chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client had a chief complaint of chest pain. Client stated that she began feeling chest pain several minutes after the start of her observation. Client has a history of depression and other unspecified psychiatric illnesses. Client stated that she takes sertraline daily and has a history of taking Risperdal. Client stated that she regularly sees a Psychiatrist. Client denied any allergies or other underlying medical illnesses. Assessment revealed chest pain located in the center of the patient?s chest. Client pointed to her sternum to indicate the exact location and stated that her arms felt "heavy." Client's airway, breathing and circulation were intact, however, client complained of shortness of breath. Client was alert and oriented to person, place, date and event while appearing slightly distractible. 02 saturation 100%. Client was negative for redness, swelling, hives, severe sweating or other signs or symptoms of anaphylaxis. Client denied any increase in chest pain or shortness of breath when breathing in or out and did not state any additional pain throughout her body. Client then added that she felt "anxious" after receiving her shot and stated some reluctance with even receiving the shot prior to her arrival. Client's mother was present and stated that client had been reading the Pfizer fact sheet she was given and had been focusing on the side effects portion before signaling for assistance. Client's initial vitals were as follows: Blood pressure:138/88, Pulse 76, Respirations 20, O2 sat 100%, Eyes equal and reactive to light, Lung sounds clear bilaterally. Client initially consented to staying an additional 30 minutes. She began to become anxious and impatient with her additional observation time. After 10 minutes of sitting the client began stating that she was afraid that her "heart would become too "fast" when she got home if she "didn't throw it away." After some encouragement, the client was able to clarify "it" as "meth" which she had hidden at home. Client stated some reluctance to go home stating that if she smoked her "meth" that her heart rate would become too "fast." Client then asked EMT if he was willing to come home with her to help her "throw it away." All staff present praised the client for sharing this information and after discussing her concerns further, client became much calmer and stated that she felt much safer and that her chest pain, shortness of breath and anxiety had subsided. Client then stated that she wanted to go home but consented to a second set of vitals before leaving. All of the client's vitals improved: blood pressure 132/88, pulse 68, respirations 16, O2 sat 98%. 1636 - 138/88, 76, 20, 100% 1651 - 132/88, 68, 16, 98%. Client was encouraged to discuss the incident with her psychiatrist and to seek further counseling. Client was also instructed to seek further medical care or the emergency room if symptoms returned. No medications were administered.
patient developed Covid-19; patient developed Covid-19; This is a spontaneous report from a Non contactable pharmacist. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The pharmacist reported that after patient received the 1st dose of the BioNTech Covid-19 Vaccine, the patient developed Covid-19 and pharmacist wants to know if it would still be okay if the patient receives the 2nd dose of the BioNTech Covid-19, 42 days or more after the 1st dose. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and a plausible temporal relationship, a causal association between the reported event and the suspect drug bnt162b2.
Patient insisted in getting both injections in the same arm, despite my recommendation against it, and experienced redness and pain at injection site
No additional AE reported; the patient was inadvertently given PROQUAD and VARIVAX on the same day; the patient was inadvertently given PROQUAD and VARIVAX on the same day; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 16-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered, extra dose administered). No adverse event (AE) was reported.
The patient was given an expired dose of Tdap (Adacel) .  I spoke to RN the immunization nurse she stated patient should be re-vaccinate.  Dr. was notified of error.  Dr. recommended patient come back in one month to be re-vaccinated.   RN  spoke to (Mom) notified of expired vaccine and patient is scheduled to be re-vaccinated in 1 month per Dr. .
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: shot 1t 1256pm, pt began coughing 105pm, had sweating and extrem cough/brionchospasms, benadryl and water 106pm, called 911, emt came 125pm and cleared 145 pm
Information has been received from a 26 year old registered nurse, with no known medical history and drugs allergies, who two weeks ago was vaccinated with a first dose of GARDASIL intramuscularly into the left deltoid.  There was no concomitant medication.  Two weeks ago she had experienced severe injection site pain that had persisted and even intensified.  She saw her primary physician for treatment.  She had been treating with rest and ibuprofen.  The pain had restricted movement in her left arm but not disabling.  No laboratories studies performed.  The patient sought medical attention through her primary physician.  The patient recovered on an unspecified date.
some pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (some pain in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (some pain in arm). At the time of the report, VACCINATION SITE PAIN (some pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded.
On 12/26/2000 the patient developed a chicken pox rash. Additional information has been requested. F/U 6/17/02: Info has been received concerning a 6 year old white male with an allergy to milk and eggs (before age 2) who on 2/19/97 was vaccinated with varicella vaccine live. On 12/26/00, the pt developed a chicken pox rash. F/U info received from the physician indicated that she had not seen the pt since 1/98, at which time his family was moving. The physician also reported that they had no records regarding any difficulty with the varicella virus vaccination that was given on 2/19/97. Additional information is not expected.
