chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her currently 4 years old grandson. The patient had no concurrent conditions, medical histories, drug reactions or allergies and concomitant therapies. On an unknown date in April 2013, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route were unknown). On an unknown date, while on M-M-R II, the patient was diagnosed with autism sensory perception disorder. The patient lost his ability to talk, became lactose intolerant and developed celiac disease (dates unspecified). The patient visited the doctor for medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the events. No product quality complaint (PQC) was involved. The causal relationship between M-M-R II and the events was not provided. Upon internal review, autism and celiac disease were considered to be medically significant. Additional information is not expected as the reporter did not want to be contacted.
Narrative: COVID infection following COVD vaccine series 06/18, Pfizer, dose #1 07/09, Pfizer, dose #2 08/09 09/01 COVID swab, result: NOT detected 08/18 COVD swab, result: NOT detected 08/22 COVID swab, result: detected 08/22 SARS-COV-2 Variant Sequencing result: pending 08/21 pt cc:fatigue, rhinorrhea, sore throat exposure: unknown 09/01 COVID swab, result: NOT detected
Information has been received from a physician concerning a 9 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient developed breakthrough chickenpox in December 2006. At the time of this report, the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected.
(unknown vaccine brand, unknown lot number) Cellulitis of left upper arm: At left deltoid, where she received Tdap vaccine. Seems more like infection than allergic reaction to vaccine but this was considered. +Warmth, redness, swelling, pain.  keflex (cephalexin) 500 mg capsules, 1 capsule by mouth four times daily x 7 d, disp #28, no refills
Patient was given a dose that was outside of the stability window according to Pfizer's guidelines by about 1.5 hours. The vaccine had expired at 2:24 PM and the dose was given at around 3:45 PM. I contacted Pfizer and CDC for next steps and CDC recommended that the patient be revaccinated immediately on the opposite arm based on Pfizer's information that the vaccine component would degrade if left at room temperature after mixing for more than 6 hours. Patient was contacted to inform her of the incident and I informed her of the CDC's recommendation to revaccinate. In regards to any side effects from the incident dose, the patient reported a sore arm and headache as side effects.
Passed out after vaccine was given. Pt did c/o nausea but no vomiting. Pt was instructed to lay down for 10 minutes. At that time B/P was normal and was able to sit. Pt was able to leave unassisted.
Arm kept getting sore and sore. She start noticing a pain in her arm which kept getting worse. She couldn't move her arm not up or down without it hurting. Now she cant do anything with her. All this is in the left arm where she rcvd her shot. And she realized that the lady who gave her the vaccine did it wrong.
Receiving a dose from an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that 10 or 11 patients received a third dose of Moderna COVID-19  vaccine.  Treatment information was not provided.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Medium
Erythema and Edema to right tricep, extending below elbow, warm to touch.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted(syncope) in store aisle shortly after receiving flu vaccine in arm. Pt stuck head on metal shelfing in aisle. Pt woke up, sat up, and was given some water then taken to the ED.
pt fainted within 1 min p/recv vax, for 1 min; no treatment given
on 4/7/2021 pt noted a soreness in her left leg she notified our office on 4/9/2021 and a doppler L leg was coordinated with showed L superficial vein clot but no DVT pt was instructed to hold her OCP; take advil TID and apply warm compresses
symptoms, Shortness of air, sat 93% room air, cough, headache, diarrhea. exposure to positive family member approx. two weeks prior to office visit on 03/01/2021, was scheduled for Monoclonal antibody treatment.
Pt recvd pneumococcal vax on 28APR92 & w/in 24 hrs devel a swollen, painful, red arm @ inject site & t103 treated w/Advil & heat;
Patient works night shift and did not eat or drink anything all day before arriving for first Pfizer dose. Patient was anxious. Vaccine administered. Patient went to waiting room to wait. He passed out in chair. Came to. Was taken into the exam room, laid down, and feet up. Patient felt dizzy and lightheaded. Gave patient water and checked vital signs. 02 97%. BP 100/60. HR 87. Patient drank more water. Slowly sat up after 5 minutes. Sat on exam table. Felt dizzy again and threw up water. Was diaphoretic and pale. Gave patient lolly pop and had his daughter go buy him an orange juice in the store. Patient drank orange juice and ate lolly pop. Reported he felt much better. He then sat in waiting room for an additional 15 minutes until he was ok to go. Left with no residual side effects.
