chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red halo around the arm at the site of injection; Warmth in the arm; Pain in the arm; Tenderness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmth in the arm), PAIN IN EXTREMITY (Pain in the arm), TENDERNESS (Tenderness in the arm) and VACCINATION SITE ERYTHEMA (Red halo around the arm at the site of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Chronic arthritis.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FEELING HOT (Warmth in the arm), PAIN IN EXTREMITY (Pain in the arm) and TENDERNESS (Tenderness in the arm). On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red halo around the arm at the site of injection). On 23-Feb-2021, FEELING HOT (Warmth in the arm), PAIN IN EXTREMITY (Pain in the arm) and TENDERNESS (Tenderness in the arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red halo around the arm at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a fine line that circled the deltoid where she received the vaccine
On 8/25/23 donor stated that her left arm was sore after receiving her tetanus immunization. Donor stated that she has had a sore arm for 9 days after receiving her first tetanus immunization.  Donor then stated that she vomited after receiving her first tetanus immunization on 04/14/23 and again after receiving her second immunization on 08/25/23 once she got home. Soreness in arm was localized to the injection site and donor did not seek any outside medical care after receiving both immunizations. There was no complaints of swelling, redness, itching, or anaphylaxis.  Donor's left arm was checked and there was no swelling, redness, or lump noted.
heart rate went up to 120 bpm; fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bradycardia. Concurrent medical conditions included Spice allergy and Adhesive tape allergy. Concomitant products included METFORMIN, METOPROLOL and ROPINIROLE.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F). At the time of the report, HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I had long COVID-19 symptoms affecting my lungs, a lot of mucus production. I developed headaches, fatigue. I went to see my doctor, who ordered chest x-ray that showed calcified granuloma, heart is normal in size, mild collapse of one of my left lungs. The P.A was not concerned she said it should go back to normal as long as I do deep breathing exercises. They recommended that I continue to using my Proventil and cupping exercises to help expand my left lungs. I do not feel back to one hundred percent.
Weakness, numbness, tingling in upper extremities. Low back pain. Weakness and tingling in lower extremities. Symptoms x4 weeks and not improving.  Not improved with conservative therapy or oral steroids.
Swollen Glands/Swollen lymph nodes in groin; Throat pain; Dehydration; Oral lesions; Oral ulcers; Fissured lips; Lethargy; Body aches; This is a spontaneous report received from a contactable physician. A 17-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6200) via intramuscular route of administration on 19Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation. The patient's medical history included type 1 diabetes mellitus, ADHD, known allergies: cats and horses, acne and depression. The patient underwent lab tests and procedures which included blood immunoglobulin g: negative, blood immunoglobulin m: negative, herpes simplex test: negative. Acyclovir (stopped when HSV 1 and 2 IgG and IgM were neg), sars-cov-2 test: negative on 24Feb2021. The patient's concomitant medications included insulin lispro (HUMALOG) and isotretinoin (ACCUTANE). On 22Feb2021, the patient developed severe swollen glands in his submand region, throat pain, swollen lymph nodes in groin, dehydration, oral lesions, oral ulcers and severely fissured lips, lethargy and body aches. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for all the events. Hydration, discontinued Accutane, gave Acyclovir (stopped when HSV 1 and 2 IgG and IgM were neg). The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today; This non-serious spontaneous safety report with reference number 2023SA122541 (and inquiry number 01581087)  was received by a partner on 18-APR-2023 and forwarded to agency on 19-APR-2023 from a HCP.  Due to the nature of the event, the causality between Vaxelis and the reported event "a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today" was not applicable.  Further information is expected.
Vials that were more than 30 days in refrigerator administered to patients/ stored from 2 to 8 °C.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vials that were more than 30 days in refrigerator administered to patients/ stored from 2 to 8 °C.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that were more than 30 days in refrigerator administered to patients/ stored from 2 to 8 °C.). At the time of the report, PRODUCT STORAGE ERROR (Vials that were more than 30 days in refrigerator administered to patients/ stored from 2 to 8 °C.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.
chronic prostatitis; It's a sensation in the head of the penis when you pee.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PROSTATITIS (chronic prostatitis) and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATITIS (chronic prostatitis) and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.). At the time of the report, PROSTATITIS (chronic prostatitis) had not resolved and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included for the past 6 months he has been on and off antibiotics because of chronic prostatitis. He has tried multiple different antibiotics and recently started a new drug and his urologist told him it was safe to take with the vaccine.
