chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after injection I developed a sudden intense itching including dermatographia where any contact to my skin immediately developed redness that I could practically write my name on my skin  causing it to flare up. The itch occurs anywhere and anytime on my body and it's throughout the day it is unbearable. My skin turns red for no reason.  My skin even turns red with contact with water. I get small raised bumps as well.  This reaction has been ongoing since November 16 with no permanent resolution.
The patient complains that she received her second moderna shot on Monday (4/20) and a few hours after this began to feel very sick. She said became very weak and fell twice that afternoon and was in bed the rest of the day and all day Tuesday and Wednesday before deciding she needed medical attention in the ER. She also complains of abdominal pain, headache, nausea, vomiting, unable to keep anything, weakness, difficulty walking, and itching on the bottom of her feet. She believes this is related to her vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N029628, expiry date 23-NOV-2018) (dosing details unknown) for prophylaxis. The vaccine was reconstituted with sterile diluent stored at room temperature. No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour 33 minutes. Previous temperature excursion included temperature exposure to 6 degree Fahrenheit to 14 degree Fahrenheit for 42 hours 48 minutes and 15 degree Fahrenheit to 46 degree Fahrenheit for 39 hours 57 minutes. A digital data logger was involved. No product quality complaint was filed.
Speech. Abnormal stuttering.  Follow up:  Change to non-serious, disregard report-parents don't want to pursue; normal boy.
Dizziness; Interfered with daily activities/work; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0198) intramuscularly on 15Jul2021 at 15:00 (at the age of 28-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were reported as none (no other medications received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0217) intramuscularly on 21Jun2021 at 15:00 (at the age of 28-years-old) as a single dose in the left arm for COVID-19 immunization. On 17Jul2021 at 15:00 the patient experienced dizziness and interfered with daily activities/work. The reporter assessed the events as non-serious. It was reported that a mild case of dizziness occurred 2 days after the first vaccination date and it resolved after about one day (AER: 202101007616). A second case of dizziness started 2 days after the second dose and had not resolved yet. The dizziness was constant and was moderate to severe and interfered with daily activities/work. The events resulted in emergency room/department or urgent care visit. Treatment was not received for the adverse events. The patient underwent lab tests that included: BinaxNOW COVID-19 test (nasal swab) on 26Jul2021 which was negative and a rapid test for COVID-19 which was negative on 28Jul2021. The clinical outcomes of the events dizziness and interfered with daily activities/work were both not recovered/ not resolved. Since the vaccination, the patient had been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the event of dizziness and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Experienced back pains, suspected to be kidney pains, left side pain. Generally felt sick and could not move.
Case previously recorded as MA2009-5157. Initial case report received from a physician via MedCom, on 19 NOV 2009. A patient 1-year-old male was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m. on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Tinnitis Narrative:  The patient developed ringing in both ears after the first dose of the vaccine. He described it as a nuisance and it goes away at night.
Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Pt felt a very sharp pain under armpit (same arm as injection) after Dose 2. Armpit lymph nodes swelled to the size of a softball about 26 hours after vaccination. This caused pt extreme pain. It took about 4-5 days for the swelling to go down and the pain to go away.  On 1/11 pt contacted her PCP asking for somehting for the pain, stating she had tried APAP and ibuprofen without relief. Pt prescribed APAP-hydrocodone 5-325 mg tab PO Q4h PRN (#10 tabs).
