chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (L.P.N.) concerning a 4-year-old male who on 25-AUG-2003 was vaccinated intramuscularly with a 0.5 ml dose of Varivax (lot# 643768/1063M). On 17-OCT-2006 the patient developed a rash and was seen by a physician on 18-OCT-2006. He was diagnosed with chickenpox and treated with an AVEENO bath. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
The flu shot put the patient on a breathing machine with a trach; The flu shot put the patient on a breathing machine with a trach; Initial information received on 08-Nov-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a male patient (unknown age) who was put on a breathing machine with a trach (dependence on respirator) (tracheostomy), after receiving INFLUENZA VACCINE .  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was put on a breathing machine with a trach (dependence on respirator, serious, medically significant) (tracheostomy, non serious),  (unknown latency) following the administration of INFLUENZA VACCINE.  The patient's wife said, so no thanks to the flu shot and it was funny that they were seeing advertisement for the flu shot, for the past year and a half, there was very little mention of it. And that the people were finally realizing that corona virus disease (Covid) was the flu. She stated that she will keep taking her vitamins C and D and zinc and will be fine.  It was unknown if the patient experienced any additional symptoms/events  There were no laboratory data/results available.   The patient did not received additional corrective treatment.   At time of reporting, the outcome of the events were unknown.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves a male patient who was dependence on respirator and had tracheostomy, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
The pharmacist injected my left arm with Moderna. The rubber in the syringe failed and a substantial, but unknown quantity, of the vaccine squirted out. Some of it dripped down my left arm. Because it was unclear how much made it into my shoulder and it could have been less than 50%, I got a full second shot in my right shoulder. The day after my vaccinations, I noticed scaly skin in a quarter-sized diameter around the injection site on my left shoulder. I did not experience scaly skin any where else, including with my right shoulder . Two months later, the skin around the left shoulder injection site is still scaly despite me applying lotion. It does not itch, hurt, or otherwise bother me, but because I heard we may get Covid patches I thought I'd report this in the event it's helpful.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # and dose, route unknown) "a couple of years ago" and she will receive her 2nd dose on 08-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The action taken was not provided. It was unknown that if the patient had sought medical attention. Additional information has been requested.
DOSES GIVEN TOO EARLY TOGETHER PER RECOMMENDATION DATES 1ST DOSE MAY 18,2021  2ND DOSE MAY29,2021 SON MESSENGER ME MOTHER THIS MORNING MAY30,2021 WHILE BIO AT CHURCH SYMPTOMS :'I'M SICK ,RLLY SICK, BARELY SLEPT LAST NIGHT BECAUSE WHOLE BODY HURT. "                                 "DIZZINESS WEAKNESS CAN'T STAND STRAIGHT LACK OF PERCEPTION ACHES AND SORENESS HEADACHE" PER MESSENGER FACEBOOK TO ME MOM 30,2021 9;48 AM CONVERSATION REQUESTED MEDICAL CARE AMBULANCE FOR HIM TO CALL HE SAYS JUST RESTING BIO AT CHURCH                               'PLEASE GET TO DR CAN THEY TAKE YOU" mom me                               "they are at church"
Vaccine placed in incorrect position in left arm. It was placed too high and too posterior. As soon as contents injected I experienced immediate 9 out of 10 pain and intense pain and tingling down lateral arm including 4th and fifth digit. This pain continued to worsen of over the next 7-10 days and now I have intense shoulder pain and am unable to lift my arm above my head.
really terrible with flu like symptom; This is a spontaneous report from a contactable other hcp and Consumer or other non HCP.  A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced really terrible with flu like after first vaccine so her Doctor of Medicine (MD) wanted to stop medication until after second dose to allow her body to recover. The outcome of event was unknown.  No follow-up attempts are needed. Information about Lot/Batch number cannot be obtained. No further information is expected.
c/o small hive 1/8" rt forearm which appeared & disappeared during the morning; c/o generalized intermittant itching; 3:00 noted fine rash lt arm from elbow to wrist, c/o itching; advised to contact personal MD; seen by MD given Atarax;
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. The pharmacist stated that, the patient on 23 MAY-2016 (reported as yesterday), was administered ZOSTAVAX vial (strength, dose number, lot#/expiration date, dose, frequency and route unspecified), was experiencing unspecified symptoms approximately on 23-MAY-2016 (reported as starting on an unspecified date). So that on 23-MAY-2016 (reported as today), her physician prescribed her a MEDROL dose pack and ZITHROMAX. The pharmacist did not have information as to why the physician ordered these medications. Therapy with ZOSTAVAX was not discontinued. Outcome of the event was unknown. Product quality complaint (PQC) was not involved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Breakthrough COVID-19 case with unknown symptom onset date: Shortness of breath/difficulty breathing, Cough. Hospitalized 8/28/2021-9/10/2021, SOB and low O2 stats (86%) reported, developed pneumonia. Death 9/20/2021. From Records COD= CARDIAC ARREST, COVID-19 PNEUMONIA. Per records, Other Significant Conditions include: None listed. Place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: MIDDLE MANAGEMENT, TELECOMMUNICATIONS .
