chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies, and reactions were not provided. The concomitant medications included sterile diluent.  On 13-FEB-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) (lot #W029899 had been verified to be a valid number; expiration date 16-MAY-2024, and upon internal validation established as the same date); varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W024335 had been verified to be a valid number; expiration date 01-AUG-2024, and upon internal validation established as the same date); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #W012118 had been verified to be a valid number; expiration date 24-DEC-2023, and upon internal validation established as the same date) all the vaccines were administered for prophylaxis (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported).   The administered dose of the vaccine hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored at a temperature of 9 degrees Celsius (C), for a time frame of 2 hours and 32 minutes, as recorded by a digital data logger. The administered dose of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature of 8 degrees Celsius (C), for a time frame of 1 hours and 40 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
BECAME NAUSEATED AND VOMITED  IMMEDIATELY AFTER VACCINE DOSE. BECAME DIZZY WHILE WAITING IN OBSERVATION STATION. BLOOD PRESSURE WAS LOWER THAN USUAL. TREATED WITH ORAL REHYDRATION IN THE FORM OF WATER
PATIENT SAID SHE WOKE UP THE MORNING FOLLOWING HER VACCINATION FEELING AWFUL. SHE HURT ALL OVER, COULD BARELY LIFT HER ARM, AND DID NOT HAVE THE ENERGY TO GET OUT OF BED ALL DAY. SHE FELT SOME BETTER THE FOLLOWING DAY AND WAS FEELING MUCH BETTER THE DAY FOLLOWING THAT.
Patient got her first dose of Pfizer became severely dizzy and became heavily sweaty and cold, vitals were taken, her saturation went down to 94 spo. she was asked if she had breakfast. She said that if at that moment 911 was called. 911 communicated with clinic and spoke with student dispatcher at the time of taking sv by the paramedic, 1210 BP: 80/60, Temp 95.1, spo92, 12:11 BP: 117/76, dx: 102, spo 97, 12:10 101 mp96. She was given nasal cannula and was transported to Medical Center. Patient was oriented with results and vs and she accepted to be transferred.
In bed all day; Fatigue; Chills; Muscle pain; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of BEDRIDDEN (In bed all day), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced BEDRIDDEN (In bed all day), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 05-Feb-2021, BEDRIDDEN (In bed all day), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) 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.   Treatment included Tylenol; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable Pharmacist. A 80-90-year-old patient received the second dose of PREVNAR 13 at single dose on 24Jul2017 for immunization. The patient had received the first dose on 18Jul2017. Medical history and concomitant medication were not reported. On unknown date the patient experienced some redness in the site of injection. The outcome of the event was unknown.
Runny nose x 2 weeks, cough and sore throat onset 5/14/21
Headache, Myalgia, Arthralgia, Fever, chills, fever of 100.0 Narrative:
LEFT ARM PAIN STARTS RIGHT AFTER IMZ, PAIN RADIATING TO NECK,NUMBNESS IN LOWER ARM: DIFFICULTY MOVING ARM VERY MUCH.
Soreness at the injection site; Indigestion; Vomiting; Nausea; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 09Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 18:00, the patient experienced soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events soreness at the injection site, indigestion, vomiting, nausea, diarrhoea and fatigue were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom states 1 hr post vax pt became irritable & scratching the soles of feet; mom noticed whelps on face & ears were swollen; mom took pt to ER-pt given cortizone & DPH; mom states MD stated pt was wheezing; later c/o feet swelling
SOME TYPE OF LYMPH NODE GROWTH; This spontaneous report received from a patient concerned a female 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced lymph node growth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lymph node growth. This report was non-serious.
Face only. Swollen cheeks, hot and red cheeks - Peeling, itching cheeks on face. Shingles shot.
lt upper arm circumferential erythema & induration 2 days p/vax; pt recv ceftroxone Im;next day improvement in erythema & induration;
Itching 2-3 hours later, hives the following day over the entire body for a week, to MD given prednisone and Benadryl, then face swelling, week later hands and feet itching, with water bubbles.
pt recv vax;noted large erythematous areas covering most of her upper lt arm;1cm of induration around inject site; c/o itching & tenderness in arm; MD recommended apap& cold compresses for low grade fever;tx hydrocortisone cream;
6/4/07 Eve - felt fatigued, mild achy then 6/5/07 awoke with extreme achiness, mild dyspnea with exertion and swelling of face. 6/4/07 Eve had been outdoors fishing, one bug bite found on her hand. ER Visit attached. Recovered in 1 day.
