chrisvoncsefalvay/vaers-outcomes huggingface dataset:
raising temp - highest was 102.8 by Monday 10-26-09, sleepy, lethargic. Was seen by family practice MD on Monday. Fever came down with Tylenol and Ibuprofen. As of today 10/28/09 baby still has low grade fever.  11/6/09:  Medical records received for date of service 10/26/09.  Dx:  H1N1 Vaccination reaction. Assessment:  Presents with fever, lethargy, feeding well.  Prescribed Tylenol. 11/9/09:  H1N1 Vaccine consent received.
This spontaneous report was received from a physician refers to a 4 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a second dose of PNEUMOVAX 23, (lot number, expiration date and route not reported). On an unknown date, the patient was administered only half a dose was administered as the syringe came apart during administration and no adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000439: US-009507513-1707USA000441: US-009507513-1707USA000442: US-009507513-1707USA000443:
This spontaneous report as received from a other health professional refers to a 61 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). About 3 days after receiving ZOSTAVAX, the developed an area of "irritation" and "soreness" in the vaccinated arm (unspecified side) (vaccination site irritation and vaccination site pain). Also reported that, if anything touched or bumped [his] arm it was very sore. The outcome of vaccination site irritation and vaccination site pain is unknown. Causality was unknown. No Product Quality Complaint (PQC) was involved.
I had and currently have severe acne that is very itchy. In addition, my hair fell out during the 1st and second dose of the vaccine, and again with the booster, I received the booster in December 2021.  There was no mixing of vaccine types this all occurred each time after being injected with the Pfizer Vaccine
Rash on eyelids with itchy, painful, runny eyes. Headache.
Bruise; Rash; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) and RASH (Rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Bruise) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, cream. At the time of the report, CONTUSION (Bruise) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Serious criteria other medically significant (OMIC). This subject was a 7 week old male, who experienced an important medical event due to a hypotonic hyporesponsive episode, while enrolled in a Study of comparative Immunogenicity of different multivalent component pertussis vaccine formulations based on a 5 component acellular pertussis vaccine in infants and toddlers. The subject received one dose of study vaccines, HCPDT IVP and ACT HIB, administered on 3/29/2006. The subject, who had no pre existing illnesses or medical history, experienced and episode of not responding, was extremely pale and had a loss of muscle tone, four hours post immunization. The subject had been taking a nap, and upon attempting to arouse him, the parent found that the subject was not responding, was extremely pale and was experiencing a loss of muscle tone which lasted for 15 minutes. After the 15 minute period, the subject was back to normal, and he was taken to an emergency room for examination. Testing included an EKG and blood glucose which were normal. At the time of this report, the subject had recovered. The subject discontinued in the trial on 3/29/2006. The event of hypotonic hyporesponsive episode was reported by the investigator as related to the study vaccines HCPDL IVP and ActHib, the Hepatitis B vaccine and the Prevnar vaccination.
