chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL DOSING FREQUENCY; ARM WAS SORE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on 06-MAR-2021 for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced arm was sore with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient recovered from arm was sore on 2021. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total, administered on 06-OCT-2021 for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 2). The product was associated with off label use. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced arm was sore for a couple of days, not long (Dose number in series 2). Patient had no redness or swelling. Laboratory data included: Pain scale 5/10 pain score. At the time of reporting, patient stated that the pain was fully gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore on 2021, and the outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221059775.
This spontaneous report was received from a physician via company representative referring to a 20 month old female. No pertinent medical history, drugs reactions/allergies nor concomitant medications were reported. On an unknown date (reported as at "13 months old"), the patient was vaccinated with VARIVAX, subcutaneous (Lot number, expiration date, anatomical location and dosage were not provided) for immunisation. On an unspecified date (reported as "within the last couple of weeks"), the patient was exposed to an unspecified cousin with chickenpox and the patient developed chickenpox on an unspecified amount of time after exposure to her cousin. Physician reported that on an unspecified date, patient's parents contacted physician's office to inform that patient had developed chickenpox. An unknown treatment was given for the adverse event. At the time of reporting, the outcome of varicella was reported as recovering/resolving. The reporting physician did not assess the causal relationship between the adverse event and the vaccination with VARIVAX.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9808) at the age of 65 years, in right arm, on 05Mar2021 as dose 2, single (Lot number: En6198) at the age of 65 years, in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years, in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "allergies", notes: known allergies: Yes - Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Contracted Covid 19". The patient contracted Covid 19 on 23Jul2022. The patient took Paxlovid for 5 days then tested negative on 30Jul2022. The patient retested on 03Aug2022 and tested positive again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (03Aug2022) Positive, notes: Retested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Swelling, warmth. Area is 4cm redness, 2 cm induration.
On 11/1/2021, I received the Moderna Covid-19 booster in my left arm. This was my 3rd dose of the Moderna Covid-19 vaccine. On 11/13/2021, I woke up to a red rash on each of my upper hamstrings/lower buttocks. As the day went on , I proceeded to develop hives and a red rash on my scalp, neck, and shoulder areas. I also have slight swelling of the eyelids. On 11/15/2021, my dermatologist diagnosed me with urticaria as a result of the Moderna Covid-19 booster. I was prescribed 20 mg of Zyrtec and 10 mg of Montelukast in the morning and 10 mg of Benadryl in the evening. This helped alleviate some of the itchiness, but the redness persisted. On 12/3/2021, during a follow-up visit with my dermatologist, I was diagnosed with dermatographia as a result of the Moderna Covid-19 booster. My medication was adjusted to 20 mg of Zyrtec and 10 mg of Montelukast in the morning and 10 mg of Allegra at night. While the itchiness and rash is manageable with the use of antihistamines, the dermatographia persists as of the date of this writing.
Left arm aches ever since the first shot (1/22/21) and continues after the second shot (2/19/21).   I can feel it much of the time, however most early mornings it is extremely painful from the upper left arm to my fingers.  It has not abated and seems to have gotten worse after the second shot.  I am wondering if this is a documented side affect and if I can expect it to get better at some point.
Rash associated with temp of 103, very fussy. Parents convinced patient was in pain. Taken to the emergency department. Normal follow-up.
Vaccine admin in morning, doing well until 3:30pm when he woke up from a nap and was shaking and had fever. At 4:30 he appeared blue, and was gasping so mom brought him to the ER. He wanted to fall asleep but if mom shouted or turned the music up he would stay awoke. He had a red bulging ear drum in exam at ER otherwise nl exam.  02/26/2007 MR received for an ER visit and 1 night admission for a 1 yr old who had a shaking episode with fever followed by an episode of cyanosis and gasping for breath on the afternoon of his 12 month vax.  Upon arrival in ER child was somnolent with an elevated temperature of 101'F. PE showed the left TM to be erythematous and bulging.  Lungs were CTA. Otherwise WNL. No seizure activity noted during hospital stay. Final DX: Febrile seizure.  Secondary DX:  Possible right middle lobe pneumonia.  Left otitis media.
