chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 20 year old daughter with allergies to dander, dust and cigarette smoke who on an unspecified date in July 2007, was vaccinated with her first dose of GARDASIL (Lot #, site and route dose of GARDASIL (Lot #, site and route not reported). In the middle of August 2007, the patient was vaccinated with her second dose of GARDASIL (Lot #, site and route not reported). On an unspecified date in January 2008, the patient was vaccinated with her third dose of GARDASIL (Lot #, site and route not reported). Concomitant therapy included montelukast sodium (MSD) and ADVAIR (taken as needed). On an unspecified date, while the patient was in college, she had "blood work done" (not otherwise specified). When the patient came home in May 2008, "she had a complete panel" and the physician told her "her immune system was out of whack". In March 2008, the patient experienced minor hair loss. In May 2008, the patient experienced major hair loss where her hair would "fall out on its own without even having to touch it, when she shakes her head, washing her hair and touching her hair as well". The patient has experienced really bad headaches "Where she cannot move" (not further specified). The patient already had dander allergies, but when they flared up it would come out as a sinus problem, but lately the allergies have come out in the form of hives (not further specified). Her menstrual period was irregular, but now it is back to normal (not further specified). The patient has seen a dermatologist who has her "not washing her hair, increase her protein and is using ROGAINE". The dermatologist gave the patient a B-12 shot, and "now the patient's food intake is being monitored". The patient is going to see her primary care physician. The patient's hair loss has persisted. No further AE information was provided. Additional information has been requested.
Edema and erythema to (R) post upper arm, warm to touch, grimaces and guards to touch. Instructed warm compresses. TYLENOL/MOTRIN for pain. FU on Monday. 3/24 - Dad states pt "fine". No fever, no edema or erythema.
5 DAYS LATER DEVELOPED REDNESS; SWELLING; ITCHINESS; SORENESS AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE). At the time of the report, VACCINATION SITE ERYTHEMA (5 DAYS LATER DEVELOPED REDNESS), VACCINATION SITE SWELLING (SWELLING), VACCINATION SITE PRURITUS (ITCHINESS) and VACCINATION SITE PAIN (SORENESS AT THE INJECTION SITE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Headaches everyday since vacine received.  Take pain releiver but after several hours, headache tarts again.
Lethargic, pale, ?weird dry throat feeling?, drinking abnormal amounts of water, unable to attend school, nauseous, feels like he?s going to throw up (but hasn?t)
Day of the Second Injection - Intense burning on soles of feet. This went on for 2-3 weeks on and off and has progressed to small fiber neuropathy with various other autoimmune issues. Cannot go into too much detail as I have been timed out multiple times. Please see medical records from Local Doctors and Neurologists at Clinic.
Information has been received from a RN concerning a 35 year old female with no allergies who on 08/17/01 and on 10/12/01 was vaccinated with a first (Lot # 638811/0498L) and second dose (Lot # 639432/0787L) of varicella virus vaccine live, respectively. Concomitant therapy included "birth control pill". Subsequently, it was reported that the pt "twice failed to seroconvert."  On 11/29/03 a titer drawn showed that the pt failed to seroconvert. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a nurse practitioner referring to two anonymous patients of unknown age and gender. On an unknown date, these two patients were administered a dose of improperly stored VARIVAX (Merck) (strength, lot number, expiry date, route and dose were not reported), which was reconstituted by not improperly stored sterile diluent (strength, lot number, expiry date, route and dose were not reported). No adverse events were reported. Additional information has been requested.
pt recvd vax; exp local rxn, fever in 4 yr old after 3rd dose of vax;
This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of VAQTA (lot# M027879, expiration date: 24-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1610USA011550.
Cough, difficulty breathing, wheezing, & hoarseness began 3 hrs. after high dose Flu shot administered. Treated at hospital emergency room.
