chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a yellow fever vaccine on 9/7/2005 and called me 9/9/2005. She said she had what sounded like an urticarial reaction with some warmth at the site of the injection without any systemic symptoms. She did not wish to return to the office for examination.
Acute on chronic systolic congestive heart failure - On the day after admission he was given IV lasix and his work of breathing continued to improve. He was transitioned to his home dose of torsemide, 20mg BID. He did develop a slightly elevated white count, however, his breathing was improved, no consolidation seen on imaging, and he had no fever, so there was little clinical concern for pneumonia. His PTA hypertension medications were held due to low pressures. His breathing was improved and he was stable for discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Severe allergic reaction; Dizziness; Made her dysfunctional; A spontaneous report was received from a female patient who received Moderna's COVID-19 Vaccine and experienced severe allergic reaction and dizziness.  The patient's reported medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On an unknown date, the patient had a severe allergic reaction and reported that she had dizziness that made her dysfunctional. Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, severe allergic reaction and dizziness, was considered not resolved.; Reporter's Comments: This case concerns a female subject with who experienced serious unexpected events of hypersensitivity and dizziness. The event occurred an unspecified time after the first dose of mRNA-1273. Based on the current available information, a causal relationship cannot be excluded.
Allergic reaction, hives, rash, itching, blisters that developed on bottom of feet approx. 6 hours after vaccination.
Information has been received from a health professional concerning a 43 year old female pt who on an unknown date was vaccinated with a first dose of hep B vaccine. The reporter stated, the pt provided info that she "broke out in hives" after receiving the first dose of hep B vaccine. The reporter noted that the pt could not remember when she received the vaccination. The reporter noted it was unknown whether a prescription drug was required. Unspecified medial attention was sought. Additional info has been requested.
Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.  No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient age was reported as 27 years and 8 months. Concomitant medication of the patient was not reported. The patient did not experience any adverse reactions after the administration of vaccine. On 10 Jun 2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine code 80777027399.  No treatment information was provided by the reporter.
On date indicated after shot, I developed a shingles-like rash on my upper left abdomen.  It was tender to the touch but not painful.  Lasted 24 hours.
Information has been received from a registered nurse concerning a 36 year old male patient with recurrent diverticulitis, degenerative disc disease, sore throat and insomnia and a history of rib fracture and clavicle fracture from car accident (1999), splenectomy, gall stones and small bowel obstruction and no known allergies who on 11-DEC-2006 was vaccinated with a dose of PNEUMOVAX 23 (lot # 655152/0889F) (0.5 mL) in the left deltoid. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified) in the same arm but different site. Other concomitant therapy included NYQUIL and ibuprofen. The patient's initial visit that day was for sore throat, he was evaluated, and given a prescription for trazadone for insomnia and amoxicillin. The patient then received the vaccinations. Within 24 hours post-vaccination the patient presented to the office with swelling of the left arm below the injection site and experienced a high fever of 104 F, chills and headache. The patient was treated with ROCEPHIN. On 13-DEC-2006 the patient appeared and swelling of left arm expanded to 5 times the original size, and patient's temperature went to 105 F. The patient was treated with 1 gram of ROCEPHIN. a CBC lab performed showed elevated WBC result of 23.5, and platelet count was elevated at 419. The patient was sent to a hospital. At the time of the report, it was unknown if the patient was hospitalized. At the time of the report the patient was considered to be not recovered. It was noted that the patient received pneumococcal 23v polysaccharide vaccine in 1999 with no untoward effects. The nurse requested a lot check. The reporter considered the patient's experiences to be disabling, life-threatening and other medical events (OMIC). Additional information has been requested.
Day 12: Hives, swollen joints.  Day 13: Tachycardia, hives continue to worsen. Went to urgent care.  As of today (over 100 days) the hives continue. Doctors were unable to find a cause, CDC V-Safe Check-In recommended completing this form.
covid arm; lump at the site of the injection; warm to touch; swelling at the site of the injection; mild itching at the site of the injection; pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at the site of the injection), VACCINATION SITE PRURITUS (mild itching at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE SWELLING (swelling at the site of the injection) and VACCINATION SITE PAIN (pain at the site of the injection) outcome was unknown and VACCINATION SITE MASS (lump at the site of the injection), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (mild itching at the site of the injection) was resolving.            No concomitant medication were reported. Treatment included 2 Tylenol and the patient reported that the symptoms are gradually getting better.
