chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; No adverse event; Erroneously patient was vaccinated with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously patient was vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously patient was vaccinated with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously patient was vaccinated with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Erroneously patient was vaccinated with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date was on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    No concomitant medications were reported. Vial size was reported as 5.5 mL. Vial did not undergo any temperature excursion. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-681156 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681156:MOD22-030180-Master Case,same reporter
After pulling out needle from patient's arm (deltoid area), it bled enough to trickle down the arm. The bleeding was stopped immediately when pressure was applied, but soon after administration, a quarter sized nodule appeared under the injection site.  It appeared swollen. Since bleeding had stopped, I decided to give patient an ice pack to ease swelling and pain if any.  Patient stated that there was no pain.  She returned back to pharmacy approximately 15-20 minutes later, and stated that she felt as if the swelling/lump went down.  I contacted patient around 4pm, she stated that nodule was still present and that she was starting to experience a little pain.  I advised her to apply ice for 15 minutes every few hours. Told her to contact us if any problems and will follow up with her as well.
The patient got dizzy, lost vision briefly and fainted; The patient got dizzy, lost vision briefly and fainted; The patient got dizzy, lost vision briefly and fainted; Vaccine reported as HPV vaccine; This spontaneous report was received from a consumer who is the patient's mother via company representative, referring to a 11-year-old female patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 14-JUL-2020, the patient was vaccinated with an HPV vaccine (manufacturer unknown) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient also received 4 other unspecified vaccines on the same date however, no information regarding those vaccines was provided.   On the same date, the patient got dizzy (dizziness), lost vision briefly (blindness transient), and fainted (syncope). It was reported that the events were resolved after a few minutes and the patient was fine afterwards.   The causal relationship between the aforementioned adverse events and vaccination with HPV vaccine (manufacturer unknown) or any of the other unspecified vaccines was not provided.   Upon internal review, the events blindness transient and syncope were determined to be medically significant.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010500:
Had flu vaccine in right arm 10/23/08, 10/24 noticed redness -> pinpoint eccynosis at site of injection, no erythema in immediate area but diffuse confluent mild erythema/ warmth/ fullness around sides and back of entire upper arm. No induration, noi tenderness.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 02/17/2021, 03/10/2021, and 08/31/2021. They tested positive for COVID-19 twice on 10/14/2021. They were also admitted to hospital on 10/14/2021 after presenting to emergency department with a primary complaint of shortness of breath. The individual experienced complications of acute kidney injury, cardiac arrest, acute hypoxic respiratory failure, COVID-19 pneumonia, and acute respiratory distress syndrome. After aggressive treatments did not improve their condition, they were transitioned to comfort care and died on 10/25/2021.
covid 19; long covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient had received the updated bivalent vaccine recently, but still got COVID. Reporter is not sure of the type of COVID-19 vaccine patient has received in the past, but she says it could have been Moderna. Reporter does not have the vaccination records of the patient.   The patient was given Paxlovid for her symptoms as well, and it helped her with her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-737195 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2023: Live follow-up information received included Patient details and updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737195:Second Son Case
BAD PAIN ON RIGHT SIDE (TOWARDS  THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS,  SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE  HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
Patient reports hives appearing 4 hours after vaccine.  Went to sleep and 12 hours later awoke short of breath, diffuse hives, and throat tightness.  Taken to ER and treated with epinephrine, benadryl, and prednisone
Began experiencing injection site reactions within 4 hours. Muscle pain in left arm increasing in pain throughout the day. Awoke at 2:45am  with muscle pain in  arm increasing in severity and muscle pain in thighs. Joint pain in ankles, toes, upper back, right hand, wrist and fingers, left fingers and wrist joint pain, right elbow joint pain,  knee and joint pain. Also awoke with a headache and sinus pressure under left eye. Sporadic calf muscle cramp or muscle pain.
slight itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRURITUS (slight itchiness). At the time of the report, PRURITUS (slight itchiness) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported. Treatment information was unknown.    Reporter did not allow further contact
Warmth at the injection site; Little bit swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE SWELLING (Little bit swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE SWELLING (Little bit swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE SWELLING (Little bit swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
PATIENT FELT DIZZY AND LOST CONSCIOUSNESS FOR A FEW SECONDS. AT THAT POINT,I ADVISED MY OTHER PHARMACIST TO CONTACT 911. I STAYED WITH THE PATIENT UNTIL EMT ARRIVED AND THEY TOOK OVER.
