chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates between 06-MAR-2017 and 10-APR-2017, the multiple unspecified patients were vaccinated with improperly stored doses (also reported as doses were administered before temperature excursion) of PROQUAD (recombinant human albumin (rHA)) injection (lot# M018636, expiry date 11-OCT-2017, dose and route of administration were not reported). Sterile diluent used to reconstituted vaccines was properly stored. No adverse effects were reported. No product quality complain was involved. The vaccines were stored in the temperature between 6 and 14 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. 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-009507513-1704USA005927: US-009507513-1705USA000161.
Developed shingles the next day. Didn't realize that was what had occurred for several days but it gradually got worse. Not saying the vaccine caused it, as it probably just lowered  his resistance, but he is never sick and this has really been hard. Just wanted to to make you aware. His physician did verify that it was shingles but too late to do anything so just waiting it out.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# K008410, expiry date 26-FEB-2016; lot # K020215, expiry date 15-MAY-2016, lot # L019835, expiry date 23-MAR-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Throat tightness, wheezing, difficulty breathing, hives on chest, faint feeling, tachycardia. To Emergency Care center. Given Solumedrol 125 mg IV, Benadryl 50 racemic epiphrephrine for severe allergic reaction.
This spontaneous case initially received on 17-Oct-2016, was reported by a health professional and concerns a(n) 58-year-old female patient. Weight: not provided; Height: not provided Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA PFS from 09-OCT-2016 to 09-OCT-2016 Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: WT52305. Action taken with suspect drug: discontinued. No additional suspect drugs. Adverse reactions/events and outcomes: The patient returned the next day (10-Oct-2016) because the injection site was red, warm and swollen. The patient was given an ice pack and ibuprofen and a recommendation to take diphenhydramine that night. The nurse mentioned perhaps the injection was too low on the arm, about 3 inches lower on the arm than idea. Special circumstances: Drug administered at inappropriate site. The outcome not reported Reporter comments: The reporter considered all events as non-serious. Follow-up was received on 20-Oct-2016: The outcome of the events was reported as recovered.
Patient received vaccine on 10/03/07. Returned to office on 10/25/07 upon return he complained of an 2 x 3cm area at site of injection that was swollen reddened and warm. Also complaining of sore throat and nasal congestion.
Swolen area under both armpits approximately 3 inches by 1.5 inches.  Swolen areas have been present ever since the day after vaccination.  Currently 6+ months have passed and they are still present.  Left armpit was much more swolen more than right initially, now they are almost the same size.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 4/8/21 (ER8737) Pfizer Dose 2 4/30/21 (ER8734) COVID Positive 9/18/21  9/17/21: -Patient is an 85 yo female with medical history of  moderate persistent asthma , atrial fibrillation on coumadin, moderate aortic stenosis  , HTN , GERD , CVA, HLD , Hyponatremia, Left thyroid nodule.  -History obtained from patient's son who is at bedside.  -She is presenting with worsening shortness of breath and wheezing. She was found to be COVID positive in the ER.  -Her symptoms started 2 days ago but got worse today afternoon.Symptoms not responding to her home inhalers and nebulizers.  -She was being managed with PO steroids as outpatient without improvement in symptoms. She follows Dr ( pulmonology) as outpatient.  -She has been vaccinated for COVID. Recieved both doses of pfizer vaccine in April  -Her vitals were significant for tachycardia 110-120s,RR 20s,  no fever, BP 135/79, saturating 93% on room air. Per ER provider she was noted to be wheezing  -CXR showed focal airspace disease at the right lung base probably representing pneumonia and 2 cm nodular density at the right apex.  Developing pulmonary nodule needs to be excluded.  Recommend the nonemergent chest CT.  -Labwork remarkable for normal wbc ,  hyponatremia 125 ( unclear baseline but has a history of hyponatremia), glucose 155, ABG ( PH 7.48, pCO2 36, pO2 91, HCO3 27), lactate 2.2 , INR 5, rapid COVID positive  -She received Duoneb , IV Ceftriaxone/Azithromycin , IV solumedrol , 1L NS with improvement in her symptoms  -ER provider concerned she may progress and needs inpatient monitoring because she is still tachycardic and tachypnoiec despite not requiring supplemental oxygen. She will also need management for her asthma/COPD exacerbation which is triggered by COVID .  10/10/21: 86-year-old woman who presented with 2 days history of shortness of breath and wheezing.  COVID-19 PCR was subsequently positive, chest x-ray demonstrated right basilar infiltrate.  She was admitted for treatment of COVID-19 pneumonia with steroids and broad-spectrum empiric antibiotic therapy.  However she went into atrial fibrillation rapid ventricular response, developed worsening hypoxia and infiltrates requiring transfer to the intensive care unit.  She required prolonged supplemental oxygen therapy via BiPAP and OptiFlow.  She was gradually weaned off supplemental oxygen, has been stable on room air for the last few days.  She is physically deconditioned however patient's family have declined skilled placement and have opted to take her home with the support of home health services.  She has been discharged in fair medical condition.
