chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11-16-2009 I got a shot for 2009 H1N1. After shot I went to class and I have reaction. I feel like difficult to breath and I ran back to Health care at my school. I was very scared for myself.
pt recvd vax;2 days later lt leg was weak & drags leg when walking;tremors visible to leg as pt try to walk;mom states pt could not walk at all for 2 days following vax;referred to MD for evaluation;due to erythema & inflammation at site;
48 yo female who presented today for her first dose of the Moderna vaccine. Vaccine was administered at 1400 in the left deltoid. Patient was directed to go to the observation area for a 15 minute observation period after administration of her Moderna vaccine. While walking, patient was assisted to the floor by two volunteers, amid a suspected seizure. Arriving on scene, patient was unconscious and having a tonic-clonic seizure that lasted 20 seconds. EMT's were on scene placing an 18g PIV in the right forearm, collecting a BG, and had placing the patient on the monitor. Patient was placed on a NRB mask at 15 L of O2. Patient again fell unconscious and had a second tonic-clonic seizure that lasted 20 seconds.    Patient regained consciousness and requested that provider unlock cell phone to collect patient medication list and husband's information. Husband was contacted and requested to enter to be by her side. Husband reported a history of seizures (tonic clonic) and current treatment/management. He requested that patient not to be taken to the ER. Provider advised husband and patient that the paramedics would determine the necessity of her transfer to the ER.    Ambulance was notified and Fire reported to the patient's side by 1435. Upon arrival, husband and patient requested not to be transferred to the ER. While answering questions, patient again was assisted to the floor and sustained a third tonic-clonic seizure lasting approximately 20 seconds. Provider aided paramedics in transferring patient to the gurney. Patient was transferred to hospital with husband and all personal belongings.
experiencing itching but not that bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experiencing itching but not that bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (experiencing itching but not that bad). At the time of the report, PRURITUS (experiencing itching but not that bad) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (clinical history of HIV and were under treatment for this illness.). Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and DOLUTEGRAVIR SODIUM (TIVICAY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took primary series of vaccination on 09-March-2021 and 06-April-2021. No treatment information was reported by the reporter.
Patient called in on 10/16 and stated that she had received both the flu shot and Tdap yesterday at her appointment and last night her face was red and hot. States this morning it was red, hot, with a rash on both side of her face that was very itchy. Patient recommended to take BENADRYL as directed on box until rash went away. Recommended to go to ER if she started to have trouble breathing. Patient is G1P0, 29 weeks gestation with EDD 12/27/18.
Left shoulder pain with injection. Pain with horizontal movement of arm shortly after injection. PCP tx with Prednisone 10/2013. 1/13/14 Tx with CELEBREX. Recommend PT.
Swollen, warm, pink area at injection site sore pain /10 on 10/10 scale treat with TYLENOL orally; use cool to warm compresses next few days.
Diarrhea with low grade fever.  Treated with pepto-bismol and acetaminophen.
DOSE GIVEN TOO EARLY. PT CAME IN SAYING IT WAS FOR HIS SECOND DOSE BUT HE HAD ALREADY COMPLETED A DOSE OF PFIZER? OUR SYSTEM WAS UNABLE TO CATCH THE PREVIOUS COMPLETED PFIZER VACCINE SERIES
Highest temp 104.8; Generalized lymphadenopathy, arthralgia, splenomegaly duration 7 days;
Today I noticed and felt a large, swollen rash on my left arm at injection site. It is warm to the touch. I got the injection on 17-Feb.  Before the rash, I also started having a mild, nagging cough about 1 week ago.
This is a spontaneous report from a non contactable consumer. This adult female consumer reported to Pfizer Internal Colleague that she received a dose of PREVNAR 13 in her arm on an unknown date. On an unknown date, after vaccination, she experienced soreness in her arm at the site of injection. At the time of the report the clinical outcome of the above mentioned event was unknown.