This spontaneous report as received from a registered nurse refers to an unknown age patient (gender unknown). Pertinent medical history, drug reactions or allergies were not reported. On 10-SEP-2013, the patient was vaccinated with ZOSTAVAX (concentration, dose and indication were not reported) lot # H011331, expiration date 08-SEP-2013. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a female who on 22-JUL-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot# 661703/0651X). On 22-JUL-2009 the patient fainted and experienced dizziness for a while after vaccination. Unspecified medical attention was sought. At the time of reporting the patient's conditions were improved. This is one of several cases from the same reporter. Additional information has been requested.
I am having tingling down my left arm, daily, multiple times. I am also having deep pain in legs, when laying down to sleep, daily.
Initially diagnosed with PNA, later found to have myocarditis based on symptoms, echo, and cardiac MRI
Information has been received from a registered nurse concerning an 86 year old female with "no important medical history to report beside normal health problems associated with age" and allergies to penicillin, sulfonamide, indomethacine sodium (MSD), (WAES# 0808USA04821), CELEBREX, rofecoxib (MSD) (WAES# 0808USA04820), and BEXTRA. Concomitant medications included: potassium, "ZANEX", BUMEX, PROZAC, VERAPAMIL SR, HYDROCODONE APAP. The patient was vaccinated previously with doses of PNEUMOVAX 23 in 2006 (no record of 2006 vaccination found) and July 2007, the patient did not remember any reaction to these vaccinations. On 06-AUG-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384u), 0.5 milliliter (ml), intramuscularly. On 06-AUG-2008, the patient experienced an injection site reaction, severe pain in her arm and neck with generalized aching. It was reported that there was no redness or warmth at the injection site, but there was minor swelling. The patient reported that the pain was severe causing moaning and groaning. The patient also experienced fever, nausea, dizziness, and loss of appetite. On 07-AUG-2008, the patient called the office. The pain was reported to still be present on 08-AUG-2008 but not as severe. At the time of this report, the patient was reported to be recovered, she stated it took about 1 week to return to normal. The events were reported as disabling because the patient could not perform her daily functions due to the level of pain. A lot check was requested. No product quality complaint was involved. This is a consolidation of 2 reports concerning the same patient. Additional information has been requested. It has been determined that WAES#0808USA03710 is a duplicate of WAES#0808USA03652. Therefore, WAES#0808USA03710 will be deleted from our files and consolidated into WAES#0808USA03652.
Acute Intra-cranial hemorrhage. ED Visit; patient died. This visit was within 6 weeks of receiving the COVID vaccine.
Bulging fontanelle, excessive crying reported by parent.  When examined in the office no bulging fontanelle, no fever, no crying.  Was diagnosed with double ear infections and placed on antibiotics.
A report has been received from registered nurse concerning a 3 year old, male patient. The patient's medical history and concomitant medications were not reported. Nurse reports that she forgot to take clip off FLUMIST syringe and only administered 1/2 of dose to two children, who are her grandchildren, administered 2 weeks ago. No symptoms to report. This case referred to the youngest. The patient experienced administered half a dose which started on 21-Sep-2012. The nurse said that the patient was fine and had no late occurring adverse events. The report was considered to be non-serious. Summary of follow-up information received 17-Oct-2012: outcome changed to recovered, reporter's phone number added. Corrected report 06-Dec-2012: Coding of event 'administered half a dose' changed from Drug administration error to Vaccine underdose, narrative updated.
neck pain; head pain; This case was reported by a other health professional via interactive digital media and described the occurrence of neck pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain and headache. On an unknown date, the outcome of the neck pain and headache were unknown.   It was unknown if the reporter considered the neck pain and headache to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient experienced severe neck and head pain.
Red and sorted spread; Swelling down to elbow; achy and tender arm; achy and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (achy and tender arm), PAIN (achy and tender arm), ERYTHEMA (Red and sorted spread) and SWELLING (Swelling down to elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D NOS, ASCORBIC ACID, ZINC (VITAMIN C + ZINC), POTASSIUM and COENZYME Q10 [UBIDECARENONE] for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TENDERNESS (achy and tender arm) and PAIN (achy and tender arm). On 16-Feb-2021, the patient experienced ERYTHEMA (Red and sorted spread) and SWELLING (Swelling down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TENDERNESS (achy and tender arm), PAIN (achy and tender arm), ERYTHEMA (Red and sorted spread) and SWELLING (Swelling down to elbow) outcome was unknown.            Additional concomitant medication included methane.  The patient used ice packs and Tylenol with both shots.   This case was linked to MOD-2021-015580 (Patient Link).
