chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HH7595), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV infection, long-term", start date: 1985 (ongoing); "bladder & Kidney cancer" (ongoing); "bladder & Kidney cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna bivalent (Dose 6, single), administration date: 26Apr2023, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna bivalent (Dose 5, single), administration date: 19Sep2022, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 4, single), administration date: 08Mar2022, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 3, single), administration date: 01Sep2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 2, single), administration date: 03Mar2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19"; moderna (Dose 1, single), administration date: 03Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Flu-like symptoms: body aches, joint and muscle pain, chills, and fever (101 degrees).
I received my second dose of the vaccine on 3/5/2021. On 3/31/2021 I started to show symptoms of COVID and tested positive on 4/2/2021. I received my positive results on 4/5/2021
12/16/09 Late morning, mom noted child shaking. Brought to office, T 102.6->105.8. MOTRIN given. Clear rhinorrhea otherwise no other symptoms. UA C&S ordered. Better 12/17 day but F to 103.3 in PM, afeb 12/18/09.
began inconsolable crying approx 3hr p/vax;no medical tx x/APAP;crying resolved w/o ER or MD visit;reports same sx p/1st DTP/HIB/OPV but did not report it until now;
This is a spontaneous report from a contactable nurse. A 3-month-old female patient started to receive PREVNAR 13 (Lot# H00672, Exp. date Mar2015) at her right thigh on 05Sep2013. There was no relevant medical history. On 05Sep2013 patient was also administered with RECOMBIVAX HB at her left thigh at 0.5 ml. It was reported that on 05Sep2013 patient had allergic reaction, irritable, fever after two hours of vaccianiton, a small raised lesion and a hard mass underneath the skin on right thigh while being on PREVNAR 13. Nurse reported that the causality of these event could be due to PREVNAR 13. There were no relevant laboratory date done in response to the event. Therapeuric measure taken for the reported events was unknown. Patient was receovering from the reported events at the time of the report. Follow-up (17OCt2013): Follow-up attempts completed. No further infromation expected.
Pneumonia; was a little bit dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C212, 037AC1B and 030A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included COPD.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (was a little bit dizzy). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and DIZZINESS (was a little bit dizzy) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Has COPD and taken medications for that. Recently she had to go to the hospital because of pneumonia.  No treatment drug was reported.  Patient felt good, but when patient had the dose, felt it, it was something like sudden. Patient felt that it was something different in her system, and was a little bit dizzy.  Company Comment - This case concerns a 63 year-old female patient with a history of chronic obstructive pulmonary disease who experienced the unexpected serious event of pneumonia. The event occurred on an unknown date relative to vaccination with first, second and booster third dose of mRNA-1273. The rechallenge was unknown as the date of the event was not provided. The medical history of chronic obstructive pulmonary disease remains a confounder for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per reporting, however there was no information in the source document supporting that the events were of a medically serious nature.; Sender's Comments: This case concerns a 63 year-old female patient with a history of chronic obstructive pulmonary disease who experienced the unexpected serious event of pneumonia. The event occurred on an unknown date relative to vaccination with first, second and booster third dose of mRNA-1273. The rechallenge was unknown as the date of the event was not provided. The medical history of chronic obstructive pulmonary disease remains a confounder for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per reporting, however there was no information in the source document supporting that the events were of a medically serious nature
Patient reported severe itching which started approximately 2 weeks ago (from 8/13/12) she said she has had a few skin eruptions which looked like pox.
Following the vax, the pt became very sleepy. She was still sleepy on the following day. Additional information received from the vaccine provider indicated that the infant also received Infanrix, Pedvaxhib, and IPV.
Soreness at injection site A few days after 2nd dose stomach cramps with diarrhea.  Two weeks after still having stomach pain and diarrhea
(R) thigh itching without rash followed by neuropathy (R) thigh pain. Presented at 3 to 4 weeks out. Started on NEURONTIN see notes neuralgia Rt outer thigh.