Local pain, redness and swelling at injection site progressed to a cellulitis diagnosed by pediatrician.
presents today with shortness of breath at the context of being on day five of COVID-19 infection
Menactra was given to a patient instead of Meningitis B with no reported adverse event; Initial information received on 28-Jun-2021 regarding an unsolicited valid non-serious case from other health professional via Medical Information (Reference number- 00659311).  This case involves a 15 year old female patient who received 0.5ml dose (dose 3) of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6920AA; expiry date: 15-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination instead of MENINGOCOCCAL VACCINE B (lot number and expiry date: not reported) on 28-JUN-2021 (wrong product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s), and family history were not provided.  It was an actual medication error due to wrong vaccine administered (same day).  It was not reported that the patient experienced any adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Systemic: Tingling (specify: facial area, extremities)-Mild, Additional Details: Had metallic taste in mouth and lips/tongue and arm had a tingling sensation and mild numbness. Patient was given 2 Benadryl and waiting abut 30 minutes with no worsening of symptoms
24hr p/vax pt left work w/temp 101, cold shakes, swelling in arm lt & soreness;mom gave APAP father who is MD looked @ arm said it looked like a mild rxn to mild;mom reports more swelling @ site, no redness, no fever
DISCHARGE DIAGNOSES: COVID-19 UTI community-acquired pneumonia   HOSPITAL COURSE: 85 y.o. female with history as outlined below as well as pertinent history of arthritis, gait instability (at baseline uses a walker for ambulation) who presents with complaints of weakness.  She was found to have COVID-19, UTI and community acquired pneumonia.  She was monitored under observation service and was seen by PT.  She was started on antibiotics for pneumonia with ceftriaxone and doxycycline.  Her UA also was suggestive of UTI, although she does not have overt urinary symptoms at all.  She denied any dysuria, urgency or frequency above her baseline.  Urine culture at this time is pending.  Nevertheless, antibiotics for pneumonia should cover as well.  Suspect she was also mildly dehydrated from poor appetite and poor oral intake and she was given IV fluids with improvement in her renal function.  Once hydrated, she felt better the following day and was cleared by PT to be discharged with home PT.   On day of DC, patient was seen and examined at the bedside.  She is reporting to be feeling better today.  Denies any abdominal pain, nausea or vomiting.  No diarrhea today.  She feels her breathing is back to her normal baseline.  Denies any dyspnea, chest pains or palpitations.  Her INR is slightly supratherapeutic at 3.4, but has no bleeding issues.  Recommended to hold Coumadin today and to resume Coumadin at 3 mg daily with close outpatient follow-up.  Spoke with her son, in agreement with current plan.
Patient recieved her first dose of Moderna. Within 10 minutes she was feeling dizzy and lightheaded. I lowered her to the floor and lifted her feet above her head.  An ice pack was applied to the back of her neck.  She started complaining  that her throat was closing up so an epi pen was administered and 911 called.  The epi pen was a temporary fix but her throat started closing up worse than before.  I administered a 2nd epipen.  Patient was violantly shivering. A  3rd epipen was administered with no relief.  At this time the paramedics arrived and she was transported to the hospital.
4/4/13 Pt awakened with c/o itchy. sl painful, red, swollen, warm to touch inj.site (L) tricep) 1 d after VARIVAX administered on 4/1/13. Treated with BENADRYL spray 1-2 x/day; No fever/ 3/4/13: Erythema 3.5" long x 3" wide; induration 1 1/2"; circumf: 3 1/2" sl pallor, decreased itching, no pain, no fever local reaction improving.
Red, hot, swelling, bumps at injection site. 10/07/10 - ER, steroid IV & steroid pkg to take at home. 10/10/10 - ER, steroid IV. Hives all over body & throat why I went to ER (twice).
Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of shortness of breath, chest pain, and weakness. Had some burning in the left, upper chest. Vital signs were stable throughout episode. EMS onsite. Baseline EKG normal. Patient requested transport to ED. Transported via EMS.
Patient was hospitalized with COVID19 Pneumonia. He is currently still admitted in our ICU.
Typical soreness at injection site.  Approx 1 hours later rash appeared at injection site and arm. By evening it spread and worsened.  By next day the hives were all over upper body (arms, chest, back, stomach). On Sunday called doctor's office told to take Benadryl and come in morning.  Treatment from Primary Care Physician on Monday was prescription for Methylprednisolone tablets.
