chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant product use was reported.   HCP stated on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Reporter was not aware of any AEs after the vaccine was given.   No treatment information was provided.  Case for the patient 10 out of 26 patients.
(R) arm swollen, rash down to fingers, ill, bones and muscles in pain, et al (i.e, ill, diarrhea, abdominal pain, temperature, sweating, chills etc.) One week! Cough respiratory.
Pt recv vax on 1/9/98; on 1/10/98 pt exp rash on chest & stomach w/pruritus x 3-4 day
Infant was given immunizations of DTaP, HIB, Hep B, and IPV on 5/9/05 and was repeated on 5/16/05. Parent was told to observe infant for any adverse reactions.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has a fear of needle. After getting the vaccine he felt fearful, sweaty, confused, and rigid. Call 911 and mother. Upon arrival of EMS he was able to communiate and walked to the stretcher with his mother and transported to the ambulance under EMS supervision.
anaphylactic reaction; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: Unknown) as a single dose for covid-19 immunisation. Medical history included allergic to bees and carry an EPI pen (Only allergy is bees which is known potentially to react). The patient's concomitant medications were not reported. Within 15 min on 05Mar2021, the patient had an anaphylactic reaction and was transferred to local Emergency Room. Adverse event result in Emergency room/department or urgent care. The seriousness is reported as medical significant. This is a  comment. It was unknown if treatment was received. The outcome of event was unknown.     Information on the lot/batch number has been requested.
Mother reported vomiting  Friday 1/6/2023 and Saturday, 1/7/2023; mother reported patient was fine on Sunday, 1/8/2023; mother reported a fever and decreased movement starting  Monday 1/9/2023 office visit - difficulty bearing weight, fever.   Thursday, 1/12/2023:  Lethargic, difficulty bearing weight and hypotonia lower extrementies - remains on antipyretics.
cervical stiffness achiness in thighs;back pain inc w/sitting;general malaise;
Information was received on 11-JUL-2017 from a physician who was reporting on an 11 months old infant (gender not reported). No medical history or concomitant medications were reported. On 11-JUL-2017, the 11 month old patient received a dose of ROTATEQ oral liquid (lot M018957, expires 22-NOV-2017) for prophylaxis. No adverse effects were reported. No further information is available. Additional information is not expected. No further information is available.
Normal pregnancy - 16 weeks + 5 days at the time of vaccine.  Due date estimated as April 9, 2022. Adverse side effects of vaccine include, pain at the injection site lasting 24+ hours, extreme headache, nausea, chills, extreme all over body fatigue.
Started my regular scheduled monthly period on Saturday following vaccination.  I had stronger than normal cramping for 3 days following.  My periods normally last 3-4 with a day or two of normal flow.  I am on my 5th day of menstruating's and my bleeding is extremely heavy.  I have also had clotting larger than a dime sometimes much larger than a quarter.  I have never experienced a period like this.  I have not been checked for uterine fibroids or anything else as this is the first month this has happened.  I cannot say for sure that this is related to the vaccine but did feel I should report it since it is abnormal for me.
A few days after Covid shot I started getting loud ringing in ears. Sometimes it pulsates as well but not always. The ringing comes and goes. I had never experienced this before.
