chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medications were reported.  During a Moderna Covid-19 vaccine clinic patient received Moderna COVID-19 vaccine monovalent instead of the bivalent dose for their booster dose. Nurse stated this happened because the monovalent vaccine with the purple border was labeled "booster doses".  No treatment information was provided.
p/vax pt was standing beside mom & turned pale & fell over on mom's lap; 911 was called; p/30seconds became conscious w/eyes open;
Started to develop necrotic ulcers, fever and redness. Eventually diagnosed as pyroderma gangrenosum as a result of immune response from flu vaccine.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient with no drug reactions/allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot#0364, Exp date: 16-MAR-2012) on 09-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012 the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient had swelling the size of a baseball and pain at the injection site. The center of the swelling had a 1-2 inch area of redness. The patient sought medical attention by calling the pharmacist. TYLENOL was given as treatment. At the time of reporting, the patient was not recovered. Additional information has been requested.
Received SHINGRIX #2 in left deltoid 8/28/18. That night developed fever, ill feeling/arm pain. Today noted hard/red/warmth at site and rash on neck/chest. Treated with KEFLEX for cellulitis 8/30/18 at inj site.
day p/vax pt exp tender, red, lymph node at superior anterior rt cervical chain devel; treated w/dicloxicillin
Information has been received from a 65 year old female with a penicillin allergy who on 17-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included lisinopril (manufacturer not provided) and lovastatin (manufacturer not provided).  On 17-AUG-2007 the patient developed local redness and itching at the injection site. In 2007, the  patient recovered from the local redness and itching at the injection site. Additional information is not expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Mom said patient lost conciousness for less then 10 seconds after injection for about 5 minutes, while sitting in observation area for 15 minutes, then patient started to feel better. Patient felt fine after sitting for 30 minutes
expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 48A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
pt had a seizure like reaction after pfizer vaccine. 911 was called to the scene. pt woke up and was checked by paramedics and was released.
Patient stated she completed her 15 minute post vaccine observation period and "felt off".  Patient went home and within one hour she felt dizzy and did not feel "right".  Patient seemed confused and laid down and took her BP.  BP was elevated at 156/98 and Heart rate was in the 30s. Patient contacted her cardiologist and they told her to go to the hospital.  Per patient, she went to the Emergency Dept and was given IV fluids and had an Xray of her heart.  She was diagnosed with bradycardia. Patient stated she feels better, but still feels tired and worn out.
Two days after receiving the Moderna COVID-19 Vaccine EUA, I felt week, light-headed and had swollen eyes. I also started menstrual bleeding despite being in what I thought to be menopause, I had not menstrated for 6 months. Three days after the shot my left lymph node in my armpit began to swell and be painful to the touch.  I am now seven days post vaccine and my armpit and lymph node are still very sore and swollen and I do not feel 100%, a general unwell feeling. I am having serious doubts that I will get the second dose.
1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt went to PCP and was diagnosed with Shingles.
3/18/2022 I was fatigued all day long. I had been in pain for 2-3 weeks because of a pinched nerve and unable to sleep. By nighttime I was coughing. On the 19th my voice was raspy. I did a home COVID-19 test and it was positive. I had a positive test at our health clinic. I was feeling better by the end of week. It took me a few weeks to not be so tired.
Probably unrelated but I am on day 3 of my normal menstrual cycle (typically 5-7 days).  Approximately 2 hours after receiving the vaccination I began passing large clots and my flow went from regular to heavy. I do have heavy cycles from time to time but found the abrupt change in cycle interesting. Other than being sore in the arm and tired I feel fine.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patient were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose ROTATEQ oral, lot#K004480, expiration date 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
pt recvd vax; pt exp abdo pain, headache & pain; pt devel also itchy, swollen eyes;
Muscular aching, diahrea and nausea for 2 1/2 days.
So this is what is going on, I went to the DR because I felt the shot go into my arm, go down my arm and into my right ring finger and stay there. After that shot, also, my Lyme disease from 2016 had been horrible. My limbs, my joints, everything felt like they were being pulled apart. It felt as though my Lyme disease was reoccurring all over again. I told the DR that and he said he has had an increase of people going in. I was bed ridden for a long time, I do not even remember. But my DR re-treated me for Lyme disease when I went in, he put me on Doxycycline daily. Each day, I do not know what to expect. Some days I am okay and other days I feel horrible for hours and hours. I take a doxycycline as night and it could feel fine, or it could feel like I am being ripped apart. Again, it was never ever this severe until after the second shot. And tomorrow is my last day on the doxycycline. Really it's like the lyme disease completely reactivated. Also, I had a rash immediately after the injection, it was double the size and thickness of a half dollar coin - it was also hot to touch. I also had five back to back, very vivid nightmares in the night and they were so bad that it distorted my reality. It was the most horrifying thing I have ever gone through. Though, the vivid dreams have continued although they are not back to back they happen here and there and they are just horrific.