Patient received Pfizer COVID vaccine on 5/21/21 (lot # EW0183), 6/11/21 (lot # EW0191), and 12/27/21 (lot # FE3594). On 2/9/22, patient admitted to our inpatient facility with left rectus sheath hematoma, spontaneous in a patient who is anticoagulated with apixaban, and COVID19 infection (incidental, minimally symptomatic).  As of today (2/11/22), patient is still admitted in the med/surg unit.
Initial report received 06 August 2009 from a health care professional. A 32-year-old male patient had received a first dose intramuscular injection of MENACTRA, lot number U2924AA on 04 August 2009, and two days later on 06 August 2009 at 02:00 hours, he developed diarrhea, weakness and rhinitis. The patient had also received an injection of Hepatitis B vaccine on 05 August 2009, twelve hours prior to the onset of symptoms. The patient had been taking TRAMADOL concomitantly at the time of vaccination and they had no past medical history and no concomitant illness. At the time of the report, their recovery status was unknown. Follow-up information received 27 October 2009 from a health care professional. Hepatitis B vaccine (lot number 0438Y, manufacturer Merck) had been an intramuscular right deltoid injection. According to the reporter, the patient recovered on 07 August 2009. No additional information was provided.
Intense lower/middle back pain; Chest tightness; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 23-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 12:30 PM, at a single dose on left arm for COVID-19 immunization. The patient received the vaccine at a hospital. The patient was not pregnant. Medical history was not reported. The patient had no known allergies. Concomitant medications included sertraline (other medications in two weeks). The patient previously received another vaccine within 4 weeks, flu vaccine on 06Jan2021. On 12Jan2021 09:30 PM, the patient experienced intense lower/middle back pain and chest tightness. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient received no treatment. Outcome of the events was recovering.
Information has been received from a pharmacy technician concerning a 77-year-old male with no previous medical history, who on 28-JAN-2008 was vaccinated with an intramuscular dose of Zostavax (Oka/Merck) (lot# 658839/1411U) (circular # 9815604).  There was no concomitant medication.  On an unspecified date, the patient experienced swelling in his upper arm to the elbow.  The patient called the pharmacy.  No laboratory or diagnostic studies were performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a pharmacy technician concerning a 77-year-old male consumer with no previous medical history and no known allergies, who on 28-JAN-2008 was vaccinated SQ (also reported IM) in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658839/1411U) (circular # 9815604). There was no concomitant medication. On 29-JAN-2008, the patient experienced swelling in his upper arm to the elbow. The patient called the pharmacy. No laboratory or diagnostic studies were performed. The outcome was reported as not recovered. No product quality complaint was involved. This is one of several reports fromthe same reporter. Further information has been requested. Follow-up information from the pharmacy indicated that the patient had swelling down his left arm from the injection site to the elbow, it was a red streak of swelling. Not painful, a little itchy. It was suggested to put ice to the injection site and BENADRYL for the itch. The patient called on 30-JAN-2008 and reported "all cleared up".
I had the vaccine it was rough; This case was reported by a consumer via interactive digital media and described the occurrence of pain during injection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain during injection. On an unknown date, the outcome of the pain during injection was unknown.   It was unknown if the reporter considered the pain during injection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient reported that he/she received dose of Shingles vaccine and he/she felt vaccine was rough but so much better than shingles.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
1st vaccine: No noted adverse side effects the following day. 2nd vaccine: Little nausea the following day. 3rd vaccine: The following day (11/8/2021) I felt disoriented and had difficulty focusing my eyes. This started to occur while I was at work. I was also experiencing some nausea. I came home early from work. The symptoms passed and I felt better the next day. Then on 11/19/2021, I began to see, "floaters" in my right eye. I didn't think anything of it until 11/25/2021 when I started seeing a shadow develop in my visual field. When I told my wife she seemed to know I was in trouble.