Pt complained of having a hard time swallowing his food following 3rd Hep B shot. It got worse over time and required 3-4 glasses of water to help food go down. Eventually he lost much weight because it became uncomfortable to have to drink so much water to swallow a meal and he didn't enjoy eating anymore like he used to. So he ate just the essentials and skipped hard foods like apples and carrots, salads, etc. Pt says his memory, concentration and sometimes his ability to organize what he wants to say is not as sharp as it was before Hep B series shots. (Neurologist will be seen). 8/15/02: MD recommends Nasal arenoscopy and ber. swallow. 8/26/02 Nasal scope: MD recommends seeing ENT. 8/29/02: MD-lymphoid hyperplasea on posterior pharyngeal wall mod. enlarged adenoidpad, tonsils enlarged etc. 8/29/02?: Another MD recommends having tonsils and adenoids out. 10/1/02: MD-2 plus tonsils, mod adenoid pad, bar swallow and endscopy  recommended, refers us to gastroenterlogist.  10/10/02: MD - endoscopy and barium swallow - suggested duct to swallowing problem. 10/14/02 Oupatient endoscopy barium swallow - recommends esophageal motililytes, refers us to pediatric gastroenterologist. 10/17/02: MD does blood work etc. Diagnosis: dysphagia. 10/21/02: Esophageal motility study. Upper GI endoscopy with bx Con. sedation. 11/4/02: PH probe - prolonged. 11/5/02: probe removed. 11/7/02: UGI endoscopy, esp dilation with balloon. 12/13/02: upper GI endoscopy with bx, X ray and barium swallow after. 2/14/02: Barium swallow. Endoscopy with balloon recommended again. 2/27/02: Endoscopy with dilation with balloon - balloon fried in sterilizer  so procedure needs to be redone. Barium swallow, X-ray after procedure. 4/24/02: Endoscopy dil with balloon. Dil had to be rescheduled as pt had flu recovery at that time. 7/3/02: Endoscopy dil with balloon 10AM. Barium swallow and/or X-ray following procedure. We will be seeing a neurologist after the dysphagia is taken care of as we don't want to overwhelm pt with everything at once. Due to memory, concentration etc. problems we will see a neurologist in the future.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-JUL-2012, the patient was vaccinated by a medical assistant at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated by a physician for onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed prednisone, PERCOCET, and acyclovir for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient started having Tonic Clonic seizures within two hours of receiving these vaccines.  He continues to have between 1-8 seizures per day. He has been hospitalized twice, has had an MRI a Lumbar Puncture, numerous EEG's and blood testing to find the cause. He is now taking three different anti seizure medications. Klonopin, Phenobarbital, Lamictal
Myalgia injection site swollen and hot, chills and fatigue Narrative:  Other Relevant History:
pt stated that she developed a headache with in first thirty minutes after receiving the covid vax.  Next day pt was really tired, sore, and still had a headache .  On third day you woke fever, body aches, nausea, stomach ache, headache, fatigued and sore throat.  She slept the entire day.  On the fourth day she still have all of the same symptoms but fever was gone by end of the day.  On fifth day, symptoms were still present.  On sixth day, she still had headache, sore throat and stomach ache but other symptoms were getting better.  By seventh day all of the symptoms have subsided except headache, sore throat and stomach ache which she still has today.  Pt stated she spoke w/ her nurse at her PCP's office and she was told to contact us.
The clinical history is that of a 19 year old man who received a smallpox vaccine 8 days prior to presenting with numerous small pustular lesions over his entire body and scalp. The histologic findings of Intracorneal vesicles, basilar layer reduplication with prominent nucleoil, scattered keratinocyte cytoplasmic changes and the presence of moderate mixed (lymphocytic/neutrophilic0 perivascular.
25APR96 pt exp chest pain; 30APR96 pt devel tics, myoclonus, muscle weakness, cognitive dysfunction, ataxia & expressive aphasia;problems w/speech & memory problems;lost control of leg d/t gait disorder;sz
Rash, Hives, Itching, Tongue swelling lasted 4 days - took high doses of benedryl; shoudld have gone to urgent care.
2 dark red separate knots, 1" diameter, (cherry red).  Started cool compresses.  8/13 orig knots surrounded by baseball size area swelling, warm to touch.  Started PO Benadryl and continue compresses.
Inadvertent administration of HPV vaccine before pregnancy test was obtained that was positive.  Subsequent US shows a 7 week pregnancy
Shot given in left arm about noon. About 5 hours later had dysentery for 2 episodes about an hour apart.  Phamarcist told me that since I had had shingles before, the inflamation circle would be larger and he made a circle of about 2 inches in diameter.  No inflamation was visable that afternoon, but formed overnight to be about 2 1/2 inches in diameter with herpes lesions showing about 24 hours after shot. Produced the same burning and pain as shingles, though a mild episode.  I had had no vaccinations in the past 4 months, but had experienced a cenipede bite on the left hand about 18 hours before and still felt the poison there.  It is now 48 hours after the vaccination and the lesions are very painful to fabric or touch, so I felt I needed to report this for your statistics. The cenipede bite poison was absorbed and gone in 36 hours.  In the past year, because I travel with my work, I have taken Yellow Fever, Hep A & B and Flu shots; all with no adverse effects.  I feel folks need to know that they may need to take a day off afterwards in case they have problems with this vaccine.