ACHINESS; FLU-LIKE SYMPTOMS; FATIGUE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medical conditions and no current medication use patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced achiness.  On 24-MAY-2021, the subject experienced flu-like symptoms. On 24-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from achiness, and flu-like symptoms on 25-MAY-2021, and was recovering from fatigue. This report was non-serious.
Having hives on my arms and chest area since the shot. Have been on two different steroid packs, soon as I get off the steroids the hives come right back. I have no known allergies.
Day 1 - OK. Day 2 - difficult to move arm (right arm) swelling, hot to the touch, tender, felt chilly/feverish - took 1 TYLENOL. Day 3 - still red but feeling better.
Approximately 2 1/2 days after receiving the vaccine I became dizzy and it lasted 3 weeks.  After a couple of weeks it would subside  during the day only to return during the night and the following morning upon awakening.  The dizziness was severe in the beginning, lessening over time but was not completely gone for 3 weeks.
Swollen lymph node under arm on right side with first injection and flu type symptoms. No symptoms with second shot
Numbness on left side of face, painful teeth on left side of jaw, muscle twitching around left side of mouth, tingling in fingers of left hand, tingling (pins & needles) in toes of left foot
FELT FLUSH, SYNCOPE EPISODE WHILE SITTING IN MONITORING CHAIR, REPORTS PREVIOUS FLUSH FEELINGS WHITH NEEDLES OR AFTER GETTING BLOOD DRAWN, VS WNL , AWAKE AND ALERT IN NO DISTRESS 120/73 BP 99% O2 76 PULSE. ASSESSED BY MD, MONITORED FOR ADDITIONAL 45 MIN, BUMP NOTED TO BACK OF HEAD,  ICE PACK APPLIED,  REASSESSED AND RELEASED HOME
Severe joint pain, muscle stiffness, fever, fatigue. Fever was on and off, readings were 99-101.  Fever ended 3/11/21 at about 12:00 pm, joint and muscle pain ended 3/11/21 around 3:00 pm, fatigue is improving still. Joint and muscle pain were debilitating, peaking about a 7/10 pain scale, and movement was extremely difficult at peak.
Nov 7, 2022 - sudden stomach pains and vomiting. Sent to ER, emergency appendectomy.  Nov 27, 2022 - excruciating joint pain all over his body with concentration on thigh/groin area, Nov 29 1AM, he could not move his legs - called ambulance, brought by stretcher to ER tested for everything, diagnosed with reactive, toxic synovitis. Needed morphine, pain killers, cane to walk for several days. Still experiencing inflammation and bloodwork is not right.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
According to wife, approximately 36 hours of fever of 102.8 degrees farenheit, extreme headache, chills, and body aches.
Mother was unaware of previous brand of COVID vaccine that has been administered and did not have the child's Vaccine Card. Online database also does not print to where the staff knows that had been given prior. As an office we have now learned how to print the online database to show the different dosing to help distinguish what brand they have been given.
fever; chills; achy joints; sore muscles; slight headache in PM 10/27/2021 through about noon on 10/28/2021 rash on 10/28/2021-10/20/2021
SOB, weakness in arms and legs, trouble walking, standing, 24 hours after injection. 6pm patient called on doctor - told to give Medrol dose pac - patient gave herself Epi-injection. Took Benadryl and used her inhaler.
Patient called through ED nurse line:  Patient calling for Acute COVID-19 Vaccine Symptoms started today around 7pm. Symptoms include:confusion, difficulty breathing, disorientation, weakness, vomiting Constant Moderate . Pertinent negatives include: Afebrile. Pt. Got booster for COVID. 3rd shot of moderna, Today at 11:30 am. Symptoms started at 7pm. Pt. Is throwing up. Hands are cold as ice and he fell alseep. Pt. Breathing is shallow. He is too weak to stand and confused. Pt. Wife very concerned, "this is not normal for him." Pt. Drove home after shot and everything went to "hell in handbasket," at 7 pm.   Pertinent Medical History: COPD  Went to ED:  (9.17.21):  HISTORY OF PRESENT ILLNESS: Patient reports having his 3rd COVID vaccine shot today.  Feeling febrile, achy, slower to respond, has not drink all day, nauseated.  Wife describes him as confused and slower to respond.  ED Disposition    ED Disposition   Discharge   Upon arrival he appears to not be feeling well and is hesitant to answer questions.  After Tylenol, Toradol, Zofran he appears to be feeling better, sitting up, moving around, and joking.  Discussed that he is not actually contagious even though he has these viral symptoms.  I do recommend he keep the fever down, and that should help with the confusion.   Advised to: You are having viral symptoms as a side effect of the COVID vaccine.  Continue overlapping Tylenol and ibuprofen to keep fever down and avoid further confusion.  May overlap Tylenol 1000 mg and ibuprofen 600 mg, taking the other medicine after 3 hours so each medicine is 6 hours from its last dose.  Drink plenty of fluids, even if not feeling like it.  May take Zofran for nausea.  Return for worsening confusion, weakness to an arm or leg, high fever that will not improve, or other problems.