Narrative: 12/24/2022 - Pt presented to ED with increased SOB after taking CBD gummies (stopped 3 days ago), wife reports pt seems off . Pt moving slowly, SOB with exertion - currently on oxygen 3L/min via nasal cannula at home. HPI: Patient presents to the ER via EMS for several day history of increasing shortness of breath and weakness. Patient states his sats were dropping into the 60s. Patient is on home O2 for history of lung cancer and a right-sided lobectomy as well as COPD. He reports that his normal chronic cough. Patient states he is extremely short of breath when he tries to ambulate. He denies any new chest pain, nausea or vomiting, abdominal pain or any other medical concerns. He also has an extensive cardiac history as well. MEDICAL DECISION MAKING (MDM): Patient with shortness of breath and especially a drop in sats when off his oxygen. Will initiate a cardiac work-up as well as chest x-ray. Patient history of COPD will give some steroids and nebulizers as well. Differential diagnosis includes, but not limited to, COPD, pneumonia, Covid, flu, ACS, PE, reoccurrence of lung CA. ER course-patient continued to drop his sats and became a little bit more confused/combative during his stay. He refused a blood gas. ICU MD was consulted and is currently here at 2300 to see the patient. Pt admitted to hospital 12/24/22 at 23:56 with principal diagnosis = acute on chronic hypercarbic respiratory failure secondary to COVID pneumonia. Pt hospital stay 12/24 - 12/30/22. ADDITIONAL DIAGNOSES: Chronic systolic congestive heart failure Chronic obstructive pulmonary disease exacerbation COVID viral pneumonia HOSPITAL COURSE: Pt required admission to MICU, subsequently patient was emergently intubated for airway control (in setting of acute hypoxic hypercarbic respiratory failure). PaCO2 on admission was 156. CT head obtained and found negative for intracranial bleed/swelling or abnormality. S/p cxr suggestive of bilateral infiltrates - covid vs pulm edema. Elevated D-dimer. ABG ordered in ED but pt refused, later obtained after intubation. Profound hypotension continued and required the initiation of levophed drip for control. Other related interventions initiated; Abtx (initiated with IV Ceftriazone & IV Zithromax -> then Vanc added), ABG pH 7.0, screening labs & imaging, central line placed, blood and sputum culture, NGT plcmt, tube feed, foley, dexamethasone, oral baricitinib started after CTA Chest confirmed negative PE/+ diffuse right upper lobe infiltrate, blood transfusion, and specialty consults (i.e. ID, Pulm, etc). S/p blood cultures - 1 set on 12/24, 1 set on 12/25, and 2 sets on 12/27 (results + Staphylococcus capitis from bld culture set obtained on 12/25)and C&S induced sputum was negative. Patient has been weaned off all drips, extubated on 2-3LNC, foley removed and medically cleared for transfer to medical-surgical unit. Pt discharged on 12/30/2022.
FluMist 11/8.  11/9 whole body rash, temp 101.8, puffy face, hands & feet.  11/11 temp 104 & continued rash.
at 6am 2 days after shot, he had slurred speech, face droop, confusion, weak left side, couldn't stand up. He went to the emergency room.
patient was hospitalized 1-28-22 with hypertension and signs of UTI and pneumonia infections. scan revealed evidence of previous mini strokes which family thinks may be due to getting the vaccine booster dose since patient seemed to have confusion happening soon after vaccination.  family also states that patient had another hospital stay of 5 days due to a clot around the time she received dose 2 of moderna vaccine which was 5-5-21 . unknown whether related.
Minimal nursing notes were provided. Patient lived at Healthcare facility  and died at their sister facility - Nursing and Rehabilitation.
Initial intradermal vaccine administration did not produce a wheal. Repeat vaccine given subcutaneous route 0.5mls to right arm.  Pt has no adverse reaction while in clinic after monitoring time complete.
Temperature of 103.7 and vomiting for 2 days. Mom used Tylenol, Motrin and tepid baths to bring fever down.
pt recvd vax & felt like throat was swelling which lasted a couple of hrs; also had itching @ the inject site which lasted 1 wk; pt recovered; not seen by MD;
Patient stated that she developed symptoms driving home  2 hours after receiving the vaccine. she called 911 and was transported to the hospital  Numbness, Tingling, blurry vision, headaches, Nausea
I felt a tickle in my throat and little bit of sniffles a day later a sinus headache almost migraine as well as sinus issues with a dry cough. I took prescription Febricol one dose two pills.
Patient identity was verified by name and date of birth. The patient was administered Pfizer pediatric dose, first dose. When we went to document the patient we found out that the patient was 13 years old. Patient had no adverse reactions or symptoms. The error was since the patient was scheduled to be seen at the clinic because the Covid clinic is only for patients between the ages of 5 to 11 years old. We are not administering vaccines to children over the age of 11 at the Covid pediatric clinic as the facility has a clinic specifically for those patients.
The patient came into our pharmacy to receive their second Pfizer vaccine.  He received the adult Pfizer vaccine for his first dose, but was accidentally given the pediatric Pfizer vaccine for his second dose.  We contacted Pfizer to see what they suggested we do for the patient.  They said that another dose is not necessary at this time unless our clinical judgement said otherwise.
