chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tues afternoon started not feeling well, very cold not able to get warm, and felt like she got hit by a truck. Wed felt the same way and was getting worse. Thur starts having a fever, every sore arm , could not touch it, arm was hot, chills, not feeling well,  the size of the rash/redness/reaction on the arm kept getting bigger and redder. Also noted streaking was starting down the arm and toward the arm pit area.    Fever 100. 0 F, chills, muscle spasms, worsening nerve pain, nausea, back neck and left arm pain, insomnia, and injection site redness, swelling, streaking down left arm and site itching. She has been taking Allegra at home for antihistamine since this started, and has a prednisone dose pack available to her at home from a former prescription.
This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a elderly male patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced feeling unwell. In May 2018, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received the SHINGRIX vaccine (unknown deltoid) in their office and reported to her that after he received the SHINGRIX vaccine, he did not feel well overall. The event lasted approximately for 3 to 4 days. The sales representative had limited details regarding the adverse event, so the sales representative asked that someone from Center reach out to the nurse who reported the adverse event to her, to obtain more details. Outbound call was placed to the nurse to obtain additional details. The reporter had limited information at the time of the call and stated that she might call back in to provide additional details.
Myalgia, Fever sore and discomfort underneath armpit (small lump growing) Narrative:
Whole arm aching; Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Hip arthritis). Concomitant products included CELECOXIB (CELEBREX) from 12-Feb-2021 to an unknown date for Hips osteoarthritis, AMLODIPINE, SIMVASTATIN and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Indication added for Suspect vaccine. Treatment drug added. Outcome updated to resolved.
Approximately around 4 and a half months after being fully vaccinated I had COVID and I experienced the following symptoms: Bronchitis, Sore throat, Body Aches, Coughing, Fever and loss of taste and smell. I experienced these symptoms for 4 weeks and till this day 03/07/2022 my taste and smell still have not come back fully and I still feel fatigued.
upset stomach; no energy; could not eat; smell sensitivity; muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity) and MYALGIA (muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, LOSARTAN, LORATADINE, PARACETAMOL (TYLENOL), ATORVASTATIN, AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea). On 03-Mar-2021, ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Other relevant medication history included flu.
FEVER, BODY ACHES, NAUSEA AND VOMITING  TREATED WITH TYLENOL FOR FEVER
Tingling on right side (side of administration) less than a minute after injection, numbness in lips.
Beginning about 4 hours after receiving shot, muscle aches in arm, from elbow radiating up the arm, over the shoulder thru collarbone & up the side of the neck to the ear.  By 6 hours after the shot, pain was excruciating and I was in literal Agony for the next 8 hours. It felt like a hot poker was being pushed along that pathway.   Tylenol & ibuprofen had no effect.  I could not sleep & could barely move the arm  at all.  (I am Not a pain Wimp)  I would say this was the longest lasting without relief/strongest pain I have ever experienced and I have had one child;+ hip & shoulder surgery which required almost no after surgery medication at all.  By 5 a.m. I was able to sleep a bit & most of the extreme pain was gone by 8 a.m.  I had some headache the following day and was barely able to function (I live alone) just from all over tiredness.  About 36 hours after injection, I was back to normal.
loss of vision; congestive heart failure; cardiovascular event; hearing problems; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 16-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.         Subsequently, on an unknown date, the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: cardiovascular event, congestive heart failure, loss of vision, hearing problems and balance issues. The outcome of the events was unknown. The reporter considered all events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the events of congestive heart failure and loss of vision were considered to be medically significant.
fogginess; tiredness; dizzy feeling. lasted 24 hours.; chills at night; cloudy minded. started approximately 2 hours after shot; sore arm for 24 hours as well; numbness in top of hand and thumb and pointer finger; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, on Arm Left on 22Jan2021 at 12:15 as a single dose for COVID-19 immunization. Medical history included coronary artery disease, cough, back issues, arthritis and multiple allergies (from an unknown date and unknown if ongoing). Patient had allergies to medications, food, or other products. Concomitant medications included levothyroxine (Levothyroxine), clopidogrel bisulfate (Plavix), dexlansoprazole (Dexilant), metoclopramide hydrochloride (Metoperon) and pravastatin (Pravastatin). All medications were received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021, immediately after vaccine, warmth radiating down left arm followed by numbness in top of hand and thumb and pointer finger. Lasted several hours. Approximately 2 hours after shot), the patient experienced chills at night and cloudy minded. At 14:00 patient had fogginess, tiredness and dizzy feeling. Lasted 24 hours. Patient had sore arm for 24 hours as well. No treatment was provided for events. Outcome of the events was reported as recovering.