April 14 ongoing intense inner ear pain, headache , neck ache ,pain inside right throat and tongue. Nausea vertigo and tinnitus. April 18 -no relief with otc me losing and Advil.  Went to urgent care was put on prednisone and zofran . Worried it may be shingles I went to e.r later that same day and was put on valacyclovir and  gabapentin. Small vesicular rash on right ear and swollen auricle. Shingles confirmed  and to follow up,with ent and neuro.  Eye rash appeared    But went away photos were taken. saw ent 4-22- and confirmed  shingles. Eye dr seen on 4-23.  Completed steroid dose pack    Currently taking  valaclovir and gabapentin along with Advil, and meclizine. To help with intense pain and vertigo.  Ice packs to neck  and ear to help with headache.  Nothing is helping pain or loud ringing. Still wait g to see neuro dr.
Information has been received from a health professional concerning a female who in 2002 was vaccination with a first and second dose of varicella virus vaccine live, four to five weeks apart. It was reported that when the pt's varicella antibody titer was tested recently, the level came back undetectable. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient felt normal immediately after vaccine, remained sitting for about 3 minutes and then stood up and told me he felt like he was going to faint. i told him to sit back down and as soon as he sat, he fainted and head went back. patient was unresponsive for about 60 seconds and then came to and felt ok. i did call 911 and EMS assessed patient and gave him the OK to leave. patient told me after the incident that this occurs regularly when he sees needles.
Error: Administered shots meant for a 6 month old instead of a 2 month old. Luckily shots required were identical except an addition Hep B vaccine.
starting 2hr p/vax pallor, fever, constant irritable crying x4-5hr
Case number PHEH2013US017737 is an initial report from the nurse received on 19 AUG 2013. This report refers to a 17-year-old male patient. It was reported that MENVEO (batch number: M11032, expiry date: MAR 2014) which reached to a temperature of 31.1 Fahrenheit for a brief but an unknown period of time and on the previous day to a temperature of 32 Fahrenheit for 24 hours was given to the patient via intramuscular route on 13 AUG 2013. It was reported that no adverse reactions reported following this medication error.  No other information was available.
A report was received from a health professional on 10/30/01 concerning a 53 year old female patient who experienced swelling of the elbow and wrist and subsequently experienced swelling of the knee, 3 and 6 days respectively after receiving the Fluvirin vaccine on 10/17/01. On 10/20/01, the patient experienced swelling of the left elbow and wrist 3 days after receiving the Fluvirin vaccine in the left deltoid muscle. The swelling spread to the hands whereby the patient was unable to put her ring on. On 10/23/01, the patient noticed swelling and pain in the right knee and had difficulty sleeping, going up and down stairs and putting pants on as a result of the swelling in the knee. The patient tested negative for gout, lupus and rheumatoid arthritis. At the time of report, the patient was still recovering. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)
Broke out in hives, itching for 3 days. Had diarrhea 1 day. Rubbed cortisone ointment on body, gave orally Benadryl.
high pitched crying beginning 3 hrs p/vax; no documented fever; mother reports episode of head jerking-5 times about 4 hrs p/vax;
Flu like symptoms. Fatigue. Myalgia anorexia. Abdominal ache
dose was given after expiration date; Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021). On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient took Booster dose of Moderna. It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  Vial did not undergo any temperature excursion.  It was reported that patient did not experience any adverse event.  No treatment information reported.
Client reported on 7/25/18 that pt. had redness, heat, softball size raised area on (R) upper arm. Saw Nurse Practitioner on 7/25/18. Dx w/cellulitis. Given Clindamycin 300 mg TID x 10 days. 7/25/18 mother called to report child had seen nurse practitioner on 7/25/18. Child had raised 5 in. x 5 in. area on (R) upper arm - red, swollen, and hot to touch. Prescribed Clindamycin 300 mg TID x 10 days for cellulitis of (R) upper arm.
Mom c/o "knots on legs" after receiving immunizations last Friday. Mom states child has slept less, and had a slight fever for 2 days. Mother gave infants APAP and Motrin for relief. Denies increased fussiness, denies reduced appetite, denies any previous reactions to vaccinations, denies redness or warmth to the area, denies any indication that the area is tender to the infant. Fever was as high as 100.4 Saturday and has since resolved, no fever Sunday nor today.
Pt complained of feeling dizzy and having hives on neck and chest. The hives then spread to all over her body and she started having a headache.
A couple of days after the receiving the vaccine I started having severe heart palpitations. I noticed that a hemangioma on my lip was extremely swollen and black and blue looking while experiencing the palpitations. I was also dizzy. I sent pictures of mu lip to my doctor at college and he encouraged me to see my primary care doctor. Both doctors agree that they suspect I had a blood clot. I also haven't had a regular period since the vaccine. I had one brief period shortly after the vaccine, and it was unlike my periods before the vaccine. I haven't had a period in two months and I don't believe that is coincidental as I was 28 days regular before the vaccine.