Patient was having pressure in his head, very confused, and lightheadedness/dizziness after receiving flu vaccine. He sat and waited for about 10 minutes and then felt better and went home. That night he was very confused and doing strange activities (put one slipper and one boot on) and acting very different than normal. He was acting  angry and easily agitated.
noticed a rash (was not present last night); left arm watch itchy and warm; left arm watch itchy and warm; headaches; chills; tiredness; eye strain; difficulty focusing vision; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 20Apr2021 at 16:45 pm (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient's medical history included migraines from an unknown date. Concomitant medication the patient received within 2 weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021, the patient experienced headaches, chills, tiredness, eye strain and difficulty focusing vision. On 29Apr2021, the patient's left arm watch itchy and warm. On 30Apr2021, the patient noticed a rash (was not present last night). No treatment was received for the adverse events. The case was assessed as non-serious. The outcome of the events left arm watch itchy and warm and noticed a rash (was not present last night) was resolving. The outcome of the other events was not resolved.  Follow-up activities completed. No further information is expected.
I have meniere's disease with vertigo and tinnitis, but it is well-controlled and I don't usually have regular episodes of vertigo. The volume of my tinnitis has been stable for many years. About four hours after vaccine was administered, I started experiencing vertigo and tinnitis in both ears. Both vertigo and tinnitis have been ongoing for 7 days now, and they aren't improving.  A 5 day course of prednisone (40 mg/day) helped symptoms (days 2-7 s/p vaccine), but now that I am off prednisone the symptoms have worsened again.   I had a similar reaction after the first covid-19 vaccine dose (Moderna Lot # 020B21A administered 3/29/21). After seeking medical attention from two different physicians, neither would report the vertigo and tinnitis to VAERS. No treatment was offered then. Both symptoms lasted approximately 6 weeks. I elected to significantly delay my second dose of vaccine as a result of this Meniere's flare up. I hoped that the time between doses would help with these symptoms, but clearly it has not.
AFLURIA Flu vaccine: Hospital nursing staff reported 3 leaking vaccine syringes between the hub and needles which also does not 'click in' properly. PREVENAR-13 vaccine: Hospital nursing staff reported 3 leaking vaccine between the barrel and the syringes where the syringe attaches to the plunger. Also reported that the barrel did not attach securely. Our staff at hospital had already reported these info to the manufacturers (Seqirus for AFLURIA; Pfizer for PREVNAR).
Vaccination given to patient outside of use by date. Vaccine use by date was 07/20/2022, as it had been pulled from the ultra freezer and placed in the refrigerator.  The vaccine had been out of the ultra freezer for 10 weeks and 4 days. No adverse symptoms from the dose. Pfizer called for guidance as to whether the dose was valid and provider, APRN, made aware, no additional orders received.
Patient received her Moderna booster on 12/28/21. Previous vaccines were 1/11/21 and 12/22/20 (Pfizer). [1st Pfizer shot, she felt fatigue for about 1 week but no symptoms after the 2nd shot.]  Patient went home to lay down after the booster vaccine as she was scheduled to work that evening.  She slept on her right side and the injection was on her left arm.  When she woke up several hours later (around 6 or 7 pm), her left eye was red and swollen shut.  She also noticed that her throat was scratchy, she had a headache and an ear ache as well as pain in her left arm at the site of the injection.  She  spoke to the infection control RN told her to place a cold compress on the eye and take Benadryl .  Patient stated she took 10ml  (25mg)  and the redness and swelling subsided.   She continued to have some eye pain but went on to work. When she got home, she repeated the Benadryl.  She also reported that on 12/30 she ran a mild fever of 100 degrees.
Pt. presents with redness, swelling, raised warm area around site and extending down 3-4 inches of arm - denies pain.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of VAQTA (lot # J016216, expiration date 18-AUG-2016, dose and route were unknown) which were exposed to temperature excursions of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
itch and hives all over both arms and across chest.  Treated with additional fexofenadine, resolved after ~36 hours
Lymph node pain; Lymph nodes enlarged; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Mar-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged). At the time of the report, LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged) had resolved.            No concomitant medications were reported.  No treatment information was provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Outcome of the event and reporter's contact details updated
LIGHT COUGH; RUNNY NOSE; COLD; NASAL CONGESTION; CHILLS; BODY PAIN; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body pain. On 16-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced light cough. On 28-MAY-2021, the subject experienced runny nose. On 28-MAY-2021, the subject experienced cold. On 28-MAY-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and chills on 16-MAY-2021, and was recovering from light cough, runny nose, cold, and nasal congestion. This report was non-serious.
Acute diastolic heart failure - Following admission, he was started on iv diuresis and 2 D  Echo was done. Seen by heart failure navigator and plan for outpatient follow-up.  IV diuresis changed to p.o. torsemide. Cr as low as 0.81 with diuresis on discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
COVID arm. I had it after the first shot and again this time, but it happened the day after and the swelling is much larger and more painful this time than last. It?s also lasted longer than last time.
Gums got sore and teeth ached.  Faded gradually in about week.  Did with both 1st and 2nd shot.  Then after 2nd shot about 1 week later, skin in area about 3 to 4 inches around injection shot got red /flushed.  Gradually faded.   Finally July 1 had shingles develop on same arm as injection but below elbow and doctor prescribed rx for that.  I had shingles in 2004 and was given vaccine that year as well.    I did speak with my dentist about gum flare up and he said he had about 5 patients who had recently complained about the same condition.
