chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it was an infection because she scratched her arm.; Arm swollen, 2 and a half inches; Itching on the arm; Red swelling lump 2 1/2 inches by 3 inches/ Redness; Red swelling lump 2 1/2 inches by 3 inches; Sore arm/ Itching on arm and it hurt; Tired; 99° F fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), MASS (Red swelling lump 2 1/2 inches by 3 inches), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet count high since 2010. Concomitant products included HYDROXYUREA for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), FATIGUE (Tired) and PYREXIA (99° F fever). On 28-Jan-2021, the patient experienced MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness). On 29-Jan-2021, the patient experienced PRURITUS (Itching on the arm) and PERIPHERAL SWELLING (Arm swollen, 2 and a half inches). On 03-Feb-2021, the patient experienced INFECTION (it was an infection because she scratched her arm.). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. On 18-Feb-2021, MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.), PERIPHERAL SWELLING (Arm swollen, 2 and a half inches), FATIGUE (Tired) and PYREXIA (99° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 99 (Inconclusive) 99°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also include sulfa antibiotics for 9 days   This case was linked to MOD-2021-089948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow up was received on 24-Apr-2021 and consumer additional details were reported
Pt. complained of numbness/tingling to Right Arm.  Diagnosed by physician with Brachial Plexis.
No vaccine related ADR reported Narrative: A 76yo male with history of HTN, DM, BPH, HLD, Orthostatic Hypotension, Neuroendocrine Tumor of Liver consistent w/ small Cell Carcinoma and Biliary obstruction per ED admission history, he had percutaneous Cholecystectomy and stent placement on December 30, 2020 and subsequent necrotizing fasciitis of R. chest / flank around tube s/p debridement and biliary stent placement received Pfizer's Covid-19 vaccine on February 6, 2021 He presented to ED on February 24, 2021 with complaint of weakness and back pain. ED documents included the patient denied Fever, N/V/D, Constipation or SOB. The patient's wife was there to five additional history and reported "he has had decreased appetite for the last month and increased weakness for the last few days" He was admitted with CT finding concerning for multiple liver abscess. He was started on zosyn and vancomycin for sepsis pending blood and liver abscess cultures. Vanco was discontinued on Feb 25. Blood culture result on February 26, confirmed presence of gm- ve Rods. He had R. liver robe aspiration on Feb 27 On Feb 28, he complained of uppder quadrant abdominal pain, also had low appetite. He was placed on isolation which was confirmed from the liver abscess/aspiration culture He had pending resolution of sepsis for staging his cancer and starting palliative chemotherapy. Developed AKI while undergoing treatment, had biliary obstruction and cholecystectomy, developed new neurological symptoms, ascites and had malignancy with multiple organ dysfunction leading to poor prognosis. Per nursing immunization note on February 6, 2021, the day he received Covid-19 vaccine, it was administered without complications, per policy and protocol. Also the patient was provided with information regarding side effect of the vaccine how to report ADR and advised to stay in the facility for 15 minutes after the vaccine was administered There were no vaccine ADRs reported in the notes The patient was status biliary stent on March 4, 2021 in palliative care and passed away on March 8, 2021.
Patient  received their first Pfizer Covid vaccine  in the left arm and she reported numbness in her face and left side. Patient was advised to go into urgent care or the ER.
I developed a rash over my whole body on 1-21-21, it lasted for 3 weeks. I then developed incontrollable facial movements in late March 2021. I have since been diagnosed with tardive dyskinesia 4-9-21. I followed up with Neurologist who confirmed the diagnosis, however I do not have the history of the medications that cause this disorder. Not sure if it is from the vaccine.
