chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have been vaccinated with the Moderna, last week, and i am being called 7 days after, to have; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have been vaccinated with the Moderna, last week, and i am being called 7 days after, to have) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have been vaccinated with the Moderna, last week, and i am being called 7 days after, to have). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (have been vaccinated with the Moderna, last week, and i am being called 7 days after, to have) had resolved.            No concomitant medication included.  No treatment medication included.
Covid19 breakthrough.  1st Vaccine received on 02/19/2021.  65y/o with PMHX of Type2 DM, Chronic Bronchitis, HTN, HLD presents to ED with 1 month c/o cough and 1 week c/o chest pain.  Pt originally saw her PCP where she tested positive for Covid.  PCP referred pt to ED for Imaging and f/u of CP.  CTA Chest with LLL opacities and small patches groundglass airspace disease RUL.  Room air sat 99%, pt afebrile.  Cardiac enzymes positive and EKG with ischemic changes.  Pt diagnosed with Covid PNA and NSTEMI.  Started on Steroids and Heparin gtt.  Plan heart cath once respiratory status improves.
The caller said his wife got the first vaccine an hour ago then experiencing multiple sneezes.; This is a spontaneous report from a Pfizer-sponsored program . A contactable reporter reported for a female patient (wife). An unspecified age of female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: Unknown), via unspecified route of administration in left arm on 13Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced the caller said his wife got the first vaccine an hour ago then experiencing multiple sneezes. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Drug interaction rash on my chest. It was veryitchy.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 06Mar2021 at 10:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patients medical history were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of the vaccination. On 15Mar2021 at 12:00, the patient experienced a diagnosed drug interaction rash on her chest, which was very itchy. The adverse event result in a visit to the doctors or other healthcare professional office/clinic visit. The patient was treated for rash pruritic with ZYRTEC, BENADRYL and topicial cortisone cream (MANUFACTURER UNKNOWN). The clinical outcome of the event drug interaction rash on her chest, which was very itchy was not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
The arm began to feel sore roughly 6 hours after injection. At approximately 10pm,  took Tylenol and went to bed but had a tough time sleeping that evening, suffering from chills mostly. In the morning,  woke with a headache, sore arm and body aches; had the day off from work so took it easy all day. By mid afternoon the day after receiving the booster, had a fever of 100.2, body aches, some tightness in his chest, and headaches throughout the remainder of the day; took ibuprofen on this day and it seemed to help temporarily with the arm pain. Went to bed that night and suffered from night sweats, woke the next morning to a very sore injection site and swollen lymph nodes in the left armpit. At the point of writing this information, it is the start of the third day after receiving the booster and he is still complaining of off and on chills & headaches, soreness throughout the body and swollen lymph nodes under the left arm.
20 minutes post vax, the pt had a local reaction at the DTAP site. 2 hours later hives appeared on arms and neck. The pt also experienced a low grade fever. Treated with Benadryl and Tylenol.
Pt. got vaccine and in 5-7 mins. he fell on the ground but was conscious. He complained that he had blurred vision and could not stand. he was made to sit in the chair in the vaccination area under observation and he was ok in few mins.
Saturday - Roughly 2 hours after getting the vaccine I became very sleepy and went to sleep. My left arm was sore at the injection site.  8 hours after the vaccine my chest began hurting if I lay flat down in my bed so I lay more upright that night.  Sunday - The next morning I woke up and my lymph nodes were very swollen under my left arm and then moved into my left breast.  Added Tylenol to meds I was taking. Monday /Tuesday - rested.  Pain in my chest grew stronger progressively each day like someone was sitting on the center of my chest.  Remained in bed most of the day.  By Tuesday night the pain was becoming somewhat intolerable.  Took an extra pain pill to keep from going to the hospital.  Did not get much sleep at night.  Had skipped heartbeats and heart racing.  Wednesday - Woke up in with a lot of chest pain.  Called my primary care doctor.  Called CDC.  Filing this.  Waiting on the doctor to return my call.  If I let the oxycodone wear off even a little the pain in my chest is so bad.  Also tried to walk my dogs in my back yard and the exhaustion was unreal.  Too exhausted to put on my makeup or do anything but go back to bed and rest.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously; lot# and expiration date unknown. It was reported that the patient received a dose of ZOSTAVAX, exposed to -10.8C for 23 hours (date of the temperature excursion unknown). No adverse effects were reported. Additional information has been requested.
upper respiratory symptom; all sorts of flu like symptoms; fever; She was sick for exactly 8 weeks; and did not receive her second dose; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose). At the time of the report, RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication information provided No concomitant medication information provided Patient sated that she received the Moderna COVID-19 vaccine last march2021 and developed upper respiratory symptoms, all sorts of flu like symptoms and fever. Patient was sick for exactly 8 weeks and did not receive her second dose. Patient's physician advised her to get the Pfizer COVID-19 vaccine. Patient wanted to know if she should restart her primary vaccination series. Patient was 56 years old when she received the Moderna COVID-19 vaccine. Patient was 57 years old at the time of reporting.