Severe stiffness in shoulder area and in neck. Could not lift my arm for a few days.  Continuous pain in shoulder area varying with small amounts of use.  Interrupting sleep and eating patterns on a regular basis.
Auditory issues: ringing in both ears.  Sometimes louder in one or the other.  Ringing is day and night.
Information has been received from a physician concerning an "over 60 year old" female who on an unspecified date, was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# reported as 06957). Two days after administration, the patient developed zoster rash-like outbreak on the right side of her face. The patient also had a localized reaction of swelling and warmth at the injection site. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. Additional information has been requested.
post-herpetic neuralgia; other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 14-NOV-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a healthcare provider at a community nursing services for the long-term prevention of shingles and/or zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers including by not limited to a physician for shingles, post-herpetic neuralgia, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, post-herpetic neuralgia, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
took pt to MD rash over most of body & 2 day p/vax it got worse so diarrhea; pt went to ER;
patient experiencing flulike symptoms including fatigue, fever, aches, vomiting and diarrhea.
Approximately 3.5 hours after receiving the vaccines, my baby became unresponsive, lost all color in her face, and was barely breathing. We rushed her to the hospital across the street where they gave her oxygen and critical care. Her color returned and she was breathing normally after 10 minutes or so, but she seemed dazed for hours. She was  transferred to Hospital that evening. They monitored her overnight with no episodes. She was released the following day. I am happy to include hospital notes. From the emergency room: Procedure The patient received 5 minutes of critical care excluding separately billable procedures and family discussion judging an infant with an altered mental status episode. The child also had decreased tone and cyanosis all of which has resolved. The child is interactive and is breast-fed and clinically has nothing to suggest meningitis and therefore a lumbar puncture has not been performed. We have discussed this with the pediatrician at Hospital and they have accepted this child in transfer. Mom is aware of the need for transfer for further observation. The patient has a slightly elevated white count normal hemoglobin and slightly elevated platelets. Differential is pending. Electrolytes are normal. Random glucose is 111 with the electrolytes. BUN is 7 and creatinine is 0.31. Medical Decision Making Child improved in the ED after having a 10 minutes episode of AMS with decreased responsiveness with cyanosis and pale appearance. Her blood sugar was normal at 114. We have instituted a septic work up that includes, labs, urine, and an x-ray. Portable chest x-ray reveals no infiltrate or other significant abnormalities per EDP Reexamination/Reevaluation Heart is markedly improved. She will however need observation and monitoring. This was more than a very brief episode. Urinalysis is also pending. X-ray per EDP and per radiology reveals no infiltrate.
APPROX 14 MINUTES POST VACCINATION PT REPORTED TINGLING FEELING IN TONGUE AND LIPS WITH SPREADING TO HER FACE AND HANDS.  DENIED DIFFICULTY BREATHING, LUNGS SOUNDS EVALUATED BY NP, REPORTED CLEAR. MINI NEUROLOGICAL EXAM WNL PER NP.  PT GIVEN 50MG BENADRYL PO. PT BP ELEVATED AT 186/90. PT AGREEABLE TO TRANSFER TO LOCAL ER.  TRNASPORTED BY EMS, DEPATED AT 12:05PM.
pt c/o sore back and shoulder muscles/ muscle spasm, panic attack.  Pt laid down, did deep breathing, relaxed.  Water given.  BP 144/80, HR 66, RR 18 -- > 95/67, 63, 18-- > 124/74, 67, 18.  Pt stable and released from the vaccination site.
On 03/27/2021, around 3:00 pm, my face swelled up. It was itchy, red, hot and it made my jaw sore. It could be because of the swelling. My face swelled up with the 1st dose of Pfizer also. I treated myself with Benadryl, but the swelling would not stop after a couple of days.  I made an appointment with the doctor on 03/29/2021. The doctor prescribed a medication that I do not remember what it was called. It took 2 or 3 weeks for the swelling to go down. Each day I could see it was kind of going down each day. On 10/06/2021, I consulted with my doctor about getting the 3rd booster. He took a TITER Test and the results were 966. He said I did not need to get the 3rd dose at this time because of my reaction with the 1st and 2nd dose of Pfizer.