Patient felt throat start to swell and get tight but never lost ability to breathe. Her face felt numb and tingling. Patient took Claritin and within an hour throat was fine but face felt tingly for several more hours.
Asthma but have never had an attack like that; Feeling extremely weak; Sluggish; Sleepy/I kept waking up gasping for air but I could not wake enough to move; Dizzy; Headache; Felt as though I had a cold; Severe muscle and joint pain; Severe muscle and joint pain; Trouble breathing; Could not sleep at all; Fever 100; Severe chills; Sweat; Still no energy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 13Sep2021 15:30 (at the age of 49 years old) (Batch/Lot Number: FD3183) as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included asthma, low thyroid, chronic pain, high blood pressure, depression, ADHD (Attention deficit hyperactivity disorder), Allergies: Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included celecoxib (CELEXA); morphine. The patient previously received the first dose of BNT162B2 (Lot Number: FD8448) in left arm on 30Aug2021 18:30 (at the age of 48 years old) for COVID-19 immunization. On 13Sep2021, within the first 2 hours patient started feeling extremely weak, sluggish, sleepy, dizzy, headache, felt as though she had a cold. Within 8 hours severe muscle and joint pain, headache, trouble breathing, could not sleep at all, fever 100, severe chills and sweat. What scared her the most was on the 15th at 6:30 am she kept waking up gasping for air but she could not wake enough to move. She has her asthma but have never had an attack like that. It felt as though she had been drugged. She finally tried to roll so she would fall off the bed. It did help when she hit the floor to wake enough to grab her inhaler. If she had not had one by her bed she truly do not believe she would be here. After that attack she slowly started feeling better. By that night she was feeling better. Still no energy. Treatment received for the event asthmatic attack, no treatment received for the other events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Sep2021.
got vaccine but had virus; Initial information received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves an adult patient of unknown demographics who had virus while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, route, administration site, batch number and expiry date: unknown) for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient reported got vaccine but had virus (viral infection) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable  It was not reported if the patient received a corrective treatment for the event viral infection nos (not otherwise specified).  Outcome: Unknown
Upon immidate injection Tongue felt  thickened, metallic taste and difficulty swallowing.  Stay at facility for 15 minutes, symptoms subsided within an hour. Symptoms have since returned. Two days later after receiving vaccine.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Patient presented to the ED approximately 2 days after receiving the 2nd dose of the COVID 19 vaccine.  It is unknown where the patient received the vaccine, since it was outside our facility.  The ED report states the patient woke up with eye swelling (bilateral). red rash on trunk.  After contacting the patient, on 25 January 2021, the patient stated that she also began using a Lotus flower facial cream that she believes may have been the cause of the reaction.
The patient was administered the Moderna vaccine into the left arm at 9:46am. The patient was monitored for 15 minutes post-vaccination without adverse side effects. When exiting the building the patient reported feeling poor. She reported palpitations and sudden chest heaviness. She was able to sit and converse without difficulty. The Doctor onsite evaluated the patient: She denied shortness of breath or pleuritic pain.  She noted mild nausea. Examination revealed no circumoral cyanosis or mottling.  She was awake, alert and conversant without use of accessory muscles. She was diaphoretic and slightly pale.  Breath sounds were normal without wheezing or stridor.  She was tachycardic (156/min, with BP 156/90.  O2 sat 99%. 9-1-1 was called. At the time of transport, the patient noted feeling slightly better, with heart rate 110/min.  Pallor and diaphoresis slightly improved. Report was called to the Emergency the patient was transported to.
Nausea at 9PM. Nausea, chills, low grade fever around 100. Vomiting, face swollen, rash on face and neck went to ER 10:30A.
On 11/27/21, pt was brought from Medical Center via EMS for positive COVID test on 11/17/21 and altered mental state; was treated with steroids, ABX, fluids; DNR; was dc'd back to SNF on 12/2/21; per death certificate, pt died in the hospital with cause of death listed as Failure to Thrive, COVID, and Alzheimer's
No adverse event; 20 year old patient was administrated a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a Nurse referring to a 20-year-old patient. The patient's concurrent condition, medical history, drug allergies/ reaction and concomitant medications were not reported. On 16-DEC-2019, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, formulation, dose/frequency, route were unknown) lot# N020613, expiry date: 05-MAY-2020 (product administered to patient of inappropriate age) for prophylaxis. No additional adverse effects reported. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sore arm at injection site, lasted approximately 30 hours Second dose on 2/23/2021: same lot number, same time, sore arm started approximately 6 hours later, ran fever next day (101,5) from 10 am to 5 m.
Patient was walking home with mother, when he said his vision was blurry and he passed out. Upon waking up 30-60 seconds later, he vomited. Later this afternoon, mom reports he is playing normally. She says he did not hit his head or joints with the fall.