Patient who is a 2 m.o. comes to the office today for follow-up from an emergency room visit 1/13/21 She is well appearing today in the office.  She was seen in the emergency room after experiencing tongue swelling.  At triage she also had a temperature of 100.5.   The tongue swelling, drooling and inability to suck/feed was noticed when she woke up from her nap approximately 5 hours after her vaccines.  She did not have a rash, vomiting or other symptoms.  She may have been a bit irritable at that time.  The tongue swelling resolved by around 5 PM (7 hours after the vaccine).She had blood and urine drawn.   recovered fully in ED and  normal exam the next day.
Patient came into clinic today around 2:15pm on 07/23/2021 and informed staff that within 24 hours of receiving dose #2 Pfizer COVID-19 vaccine that she experienced Left arm pain, swelling to her left shoulder/neck area that last 2 days, a d fever times 1 day and nausea times 1 day.  Patient stated that swelling went away after 2 days.
Admin vx at 1530.  Developed itching on lips at 1535.  Pt reports this as a reaction to the surgical mask she was wearing.  Exchanged surgical mask for cloth mask.  1555-Pt reports increased itching.  BP 120/84, P 82, O2 96%.  OHN offered Benadryl per S.O.; pt declined.  1600 BP 122/83.  1605-BP 133/84 P 84 O2-96%.  Pt continues to report increased itching.  Reports "internal itching" and itching of feet.  No obvious rash visible.   Offered Benadryl, pt declined.  Offered to set up appt with Med Group to be seen now; patient declined.  OHN again encouraged pt to f/u with OH doc.  Pt seen in clinic at approx 1645.  Dr. reports admin of depomedrol and phenergan.
Patient right became weak after 15 mins of getting the shot. The right are was tender to the touch and individual couldn't lift it at all with any weight added striking pain would bounce between the elbow to the finger tip.
Adverse event: burning in arm from injection site down arm, later swelling to palm of injected arm; Exam after injection: normal aside from very mild edema at the injection site; Treatment: cool compresses and ibuprofen; Outcomes: resolved by follow up (time from injection to follow-up 5 hours) but specifically time resolved is unknown.
Patient received a third dose, first booster, of the covid bivalent vaccine on 12/1/2022 at 12:20pm. The dose the patient received was from a vial that was opened the day prior at 9:22 am and had expired as of 9:22 pm the night prior. The pharmacist called the Pfizer clinical line and spoke to a representative who advised that the efficacy of the vaccine is viable when left at room temperatures for up to 24 hours. The patient does not need another dose and is considered immunized. There are no expected negative symptoms or outcomes or necessary treatments at this time.
Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration; administered expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. The vial did not undergo any temperature excursions. No adverse events were reported by the patient. The vial was initially not stored in the refrigerator they directly thaw them from the freezer before administration. No treatment information was reported.
After given HD flu, pt was seated and started to slouch over, became pale with respiratory distress appearing to have VASAL VAGALE per MD. CODE called, then CODE/EMS called after pt became unresponsive with sternal rubs. CODE TEAM responded. Code was called at 11:18 AM. Patient was in exam room pale, slumped over after receiving a flu shot. Code and EMS called. Patient then became responsive and code was changed back to code. Patient states he did eat this morning. Placed on 3L of oxygen. Pt denies chest pain, shortness of breath, or headache. Pt was given Zofran 4 mg ODT under the tongue at 11:27 AM for nausea per Dr. Patient states he felt better at 11:29 AM. EMS arrived
I had my first shot for the vaccine and the next day I wasn't really feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I had my first shot for the vaccine and the next day I wasn't really feeling well". Clinical course: Patient had the first shot for the vaccine and the next day, wasn't really feeling well. Patient was due to get the second and was hesitating to do that. Patient was asking for advice.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N008823, expiry date: 26-MAY-2018, and M-M-R II lot # M045392, expiry date: 17-NOV-2018; dosing details were not reported, both for prophylaxis (incorrect product storage). The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Right anterior thigh induration, erythema and tenderness. Erythematous localized rash.
Right deltoid (right arm) spasm and numbness - started in the right deltoid and going to the first right finger. No limitation of motion in the right arm, nor in the fingers. No deformity.
5 days post vaccine developed a rash over face, anticubital area both arms, lower abdomin, groin and upper thighs
Fever 12 days after shot, rash 14 days after (was not sure if it was reaction to vaccine, another type of virus OR reaction to antibiotic (augmentin)
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL (lot number K016966 and expiration date 10-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.