chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an investigator concerning a 2 month old female who, on 5/25/2000, developed somnolence and altered mental status. The infant was waking up and feeding every 4 hours (normal interval was every 2-3 hours), however, was taking same amount orally. During exam, the infant was easily arousable, vigorous and attempted to focus on the examiner's face. Her temperature was 99.2F, HR was 152 beats per minute and respiratory rate was 36 per minute in triage and later was 20 per minute in the ER. She was hospitalized to rule out sepsis. One day later, she recovered and was discharged. Given the temporal relationship of the event to vaccine administration, the medical monitor and investigator agree that excessive sleepiness, post vax (hospitalization for drowsiness is unexpected per the investigator brochure), is possibly related to the study vaccine or the concomitantly administered vaccines. This is a study combination of IPOL (PMC) and Acel-Immune(Lederle).  Follow-up information dated 6/5/00 indicated that the event did not warrant hospitalization, the anxiety of the infant's parents precipitated a decision to hospitalized the infant.
Feels like a month of internal shingles; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.   This case involves a patient (unknown age and gender) who feels like a month of internal shingles (herpes zoster), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to neomycin (Drug hypersensitivity).   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious internal shingles (herpes zoster) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign was reported, it was assumed that the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, outcome of the event was not reported.  There will be no information available on batch number for this case.
ARM VERY VERY SORE- WORSE THAN EXPECTED, OVER THE PAST WEEK HAS GOTTEN SO SORE IT CAN BARELY BE LIFTED (BEEN TAKING TYLENOL WITHOUT ANY RELIEF) ENTIRE DELTOID MUSCLE IS HARD AS A ROCK.
High pitch screaming, fever, diarrhea for over a month, personality change. Later seizures. Child developed beautifully his first year of life. All expected milestones were on time or sooner than anticipated. He was talking at 10 months of age. He mimicked parents, loved socializing and interaction with other toddlers. He seemed on the same track as siblings. MMR was received immediately following his 1st birthday. He was given his 4th DPT on a sick child visit at age 15 months while ill. Post vax, he became sick with diarrhea and general ill health for a couple months afterwards. He later developed seizures which is believed to be a direct result of the vaccines. The so-called health center that administered these vaccinations, never explained risks, and didn't practice good vaccine safety measures.  Child is now considered autistic. He doesn't experience the once in a life time magic of childhood. He cannot speak. He no longer plays with children. Various tests including blood work have been conducted to rule out genetic link. He has levels of toxins in his body due to the vax ingredients.
After receiving the medication, the patient stated that she felt tingling in right arm. She states that she had a headache. It subsided in 20 minutes.  Blood Pressure was very high     5:13PM   175/102  P94  O2 100: 5:19 PM  183/109   P96  O2 100 5:23PM  173/101  P99  O2 100 5:53 PM  162/98    P92   O2  99
It was reported that a female pt who, post vax, reportedly, her hamstring of her right leg began to hurt within days of the vaccinations. The pain was so intense that the pt was unable to walk. Pt was hospitalized for 4 days and was dx'd with arthritis in the hip. Pt is on crutches and experiences muscle pain with shooting pains down her leg. As long as pressure is off leg, the pt only experiences muscle weakness, no pain. Further information has been requested.  Follow-up dated 7/11/00, it was reported that the pt began experiencing pain in her right leg on 5/10/00. The pt was hospitalized from 6/1/00 to 6/4/00 for further evaluation. A x-ray of the right hip was positive for arthritis. Additional pt and vaccine administrator info were also provided. Follow-up 05/15/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (added myasthenia). The case is closed.
Patient received Moderna vaccine on Monday afternoon. That evening she started having body aches and a sore throat.
Pt recvd vax & 3 hrs p/vax 12JUL93 pt became fretful had high pitched cry, inconsolable, lasting all evening & into noc, t102, local erythema;
had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient).  A 42-years-old female patient  received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020.  The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.
