chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kidney infection; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced kidney infection (medically significant) on an unspecified date. The 2nd dose will be on 15Apr2021. Last 08Apr2021, she was advised to take antibiotics for kidney infection. The patient would like to know if that will affect the vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
perfuse sweating; rash; This spontaneous report as received from a nurse practitioner via a company representative refers to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 04-NOV-2019 (reported as 10 days ago), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, lot # and expiry date was not reported) for prophylaxis. On the same day, other suspect therapies received by the patient included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (dose, lot # and expiry date was not reported), diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid(PENTACEL) (dose, lot # and expiry date was not reported) and hepatitis a virus vaccine (unspecified) (dose, lot # and expiry date was not reported). On 04-NOV-2019, reported as after the administration of the vaccines, the patient experienced rash and profuse sweating reported as "perfuse sweating" (hyperhidrosis). The patient visited the physician office and there was no treatment given for the events. The outcome of hyperhidrosis and rash was reported as not recovered. The relatedness between the events and the suspect therapies was not provided.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 04-Nov-2021. Dates of administration of vaccine was 05-Nov-2021 and 12-Nov-2021. The vial didn't undergo any temperature excursions.
patient called in today 4/30 and states that arm has been itching and has redness and warmth where she got her covid injection
Patient admitted to the hospital w/NSTEMI, possible myocarditis on MRI chest noted.
My arm just below injection started itching  on the evening if the 8th day after my vaccine.  The next morning I noticed my arm was red and warm to the touch.  I used topical Benadryl cream on it.  On day 10 I went to the site where I received the vaccine and verified that it was most likely Covid arm and she told me to report it.
This case was reported by a healthcare professional and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved.
7:00 PM Felt queezy in stomach off and on in evening. 10:30P - 400 A Got chills with shaking - to bed. 130 A - 300 A Felt my heart pounding in my (L) ear. Had to urinate large amts several times in the night. 400 AM - warmed up - slept - ok next day - except both arms hurt about 3 days. (R) arm more than (L) arm.
dizziness and brain fog, falling down for no reason, throwing up, sleep for 3 days and nights, neurologist, family doctor.  Joints jerk, shakes, walk with a cane to keep balance. Sometimes my words don?t come out right.  Eyelids twitch, I have asthmatic bronchitis, prescribed an emergency inhaler and a daily one, headaches.
Child presented to med center ER the next am unresponsive and apneic. Paramedics reported that the baby was found apneic and pulseless at home by the home. Mother was lying beside the child in bed and the last time this child was seen well was about 7:30am this morning. The pt was noted to be asystole in the field. Was given four rounds of epinephrine without any return of spontaneous circulation. The pt then had CPR initiated. The pt was intubated and interosseous line was started. Further review of systems unable to be obtained given the fact that the parents are not here during resuscitation and pt is intubated and too young to give further history of present illness. This 2 month old male with cardiac arrest. At this time presenting apneic and pulseless. The possible etiologies include sudden infant death syndrome. At this time the coroner office was also invovled and will also be exploring any possible other etiologies. At this time pt will undergo a full body x-ray series and will also undergo autopsy. While pt was here in the emergency dept, the pt underwent further resuscitation and received two more doses of epinephrine and CPR was continued for another 10-15 minutes here in the emergency dept. The pt remained in asystole. This is documented in two leads afterwards. After 45 minutes of resuscitative efforts the resuscitation was discontinued given the futility of further intervention. The pt's care and examination was discussed with MD who is the pt's primary care physician. The family was also notified of the pt's recent demise. Diagnostic impression: Cardiac arrest, uncertain etiology. The autopsy result states undetermined cause of death.
Pt report injection site is red, swollen, blotchy, warm 2" diameter from injection site c/w cellulitis. Treated with KEFLEX.