No additional AE details; Professional in charge of vaccine storage calling for evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Professional provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report has been received from a professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1879864 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number 1879864 confirmed to be valid, expiration date reported and stablished as 19-OCT-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003021:Case number: 02242077 S-009507513-2209USA002510:Case number: 02242136 US-009507513-2209USA002566:Case number: 02242139 US-009507513-2209USA002779:Case number: 02242131 US-009507513-2209USA002481:Case number: 02242135 US-009507513-2209USA002570:Case number: 02242096 US-009507513-2209USA002722:Case number: 02242097 US-009507513-2209USA002574:Case number: 02242099 US-009507513-2209USA002469:Case number: 02242101 US-009507513-2209USA002573:Case number: 02242103 US-009507513-2209USA002606:Case number: 02242106 US-009507513-2209USA002532:Case number: 02242109 US-009507513-2209USA002746:Case number: 02242132
Warm to touch the injection site; Redness in the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant  product use was not provided by the reporter. No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX) for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In April 2019, unknown after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGIRX. Additional details were reported as follows: Initial information reported by the patient's husband. The patient received SHINGRIX and diagnosed with Shingles early in the week of reporting. The patient had no outbreaks of shingles since June 2018 when the patient received most recent dose. The reporter was driving during the report, so as much information was captured. The reporter did not consent to follow up.
Localized redness, warm to touch, itching, discomfort. Proquad was reconstituted with the Kinrix.
Patient started with a red area size of half dollar on 12-27-06 then redness increased to include arm from shoulder to elbow some swelling treated with Benadryl.
Achiness on my left side of my neck; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Patient had not been diagnosed with or tested positive for COVID-19.  The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Food allergy (Red dye 40 allergy and intolerance), Food allergy (Yellow dye 5/6 allergy and intolerance), Hypothyroidism since 05-Mar-2021 and Scoliosis (Lumber spine) on 06-Jan-1975. Concomitant products included LEVOTHYROXINE from 05-Mar-2001 to an unknown date for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 from 12-Sep-2019 to an unknown date and ASCORBIC ACID (VITAMIN C WITH ROSE HIPS [ASCORBIC ACID]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue). At the time of the report, NECK PAIN (Achiness on my left side of my neck) and FATIGUE (Extreme fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.       Frequency of Vitamin C with rose hips was reported as as necessary.  Treatment medications were not provided.   This case was linked to MOD-2021-020909 (Patient Link).
Case number PHHY2014US021411 is an initial literature report received on 15 Feb 2014. The author discussed about the high intensive care unit admission rate for 2013-2014 Influenza associated with a low rate of vaccination. Thirteen of 55 (23.6%) patients were vaccinated against influenza at least 2 weeks prior to the onset of their acute illness. This report refers to a patient of an unknown age and gender, among the thirteen patients who received influenza vaccination. His current condition included chronic lymphocytic leukemia for which the patient received rituximab. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient got admitted in the intensive care unit. The patient tested positive for influenza virus. It was reported that there might be likely an impeding adequate immune response to vaccination. The outcome of the event was not reported. The author concluded that there observations support encouraging influenza vaccination for all individuals without a contraindication, as this might prevent severe lower respiratory tract complications requiring ICU level care. Following an internal review, a significant correction was done for the information received on 15 Feb 2014. Added events (influenza and vaccination failure). The case upgraded to serious from non serious due to vaccination failure.
The patient developed redness, induration, and swelling of the left thigh at the site of the polio, varicella, and influenza immunizations, increasing over 36 hours, subsequently treated with cephalexin and TMP/SMZ for suspected cellulitis and lymphangitis, and much improved by 10/21/11. Immunizations given in the right thigh posed no problems.
Diarrhea, vomiting, muscle spasms/body shaking for one hour 36 hrs after first injection of covid vaccine.   Could not stop the body from shaking. No temp. Vomiting 3 times then stopped. Fine the next day so within 48 hours no symptoms.
