chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a healthcare worker and a consumer (the patient's mother) concerning an 18 year old female patient. None concurrent conditions, pertinent medical history and drug reactions/allergies were reported. The patient was not pregnant. On 12-FEB-2015, the patient was vaccinated with the first dose of GARDASIL, (Lot # K009902, exp. date unspecified). On 30-JUN-2015, the patient received the second dose of GARDASIL, (Lot # K011138, exp. date unspecified), 0.5 ml, intramuscular injection, as recommended by the physician. There was no concomitant medication reported. In approximately November 2015 (reported as "about a month ago"), the patient had a ferritin level drawn at her school for an unspecified reason which result was "low" (unspecified level), the patient sought medical attention. There was no significant disability or incapacity, hospitalization or prolonged, nor life threatening. At the reporting time, the outcome of the patient's ferritin low was reported as not recovered. The causal assessment of the patient's ferritin low to GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
I got the vaccine and the following morning I had the worst headache I have ever had. I felt like my head was going to explode, and I took ibuprofen and Tylenol. I also had a fever and excruciating pain at the injection site, this all went away within 3 days. On 05/07/2021 I woke up with a really bad headache and I was dizzy, I took ibuprofen and Tylenol and it seemed to be getting better. And finally on 05/11/2021 I woke up again with a headache and dizziness, this is the day I went to my primary care doctor and he told me that he has seen this pretty frequently with the moderna vaccine. He said that it was brain swelling and inflammation. He told me to take ibuprofen and Tylenol every 6 hours for a week and that if I was still experiencing these side effects then I can come back and he will prescribe me steroids. It has now been 3 days, and my head still hurts and doesn?t feel normal. He also told me that if I get tingling in my fingers or blurred vision to go to an emergency room right away.
Had temperature of 101.8 degrees F at 8 PM. Gave Tylenol 650mg. Two hours later, temperature was 99.7 and I gave Motrin 400mg. Temperature was 97.7 by the next morning at 07:10 AM.
Had no immediate symptoms - a bit of pain initially. Then 7 days after receiving the first dose, noticed my arm itched. I looked and there was a large puffy red circle where I received the injection. The redness has lessened after four days, but still itches.
Pain at the injection site started on Friday 10/01: it hurts to elevate the left arm but can tolerate the discomfort.  Redness at site of injection started on Saturday, 10/02: not a big deal either. However, scary symptoms commenced this morning (10/04/2021), approximately at 9:30/10:00 --it gradually started with muscle pain (back and neck),  fainting feelings, strange stomach discomfort; low blood pressure (103/67; heartbeat: 74. Started to feel packnicky and my heartbeat accelerated. Now I feel I am getting a stuffy nose.
No fever, 8 cm x 10 cm erythematous indurated area on 3rd day after vaccine was administered. Minimal erythema and warmth by 3rd day.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no pertinent medical history or drug reactions/allergies. On 10-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K007986, 09-MAR-2015) (dose and route not reported). There was no concomitant medication. On 10-NOV-2014, the patient developed a 4-5 inch are of swelling and redness at the injection site after administration of ZOSTAVAX. The area of reaction was painful and itchy. No lab test was performed. The patient self-treated with unspecified topical anti-itch cream and antibiotic cream applied to the area of reaction. The patient sought medical attention via calling the pharmacist. The pharmacist suggested to the patient to take ADVIL. At the time of reporting, the patient had not recovered from the events. The causality between the events and ZOSTAVAX was not reported. Additional information is not expected, as the physician asked not to be contacted.
Pt received hepatitis A shot at unknown PCP around 12pm. Mom said he was in usual state of health prior to that. Later that day, Mom took child to park and he developed a generalized tonic-clonic seizure that lasted around 2 minutes. He was transported to ED. He had brief post-ictal period but was back to baseline by 3pm.
Bad vomiting, ever 20-30 minutes, diarrhea every two hours, fever 101 degree , dizzyness 12-24 hrs, migraine (no hx).  Onset 08/15/2008. Went to Medical Center received medicine for vomiting.  No antibiotics if virus. Symptoms diminishing by 08/17/2008.  ER suggest flu but mother disagreed as daughter had similar reaction in 2006 after taking Menactra Vaccine. Vaccine received on 07/29/2008 was HPV Vaccine.
High fever, chills, aches, dizziness, pain in lower extremities.  Diagnosed with the "flu" following the shot.  Hospitalized with pneumonia, severe pain in lower extremities, vomiting and dizziness.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-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 PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment included Aspirin
Patient has blister like bumps on her arms and she said it was on her chest. However,  those on her chest were not as bad and getting  better. The spots did itch and she did get some cortisone cream to put on them. She did claim that she had been working on pulling weeds around the same time she had received the shot so she was unsure if the shot had caused this or if she was exposed to something.
Sick; Not able to eat/was just eating cereals; Threw up twice last night; Sore arm; Feel like crap/Knocked out for four days; She could not get out of the bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Amantadine. Past adverse reactions to the above products included No adverse event with Amantadine. Concurrent medical conditions included Multiple sclerosis since December 1994 and Fibromyalgia since 2000. Concomitant products included PANTOPRAZOLE, DIMETHYL FUMARATE (TECFIDERA), VITAMIN B3, VITAMIN B12 [VITAMIN B12 NOS], CLONAZEPAM and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed) and PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VOMITING (Threw up twice last night). On an unknown date, the patient experienced ILLNESS (Sick) and FEEDING DISORDER (Not able to eat/was just eating cereals). At the time of the report, FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals), PAIN IN EXTREMITY (Sore arm) and VOMITING (Threw up twice last night) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins B12 & D3. Treatment information included icing on arm for sore arm The patient thought adverse events were caused as the patient stopped taking amantadine.      Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information received on 27-Apr-2021: Reporter details, patient details, medical history, concomitant medications, update on initial adverse events and new adverse events were added. On 28-May-2021: Initial additional information received on 28-May-2021: Patient demographics, medical history, concomitant medications, and event outcome were added.