FNP contacted local county health department and reported toddler non temperature of 100 degree F next day and by weekend temp was 105 degree F.
Received injection 9AM, 2/26 - I was fine all day - went to bed 10PM - awakened at approx 12:15  AM  , 2/27        -                                                                                    - my body was shaking severely - this lasted approx 10-15 minutes   - I was unable to go back to sleep - laid awake all night -          I was OK for the rest of the day, other than being tired from lack of sleep.
It was reported that Fluzone vaccination was administered to 2 persons who had local reactions at injection site. No specifics were provided. No pt info was provided therefore this case is not meeting the reporting criteria at the present time. Additional info received on 9/26/02: It was reported that the pt was vaccinated with Fluzone in the left deltoid on 10/24/01. Within 1-2 days post vaccination, the pt's whole upper arm became reddened and inflammed, swollen, tender and firm to the touch. The events subsided after one week. This case is closed.
pain on one side of his head/headache; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (pain on one side of his head/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). On 06-Apr-2021, the patient experienced HEADACHE (pain on one side of his head/headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (pain on one side of his head/headache) had not resolved.            No treatment information was provided.  No concomitant medication was provided.
Starting around 09:30 PM I started to get tired and cold. I was dizzy and unable to drive so someone drove me. At 11pm (exact time unknown but travel time estimate is one hour and thirty minutes) I was shaking from chills, could not get warm, nauseous, and dizzy. That evening (hours 12AM - 5AM) I experienced nausea, joint pain, chills, sweats, shaking, and a migraine. The symptoms remained but lessened in severity 36 hours after the injection time.   It is important to note that the only other time I have undergone those symptoms was when I removed myself off of Vicodin. I had been prescribed vicodin for pain management in 2016 and took myself off the medicine and went through withdrawal effects and the symptoms from the vaccine were the same as those I experienced as withdrawal from vicodin.
Information has been received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K025004, expiration date 22-JUL-2017, dose and route were unknown) (Incorrect product storage). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Loss consciousness that evening of injection. Found next morning at 9am still unconscious. Loss of memory for 2 days. Fever for 2 days. Vomiting for 2 days, No appetite 5 days. Rash -red dots started on legs, now on arms, trunk. Toes are red / prune looking. Throat sore. Auditory hallucinations on Friday 11th. Unable to function for 2 days. Unable to perform ADL's. Needed someone to do everything for her. Was seen by home nurse. Is now able to get to the restroom by herself after 5 days.
On 05/28/22 a patient with parent arrived with a document for a COVID (Pfizer) vaccine appointment from the previous day. The document was taken and processed and the vaccine was given. After vaccination, the incident was discovered. The standard Pfizer 0.3 mL dose was administered in place of the pediatric vaccination dose. No known adverse effects from the incident, patient's parent was informed and understanding.
Patient is here for immunizations per order of Dr dated 5/24/18. Vaccine information sheet(s) were given on 05/24/18. Verbal consent was obtained. Patient tolerated the immunization well without incident. 1532-Patient stated she felt fine to leave, went to front desk to set up apt and passed out. Denies hitting head, came too right away, FOA with patient, I came to the front of the office and got patient a cool cloth and FOA got water for her. We escorted her to a chair. Patient talking and laughing and drinking her water. Denies any pain or injury anywhere. Dr called, notified of incident, verbalizes understanding. No order given. 1546-Patient states she is feeling much better, has drank 2 cups of water, denies any discomfort or injury, states she has to go to work. Patient was advised to let us know if she had any issues or concerns, she verbalized understanding. Patient walked out of clinic with a steady gait, states she feels fine.
