chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021); A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021).   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 22 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 on 09 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.   HCP (healthcare professional) reported that a patient was administered with the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021). No further information was reported.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event was unknown.  The reporter did not provide an assessment for the event, patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021).; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Child received H1N1 injection at 9:48 am and at 9:52 passed out. Came to within a few seconds and was A&OX3. Approximately 5 min later she vomited and was taken to medical room and 911 called. Was evaluated at ER and discharged with diagnosis of Syncope-Vasovagal.
big rash; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (sore) and RASH (big rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, ROSUVASTATIN, DULOXETINE, ZINC, PROBIOTIC 10, UBIQUINOL and VITAMIN D2 for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (sore). On 03-Feb-2021, the patient experienced RASH (big rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. On 28-Jan-2021, PAIN (sore) had resolved. At the time of the report, RASH (big rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The pharmacist, did not dilute the pediatric pfizer shot. She  gave patient 0.2mls of undiluted pediatric pfizer vaccine
Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6201), on 10Mar2021 as dose 2, single (Lot number: EN6208) and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jul2022 as dose 4 (booster), single (Lot number: 060A22A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 28Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jul2022, outcome "unknown", described as "Name of Drug as Reported: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovoid from 10Jan2023 to 14Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & pt exp elevation in liver enzymes;the nurse reported two patients;they were assigned WAES96071016 & 96071017;
Patient was still experiencing fatigue, and local redness and soreness at the injection site a week later.
24hrs p/vax pt started fever 100.7 to 103.8 controlled w/APAP but pt was very listless & had low grade fever until 2JAN96;11Pm temp back up to 103.8 was seen by MD & referred to hosp for admission on 3JAN96
Second shot I had mild fever; mild right shoulder pain.; flulike symptoms; Shaking; chills/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking), CHILLS (chills/severe chills), PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No medical history was provided by the reporter.  On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking) and CHILLS (chills/severe chills). On an unknown date, the patient experienced PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.). On 09-Mar-2021, INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking) and CHILLS (chills/severe chills) had resolved. At the time of the report, PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.) outcome was unknown. No concomitant medications reported. No Treatments were reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: added fever. shoulder pain.
administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 3rd October 2022, the patient received Havrix. On 3rd October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 03-Oct-2022 Reporter's comment: The nurse called and asked for the information about the administration of an expired dose.  The reporter asked for recommendations about patient re-vaccination.  The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
patient received his bivalent booster in december 2022 and he received again another bivalent booster 03/13/2023.  no reaction and it has been 3 months since original bivalent was given
This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a adult female patient who received FLUARIX. Co-suspect products included FLUARIX. In 2009, the patient received FLUARIX. In 2012, the patient received seasonal Influenza vaccine. On an unknown date, an unknown time after receiving seasonal Influenza vaccine and not applicable after receiving seasonal Influenza vaccine, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was recovered/resolved and the outcome of the lip swelling was unknown. It was unknown if the reporter considered the lip swelling to be related to seasonal Influenza vaccine. It was unknown if the reporter considered the lip swelling to be related to seasonal Influenza vaccine. Additional details were received as follows: The reporter stated that, each time after receiving Flu vaccine the patient experienced lip swelling. In 2009, the patient received unspecified brand Flu vaccine. In 2010, the patient received Flu nasal mist (unknown brand). In 2012, the patient received unspecified bran Flu vaccine. The patient experienced lip swelling each time after receiving Flu vaccine and Flu nasal mist. The reporter did not know if patient was treated for the lip swelling. The brand names and batch numbers of the vaccines were not available.
Very sore arm, large light red rash below injection site occurred within 12 hours of getting shot. Then developed normal symptoms of severe muscle aches (legs and buttocks most severe), fatigue and general malaise (but no nausea).
2nd shot was 03/05/2021. Left arm was sore almost immediately.  Mild flu like symptoms next 3 days. Extreme fatigue. 04/09/2021 left side of neck - 3 swollen lymph nodes. Started as stiff sore neck.  Made appointment with primary for the next Monday 04/12/2021. But in Friday my right side of neck swelled and hurt. Then the lymph nodes swelled. Sore throat. Became worse than left side which was still swollen. Also had sore develop inside mouth. Severe itching to lower face. Saturday I went to Urgent Care. Dr. believed it was allergic reaction to cleaner I was using. The itching probably was. But I have never had my lymph nodes swell like this before. Today is the 23rd and my lymph nodes are still slightly swollen.
I did not have an adverse reaction to the vaccine. I was very sick prior to testing positive for COVID-19 on 09/09/2022. I had fever, respiratory issues and brain fog. I contacted my doctor and got a prescription to help with my symptoms. As of today, I have horrible migraines.
10 days after MMR and varicella vaccines given awoke with red spots all over body.
Pt experienced lightheadedness after receiving a FLUVIRIN vaccine. He gently lay down on the floor. Check BP 70/50 - pt rested for 45 minutes and his BP returned to normal.
