chrisvoncsefalvay/vaers-outcomes huggingface dataset:
each time I break out Grovers Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200426198 (Pfizer).  A 78 year-old patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart bypass" (unspecified if ongoing), notes: I am 78 with heart bypass 17 years ago. The patient's concomitant medications were not reported. The following information was reported: TRANSIENT ACANTHOLYTIC DERMATOSIS (non-serious), outcome "recovered", described as "each time I break out Grovers Disease". The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen lymph node on her neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on her neck). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on her neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Myalgia Headache, fatigue, body chills Narrative:  12 hours after vaccination patient started experiencing headaches, joint and body aches, chills. Employee had to miss one day of  work. Symptoms resolved 24 hours after starting.
Client called 04/14/2021, stated that she got a rash approximately 03/15/2021.  She went to her doctor a week ago.  He told her that he thought it was from the vaccine.  He directed her to use cortisone on it and she said it does help but the rash continues.  I moves all over her body (torso, hands, feet, arms, legs).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015 23:16, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 9.8 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
R09.02 HYPOXIA 2/26/2022 SMALL BOWEL OBSTRUCTION R09.02 HYPOXIA 2/26/2022 HYPERNATREMIA
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with improperly stored (Oka-Merck) PROQUAD (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with (Oka-Merck) PROQUAD was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with (Oka-Merck) PROQUAD was unknown. This is one of the many reports from the same source. Additional information has been requested.
Information has been received from a nurse concerning a 12 month old patient who was vaccinated with a dose of Proquad. Concomitant therapy included a dose of hepatitis A vaccine (inactive) (manufacturer unspecified). "Within the last month," in approximately August 2006, the patient experienced "a rash of 20-30 pox about 2 weeks after receiving Proquad. Unspecified medical attention was sought. No product quality compaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 3 year old patient who on 31-AUG-2006 was vaccinated once IM with a 0.5 mL dose of PROQUAD (Merck). Concomitant vaccination administered the same day included six other unspecified vaccines. Two of these vaccines were given in the same site as the MMR II (Merck). On 12-SEP-2006 the patient "developed a node near the injection site in the left leg". Unspecified medical attention was sought. It was reported that the patient was receiving these vaccines for "catch up vaccination" and that they are not discontinuing the series. No further information was provided. There was no product quality complaint involved. Additional information received from a certified medical assistant indicated that the node must have resolved within one weeks time since they instructed the patient's parent to call back if it had not gone away in one week. She stated that they never heard back from them. Additional information is not expected, the physician cannot be contatcted.
ARM HURT FOR SEVERAL DAYS; MILDLY FATIGUED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurt for several days, and mildly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mildly fatigued and arm hurt for several days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354397.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 0 for 168 hours and 1.1 Celsius degrees for 920 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mom reports pt c/o arm soreness after school. Mom stated red spots "like pimples" with blue/black discolouration. Then below raised pink area, slightly larger than half dollar. Pt also had loose stool all day.
a fever of 103F; sick; in bed for 3 days; ached; couldn't move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EL9267) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose- 21Jan2021, given in right arm around 10:30-11am, Lot EL3249), administration date: 21Jan2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "sore arm", "Red Arm". The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "a fever of 103F"; ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "sick"; BEDRIDDEN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "in bed for 3 days"; PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "ached"; MOVEMENT DISORDER (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "couldn't move". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 21 month old female who on 7/30/99 was vaccinated with one dose of varicella. On 3/15/00, the pt developed chicken pox, was seen in the ER and was treated with acyclovir for two days. On 3/17/00, the pt was hospitalized with chicken pox and a swollen right lower leg. Her right lower leg swelling was diagnosed as acute cellulitis with beta hemolytic streptococcus group A infection post varicella outbreak and she was treated with antibiotics. On 3/31/00, the pt was discharged from the hospital however, the outcome was not reported. Additional information has been requested.
Complained of dizziness and headache, monitored for 1 hour, parent notified, sent back to class.