Fever, sore throat, nausea, abdominal pain, cough, fatigue, runny nose, irritability, extreme sensory - said he was "burning" didn't want clothes on, impulsiveness, OCD behaviors and sudden onset of tics: blinking, face grimaces, neck stretching, snorting, screams.
Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 07-May-2021, BELL'S PALSY (Bell's Palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Patient stated, he was given 2 medications of unknown names for treatment of bells palsy and symptoms gone way after a week of taking those meds.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event start date, stop date and outcome updated. Vaccine given date updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
May 12th pt. received the TDAP vaccine. Patient reports - first two days lt. arm was only a little sore but nothing else happened.  By 05/15/21 , pt. noticed swelling, redness and more pain.  Currently, patient reports lt. arm is aching much more (a kind of pain that goes from the vaccination site to the elbow), reports pain 5/10 on a 1:10 pain scale ratio; swelling, redness, warmth to injection site, fingers are feeling tingly. Patient reports using ice intermittingly. RN suggested warm/ cold compress, use of Ibuprofen for swelling and pain, and to seek medical attention for increasing concerns or if numbness continues.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/26/2023 HTN (HYPERTENSION) HYPOTENSION 4/26/2023 HTN (HYPERTENSION) ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/26/2023 HTN (HYPERTENSION)  HYPOXIA 4/26/2023 HTN (HYPERTENSION)
Hypotension, shortness of breath, tachycardia, fever, hypoxia, tachypnea,
Generalized maculopapular and erythematous eruption; pruritic. Spares palms, soles and face. This appeared about 6 hours, post vax. Treated with Atarax 25mg for itching.
fever; pain; This case was reported by a other health professional and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The reporter said that should a patient had to administer another dose of Shingrix. After receiving 1st dose of Shingrix, the patient experienced fever and pain. The reporter said that should a patient had to administer another dose of Shingrix. The reporter did not consent to follow up.
The Moderna Bivalent Vaccine had expired on 5-19-2023. Inmate had no signs/symptoms. No adverse outcomes to this date.
I started getting a scratchy throat on the same day of Moderna dose 4 vaccine, but it was before the vaccine was administered. I began having up to 101 fever on 4-27-2022 then it progressed to 102.0. I had a friend tell me that they tested positive to COVID so I called the doctor and they prescribed erythromycin for 5 days. I started taking them on 4-28. I took a home test on 4-28 and tested positive for Covid. I also had a PCR done at a drive thru Pharmacy on 4-28 as well. It was positive also. I am reporting a breakthrough COVID case.
Dizziness, fatigue, chills, headache neck soreness x 24 hrs.Swelling and soreness of lymph nodes under left arm X 5 days. Self treated with Advil.
Very large rash that spread over 3 days; 14 days after vaccination; still have it
Pt has chronic kidney disease and diabetes and arrives with worsening shortness of breath and cough.
The pt was found apneic and pale at daycare. She required mouth-to-mouth resuscitation. In ER, she was noted to have decreased activity and color.
