chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot # K022992 with expiration date of 30-JUN-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended storage range. No adverse effect was reported. This one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning his 22 year old daughter with no pertinent medical history and no known drug allergies who was vaccinated with all 3 doses of GARDASIL (lot numbers not reported) 0.5ml intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified).  Patient had a PAP test done on 22-MAY-2006 which was negative and on 19-DEC-2008 patient had a PAP test that revealed that she had mild cervical dysplasia.  Physician reported that he did not have the dates of administration but said that his daughter finished GARDASIL series a year before she had the abnormal PAP test.  Patient sought unspecified medical assistance.  At the time of this report patient had not yet recovered.  Additional information has been requested.
Redness & swelling of upper arm fine rash on palms treated w/injection - Methylprednisolone 40mg.
Within the hour of first dose: tongue tingling and gums, felt like a nervous system reaction, persisted on and off for weeks. Day 4: Woke up with swollen lips that went down on their own after a few hours without medication. Unresponsive to antihistamines. Pattern has repeated every day since though it is less swollen and goes away quicker. Day 5: hot flashes Month 1.5- Shingles
BROWN SPOTTING BLISTERS ON BOTH ARMS, THEN THEY DRY UP AND LEAVE SPOT AND DRY BLISTER FLAKS OFF. IT STARTED ON FIRST SHOT BUT I WAS NOT SURE UNTIL I GOT THE SECOND THAT WHENI REALIZED  WHERE THEY WERE COMING FROM. PERM DAMAGE TO SKIN
Administration of expired moderna vaccine that were given as booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine that were given as booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines were stored in freezer, took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Patient received first dose of Pfizer vaccine 9/12/21. Second dose administered 10/3/21.  On 10/6/2021, patient developed symptoms of shortness of breath, elevated d-dimer and CT scan revealed PE.
My COVID-19 infection symptoms started on 01/11/2023 in the evening. I had severe tremors, I felt cold, fever, and shaking uncontrollably. At night I went to the emergency room where they did COVID-19 test which was positive. They prescribed TYLENOL and PAXLOVID for 5 days. I was testing positive for a while but I felt better from symptoms after 2-3 days.
I developed transverse myelitis and optic neuritis . I?m having trouble walking. Headaches. I have lesions on my brain and spinal cord.
Narrative: A 64yo male with no known PMH who flew in from the previous week, presented to the ED with Chief complain of body rash and some chest pain, on July 6, 2021 ED physician's documentation indicated the patient reported he had J&J Covid-19 vaccine on June 23, 2021 and had an intermittent body rash accompanied by itching on various parts of his body. Addionally he reported having three episodes of chest pain described as "pressure" Physician's A/P included the rash was a possible reaction to the vaccine and was treated with Solumedrol 125mg iv and famotidine 20mg Elevated D-dimer and CT scan were concerning for a mass in his right lung, which were discussed with the patient for further testing and recommendations by the physcian EKG and Blood work were also checked prior to discharge and there was no evidence of PE HIs discharge medications included Medrol dosepak, famotidine 20mg by mouth twice a day and topical hydropcortisone 2.5% sparingly to the affected area twice a day On July 8, 2021 the patient returned to the ED with chief complain of generalized unrelieved itching and was concerned due to a return flight of travel, the following day. Benadryl 25mg three times a day as needed was added to his discharge medication regimen, famotidine dose was increased to 40 mg twice a day and Prednisone tapering over 14 days
on 8th day after vaccination I woke up with a sore arm.  Upon investigation, the vaccination site was swollen and splotchy red and warm.
A few hours after the vaccine he got chills and muscle aches. This continued into the  next day and he got a bad headache and couldn't go to school. Went to school Wednesday and came home with a migraine. He had migraines, congestion and extreme fatigue for next ten days. He was diagnosed with a sinus infections but could not break migraines so ended up in the ER and had an adverse reaction to Compazene. His heart rate dropped to below 42 beats per minute and his blood pressure was all over the place. He was basically sick for 6 weeks after getting the vaccine.