A couple hours after vaccine, redness occurred under band-aid. Hours later, injection site became raised and hot to the touch, itchy, red, and swollen.
chest congestion 10 days; nausea; fatigue; body aches; chilling; diarrhea; hives 2 days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 20Mar2021 at 14:00 (at the age of 71-years) as dose 2, single for covid-19 immunization. The patient medical history included parkinson's disease. The patient had known allergies to Drug Sulfa. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 27Feb2021 at 13:00 (at the age of 71-years) as dose 1, single for covid-19 immunization. The patient's concomitant medications included omeprazole (OMEPRAZOLE); sertraline hcl (SERTRALINE HCL); carbidopa, levodopa (CARBIDOPA LEVODOPA). The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient had experienced fatigue, body aches, chilling, diarrhea, nausea. On 27Mar2021, the patient had Chills, fatigue, body ache for 12 days; nausea diarrhea for 8 days; chest congestion for 10 days; hives for 2 days on 23Apr2021 and 26May2021. The patient had not received any treatment for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events nausea, fatigue, body aches, chills, diarrhea were not recovered while for the events chest congestion, hives was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
The second house is the one that caused me to have allergic reaction my left side of my face was numb and swollen
Patient had itching  and pins and needles sensations down lateral sides of body that began 1 week after vaccines and persisted for more than 2 months then resolved.
This was a young girl brought in by her mother, they were new to the area and the had not been able to establish with a pediatrician yet. The school was requiring vaccines prior to the child being allowed to register for school. It is my understanding that mom requested the Tdap and MMR from the list the school gave her. Consents were signed for both immunizations, and VIS given. I was unaware of the age constraint of the Tdap ? the box shows ?for adolescent and adult use?, and I assumed it lined up with our other age ranges for vaccines, such as flu. This lack of knowledge has been rectified and the rest of my staff educated. We have posted the number for the health department in our nurses station so as to always have access to correct vaccine information, and to prevent any further errors in the future. Error caught at next WCC by pediatrician,  no immediate action as taken.  Patient was seen by Dr. on 6/3/19 and that's when medication error was found.  Dr. said that no harm was done to patient and that as long as it was given after 4 years of age, it is ok and DTAP was not given.  Patient's mother was informed of this error.
itching; COVID arm; This is a spontaneous report based on the information received by Pfizer: NUS2021US039669) from a contactable consumer (patient).  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the 4 weeks of vaccinated on an unspecified date the patient experienced itching, and COVID arm. The patient stated she used a topical gel prescription to treat her symptoms including itching. The outcome of events unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I?ve had a red spot on my arm that tripled in size and felt it had fever to it at/near site of injection. The redness lates 2-3 days but heat sensation is there.