11/12/2021: 3:30 PM:  severe inner ear pain, pain radiating into neck approx 5:00 PM: visited urgent care; diagnosed with ear infection; prescribed amoxycillin 11/13/2021: Morning: awoke with paralysis to left side of face; went to emergency room, diagnosed with Bell's Palsy; prescribed Prednisone 20mg/ 3x daily for 7 days and Valtrex 1G, 3x/day for 10 days; adiviseds to stop Amoxycillin as there was no ear infection present 11/15/2021: Experienced severe pain in left eye; went to ophthalmologist; diagnosed with 5 corneal abrasions on left eye due to inability to close eye because of Bell's Palsy; prescribed Ofloxacin Ophhalmic Solution 0.3%.       11/15/2021:  Office visit Dr. (filling in for pcp); diagnosed with Bell's Palsy. 11/17/2021: Follow up visit to Ophthalmologist; punctal plug inserted; prescribed artificial tears and moisturinzing gel for eye at night 11/29/2021 : Office visit, Dr., neurologist diagnosed Bell's Palsy: "This is most likely Bell's Palsy secondary to vaccine booster"stated in doctor's Clinical Notes. 12/1/2021: Visit to Opthalmologist: follow-up 1/12/2022: Visit to Ophthalmologist : follow-up In addition; I have been receiving physical therapy 2z weekly
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 17-FEB-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; This is a spontaneous report from a contactable consumer or other non hcp and from Pfizer-sponsored program. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 21May2021 09:00 (Batch/Lot Number: EW0169) as 1st dose, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a sore left arm after her first Covid-19 vaccine dose, but other than that felt fine on 22May2021. Patient asked if it would be ok for her to take a herbal cleanse after receiving the first COVID-19 Vaccine, stating she wanted to make sure there wouldn't be any problem doing so. Patient also wants to know if the following ingredients would effect the vaccine: Magnesium Citrate, vitamin B6 (pyridoxine HCI) vitamin B12 (cyanocobalamin), sodium, potassium citrate, potassium sorbate, hexametaphosphate, sodium benzoate. Patient said she didn't notice the left arm soreness until upon waking on Saturday morning, 22May2021. She said her left arm was still tender, but the left arm soreness had improved. It was reported patient took TYLENOL (clarified as generic Acetaminophen 500mg), and (generic) Ibuprofen 200mg to treat her left arm soreness. She said she did not have the generic Acetaminophen 500mg and generic Ibuprofen 200mg NDC Numbers, Lot Numbers, and Expiration Dates to provide because she had transferred the generic Acetaminophen 500mg and generic Ibuprofen from their original product bottles to a smaller bottle that she kept in her purse. It was reported patient found a Manufacturer's Date (Oct2020), but did not see a Expiration date on the product's outer packaging or product bottle. She stated she purchased the Herbal Cleanse liquid directly from the manufacturer (It Works), and only had the Herbal Cleanse liquid for about 5 weeks or so. She said she did not see a UPC Number listed on the product packaging. She said she was using the Herbal Cleanse liquid as a kick start to weight loss. She said she had planned to take the Herbal Cleanse liquid over a 2-day period, taking one-4 oz. bottle before breakfast, and one-4 oz. bottle before dinner over two days. The outcome for event sore arm (pain in extremity) was unknown and outcome for limb discomfort was recovering.  Follow-up attempts are needed. Further information is expected.
High fever for several days, upset, ear infection, and lethargic at times. Had difficulty sleeping, at night she would dig her head into her pillow, grunting and clenching teeth, seemingly to be in pain. Her head hurt and it took her over an hour longer than usual to fall asleep. She wouldn?t eat and cried much more and for longer than usual.  She had stomach issues afterwards as well.
Case number PHEH2013US18987 is an initial spontaneous report received from a nurse on 05 Sep 2013 and a follow up report from the nurse received on 10 Oct 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11077, expiry date: 01 Apr 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 09 Aug 2013 (09:15). It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up report from the nurse received on 10 Oct 2013: The vaccination site was updated.
Left thigh red, swollen, warm to touch, knot felt upon touch (1/2 dollar size), fussy, no fever voiced by parent. T- 96.8 3/28/03 while at health dept at 1:55 p.m.
Rash on body x 5 days, began on trunk and has spread to limbs and scalp. Rash very pruritic dx of varicella, uncomplicated.
A little over 2 weeks after receiving the J&J vaccine I noticed sudden significant pain in both shoulders. The pain was a deep aching pain all around the shoulders (not one spot). Pain was different than I had ever experienced before was constant (24/7) worse first thing in AM then better after a shower. Pain ranged from 3 to 8. Over time the pain spread to collar bone/neck. Tried Advil and it had no affect. Starting trying all types of pain medicines and rubs. The only pain medication I used that had any significant effect was Aspirin. I was taking 2 Excedrin around 8:00 AM, 2 Aspirin around 2:00 PM then two Tylenol PM and two extra strength Aspirin around 10:00 PM when going to bed (to try and get some sleep). Las Lasted till normally about 2:00 AM then full pain back. Very difficult to get sleep even when med was working (still much pain)and normally sleep on side. Made an appointment at Orthopedic doctor for the shoulder pain. Dr did exam and ordered blood tests. Dr indicated it was likely shoulders and not neck. The blood tests showed non-specific inflammation and said he needed to refer me to Rheumatologist for treatment. Took several months to get into a Rheumatologist (all booked). Miserable in the mean time - not much sleep. Finally got into Dr (privacy) at the Clinic on 12/10/21. After a lengthy exam he diagnosed me with Polymyalgia Rheumatica and prescribed Prednisone to treat it. The Prednisone reduced the severity of the pain almost immediately (reduced pain to lower average 2 - 3). Continued to take two Tylenol PM and two Aspirin at bedtime to help with sleep.  Read that Aspirin maybe should not be taken with Prednisone so asked Dr and received note to not take it so stopped taking two Aspirin with Tylenol PM as of 12/22/21. Worried about long term effect of using Prednisone reading it has significant side effects (sugar diabetes, weight gain amongst others).