Information has been received from a nurse concerning an 81 year old male who on 13-FEB-2009 was vaccinated SQ with a dose of PNEUMOVAX vaccine into the right arm and tetanus diphtheria into the left arm. On 13-FEB-2009 evening, the patient developed cellulitis on the right arm. It was reported that the patient was followed-up on 16-FEB-2009. The patient was given an unspecified antibiotic. The patient was seen for medical attention. Follow-up information was received from a physician office staff member concerning 81 year old male sulfonamide and terazosin allergy, hyperlipidaemia, hypertension, abdominal aortic aneurysm, angina and carotid bruit and a history of stent placement who on 13-FEB-2009, at 13:00, was vaccinated SQ with a 0.5ml dose of PNEUMOVAX vaccine into the right arm. Later that evening from injection site down past the elbow to just above the wrist, the patient exhibited an onset of redness, swelling, pain and flesh which was warm to hot the touch. The physician's diagnosis was cellulitis and prescribed doxycycline 100mg twice daily for 10 days. At the time of this report, the patient was recovered. Cellulitis was considered to be an other important medical event. No further information is available.
chest pain on 12/20/21 intermittently, then continued through the night into the early morning on 12/31/21. Seen in the ED with chest pain and had elevated troponin 10K, peak was 12K and elevated crp. Nml d-dimer. Admission for myocarditis overnight stay
11:34. Sudden onset of rapid pulse, anxiety, feeling cold all over.  11:36 - evaluated onsite by NP and EMS. EKG showed SVT with rate of 152; BP 183/117 -   Vagal manuevers provided some decrease in rate but no appreciable change.  EMS called and transported patient to Hospital.  11:45
Fever 101.0, body ache, vomiting  24-26 hours post vaccination.
Diagnosed with Covid 19; Diagnosed with Covid 19; This is a spontaneous report from a contactable Nurse reported for herself.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 09Jan2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported.  She was diagnosed with Covid 19 on 18Jan2021. She was supposed to get second dose on 26Jan2021. The outcome of the events was unknown.  Information about batch number was not available and is going to be requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
13.5 x 14 cm erythema, heat and itching at injection site - onset < 48 hrs after vaccine admin. No systemic rxn.
Narrative: Administering nurse reports pt received a vaccine today after receiving a vaccine on 4/15/22 at another location that was not reflected in record. Administering nurse reports checking the registry prior with no documentation noted of a prior vaccine. Pt also did not recall to administering nurse ever having a COVID vaccine. Radiology department later spoke with daughter and radiology notified vaccine clinic that pt had received a covid vaccine at Pharmacy on 4/15/22. Administering nurse rechecked registry and noted documentation of a Pfizer COVID vaccine on 04/15. Administering nurse reports pt left in stable condition with transportation and notified that daughter reported pt is currently stable at home. Administering nurse instructed daughter of signs and adverse reaction monitor for and when to seek medical attention. Administering nurse instructs of plans to consult with subject matter expert on further COVID vaccination due to interval and plans to notify daughter upon follow up of recommendation.
she passed out in the chair. She eats well and drinks water.; her blood pressure was so low; dizzy; lost all color in her face and lips; dehydrated; This is a spontaneous report from received from a contactable consumer (patient's parent). A 14-year-old non-pregnant female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 02Jul2021 02:30 PM (at the age of 14-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history was not reported. No concomitant medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the next morning (03Jul2021). Her daughter woke up and they went to the (privacy) within 45 mins of waking up. 30 minutes later she passed out in the chair. She eats well and drinks water. They had to be transported in an ambulance because her blood pressure was so low, she was dizzy and lost all color in her face and lips. They spent three hours in the hospital and all the blood work came back good, but her body was dehydrated for some reason. So they pumped her with fluids. Onset date of events was reported as 03Jul2021 at 12:00. The events resulted in emergency room/department or urgent care visit. Treatment (pumped her with fluids) was received due to dehydration while it was unknown if treatment was received due to other events. The case was reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.  Information about lot/batch number has been requested.