She was sick after two week; urinary tract infection; hives; She missed her 2nd dose which was due on 31st March; Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), ILLNESS (She was sick after two week), URINARY TRACT INFECTION (urinary tract infection), URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (She missed her 2nd dose which was due on 31st March) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm) and PRODUCT DOSE OMISSION ISSUE (She missed her 2nd dose which was due on 31st March). On an unknown date, the patient experienced ILLNESS (She was sick after two week), URINARY TRACT INFECTION (urinary tract infection) and URTICARIA (hives). At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), URINARY TRACT INFECTION (urinary tract infection), URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (She missed her 2nd dose which was due on 31st March) outcome was unknown and ILLNESS (She was sick after two week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication information not provided. Treatment medication include Antibiotics, Bactrim DS.
Immediately after vaccine patient reported an onset of numbness/tingling in left arm.  Patient had decreased sensation to deep touch.  Patient reported no issues with 1st vaccine dose.  Patient's BP was 136/68 with a pulse of 68.  Upon further discussion with patient, she described having been in a coma for approximately 6 months at age 11 or 12.  During the coma, patient suffered a stroke and has had had numbness that comes or goes in her left arm or right leg.  The numbness lasts for approximately 24-36 hours at a time.    Patient is being transported with clinical observer via shuttle to the ED for further evaluation.
Patient reported eating dinner (at restaurant), went home and began noticing swelling in lips, nose, throat and face. Her daughter is a nurse and administered BENADRYL. Patient appeared to be recovered today.
Information has been received from a physician concerning a newly hired female employee with no known allergies or pertinent medical history who on an unspecified date was vaccinated SQ with 0.5ml of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  There was no concomitant medication.  Subsequently, two weeks after vaccination the patient developed a rash on her trunk and face.  There was no fever involved.  The patient was seen in the emergency room and was admitted for 24-48 hours.  The patient was diagnosed with Viral Syndrome vs. Atypical Measles Syndrome.  It was reported that the patient recovered on an unspecified date.  There was no product quality complaint involved.  Additional information has been requested.
Started with a cough, sore throat, dizzy, all joint hurting, vomiting, cold shivering, all lasting until 2am 9/29/2013.  Headache and weakness on 9/29/2013.
Possible invalid dose/extra of the vaccine from the syringe; She felt her arm was wet after dose; A spontaneous report  was received from a consumer concerning a 24-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 18 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The patient stated that she felt her arm wet after the dose, as the pharmacist administered the dose that was extra (overfilled the syringe).  Treatment details were not reported.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events felt her arm was wet after dose/ exposure via skin contact and administered the dose said that was extra of the vaccine from the syringe and that he overfilled the syringe/ inappropriate dose of vaccine administered were considered as unknown.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact for mRNA-1273 with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050266:crosslinked for Dose 1
October, 2007 - Back and Hip pain         Winter, 2007/08 - addition of shoulder and elbow pain, ankle pain and weakness, increase in back and hip pain  - medicated with Advil/Tylenol (OTC)                                       March, 2008 - addition of tingling and numbness in arms and legs.  Shooting pains in arms and legs.  Extreme exhaustion and fatigue        June, 2008 -  Treated with Physical Therapy and Mobic/Advil.  Had MRI of Lumbar spine on 7/07/08                                         August, 2008 - extreme pain when running.  All of the earlier symptoms were still present.  Intense muscles cramps in legs and arms, especially at night.  Addition of muscle cramps in hands when writing or playing piano for a very short time (10 minutes).           September, 2008 -  All symptoms remain.  Addition of hair loss, weight loss, increase in fatigue. blurry vision.  lightheadedness, dizziness 3/19/09 records received-office visit 7/1/08-multiple complaints over sometimes, Active in gymnastics, somewhat knock-kneed. C/O left hip popping in and out with activity appears to be iliotibial band phenomena. Right knee and kneecap popping in and out with activity and some tightness in tendons in back with activity. Right elbow complaints with activity. Spot on left forearm been there a few months, looks like possible pencil lead in skin. Assessment: hip problem suspect iliotibial band. Knee problem looks like patellar malalignment. Elbow problem looks like tennis elbow phenomena. Referral to sports medicine. office visit 3/16/09- No complaints.