Body aches in my spine and spread from there, legs, arms, neck, shoulders, headache, fever (that hit about 07:00 pm or 08:00 pm). Those symptoms lasted for five days. Some nausea, too. At site injection, had a lump and it was very sore, and it moved down my arm in my muscle. It was there for about a week. My lungs were real congested, very congested.  I am still having headaches, breathing problem, and memory problem. History: My doctor said I had Pleurisy in October of 2020.  Back in Jan of 2020, I didn't get tested, but right before the holidays, the December before I got really sick, and I didn't know what it was and in January it attacked my lungs whatever it was.  I went to ER for that. On April 2nd, 2020, for my breathing, I went to ER. I went to ER in. They gave me an Albuterol treatment. They documented at the hospital incorrectly the wrong reason for the visit. They documented it as a Migraine, which I didn't understand at the time, but that was incorrect. They gave me when I left ER, an Albuterol prescription, and a nebulizer. And they upped my dosage of my emergency inhaler. Then, I got my first COVID-19 vaccine Pfizer on 3rd of April. My breathing has not improved, but some days are better than others. Most of the time, I am out of breath if I get up to go to the bathroom and back. Also, my memory is bad. I cry because I can't remember things and I'm getting confused more easily. I do not have a fever. I have headaches on and off. I have mental cloudiness, which is on-going - very forgetful. It's gotten worse. Since January of 2020, I don't go anywhere. I have to have someone shop for me because I have to stay down most of the time due to be out of breath, just a little movement to the bathroom and back. My doctor I see him most often. They have us all seeing PAs now. Zoom visits and not in person.  I have Symbicort that I do twice a day.   September 14, 2021 - Flu Vaccine/Shingles Vaccine - Did them both on the same day - I got really sick and was down for about three days.
10/10/02 pt at health dept with c/o redness and inflammation in L arm below flu shot area with itching. No other complaints. Area appeared red and inflamed approx 1 inch below from shot area. Referred to PMD for evaluation and recommendation for future flu shots. 10/11/02 call from pt went to ER and received antibiotics and med for itching. Was told unsure of cause of inflammation and swelling but could continue flu shots in future.
Information has been received from a licensed visiting nurse concerning a 10 year old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with a SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658058/0837U) in the left arm. There was no concomitant medication. ON 24-AUG-2007, the patient experienced 1.5' X 1' area of injection site swelling, redness and itching. The patient sought medical attention through a telephone call to the physician's office. No lab diagnostic studies were performed. The patient was treated with Motrin, Benadryl, and warm compresses. The patient was not recovered. There was no product quality complaint. Follow-up information has been received from a licensed visiting nurse indicating that the 10 year old male with a history of seizures who on 23-AUG-2007 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658058/0837U). There was no illness at the time of vaccination. The patient recovered from redness, itching and swelling. Additional information has been requested.
Evening of 12/13, approximately 2 weeks following COVID booster, patient began to experience hives that started centrally and progressed to extremities. Hives lasted on average 30-60 minutes, but were reproducibly provocable with almost any physical contact with self or objects. Wheals formed centrally where any tight or heavy clothes touched, as well as on palms and soles, in axilla, inguinal region, and gluteal cleft.   No immediately recognizable changes to patient's environment was discernable. No change in clothing, detergents, hygiene products, or exposure to new environments. Perhaps of note, patient's house has been under construction for the last 2 years--patient is slowly completing remodeling himself. It is possible that there has been infrequent and mild exposure to paints, dust, mold etc, however, none that are temporally correlated with the symptom onset.  Patient has taken diphenhydramine 25-50 mg every 6-8 hours around the clock for 2 weeks to date.  Other mildly alleviating treatments included epsom salt baths, calamine lotion, and OTC 1% hydrocortisone ointment. Patient has been effectively on bed rest since symptom onset.   Both the sensitivity of urticarial provocation with physical contact as well as the extent and longevity of wheals has been diminishing over the 2 weeks since the start of the adverse event on 12/13. Patient stated no adverse effects for the first 2 doses of the moderna vaccine.
had the shot and still got shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient received the shingles vaccine shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
I had a sore throat on December 31st. I tested for COVID-19 and it was negative. I tested again on January 02, 2023 and was positive. I called the doctor and the provider prescribed PAXLOVID. I also had a friend to pick up TYLENOL liquid. I noticed itching and a rash after taking the TYLENOL. The symptoms were gone by that Friday. I may have had a low grade fever around 98 which is higher than normal for me. I also got diarrhea which was also a side effect of the vaccine. The PAXLOVID gave me a bitter taste in the back of my mouth. I completely recovered by Saturday January 07, 2023. I retested on Tuesday January 10, 2023 and was positive. I remained isolated until the 15th.
This case involves a 16 months old female patient whom TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] vaccine was inadvertently administered (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 17-Dec-2021, the patient received a dose of suspect TYPHIM VI (0.5 ml, lot T1E371M and expiration date: 14-SEP-2022) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to Inappropriate age at vaccine administration 9same day latency). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI . The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, since 15-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX  lot # reported as M033214, expiration date: 13-JUL-2018 and lot # M024702, expiration date: 18-MAY-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported.     The temperature excursion was between >5 °F - <14°F, for a time frame of 50 minutes and >14 °F - <46°F, for a time frame of 5 hours, the cumulative time frame was 5 hours and 50 minutes. There were no previous temperature excursions. The call was  because of a data logger (reported as log tag in use). This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007889:
Same day/evening:  chills, severe headache, sleeplessness, chest pain Next morning/afternoon:  fever, muscle soreness, worn down
Smallpox vaccination site swollen with pus filled exudate and there are 8-70 blisters/vesicles filled with clear fluid and exudate under the vaccine site. Also, axillary swelling and pain.