10/28 client stated few hours after shot had fever, redness, tenderness and emesis. Client called clinic with c/o redness and swelling, spoke with RN, advised a compress. 10/29 client called clinic at 4:27 c/o right arm red, swollen, and tender to touch, advised client to come in. Client arrived at 4:45 with a right arm tender to touch, redness below deltoid to anteriorbital, T 99.6, advise to go to ER
Initial injection severe bleeding, difficult to stop and bruising for six weeks.  In addition, intermittent muscle ache/pain - severe enough to wake me up from sleep
Asymptomatic breakthrough COVID-19 case. Death 5/22/2021. From Records cod = ALZHEIMER'S DEMENTIA, COVID 19, HYPERLIPIDEMIA, PULMONARY HYPERTENSION. Other patient details: pt has dementia, adult failure to thrive . glaucoma, and sepsis. place of death: HOSPITAL-EMERGENCY ROOM/OUTPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: PLAYGROUND DIRECTOR-BOARD OF ELECTIONS
Arm is a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR118362   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingles vaccine. The patient experienced sore arm. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR118362. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118362:Second dose case/Same reporter
DID NOT GET ALLERGY FROM ANIMAL DANDER AND FAT PUMP DECREASED BY HALF; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included allergy to animal hair, and fiberglass allergy, and concurrent conditions included hypertension, abstains from alcohol, non smoker, and huge fat pump on left arm, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1818609) dose was not reported, administered on 15-MAR-2021 14:00 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, hydrochlorothiazide for hypertension, lisinopril for hypertension, and metformin for hypertension. On 2021, the subject experienced did not get allergy from animal dander and fat pump decreased by half. The action taken with covid-19 vaccine  was not applicable. The outcome of did not get allergy from animal dander and fat pump decreased by half was not reported. This report was non-serious..
Patient received 2nd dose of HPV vaccine on 3/26/2018, on 3/30/18 she presented to a walk in clinic with trouble breathing and welts on entire body. Was given BENADRYL and now still has some red areas from where patient had scratched.
On 02-Feb-2000, the patient received his first injection with Lymerix 30 mg for prophylaxis. Sometime thereafter, he experienced a swollen knee which he was unable to bend or use for one week. The second dose of Lymerix was not given. The information on 07-Apr-2000 reported the symptoms resolved.
Swelling and itchiness near injection site lasted 3-4 days. Itchy rash on both feet began around day 8 (after vaccine) and lasted until day 12. Rash started on my ankles along the heel and then spread to the lower outside part of both feet.
Pain in Shoulder at injection site, pain radiating up into the neck and down toward elbow and length of arm, loss of motion and strength.
Administration Error--undiluted vaccine administered. Patient received one undiluted dose of Phizer-BioNTech vaccine (0.2 mL).  Provider who administered dose did not add the 1.3 mL dilutent to the vial.  Therefore, the administered dose was incorrect.  The error was noted 4 hours later.  At the time of administration and prior to leaving clinic, patient was asymptomatic.
pts mother called w/ complaints of hive like rash on 12mth old 3 days after receiving vaccines along with fever and fussiness. later that day pt had left knee swelling with difficulty walking.
states firs devel facial rash then a chronic optic neuritis w/permanent damage to rt eye;states pt is blind in rt eye;pt contacted reporter with this information 23FEB99 stating had never made the connection before;
Right after Thanksgiving I started having a lot of nasal congestion, it kept getting worse, it went to my chest. I went to Urgent Care where they tested me for COVID-19 and Influenza, both tests came back negative. I was given antibiotic to help clear up the head congestion. I toll the medication, but I had to back to an Urgent Care while I was out of town as the congestion had moved into my lungs. They tested me for COVID-19, the test came back negative. I was given more antibiotics; I know I had bronchitis by the way I was coughing.
Several days after my first dose a broke out in hives/rash all over my arms legs and body. I have intense uncontrollable itching and skin is burning and painful. I feel hot (flushed), achy and unwell. This has disrupted my daily activities and interfered with sleep   I went to my regular doctor first and was started on prednisone.  I went back 2 days later because I didn?t see an improvement.  They gave a medrol dose pack of steroids. Later that night it continued to get worse so I went into the ER.  Was treated there with solumedrol, and benedryl by IV.  Left that night but returned again to the ER the next day because of unbearable pain in stomach and violent throwing up that wouldn?t stop.  They treated me with pain medication, solumedrol, benedryl and epinephrine. On March 24th I was able to see the allergist Dr and he treated me with 2 antihistamines  and steroid.   3 days later I was worse so he saw me again and gave me injection of dexamethazone steroid shot.  That helped me get through the weekend. So by the next week he dropped to taking 6mg if dexamethazone and continuing this whole time with the antihistamine regimens he prescribed.  Dr has diagnosed me with a ?type IV delayed allergic reaction?. Unfortunately these take weeks or even a couple months to resolve.  It calms and flares again repeatedly.
HAD INCREASE IN HEART RATE/BLOOD PRESSURE BEGINNING 5-10 MINUTES AFTER RECEIVING THE VACCINE.