Approx. 30 mins post injection child had trouble breathing and became pale. Epinephrine 15mg given then child sent to ER.
passed out in car and went into an accident; passed out in car and went into an accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the right arm on 21Jun2021 16:00 (batch/lot number and expiry date unknown) at 36 years of age as dose 1, single for covid-19 immunization in a doctor's office/urgent care facility. Medical history included malignant melanoma. The patient had no covid prior vaccination. There were no concomitant medications. The patient had no other medications in two weeks. The patient had no other vaccine in four weeks. The patient informed that on 21Jun2021 16:30, she passed out in car and went into an accident. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. The patient has no covid tested post vaccination. The patient did not received treatment due to the events. The outcome of the events was recovered.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
No adverse event occured.  We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Redness developed at injection site the day of administration. Complains of itching at site. Erythematous from top of deltoid to 4cm above elbow. Cool compress, Benadryl, Motrin as needed
Received moderna vaccine on 04/07/21 and 05/05/21. Presented to ED on 1/7/22. Presented to ED  with 10 days history of intermittent abdominal pain, worse for few days, patient denies any fever, nausea vomiting and diarrhea. COVID positive 2 days ago but he denies any fever, cough shortness of chest pain. Regarding labs WBC 17.37, C-reactive protein 157  otherwise CBC CMP unremarkable, Admitted for perforated diverticulitis though. Discharged on 1/13/22
Delayed dose Administration; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) and ARTHRALGIA (Aching joints) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Psoriatic arthritis and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and COVID-19 VACCINE (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) and ARTHRALGIA (Aching joints). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) outcome was unknown and ARTHRALGIA (Aching joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided  No treatment information was provided
Patient called to report redness of apx. 1 inch in diameter at vaccination site, itching and headache. She has notified her primary care physician.  Was advised to take Benadryl for itching  and Tylenol for headache.
My arm was very difficult to raise and experienced serious pain for 48+ hours. I was unable to sleep due to pain and felt my shoulder and arm were not able to lift, push or pull any weight. I am still experiencing pain even though I am taking Advil.
Noticed black dot on patient's right arm immediately after administration of MMR. 04/16/2009 Office protocol requires MMR to be administered via Safety Glide needle.
RECEIVED 0.25ML OF H1N1 VACCINE INSTEAD OF 0.5ML. THIS WAS BOOSTER DOSE.  PER SANOFI, IT ISN'T NECESSARY TO REDOSE.
Pt woke up 10/10/02 with pain, swelling, erythema and induration of lateral aspect of left upper arm.
One day post vax, pt developed a fever of 103F, nausea, hypertension and dizziness and was taken to the ER.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.32 No concomitant medications were reported. On 31-Mar-2021 at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit, total 199 doses given for the day and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 31-Mar-2021. Number of vials sent to clinic was 3.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
On March 11th 2021 my mom collapse from a sudden brain hemorrhage. The was a little than 2 weeks after her 2nd Covid Vaccine. Following her first vaccine she experience brain fog and an increase in migraines. This continued for a week to a week 1/2. Then following her second she had the same symptoms again which lasted 1-2 weeks.
Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose (unknown), and route of administration (unknown), for unknown indication. No concomitants were reported. On an unknown date, the patient developed a case of shingles after receiving the ZOSTAVAX. On an unknown date, the patient broke up in a rash with blisters around her torso. Also felt nerve pain around her abdomen. No product quality complaint was involved. The outcome of event was unknown. Causality was not provided. The reporter did not wish to document or share any contact information. Additional information has been requested.
pt currently pregnant. Negative pregnancy test while in office on date of administration. According to ultrasound pt would have been pregnant on date of administration. EDD 8/2020
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included CEFOPERAZONE SODIUM (BACTIMED [CEFOPERAZONE SODIUM]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
pt recvd vax;toes became numb;numbness spread up legs, trouble breathing,unable to swallow,blurred vision;adm to hosp 5jan95;dx:GBS; still hosp;
Sore arm; Quick tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  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.
Apparently a day prior to presentation he had a mechanical fall at the living facility where he resides .  In the ER he was noted to be hypoxic COVID-19 testing came back positive Seen with some lactic acidosis, with creatinine elevated to 1.4, he was commenced on steroid.  Discharge diagnosis :  Acute encephalopathy COVID-19 infection Acute renal failure Elevated blood sugars Elevated CRP Lactic acidosis resolved
My left arm hurt very bad. Within three days , my shoulder was in too much pain to use. It worsened and ached and throbbed with Extreme pain even when not moving it. I could not sleep or use the arm at all. The whole shoulder and arm. It was constant agony red.
Lt arm - significant swelling and redness Rt arm measures 11 in - Lt arm measures 13 in.
6/22/11 1:45pm.  T.C. rec'd from pt's father, stating that daughter had swelling at the site of one of the shots she had rec'd on 6/20/11.  States that the swollen area is slightly red and warm and "only covers the area of the shot".  I asked the father to tell me which arm and he stated "the one that only had one shot", but he couldn't tell me right or left.  When I prodded and said it was a very important piece of information for documentation he stated that he wasn't sure because he wasn't with his daughter right now to see but he thought the right arm.  He also stated that his wife was putting ice to the site.  I instructed him to give comfort measures including cold compress to site and Tylenol or Motrin as directed on bottle and to monitor the site and take daughter to Pedi or ER if condition worsenes.  Also informed him that I would be completing VAERS for CDC and for him to contact me if the information on site was incorrect.  He verbalized understanding.