Pt complained of pain and redness at injection site following injection, 48 hours following injection developed significant pain and an area of induration with three red hematoma-appearing areas
Severe thrombocytopenia (Platlet Count of 18)  HPI: 33 y.o. male with no PMH coming in now w/ progressive thrombocytopenia to 18. He received the J&J covid vaccine on 4/8 and felt well afterwards. Last Friday (4/16) he began to experience constitutional symptoms (fever to 100.4, chills, night sweats feeling drenched, decreased appetite) so decided to get his labs drawn as an outpatient for further evaluation. Symptoms progressed until Tuesday, when they began to subside slightly. At that point, his labs resulted and were notable for thrombocytopenia. He got his labs redrawn the day before admission and it was noted that his thrombocytopenia was worsening, so he was directed to the ED for further evaluation.  Patient seen by hematology, started on dexamethasone 40 mg PO daily as well as IVIG treatment x2. MRV of brain without evidence of dural venous sinus thrombosis  ***PATIENT CURRENTLY HOSPITALIZED***
Had the injection Friday evening. Very quickly had my heart rise and felt shaky (like when you take an inhaler). Heart rate stayed up for about 30 min, shaky for about another 1 and half.  but left factily after 15 minutes, as I was shaky, but ok.  About 20 min after shot, the tip of my tongue and lips got tingly/numbish. Not swollen, just tingly.  (They were very slightly the same way the next day). I went home and contacted  hotline. She suggested I call a dr. I called a dr who told me to take a benadryl.  I ate some food and took the benadryl. I fell asleep and slept for 14 hours (definitely not normal). That next day (Saturday) I had a headache, upset stomach, lowgrade fever (below 99.9) and pretty good pain in the injection arm. Stomach was settled by that evening, headache was gone Sunday. Off and on low grade fever (highest was 100.3) still ongoing (Tues 3/2, but highest today is 99.1))
My son is having redness and hot area to the touch on both thighs in the area given the vaccine. My son was evaluated by the pediatrician on September 15, 2020.
2 hours after vaccine. C/o arm pain that spreads up arm and under armpit and covers chest. Feels like it is in lungs. Unable to breathe deep. Is feeling slightly better today but still having pain and difficulty breathing. Refused to go to ER or doctor's office.
tried to get his second dose after recovery but was denied at the site; Patient got COVID infection after first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Patient got COVID infection after first dose of Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Patient got COVID infection after first dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site). At the time of the report, COVID-19 (Patient got COVID infection after first dose of Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided.
11 hours after injection, patient experienced 6 hours of intermittent, sharp, muscle spasms(?) throughout the neck, shoulders, abdomen, back and thighs. These areas were very sore through the next 24 hours.  A mild fever commenced 17 hours after vaccination and lasted approximately 12 hours. A bright red, painful, hot to the touch rash, extending from the injection site to 8 inches below, began 24 hours after injection. The rash took over 72 hours to resolve.
Moderna COVID-19 Vaccine EUA Two hours after injection, left deltoid very sore, difficult to raise arm over head because of pain.  Roughly 36 house post injection, nausea and vomiting. Vomited four times between approx. 5:30 a.m. and 11 a.m. on Sunday, 3/14. Fever up to 100.2 ° F. As I am completing this form roughly 12 hours after the first episode of vomiting, I still wouldn?t say I?ve fully recovered yet.
Breakthrough case admission after 3 vaccines Pfizer 7/28/21 lot# EW0164;  Pfizer 8/18/21 lot# EW0164;  Pfizer 6/14/22 lot# FM7553
Vaccines of DTaP+Hib+Varicella were given on RT on the 4th of September evening. On the 14th mom noticed bump nickle size red, hot to touch and bruise around it cranky no fever. Taken to ER-dg with abcess. Recheck 9/15/03 ER dig. cellulitis. Prescribed Aphalosporine 125mg qid 6 susp. 9/25/03 TC with mom 14 mo old's leg is healed no further symptoms.