The morning after receiving the vaccine I woke up feeling achy and had a head ache. I vomited. Later that day I was in a doctors office and my heart rate was 150s at rest. I was sent to the ED for assessment, EKG normal. I received fluids and my heart rate came down to 100-115. I went to my PCP for f/u the next week and they checked my thyroid which was elevated and I was sent to an endocrinologist. My symptoms of tachycardia had started to subside so thyroiditis r/t vaccine and/or post partum are leading on my differential.
Cried uncontrolable for more than 24hrs - site of inject quite reddeness & tender for more than 24hrs.
Arexvy - Subcutaneous instead of Intramuscular injection; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (subcutaneous). On an unknown date, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: Arexvy - Subcutaneous instead of Intramuscular injection).The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2023 The healthcare professional called to report the subcutaneous administration of Arexvy to a patient, which led to intramuscular formulation administered by other route. The healthcare professional asked if the dose should be repeated.  The reporter did not provide information about patient (patient initials, age, gender). Due to the nature of the call permission to follow up was not requested.
This spontaneous report as received from a nurse refers to a 68 year old patient of unknown gender. No medical history provided. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4" x 10");
N17.9 - Acute kidney failure, unspecified DIZZINESS WEAKNESS - GENERALIZED
since yesterday is with fatigue, like extremely tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (since yesterday is with fatigue, like extremely tired.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced FATIGUE (since yesterday is with fatigue, like extremely tired.). At the time of the report, FATIGUE (since yesterday is with fatigue, like extremely tired.) had not resolved.            Patient was not taking any concomitant medication.  Patient took booster dose in her left arm (non-dominant).   No treatment information was reported.
Received vaccination on 10/6/17 at 1400. Mild pain noticed at 2330 that night. Next morning, she had erythema, swelling from deltoid to distal left elbow, pain, increased warmth, and descreased ROM. Applied ice. Symptoms mostly subsided after 3 days.
Patient c/o chills, fever and aching for 3 days,  Left arm at site of injection became red swollen and painful.  Patient called after 3 days and stated the symptoms were all subsiding.
upon awakening eyes fixed & glassy, arms & head jerkie x 30-40sec then body became limp; no temp; 1 hr p/MD noted excessive salavation w/arms & legs jerkie; face flushed & inc perispiration; took pt back to MD;
testing positive for Covid 19; testing positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing), notes: Patient had psoriasis and was on tremfya. Concomitant medication(s) included: TREMFYA taken for psoriasis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Clinical course:Patient reported she tested positive for Covid 19. After symptom resolution, patient received Covid -19 booster shot and again tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
highly exposed to covid; got the second dose there was still some swelling from the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, First Dose: hands and feet had severe swelling), administration date: 28Dec2020, for COVID-19 immunization, reaction(s): "First Dose: hands and feet had severe swelling"; Bnt162b2 (1st Dose, First Dose: hands and feet had severe swelling), administration date: 28Dec2020, for Covid-19 Immunization, reaction(s): "irst Dose: hands and feet had severe swelling". The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "highly exposed to covid"; SWELLING (non-serious), outcome "unknown", described as "got the second dose there was still some swelling from the first dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of exposure to sars-cov-2. The patient was 67 when she received her vaccines. The patient was part of the first group that got the vaccine. The patient received her first dose on 28Dec2020 the second one was weeks later in Jan2021. In Aug the patient received the Regeneron IV treatment because she was highly exposed to covid and was given that IV prophylactically. The patient had that protection since Aug2021. As there were increased cases of Covid, 2 residents and 2 employees in the patient's nursing home had tested positive. The patient refused to have the booster as the patient needed some sort of concrete information if it was safe to get the booster dose- the third dose, with that kind of reaction initially. The patient had health issues and takes lots of medications.  The lot number for bnt162b2 was not provided and will be requested during follow up.
threw up; minor headache; not felt well; Sick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not felt well), ABDOMINAL DISCOMFORT (Sick to my stomach), VOMITING (threw up) and HEADACHE (minor headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced MALAISE (not felt well) and ABDOMINAL DISCOMFORT (Sick to my stomach). On 16-May-2021, the patient experienced HEADACHE (minor headache). On 17-May-2021, the patient experienced VOMITING (threw up). At the time of the report, MALAISE (not felt well), ABDOMINAL DISCOMFORT (Sick to my stomach), VOMITING (threw up) and HEADACHE (minor headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Patient was offered the vaccine today at the clinic he said yes, gave patient the dose monitored patient for 15 min. Patient had no reaction to the vaccine. Went to put the vaccine into system and noticed patient was already vaccinated.