8 hours after injection  Chest palpitations  Nausea  Vomiting  Diarrhea  Headache
Jan 17, patient started with runny nose, thought he caught a cold. Jan. 22, started with fever about 101.2, fever continued with administration of 5 mL. acetaminophen. Fever was about 102 on Fri, brought patient to Dr. to check if ear infection was gone or if it had gotten worse. Dr's office told me patient still had ear infection, but it was mild, they said his fever was more than likely from the MMR vaccination he had received on the 15th. Fever spiked to 103.8 around 1:30 a.m. on Jan. 24. By Saturday afternoon, fever was gone. Jan. 26, around 6:00 a.m. when baby woke for the day, noticed rash on face, and entire body. The worst of it is on the trunk of the body. Patient has been very fussy and irritable from Jan. 22 to present time. Contacted Dr's office again around 8:30 a.m. Jan. 26, they said to continue giving Motrin or Acetaminophen for aches and pains, and creams would not help the all over body rash; would just have to wait for it to go away. Was told that this would not be contagious to other children.
Numbness on my arm, hand, feet; headache, muscle weakness, swelling, itching, hair loss, loss of appetite, fatigue. I went to the doctor, and they referred to an immunologist and this doctor said that my body is reacting to the vaccine. They told me to take Benadryl.
Child was normal until given his first vaccine DT at 7 1/2 months of age. Later that day mod fever, very irritable, lot of screaming. Parents felt that by 2 weeks he was a changed child, later dx'd autistic. Pt's caregiver reports: I was pt's mother's caregiver during pregnancy. It was a normal pregnancy. Pt was born by cesarean section because of cephalopelvic disproportion. He showed normal growth and development for the first 7 1/2 months after birth. At his 7 1/2 months visit his development was normal and in fact exceptional in some respects-he was using the potty upon his parents command! He enjoyed peek-a-boo, was laughing, responding to his name. Enjoyed books, etc and was generally cheerful. There was no indication of any neurological or other difficulty. Also at that visit (7 1/2 months) he was given an injection of a single vaccine 0.5 of pediatric diphtheria/tetanus toxoid (DT). He had an immediate reaction to the vaccination that included fever and inconsolable crying. This incident appears to have marked a turning point in pt's development. He changed from a good natured, happy child to one who had became increasingly irritable and difficult. The next time I saw him was about 1 month after the vaccination. His chief complaint was a persistent cough. His parents reported that he had displayed unusually severe crying for about a week after the shot, and irritability, restlessness, poor sleep, etc. was continuing. My conclusion at that time was that he had had a significant neurological reaction to the vaccine. I saw him again about 3 1/2 months after the vaccination. His chief complaint at that time was fever with rash which we diagnosed as a viral exanthem. The irritability etc. was continuing. The next time we saw him was when he was 26 months old. It was obvious at that time that he was suffering from a developmental delay that stemmed from the time of the vaccination, and we recommended that he get specialized diagnosis and treatment. DX with autism about 8 months later. I haven't seen the child lately (in the past 3 years). I believe he is still autistic. The connection between the vaccination and the behavior/neurological disorder is obvious.
Patient seen on 5/24/07 for left leg pain and redness at injection site x 3 days. Symptoms improving. No treatment. Monitor for worsening symptoms.
Caused swelling in whole upper arm. Very red and hot. Itchy. Lasted 3 days.
This spontaneous report as received from an office manager, who was also a medical assistant regarding an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL 9 (Lot # M042859 with expiration date 17-JUL-2019, Lot # M040412 with expiration date 30-JUN-2019, dose and route were unknown) for prophylaxis. The vaccine was exposed to a temperature of 53 Fahrenheit degrees for 30 hours (Lot #M042859) and a temperature of 49 Fahrenheit degrees for 56 hours (Lot #M040412). There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010395:
started to get really hot became confused;felt exhausted;became unconscious;awoke to see nurse bending over her;felt better, but then became faint again;this started 10min or so p/vax; poss sl convuls;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:47 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.35.   No concomitant medications were reported.  Vial was moved to fridge on 05-Oct-2021. Product moved to clinic on 03-Nov-2021. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10AM. Beyond use date for the vial was reported as 05-Nov-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
The pt developed 17cm x 12 1/2cm area of erythema at the right upper thigh.
Received injection 10/25/06 Rt arm sore on 10/26/06. Injection site red, swollen hot on 10/27/06.
Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almost exactly 24 hours after the shot, I started feeling very tired, severe body aches and chills. The next morning on January 22nd about 3:00 a.m. those symptoms where much better BUT down below the injection site is swelled up, red in the size of about a softball and very hot. It is now 5:40 p.m. January 22nd and no improvement with that.