Left arm w/ 4 cm area of erythema, excoriated with several breaks in the skin. Area of induration noted that is 2.5cm in diameter, no fluctuance non tender to palpate. No streaking noted.
Received Flu vaccine 9/8/11 in AM. Approximately 5 hrs. later developed acute dizziness with nausea & vomiting. Sat down with head over knees & felt better. She then remembers walking to bedroom & must have passed out as she woke up on bedroom floor. Again vomited. Stayed in bed & felt better the next day.
patient was administered an expired Daptacel, with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 5 years old male patient who was administered an expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient received 0.5 ml dose (strength: standard; frequency: once) of expired suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot C5893AA and expiry: 21-Jun-2023 via intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered an expired daptacel, with no reported 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 guidelines. 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.
Localized skin rash (4cm round). Recommended ice pack/hydrocortisone cr.
Erythema, edema, pain to area surrounding site. Prescribed prednisone dose pak and cefuroxime.
Rapid heart rate, shakiness, headache,  rash, scratchy throat, raspy voice, dizziness, extreme weakness
Numbness of right arm from below shoulder to above elbow. As of this date, 11/9/17, numbness has resolved 90%.
Hospital said: Acute allergic reaction, initial encounters, allergic reaction   Anaphylaxis; swollen Vocal cords; loss of voice; bad cough; & headache   Reaction Started 20 minutes after shot; cough was about 30 minutes later;  headache started about 3 hours after shot
Patient passed out within 5 minutes of vaccine administration. Patient became alert and oriented after 2-3 minutes of being unconscious. Once patient alert, he had emesis x 1. While patient was alert, he had complaints of abdominal pain and fatigue.
7-25-17 Returned to Hospital for Day 14 injection, my final injection in my right arm (dominate arm). This injection was incredible painful, given higher up than the other injections, I felt immediate radiating pain up my neck, down my arm and into my back shoulder region. Every day after that pain became greater and greater. I lost a great deal of mobility and function in the arm.  I have to have aid dressing, preparing food and can accomplish no chores around the house such as laundry, changing bed sheets and dishes. I had to stop my daily workouts that involved weights and only use the recumbent bike. My rowing machine in not useful to me anymore.I took large quantities of Tylenol and Motrin, hoping
Nauseated, hearing deficit, pale, light-headed, dizzy. Had patient lie down for 20 minutes.
No ADR, timing ERROR, 2nd dose given 44 days after 1st Narrative: No ADR, timing ERROR, 2nd dose given 44 days after 1st
Patient received vaccine, was monitored 15 minutes and sent home. At home while doing yardwork patient began to have self-described blisters around the vaccination site that traveled down his arm, then spread across body. Patient began to have difficulty breathing and went to the emergency room where he was treated with steroids, epinephrine, and antihistamines and released.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015 the patient was treated at a health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information was requested.
Noticed pain, tenderness, and itchiness and swelling of 3 inch diameter on under part of upper arm at injection sight.  Called clinic and was advised to come in for evaluation.  Dr. diagnosed it as an infection and prescribed Keflex antibiotic 500mg, to be taken 4x a day.  He outlined the injection site and said to call the next day if the redness had spread.  It did spread and PCP was contacted via phone on Monday, March 12 about 8AM, and he prescribed Amoxicillin to be taken 2x day. Redness and itchiness began to subside by Wednesday, Mar14, but some symptoms still persist.
Developed Tinnitus in both ears shortly after the second does of Moderna. Have seen an ENT and a neurologist.