-Pt. reports stomach upset following admin. on 8/7 -Pt. reports itching, redness, soreness, and knot @ injection site starting 8/12/19 -pt. first contacted pharmacy on 8/14/19 @ ~6:30 pm
Information has been received from a healthcare professional concerning a patient who in 1999 was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient experienced chickenpox. Medical attention was sought. Three other patients had a similar experience following vaccination with varicella virus vaccine live. No further information is available.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reaction/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L038503 with expiration date 18-DEC-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 31.8 Fahrenheit for 4 hours. There was no prior temperature excursion. It was unknown if data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Body aches, nausea, vomiting, severe headache, and the next day a rash on torso.
syncope; This spontaneous report was received via a company representative from a pharmacist who is also a patient's father and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date (reported as "unspecified date years ago"), the patient experienced syncope after receiving the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (date of vaccination, dose, route of administration, lot# and expiration date were not reported) and on an unspecified date, she had "worsening syncope" after receiving the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (date of vaccination, dose, route of administration, lot# and expiration date were not reported). The patient sought medical attention. The pharmacist also reported that "even now she still sometimes has syncope, but is fully recovered".  The outcome of syncope was reported as recovered/resolved on an unknown date. The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  Upon internal review, the event of syncope was considered to be medically significant.
Patient had pain/tenderness in right arm and red streaks on chest.  ER doctor gave patient IV Abx, Zantac, Cephalerin, sm x 1 tmp and hydroxreine.  Patient states 10/8/08 he has improved.
Fever as high as 103,  muscle aches, joint pain, nausea, change in smell and taste, headache, chills
Numbness and tingling in left leg and toes, both feet toes cold, numbness and tingling in arms, muscle weakness, fatigue. Went to ER and they were unsure of what was wrong.
Patient tested positive for C19 on 09/12/2021. Pt was admitted to the hospital on 09/12/2021 and required intubation and immediate dialysis. Patient had an admitting diagnosis of acute hypoxemic respiratory failure: secondary to volume overload and C19 infection; C19 infection with Hypoxia, suspected pneumonia, acute on chronic kidney disease stage IV; pulmonary edema/volume overload due to congestive heart failure vs. worsening renal failure; acute on chronic congestive heart failure; cardiomegaly; hypertension; hyperlipidemia; diabetes type 2; atrial fibrillation in a controlled rate. Patient was intubated for 13 days before passing away.
The pt received his vaccinations on 12/09/99 and within 24 hours he developed an injection site reaction with redness, warmth and swelling. Upon internal review it is deemed necessary to amend the latest received dte for this report to read correspondence received on 11/16/01. This case is closed.
Patient was registered online for adult covid appointment with dob of 10/09/2009.  Age would be 12. At time of appointment, age  and dob was verified and confirmed. MD office contacted us 11/4/21 to verify adult dose was given. We confirmed dob with MD office and confirmed false information was given at time of appointment.
Moderately painful arm progressively worsened for 12 days; fever of 102 degrees; full body rash, very itchy and painful, started at face and spread for 14 days; headaches; very tired and weak; sneezing and runny nose; swollen eyelids; loss of appetite
12/31/2020 Vaccination  15 Minutes later, I experienced lower mild back pain.  1/1 Fever of 99.8, HA 2 weeks symptoms of 'couldn't get warm in the evening'. No fever. HA persisted.  1/2 Dizziness, sinus congestion.  Day 8, rash appeared on arm of injection site, below. Upper arm was 'weird'. About 6 cm in diameter at largest.  1/6 telehealth medicine. Prescribed antibiotics for possible sinus infection. It didn't do anything to help.  Day 14/15 all my symptoms went away at once.  * waves of sinus pressure and dizziness; walking and getting feeling of a 'spin'; ongoing; NOT vertigo  *putting off second vaccine
Case previously recorded as MA2009-4800. Initial case report received from a nurse, on 18 NOV 2009. A 2-year-old female patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 1021261P1A, expiration date FEB 2010) i.m. on 15 NOV 2009, an off-label indication. No adverse event was reported. Reference no: NA09-008489.