Post vax, pt was in his mom's car, riding home, when mom noticed excessive sweating, pale and lost consciousness for 10-15 seconds. He also, lost sphincter control. Mom brought him hack to clinic for possible seizure.
Call receive Madonna vaccine at approximately 10 AM while driving home around 12:30 PM I started having severe stomach cramps those lasted until February 5 when I woke my husband up saying I needed to go to the emergency room I was vomiting severe diarrhea heart rate accelerated scared tingling all over couldn?t keep anything down this lasted the entire month of February I had to emergency room visits CT scans done bloodwork a colonoscopy endoscopy and I can?t find anything wrong I?m miserable I still can?t eat or drink anything my life is just terrible all because of the vaccine
NONE Given expired covid -19 vaccine: expired 11/22/2022 given 12/19/2022
Symptoms started 2 weeks ago.  Symptoms include: Complaint of having COVID the first week of April. She's been coughing on and off since then. She received her first dose of the Pfizer COVID vaccine on 5/20. Two days later she started coughing more severely, which makes her SOB, and having cold symptoms. She's only SOB when coughing. Today she started wheezing and when she takes a deep breath she feels a "pop" in her chest.   Pertinent Medical History:  Restrictive lung disease from pneumonia in 2015, usually only needs her inhaler 3 times a year.  Went to ED for evaluation -  CHIEF COMPLAINT:  WHEEZING (pt reports wheezing starting today with cold symptoms since may 22. had first dose of pfizer vaccine may 20, had covid back in april) FINAL DIAGNOSIS & DISPOSITION 1. Bronchitis  2. History of COVID-19   MEDICAL DECISION MAKING    Patient presents for evaluation of wheezing with mild cough and shortness of breath.  She had COVID-19 in April, followed by the 1st dose of the Pfizer vaccine on 05/20/2021.  She states her symptoms initially started with what she thought was allergies, but then moved to her chest more recently.  Lung sounds are coarse bilaterally with bronchospastic cough.  Clinical presentation consistent with bronchitis, suspect this is more allergic rather than infectious based on the history.  I did not test for COVID-19, since she is still within the 90 day window of confirmed infection.  Chest x-ray is obtained and shows mild atelectasis on the right, but no pneumonia.  She was given 4 puffs albuterol MDI with improvement in her symptoms.  She has an inhaler at home, advised her to use this as needed for respiratory symptoms.  Patient given 60 mg prednisone in the emergency department, I prescribed for additional days of 40 mg daily to start tomorrow.  She was also prescribed Tessalon Perles for the cough.  Patient advised to follow up closely with primary care for further evaluation and management, she will return if worse or any other concerns.  All questions were answered.  Patient verbalizes good understanding, comfort, and agreement with the plan of care as described.  Patient is discharged home in stable condition.
Influenza given IM right deltoid on 11/7/18. On 11/8/18, noticed lump 1 inch or quarter size, sore, pink and itchy. Took po BENADRYL 2 pills x 2. BENADRYL relieved soreness, swelling, itching. 2 pills of BENADRYL on Sat 11/10/18 and 2 on 11/11/18. Noticed difference (improvement with 1 dose). No ill effects, since 11/12/18.
Breakthrough covid case. Patient presented to ED on 6/16/22 with c/o of runny nose. Fully vaccinated with Pfizer, plus booster. Prescribed Paxlovid. DC home.
Patient was given a Monovalent Pfizer COVID vaccine instead of a Bivalent.   Patient notified. Will contact him to re-immunize in 2 months.
