chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details provided.; Nurse calling in to report an AE for a patient that received MMR-II that was improperly stored. No additional AE details provided. No PQC.  Names of vaccines involved (including lot/exp): MMR-II (U006486  2/26/2023;  U019290 6/18/2023)  Temperature; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 5 milliliter, subcutaneously, lot# U006486, expiration date 26-FEB-2023 (dose number and vaccination schedule were not provided) for prophylaxis. This vaccine and the other vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) lot#U019290, expiration date 18-JUN-2023 had been improperly stored in the temperature of 61.5 Fahrenheit degrees (F) for 9 hours 20 minutes with no previous temperature excursion (product storage error). It was unknown if digital data logger was involved. No additional adverse events were reported.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 28-JAN-2019, the patient was vaccinated with PROQUAD lot # R017802, expiration date 19-DEC-2019 (strength, dosage, frequency were not reported) for prophylaxis with the respective diluent, the call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of PROQUAD that were improperly stored.
The first time went to ER. I experienced shortness of breath and blood clots in left leg. This past weekend on December 11, 2021, I experienced tight pain on left side, inability to lift left arm and difficulty breathing. I have been recommended to the Cardiologist have never had any heart issues before. My watch tracks my heart rate lately it's higher. The normal resting heart rate is 70 now it is 100 since second vaccine.
Patient reported rash all over body and face. Patient was referred to dermatologist where provider stated they believe it was a reaction to the vaccination
High fever of 104°+ lasting for three days so far. We are alternating Tylenol and Motrin and can only get the fever as low as 102°. As the medicine wears off, the fever returns to 103-104°. We are currently on the third day and his temperature is 103.1° with Motrin.
The pt experienced high pitched crying for 1 hour post vax. The pt calmed down with Tylenol. The pt experienced slight tenderness of both thighs.
Started with redness/swelling in the morning after vaccination. Developed itching throughout the day, which lasted about 2 weeks. Gave diphenhydramine 1-2 times daily for 2 weeks, until itching resolved.
Approximately one week post vaccination I began to feel a dull pain behind both eyes but primarily behind my left eye. This pain very slowly increased over the course of a week and one week in to symptoms I began feeling a sharp pain with eye movement. This lead  me to see my ophthalmologist (now three weeks after vaccine) After normal visual acuity and ocular pressure tests, and also noting my sensitivity to lights, he said I either had uveitis or scleritis and knowing that my symptoms had not improved with regular NSAIDS he prescribed oral prednisone. I saw him again one week later (4 weeks post vaccine) and my symptoms had not notably improved and the pain was even waking me from sleep. With an ultrasound imaging machine he documented fluid/inflammation in my posterior sclera bilaterally and prescribed continued prednisone. Over the next week pain on movement resolved but there is still severe pain behind my eyes and I still have intense light sensitivity. I am awaiting my next follow up (five weeks post vaccine).
Red spot on arm at vaccine site. Growing from dime size to quarter size over 72 hr period imm after vaccine. Arm is sore pain up into shoulder, down to elbow.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 1-year-old patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, injection site erythema, inadvertent exposure to vaccine, exposure via skin contact and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, injection site erythema, inadvertent exposure to vaccine, exposure via skin contact and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. One year patient received a dose of BEXSERO, which led to inappropriate age at vaccination. During the first injection some of the vaccine liquid got out on the child's forearm and was wiped off by the nurse (not much though, a few drops), which led to inadvertent exposure to vaccine and exposure via skin contact. The nurse and the doctor reassured me that the vaccine would be effective and nothing to worry about. The patient had a mild fever for about 24 hours following the job and the injection area was red. The reporter was asking that the immunization was effective or should repeat the vaccine (if so, how much time should pass), or was there any treshhold for antibodies detectable in blood that could tell whether it was effective or not.
