chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the injections were given, later in the day there was a lot of edema, redness and firmness noted around the injection site. This lasted up to this AM. The family applied cold and warm packs and tylenol was given. Today the site is slightly red-small amounts of edema and it is sore to touch.
1205 itchiness and rash light red to arms and back. Reports allergy to shrimp. 2 nd vaccine . No SOB. BP 155/90, resp 18, Sats 98, HR 78. 1208 Educated on the side effects of Benadryl and rational verbalized understanding and to the administration. 50 mg right deltoid administered by Paramedic. 1223 rash and itchiness improved. Educated on S/S to seek immediate care for and to continue taking Benadryl 25 mg every 6 hours for the next 24 hours. Left ambulating accompanied by friend who's driving. All information translated by portegues speaking staff.
ACUTE RESPIRATORY FAILURE 1/3/2023  &   2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a other health professional refers to a 12 months old patient. On 15-JUL-2014 the patient was vaccinated with MMR II (lot # J015503, EXP 05-DEC-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23, lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750. (Same reporter). This case involves a 09 year old patient who received 0.5 ml vaccine FLUZONE QUADRIVALENT that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a 0.5 ml dose of suspect QUADRIVALENT INFLUENZA VACCINE lot number U1997AA, expiry date 30 June 2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to product storage error. It was not known whether patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
extremely dizzy/light headsd; sweats; extremely dizzy/light headsd; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 07Apr2022 at 12:00, outcome "not recovered" and all described as "extremely dizzy/light headsd"; HYPERHIDROSIS (non-serious) with onset 07Apr2022 at 12:00, outcome "not recovered", described as "sweats". Therapeutic measures were not taken as a result of dizziness, hyperhidrosis, dizziness.  Additional information: The clinical course was reported as patient had received more than 3 doses. The patient had not received other vaccine in 4 weeks. Patient had not other medications in 2 weeks. Patient had not covid prior to vaccination and had not covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA.  Strong headache and mild nausea all day.  I took some tylenol in the morning when first noticed the symptoms but the headache didn't begin to recede until around 3pm.
This is a 78-year-old male past medical history of dementia, prostate cancer, colon cancer, diabetes, hypertension, and chronic Foley catheter, presenting on 9/30/21 for concerns of Covid 19 infection. Patient is alert and oriented x 0. Arousable with sternal rub however unable to verbalize or nod to any review of systems. I am able to reach the sister-in-law, who provides most of the history. Has a history of CVA approximately 3 years ago, and has since had residual difficulty forming sentences, as well as inability to stand or walk. He is chronically bedridden. He also cannot use his right arm. Patient was recently admitted for altered mental status secondary to sepsis due to a urinary tract infection. He has a chronic Foley that he has had since his stroke 3 years ago and has had multiple urinary tract infections. Prior to his admission, the sister-in-law states that he typically knows we water, where he is, he understands his surroundings, he will answer with few word responses, cannot make out full sentences however. He is bedridden. Upon my examination, the patient is alert and oriented ×0. He will move with sternal rub however unable to verbalize her not to any review of systems. He is able to squeeze my fingers with his left hand, unable to do so with his right hand.
Swelling size of an egg, a red spot about 1 1/2 times the size of a silver dollar and a white spot in the center at the injection site similar to a hornet sting/bite.  It feels hot and on the 2nd and 3rd day became itchy and sore to the touch along with other muscle and joint pain.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient. No information on the patient's pertinent medical history, concurrent conditions and concomitant medication was provided. On 21-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, frequency, lot# and expiry date were not reported) for prophylaxis. Recently and soon, on approximately 22-SEP-2017 (reported as: "a day or two after receiving"), the patient developed itchy rash near the injection site. No treatment was given for the event. The patient sought for medical attention by calling a pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not reported.
1 of 4 pts exp an inject site react which began 1 wk following vax; no other clinical information available;
Extreme pain at the injection site. Heavy fatigue and lethargy for two weeks following injection. Heavy cold symptoms for two weeks.