have received 3rd dose of vaccine; Case is crossed linked with MOD21-084772 Warm Transfer from Moderna Customer care service, case number 00163946.  HCP is returning a missed call from Moderna Medical about an earlier inquiry on how to code a 3rd dose received by a clinical trial patient. They were not sure about the department of Moderna that contacted them. Nurse wants to be contacted back for response as soon as possible.  Best method of contact would be email or phone number. They gave consent to be contacted by Regulatory Authorities
fever 102F; chills; body aches; sore arm; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Dec-2020.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue). At the time of the report, PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
no adverse event; the second booster dose of V AQT A was given to a child 16 days before the sixth month mark from the first dose of V AQTA given to the child; This spontaneous report was received from a nurse and refers to a child patient of an unknown gender. Ni information regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis. On 03-FEB-2021, 16 days before the sixth month mark from the first dose, the patient was vaccinated with second dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter (route of administration, lot # and expiration date were unknown) for prophylaxis. No adverse event was reported.
Persistent hives remain still after 2 1/2 months.  Steroids prescribed for 2 weeks immediately after presenting hives 2 hours after injection.  Continued with antihistamines 2 ongoing since presenting.  Loratadine and Cetirizine Hydrochloride.  Added additional dose of Benadryl to those March 29th.  Still taking one pill of all three with no improvement.
PATIENT STATES THAT AREA WAS RED AND INFLAMMED FOR A COUPLE OF DAYS. WENT TO THE EMERGENCY ROOM AND THE DOCTOR DIAGNOSIS IT AS CELLULITIS AND PRESCRIBE THE PATIENT 2 ANTIBOTICS
1 minute after receiving the vaccine my face and tongue began to tingle.  The tingling lasted 3 hours.   30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days.  The following morning I also had flu like symptoms. Those lasted 24 hours.
June 7, 2013 - injection. June 8, 2013 - sore at injection site, AM - arm swelling, and pain PM. June 9, 2013 - right arm weakness, (R) breast swollen, (R) leg weakness, incontinence -> ER.
Patient feels pain on her left arm and complained about it. She was assessed with 2 RNs and refused EMS. Instruction was given to patient.
1 day post shot patient had rash over face and cheeks, with some minor cheek swelling. She presented 3 days later with rash over chest and L arm, with some discomfort in throat feeling tight. No difficulty breathing, no lip or tongue swelling, no obvious signs of anaphylaxis. Given delayed allergic reaction and presentation > 72 hours after vaccine, treated with prednisone and an OTC antihistamine with clear return precautions, with close follow up with PCP in 2 days.
1SEP95 tc to pt states recvd vax 23AUG95 around 5PM state had no problems until 25AUG95; woke up about noon & had hives over body; took DPH; hives on rt arm only 31UAG95
REDNESS, WARM AND SMALL LUMP  AT THE INJECTION SITE.  PATIENT STATED THAT CONDITION IS IMPROVING SLOWLY.  ADVISED: APPLY WARM COMPRESS TO AREA TO IMPROVE REDNESS AND SMALL LUMP.  OTC MEDS AS NEEDED FOR PAIN.  SEEK MEDICAL ATTENTION IF CONDITION WORSEN
Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not applicable. No specific patient was involved. The reporter reported that many patients experienced pain after receiving Shingrix.  The reporter consented to follow up. This case is 1 of 3 cases reported.
pt recvd vax;devel a little red knot which was raised,& a warm area near the inject site in the thigh;
This spontaneous report was received from a patient's mother and refers to a 2-year-old male patient. The patient's concurrent conditions, medical history, known allergies and concomitant therapies were not reported. On 13-MAR-2017, the patient received a dose of VARIVAX injection (dose, lot# and expiration date were not reported). In the night of 13-MAR-2017, the patient developed a red rash at the injection site which was warm to the touch. The patient was taken by the mother to the emergency room. The patient was prescribed diphenhydramine hydrochloride (BENADRYL) to be used every four to six hours and prednisone (manufacturer unknown). At the four or six hours, the rash reappeared after having gone away. The patient's outcome was reported as not recovered. The causality between adverse events and VARIVAX was not reported. Additional information has been requested.