Left thigh erythema with purplish discoloration centrally, non tender, warm about 4x6 inches in size.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: PATIENT DEVELOPED A RASH AFTER THAT MAY BE RELATED TO VACCINE MODERNA BIVALENT ON 9-20, ADVISED TO SEE MD AND TO TAKE BENADRYL AS NEEDED
Developed Shingles shortly after: Skin sensitivity began 3/1/21, severe back pain following 2 days later, and rash appeared 3/6/21
Fever 102 for 8 hours, chills Headache for 3 days Generalized muscle and body aches for 3 days
dizziness; losing weight when I was not trying to; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), WEIGHT DECREASED (losing weight when I was not trying to) and MYALGIA (little soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included PRAVASTATIN for Cholesterol, TAMSULOSIN for an unknown indication.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (little soreness). In July 2021, the patient experienced DIZZINESS (dizziness) and WEIGHT DECREASED (losing weight when I was not trying to). On 21-Jan-2021, MYALGIA (little soreness) had resolved. At the time of the report, DIZZINESS (dizziness) and WEIGHT DECREASED (losing weight when I was not trying to) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 106 (Low) systolic pressure-106- low, 95/48 (Low) 95/48- low and 127/70 (Low) 127/70-low. On an unknown date, Weight decreased: 200 (Low) 200 lbs -  weight decreased.         Relevant concomitant medications were also included water pill and  blood pressure medications.  It was reported that when patient  was put on blood pressure medication, he was physically fit with 175 lbs , and when he was in his 50s he had some injuries due to which he ended up gaining weight and became 250 lbs.  Patient  took his blood pressure medicine when he experienced dizziness for the second time and the blood pressure dropped to 95/48. He stopped his blood pressure medication when the blood pressure started dropping and he had been off his medication for 11-12 days .  The treatment information was  not provided.   This case was linked to MOD-2021-292974.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot# K010222, expiration date: 12-MAY-2016, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Booster; Tested positive for Covid on 04Jan2022; Tested positive for Covid on 04Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Tested positive for Covid on 04Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Clinical course: adverse event: (withheld) said that someone they saw at # tested positive for Covid on 04Jan2022. withheld got tested on 05Jan2022 and is awaiting results. They are fully vaccinated and boosted, and they have noticed no symptoms 5 days from potential exposure. They believe they have avoided contracting Covid but the test will confirm. (withheld) is of #. I do not know what vaccine they have gotten (Moderna vs Pfizer). I reported info for (withheld) in this submission, but I really wanted to submit this information because the person they were hanging out with may have also been vaccinated - unsure as I do not know who it was.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Received the first of three Hepatitis B (Engerix B) shot in the left deltoid at 16:10 on 5/17/06. Already read the Hepatitus B info packet and signed the consent form. Also stated that he was not allergic to bakers yeast. After the shot, I asked to have a seat for 20 minutes to make sure he doesn't have an allergic reaction. At 16:17, the employee was standing at the front desk typing into his pager when he said he wasn't feeling well. I caught the employee as he was beginning to go limp. I got the employee back to the exam room and laid him on the exam table. The employee was sweating profusely and signe of pallor. Stated that he was feeling diszzy, nauseaous and might throw up. Also stated the he was very tired and his arms and legs were tingling. Upon observation, the lips began to swell up. Stated that he did not feel any tightening in his throat.  I had the MERT team paged out and EMS system implemented.  I immediately placed him on 15 liters of oxygen via non-rebreather.  The vitals were BP 142/102, pulse 126 and breathing was shallow. Ambulance arrived on scene and transported to hospital.
Severe headaches for 12 days following vaccination More debilitating was the onset of severe gait imbalance, dizziness, and vertigo.  Evaluated in emergency room on November 29, 2021 after being home and essentially bed ridden for almost two weeks after vaccination. Unable to work ( I am a physician ). Had MRI of brain and carotid duplex. Likely diagnosis ; vestibular neuritis triggered by covid vaccination. Now on high dose prednisone and receiving vestibular rehabilitation to aid in recovery. Needed to reduce to part time employment for month of December 2021.
Immediately after vaccine patient felt light headed. Observed her at site and After about 30 minutes felt better. She was able to walk to join her father. Approximately 45 minutes after leaving vaccine site (1hr 15 min after vaccine) had brief LoC likely vasovagal incident. EMTs responded and patient taken  to ER. Was responsive after episode.  No evidence of airway edema, mucosal selling or SOB.
Incorrect diluent volume but 0.3ml dose was still given. Higher than authorized dose volume administered. Patient had no immediate side effects to vaccination. Patient was contacted once medical error was noted and patient reports no additional side effects at the time other than slight elevated heart rate with no chest pain. Requested that he monitor his symptoms and call office if any occur or seek emergency care if necessary.
On the right side of my upper body, I notice a red rash that was painful and itchy. I could not lay down to sleep or put pressure on any of the areas. I was out of town, so I went to a local Urgent Care and upon examination she knew I had shingles. I was prescribed a 10 day course of antiviral. Within three weeks I feel like I have recovered.
Red indurated area on left deltoid subcutaneous area with increased warmth at site of MMR injection - Pt came to clinic 48 hours later.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J000445, expiration date 11-APR-2014), (dose and route unspecified). The outcome of the event was unknown. This is one of several reports received from same source. Additional information is not expected.
Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell.
Patient states that she has had two cases of shingles since getting the vaccine, in a different dermatome and with more pain, than her breakouts previous to the vaccine. She believes she may have gotten a "bad batch" and would like it reported.
daily t102-104 lasting up to 3 wks assoc w/severe arthritis shoulder, hips, knees, neck;arthritis responded dramatically to naprosyn but still has fever; onset 21 days following MMR:
Patient is on ACTEMRA for RA and should not have received any live vaccines, the patient did not report any symptoms from MMR vaccine. However, since the patient received 4 vaccines in one arm, patient has stated its been more than a month and her arm is swollen, sore, painful, and hard for her to lift her arm up.
vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 10-week-old female patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient had no known drug allergies (NKDA). Concomitant therapies were not provided.   On 15-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the right upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the left deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2309USA002333 and 2311USA005371).
11/12/2020 at 9:30 pm patient starting having immediately that progressed through out the weekend.  Caller had sever nausea and did not have the use of the arm. No redness or swelling. Caller went to  primary care on 11/23/20 and was told to take Ibuprofen and wait for the pain to lessen. Caller is still  in a lot of pain.