chills; headache; fatigue; cough; labored breathing/shortness of breath; swelling of the left lymph node; This spontaneous case was reported by an other and describes the occurrence of CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), COUGH (cough) and DYSPNOEA (labored breathing/shortness of breath) in a 77-year-old female 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.     The patient's past medical history included COVID-19.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), COUGH (cough), DYSPNOEA (labored breathing/shortness of breath) and LYMPHADENOPATHY (swelling of the left lymph node). On 15-Feb-2021, CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue) and LYMPHADENOPATHY (swelling of the left lymph node) outcome was unknown. At the time of the report, COUGH (cough) and DYSPNOEA (labored breathing/shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within several hours of Vaccination patient presented nausea with vomiting and severe Diarrhea. Vomiting and nausea persisted for 4 days Diarrhea for 7 days at. Present
Woke up the next morning after vaccination felt hands feet very cold, and chills, drove to hospital, temp 99.6-100.4  was given Tylenol, baby aspirin,  IV fluids, CXR, EKG, SOB chest pain, chest tightness.  Was under observation for 24-28 hours, continued with Tylenol until discharge, has been feeling well since, some hot flash feeling and fatigue not unusual but not numbness or tingling has been noted since
after receiving vaccine ee c/o nausea and headache.  B/p 157/84 HR 95 02 sat 98% DD EE left clinic stating she would follow up with her PCP nausea resolved continue to have h/a 4/10 scale unchanged.  b/p 146/73 HR 82 and 02 sat 96%  EE refused RRT or ED evaluation
First, extremely swollen lymph nodes in armpit. Visible swelling. Later, pain the shoulder joint for 2-4 days. Sudden onset of pain.
She was a little faint and dizzy and weak, No EMS was called for her, she said she had not eaten or hydrated well., Has low blood pressure, has low heart rate and low blood pressure the patient stated.  Pt was observed for over an hour.  When she had experienced the lightheadedness and dizziness she was assisted to the cot and her legs were elevated.  She continued to feel lightheaded, she refused to have ems called and vitals were taken several times.  At 12:50 she started to feel better she did not complain of any discomfort and was encouraged to walk before discharged.
Initially, I thought I had a sinus infection because I had congestion, shortness of breath, a light cough and a headache. After 3-4 days of my condition getting worse and OTC medicine not aiding me, I got up and put on clothes and went to get tested for COVID-19. As I was walking up to the clinic, I fell over outside walking towards the clinic doors. A nurse and gentleman walked over to assist me. They drew blood and found I had blood clots in both lungs and pneumonia in both lungs. They transported me to the Hospital on 10/20/2021 to 11/02/2021 and was discharged. Once I got home, I couldn't make it up the stairs because I still had shortness of breath. The next day, a nurse was sent over and thought I was fine, but I still had shortness of breath. That next night, I struggled breathing and called 911; the EMT came and checked my oxygen concentration and discovered my O2 levels dropped to 77%. They took me to the Hospital from 11/03/2021 to 11/06/2021 and conducted chest x-rays and was transported to a rehabilitation center for 22 days and was discharged. Since then, I'm slightly recovering but still having some shortness of breath periodically and just recently saw a pulmonary specialist who ordered tests to check the condition of my lungs on 03/15/2022.
This spontaneous report was received from a licensed practical nurse regarding an unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified date since 02-JUN-2015, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported, lot # K011800 with expiration date 21-AUG-2016 and lot #L002871 with expiration date 27-JAN-2015). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 19-SEP-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JAN-2022, the patient experienced Covid-19 test positive. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 test positive was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000215029. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events). This report indicates medical adverse events for the patient, there was no product quality issue described. Based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220202166.