR IT, JUST DISAPPEARED AFTER 5 DAYS.
The injection was given too low to be in my deltoid muscle.  Today I have developed induration and erythema at the injection site as well as a knot.  The induration is measuring 1 1/2 x 3 1/2 inches.
PATIENT REPORTED FEVER OF 101 AND BODY ACHES. ADVISED PT TO TAKE TYLENOL OR MOTRIN. AND TO CALL US IF NOT RESOLVED IN 1-2 DAYS.
Pt experienced left upper arm swelling, puffiness and edematous up to the elbow. A fever of 99.0. Treated with ibuprofen and cold compresses.
Patient experienced several weeks of cough, muscle aches, and malaise beginning three days after receiving FLUZONE vaccine.
lyophilized portion of the vaccine was diluted with a sterile liquid; lyophilized portion of the vaccine was diluted with a sterile liquid; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date 30th June 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The case was reported by Medical assistant. The age at vaccination was not reported. The patient received Menveo vaccine which had been reconstituted lyophilized portion of the vaccine was diluted with a sterile liquid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported at the time of the call. The reporter did not consented to follow up.
Dizziness, NauseaVomiting, HYPERtension, not feeling well Narrative: Patient left after 55 minutes feeling much better.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with improperly stored doses (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
dizziness, went limp & hyporesponsive for few minutes 2-3 minutes;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. In 2009, the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (strength, dose and lot# not reported). In 2009, the patient developed dizziness, blacked out and shaking shortly after receiving the scheduled second dose of VARIVAX (Merck). The outcome of dizziness, blacked out and shaking was unknown. Upon internal review, black out was considered to be medically significant. This is one of the several reports from the same source. Additional information has been requested.
Every day after the vaccine shot he had more difficulty moving around till he could no longer walk by the 17th of March
Generalized rash started on upper outer arms. Itchy with red and raised skin. Spread to belly a couple days later. Spread to thighs the next day.
One day post vax, the pts thigh was red and swollen half way down. The pt was treated with Tylenol. No further information is anticipated for this report. The case is closed.
Pt. recv. vax. on 10/25/97 and four hours later exp. arm pain, injection site rash, and musculoskeletal stiffness.  Pt. took Tylenol and Advil without effect.  Pt. was treated with Benadryl which helped immediately.
Severe Sweating; Eyes were bloodshot red; headache; injection arm burning; Felt really fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue). At the time of the report, HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Upon receiving vaccinations patient broke out in hives and became light headed. She sat and waited and tried to calm herself down. Her wheezing continued to become worse and a red rash started on her neck and upper arms of both arms. She used her albuterol inhaler and took some Benadryl that she had with her. She has had allergic reactions in the past. Allergy testing wasn't able to determine the agents due to the strong immune response she was exhibiting. She carried an Epi-Pen but it was not used. Her mother arrived after being notified and she was able to help calm her further and assist her with deep breathing to abate symptoms.