Irregular heartbeat No outcome yet as I am STILL WAITING for another test, the symptoms have improved, but are still present.  Just with less frequency.
I spiked a 103 temp at 2am. Became nauseated, excruciating headache and neck ache, coughing badly, eyes burning.  By 5:30 am, I decided to take an Aleve to try and bring down the fever.  I also had 1 puff of my inhaler to try and calm the cough with no luck.  I was finally able to sleep for about an hour with my head on an ice bag.  It?s now 9am and my fever is returning and so is my headache.  My whole body is sore from shivering with the fever and my injection site is sore with a hard lump under the skin.
Sudden onset of very rapid heartrate lasting 15 minutes or more and including shortness of breath and dizziness and feeling of being light headed.   In the 4 days following I had several subsequent similar episodes multiple times per day, but not lasting as long as the first one.   Perhaps lasting a few minutes to about 5 minutes.  Sometimes I also had a low grade headache.
Almost right after receiving the vaccine, I started to feel sore under my neck and my shoulder. The gave me an ice pack. I took 800mg of Motrin. The same night I started to feel like I had the flu. There was muscle and joint pain throughout my body. I had a headache and my stomach was hurting me. I developed a fever and it went as high as 105 degrees. I called the on-call doctor the next day and she said that I would probably be fine by Sunday. I did not feel better and my symptoms continued. My blood pressure became very high too, and I was advised to see my doctor, but it got better. My knees felt like they were on fire. My appetite went away come completely. On Sunday, I called the doctor again and told her how I was feeling. My doctor told me to go to the hospital to get an IV because I wasn't drinking fluids. I couldn't even get out of my bed and I had urinated on myself. I did experience a couple of UTI's after the vaccine. I told the doctor that I would drink broth and my son made me some. Sunday my fever went up and down and at one point. On Monday I started having a headache again and I was very nauseous. I went back to work on Wednesday with a headache. I took homemade soup and I ate there. I still had a headache throughout the day. On Thursday, I felt a lot better. A few days later, I experienced some dark vaginal bleeding, not related to my period. I had a vaginal ultrasound. I had a biopsy and everything was fine. The heavy bleeding continued and I ended up having to get an IUD to control the bleeding. I had some blood work done and my live enzymes were elevated. I had an ultrasound to check everything. I had a fibroid scan as well. I had an endoscopy. The doctor thinks I might have liver sclerosis. I told him that I do not drink. I'm meeting with my liver doctor tomorrow. There are now complications with my thyroid. I saw an endocrinologist and he said that I may need calcium in my body.
Menses occurred halfway through my cycle. Which I have always been regular 28 day on the day cycles. This period began with spotting and progressed to a heavy, painful, period with heavy clotting. The clots were bigger than quarters, numerous,  and lasted a few days. This was unlike any period I have ever experienced. My periods do not give me any trouble and this one is as so bad. I almost called off work. I had to take a heating pad with me. It was not normal. My next period came early as well and now I?m over a week late. I took a pregnancy test and I?m not pregnant. To be concluded...  the conclusion of possible effects are yet to be determined
Immunizations given on 8-27-07 Mom called on 8-27-07 reported increased swelling at injection site. Area red and hot to touch. Seen by MD on 8-29-07" Lt deltoid 3 cm induration, inj. point visible overlying. Total induration 12 cm sup to inf and 5-6 cm ant post. No streaking, No discharge, No crusting, mild ant edema no erythema
When it was time to mix the diluent with the pfizer vaccine, I was reading through the instructions and I had someone draw up the diluent. She drew up the correct amount of 1.8 ml and I checked it. As she was putting the diluent into the pfizer vaccine, a very small amount of the diluent spilled from the syringe and at the top of the needle. She put in the rest of the diluent and then we took the rest of what was left of the diluent and put it inside the the vaccine. When it was all mixed, it looked like we would have the correct amount. We withdrew 1 dose at a time with the correct amount. When we withdrew the the 4th dose, there was only a little bit left on the vial but not enough to give the 5th dose. I really thought there would be enough for 6 doses since we took the rest of the diluent that was left over and put it inside the vial which was 0.2 ml. I should of stopped what I was doing and called someone for help. I will take this as a learning lesson and will be more diligent in the future.
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 17-Jan-2023, 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 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medicine were reported. No treatment medicine were reported.   This case was linked to MODERNATX, INC.-MOD-2023-698746 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698746:Master case