Felt fine for 8 hours, then woke up with 101 degree fever, intense sweating, joint inflammation (extreme pain), intense fatigue, 4 days straight of these symptoms. Unable to work for that entire time. Took tylenol for fever (did not go below 99 for the 4 days), intense chills when the fever spiked, normally never cold (but freezing the entire time), spasms/shivers. Did not feel fully recovered for a week and a half.  Called the number for the clinic (because it was early in the pandemic).
The morning following the vaccine he was extremely tired. He felt light headed. Could not drive home he later had a fever of 102.4. Symptoms continued for 5 days. On day 4 he noted large area of redness and edema to his arm and deltoid.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-038236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038236:Crosslinked case
This spontaneous report as received from a 72 year old female patient refers to herself. The patient stated that she has had shingles twice, in 1996 and in 2002 (unspecified dates). On an unknown date in August 2012, the patient was vaccinated with ZOSTAVAX (first dose, subcutaneous). On 08-DEC-2015 (also reported as three years later), after developing a painful rash around her eyes she was diagnosed with shingles again (herpes zoster and drug ineffective). No treatment was given for the event. The outcome was reported as not recovered/not resolved. The patient sought medical attention by visiting the physician's office. No product quality complaint was involved. Additional information has been requested.
An attorney reported that a male child received a series of HibTITER, Acel-Imune vaccines as well as MMR II vaccine, IPOL vaccines, Recombivax HB vaccines, hepatitis B vaccine, and Varivax vaccine from 9/3/03 through 8/12/99. Concomitant medication included tuberculin PPD. It is alleged that as a result of exposure to toxic mercury in the form of thimerosal contained in the vaccine(s), the child developed neurological injuries, including disintegrative (or regressive, late onset, or degenerative) autism. Mercury poisoning and autism were considered medically important (OMIC).
An immediate increase in heart rate, followed by a tingling in the back of the throat and tingling of the lips. Adverse reaction resolved after one hour and 30 minutes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 as dose number unknown, single (Lot number: 33025BD) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: other medical history: Multiple Sclerosis; "Crawfish" (unspecified if ongoing), notes: known allergies: Crawfish. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; IBUPROFEN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13May2022) Positive, notes: COVID came back. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 03May2022 to 08May2022.
Light-headed, nauseous, sweating, shivering, headache, fatigue.
patient stated starting the day after her vaccine, she has been unable to lift her arm more than 3-4 inches past her shoulder and it is painful
About 5 minutes after receiving the second Moderna vaccination the patient had apparent Shortness of Breath, but she had good coloring in the lips and face. It seemed that she was having a panic/anxiety attack, but was given two BENADRYL just in case, and a bottle of water. She seemed to improve over the next few minutes. I offered to call the paramedics to come check on her, to which she declined. After a few minutes of fresh air under supervision, she felt good, and her husband/partner drove her. I recommended going to the hospital to get checked out.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Fatigue, chills, body aches, mild cough, headache, sweats for 36 hours Arm soreness for 5 days
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received BEXSERO (batch number 154101A, expiry date May 2017). Previously administered products included BEXSERO (1st dose, the patient did not experience an adverse events). In September 2016, the patient received the 2nd dose of BEXSERO. On 12th September 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, fever and low back pain. On an unknown date, the outcome of the injection site pain, fever and low back pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and low back pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced unresolved pain in the arm (at the injection site), pain in the lower back, and a low grade fever after receiving the second dose of BEXSERO 2 days ago. The patient's date of birth, health care professional refused to give the year.
