chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours patient developed generalized urticaria and a sensation of a racing heart. She took Benadryl and it took 2 and 1/2 days for the hives to resolve.
A 3 1/2" diameter hot red circle appeared around injection with a 1/2" hard, hot, bump in the center.  Pt. reported irritability, pain and swelling.
No additional AE's/PQC's reported.; products experienced an excursion of ( 4C) for 20 minutes on 9/7; This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to a 7-year old patient of unknown gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.    Per reporter, varicella virus vaccine live (oka/merck) (VARIVAX) with lot# U015682, U002394, and U010400 experienced an excursion of minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 07-SEP-2021 during transport and minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 09-SEP-2021 during transport. On 15-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U010400, expiration date 01-APR-2023, dose: 1 (unit unknown); strength and route were unknown) for prophylaxis (product storage error). No additional adverse event and product quality complaint reported.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2109USA005628:
Patient states that he immediately experienced burning/stinging at the injection site.  Other complaints following vaccination include redness from his elbow to his shoulder in the injected arm, a subcutaneous knot that would come and go, itching at the injection site and that the injected arm was warm to the touch.
No adverse events or reactions, vaccine was given off label at the direction of patients family physician  MD. Family was educated on the off label use has chosen to continue with second dose of vaccine at the recommendation of family physician MD. Facility Medical Director MD was notified of the off label use and request by family physician to receive both doses.
Patient reported flushing in her ears after 5 mins in observation after receiving her  1st Moderna vaccine , she was brought to room 1 with no additional symptoms Her vitals were as follows   B/P  168/88 Heart rate 84 SPO2 100   Dr. called to consult 104 pm , patients skin is warm and dry to touch, her injection site is clear of any rash or redness and is cool to touch.   Patient denies chest pain, or Shortness of breath, no nausea or dizziness.   Dr.  did advise the patient to take an additional Zyrtec this pm if she is still feeling flushing in her ears.   Vitals 12:09 pm B/P 162/86 Heart RAte 810 SPO2 100%   Vitals 12:13 pm B/P 158/80 Heart Rate 64 SPO2 100%   Patient symptoms remain stable no new symptoms and the flushing in her ears remains unchanged. Vitals 12:20 pm 159/80 Heart Rate 57 SPO2 100%   Dr. did consult and released the patient to her vehicle. She will call our office to report any additional symptoms or phone 911 if anything emergent arises.
Pt recvd Engerix-B & 15JUL92 exp blisters rt side of face, both feet swollen & severe rt arm pain @ inject site; seen by MD;
fever, sz-EEG screen, APAP q 4-6 PRN;
Fever to 102.5, shaking chills, body aches, malaise, arthralgias
none covid 19 vaccine expired 11/22/2022 given 12/19/2022
Information has been received from a medical assistant referring to a 2 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Pt had a fever, soreness (immediate) and Diabetes Type I (developed over time). Dx'd on 11/20/1999.
patient went to ER for pain behind right knee that extended up to her thigh with intermittent numbness/tingling of lower leg, patient also having bilateral numbness/tingling, dx with peripheral neuritis
Patient called the pharmacy on  04/13 to report that 4 hours after leaving the pharmacy and arriving home she had severe symptoms of headache, nausea, sharp abdominal pain, vomiting , chills and extreme fatigue. Advised the patient if her symptoms did not improve to seek help from her PCP
shingles; rash was bad enough; did no get the 2nd shot; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shot and was promised that the vaccine would not give him/her shingles, but it did. The patient also experienced bad rash. Till the time of reporting, the patient did not get the second shot, which led to incomplete course of vaccination. The patient thought that the single dose was enough. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR201148, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201148:Same reporter
Rapid heartbeat and face flushed the next day; face flushed; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Mar2021 at 15:00 as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unspecified date. The patient had no known allergies. Concomitant medications included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported; metronidazole (METRONIDAZOLE) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Mar2021 at 10:00, the patient experienced rapid heartbeat and face flushed the next day and face flushed. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for adverse events was Unknown. The patient underwent lab tests and procedures which included heartbeat (heart rate): Rapid heartbeat on 02Mar2021. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Minor localized redness w/o SOB. Admin. 25 mg Benadryl SL with relief within 5 minutes. Notified Med Control. Patient release with total relief at 19:15.