sore arm, hard and hot to the touch, extreme/severe vomiting, chills and high fever (102+), elevated heart rate for extended period (130+), blood oxygen levels fell 10 91-92.  Low shallow breathing with dry intermittent cough.    2nd day extreme fatigue, shallow breathing. sore neck at the base of my skull with pain in eyes and sensitivity to light, accompanied with fluid sensation in years. lack of appetite.   3rd day,  sore chest and rapid heart rate, and sore chest cavity, prickly rash on chest and torso.  fatgue
Around 3 hours after getting immunization experienced difficulty breathing/catching breath fully/weight on chest, chills, shakes, fever of 100 degrees F. The next day experienced general weakness and fatigue, ongoing for a couple days after that.
Patient came in for hep a vaccine and let us know that he experiences some dizziness with vaccines. Almost immediately upon administering vaccines, he turned into a limp noodle on his chair. He told me that he needs to lay down and at that point my technician and I were able to lay him on the ground. I was wearing a couple of tops, so I removed my smock and placed one of my tops underneath his head (we had to lay him on our cement floor). He asked if he got the whole vaccine (and yes, he started to turn limp as I was removing needle from his arm). He kept assuring me that he was OK, that he needed to lay down. He did not ask for anything, but I did take him an extra bottle of water that I had with me today. He was slowly able to go from laying down, to sitting up on the ground. I stayed with him and then went back and forth - to and from the pharmacy, while he was recuperating. He came over to my window and assured me he was ok and thanked me for not administering the vaccine before we went went to lunch, and stated that he understood now why that was.
This case was reported by a consumer and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline) or hepatitis A vaccine inactivated. A physician or other health professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown route, unknown lot number) or unspecified dose of Hepatitis A vaccine (unknown route, unknown lot number). In 1996, at an unspecified time after vaccination with Hepatitis A vaccine or Hepatitis B vaccine, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified.
Patient had a hive like reaction at the injection site. It was about 4-5cm red, raised and itchy. Patient was advised to use cool compresses, Zyrtec and Benadryl prn.
Information has been received from a medical assistant concerning 5 male patients who on unknown dates were vaccinated with a dose of GARDASIL (dose, route and lot # not provided). The medical assistant in the physician's office reported that on unknown dates, all 5 patients experienced convulsions and eyes rolling up in their head (results not provided). On an unspecified date, the physician ordered a head exam for one patient. On unknown dates, the patients recovered from the events. The patients sought unspecified medical attention. Upon internal review experienced convulsions was considered to be an other medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 64 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 62 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On an unknown date in 2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: ew0161) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=26Jul2022, treatment stop date=27Jul2022, lot number=1917015A, indication=Treatment of COVID-19.Other medication received in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Suddenly without any warning the room started spinning and I could not stand up and could not safely get to the floor. I had to hold onto the kitchen counter to keep from falling. My head was spinning and I was nauseous. My husband rushed me to the ER where they diagnosed vertigo and treated it with medication. The dizziness and nausea lessened over the next few weeks but took more than a month to go away. After my second Covid 19 shot on 3/19/2021 a similar reaction occurred on March 22. However I did not go to the doctor or hospital at that time. It took a day or so to lessen enough so that I could go back to work. Again, it occurred less and less frequently and severely over the following weeks.
Moderna Vaccine 1st dose: I have an itchy rash on my upper right arm, just below the Moderna vaccine injection site.  Rash is recent and just noticed it this morning.  Received the shot 8 days ago, on Friday Feb 26, ~5pm. Other than a sore arm for the first 3 days, I've had no other reaction.  This is NOT an emergency and we just applied topical Benadryl to help quell the itching.  But thought I should report it.  I do not recall having a reaction like this to other vaccines.  We took photos - can submit if you want.
Mother refers that the patient presented pain and weakness in legs and back and problems or difficulty breathing in the afternoon post vaccination. No medical evaluation till 4/21/16 when the mother notifies that the patient continues with symptoms and it is recommended she is seen by doctor.
Diagnosed with HPV strains against which was vaccinated with GARDASIL in 8/23/2008, 3/11/2008, 12/29/2007.
This case was reported by a pharmacist via sales rep and described the occurrence of ophthalmic herpes zoster in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 122 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported having shingles approximately 4 months from receiving a dose of SHINGRIX. It occurred around his eye previously and he reported did have in eye. The patient did eventually completed the series with 2nd dose of SHINGRIX on an unknown date. The patient agreed to be contacted for follow up.