Headache with first dose COVID-19 Vaccine; This is a spontaneous report from a contactable consumer and received from a Pfizer sponsored program with Regulatory Authority support. A contactable consumer reported for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 04May2021 (Age at vaccination: 77-year-old) as DOSE 1, SINGLE for COVID-19 immunization (Reason for no lot number: of COVID-19 Vaccine: complainant did not have the product with them at the time of call) and budesonide (BUDESONIDE), route of administration, start and stop date, batch/lot number and dose were not reported for diarrhoea (continuous diarrhoea) (Reason for no lot number of Budesonide: Complainant does not have the product with them at the time of call). Medical history included diarrhoea (had diarrhea in the past) from an unknown date and unknown if ongoing. Patient clarified that the continuous diarrhea was experiencing now began prior to the first dose COVID-19 Vaccine. Took Budesonide for three months. Is having continuous diarrhea again. Patient had taken Budesonide in the past for diarrhea and it worked. Concomitant medication was not reported. Doctor heard, that when take Pfizer COVID vaccine should not be using Budesonide (budesonide) 2 weeks after the second dose. The patient experienced Headache with first dose COVID-19 Vaccine and patient had a headache last night, but it went away. Patient feels great today and recovered completely. Patient received the first dose of the vaccine yesterday and arm did not hurt, but Budesonide (budesonide) was prescribed to start it today for continuous diarrhea. Patient had taken it previously for 3 months for same reason. Patient wanted to know if its ok to take steroids with vaccine patient was supposed to start steroid treatment (today). Wanted to know if she should not take the Budesonide until after the second dose COVID-19 Vaccine was done. A person evidently spoke to doctor stating she thinks caller should not be taking the Budesonide with the first COVID-19 Vaccine and should wait two weeks after the second shot. This person who spoke with doctor. Doctor did not know and advised caller to reach out to the pharmacist. As of right now, patient had not taken Budesonide yet, but was supposed to start taking (today). Dose: will take 3 pills per day, believes each pill is 9mg each. Dosage was not written down on the notes provided by the doctor. Stated she does not have a bottle of Budesonide, but picking up the prescription from the pharmacy (today). The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough case admission after 3 vaccines Pfizer 2/27/21 Lot# El3248;  Pfizer 3/20/21 Lot# El9265;  Pfizer 9/29/21 Lot# 312830;
Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching throughout her entire body and burning to her perineal area. SQ Epi given on scene and IV benadryl given in route by EMS.
Plans to receive second dose >35 days from first dose; TSH increased; T3 increased; t4 increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Plans to receive second dose >35 days from first dose) outcome was unknown and BLOOD THYROID STIMULATING HORMONE INCREASED (TSH increased), TRI-IODOTHYRONINE INCREASED (T3 increased) and THYROXINE INCREASED (t4 increased) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated (High) Routine bloodwork done and it came back with elevated TSH, T3, and T4..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  The patient then had a visit with his endocrinologist and was told to restart the series there while his HCP (health care professional) wanted him to get the second dose even though his thyroid values were abnormal. Currently, his values are all back within normal range and plans on following through with his HCPs recommendations about getting the second dose. Wanted to know if that had been reported before and if he needs to restart the series due to him currently being at day 55.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Information regarding Prevnar was received from a healthcare professional regarding a female infant (between 0 and 6 months) who on 26-NOV-2007, received a first dose of Prevnar along with a dose of Haemophilus Influenzae B (manufacturer unknown), a dose of Pediarix and a dose of Rotarix. On 26-Nov-2007, the patient received a dose of Prevnar along with other childhood vaccines. On 28-Nov-2007, approximately 48 hours post-vaccination, the child died. The cause of death was unknown. An autopsy was performed, but results were not provided. No additional information was available at the time of this report.  1/22/08 Reviewed ER medical records of 11/28/07 which reveal patient found in crib by family.  Transported to ER via EMS & pronounced DOA. 1/24/08 Reviewed pcp medical records which reveal patient in good health on 11/26/07 except for slight weakness of left arm & suspected brachial plexus birth injury.  Note indicates patient received Pediarix, Prevnar, Hib & Rotavirus vaccines but no vax record included w/notes. 2/12/08 Received vax records.  5/6/08 Autopsy report states COD as SIDS.  Manner of death: natural.