4/9/08 Recieved TDAP: normal soreness at injection site  4/18/08 Knees felt stiff and took effort to get up and down 4/19/08 Joint paint in knees, elbows, wrist, shoulers, ankles when used to apply force; could not function normally: opening objects, brush hair, climb steps, put on seat belt (took advil and did not help joint pain. no other symptoms) 4/20/08 went to E.R. Examined by intern: wanted to do blood work but had to check with attending first. Examined by attending: told me to take motrin and sent me home. (I am VERY frustrated at this point because nothing is helping the pain, and the ammount of money I spent at the E.R. to get no answers) 4/21/08 Joint pain was now in virtually every joint in body progressing to jaw, fingers, toes etc. Called Med Center to make appointment with my dr and couldn't get in until Wednesday 4/23/08 Joint pain was begining to go away...latest joint pain occurring was first to go away. Dr ordered blood work. 4/25/08 Joint pain was now localized where it originally started: knees and ankles. Blood work came back that my count for Rhematoid arthritis was over 40. It is now in October and I have not had any of the above signs or symptoms.
Pt did not have adverse reaction but did develop shingles after getting inject 1.5 year later.
MMR blood titers indicated patient was immune to MMR. RN still administered SQ injection of MMR vaccine despite pt's immunity.
Immunocompromised patient developed rotavirus after an infant sibling received Rotateq; Immunocompromised patient developed rotavirus after an infant sibling received Rotateq; This spontaneous report was received from a physician via company representative and refers to a pediatric immunocompromised patient of unknown age and gender. The patient was participating in the program. The patient's medical history included allogenic stem cell transplantation.     On an unknown date, when the patient was approximately 4-8 weeks post an allogenic stem cell transplant his or her infant sibling received a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (dose, lot # and expiration date were not reported) for prophylaxis (case # 2011USA016850).         On an unknown date, the patient developed rotavirus (gastroenteritis rotavirus and Infection via vaccinee) and was hospitalized. On unknown date, the patient recovered from gastroenteritis rotavirus and Infection via vaccinee.  The patient's family was counseled prior to the infant sibling receiving the vaccination that it was not advisable due to the risk of the immunocompromised patient developing rotavirus. The family went ahead with vaccination of the sibling infant vaccination despite recommendations.  At the time of the report, the relationship between gastroenteritis rotavirus, Infection via vaccinee and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was not reported.  Upon internal Review, gastroenteritis rotavirus was determined to be medically significant.
All of these side effects are explained in medical records by my doctors. All dates are during 2021  Symptoms:   February 28- March 1: Few days after the vaccineI was a bit tired with mild flu-like symptoms and sore in my arm just like the first shot.   March 2 - I woke up with a mild migraine. It started with neck tension and pain in my head. I went about my day until the pain got worse by the evening.   March 3: I had the migraine all day and tried to stay in bed and drink lots of water.  March 4: Migraine got progressively worse this day. I couldn?t go outside because the light was too bright. I had to lie down to minimize pain and kept my eyes closed.   March 5-10: Migraines were extremely painful. I was delirious, unable to get out of bed. Extremely sensitive to light. Very nauseous. Vomiting. Crying from pain. I experienced flashes of light with my eyes open and closed  March 11-12: Migraine symptoms began to abait. Much less pain. Vision became increasingly impaired. Chest tightness and pain began.   March 13-20: Vision almost totally foggy with spots of total blindness. Unable to drive safely. Confined to bed with continued chest pain.  March 20 - April 9: Vision still noticeably foggy but less so. Persistent chest pain. Persisting dark spot in center of left field of vision.  April 20: Foggy vision cleared up with minor chest pains.  To this day, I still have a blurry spot in the center of my vision in my left eye.   Medical Visits related to problem:  March 7 - Emergency Room  March 8: Primary doctor visit March 10: MRI March 12: Neurologist Visit March 17: Neurologist visit April 1: Eye institute visit for tests April 5: more eye tests, labs, chest x-ray April 9: Eye institute for exams  April 21: Neurology visit April 28: Eye institute exam May 3: Primary care visit