chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severely immunocompromised patient due for booster who presented to ED and subsequently admitted with GI and respiratory distress.  Provider discharge note below:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented with dyspnea found to have covid pneumonia as well as acute hypoxic respiratory failure and viral sepsis. Treated with decadron and merrem for superimposed bacterial pneumonia. Recovery was slow. She remained weak so went to HCF to get stronger."
No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine 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 (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
This spontaneous report was received from a pharmacist via a company representative, concerning a male patients with unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#: N032092, Exp. Date: 12-SEP-2019) one dose, once for pneumonia prevention and FLUAD (strength, dose, route, frequency, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced redness and swelling at the injection site (injection site erythema and injection site swelling) that went from shoulder to elbow, the skin at the injection site was painful to touch (injection site pain), and the patients were feeling under the weather with flu-like symptoms that persisted for 3-4 days. At the reporting time, the outcome of injection site pain, flu-like symptoms, injection site erythema and injection site swelling were reported as recovered on an unknown date. The causality between PNEUMOVAX 23 and FLUAD and injection site pain, flu-like symptoms, injection site erythema and injection site swelling were not assessed. This is one of three reports from the same reporter; Sender's Comments: US-009507513-1810USA004364: US-009507513-1810USA006560:
Thrombophlebitis in my left arm. very painful hardening of the veins. 3 week duration. Swollen veins, redness. bruising. As of today my right arm has a hard vein in my right hand between my thumb and forefinger.
This spontaneous report as received from an office manager refers to a non-pregnant female patient who is currently 81 years old. While she had no drug reactions/ allergies, her medical history, concurrent conditions and concomitant medications were not reported. On 15-NOV-213, the patient was vaccinated with ZOSTAVAX (which had a lot # of H019092 with an expiration date of 09-FEB-2014; however, the dose, dosage number, and anatomical location were unknown), intramuscularly, for prophylaxis. Subsequently, on an unknown date, the patient developed shingles. She sought medical attention by going to the doctor's office, where she received an unknown treatment. The outcome of the event, and the causal relationship between the event and the vaccine were unknown. Additional information has been requested.
HEADACHES, ACHY BODY AND JOINTS, UNCONTROLABLE CHILLS AND SHAKING, ELEVATED BODY TEMPERATURES. SIDE EFFECTS HAVE PERSISTED FOR 6 DAYS
Resident received 3rd dose of COVID-19 vaccination d/t immunocompromising condition - ESRD with dialysis. Following the vaccination he had not adverse reactions or side effects.  The family met with the MD and reviewed resident status.  The resident was told his dialysis treatments were not working.   Resident's wounds were worsening and he was not a surgical candidate. Family and resident decided to utilize hospice and palliative care approaches and   dialysis treatment was stopped on 9/8/21.    Reported to VAERS d/t death after COVID vaccination.  In this case the decline in condition seems to be stopping dialysis treatment but reported d/t unclear information on reporting requirements.
Less diluent was added to the vaccine. A .3 of the sterile diluent was added to the vaccine instead of 1.3ml of diluent.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Headache; Significant flu-like symptoms; Pain in right hip; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in arm left on 25Mar2021 at 13:00 (Lot Number: EL3247) (age at vaccination 49-year-old) as DOSE 2, SINGLE for COVID-19 immunisation at clinic. The patient had no known allergies to medications, food, or other products. The patient relevant medical history and concurrent conditions was reported as none. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient received historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in arm left on 04Mar2021 at 13:00 (Batch/Lot Number: EL3247) as dose 1, single (age at vaccination 49-year-old) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had headache day of dosing Significant flu-like symptoms all day the next day and pain in right hip on 25Mar2021 at 06:00 pm. The symptoms were continuous from 25Mar2021 through 26Mar2021. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that SHINGRIX shot was painful. The pain was resolved within 48 hours.   The patient declined demographic details and any other questions. Only information given was that reported. For tolerance after 2nd dose refer case US2018GSK152775.
pt recv vax 24JUL97 & woke up Friday AM 25JUL97 w/t101.7, stomach cramps & aching joints;broke out in rash 26JUL97;started on face non-raised & itching;27JUL97 taken to Er & given DPH & cortisone;MD stated not r/t MMR r/t hep b;
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a 0.5 ml dose of Zostavax (Oka/Merck).  The patient received an "allergy shot" about 24 hours prior to vaccination.  Subsequently the patient developed a raised quarter-size welt after vaccination.  The injection site was outlined in redness (3x2 inches) and it was warm to the touch.  Unspecified medical attention was sought.  The patient treated the site with ice and hydrocortisone cream.  At the time of the report the symptoms had improved and the patient was recovering.  There was no product quality complaint involved.  No further information was reported.  Additional information has been requested.