Nausea, vomiting, diarrhea, headache, soreness, vertigo, dizziness...started at 3:30am and continuing.
abdominal pain fatigue leg cramps and severe head pain and shortness of breath  i now have full blown stage 4 lung cancer that  has spead to neck and lymph nodes on left and right sides i was perfectly healthy before the vaccine i blame all of this on the vaccine
Patient is fully vaccinated. She states that she tested positive for COVID 19 just prior to ED visit 1/1/2022.  60-year-old female with history of obesity, diabetes, and hypertension presents with generalized body aches, shortness of breath, intermittent fevers and chills for approximately 5 days.She denies any chest pain, abdominal pain, constipation, or diarrhea. CXR: Bibasilar airspace opacities may reflect atelectasis or developing infectious consolidation. Patient's oxygen saturation was greater than 93% Imaging was negative for any acute pathologic process, the patient's lab workup was benign. She is currently stable for discharge. She has been set up for outpatient monoclonal antibody therapy.
This spontaneous report was received from a registered nurse, via company representative, concerning a 6 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2017 the patient was vaccinated with a booster dose of VARIVAX lot # N007930 and expiration date 08-MAR-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. On 22-OCT-2017, the patient broke out in lesions on the mouth, feet and most of his extremities (varicella post vaccine). The patient visited an unknown physician's office on 25-OCT-2017, and was treated for Varicella. At the time of this report, the outcome of varicella post vaccine was reported as recovered on an unknown date in 2017. The reporting nurse did not asses the causal relationship between the Varicella post vaccine and the vaccination with VARIVAX. There was no PQC involved.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 11:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.48.  Concomitant products were not provided. On 24-MAY-2021, Excursion time was 08 AM, and 9AM. temperature was35 and 35 respectively. total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-MAY-2021, vial was moved to clinic on 24-MAY-2021. 1 vials were sent to clinic. Vaccine BUD date was 02-JUN-2021.  On 24-MAY-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness
Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Patient was given a Ped/Adolescent Hepatitis A vaccine instead of an Adult Hep B vaccine. Patient was notified of the incident and no informed that no harm would come to him due to this. He will resume his normal Hep B vaccination schedule 1 month from the date of the incident.
Employee arrived to receive her second dose of the Moderna COVID-19 Vaccine. At this time, we were operating with 5 Pfizer rooms and 1 Moderna room. Because of this, they were not issuing out yellow "Pfizer" cards to patients receiving the Pfizer vaccine; only the blue "Moderna" cards were being given to patients receiving the Moderna vaccine.  With this employee, the blue "Moderna" card was not given to her in order to differentiate which dose she should receive. Additionally, she did not have her first dose vaccine card; a copy of a new one was made and issued to her at the vaccination site. She did not have her first dose vaccine card; a copy of a new one was made and issued to her at the vaccination site. When in line, my runner called for the next individual coming in for a Pfizer vaccine. She came in to our room, informed us of the situation regarding her COVID-19 vaccination card, and handed her new card to us to be filled out. After entering her information into the system, and verifying that this was indeed her second dose, I administered the Pfizer vaccine instead of the Moderna vaccine.
Tdap given 2/4/13 LD - Today 2/7/13 - patient arm is red, edematous, blotchy area approx 5cm X 8 cm (upper-mid upper L arm). C/O slight discomfort. No itching noted. Patient reports low grade temp last night. Dr assessed patient - will see patient in A.M. Dr gave pt emergency contact number. Instructed TYLENOL/Ibuprofen.
On January 31, 2023, I had developed bronchitis symptoms. I had a head cold and a cough. I did a telehealth visit with my doctor. I had a negative COVID-19 test so my doctor said I'd be fine. By the next Friday I had full on bronchitis, and treated myself with MUCINEX and ADVIL. I had a fever and chills during that time. I was fine by the 10th of February. Then on Saturday March 4th I developed a sore throat. I was experiencing cold symptoms on the following Sunday. I tested positive for COVID-19 on that Monday and got a prescription for PAXLOVID. It had gotten worse over the night of February 6, 2023. I felt better that Wednesday morning.
Patient was given Moderna bivalent booster was not approved for him to receive as he had gotten 3 Pfizer vaccines.