Received vaccines on 9-25-14. Hives and wheezing started on 9-26-14. Pt to ER on 9-27-14. 9-30-14 follow-up visit PCP. 9-27-14 meds received at ER visit: Albuterol 2.5 mg. (inhalation), SOLU-MEDROL 125 mg. IV, BENADRYL 12.5 mg. IV, PEPCID 20 mg. IVPB, Hydroxyzine HCl 1 tablet Q 6 hrs., Prednisone 2 tablets once daily.
Patient was hospitalized with COVID, diagnosed on 7/18/2021; currently in our ICU; AKI, possible bacteremia
8-19-12 - soreness, redness, heat & swelling at site. "Hearing sounds like underwater". 8-20-12 - redness at site resolved into raised bumps soreness decreased. No SOB no fever.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the vaccine MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012481 and 1405USA004216). Additional information has been requested.
Patient fainted on bathroom floor at 10:30am, his head hitting the floor. He then regained consciousness, and has since been resting in bed.
About two and a half hours after receiving second dose of vaccine became overwhelmed with fatigue and the beginning of headache, needing to be assessed by facility doctor prior to being released to the care of his father to bring him to be seen by his primary care doctor. Vital signs: BP 150/100, P110, O2 99%, BG 85. After first dose-had rash on arm and arm pain
Rash, fever 102 x3 days, rash started on face started 10/23 macular papular rash to face then spread to trunk and extremities. Vaccines on 10/13/2006.
Pt reported a day's worth of fatigue, large swelling, bruising on the site of administration.
I took the second Pfizer COVID19 vaccination on 4/2/2021 (Friday). On Sunday evening, I started feeling ringing in my left ear. I thought I was too tired, just went to sleep.  From Monday (4/5/2021) morning, I felt frequently ringing in my left ear.  Now (4/7/2021), when I talk to people or watch TV, I hear lots of echoes from my left ear. I also felt ringing inside of my left ear even no sounds outside.
evening of 22JAN96 pt exp fever 102-104.8 & persisted until AM 24JAN95;temp relieved w/APAP or children's Motrin;no vomiting follow up visit in ofc;24JAN96 temp 99R,runny nose active;no redness @ inj
Mylene received a positive COVID test result  (3/12/21), after completing her vaccination series on 1/26/21. Her husband first became symptomatic over the previous weekend and tested positive on 3/8/21. Then followed by her son, testing  positive 3/9/21 (symptomatic), with the other son testing positive on 3/10/21 (also symptomatic).  Her husband and 2 sons both had ONE dose of the COVID vaccine and were due for their boosters soon (not at our clinic).  By Wednesday night (3/10/21) Mylene became symptomatic, reporting coughing, muscle pain/ body aches, fatigue, sore throat and congestion, tested 3/11/21 and received her results 3/12/21 morning.
Fainting, convulsions. Put child's feet up, gave water, blood pressure normal.
Eyes were blurred, Leg pains and tingling. Tingling in the fingers. Back pain, stomach ache, chest pain and hard time breathing, fatigue. Dizziness, muscle spasms, senitivity to light. Broke out in a mass of bumps on chest, back, stomach, underarms.
tired; muscle pain; headache; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache). On 15-Mar-2021, FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient got tired, muscle pain, and headache 1 hour right after that and it lasted for 3 hours.
I RECEIVED A CALL FROM ASSISTED LIVING FACILITY DIRECTOR OF NURSING THIS MORNING THAT DR. PASSED AWAY LAST NIGHT AROUND 8PM.  SHE WANTED TO LET US KNOW SINCE HE HAD HIS VACCINE FOR RSV YESTERDAY  BETWEEN 3 AND 330 PM.  NO ONE KNOWS IF THAT WAS INVOLVED, BUT WE WANTED TO REPORT .