This was not an adverse reaction but rather an administration error. The patient received a diluted Grey cap dose. The dilution was 1.3ml and the dose was  0.2ml. the patient received a dose 40% higher than the approved dose for children 5-11
administering dose post temperature excursion with reported adverse event; vaccine had multiple temperature excursion with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA327223(CLUSTER).  This case involves a 18 years old male patient to whom  IPV (VERO) [IPOL] was administered a dose post temperature excursion with reported adverse event and vaccine had multiple temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Immunisation; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 05-Jul-2022, the patient received a 6th dose of suspect IPV (VERO), suspension for injection, at dose of 0.5 ml once (lot U1A452M and expiration date: 20-Feb-2023) via intramuscular route in the left arm for immunization post temperature excursion with reported adverse event (poor quality product administered) (latency: same day).  It was reported that vaccine had multiple temperature excursion with no reported adverse event (product storage error) (latency: same day) the first on unopened MDV on 05-APR-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes and the second excursion occurring on 05-JUL-2022 at a high of 11.22C out of range for 10 hours, and on 18JUL2022 a low of 1.17C for 45 minutes, on 29JUL2022 at 10.93C for 12 hours, and on 06AUG2022 at 1.6C for 1 hour.   Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Needing to physically rest each afternoon and taking naps. I have been trying to take B-12 vitamins, caffeine and green tea. I am able to finish my work but I need to lay down. I am averaging 7 hours of sleep. Hoping that more rest will help. Experienced Diarrhea. Watched my diet and got prescribed a probiotic. I immediately take Imodium to stop my diarrhea but normally I will avoid foods that will irritate my stomach. I lost 2lbs due to diarrhea.  The fatigue is still around.
soreness at injection site; redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for herself. The age at vaccination was not reported. The patient experienced redness and soreness at injection site. The reporter consented to follow up. The case has been linked with the case US2020138148 and US2020AMR138449 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138148:same reporter US-GLAXOSMITHKLINE-US2020AMR138449:same reporter
This spontaneous report was received from a physician via a company representative and refers to a 22 year old male patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patient was vaccinated with a 2 dose series of M-M-R II for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown. The patient had 3 additional booster doses of M-M-R II on unknown dates. On an unknown date, the patient showed no titre for M-M-R II. The outcome of the mentioned events was unknown. Causal relationship between M-M-R II and the mentioned events was unknown.
Pt describes feeling dizzy/lightheaded immediately after receiving vaccine. Upon arrival is A&0 x4 with no signs of distress. . Pt was Released At 1525 To Self. Ambulate Was Offered but refused, Pt Was escorted to exit by Staff. VS Are As Follows. 1517: BP 125/81, HR 87, RR 12, O2 Sat 97% on RA 1524: BP 123/82, HR 88, RR 12, O2 Sat 97% on RA
Temperature of 102.2 (afternoon of 2/6/2021) Headache (11:30 am 2/6/2021 - am of 2/7/2021) Ear ache (11:30 am 2/6/2021 - am of 2/7/2021) Fatigue (11:30 am 2/6/2021 - pm of 2/7/2021) Body aches (11:30 am 2/6/2021 - pm of 2/7/2021) Felt like my body temperature had trouble regulating (pm of 2/7/2021 until am of 2/9/2021)
Information had been received from a physician concerning a patient who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). Subsequently the patient experienced abdominal pain and suprapubic pain that radiated to the vaginal region. No further details were provided. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a physician concerning a patient who on 24-OCT-2006 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 653937/0637F).  Subseqently on 24-OCT-2006, the patient experienced abdominal pain.  The abdominal pain was described as being located at the umbilicus to genital area.  The abdominal pain spontaneously resolved 3 days after the vaccination.  No further details were provided.
