chrisvoncsefalvay/vaers-outcomes huggingface dataset:
canker sores; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: APHTHOUS ULCER (non-serious) with onset 29Mar2021, outcome "unknown", described as "canker sores".  Additional information: Caller mentioned that she just received her 2nd dose of the Pfizer covid19 vaccine 2 days ago. She was calling to check if she could take an antiviral, Valtrex (valaciclovir) for canker sores. She had coffee this morning and could feel the onset of canker sores. She called her local pharmacist and was referred to Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
edema @ site;rash @ inj site & descending down arm to elbow;placed on atarax;cool compresses;rechecked in 2 days;
Information has been received from a physician concerning a female patient, who was vaccinated with the third dose of Gardasil.  Subsequently, the patient developed tremors and partial paralysis.  The patient was referred to a hospital.  The patient sought unspecified medical attention.  At the time of the report the outcome was unknown.  No product quality complaint was involved.  Upon internal review, partial paralysis was considered to be an other important medical event.  Additional information has been requested.
Patient is 20 weeks and 6 days pregnant at time of vaccination. Clinician pulled wrong vaccine in error. Patient to receive monovalent Pfizer as first dose Covid vaccine but inadvertently given bivalent Pfizer vaccine. Patient observed for 15 minutes after administration. Patient tolerated well, no immediate reactions noted.
Pt reported feeling some nausea approx 10 minutes post injection, along with feeling hot. Pt denies vomiting, denies shortness of breath, rash/hives, difficulty swallowing and other symptoms. Pt reports a single reaction to an antibiotic in the past, denies Hx of vaccine reactions. Pt states she feels cooler after removing two of her three long sleeve layers. Nausea treated with 8mg ODT ondansetron, with noted relief.
My left arm was very swollen, red and painful within 6 hrs of shot and stayed that way for 3 days.  The morning after the immunization, I had 100.8 fever, weakness, sore throat, some shortness of breath and I stayed on the sofa as I was so weak with chills, shivering, weakness and headache. This lasted for 2 almost 3 days. I felt very ill. I thought it might be Covid 19.
Patient received vaccine no issues, waited 15 minutes reported no issues, left pharmacy for approximately 5 min,  returned complaining for dizzyness, we got her water and had her sit down, she began having seizures, she had 5 episodes before emd arrives, she was taken by ambulance
fell into a deep coma like state; thought that she had COVID and was dying; fast hear tbeat; intense fever that came on quickly and was quite high (4-5 degrees high). / fever; chemical toxic taste like iodine on steroids in her mouth / very pungent and disgusting; fatigue; unable to get up; Unable to get water; unable to think; This case was reported by a consumer via call center representative and described the occurrence of thinking reduced in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroid.   On 20th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, several hours after receiving Shingrix, the patient experienced thinking reduced (serious criteria GSK medically significant), heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia. On 20th August 2020, the patient experienced altered state of consciousness (serious criteria GSK medically significant) and suspected covid-19. On an unknown date, the outcome of the thinking reduced, heartbeats increased, fever and taste chemical were recovered/resolved and the outcome of the altered state of consciousness, suspected covid-19, fatigue, mobility decreased and asthenia were unknown.   It was unknown if the reporter considered the thinking reduced, altered state of consciousness, suspected covid-19, heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. Several hours after vaccination,the patient thought that had COVID and was dying. The patient felt into deep coma like state and was unable to think and get water or get up. The patient experienced severe fast heart beat which was unusual because had an unusualil heart rate. The patient experienced intense fever (4 to 5 degrees high) that came quickly after vaccination. The patient reported that, after vaccination when came to home in that morning all of the sudden had a chemical toxic taste like iodine on steroids in mouth. It was very pungent and disgusting and it lasted 5 minutes. The patient stated that 5 hours later all other symptoms hit. The patient received natural steroid medication. The reporter consented to follow up.
Acute lower back/sacral pain without sciatica-MD diagnosis.  Mild tingling neuropathy to thighs and acute constipation.  Began 02/01/21, early am.  Advil 400 mg q 6 hours, Salon pas patch and heating pad provided some relief.  Mirilax and prunes gave some relief from constipation.  MD seen on 02/05/21 and above dx given. Flexeril  5mg given for spasms and Methylprednisolone 4mg  tapered dose for inflammation.  To follow up with MD after 02/11 if no relief or change in condition.
Almost immediately after the shot was given, I developed a  metallic taste in my mouth that lingered for about 1 1/2 hours after the shot was given.
By the next day arm was hurting.  Patient had no shivers but felt like had the flu--very weak.     12/28/18 Nothing happened.