Within 1-11/2 hours of receiving flu vaccine right upper lip became swollen and roof of mouth felt slightly like itching sensation-see progress notes-physician not sure if from vaccine or possibly R/t BP med (lisinopril)
72 y.o. 3/6/1950   Admit Date:  7/24/2022   Discharge Date:   7/27/2022   Discharge Diagnosis:  Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   Syncope   Essential hypertension     Hospital Course:  72 year old vaccinated female was admitted for Covid-19 pneumonia. She was started on decongestant and Remdesivir therapy. She responded well and did not require O2. D dimer was normal. She was discharged home in stable condition after 3 doses of Remdesivir were given. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98.2 °F (36.8 °C) Heart Rate (Monitor): 86 Pulse: 88 BP: 136/76 Respirations: 18 SpO2: 96 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm,  Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   TTE, CXR   Operations: none   Disposition:  Home    Discharge Condition:  Fair    Discharge Medications:   Discharge Medication List as of 7/27/2022  1:15 PM   CONTINUE these medications which have NOT CHANGED   Details oxybutynin (DITROPAN) 5 mg tablet TAKE 1 TABLET BY MOUTH TWICE DAILY, Historical Med   pantoprazole (PROTONIX) 20 mg DR tablet Take 40 mg by mouth Daily., Historical Med   albuterol (VENTOLIN HFA) 90 mcg/Actuation inhaler Take 2 Puffs by inhalation Every 6 hours as needed., Disp-1 Inhaler, R-0, Normal   MULTIVIT &MINERALS/FERROUS FUM (MULTI VITAMIN PO) Take  by mouth Daily. SUPPLEMENT, Historical Med   Ascorbic Acid 1,000 mg Tab Take 1,000 mg by mouth Twice a day. daily, Historical Med   aspirin 325 mg tablet Take 325 mg by mouth DAILY., Historical Med   CHOLECALCIFEROL, VITAMIN D3, (VITAMIN D3 PO) Take  by mouth Daily., Historical Med     STOP taking these medications     LORazepam (ATIVAN) 1 mg tablet Comments:  Reason for Stopping:        benzonatate (TESSALON PERLES) 100 mg capsule Comments:  Reason for Stopping:        ipratropium (ATROVENT) 0.06 % nasal spray Comments:  Reason for Stopping:        diltiazem (CARDIZEM CD) 240 mg capsule Comments:  Reason for Stopping:        Fexofenadine (ALLEGRA) 60 mg tablet Comments:  Reason for Stopping:        ZINC PO Comments:  Reason for Stopping:        Glucosamine-Chondroitin 250-200 mg Tab Comments:  Reason for Stopping:        diclofenac (VOLTAREN) 75 mg DR tablet Comments:  Reason for Stopping:        methocarbamoL (ROBAXIN) 500 mg tablet Comments:  Reason for Stopping:        montelukast (SINGULAIR) 10 mg tablet Comments:  Reason for Stopping:        losartan (COZAAR) 50 mg tablet Comments:  Reason for Stopping:        promethazine (PHENERGAN) 25 mg tablet Comments:  Reason for Stopping:        CALCIUM PO Comments:  Reason for Stopping:        BETA-CAROTENE,A, W-C & E/MIN (OCUVITE PO) Comments:  Reason for Stopping:
Patient present to clinic on 2/10/06 with "20 x 16 cm red elevated sore"  Swelling started 2-3 hours after injection.  Given prescription of Keflex 500 mg qid x 7 days and ibuprofin 800 mg tid.  On 2/13/06 patient returned for follow up.  Per chart note, "inner elbow continues with swelling, upper arm with decreased swelling, discolored yellow around injection site, pain decreased.
Patient complained of stinging upon administration of vaccine, but did not complain of any other symptoms at that time. When I called to follow up with the patient on 11/19/2014, she stated that around 4:30 PM she began to get chills, a fever, and could not swallow due to swelling in her throat. She immediately went to the emergency room for treatment and was told her symptoms were likely due to a reaction to the vaccine.
Mild symptoms began on 01/21/2023. That day I woke up with a scratchy throat. Ibuprofen covered it throughout the day. On 01/22/2023, symptoms did begin to progress. Then later into the middle of the night, I could hardly swallow and the pain was radiating through my ears. The next morning I called my doctor and they swabbed me for Strep A and it was positive. I was prescribed penicillin VK 500mg 1 tablet twice a day for 10 days and after the start of the course of the medication, my symptoms were already getting better.
Tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for Covid) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: postive (Positive) Tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt had TDAP 5/6/11 felt she had not had tetanus for many years - had fever, body aches, joint pains, fatigue, redness, swelling at site.
Spinal issues with and surgeries in the past. 12 hours later  feeling unwell at 09:00PM on set of pain and chills;  middle of the night awoke to body chills body cramps and flu, chest congestion and coughing that lasted 24 hours  full 24 hour.   Then next morning new issue of pain and problem, is the lose the use of right leg extreme pain and new issue sought assistance from pain doctor and not to the point that the leg scheduled for a spinal  MRI diagnosis 12/13/2021 Neuroforaminal Foraminal stenosis  Bilateral at three different levels in spine ,  Compression of the nerve root is getting irritated. Schedule procedure Steroid injections.  Sent for MRI diagnosis and saw him for follow-up and scheduled the inject.