Patient passed out briefly after receiving MMR vaccine and fell on floor. Color was pale. Pupils were normal. No bump or red mark on head. Pupils remained normal. According to mother, on 2/17/2012 his hands started trembling, felt "buttery", dizzy, head hurt. According to mother he has had dizziness, headache, and weakness in legs every day since February 17th. She said he has awakened at night, unable to sleep because everything is spinning. When asked how many times a day he exhibits symptoms, she said "He's a boy, I don't know for sure." She took him to the emergency room on 2/25/12. She said he had a CT scan and results were normal. She said he has post concussion syndrome.
Patient developed raised red rash, some with white dots in center, all over her body, except face and hands. The rash lasted two weeks. Patient went onto develop ataxia, which has not resolved nor been explained. Although we hope this is not permanent, it has been now been at least 5 months and is on-going.
Patient received her second vaccine of Moderna at 5PM friday on 4-2-21 and at 10PM on 4-5-21, she started throwing up and couldnt keep food down.  Went to healthcare facility at 4PM diagnosed with appendicitis and went to healthcare facility at 8PM.  Surgery happened midnight and appendix apparently burst on the operating table--it was so swollen.
No adverse event; Expired dose of M-M-R II; This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 21-APR-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R011221, expiry date: 17-APR-2020) therapy type recombinant human albumin (rHA) for prophylaxis. Concomitant therapies included sterile diluent. No additional adverse event. The outcome of expired product administered and no adverse event was unknown.
This case was reported by a nurse via sales rep and described the occurrence of blister in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced blister and swelling. On an unknown date, the outcome of the blister and swelling were unknown. It was unknown if the reporter considered the blister and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The other healthcare professional called to report that she did not like the FLUARIX QUADRIVALENT vaccine because 3 patients received the vaccine in 2014 and experienced blisters and swelling. The sales representative did not have any further information. This case has been linked to cases US2016031743 and US2016GSK034531, reported by the same reporter.
UPRAISED SLIGHTLY RED AND SCABBY AND CONTINUED TO BURN AND ITCH AT INJECTION SITE.  ALSO A PERSISTENT DRY COUGH.
Pt states that in 2004 she received the flu shot while on duty as an RN at the TriCare clinic.  Within 15 minutes she had itching at the site that then spread to her entire body.  Next she had hives on the arm where she received the injection that spread to her entire body.  Then she experienced wheezing and SOB.  The pt states that a physician in the clinic gave her 50mg of Benadryl po.  Her symptoms resolved entirely within a couple of hours.  She was given a prescription for Zyrtec.  The pt states that she took one dose.
Friday evening - overall not feeling well and low grade fever, soreness at injection site Saturday - backs of legs hurt really a great deal, fever 101.7 - 102, all over aches, pain at injection site, pain was severe with touch, chills, fever, aches and headache all day and evening. Overnight severe sweating (most likely fever breaking), chills, and body aches. Sunday/ Monday - low grade fever, bad headache when standing or sitting without head resting on pillow and fatigue. Tuesday severe fatigue slept most of day on and off low grade fever and headache in evening. Wednesday - light headache and fatigue. evening legs ached and very low grade fever. Thursday - tired feeling all day
This spontaneous report as received from a physician via company representative refers to a 72 year old male patient with hypertension, Coronary Artery Disease (CAD) and hyperlipidemia. The patient had no allergies. The patients medical history included bladder cancer. On 07-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021712, expiry date and the dose was not reported) in the left arm(deltoid). Concomitant therapies included atenolol, simvastatin, amlodipine, lisinopril and tamsulosin hydrochloride(reported as tamsulosin). The reporter stated that 48 hours post vaccination (09-MAR-2013), the patient woke up with pain on backside on his neck. The patient sought medical attention for the same and on 12-MAR-2013 was seen at the doctors office and was diagnosed with shingles where he experienced the pain of his neck. The physician also stated that the patient had dermatomal rash from neck to back of his skull with one sided pain. The patient was put on antiviral and pain medication. The dermatomes involved were C3, C4 and C5. The patient maximum temperature was 100.6 (units unspecified). VZVIP (Varicella Zoster Virus Identification Program) sample of the vesicle/lesion was obtained on 14-MAR-2013. The outcome of all the reported events was reported as not recovered/not resolved. Additional information has been requested.