1244: Patient was complaining of dizziness. Patient evaluated by on site NP and EMT. Patient was given water and vital signs were taken . BP 150/103, pulse: 84, o2: 99%, respirations:18. Patient stated that sipping on the water aided her symptoms. Symptoms lasted about 5 minutes. Patient stated she had a light breakfast, and that she has been eating minimal to now carbs daily to lose weight.  1250: Second set of vitals taken, BP: 151/94, pulse: 84, 02: 99%, respirations 16. Patient stated she was comfortable to be driven home by husband.
total boddy incthing, partailly treated with  benadrly , no hives or other symptoms
In January 2000, the patient was vaccinated with varicella virus vaccine live. In June 2000, the patient received the polio vaccine and the tetanus toxoid and a week later experienced paresthesia, which is still ongoing. A MRI was negative for MS. Medical attention was sought. No further information is available.
Pt was given Tylenol for pain in left arm. Then every four hours during the day. Pt had temperature of 104, temperature range 100 - 101 through the night.
BLOOD PRESSURE WENT UP TO 192; SPASM; NERVE END HURT/PAIN; MUSCLE TWITCHING; MUSCLE ACHE; PAIN IN LEG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. she was allergic to some unspecified medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04ZA114, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, and muscle ache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) went up to 192 (unit not provided), 120/70 (normal) (unit not provided). Treatment medications (dates unspecified) included: clonidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, pain in leg, and muscle ache. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case
This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered, (Dose number in series 1), start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient (reporter's friend) had stroke (dose number in series 1).  The action taken with covid-19 vaccine was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211248907, 20211258812.; Sender's Comments: V0: 20211258956- JANSSEN COVID-19 VACCINE Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient reports soreness, and feels like she is  "unable to lift" her arm up - "it feels heavy".  Patient reports unable to life weights  with arm due to lack of strength, pain  soreness. Shoulder joint aches.
Monster headache, Chills, Intense back, hip and neck pain (aches), nausea, fatigue
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
About 2 days after receiving the second Pfizer vaccine, he began feeling severe pain, heaviness and burning in his legs from the knees downward. It was like having "flu in one's legs". The pain was so severe at times he had difficulty walking. The pain would last for an hour or more at a time. The pain came and went multiple times daily for a period of about 5 months.
In addition to the normal vaccine reaction such as Chills, heavy head, nausea, etc.  I had severe diarrhea for 2 days. was able to resolve with 3 pills of imodium over a time period of 15 hours
Patient received on 5/19/2023 vaccine that expired on 5/17/2023.  Patient did not report any adverse reaction
Patient experienced lightheadedness, tingling in lips and redness in face x 5-8 minutes of moderna vaccine. shot 2. shot 1, had no symptoms except for soreness on arm. hx of cyclic neutropenia and migraines. no hx ofallergies or anaphylaxis. no SOB. no itching. no N/V stomach pain. no other rash/ redness except for face. swallowing is nromal. no throat or tongue orlips swelling. Patient was monitored until symptoms resolved, no addition medications administered.
At day 10 after receiving the first dose, a large lump, redness,  itching and hotness started at the injection site.  Over the next two days this spread to my elbow and all around to the inside of my arm.  I understand this is known as Covid Arm.  It lasted for a little over a week and has now gone away completely.  I treated it at home with Benadryl and Cortisone cream for the itching.  Did report it to my Oncologist .
I got shot and still got shingles, a milder case/Suspected vaccination failure; Shingles, a milder case on forehead n top of head real close to eye; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient was told it was a milder case, the patient had it on left forehead and top of head, real close to eye and said he/she was lucky. The patient stated that, glad you got shingles shot but no guarantee that you could not or would not get shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
05/15/2022 I started to get a little bit of an itchy throat. It was so mild I didn't know if it was there. May 16th 2022, my throat became more sore and I had a runny nose. I did a home test and it was negative. By the end of the day, it was clear that I was definitely sick. When I woke up on the 17th of May 2022, I was getting more congested, having a headache and a sore throat. I retested and my test came out positive. 05/18/2022, I have a headache that is significantly worse and I also have congestion, runny nose, coughing as well. I met with my doctor on 17th 2022 and was given Paxlovid and have started taking it.
Patient has been tired; Patient don't have more energy; This is a spontaneous report from a contactable consumer (reported for himself). An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175/Batch number was not reported), dose 1 via an unspecified route of administration, administered in deltoid left on 25Jul2021 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the consumer stated patient has been tired, and patient don't have more energy. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
received expired dose; Patients were administered a dose from a vial that was punctured and left at RT for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 030A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022 at 5:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Feb-2022 at 5:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days). On 01-Feb-2022 at 5:15 PM, EXPIRED PRODUCT ADMINISTERED (received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received booster dose on deltoid.  Date the vial was initially stored in the refrigerator- 27-Jan-2022. Vial was first punctured on 27-Jan-2022 at 8.30 AM. Vial stored post puncture at room temperature and didn't undergone any temperature excursions. It was reported that the patient did not experienced any adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Updated patient demographics, suspect details (dose time) and narrative.