My horomones and thyroid became messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE ABNORMAL (non-serious), outcome "unknown", described as "My horomones and thyroid became messed up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported, her hormones and thyroid became messed up after getting the vaccine. So, she didn't want it to mess anything up again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cardiorespiratory arrest/apnea 5/18/04. Ventricular tachycardia/cerebral infarct. Gastrostomy tube/hydrocephalus. Do not resuscitate. Possible seizures; positive VSD.  Nurse follow up on 08/23/04 states: "irritable; induration of L forearm; decreased muscle tone."  Nurse follow up on 08/30/04 states: "Complete."   Per the follow up report-We have not seen this patient since the event. Thank you!
Patient has an extremely large bruise, spanning over half the diameter of the arm. She reports that the bruise developed immediately after the shot. Patient also has a red rash surrounding the bruised area, which she reports began approximately 3 days after she received the vaccine and has steadily worsened. She reports that the rash is itchy, and she has been using hydrocortisone successfully to control the itching.
Headache for the past 3 days Vomiting, 2nd day after getting the shot
Fever 102.4, feeling of nausea, vomiting, diarrhea, dizzy, joint pain in back mostly, syncope.
Injection site bleeding, bruising, redness, swelling, stiffness- onset immediate to a few hours after, lasting 9+days (still experiencing bruising, swelling, redness) Tinnitus in ear on same side as injection- onset 30 min after, lasting  4 hours Headache- onset 1 hour later, lasting  2 days Fatigue, muscle soreness, muscle stiffness- onset 1 hour later, lasting  4 days Head rushes, Dizziness, Vertigo- onset 1 hour later, lasting 4 days Lymph node swelling- onset 6th day, lasting 3+days  (still present) Low grade fever (98.8-99.5 degrees F)- onset paired with lymph node swelling onset, lasting 3 days Large red swelling area surrounding injection site, warm to touch, "Covid Arm"? - onset days 7-9+ (still present)
Fever 102, generalized aching, headache and nausea lasting for 6 days pt was advised to make appt on 06022010 if she was not better and she did not schedule appt...
I contracted COVID-19 on 06/27/2022 with symptoms of headache, nausea, diarrhea, and fatigue. I was prescribed Paxlovid 06/27/2022. I was ill for 7 to 8 days before my symptoms began to resolve. My symptoms had resolved after 10 to 14 days, but I have had symptoms of cough and swollen lymph nodes begin on 07/17/2022 that I will be seeing the doctor for.
swollen lymph nodes/tissue under left arm. This felt like cotton balls stuffed under the skin for about a week. It was visibly swollen.; I felt like I had food poisoning after eating dinner; I experienced extreme vomiting and diarrhea; I experienced extreme vomiting and diarrhea; My stomach continued to hurt for the next 4+ days; My fever peaked at 103.2/fever of 99.1; nausea/vomiting; I am extremely tired; lymph nodes are still sore; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:15 (Batch/Lot Number: fl2588) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included breast cancer - right side. The patient has no Covid-19 prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and tamoxifen. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 10:15 (at the age of 49 years old) (Batch/Lot No: er8727) and the second dose on 07Apr2021 17:30 (Batch/Lot No: en0151); both via an unspecified route of administration in the left arm for Covid-19 immunization. The patient previously took aspirin and experienced allergies: Reye's syndrome at age 12. The patient had no other vaccine in four weeks. The day after the shot, on 04Oct2021 at 12:30, the patient experienced swollen lymph nodes/ tissue under left arm. The patient stated that it felt like cotton balls stuffed under the skin for about a week. It was visibly swollen. One week post shot (Oct2021), she felt like she had food poisoning after eating dinner. That night, she experienced extreme vomiting and diarrhea. Her stomach continued to hurt for the next 4+ days. Her fever peaked at 103.2 before she called a doctor, and they prescribed a medicine to alleviate the nausea/vomiting. This allowed her to take Tylenol which brought the fever down over the next 2+ days. She was 5 days out now and her stomach still hurts, and she has a fever of 99.1 this AM, her normal temp runs around 97.6. The patient also stated that she was extremely tired, even though she just woke up from sleeping 11 straight hours. The lymph nodes are still sore to the touch but not as swollen as they were. The events resulted in doctor or other healthcare professional office/clinic visit and were treated including medicine to stop vomiting. The patient was not tested for Covid-19 post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
1st dose on March 2019 and 2nd dose administered on 04-JUN-22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of shingrix received on March 2019).   On 4th June 2022, the patient received the 2nd dose of Shingrix. On 4th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK receipt date:23rd June 2022 Reporters comment: The reporter consent for follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule
Pt c/o 3" x 4" red, hot, swollen area to left deltoid at DTaP site. All noted today 9/15/03.