Breakthrough case admission after two vaccines MOderna 3/18/21 Lot# 045A21A;  Moderna 4/13/21 Lot# 016B21A
Patient is a 73 y old F with T2DM, hypothyroidism, OSA, HTN, HLD, depression, and CKD stage 1-2 who was admitted to HCF 12/10/21 for AHRF 2/2 COVID PNA. Episode of aspiration whilst on NIV which dramatically increased her O2 requirement 12/10 and was subsequently intubated. 12/13 developed episodes of intermittent A fib with normal ventricular rate and was anticoagulated with heparin due to CHA2DS2-VASc score of 4. Started ertapenem 12/14 for UTI and possible aspiration pneumonia coverage. On 12/20, patient's central line was being removed in the afternoon when she went into asystole. A code was called, with ROSC achieved. Passed ZEEP trial on 12/28 on 5/5 support, extubated later that day. Transferred from HCF to FM service, general floor on 1/2, where she continued to wean O2 until on room air. Evaluated by PT/OT, with SNF recommended. Pt and family ultimately elected for Home Health and pt stable for discharge 1/20 with HH services arranged.
acute respiratory distress, COVID-19 pneumonia, intubated on ventilator, Renal failure requiring dialysis,
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored (temp. 12 degree Celsius, time 6 hours) GARDASIL 9 (lot # L020015, exp. 16-AUG-2-17, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality was involved. This is one of the several reports from the same reporter link. Additional information is not expected since the reporter did not wish further contact.
Approx 12 hours after DT, developed fever to 102 degrees F, N/V, red papular rash distant from injection site.
SEVERE PAIN & SWELLING TO RIGHT WRIST. KNOTS IN RIGHT ARM. ON 10/26/2011 I CALLED THE HEALTH DEPT & REPORTED THE SWELLING & PAIN TO RIGHT WRIST. ON 10/27/2011 WENT TO MY DOCTOR WHO SENT ME ON TO THE EMERGENCY ROOM. BLOOD CLOTS & FRACTURES WERE RULED OUT. I WAS GIVEN PAIN MEDICINE & TOLD TO SEE MY DOCTOR IF PROBLEM PERSISTS. I AM GOING BACK TO SEE MY DOCTOR ON 10/31/2011 DUE TO EXTREME PAIN & SWELLING. THERE HAS BEEN NO TRAUMA TO MY ARM & IT ONLY STARTED HAVING PROBLEMS AFTER THE FLU VACCINATION WAS ADMINISTERED TO ME ON 10/25/2011.
After the vaccine I had no reaction at all but back in Sept my husband was negative on COVID-19 but my grandson that lives with us and he complained of headache.  My husband had cataract surgery and within 48 hours after the surgery we both had COVID-19. We don't know where  we got it. And then I felt pressure in my chest, it got to a point that I could not walk, very fatigue, I had breathing symptom for 1 week, I could not walk more than 6 ft.
pain; blood pressure went up; pulse went up; nausea; headaches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PAIN (pain), HYPERTENSION (blood pressure went up), HEART RATE INCREASED (pulse went up), NAUSEA (nausea) and HEADACHE (headaches) outcome was unknown.            Concomitant drug was not administered.  Treatment for the event was not reported.
26Apr91 pt vax 3rd dose;  4-6 hrs after vax exp allergic reaction, arm swollen, difficult to breathe, swollen eyes, & red blotches.  Tx w/ meds.  H/a tx w/ meds.
Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; patient was administered with an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     Patient has no acute illness at the time of vaccination and up to one month before. It was unknown that patient ever tested positive or diagnosed with COVID-19. It was also unknown that if patient had any chronic conditions.  Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 1:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 1:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) to be related.    The race of the patient was reported.  Concomitant medication information was unknown.  The vials were initially stored in refrigerator on 25-Apr-2022. The vials has not undergone temperature excursion. It was reported Moderna booster was given on 25-Apr-2022, thinking that expiration date was 27-Apr-2022. Later noticed that vaccine expiration date was 24-Apr-2022.  No treatment medication information was given.