Administered vaccine using the wrong needle-tip - used 5/8" instead of 1". Administered vaccine in an intramuscular fashion.
more intense migraine and it became worst everyday; redness but it did not last long; swelling but it did not last long; in frequency daily headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (more intense migraine and it became worst everyday), VACCINATION SITE ERYTHEMA (redness but it did not last long), VACCINATION SITE SWELLING (swelling but it did not last long) and HEADACHE (in frequency daily headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic back pain and Ulcer. Concomitant products included GABAPENTIN for Chronic back pain, GLUCOSAMINE for Product used for unknown indication, VITAMIN D NOS, FENTANYL (DURAGESIC [FENTANYL]) and AMITRIPTYLINE for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MIGRAINE (more intense migraine and it became worst everyday), VACCINATION SITE ERYTHEMA (redness but it did not last long), VACCINATION SITE SWELLING (swelling but it did not last long) and HEADACHE (in frequency daily headache). The patient was treated with CELECOXIB (CELEBREX) for Adverse event, at a dose of 200 mg twice a day. At the time of the report, MIGRAINE (more intense migraine and it became worst everyday) and HEADACHE (in frequency daily headache) outcome was unknown and VACCINATION SITE ERYTHEMA (redness but it did not last long) and VACCINATION SITE SWELLING (swelling but it did not last long) had resolved.            This case was linked to MOD-2021-187583 (Patient Link).
Pt came to ED evening of 9/17 with chest pain.  EKG and troponin consistent with myocarditis/pericarditis - most likely related to recent covid vaccine.  He had normal CXR. He had normal ECHO. Initial troponin was trending up so decision made to keep him in hospital until it started to trend down.  In the afternoon troponin started to drop so he was sent home.  Consultation with cardio DR - He recommends the following: 1.  Motrin - 600 mg Q8 x 10 days 2.  Colchicine - 0.6  Mg daily x 4 weeks. 3.  Famotadine - 10 mg twice daily x 2 weeks.  He should follow up and have repeat EKG and troponin in 2-3 days. At this point cardiology should be updated and discussion for further follow up and plan.
Extremely sore arm; fever; unable to breathe; exhaustion; nauseated; pain in joints.
Complaint of fatigue, muscle and joint discomfort, effecting mostly her back, neck and shoulders which began 48 hours after receiving immunization. Self-medicated with ibuprofen p.r.n., symptoms resolved in three to four weeks time.
Child received TD, IPV,HEP A,MMR and VARICELLA on 8/31/2009. Within 5 mins. of receiving vaccines client got up and loss consciousness and fell to floor. Witnessed client hitting head on floor. Also noted twitching and eyes rolling up while lying supine on floor. Regained consciousness within 5 seconds. Pale and slightly diaphoretic. Talking and telling parent that she wanted to sleep. No obvious signs of injury including bumps,cuts or abrasions on head or body. No significant health history noted per parent. Parent instructed to take child to the Emergency Room for further assessment. Parent states understanding need for going to the ER. Child awake and offering no complaints at time of leaving health dept. Spoke to parent on 9/2/09 confirmed pt was taken to ER and later released.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 87 and patient was in rehab in Feb 2021 in slow multi organ failure requesting d/c to hospice. Patient was in hospice 2/13-2/19 for severe heart failure resulting in 40 pound fluid weight gain since November 2020 before returning to ER on 2/19/21 after wishes to restart aggressive life sustaining treatment vs. palliative approach. He was stabilized and discharged home on 3/3/21. Patient was readmitted on 3/16/21 after his condition continued declining at home. His heart and kidney failure progressed while inpatient until he passed away on 3/20.21. His Comorbidities include chronic afib on apixaban, severe mitral regurgitation, aortic stenosis, AAA, OSA, CKD, HTN, CHF.