Patient had to travel after the Vaccination. She travelled and by the time she landed there her voice became very hoarse. She visited the Physician  and found to have Keratotic Patch on her vocal chord (Bilateral). Patient is a non-smoker and has no known allergies. This started on 17th Nov, 2022 and within a week she lost the voice almost completely. the voice back. Physicians/Specialists are treating her with medications and have advised if situation remains same may need surgery. She still have the symptom and cannot talk. She doesn't have any other symptoms - no fever, no runny nose, no allergic conditions.
Hard large firm painful lump at injection site approximately 8 inches x 2 inches in size. Lower back and leg pain,Headache, weakness,  and nausea.
patient wrote date of birth down on consent sheet but when i contacted the insurance they say the date of birth is a year later than stated which would make the patient 11 years old instead of 12.
Patient reported a fever over 100F, weakness, and upset stomach in the 2 days following vaccination. Patient reported that she was unable to participate in normally daily activities due to these symptoms. She stayed at home and rested for both days.
First dose I started having a headache within 30 min after receiving the vaccine. this headache last 2 weeks off and on again directly in the center of forehead causing pressure behind my eyes.  Second dose-  received 01/26/2021once again headache started within 30 min after receiving the vaccine, by 10:00 that evening I was having chills which continued through the night. 6am the next morning on 01/27/2021 my body was in alot of pain, my husband states that he had a hard time trying to wake me. I was able to get up with help at 11:30 a.m. to use the restroom and straight back to bed. I did not wake up again till 10:00a.m. on the morning of 01/28/2021 I had slept for more than 36 hrs straight. I just could not wake up during this time my eyes were heavy and my body felt wiped out, very tired. I feel better today although I am extremley weak with little strength. It has been a horrible experience. I was afraid that I was not ever going to be able to wake up again.  What would cause my body to shut down like this????????  Wishing I did not get that second dose
He took 2 doses of the Pfizer and now he is dying.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: TERMINAL STATE (medically significant, life threatening), outcome "unknown", described as "He took 2 doses of the Pfizer and now he is dying.". Clinical course: Patient mentioned that he took 2 doses of the Pfizer and now he was dying. He was asking why. He said that it was the vaccines that he have gotten. He said his doctor said that he was dying. He said that his doctor said a lot about it. He said why Pfizer want to kill people.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient described significant flare-up of arthritis symptoms including joint pain and swelling. Likely due to typical post-vaccination immune response, but more severe considering this patient's underlying medical conditions and treatments. She returned for the 2nd dose, but wanted to report to increase available data regarding this vaccine in immunodiverse individuals.
tinnitus (both ears)/buzzing sound/hazy/constant (both ears); This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (on left arm requiring physical therapy) in January 2021. Concurrent medical conditions included Hypothyroidism, Arthritis, Drug allergy (Becomes nauseated if she takes Codeine and Erythromycin) and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, CELECOXIB (CELEBREX) and RALOXIFENE for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)). At the time of the report, TINNITUS (tinnitus (both ears)/buzzing sound/hazy/constant (both ears)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Approximately one month after the second dose, the patient noticed tinnitus in both ears. The patient described the tinnitus as a buzzing sound, and was hazy, and tinnitus was constant in both ears. No treatment medications were reported.
severe leg cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Primary Immunization), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), outcome "not recovered", described as "severe leg cramps".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Right side of head and right arm tingling. 122/78   pulse 72     PSO2 95%      Respirations 18      no s/s of distress monitored then released
Redness, swelling, soreness of site Flu symptoms Stomach pain/upset Leg cramps Pain radiating up into shoulder and neck from abdomen
I observed a tiny red spot on left side of my scrotum which grew into hard mass which visually appear more like a tumor than a pimple. It does not pain on touching but I am afraid to check tenderness by pressing. I have recently moved to the area so I do not have a PCP. Is this something due to vaccine that I need to get checked in emergency?
Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
No adverse symptoms reported; patient was "inadvertently administered an expired; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender.  The patient's medical history, historical drugs, concurrent conditions were not provided.    On 20-JUL-2020, the patient was "inadvertently" administered an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R017636, expiration date 20-JUN-2020 (Strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent.  No adverse symptoms were reported.
Inappropriate route of vaccination; No adverse effect reported; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated by intramuscular route (incorrect route of product administration) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, lot number, and expiration date were not provided), for prophylaxis. No adverse effect reported.
Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then , and still had periods.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Lot number: EN6206) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe asthma" (unspecified if ongoing), notes: Verbatim: severe asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6201, administered in left arm), administration date: 14Feb2021, when the patient was 33 years old, reaction(s): "Covid-19 Vaccination". The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Her second vaccine it happened, but she was due for her period at that time. She was on a different birth control then , and still had periods.". The event "her second vaccine it happened, but she was due for her period at that time. she was on a different birth control then , and still had periods." was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
PT GIVEN PRIVATE DOSE OF VACCINE THAT EXPIRED 6/2/2022 IN ERROR.  MULTIPLE PEOPLE INCLUDING NEW HIRE INVOLVED CAUSING CONFUSION IN GIVING VACCINE.  PT EXPERIENCED NO ADVERSE REACTIONS NOTED AS OF 9/20/2022.  PROVIDER CONTACTED PTS MOTHER/GUARDIAN REGARDING THIS.
Pins and needles (August 23, 2021 - present) Muscle tremors (August 29, 2021 - present) muscle weakness/difficulty walking (September 1, 2021 - September 6, 2021) dysarthria (September 1, 2021 - present) Treated at Emergency Room on August 30, 2021 Treated at Emergency Room on Sept 1, 2021 Admitted to Medical Center on Sept 1, 2021 - Sept 3, 2021
She went into anaphylaxis; She had a seizure; Because looked like was choking; Wheeled out on stretcher looking unconscious; Was vomitting; Though her body at one point shook; Coughed some stuff up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Mental health struggles (believe depression)" (unspecified if ongoing), notes: Verbatim: Mental health struggles (believe depression). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1), when the patient was 27 years old, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She went into anaphylaxis"; SEIZURE (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "She had a seizure"; CHOKING (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Because looked like was choking"; LOSS OF CONSCIOUSNESS (medically significant) with onset 12Dec2021 10:45, outcome "unknown", described as "Wheeled out on stretcher looking unconscious"; VOMITING (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Was vomitting"; TREMOR (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Though her body at one point shook"; COUGH (non-serious) with onset 12Dec2021 10:45, outcome "unknown", described as "Coughed some stuff up". The events "she went into anaphylaxis", "she had a seizure", "because looked like was choking", "wheeled out on stretcher looking unconscious", "was vomitting", "though her body at one point shook" and "coughed some stuff up" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, choking, loss of consciousness, vomiting, tremor, cough.  Clinical course: The reporter reported that patient collapsed during 10:45 AM church service warranting emergency services to be called and to take to hospital. Rumors circulated that she went into anaphylaxis, or that she had a seizure and was vomitting. From things overheard, seems like received epinephrine and had to have chest compressions (heart stopped) prior to paramedic arrival. Reporter saw wheeled out on stretcher looking unconscious, though her body at one point shook because looked like was choking and coughed some stuff up. Know individual has Crohn's disease and has passed out before, but do not believe this may have been a similar event. Patient is 27 Years old as of Mar or late Feb (probably Mar) this year. It was unknown that the patient diagnosed with COVID-19 prior to and since vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Per the employee's incident report, "5 hours after receiving the covid19 vaccine i became very nauseous, light headed, and clammy while walking back from the bathroom.  This caused me to faint.  I hit the floor with my chin and had to get sutures"
Headache and muscle aches and joint pain; Headache and muscle aches and joint pain; Headache and muscle aches and joint pain; I woke up feeling sore. But then, as the day progressed I started feeling more achy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3247), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation.  Medical history included none.  There were no concomitant medications.  After she took the 1st dose she had a headache and muscle aches and joint pain. The patient stated, " I received the vaccine about 24 hours ago. At this point, I am just wondering if I can take Ibuprofen to help with some of the symptoms that I am feeling. If I do take Ibuprofen, is that going to like impact the response of the how the vaccine is working? I woke up feeling sore. But then, as the day progressed I started feeling more achy. So, like more muscle ache and headache." The outcome of the events was unknown.
Patient had an anaphylactic reaction to his pfizer booster covid vaccine. A code blue was called for an adult code blue in the west building. He was getting his booster in the booster clinic.  He is an employee of school. He was on the job here to get his booster vaccine. He has a history of anaphylaxis to the covid vaccine. He had been intubated for his first shot (pfizer) and was admitted to the ICU for a short stay. He was here today to receive his booster and had similar reaction.  Today after the third shot, Patient became apneic and hypoxic with an acute life threatening anaphylaxis reaction and team was unable to get an IV in. An I/O was placed and patient was taken to OR and intubated and then transferred to  Adult care where admitted to ICU.
fever; flu like symptoms; general aches; muscle aches; This case was reported by a pharmacist and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, influenza-like symptoms, general body pain and muscle pain. On an unknown date, the outcome of the fever, influenza-like symptoms, general body pain and muscle pain were unknown.   The reporter considered the fever, influenza-like symptoms, general body pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient received Shingrix and experienced flu like symptoms, fever, muscle aches and general aches due to the vaccine. No other information was received.