Presented in office 10/20/05 C/O rash L leg X 3 days. Received immunization on 1/17/05. DTAP LT, MMR RT, Dx with reaction to DTAP.
Patient felt stabbing pain after Adacel was given. To the point where he was crying. Other arm felt fine. Site was (L) Deltoid. No swelling, bleeding, inflamation at site. Gave Ice pack and 200mg Ibuprofen PO. Patient felt better after 20 minutes.
This spontaneous report was received from a consumer (patient's mother) reporting on a 11 month old male patient. The patient's pertinent medical history and concomitant therapies were not reported. On an unknown date in 2001, the patient received (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported) 6 days before his first birthday, which was different from the prescribed label. There were no adverse event to report. The misuse of the vaccine was discovered at the close of the call therefore the reporter did not participate in this report. The mother sought medical attention by speaking with pediatrician. Additional information is not expected as there were no contact details provided.
Forgot to reconstitute the vaccine; Administered just the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   On 15th May 2020, the patient received Shingrix. On 15th May 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The pharmacist reported that she accidentally administered just the adjuvant for Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist forgot to reconstitute the vaccine. The reporter consented to follow up. This case had been linked with US2020083389, reported by same reporter.
(1) Persistent ringing in both ears; has remained constant for the last 3 weeks.  (2) Elevated heart rate and shortness of breath. Can't walk up stairs without having extreme heart palpitations and trouble breathing. Walked 3 miles per day without issues prior to vaccine.  (3) After vaccine, I can't sleep lying down; feel like I am suffocating.
Left arm  around injection site has red, itchy rash that comes and goes about half dollar size. Left arm around injection still has swelling and achiness. Post six weeks from administration of vaccine. (shoulder is not involved)
1/25/21 @ 12:30PM: Spoke with client who stated on day 2 after injection, he woke up with body aches, fever, and chills that lasted until 1/24/21.  Client denies any symptoms at this time.  Client informed to call PCP for advise prior to next dose of vaccine. Client was agreeable.
Vaccine administered 08/14/06. Patient brought to ER 08/15/06 with fever of 102 and diarrhea (about 15 diarrheal diapers)- recieved IV rehydration.
Bodily aches, Headache, bright red rash on both arms and both thighs.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 23-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Pt received Pfizer x2.  Pt tested COVID + on 8/10/21 and admitted to hospital for COVID on 8/11/2021. Pt received remdesivir and dexamethasone.
Mother reports warmth, redness, swelling that started on Saturday, the day after injection to dtap site. Then on Sunday night (5/22/22) small vesicles formed around injection site.
The night after I got the shot, my arm swelled up and hurt so bad I couldn't sleep on it, it lasted about 2 days. Then on day eight I went out for a walk and my arm started itching.  Later that evening it started getting red, swelling up and was hot to the touch.. It was also red and swelling up about an inch below the injection site. The rash was going down my arm. There was an aching pain all the way down my left arm to the hand. So painful and swollen I could not sleep on that side for two nights. I still have a bit of the rash today, but it is definitely better on day 11. Should I get the second shot?
Information has been received from a healthcare worker referring to multiple, unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L011846, expiration date 16-JUN-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Small red area for 6 days, faded small red area on 7th day, LARGER RED AREA ON 8TH DAY WITH ITCHING.  This is 9th day and red area continues to enlarge with more itching.
1st dose, sore arm.  2nd dose approximately 6 hours later body aches, heavy legs.  12 hour after 2nd dose Fever of 101.9 chills, joint pain. Fever subsided 30 hour later. Body aches lasted 48 hours.  Heavy menstrual cycle started the day after the second dose. It was 2 weeks early and normally it is regular like clockwork.  Recovered from everything but the menstrual cycle hasn't stopped.
Pt. came in 11-22-14 and still complained that arm getting worse - hard to move and wondered if frozen arm syndrome - thinks injection site unable to move freely - pt. will see her primary care soon and ask as well.