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of VAQTA (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age (reported as an employee at her hospital). The patient believed that she was vaccinated with M-M-R II as a child but she could not produce written immunization record for previous doses and to meet hospital's requirement. On 02-FEB-2015, the patient was vaccinated with a dose (reported as the first dose) of M-M-R II (0.5 ml, subcutaneous (SQ), lot# and expiration date were not reported) and on 23-FEB-2015, the patient was vaccinated with an additional dose (reported as the second dose) of M-M-R II (0.5 ml, subcutaneous (SQ), lot# and expiration date were not reported). It was reported that, two doses were administered less than 28 days apart and that the second dose was administered too soon. No adverse effects reported. Additional information has been requested.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis and Plaque psoriasis.  No Medical History information was reported.  On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.  No concomitant medications were reported. It was reported that patient was recovering from COVID which patient had for the last two weeks of 15Jun2022. It was reported that Booster dose was discontinued. It was unknown if patient was enrolled in COVID-19 vaccine trial. The reporter's causality for the event of COVID-19 was not provided with Skyrizi (risankizumab) and considered possible with mRNA-1273 vaccine (Moderna COVID-19 vaccine). No treatment medication was reported.  Company Comment: This spontaneous case concerns a 78-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious of COVID-19. The event occurred on an unspecified date in Jun2022 after receiving the booster (third) dose of the mRNA-1273 vaccine on an unspecified date. Treatment information was not provided. It was reported that the patient was recovering from COVID-19 which he had for the last 2 weeks 'as of 15Jun2022'. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 78-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious of COVID-19. The event occurred on an unspecified date in Jun2022 after receiving the booster (third) dose of the mRNA-1273 vaccine on an unspecified date. Treatment information was not provided. It was reported that the patient was recovering from COVID-19 which he had for the last 2 weeks 'as of 15Jun2022'. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Swelling at injection site, lymph nodes  under left arm are swollen, hard and painful.
My blood pressure spiked 36 hrs after the 2nd dose of the vaccine was administered.  It's typically stays around 125/85. Following are my readings over the last 2 days: on 5/4 at 12:18pm 158/100, at 3:31pm 175/114, at 6:45pm, 130/88, then on 5/5 at 6:58 am 139/97, at 11:21pm 138/109, at 1:42 pm 152/100 .
2 days after received vaccines left arm noted to be red 5cm x 4 cm marked area. Slight warm to touch.
4x4cm red, raised, tender, tingling lesion around site of injection at 48 hrs. No lymphangitis. No regional nodes. Rx: Atarax 50mg q 6 hrs.
Severe and debilitating headaches . Menstrual cycle came on but refused to flow. Severe sinus pain.
Swelling of both hands within 10 days of vaccination ' Various arthritic treatments. Still swollen after three months.
This spontaneous report was received from a medical assistant and refers to a 69-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an elderly patient (age was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number and expiry date was not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due vaccine underdose. It was also a case of syringe issue since part of the vaccine leaked out. It was unknown whether the patient experienced any adverse events. 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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
After my second Covid shot, I have noticed that I have a low grade fever. It was about 99.5F (ANDER ARM) on the day after the shot. I did not think much of it but decided the check my temperature the following day to make sure it normalized. The following day it was about 99.1F. Since then, it has been over 6 months and my temperature never normalized, it is around 99F most of the time (I always take it under arm). I am not sure if it started after this vaccine (I did not check my temperature in the weeks before vaccination) but in general my temperature had always been 97.8F (under arm). My doctor recommended that I report this. I had various blood work done in May and in October. Nothing significant was found, though my recent ESR was high (41). Blood culture showed "no aerobic or anaerobic growth in five days" and also negative for Lyme disease. I also have increased cholesterol since last year (220+), with LDL at 99. The cholesterol increase is of unknown origin because I have always eaten well and exercised, am not overweight etc. I also would like to mention that I receive a combined Hepatitis A+B vaccine in 3 shots at the doctor's recommendation in September and October 2020 and May 2021 (3rd shot).
Parent reported an axillary temperature of 103 and shaking and shivering within 24  hours of shots. Child had not been given any Tylenol until the onset  of these symptoms. Temperature dropped to normal by Sunday with the aid of Tylenol.
Nausea, vomiting. Subjective fever. Supportive treatment (ZOFRAN and rest).
Minor got Pfizer pediatric  monovalent dose instead of Bivalent Pediatric dose. Mother advised to bring minor to the clinic in 2 months to get the Pediatric Bivalent booster.