CDC reports: 6 mo infant developed fever to 104, local rxn & cried for 45 min. following immun. Duration of illness 15 days.
c/o dizziness, egg-size bump on upper arm,  throat itching  -- 1 Benadryl 25 mg given PO and ice pack applied to area
After last vaccines on 1/12/2023 the next day he woke up with a swollen face. He had received Dtap-IPV,  MMRV, flu, and covid#1 on that day. He had a swollen face, slowly decreased through the day. No trouble breathing, no lip/tongue swelling, no wheezing, no vomiting. Normal oral intake and energy that day. Slowly resolved over the day. No hives. No fever. No other symptoms.  Since he did not have symptoms of anaphylaxis and I am unsure which vaccine caused the facial swelling or if it was from something unrelated to the vaccines, I believe it is okay to go ahead with his second covid vaccine today. Mom is in agreement, and will let us know if he experiences any adverse reactions. I will ask the nurses to report his reaction to the last set of vaccines.
no adverse event; VARIVAX was administered after experiencing temperature excursion; This spontaneous report as received from a medical assistant refers to a 12 month old patient. On 19-OCT-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032932 exp date 28-SEP-2022) (dose and route not reported) after experiencing temperature excursion. The temperature of excursion was 6°F to 14°F (8.5F) for 0 hours 18 minutes 0 seconds; 6°F to 14 °F (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe was 1 hour and 18 minutes. There was no previous temperature excursion.
Right after giving Flu vac, she bled quite a lot, and a 1/2 dollar size welt came up. No other adverse reaction occurred. Patient went to ER. MD said I hit a small vein and that vac could still be effective per patient. Patient was fine!
Pt passed out after receiving flu shot. It did bleed a bit. Patient seemed to seize once, but then was layed down. She awoke and was coherent.
My husband first noticed welts on my neck. I started itching on my thighs, neck, face, arms, and back. My skin broke out in hives. I was really itchy. I had to take OTC allergy medicine called Allegra D. I had to take it daily at that time. Anytime I would scratch I would get a welt. My skin would get really red and raise up. I had to take Allegra D daily for almost several months. Many years ago I went through a period where I would get hives for a few months, and then they would go away. This is the first time, in a long time, that I had the hives come back. I have to take Allegra D with me everywhere I go. When I caught COVID in November 2021 I had a cold and congestion. It took 10 days to clear up. I had lost my taste and smell. I could only taste salt. I slept a lot. I had post nasal drip and coughing.  I am getting my sense of smell back now.
Information has been received from a nurse practitioner concerning a 63 year old female who on 19-JAN-2007 was vaccinated with a dose of Zostavax (lot # 654603/1405F). There was no concomitant medication. On 21-JAN-2007 the patient developed arm soreness and cold like symptoms. Medical attention was sought. The patient was treated with lidocaine cream for her sore arm. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007: 6/22/2007. Information has been received from a 63 year old female consumer with a compromised immune system, fibromyalgia, asthma, allergies to codeine, vicodin, iron, keflex, pamelor, all anti-inflammatory medicines, all anti-depressant medicines, all anti-seizure medicines and levaquin and chilli pepper allergy who on 19-JAN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 652966/0722P). Concomitant therapy included SYNTHROID, LIPITOR, Ateolol (manufacturer unknown) and omeprazole (MSD). "Two days later," on 21-JAN-2007 the patient developed swollen lymph nodes in her neck, knots "all up and down" her arm (also reported as 3 knots on her arm above the injection site), a large red rash on the injection arm, pain all over her body, a sore stiff neck, a burning sensation inside her nose, and her chest teele itchy in the respiratory area. The patient reported that she also experienced a cough that she developed 48-72 hours after vaccination. It was reported that the side effects have gotten increasingly worse. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Follow-up information from the patient's primary physician stated that his office did not administer the vaccine and did not have any additional information. Additional information was received from the consumer who reported that the lot number previously provided was incorrect. The correct ZOSTAVAX (Merck) lot number is 654003/1405F. The consumer also reported that she has not had any improvement. The pain in her neck and shoulders was worse and it triggered and episode of fibromyalgia. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: PT HAD VASOVAGAL REACTION AFTER RECIEVING COVID IM VACCINE
9:20am vaccine 3:30pm Severe chills & nausea. 4:00pm - 9pm Body Aches, fatigue, HEADACHE & Fever 103.1 03/15/2021  7:00am Fever & nausea has subsided but severe headache remains.
Pt reported experiencing extreme pain.   She cannot lift her arm after being adminstered the vaccine.