Upon arriving home after the office visit at around 10:30pm on 2/23/15 I noticed patient to be wobbly when she walked and she seemed disoriented. Within 24 hours her belly appeared to be distended. Patient began displaying cold like symptoms of runny nose, cough and sneezing. This lasted for two days. The symptoms appeared to be getting better by 3/3/15 and then on 3/4/15 she began running a low grade fever; not more than 100.3. The fever came and went over the course of the next two days. She was irritable and fussy and began sleeping poorly. Her mood seemed to have changed where she was more easily irritated and would scream a lot at the top of her lungs. She has never showed this behavior before. On 3/6/15 is when she started to get worse. She only took one 35 minute nap and was clearly tired but would not go to sleep. Her appetite was affected as she would not eat very much solid food. She was also not willing to nurse as she normally would.  She went to bed for the night at 7:30pm and then was awake at 11pm and was crying and inconsolable from 11pm to 2am. This was very abnormal behavior and extremely alarming. I have never seen her this upset or crying this much ever in her life. She did not have much interest in nursing or eating solid food on Saturday, 3/7/15. At about 9:30 AM I noticed a red rash all over the trunk of her body (abdomen, chest and back and diaper area). The rash was not raised. I contacted the Dr. to have her seen immediately. The Dr. seemed to think it was a viral issue and not caused by the vaccine. She continued to be easily upset and throw intense temper tantrums when she was unhappy about something. She did not want to take a morning nap that day and took a mid-afternoon nap instead of one mid-morning nap and one late afternoon nap. Her sleep was a bit better on the night of 3/7/15 and she was only up for about 1 hour and was not nearly as upset as the night previously. 3/8/15 was similar to the previous day in terms of sleeping and not wanting to nurse or eat solid food. The rash was almost nearly gone by the morning of 3/9/15 and then reappeared again in the afternoon. It has spread to the lower parts of her face and is now on her legs on 3/10/15. Her mood has improved somewhat along with her appetite, sleeping and willingness to nurse.
Bad taste in mouth for 20 hours Nausea for 30 hours No appetite for 30 hours Awful Headache for 30 hours Difficulty swallowing 24 hours Facial hives started while sleeping but once awake took about 10 hours to go away after being treated with 2 doses of benadryl Face extremely red and swollen about 30 hours Felt hot but didn't take a temperature about 30 hours Tired and felt little energy about 30 hours
Severe Flu like symptoms. Soreness/aches in my neck, shoulder, chest, arm all on the left side. Fever-101.8, severe chills, tiredness, headache, Dizziness/weakness, weakness in arms and legs.  Treatment: Tylenol Recovered in 36 hours
I have had a headache since injection was given on the day of I did have. Diarrhea the day of. And also neck stiffness for three days after vaccine
experiencing a lump at the injection site like half an egg, area is hard and has heat; experiencing a lump at the injection site like half an egg, area is hard and has heat; weakness in limbs; fatigue; mild dizziness; fever of 101; mild headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 72; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced weakness in limbs, fatigue, mild dizziness, fever of 101, mild headache while on an unspecified date, experiencing a lump at the injection site like half an egg, area is hard and has heat. IT was reported that Caller stated that prior to 3 o clock Monday it was like any other day. Caller stated the side effects of weakness in limbs, fatigue, mild dizziness, fever of 101 and mild headache went away in 24 hours like everybody said. Caller stated she has heard others have had headaches like migraines. Caller stated that she still was experiencing a lump at the injection site like half an egg, area was hard and has heat. Caller stated that it was half of what it was on Tuesday. Caller wanted to know should she be concerned, is this normal. Caller stated her brother did not have any side effects. The patient underwent lab tests and procedures which included body temperature: 101 on an unknown date. The outcome for event mild headache was recovering while all events outcomes was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Bone pain; Strong body aches; Headache; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19, Panic attack, Breathing difficult, Fever, Chills, Nausea, Vomiting and Diarrhea.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Thyroid disorder: inconclusive (Inconclusive) Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       The concomitant medications were provided as unknown medication for thyroid.  Action taken with mRNA-1273 in response to the drug was no change   This case was linked to US-MODERNATX, INC.-MOD-2021-070034 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070034:
Reported Symptoms:  10003658:ATRIAL FIBRILLATION;  10003662:ATRIAL FLUTTER;
Patient developed a marked local reaction to the immunization shot. She subsequently developed a raised, erythematous lesion that deteriorated into a about 3 cm x 6 cm abscess with necrotic skin centrally. The lesion has been drained and may require skin graft.
AFTER 10 MINUTES PATIENT COMPLAINED OF FEELING THROAT SWELLING. DRANK WATER.  PER PATIENTS OWN BLOOD SUGAR MONITOR, PATIENT REPORTED BLOOD SUGAR OF 252.  PATIENT GAVE SELF 1.5 UNITS BY HER OWN INSULIN PUMP. REPORTED FEELING BETTER.