Patient stood up and went to seated waiting area while I finished filling out his COVID Record Vaccine Card. I walked over to him within 60-120 seconds after the vaccine administration and found him to be in a stiff full body extended position while sitting on a chair. I asked him if he was ok. He did not respond. Called over the nurse and we were about to bring him down to the ground after suspecting a seizure. Patient "came to" after about 90 seconds of no movement. Patient became alert and orientated. When asked about prior seizure history, patient stated they had a traumatic injury to their back within the last month which resulted with spontaneous seizures throughout the past 2 weeks. Patient was asked to follow-up with primary care provider or seek urgent care/emergency care if it happens again. Patient observed for 30+ minutes until his girlfriend came to pick him up.
Generalized rash for 2 days (possible generalized vaccinia). Not itchy but bumpy. No treatment given. Reassurance that the patient is ok.
Within 15-minutes of vaccination, patient reported feeling lightheaded. EMS managed patient on-site.
16 year old received dose of Moderna instead of Pfizer, which is indicated for age less than 18.  No adverse effects, informed patient, patient's mother. Consulted pediatrician and family medicine physician for recommendations. Per conversations with all parties involved and CDC recommendations, family is planning to have patient receive second dose of Moderna.
ED Discharged  2/26/2021 (3 hours)  Last attending ? Treatment team COVID-19 Clinical impression Rapid Heart Rate ? Fatigue Chief complaint ED Provider Notes  (Resident) ? ? Emergency Medicine Cosigned by: at 3/1/2021  7:31 AM Expand AllCollapse All        ED RESIDENT NOTE            Chief Complaint      Chief Complaint Patient presents with ? Rapid Heart Rate ? Fatigue       History of Present Illness     is a 70 y.o. yo female presenting to the ED with palpitations.  Patient states that last evening and this morning she has had the sensation of her heart racing.  She is also been coughing white sputum.  She feels generalized weakness.  Her grandson who she lives with is currently having a cough and fever and is being tested for Covid.  She presents with concerns for heart problem versus infection.  She did have her first dose of her Pfizer Covid vaccine last week.  She denies any pain at this time.  She does not feel short of breath.  She states she has not been eating or drinking as much as normal.       Medical Decision Making     Patient presents to the emergency department with generalized weakness, sensation of heart racing, and productive cough.  Patient was found to be febrile in the emergency department.  Her son who she lives with at home is also currently sick with a upper respiratory illness.  Covid test is pending for him.   I have high suspicion patient is likely suffering from Covid infection.  We will get Covid swab.  We will get basic lab work, EKG, chest x-ray.  Patient is maintaining O2 sats on room air.  Low suspicion for PE at this time.   Patient does appear a little bit dry on clinical exam so we will give her some IV fluids.  Will also give her Tylenol for fever. Anticipate patient is likely Covid positive and we will discuss with PCP about setting up for monoclonal antibody infusion.         ED Course as of Feb 27 1339 Fri Feb 26, 2021 1155 Sinus rhythm at a rate 80 bpm.  Normal axis, normal intervals.  No STEMI.  No EKG to compare to from prior.  ECG 12-lead: HOSPITAL or TEST FACILITY Once Chest pain, (r/o) Arrhythmia, Shortness of breath [BH] 1216 Lymphocytes # (Auto)(!): 0.93 [BH] 1216 Unremarkable  Comprehensive metabolic panel - STAT(!) [BH] 1301 COVID-19 SARS-CoV-2 Overall Result(!!): Detected [BH] 1439 Set up for monoclonal antibody testing in the outpatient setting.  Return precautions instructions given.  Social work will be reaching out to the patient to set up the monoclonal antibody infusion.  Patient discharged home in stable condition.   [BH] Sat Feb 27, 2021 1338 No acute cardiopulmonary abnormality.  X-ray chest 1 view, Portable [BH]
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 20-MAR-2013 was administered a dose of GARDASIL (lot # and expiration date were not reported) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Moderna first dose was given on 7/29/21: no adverse event (Additional covid vaccine) Janssen was given prior to admission to our facility on 7/21/21, but the prior facility failed to document or communicate that she had received the vaccine.
Full body hives/rash, began morning of 5/11, progressed to more swelling itchy throughout day more developed following morning 5/12