Headache within 15 mins. of receiving shot, increasing to migraine level, persisting for 3 days post-shot. Light-headed, dizzy for 20 mins. after receiving shot. Nausea/diarrhea persisting 2 days post-shot. Vomitted first morning after receiving shot. Arm and shoulder pain. Pain spreads left side shoulder, back of neck, head,  left ear, remains 4 days post-shot. Extreme, dibilitating lathargy for 6 days post-shot. Did not seek medical attention. Was not experiencing anaphylaxis symptoms and had experienced similar symptoms after the 1st shot. 7 days post-shot, symptoms have passed. (Ref.  VAERS report #616408)
Received 1st dose of COVID vaccine while pregnant on 3/19/21. Subsequently had an uncomplicated vaginal delivery on 3/30/21. Received 2nd dose of COVID vaccine while postpartum on 4/2/21. After receipt of 2nd dose, started to feel unwell, ultimately spiking a fever and clinically worsening on 4/7/21. Presented to the hospital on 4/9/21 with fevers and pelvic pain. Was found to have MSSA bacteremia secondary to left septic pelvic thrombophlebitis.  Required broad spectrum antibiotics with a plan for 4 week IV cefazolin as outpatient, as well as therapeutic anticoagulation with lovenox with a plan for a 3mo outpatient course.
Experienced chills and fatigue 24 hours post vaccine which lasted for 20 hours.  50 hours post vaccine, experienced nausea, and vomiting which caused dehydration lasting for six hours.
I started to give injection and realized I did not get the air out of the prefilled syringe. I stopped and pulled it back out. But I had injected a little bit of it. The area was a little puffy and dark. I took later to see Dr's nurse and she said it was okay to just use some ice on it today.
became totally disoriented; was unaware of verbal & physical activity; vision was also disoriented;
Information has been received from a registered nurse concerning an 18 year old female, with environmental allergies and no pertinent medical history, who on 23-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine and on 16-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (Lot No. 660557/0072X). There was no concomitant medication. On 17-JUL-2008, the patient developed right and sometimes left leg pain and fever. She also had soreness and bruising at the injection site and some tingling of her hands. She had a sore throat when vaccinated. She has been prescribed ADVIL and will see her primary physician. At the time of the reporting the patient has not recovered. The patient sought medical attention, phone call. Additional information has been requested. Follow-up information was received from the registered nurse. The patient experienced joint pain and stiffness on 17-JUL-2008. Patient did have sore throat before injection. Patient was taking TYLENOL and ws given anti-inflammatory. The patient saw primary care physician. At the time of the reprting the patient had recovered. No additional information is expected. 9/26/08 Reviewed OB/GYN medical records of 5/23-8/11/08. FINAL DX: none provided Records reveal patient in good health on 5/23/08, day of HPV #1, Lot 1968U.  Received HPV #2, Lot 0072X on 7/16/08 & had sore throat prior to vax.  Experienced joint pain & stiffness, fever x 4 days.  Seen by PCP 7/18 & dx w/tonsillitis.  Had sore throat x 1 wk.  Joint pain & stiffness resolved.
Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced injection site hard red welt. At 4 years of age, the patient received a dose on 16-Aug-2010. It was reported that the child had completed her PREVNAR 7 history by the age of 2 years and fell within the window of needing a booster shot. On 16-Aug-2010 after receiving PREVNAR 13, some redness was noted when the patient's Band-Aid was removed. The next day a hard, red welt bigger than 1 inch but smaller than 2 inches was noticed at the injection site. The event was called into the pediatrician's office: they reported that the welt was normal and a cold pack could be applied to the area. The outcome of the event was not specified.
States after receiving vaccine (L) arm "felt like it was on fire" as walked to car; approximately 30 minutes later noticed (L) arm was red and felt knot near/at injection site. States started taking BENADRYL, by mouth, 3/7/14. By 3/8/14 - A.M. - states had swelling, heat, redness from (L) armpit to below elbow. States 3/8/14 saw MD "who I used to work for" - was told was allergic reaction. 3/11/14 - seen at DOH - has oval red, warm, swollen area on back of (L) upper arm - approximately 8 cm x approximately 6 cm.
Swollen lymph node under left arm  Advised to continue ibuprofen, acetaminophen, and ice/warm compress