No additional AE reported; HCP reporting an expired dose of STERILE DILUENT was administered to a patient. Caller stated the dose of STERILE DILUENT was used to reconstitute a dose of MMR II (which was not expired) was administered on 12-DEC-2022; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent, concomitant therapies and previous drugs reactions or allergies were not reported.  On 12-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) dose given per the prescribing information, lot #U006485, expiration date: 26-FEB-2023, administered for prophylaxis (strength, and route of administration were not provided) reconstitute with an expired sterile diluent (MERCK STERILE DILUENT) dose given per the prescribing information, lot #U031356, expiration date: 23-NOV-2022 (Expired product administered). No additional adverse event was reported.
reports having soreness in left arm at site of injection site.  developed loss of appetite that afternoon after receiving vaccine.  noticed shortness of breath while walking the dog.  sunday evening, developed left axillary lymph node swelling.  also with fever 99.8 - 100.2 degrees F.  had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
Patient passed out for about 30-60 sec about 5 min after receiving the vaccines. When he awoke he was thirsty and drank some water. Was fine at 15 min or so. Said it happened before with vaccine -> decreased BP, anxiety and decreased blood sugar.
caller uses prevnar and pneumovax 23 interchangeably; This spontaneous report was received from a physician via Pfizer refers to a 65 year old female patient. The patient's concurrent condition, medical history and concomitant medications were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, lot#, expiry date, dosage information, route of administration and anatomical locations were unknown) for prophylaxis interchangeably with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)  (also reported as "PREVNAR 23") (strength, lot#, expiry date, dosage information, route of administration, anatomical locations and indication were unknown, Wrong product administered). It was reported that the patient was supposed to vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) but she was vaccinated with pneumococcal 13v conj vaccine (PREVNAR 23) by the medical assistant. The outcome of wrong product administered was unknown.
3 days after I received the vaccine I got a sore throat and then I started having  joint pain in my hips, muscle cramps in my legs. Migraines for 3 straight days. Fever, chills.
weakness; aches and pains; fever 101-103; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101-103 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided  Treatment information was not provided
soreness when touched, when raises arm;tired feeling in arm;no discomfort when not using or touching arm;sxs improving;No MD consulted, prefers not to consult MD @ this time
Information has been received from a nurse practitioner concerning a 26 year old female patient with eczema and no drug reactions/allergies who on 28-JUL-2010, was vaccinated with a standard first dose of GARDASIL (Lot# not reported). Concomitant medication included birth control pills. No lab diagnostic studies were performed. Subsequently, the patient developed redness, pain, and swelling at the injection site. The redness and swelling disappeared after two weeks. The patient had not recovered from pain. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse practitioner concerning the 26 year old female patient with eczema, migraines, unspecified allergies and elevated lipids who on 28-JUL-2010 was vaccinated into the left deltoid arm with the first dose of GARDASIL (Lot# not reported). Patient possibly had minus cold at time of injection . It was reported that pain, redness and swelling on left deltoid arm began on 28-JUL-2010 and persisted for one month. The patient required doctor visit (date unspecified). On 24-AUG-2010, it was prescribed MEDROL dose pack (on 30-JUL-2010 was seen by a registered nurse practitioner and told to use TYLENOL). At the time of the report the pain in the left arm persisted. There were no relevant diagnostic tests and laboratory data. No further information is available.
Urticaria daily for more than 3 weeks.  Required antihistamines and steroids and allergist referral.  Diagnosis there was idiopathic urticaria but still in process of workup. Also developed hemorrhoids. Unclear whether any of the above related to HPV vaccine.
Client was inadvertently scheduled at a Moderna  Covid vaccination POD per mother, client is 17 y/o and Moderna is licensed for 18 years and above. Mother aware that the vaccination POD was for the Moderna vaccine and for 18 years and above. After realizing that the recipient of the Moderna  vaccine was 17 y/o, parent was notified and alerted that the booster dose would not be able to be given due to age of the client.
Allergic reaction of tightness of chest, short of breath, difficulty speaking right after shot. Recovered with benedryl   Fever of 102 sustained for 36 hours even with medication.   1 migraine wed and 1 migraine Friday. After migraine on Friday I had a convulsive event. Then another then another while waiting for the ambulance and another while with them. One in the waiting room, one in trite etc. I had a total of 15 convulsive events in a day.  6 more the next day. Now just on rare occasions
Patient developed a large, egg sized, bruise at the injection site. It was warm  and firm to the touch and itchy. Provided patient with a cold compress.