Pt received both doses of the Moderna COVID-19 vaccine (on 4/22/2021 and 5/20/2021).  Pt tested positive for COVID 19 on 8/30/2021, subsequently had 4 ED visits for COVID follow up, before being admitted to Hospital on 9/15/2021. "Patient is a 52 y.o. male with history remarkable for multiple sclerosis, history of tobacco use, depression, ADD and vitamin D deficiency admitted 9/15/2021 with COVID-19 infection. This has caused arthralgias, loss of taste and smell, nausea, significant weight loss more recently 5% weight loss, worsening weakness and intermittent loose stool.  He at times has felt short of breath but has had no respiratory failure with hypoxia and required no )2 while inpatient saturating between 97-98%.  He is a vaccinated, immunocompromised individual with his MS treatments who first tested positive on August 30, and first felt symptoms August 28."  Discharged 9/18/2021
Pt recvd 3 doses of Engerix-B vax 8JAN91, 8FEB91 & 8JUL91 & 14AUG91 it was determined by titer result that pt did not respond to vax series;
Tinnitus. Mild but constant for at least one week. I still have it. Seems to be improving especially in my left ear.   Will consult with my primary care physician tomorrow.
Fluzone .25mg was given to this patient who is 5 months and 11 days old.
Tthroat and chest burning, lightheadedness, facial/lip swelling, tongue and mouth numbness, tongue swelling, difficulty taking full deep breath.
Information has been received from a 23 year old female with penicillin, metals, FLOXIN and bromafid allergy, who on 29-FEB-2008, was vaccinated with the first dose of GARDASIL (lot no. 655327/1287U) 0.5 mL, IM. On 12-MAY-2008, was vaccinated with second dose of GARDASIL (lot no. 0152X) 0.5 mL, IM and on 12-SEP-2008 was vaccinated with the third dose of GARDASIL (lot no.660557/0072X) 0.5 mL, IM. The nurse reported that the patient experienced a metallic taste and smell of ammonia after each vaccine. The patient had nose bleed 2 hours after vaccination with first and second dose of GARDASIL that lasted for a few minutes. The nurse reported that no treatment was required. No laboratory tests were performed. The patient sought medical attention at the doctor's office. Additional information has been requested.
Information has been received from a physician concerning a 12 year old female who on 18-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) injection. On 18-JUL-2008 the patient left the office, walked out to the parking lot and fainted. Medical attention was sought. There was no additional information provided. At the time of the report the patient recovered. Additional information has been requested.
Started having very strong aches in left arm 3 hours after injection. Around midnight, or 8 hours after injection, woke up with very strong joint and body aches. Vomiting occurred around 1 AM following the injection. Body aches and fatigue continued for at least 3 days following the injection.
Patient reports feeling anxious, and feels like fainting.  RN had patient lay down on cot for approx 30 minutes until patient felt well enough to stand and walk to car with assisstance of husband. VS 5:52pm 115/85 p78 96.9temp pox97% 6:00pm Pox99% p78 118/78  6:10pm  122/80 98% p82
having chills; my body is just sweating profusely; it feels as my head has like pressure all around it; my entire abdomen and lower back is sore; my body burning all through my leg; my entire abdomen and lower back is sore; I had chest pain; headache relevant symptoms; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22May2021 patient experienced chest pain, headache relevant symptoms and on 23May2021 patient having chills, body is just sweating profusely, it feels as my head has like pressure all around it, entire abdomen and lower back is sore, body burning all through my leg. It was reported that patient received second vaccine of Pfizer yesterday and would say that may be so it was even a headache relevant symptoms and going through the night, and now this morning, patient having chills, body is just sweating profusely, it feels as patient head has like pressure all around it, entire abdomen and lower back is sore and patient body burning all through my leg and had chest pain through the night. Patient asking So should I go to the doctor or what should I do. Patient have never tested positive for Covid. The outcome of all event was Unknown.   Information on the lot/batch number has been requested
Patient was administered vaccine that had been at room temperature for 8 hours and 30 minutes, which is 2 hours and 30 minutes past the allowable 6 hour window. Patient was made aware of the event and did not have any adverse events at 1 hour, 12 min post-vaccination.
April 23rd-sore throat ,hard to talk,  April 24th nausea , dizziness, muscle ache , fatigue, weakness lasting for 6 weeks & still dealing with lightheadedness & fatigue today June 2nd.  went to get covid 19 tests twice since vaccination because felt really sick-both negative  and also went to ER feeling nausesous & weak , & low temp .  DID NOT GET 2ND VACCINATION.