Note: Unsure about the flu vaccine type, but the nurse did mention that it was four strains. Rash on areas throughout body (reddish). Persistent Itchiness on areas throughout body. Itchiness more pronounced on same arm as the vaccine given (upper to middle part of arm). Initially, rash appeared on same arm as the. Elevated blood pressure (159/79). Had been consistently in 120 or below range.
I had chills, 102.7 fever that lasted the evening of 27th until about noon on 28th, some loose stool but a lot better
Outer left thigh area; swelling; redness, knot under skin.  Treatment: Tylenol.
I have a large red square on my arm just below the injection site...........it is about 2x3 inches and itches
Information has been received from a health professional concerning an employee who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The reporter indicated that the patient had a reaction to the vaccine. The event was not further specified. A product quality complaint was not involved. Follow-up was received from the health professional that indicated that she is waiting more information in order to fill out the hard copy report. It was reported that the client priginally had an adverse reaction to measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) years ago. The patient subsequently experienced an adverse reaction after vaccination to mumps virus vaccine (Jeryl Lynn) (MSD, WAES# 0608USA03615). Additional information has been requested.
Next day after shot - legs were very weak and I could hardly walk in  a straight line. Went for a routine physical with my Doctor at 1PM and never made it there.  I had no idea of where I was going or where I had been.  Half hour later I remember being in a store buying lottery tickets and the clerk had to help me in my car. Went to bed for the rest of the day and have been improving little by little each day. Was  very, very tired at first and still a little tired now.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a nurse regarding an 18 month old female patient who developed severe speech delay. At 3 years of age, the patient received the second dose on 6/4/04. The patient also received a first dose of Varivax vaccine, the second dose of Tripedia vaccine, and a second dose of Act-HIB vaccine on 6/4/04. The patient has a past history of ear infection. Indication for Prevnar was immunization. Product was administered on 6/4/04. Dose regimen was 1 dose (IM). Concomitant vaccines included Varivax, Act-HIB, and Tripedia on 6/4/04. The patient received the first dose of Prevnar on 8/29/02. In April 2002, when the patient was 18 months of age, the mother noticed speech delay in her daughter. The child was not a patient of the current pediatrician at that time. On 10/31/02, the child was seen in the physician's office for a normal exam. On 1/10/03, the child was treated for an ear infection. on 2/28/03, the child was seen in follow up and had a normal exam. The child was not seen in the physician's office again until 6/4/04, the day several vaccinations were administered. The mother subsequently reported speech delay to the pediatrician, after receiving vaccines on the same date. The child was then 3 years of age. On 6/10/04, the child was examined by a physician; a diagnosis of severe speech delay was made. The child is currently receiving speech therapy. As of 11/15/04, the child had not recovered. No additional information was available at the time of this report.
Rapid pulse of 100; weakness in legs, trouble walking; up 3x during night to urinate; trouble sleeping; mind foggy next morning.
After receiving the second dose of the vaccine on Wednesday I started experiencing a myriad of symptoms starting that night during sleep. I had body aches, nausea and diarrhea starting earlier the next day then once I threw up once I started feeling better then broke a couple of fevers. By Friday, however, I was feeling much better. I went through the weekend feeling totally fine, then Monday came and I was really achy throughout my body in my joints. Then that night when I went to sleep the joint pain worsened drastically and I started feeling a pins and needles sensation throughout my extremities only.   I got no sleep that night from the pain. These body aches felt wildly different from those from the first immediate reaction.  From there, I got a COVID test, Flu, and strep test taken all of which came back negative. The pain continued to worsen unbearably so I went to the ER. There, they tried a few pain medicines to ease the pain. It was the most uncomfortable time I've ever spent in my body. The doctor said the vaccine essentially attacked my nervous system and I had no idea what was happening to me because it isn't being mentioned as a possible side effect. However, both doctors I visited said they have been seeing neurological adverse effects in the hospital following the vaccine rollout. The pain lasted for a full week, and as of this past Saturday I've been feeling much better. I am still dealing with the lasting effects, the pins and needles are very faint but still active every now and then and my calf muscles are extremely tight in the morning making it still hard to walk, and my knees ache often. I've been stretching to combat the issues in my legs and it's been helping. I'm hopeful the pins and needles sensation will completely go away very soon. It has been 9 days since the second adverse reaction started.