October 29 started nausea which was pronounced for six days.  No vomiting just aversion yo food sight or smell.  The following Friday, one hour after nausea stopped, dizxiness began.  Checked blood pressure and it was 188 over 82, much higher than ever before.  Went to DC octor and she increased metropolol. However, systolic pressure kept climbing over weekend and went to ER twice on Friday then Sunday.  Systolic reached over 200 but diastolic normal, heart rate normal and EKG and heart rate ok as well as blood and urine.  It took two weeks, an addition of amlodopine and upping lorazepam to one mg to get pressure back to normal.
c/o right arm pain  from shoulder to wrist onset a couple of days post vaccination.  states pain is constant, sharp and achy, has not taken any medication or received any treatment.  not worse with movement. states nothing makes it worse or better.  rates 9 out of 10 on 0-10 pain scale.   patient reported to receive dose # 2 today, but reported above symptoms.  instructed to follow up with PCP prior to receiving dose # 2.
After administering the vaccine, there was a significant bleeding at the injection site at the right deltoid muscle. The bleeding started from the injection site and ran down the arm to the elbow. The patient did not need to seek medical attention for this event. I was able to stop the bleeding and put a band-aid over the injection site and clean up the rest of the area of arm.
Pt fainted with assistance to floor. Posterior head was struck on fridge. Pupils dilated approx 7mm - pt was not following commands to squeeze hands or track movement. Symptoms lasted approx 30 seconds. Dr. in vaccine room prior to pt becoming responsive. Per mother pt has a history of fainting when seen blood.
Patient received a scratch on his arm when he pulled his hand out of his Moms grip and grabbed the vaccine just as I poked his arm. It is unclear if it was the needle or the safety device that scratched him.
lt upper arm red, swollen & warm 29AUg97 130PM;mild local pain 31AUg PM inc pain redness, swelling 1SEP AM pain bitter, redness remained, devel itching;
Pt. developed gradually worsening myalgias and muscle weakness after receiving the Zostavax on 12/22/08 and had elevated ESR of 71 consistent with polymyalgia rheumatica.  His symptoms have resolved with prednisone therapy.
Headache; This is a spontaneous report from a contactable consumer reported for herself. This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 09:15 AM Left arm at single dose (Lot # EL4237) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. No Allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. Headache occurred about 1 hr after receive vaccine 26Jan2021 10:15 which was non serious, went away within 2 hours. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 26Jan2021.
Hep A was given a 1 1/2 month early. Was not due until later date. Private practice office/clinic HAVRIX Lot # AHAVB481BB exp. 5/10/13 manufactured by GlaxoSmithKline. 720 EL U/0.5 mL single dose vial.
Headache & Fever Narrative: dose 1-day 2-3 pain/discomfort at inj site; chills/ fever dose 2-day 2-4-pain/ discomfort at inj site; chills/fever/ha  Other Relevant History:
Experienced muscle aches at thighs hours after vaccination. The started radiating to hips about 4 days later.  Pain began to increase for two weeks. Went to hospital, diagnosed with myositis (creatine was high). Following up with clinician , started physical therapy on 11/15/2022. Still experiencing mild pain and muscle weakness after standing/walking for a short time.
crying, very pale, limp taken to ER seen & sent home; improved w/in 8-10 hrs;
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration was 07-May-2021.   This case was linked to MOD-2021-365132 (Patient Link).
Severe hip and knee joint pain starting in the evening after vaccine received, fever of 102 or greater for more than 24 hours, nausea and multiple instances of vomiting, excessively swollen lymph nodes in arm where COVID vaccine administered (left armpit). All signs and symptoms treated with OTC acetaminophen, ibuprofen, and ice compresses with minimal relief 48 hours after vaccine administration. Joint pain still lingering.
Mixed dose series. Patient was given Moderna as a second dose, but should have received Pfizer.
The patient's right deltoid was red, warm and indurated in an area 3"x3 1/2". The patient did not have a fever or shortness of breath. Myalgias and arthralgias were present. The patient was treated with Medrol.
severe headache; got cold; Chills; pain in the back of his waist; swelling face (having some swelling as his face was looking puffy); This is a spontaneous report from two contactable consumers. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Feb2021 17:30 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced severe headache, got cold, had chills, pain in the back of his waist and swelling face (having some swelling as his face was looking puffy) on unspecified date in Feb2021. Therapeutic measures were taken which included taken 2 diphenhydramine hydrochloride, paracetamol (TYLENOL PM); however, symptoms were still there. If someone could alleviate the pain the patient would appreciate it as reported. Reporter stated that patient was going to go ahead now to emergency room and to seek medical attention now. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
The patient was vaccinated at 18 months of age. Subsequently, at 7 years of age, the patient developed varicella with more than 100 lesions. The patient sought unspecified medical attention. Also reported were other patients who were vaccinated and experienced similar events. Additional information has been requested.