Woke up with a really sore arm the next day.The day after around 2:00 pm - at work, started feeling achy.  Home at night - still extremely achy. I felt better the next day. I felt pretty normal until I went to work. Achiness again  - on Thursday (New Year's Eve). Temperature was very low grade. Took Tylenol sporadically Tested for COVID  - 31st- positive test result on New Year's Day. Others in my family had COVID. Got out of quarantine on the 9th - I was fever free for three or four days by the 9th. Lost my sense of smell for a couple days during my quarantine time, too. Went to urgent care to get seen and to take the COVID test.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 73-year-old patient (pt) of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by a healthcare provider and on or about 20-DEC-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions (dose, route, vaccination site, lot number and expiration date were not provided).   On unspecified date, the pt was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of the event was not provided.  Additional information has been requested.
The evening after my shot I had a deep flutter of the heart while lying down to go to sleep. It was a scary feeling so I took notice of any other abnormalities but nothing else occurred that night. The next morning as I was preparing to get up I felt like I almost fell over to my left side and it felt like I lost conscience very briefly because I started falling over (to the left). I paused to  focus and proceeded slowly getting up.  Nothing else happened that day. It?s A few days later and I notice some chest heaviness. I keep taking deep breaths and and drinking water.
NDC:58160-0823-11 The day of the shot I felt a burning kinda near my armpit on the left side like it was on fire. I  started itching on the left side and had red rash on the left side. I had a blister that I cleaned it with alcohol and Neosporin. My joints were hurting really bad. I felt like I was hit with a car. A tingling feeling in my right hand. I took zyrtec on that day and then today 6/12 I took benadryl. I took aleve.
area around injection site was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first dose of Shingrix on 9th September 2020 and that the patient reported that the after Shingrix vaccination the area around injection site was itchy for approximately one month.
Pt received Pfizer vaccine on 6/16/2021 but patient had already received both doses of Moderna on 2/2/2021 and 3/3/2021. Pt stated she did not remember receiving both doses of Moderna in the past. Pt advised and explained it won't be necessary to received second dose of Pfizer due to being fully vaccinated with Moderna.  PCP notified, pt will not receive any additional doses. Pt monitored for 20 minutes with no adverse effects noted.
Terrific Headache on left side of head, numbness on left side of my face, sick to stomach   10/28/09:  Hospital Records and Discharge Summary received for dates of admission from 10/19/09 to 10/20/09.  Dx:  Migraines. Assessment:  Presented with sudden onset left-sided facial paresthesia shortly after receiving a flu shot.  Denies fever, chills, night sweats, vomiting or diarrhea.  Has chronic left leg numbness which is unchanged this episode.  No facial droop.  When numbness started pt. felt a "fluttery feeling" in her heart. A 2D echo was done, and was normal.  Stroke was ruled out.  Neurology consulted, comfortable with dx. of migraine and discharge to home.
Lump at the injection site; size of an egg; arm was very sore; a red dot 3 inches below the top of her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Lump at the injection site), VACCINATION SITE PAIN (arm was very sore), VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder) and VACCINATION SITE SWELLING (size of an egg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 18-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Lump at the injection site) and VACCINATION SITE SWELLING (size of an egg). At the time of the report, VACCINATION SITE INDURATION (Lump at the injection site), VACCINATION SITE PAIN (arm was very sore), VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder) and VACCINATION SITE SWELLING (size of an egg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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.; 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.
12 day p/vax w/fever, 2 days later palpable rash on body & post auricular;
3-4 days after injection developed lip and front 1/4-1/2 tongue swelling.  Denies difficulty breathing, etc.  Took no medications.  Lasted approximately 24 hours.    This repeated on day 6-7 post vaccine administration and lasted 12-13 hours.  2 weeks post the vaccine these symptoms repeated and lasted only 2-3 hours.Denies any new medications, foods,etc.  Did not seek any treatment at the time.
experiencing soreness in her left arm; she received a 0.5mL booster instead of the 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing soreness in her left arm) and ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 007M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jan-2022, the patient experienced VACCINATION SITE PAIN (experiencing soreness in her left arm) and ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL). On 06-Jan-2022, ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL) had resolved. At the time of the report, VACCINATION SITE PAIN (experiencing soreness in her left arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received a 0.5 milliliter booster instead of 0.25 milliliter at roughly 6.15 AM on 06 January 2022. The only symptom that the patient was experiencing is soreness in her left arm.