I slept a lot for the first 2 weeks after receiving the vaccine after those 2 weeks I started having joint pain and my hand swelled up and I lost muscle mass in my arms and I was having getting up and down off the bed and tolite and trouble walking. I lost 9lbs and it was basically muscle mass.   Last doctor visit:  8/11/2022
Dizziness, low-grade temperature, complete lost of appetite, lost of energy, sore arm at injection site, swelling of glands in armpit, generally felt ill and did not get out of bed other to go to the bathroom for 48 hours. Now, feeling weak and listless (60 hours later).
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# ER8736), via an unspecified route of administration, on Apr 29, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient had bronchitis on May 14, 2021. Reportedly, patient was supposed to get 2nd dose tomorrow, May 18, 2021, and wanted to know if she can get the vaccine while taking prednisone or if she needs to wait until she finishes before getting the vaccine. Therapeutic measures taken as a result of event included prednisone. She started taking it on Friday, May 14, 2021. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Nausea, dizziness, running nose, muscle soreness, fatigue, general unwell feeling.
The night of the shot I had a headache and some fatigue with some nausea. The next morning when I woke up around 8 am my arm was sore and my entire body felt achy. Over the next couple hours my body was progressively achy to the point of not wanting to move. By 12 pm I was in tears of just how much my body hurt. This is also around the time I had a fever of 101.3. I took a double dose of ibuprofen and attempted to sleep it off however I was only able to fade in and out of sleep because despite taking medicine my fever started to climb more and more high and the chills started to intensify. I recorded my fever through out the day and watched it climb more and more high until about 6 pm it was at 103.4. My head was pounding, my ears were hearting, my body aches so much and despite having chills I felt as if my body was over heating to the point where I had to put a bag of ice on my neck and a cool wash cloth on my head to cool down. I took more ibuprofen and eventually my fever went down again. By 11 pm it was back down to 101.3 and I felt so exhausted o went to bed however I woke up about every 2 hours and tossed and turned all night as my fever went back up to about 102 and I had chills. I woke up today about 7 am feeling better from yesterday but my body is still slightly achy, fever is low grade at 100.6 and the chills have eased. The sides in the back of my throat are very swollen and painful still though and have been since the night I received the shot.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient had syncope with her 1st dose of Pfizer and also experienced similar symptoms this time as well. First BP reading was 98/48 HR 89 and second reading 104/70 HR 87. She recovered after 15 minutes.
p/vax pt exp arm (inj site) was swollen up to the shoulder; hot to the touch; painful; red; addl pt had a rash (inj site); ER visit required;
An extra dose of VAQTA was given to an 8 year old female patient. She states that the physician did not have records at the time of administration and after going back to look at records when they became available the serie was completed; This spontaneous report has been received from a registered nurse regarding an 8-year-old female patient. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On an unknown date, the patient was vaccinated with an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscular injection, at a dose of 0.5 mililliters, administered as prophylaxis, (strength, route of administration, and anatomical location were not provided; lot number W036268 had been verified as a valid number and the expiration date was established as 20-MAY-2024) (extra dose administered).
Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad; Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (he only has little issues with dairy products) and Hypercholesterolaemia (High cholesterol started before receiving the vaccines).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itchy, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) ongoing since an unknown date for Hives and Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) to be related.    Concomitant medications included medication for his high cholesterol once in a while. Patient went to the doctor and he told him his symptoms were caused by the Moderna vaccine and that they could last from 2 weeks to 2 months, patient was taking Benadryl but it did not worked, then he took Allegra and worked fine. Symptoms have improved, but patient stated that it has been more than 2 months and he is still having symptoms and taking medication. Patient was willing to help by giving his blood for research. Patient was never tested positive for COVID.   This case was linked to MOD-2022-504212, MOD-2022-504209.
Patient received Gardasil immunization at approximately 12:15 pm. Stayed at doctor's office for 20 minutes following the immunization. At approximately 1:30 pm received call from patient's mother stating she was having a swollen tongue and hives on the right side of her face. Patient has history of significant allergies. Requested that mom give patient benadryl and to monitor for changes. Patient's mom was instructed to use epi-pen and call 911 if the patient's symptoms did not improve after benadryl.
Patient's daughter stated her mother developed a round swelling at the injection site- 2 weeks after the injection. The color was light pink and it was the size of her hand. Patient went to see her primary doctor and was prescribed Medrol dose pack. The medication took away the swelling per daughter.