After the vaccine he stated starring and his eyes would roll up. Didnt think anything was wrong and then he started jerking. Diagnosed with epilepsy
My joints were aching (shoulders and knees) and I felt flu like symptoms went to urgent care all tests for flu and Covid came back negative. Primary care referred me to orthopedic doctor.
joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a contactable nurse.   A 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm right, on 13Jan2021 14:15 at single dose for covid-19 immunisation.  The patient previously received the first dose of BNT162B2, intramuscular in arm right, on 23Dec2020 13:15 at single dose for covid-19 immunisation.  The vaccine was administered at Physician Office.  No other vaccine was administered in four weeks. COVID was not tested post vaccination. No known allergies. Medical history included migraines from an unknown date and unknown if ongoing.  The patient had COVID prior vaccination.  The patient's concomitant medications included butalbital, caffeine, paracetamol (FIORICET). On 13Jan2021 the patient experienced joint pain, chills, headache, severe injection arm pain, fever. The patient was treated for the events with OTC fever and pain reducer and IBUPROFEN. The outcome of the events was resolving.  Information on the lot/batch number has been requested.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) 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) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
Daughter said patient was hospitalized after both shots of Moderna vaccines. According to her he wasn't able to move his body and had fever.
Within 48 hours had 4 red cyst type spots that grew in size.  One on right side front, two on back ride side.  Irregular shape.  Itch, very sore and painful.
More numb; Tender at site of injection; site of injection on right arm started becoming red; Injection site bit swollen; Hardness at injection site; Hives as allergic reaction; Palpitation; Tongue and throat felt numbing; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation), HYPOAESTHESIA ORAL (Tongue and throat felt numbing), VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE INDURATION (Hardness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation) and HYPOAESTHESIA ORAL (Tongue and throat felt numbing). On 05-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen). On 06-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE PAIN (Tender at site of injection). At the time of the report, URTICARIA (Hives as allergic reaction), VACCINATION SITE HYPOAESTHESIA (More numb), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PAIN (Tender at site of injection), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen) had not resolved, PALPITATIONS (Palpitation) outcome was unknown and HYPOAESTHESIA ORAL (Tongue and throat felt numbing) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment medication included acetaminophen and Benadryl.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This is my 3rd dose as I have a weakened immune system.  This is the first time I had noticable pain under my left arm for the past 48 hours.
08/16/2021 A couple hours post vaccination I was going to go to bed and began to get an excruciatingly bad headache. I was unable to sleep and I felt both hot and cold throughout the night. And through the next day I was suffering from all of that as well. I felt nauseous exhausted, headache, and hot and cold episodes. Fever never got above 99.8 F. Half of day two post vaccination I was still experiencing the same symptoms. My kidneys were starting to hurt, and when I went to the bathroom it was orange. Third day post vaccination I was beginning to feel better however fatigue was still there for about a week. I am feeling well now and everything like that. No lingering issues currently.