Woke up the morning of 1/12/2021 with a headache and soreness on the left side of my neck- when I got out of bed I realized my left arm was also very sore and itchy. I looked in the mirror and realized the injection site was very hot to the touch, swollen, read and inflamed. I called my dr's office and they made me an appointment for the next day which was this morning. The dr said he hasn't heard of any adverse reactions this far after the initial injection.  He said it's possibly cellulitis and to monitor it- if it gets worse present to the ER /Urgent Care to be seen. He prescribed an antibiotic and said to take it if the symptoms get worse or linger on.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: This case was reported by a medical assistant (MA). The age at vaccination was not reported. The nursing student received ENGERIX B and showed no protective titers for hepatitis B which led the patient to be a therapy non-responder. A complete 2nd series was subsequently initiated. The patient had received the first doses of the series, with the most recent dose given 5 months before the reporting date. The health care professional did not have any lot number and expiry date of the doses given. Also of note, the patient was pregnant at the reporting time, but was not pregnant at the time of vaccination.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
lump in arm; tooth ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache). On 17-Feb-2021, VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Reporter stated that Patient was planning to see a dentist.
I have never had a problem before, and I asked If I could just leave after the vaccine. When I was driving down the road, I started noticing swelling in my throat about 15 minutes after receiving my vaccine. I went to urgent care, and they told me to take BENADRYL, and to come back if things got worse. The BENADRYL cleared it up and I didn't have any other issues.
This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients each were vaccinated with improperly stored doses of ROTATEQ (strength, dose, lot #, expiration date were not reported) (incorrect product storage). No adverse event was reported. The vaccines had been exposed under temperature 48.7 degrees Fahrenheit for 1 hour 30 minutes. There was no previous excursion reported. Data logger was involved. The nurse stated that she was unable to provide any patient identifiers, lot numbers, expiration dates or dates of vaccination, as she had stated when she called into our National Service Center. This is one of several reports received from the same reporter. Additional information is not expected as further information is not available.; Sender's Comments: US-009507513-1702USA001497: US-009507513-1703USA012893:
The hives appeared about 3 hours after getting the vaccine. The sensation is best described as feeling like my skin is crawling and has a slight burning sensation. Then a patch of small itchy hives will erupt and last for a few hours then subside and a new patch of hives in a different location will appear. The itch at the location of the hives is intense. The injection site is red and warm and extremely itchy. I can best describe the itch as being a deep itch that you cant get to. Scratching does not alleviate the itch. Benadryl does nothing to help the itching either topically or taking OTC medication by mouth.  I have concerns about getting the second dose of the vaccine in 3 weeks. My current event has been going on for 48 hours at the time of my report
No symptoms until the afternoon, which started with a headace; took Advil.  Sweatiness, body aches with exception of extremeties. From 2:0 am to 10:00 all symptoms continues and by 10:00 pm on 2nd day.
put me out of whack; just has a sore arm; Patient's blood pressure has gone down enough; This is a spontaneous report from a contactable consumer, based on information received by Pfizer  (manufacturer control number: EC-2021-088255), for BNT162B2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 11Feb2021 to 11Mar2021, at 10 mg, daily, for endometrial cancer.  The patient medical history included endometrial cancer. The patient's concomitant medications were not reported.  The patient experienced feeling "out of whack", sore arm and blood pressure increased on unknown dates. It was reported the patient's blood pressure had gone down enough, and if it stays stable then her physician might increase her dose of lenvatinib mesilate. The patient also had a COVID shot (manufacturer Pfizer) on Monday, 08Mar2021, which "put me out of whack" but she's feeling better, just has a sore arm.  The action taken in response to the event for lenvatinib mesilate was unknown. The outcome of the events was unknown.
pt recv vax; failed to seroconvert;lab eval showed titer done by ELISA & was neg;
broke out in a rash on my arm and around my neck. Severe joint pain and had a 101.4 fever. Still continue to be itchy all over my body and still have rash on my neck.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Information has been received from a registered nurse concerning a 14 month old patient who on 19-MAY-2009 was vaccinated with ZOSTAVAX (Merck) instead of VARIVAX (Merck). There was no product confusion involved. The patient has not experienced any know symptoms by the report time. Additional information has been requested.
About a week later, swelling and itching at vaccine site.  This has lasted a few days.