Multijoint inflammation and bilateral tinnitus onset within the week of the injection. The joint inflammation quickly subsided except for the left shoulder which has been diagnosed with adhesive capsulitis.  Full orthopedic workup shows no other left shoulder injury.  A full ENT evaluation, MRI and MRA of the head and audiology exam show no other cause for the bilateral tinnitus. No prior history of tinnitus or hearing loss.
Chills, low fever for two days Episode of Tachycardia that required hospitalization; symptoms continued to persist for 4 months. Symptoms remain but at much lower intensity
Developed common side effects of low grade fever, muscle aches, malaise the day after receiving my first vaccine.  Symptoms similar to the pain of acute diverticulitis also started simultaneously and culminated with a diagnosis of acute omental infarct.
Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BRUISE ON LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 15-APR-2021, the subject experienced bruise on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on left arm. This report was non-serious.
redness and swelling at injection site with  a secondary, smaller site of redness and swelling at a separate (but nearby) location on the same arm (right arm)
On OC with good cycle. Started bleeding after GARDASIL. Bled rest of cycle - Moderate, needed maxi pads (happened to a friend also).
Case number PHEH2014US022103, is an initial spontaneous report received from a nurse on 31 Oct 2014. This report refers to a 3 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 145705) intramuscular on 29 Oct 2014. No adverse event was reported. No further information was provided.
received first dose and contracted covid a couple days later; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the received first dose and contracted COVID a couple days later. The reporter and the patient would like to know if they can still get the second dose as it has been 17 days from first onset of symptoms. The event was considered medically significant. Outcome of the event was unknown.   Information on the lot/ batch number has been requested.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. On 08-NOV-2012, the patient was vaccinated with an expired dose of ZOSTAVAX lot # (671452/1124AA) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Incorrect product formulation administered; Wrong product administered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID. The original narrative from the sender is the following:  Patient was given Moderna Bivalent Pink cap, as first dose.  No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.  The causal relationship between Vaxelis and the events " Incorrect product formulation administered and wrong product administered." was assessed as not applicable due to the nature of the reported events.  No further information is expected.  is not working, added State under vaccine facility information and Reporter State.
He did not receive the second dose of the Shingrix; He could not walk and had to crawl / to go to the restroom; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis, PNEUMOCOCCAL VACCINE for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season, the 1st dose of PNEUMOCOCCAL VACCINE and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and PNEUMOCOCCAL VACCINE and not applicable after receiving Shingrix, the patient experienced walking difficulty and incomplete course of vaccination. On an unknown date, the outcome of the walking difficulty was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported but could be 69 or 70 years and was not applicable for 2nd dose of Shingriix. In 2019 on the same day, the patient received the 1st dose of Shingrix vaccine, a pneumococcal vaccine and an influenza vaccine all at the pharmacy and stated might be all were given to him on his left arm (he did not remember) and by the time patient reached home, he could not walk and had to crawl on his hands and knees to go to the restroom and slowly the ability to walk returned in about a week. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix vaccine, which led to incomplete course of vaccination. It was unknown if the reporter considered the walking difficulty to be related to Pneumococcal vaccine. The reporter consent to follow up. For tolerance of influenza vaccine received in 2020, refer case US2021AMR072042.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072042:Same reporter
suspected vaccination failure; I get them; Have had 3 shingle shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received 3 doses of Shingles vaccine, which led to extra dose administered. After receiving Shingles vaccine, the patient got shingles. The patient stated that Shingles vaccine did not help. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Patient was administered PNEUMOVAX and FLUAD on the same arm by the pharmacist on duty on 08/24/17. Patient came in on 08/26/17 and reported soreness and redness of the arm. Also reported heavy headedness. Redness was noticed almost around the upper arm. Patient was asked to take TYLENOL for soreness and asked to see a doctor if no improvement. Tried Calling in the evening and was unable to reach. Left voicemail.