chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (strength, dose, route were not reported) lot # R017640, expiration date 20-JUN-2020, for prophylaxis. No adverse effect were reported. Administered dose experienced temperature of excursion of -4.8 degrees Celsius for 13 hours 12 minutes. Previous temperature excursion of -1.5 degrees Celsius for 5 hours 41 minutes. Digital data logger was involved. This is one of 3 reports received from the same reporter.
Pt recvd vax & indicated that react occurred w/in 2 hrs of inject; also has positional muscle spasm that was followed by induration & swelling maximum; swelling occurred the next day;
I had SEVERE pain in my left upper arm that kept me from being able to sleep. I took 4 (200mg) Ibuprofens and a 500mg Acetaminophen as well as attempted to use a warm pack or ice to help with the pain. I have had flu shots in the past and my arm was sore for a few days but I have never had pain to this extent. I was finally able to fall asleep around 4am. The next day I coninued to have pain (just below my deltoid - not in the area where the shot was given), it went down to my elbow and then I had tingling and numbness in my pinkie with numbness in the other fingers as well. This continued for at least 4 days and I still have pain (to a lesser extent) in the arm extending to my elbow with occasional numbness in my fingers. I also have had very occasional difficulty raising my arm in one fluid motion. It seems to stop midway and then I have to think about raising it higher.
REDNESS, HEAT, SWELLING AROUND INJECTION SITE ,PATIENT NOTICED 3 DAYS AFTER INJECTION GIVEN.                                           FAMILY PHYSICIAN ON DAY 4 AFTER INJECTION TREATED PATIENT WITH PREDNISONE 20MG QD X3D, ZYRTEC 10MG QD X3D, AND AUGMENTIN 500MG BID X5D
He developed a fever and full body rash/hives on 9/29/2013 and the rash/hives lasted for over 10 days Then his health and immune system quickly deteriorated. On 10/15/13 he developed candida diaper rash and impetigo. On 11/11/13 he developed a sleep disorder and feeding problems. On 12/17/13 he developed his first ear infection, on 1/9/14 he contracted the flu, on 2/21/14 he developed a second ear infection, and on 3/12/14 he developed a third ear infection. On 3/17/14 his stool changed. On 3/24/14 he developed a fourth ear infection and on 3/25/14 a fever.  In March and early April of 2014 he lost his eye contact, stopped responding to his name and stopped saying all the words he knew at the time including (Mama and Daddy). He started developing ritualistic and exclusive behavior likes lining up his cars and tuning out everyone around him. On 5/3/13 he developed a fifth ear infection, on 5/7/13 he had vomiting, on 5/15/13 he contracted hand, foot and mouth disease, and on 5/17/13 he had sores in mouth and difficulty swallowing. He continues to have a weakened immune system and in Dec. 2014 was diagnosed with Autism after 9 months of waiting for appointments for an evaluation and diagnosis of his condition.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date 08-JUL-2016, (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
I had had nausea because of the pregnancy,  but the day of the vaccine the nausea was terrible. I vomited about 10 times - just couldn't keep anything down. Even water. I went to ER that evening around 08:00 pm. They gave me IV fluids. I was very fatigued and feeling very weak. I didn't eat anything until the next day around noon. It seemed like my pregnancy symptoms were just very heightened. I had the soreness in the arm where I got the shot but it was more about the nausea, fatigue and weakened.  I was sick for three for about days after vaccine. And now I still experience nausea but it's more back to normal - it's just a little bit at night or during day but it's tolerable and I am able to eat and drink again.  Pregnancy history - this is my second pregnancy and no complications before; I am currently breastfeeding; Estimated date of delivery - November 7, 2021
Localized pain - fever, chills, lethargy. Spent 3 days in bed sick.  Deltoid arm pain continued.  Now deltoid arm pain at injection site comes and goes - feels like a deep stabbing pain, then sore, tender.
Received first does on 3-14-21 at 4:00 p.m. No adverse effects. Received second dose on 4-11-21 at 3:00 p.m. Well hydrated the day before. Woke about 2:00 a.m. due to pain in injection site. Took one Tylenol tab. Restless light sleep for about 4 hours. Some chills. Woke about 5:00 a.m. Ate light breakfast. Developed low grade fever (99) for several hours. Took second Tylenol tab. Fatigue, Lack of appetite. Sore injection site. Slept 2.5 hours. Lethargic rest of the day. Didn't eat much. To bed early. 4-12-21 Considerably better. Although developed metal taste in mouth all day.  4-13-21 Feel normal and metallic taste gone.
Elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Urticaria. Pruritus. Diphenhydramine 50mg once.
Pt recved 3 doses of Hep B vax 21MAY91, 21JUN91, & 21NOV91 & 15 hrs following 3rd dose pt c/o severe vertigo; pt presented to ER; MD felt pts exp was due to vax;
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis, Allergy (bactrim allergy) and Allergy (Feldene allergy). Concomitant products included METHOTREXATE for Arthritis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.   Treatment information was not provided.
Rash on trunk of body all the way up to the neck and under arm pits; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on trunk of body all the way up to the neck and under arm pits) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 026D21A, 004M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Illness (Cold) and Rash (mild rash on neck and abdominal area). Concurrent medical conditions included Diverticulitis. Concomitant products included PROBIOTICS NOS from 2020 to an unknown date for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on trunk of body all the way up to the neck and under arm pits). On 22-May-2022, RASH (Rash on trunk of body all the way up to the neck and under arm pits) had resolved.            It was reported that 1.5 days after second booster patient experienced rash on trunk of body all the way up to the neck and under arm pits which went away itself in 2.5 days. The patient did not inform any HCP. No treatment medications were taken.