Within 24 hrs of 12 month vaccinations (6) the pt became limp, irritable, non-verbal, and fussy for approximately 3 weeks. No treatment was given.
No adverse event; The vaccine was given BUD; Administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD), PRODUCT ADMINISTRATION ERROR (Administration error) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     It was also unknown if there was any acute illness at the time of vaccination or any chronic or long standing health conditions of the patient.     On 27-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and PRODUCT ADMINISTRATION ERROR (Administration error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and PRODUCT ADMINISTRATION ERROR (Administration error).    No concomitant medication was reported. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive.  BUD date was given as 23-Jun-22. Reporter further reported that as per Moderna, the lot was still active and patient need not to be re-vaccinated.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-599989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-599989:Master case
passed away a week after the flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who passed away a week after the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed away a week after the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was fatal.  It is unknown if an autopsy was done. The cause of death was captured as Influenza.  Information on lot number was requested.; Sender's Comments: This case reported involved a female patient (age unspecified) who passed away a week after influenza following vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: passed away a week after the flu
for approx 48hr p/vax pt had temp of 101 R;pt treated w/ 1/3 tsp Ibuprofin;10 days p/vax pt devel fine red raised rash on face, chest & legs lasting 5 days in duration;mom concerned how long rash will last;
Patient presented for second dose of Hepatitis A series, inadvertently received extra dose of MCV-4 which was not forecasted. This writer contacted mother of patient on 12/4/17 regarding incident; mother has rescheduled patient to received scheduled Hep A vaccine. Mother reports no adverse reactions.
approx 10hr p/vax mom describes inconsolable crying, fever-in ER 103.4 pt given APAP during noc;possible sz activity;stiffening of limbs, lethargy;
This spontaneous report was received from a medical assistant and refers to a female clinical assistant of unknown age. The clinical assistant's pertinent medical history and concurrent conditions were not provided. On an unknown date, the clinical assistant was preparing a RECOMBIVAX HB syringe (lot # K008986, expiration date 01-APR-2016) for insertion and there was a syringe issue and a product quality issue because the syringe broke. The clinical assistant experienced laceration as well as an accidental exposure to product when she cut her finger from the glass of the broken syringe. It was unknown if the clinical assistant sought medical attention. At the time of the report, the clinical assistant's status was unknown. Additional information has been requested.
Shortness of breath; Chest tightness; burning; This is a spontaneous report from a contactable consumer (Patient). A 22-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in right arm on 09Mar2021 (at the age of 22-years-old), as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:00 as single dose for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. On 09Mar2021 at 08:00 (same day of vaccination), patient experienced shortness of breath, chest tightness and burning. Patient did not receive any treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: unknown results (Nasal Swab) on an unspecified date. Patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Fatigue, muscle aches,  chills, fever, nausea, diarrhea for a full week and wasn't over it for two weeks.  The worst symptoms began the night following the injection.
SORENESS OF LEFT SHOULDER; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient has no allergies,no drug abuse or illicit drug usage. patient was non alcohol consumer, non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced soreness of left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness of left shoulder. This report was non-serious.
A large portion of the upper arm became very swollen, skin very hot to the touch, itchy, red, and hard. Was worse two days after the shot, resulting in a follow up consultation with the doctor's office. Treatment was advised with ice packs, Benadryl, and pain medication. It is now 5 days after the shot and most symptoms are starting to reduce in severity and extent.
On 12/4/2021, 1 day after Moderna Covid-19 booster shot, patient developed decreased vision in the R eye. This progressed over the next 3 days to near complete loss of vision in the R eye. He was seen by an ophthalmologist on 12/7/2021 who recommended he start aspirin 81 mg PO daily & scheduled him for visual field & color plate testing in January 2022. With no change/improvement in vision, he went to a different ophthalmologist on 12/14/2021 for a 2nd opinion. B optic nerve edema was noted & findings concerning for R optic neuritis. He was sent to the ER for evaluation & was admitted to the hospitalist service.  He was seen by neurology, underwent MRI brain & MRV head. We were also concerned for optic neuritis. He was given a 3-day course of IV Solu-medrol 250 mg IV Q6 hrs. He has had significant improvement in his R eye vision & his ophthalmologic exam is also improved vs previous.  Vision is currently improved but is not back to normal.
-soreness at injection site approximately 2 hours after injection. -headache approximately 10-12 hours after injection. -high temperature (38.5+/101.5) 12 hours after injection lasting 4-5 hours. -chills, shivering -some dizziness before fever, dizziness and reduced alertness during fever. -night sweats after fever broke.
High fever, 103.2 , on 04/04/22, and low grade fever for 10 days straight.