Information has been received from a nurse practitioner, via a company representative, concerning an approximately 22 year old female who was 6 weeks post partum and had completed a pelvic exam followed by the vaccination of the first dose (dose unspecified) of Gardasil. The nurse reported that 45 minutes after the appointment, the patient began to experience dizziness. The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. The patient sought unspecified medical treatment. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a nurse practitioner, concerning a 21 year old female patient, with a shellfish allergy who was 6 weeks post partum who on 23-DEC-2006 had completed a pelvic exam at the visit, who was then vaccinated, IM at 3:30pm, with the first dose of GARDASIL (Lot # 653938/0954F). The nurse reported that at 4:00 pm (previously reported as 45 minutes after the appointment), the patient began to experienced dizziness. The patient was observed in the nurse's clinic and was then sent to the same day clinic for observation. The patient's vital signs were reported to be normal, and a random blood sugar was 110 (units not specified). The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. No further information was expected.
12 hrs after injection a large, circular red rash appeared at the injection site (upper right arm). Area was approximately 3inx2in. Remained red and with a large knot under it for approximately 36 hrs. After 36 hrs the knot went away and the redness/pain went away.
syncopal episode began with client answer to nurse that he had fainted at one time in his life after he broke his finger and that he felt "fainty now" Nurse sat back down in chair by patient, and mother of client moved to his other side. As client was sitting in chair he slumped down and nurse grabbed hold of upperbody and asked mother to get onto floor so she could hold her sons head in her lap as the nurse laid the child on the floor. As the child's head was laid in mothers lap; the client's arms and legs began to flail in slow movement x 5 seconds. As this movement subsided the young man awakened, frightened calling for his mother. Both nurse and mother were able to calm the client.At this point he was able to lye quietly and nurse elevated the lower extremeties on a chair. Nurse and mom continued to speak with the young man-Nurse questioning previous episode of fainting-Nurse observed that the client was pale, with a strong, slow, and regular pulse approximately 60 bpm. After 5-7 mins. client was slowly sat up and was placed in a chair for approx. 5 mins. Client cont. to recover and was slowly stood up and walked a few steps to door wherein the client reported he was getting dizzy. Nurse slid client down the wall to sit on the floor for 5-10 mins. Upon closer questioning nurse deduced client had not had any protein in his diet today and the time was after lunch. Grandfather does have a hx of DM. A protein and carbohydrate bar was given to the client with a glass of water. After food intake client sat on floor 5 minutes and then was helped to a seat in the lobby. Client was observed for another 10 to 15 minutes and then allowed to go home with Mom. RN reinforced with Mom to call agency if anything should come up in the next days to call agency with info.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. NYSDOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from NYSDOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Information has been received from a physician concerning a female patient in her 60's who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  It was reported that the patient was vaccinated shortly after she was discharged from the hospital where she was treated for Legionnaire's Disease.  Subsequently, the patient experienced a severe local reaction.  Unspecified medical attention was sought.  She was treated with acetaminophen (Tylenol) and amoxicillin.  The patient's outcome was unknown.  No product quality complaint was involved.  It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (MSD) and had adverse events.  Additional information has been requested.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported
15OCT93 late PM felt tired & weak; 18OCT had severe muscle & joint aches & stayed in bed; does not recall fever, chills, or feeling warm; did not take temp 19OCT had non productive cough; seen by MD 21OCT laryngitis; dx bronchitis;
pt recvd vax 15AUG94 & on 20AUG presented w/welts & malaise-mom called nurse 21AUG to see MD-seen & started on DPH; 22AUG condition improving;
This spontaneous report as received from a pharmacist via representative refers to unspecified number of patient of unknown demographics. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, lot and expiry date were unknown. The pharmacist stated that an unspecified physician noted the occurrence of ophthalmic zoster post-vaccination with ZOSTAVAX in an unspecified number of patients. The outcome of event was unknown. Additional information has been requested.
patient received full 0.5 ml dose when 0.25 ml was indicated patient has not yet had any symptoms but has been notified to reach out the the health care provider if he experiences any symptoms
had the new shot, came down with shingles/suspected vaccination failure; shingles; I felt I was on fire; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date:08-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. The patient self-reported this case.  The patient had the old shots and had the new shot but still came down with shingles. It was horrible.  The patient stated that the worst was when ever he/she was in the sun, it felt the he/she was on fire. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.