Death Narrative:  The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN.
Pruritic painful reddened area along abdomen, pelvic area, on penis; small area on left shoulder and left calf area. Within 24 hrs became clusters of pimples and scabbed over 3 days later. Reoccurred end of April, lesions tested positive for herpes. Herpes diagnosis
Information has been received from a healthcare worker referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The healthcare worker reported that on unspecified dates since 15-OCT-2015 the patients were vaccinated with doses of ROTATEQ (dose not reported, lot # L008059 with expiration date 18-DEC-2016 and lot # L013202 with expiration date 27-JAN-2017, orally), which were exposed to the temperatures outside of the recommended range (temperature: 31F and time frame: 838 hours 59 minutes). The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness Narrative:  c/o lightheadedness after 2nd dose. monitored 60 min. d/c'd to home stable 136/75, 65, 98%O2 sat.
Left facial paralexia; Not able to hear; Ears are stuffy; Pain in the left eye; Tingling in the left eye; Very dizzy; Fatigue; Not able to focus; Not able to concentrate; Left side of the face like numb; This spontaneous case was reported by a consumer and describes the occurrence of READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy) and DISTURBANCE IN ATTENTION (Not able to concentrate) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to a stomach medicine but not specified.), Stomach pain and High cholesterol. Concomitant products included ATORVASTATIN and CALCIUM for High cholesterol, ESOMEPRAZOLE for Stomach pain.    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 HYPOAESTHESIA (Left side of the face like numb), DISTURBANCE IN ATTENTION (Not able to concentrate) and VISION BLURRED (Not able to focus). On 16-Feb-2021, the patient experienced EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy) and FATIGUE (Fatigue). On 18-Feb-2021, the patient experienced HYPOACUSIS (Not able to hear) and EAR DISCOMFORT (Ears are stuffy). On 21-Feb-2021, the patient experienced READING DISORDER (Left facial paralexia). At the time of the report, READING DISORDER (Left facial paralexia), HYPOAESTHESIA (Left side of the face like numb), HYPOACUSIS (Not able to hear), EAR DISCOMFORT (Ears are stuffy), DISTURBANCE IN ATTENTION (Not able to concentrate), EYE PAIN (Pain in the left eye), PARAESTHESIA (Tingling in the left eye), DIZZINESS (Very dizzy), VISION BLURRED (Not able to focus) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Globidoblep   This case was linked to MOD-2021-020813 (Patient Link).
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. MODERNA DATE ORDERED was reported as 01-Nov-2021 and 15-Nov-2021. No treatment information was provided.
The patient was administered the Janssen vaccine at 3:00 p.m. The patient doesn't meet age requirements for the vaccination. The patient has not experienced any adverse reactions as of yet.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
On 4/23/2021 I suffered a seizure while showering, after meeting with my doctor and a neurologist I was advised to fill out this form while they are still researching what had caused the seizure.
On 9/17/22 I experienced dizziness. EKG on Watch showed numerous premature ventricular contractions (I am a physician).  PVCs resolved within 30 minutes. Dizziness resolved by late afternoon.
Gave PREVNAR instead of PENTACEL. Provider notified. Gave PENTACEL as ordered.
Vaccination site pain; Twitch that now comes and goes; Fever was very intense; Very tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 20-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain), MUSCLE TWITCHING (Twitch that now comes and goes), PYREXIA (Fever was very intense) and FATIGUE (Very tired) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported   This case was linked to MOD-2021-054410 (Patient Link).
A report was received from a healthcare professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown sex who inadvertently received Fluvirin from approximately 11/07/2002 onwards.  From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old.  There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/2002: A follow report was received from a healthcare professional on 12/10/2002 indicating that an 11 month old male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/12/2002.
This spontaneous report as received from a other refers to a patient of unknown age. On 01-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # L016428 for prophylaxis. On 01-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
crying; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; This is spontaneous report received from contactable Pharmacist. This Pharmacist reported for 18-year-old female patient that received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0180, expiry date: Aug2021) via an unspecified route of administration on left arm on 09Jun2021, (18-year-old at the time of vaccination) 0.3ml as a single dose for COVID-19 immunization. Patient previously took first dose of covid-19 vaccine and on 13May2021 received second dose of Pfizer covid vaccine. The patient's medical history included anemic. The patient's concomitant medications were not reported. On 09Jun2021, the patient experienced patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer COVID vaccine. Caller States that the patient was only 18 years old and was now crying because she was worried about having side effects. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information was expected.
02/28/22 I noticed a spot by my knee. It was a circle and I thought it was ringworm. I kept thinking it would go away. In March I saw a friend who is a nurse, she thought it was ringworm. I saw a Dermatologist in June and he said it was not ringworm. He said it looked like granuloma annulare. I had a biopsy and it was verified.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K021485 and expiration date 03-NOV-2016; lot # K026386 and expiration date 15-DEC-2016; lot # L001327 and expiration date 13-JAN-2017; lot # L006386 and expiration date 25-FEB-2017, exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of -13.3C for 208 hours before administration. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a 62 year old female consumer via company representative referring to herself. In approximately 2013 (reported as "at 60 year old"), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). In 2015 (at the reporting time), the patient had shingles, she was reporting the failure and her disappointment (Vaccination failure). Her torso was covered with the shingles rash. The outcome of events was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.