C-reactive protein was 56 times the normal level; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient (unknown demographics) whose C-reactive protein was 56 times the normal level (C-reactive protein increased), while he/she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2020 at 15:00, the patient received 0.7 mL(once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 16-Oct-2020 at 10:00, the patient's C-reactive protein was 56 times the normal level (C-reactive protein increased) 2 days 19 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory test results included: C-reactive protein - On 16-Oct-2020:  [C-reactive protein was 56 times the normal level]. It was also reported that physician states all the past C Reactive Protein levels for this patient have been normal.  It was not reported if the patient received any corrective treatment.  Outcome: Not applicable  There will be no information available on batch number for this case.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA004971 MARRS 1308USA005804 MARRS 1308USA005803). This is one from several reports from the same reporter. Additional information has been requested.
pt recv vax & exp severe pain of whole arm,shoulder,& spine;pain has been lessening,but numbness & tingling of arm persists p/one month;
Injection site got, red, swollen, itchy from time of injection until 5 days later. All symptoms went away day 6. 7th day, got Covid arm; hot, red, swollen, incredibly itchy, swelling growing bigger about the size of a baseball. 45 min after Covid arm, my left anterior forearm felt like skin crawling and was kind of itchy (medial side) until it intensified to tingling and numbness throughout my arm. Then I had right arm tingling/numbness. Then facial tingling/numbness. Then back of neck tingling/numbness. Went to lie down, got bilateral leg tingling/numbness with severe, intermittent calf pain bouncing between both calves. Bilateral leg tingling/numbness lasted 2 hours, with intermittent loss of feeling in both feet. Despite the intermittent lack of feeling in both feet, I was still able to move all extremities. Everything stopped after 2 hours. However, about 3 or 4 times since then, I?ve felt the tingling/skin crawling in left forearm with no sign of any infection/injury/etc. Goes away on its own after a few minutes to a few hours. I feel intermittent weakness in ring finger and pinky on left arm and occasionally on right arm ever since.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 21-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Vomiting-Medium
5-10 minutes after vaccine administration, pt developed scattered erythematous papular rash across face & scalp. Rash resolved/faded over course of subsequent 15 minutes.
Weakness, headache, high level myalgias, fever, nausea, cold intolerance, shaking
Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies, who on 12-MAR-2008 was vaccinated IM in the deltoid (unspecified which deltoid) with a 0.5mL first dose of Gardasil (Lot# 659962/1740U).  Concomitant vaccination included Tdap.  On 12-MAR-2008 the patient experienced dizziness and nausea when she turned her head.  The patient spoke to the office on 20-MAR-2008.  The patient reported that the dizziness was ongoing.  The patient went to the emergency room.  The patient was not hospitalized and the emergency room could not determine a diagnosis.  At the time of the report, the patient was not recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with one dose of GARDASIL. The dose had been stored in a refrigerator without a thermometer and the healthcare worker did not know the storage temperature. No adverse effect reported. Additional information has been requested.
Case number PHEH2012US010027 is an initial spontaneous report received from a pharmacist on 11 May 2012: This case refers to an adult patient of unknown age and gender. This patient was mistakenly received MENVEO (batch number: unknown), two years in a row. No adverse event was reported following this drug administration error.
Information has been received from a consumer concerning her son who has no known drug reactions/allergies and a history of high mercury levels, suicide attempt at 7 years old, numbness in extremities and motor control issues who was vaccinated IM with a dose of MMR. Concomitant vaccination included HIB conjugate vaccine, diphtheria toxoid (+) pertussis acellular 4 component vaccine (+) tetanus toxoid, HIB conjugate vaccine, poliovirus vaccine live oral, diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid, varicella virus vaccine live and hepatitis B vaccine. It was reported that some vaccines were thimerosal free. Subsequently, the patient developed autism with motor and behavioral problems and was hospitalized. Lab diagnostic studies included: baby teeth analyzed for mercury content the result of which was 3040 PPB, and chelating therapy to measure urine levels of mercury, results not reported. It was reported that the patient's mother's family has a genetic abnormality that prevents them from removing mercury from the body. At the time of the report, the patient had not yet recovered. There was no product quality complaint involved. The patient's autism was considered to be disabling. The patient's sister (WAES0503USA01574) had a similar experience after vaccination with MMR. Additional information is not expected.
Immediate fever and neck rash that lasted for 3 days. Starting on day 3 post-vaccination, diarrhea began and child stopped speaking and would make no eye contact. Still currently having chronic diarrhea 6 months later at age 18 months. Diagnosed with PDD (suspicion of autism) at 15 months (3 months after vaccination.)  11/05/09 Vaccine records and medical records received.  Peds well visit notes. Notes questionable autism at 15 month visit.   !8 month visit notes doing great, babbles (says mama).