Has appearance of angio edema localized to phallus/scrotum. Not described with Zostavax, but this only when exposure; HPI: Patient presents today with painless swelling involving scrotum and penis. No pain or tender. Came out of the blue. No recent sexual activity(erectile dysfunction). Has been using prescription antifungal for Dr. to control chronic/recurrent T. cruris; Examination: Male GU Swelling on underside of penis just distal to the tip with an almost edematous, fluid filled appearance to the skin. Similar findings at base of penis/scrotum. No masses. No hernias. L testicle pushed up toward inguinal canal.
Itchy rash on bilateral ankles; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (Itchy rash on bilateral ankles) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on bilateral ankles). At the time of the report, RASH PRURITIC (Itchy rash on bilateral ankles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up report received and injection site location was updated
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (strength, dose, route of administration, lot number and expiration date were not reported)  for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 4 centigrade degrees for a time frame of 2 hours and 55 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA012142:
Patient was found dead in her bed 1/17/22 by a friend at around 4:30 pm. Patient had been observed to be in good health by the same friend that morning. An autopsy is planned.
Right after getting the vaccine, patient got dizzy and experienced blurry vision. I had patient lay down on the floor and elevated her feet. Gave her an ice pack because she complained of sore arm. I also gave her some orange juice to drink after about 10 minutes when she started feeling better. after about 25 minutes patient felt fine and ended up leaving the pharmacy area with her mother. Called patient after about 2 hours and patient was back to normal.
Within 1 minute of receiving the vaccine, I felt as if my body was on fire, along with dizziness and feeling like I was going to faint.  When I alerted the pharmacist, she brushed it off saying that I was just nervous. I waited the 10 minutes at the pharmacy and then left, still feeling dizzy and spacey. Then a feeling as if the vaccine was coursing through me, it was like an electrical shock feeling stinging me everywhere.  I called my mother being nervous, she ordered I go to Urgent Care. I told them what was going on, they wanted to call an ambulance. I said absolutely not since all of my vitals were normal. My breathing was normal. From 3-21 and on, I sporadically feel the electrical shock feeling at all different parts of my body. My skin also feels sunburned, but there is no rash anywhere. A day or two after, the left side of my face was swollen. That is currently no more. I went to my regular Dr., he strongly suggested for me not to take the second dose. He took blood to check for sediment rate I believe, that all came back normal. He referred me to an allergist, waiting to get that appointment.  To date, dizziness went away, sunburn feeling went away, electric shock feeling still comes and goes.  I never had any temperature, no tiredness, no rash.
had an allergic reaction / allergic to Bexsero; This case was reported by a other health professional via other manufacturer and described the occurrence of allergic reaction in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient received Bexsero and had allergic reaction. The medical assistant declines to provide additional information. The reporter would like to know if the patient could receive the Pfizer Covid-19 vaccine The reporter did not consented to follow up.
Patient received the flu vaccine in her left arm - no problem and the pneumonia vaccine in her right arm on 9/17/21. Patient states right arm was sore since vaccination. On 9/24/21 in the evening patient was resting and arm was hurting. Patient got up to observe and noticed arm was warm and mildly swollen with a rash the size of a golf ball.  Patient presents to the pharmacy on 9/25/21 with these complaints and rash is slightly smaller than picture shown to pharmacist of night before and redness is significantly improved. Patient said she washed her arm with witch hazel and put hydrocortisone 2.5% cream on her arm last night (9/24/21).  Patient states no previous reaction to vaccine in the past and only known allergy is to latex. Patient states no other issues and since the steroid cream has improved the rash was told to continue this treatment.