Pain and achiness at injection site and upper arm. Decreased range of motion. Decreased strength for pushing, pulling and lifting.
Patient went to hospital blood pressure was 200/173, severe headache, arm swelled up, and warm to touch.
c/o Blurred vision, chest discomfort and very anxious. B/P 184/98 at 12:49. OJ given and pt. stated did not take B/P meds. as prescribed this a.m. Took B/P over, while resting in clinic, 1:05pm. B/P 164/86.
fever of @ least 105 lasting 36hrs w/onset 2 hrs p/receiving vax; pt would not move or use legs for-20 hrs p/vax; then gradually regained nl use of legs over the next 1 1/2 days;
Approx 5pm on 7/27/2018 had self reported funny heart rhythm. On 8/1/2018 pt went to emergency room (traveling) where they did EKG which was normal (he thinks?) (he is getting records transferred). Pt saw Dr. on 8/16/2018 to follow-up. Per pt MD didn't find anything abnormal. Per pt he also on Tuesday night 7/31/2018 had experienced total vision loss in left eye for approximately 10 minutes.
pain; dry heaving; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting). On 08-Feb-2021, PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided. The patient wanted to confirm if her scheduled steroid shot in the following days would interfere with the second dose of her vaccine or not.  Follow-up information on 03-May-2021 included: The patient believed that her symptoms that she was experiencing after her first vaccination were actually caused by extreme back pain due to a herniated disc that happened later on the same day of her injection. She agreed with that, did not have any adverse effects after her second vaccination (details not provided), and therefore did not feel she had any adverse reaction to either vaccination.
Temp Excursion - Yes; Temp Excursion - Yes; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (Temp Excursion - Yes) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion - Yes).    No concomitant medications were reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.   No treatment information was reported.
I was diagnosed with a mild case of covid-19  in October 2020. The day after my first vaccine I experienced side effects from  the vaccine (nausea, slight fever,  body aches) that were almost as severe as when I  had covid. These  symptoms are still present 5 days  after the  vaccine.
This spontaneous report as received from the certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. On 26-NOV-2014 improperly stored LIQUID PEDVAXHIB (lot # K002746, dose, frequency and expiration date not reported) was administered to the patient. No adverse events were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
TINGLING ALL OVER; WEIRD FEELING LIKE NUMBNESS; JERKY LEGS; FEET FEELING LIKE  CRAMPING UP WITH CHARLIE HORSE; WEIRD FEELING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 113 pounds, and height was not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced weird feeling in hands and feet. On 12-APR-2021, the subject experienced not quite pins and needles. On 12-APR-2021, the subject experienced tingling all over. On 12-APR-2021, the subject experienced weird feeling like numbness. On 12-APR-2021, the subject experienced jerky legs. On 12-APR-2021, the subject experienced feet feeling like cramping up with charlie horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling all over, weird feeling like numbness, jerky legs, feet feeling like cramping up with charlie horse, weird feeling in hands and feet, and not quite pins and needles. This report was non-serious. This case, from the same reporter.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Pt recvd vax 3JUN92 & approx 9JUN92 pt devel diarrhea w/flu-like sx & dizziness; sx persisted for 1 day; no further details were provided;
Presents to ED c/o cough/SOB/diarrhea; had been dx'd with COVID 2 days prior to arrival; req BiPAP, unable to give Remdesivir d/t low creatinine clearance d/t nephrectomy, on Rocephin & Zithromax, Dexamethasone, Baricitinib for COVID pneumonia.  Continued to worsen, req intubation, dialysis, family withdrew care and expired.
HOSPITALIZATION WITH COVID-19 BREAKTHROUGH CASE 1/5/22 - ongoing
Was given the vaccine subcutaneous in underside of left upper arm - supposed to be given IM in deltoid - vesicle formation, severe pain, warmth, swelling and erythema from axilla to elbow - Pain scale- immobile- 6/10 with mobility 10/10.
approximately 2:35pm after the first dose of Covid-19 Pfizer was given, patient's face became red and splotchy.  Lip felt numb/tingling.  Not itchy and no breathing issues.  Gave Benadryl 50mg and the reaction subsided.