Most of the dose spilled out of needle down the patient's arm; Gave another dose to patient; A spontaneous report was received from a Healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe connection issue and accidental overdose.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch number unknown) intramuscularly in the for prophylaxis of COVID-19 infection.  On unknown date, while taking the vaccine, most of the dose spilled out of the needle and down the patient's arm. The immunizer then drew up another dose and gave to the patient. It is very possible that the patient received more than a 0.5ml dose.  Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This report refers to a case of accidental overdose, exposure via skin contact and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Pfizer dose 1 3/20/21 (ER2613) Pfizer Dose 2 4/24/21 (EW0153) COVID Positive 1/14/22  1/13/22: A 67-year-old female with a past medical history of COPD not on home oxygen, type 2 DM with neuropathy, hyperlipidemia and history of aorto-femoral bypass surgery comes to ED complaining of cough and shortness of breath. Patient states that since last week she has been feeling weak with cough and shortness of breath.  Cough is productive with small amounts of mucoid sputum.  The last couple of days she is feeling more short of breath and also feels chills.  Two days ago she did give home COVID test and it was reported positive.  Patient lives alone, no sick contacts.  She states she took 2 doses of COVID-19 vaccine, but not booster.   In the ED, temp was 19.9 degree F, pulse ox 94% on room air, vital signs stable.  Blood work is significant for mild leukopenia and mild hyponatremia, mild lesion CRP and elevated D-dimer..  Chest x-ray negative for infiltrate. CT angio chest is done and is reported negative for pneumonia or infiltrate, positive for chronic bronchiectasis and bronchiolitis.  She was given IV dexamethasone 6 mg, IV ceftriaxone, IV Zithromax and the duo nebs in the ED. patient was placed on nasal cannula oxygen for comfort, no documented hypoxia.  COVID-19 PCR pending.  1/16/22:  67-year-old female with a history of COPD admitted for COVID-19 pneumonia and acute hypoxia.  Patient was managed with IV remdesivir, dexamethasone, antibiotics in addition to other supportive treatment on re-evaluation today she feels fine with complete resolution of hypoxia. She will be discharged on pre-admission medications.
Chills ~ 4 hrs after injection persisting for 12 hrs Body/Muscle Aches ~ 4 hrs after injection persisting for ~ 2-3 days Redness, Swelling and Pain at injection site ~ 4 hrs after injection persisting for ~ 2-3 days Syncope ~ 20 hrs after injection (single event leading to minor contusions)
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unknown dates, the patients received improperly stored VARIVAX (Merck) lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Additional information has been requested.
PATIENT CAME IN ALERT AND ORIENTED. STATED HAD A REACTION IN PAST TO VACCINES AND HAS FAINTED. PREVIOUS VACCINE FOR GOING OUT OF COUNTRY. PATIENT AGREED ALONG WITH MOTHER TO GET VACCINE TODAY. PATIENT RECEIVED VACCINE WITH NO INCIDENT. WE HAD HER SIT THERE AND SHE STARTED FEELING FAINT. SECOND VACCINATOR ALSO NEXT TO PATIENT. PATIENT DID FAINT AND SEEMS TO HAVE A SMALL SEIZURE AS HAD INVOLUNTARY ARM MOVEMENT AND HAD LOST CONSCIOUSNESS. PATIENT BECAME ALERT IN ORIENTED WITHIN 30 SECONDS. PATIENT STATED FELT BETTER BUT CALLED 911 FOR THEM TO COME ACCESS HER. MOM CALLED INTO ROOM AND STATED THIS INCIDENT HAD OCCURRED BEFORE. FIRE DEPARTMENT (EMS) IN STORE AND RESPONDED ALMOST IMMEDIATELY. PATIENT WAS ON FLOOR AT THIS TIME BY DIRECTIONS OF PHARMACY STAFF WITH FEET ELEVATED. BREATHING NORMAL, ALERT AND ORIENTED BUT APPEARS PALE (MOM STATES NORMAL SKIN COLOR). PATIENT ASSESSED BY EMS AND BLOOD PRESSURE LOW. PATIENT AGREED TO GO GET CHECKED OUT BY HOSPITAL DUE TO LOW BLOOD PRESSURE, PALE. LEFT WITH EMS STAFF.