chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first Moderna vaccine on 4/17/21. The day after I received the vaccine until today, I have symptoms like UTI.  I waited for a couple of weeks to see if it goes away by itself. Since the discomfort and pain weren't going away, I visited my doctor and she ordered urine tests. Even though the test results didn't have any serious abnormalities but due to the slight presence of bacteria, the doctor prescribed fluconazole & sulfamethoxazole. Since that didn't make any difference to my issue, I visited the doctor again and she referred me to a urologist. The urologist also ran some tests and she too couldn't find anything wrong. Same medications were prescribed and those didn't make any changes to my symptoms. I visited Urologist once again and she suggested Azo, Dmannose & Uquora *supplements/over-the-counter to treat UTI) and that too isn't making any difference. I drink about 2.5 liters of water every day and this practice started way before getting the COVID vaccine. So I don't think the issue is related to not drinking enough water. I found an article about a rare potential connection between the COVID vaccine and UTI in some cases and I was wondering if that's going on in my case. I had another doctor's appointment today for the same issue and they too ran some tests but no abnormal readings. At this point, we strongly believe that the discomfort that I am facing is a side-effect of the vaccine. I have reported this issue to Moderna on the 14th of September, they have acknowledged my complaint but no resolution or help from them yet. CDC too was notified but no response yet. I am not able to fine any relieve for my troubles instead my medical bills are piling up. I was wondering if FDA has any information that could help me. I have all the test results available and willing to share those if required.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included APIXABAN (ELIQUIS), CLOPIDOGREL, ATORVASTATIN, METOPROLOL, LISINOPRIL, OMEPRAZOLE, ACYCLOVIR [ACICLOVIR], MULTIVITAMINS [VITAMINS NOS], DILTIAZEM HYDROCHLORIDE (TIADYLT ER) and PROBIOTICS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.
Rash on upper chest-started sternum area and  now moving to upper right and left quadrant.
This spontaneous report as received from a female patient of unknown age, who is also a nurse, refers to herself via company representative. The patient pertinent medical history was not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). I was also reported that, at the same time, the patient additionally received another unspecified vaccine. On an unknown date, the patient experienced itching and swelling at the injection site. The nurse reported that she did not receive treatment, but the symptoms resolved on their own on an unspecified date. The patient did not seek medical attention. The relatedness between the events and the ZOSTAVAX was not provided. Additional information is not expected because the reporter did not wish to be contacted.
Information has been received from a nurse concerning a 67 year old female with a diabetes and a history of childhood chickenpox, who on 27-FEB-2008 was vaccinated into the left upper arm with ZOSTAVAX (Merck), lot number: 659326/1824U, subcutaneously. The nurse reported that the patient developed a mild case of shingles after receiving ZOSTAVAX (Merck). The patient came into the office on 19-MAR-2009. The patient developed approximately 19+ lesions (also reported as 20 to 25) on her hip. She complained of pain when some pressure was applied to the rash. A viral swab was obtained (results not reported). The patient prescribed FAMVIR 500 mg three times a day for 1 week. On 19-MAR-2009, a sample of the lesion was collected. The sample was taken from a vesicle in the right hip and was taken to the lab for a viral culture. The results were "No varicella virus detected by rapid viral culture". The patient's pain was measured as a 3 on a pain scale of 0 to 10. The physician reported ZOSTAVAX (Merck) was administered on 26-FEB-2008 (previously reported as 27-FEB-2008). It was reported that the patient had 20+ lesions and experienced them for a 2 week duration. Follow up information has been received from the physician who reported that the patient (height 62 inches, weight 145 pounds) experienced on 19-MAR-2009 at 11:00 AM, a slightly painful eruption on right hip, the patient had crusted microvesicular erythematous lesion. The physician reported that the patient recovered approximately on 09-APR-2009 (3 weeks later). The physician considered the mild/shingles slightly painful eruption on right hip and crusted microvesicular erythematous lesion to be an other important medical event. No further information is available.
NSTEMI during dialysis session 7/19, patient has a history of previous NSTEMI 2019, dose of COVID vaccine given 7/16, Patient transferred to hospital ED
rm was just a little red below the injection site after first dose; rm was just a little red below the injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose). At the time of the report, VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) outcome was unknown. Not Provided          No treatment information was provided.    This case was linked to MOD-2021-028240 (Patient Link).
chills; dizziness; fatigue; headache; nausea; fever 100° F; This is a spontaneous case from a contactable consumer. This 72-years-old female consumer (patient) reported for herself. A 72-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9265) via an unspecified route of administration in arm left on 08Feb2021 15:30 as dose 2, single (age at vaccination: 72 years) for COVID-19 immunisation. Medical history included sjogren's, hashimoto's thyroiditis, CAD, osteoporosis, high MCV, MTHFR, known allergies: iodine dye, reglan, motrin high dose, all from an unknown date and unknown if ongoing. Concomitant medications included clonazepam (KLONOPIN); amlodipine besilate (NORVASC); asa (ASA), multiple vitamins all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number was not reported) via an unspecified route of administration in arm left on 17Jan2021 03:45 PM as dose 1, single for COVID-19 immunisation. No covid prior vaccination and did not tested covid post vaccination. On 19Feb2021 03:30 PM, the patient experienced symptoms of chills, fever 100 degree fahrenheit, nausea, dizziness, fatigue, headache occurs 10-11 days after 2nd dose. No treatment was received. The patient underwent lab test and procedure which included fever resulted as 100 degree fahrenheit on 19Feb2021. The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
12/2/03: diagnosed with chicken pox disease. Parents noticed rash on back 11/30/03. Spread rapidly, red papules on torso, legs, etc.
Large area of swelling with induration of right thigh (anterior lateral). Pain with limping within 24 hours, post vax. Now, 7 days later, still with 11 1/2cm x 7 1/2cm purplish red lesion with central induration and mild pain anterior bilateral thigh right otherwise healthy.
At 10:45 am 3/14 pt received Hep A. No other shots given. That night when dad put child to be bed he had a tonic seizure (rigid only). Took to ER-work up done-nothing found. Will refer to neurology. 8:15 pm child was afebrile also.
The morning after my 1st vaccination, I woke up with blurry vision. I wear progressives and just got the prescription renewed 4 months prior to the vaccine. I was very happy with my eyesight and was having no issues until after the vaccination. I have waited to see if it would clear up on its own but it has not. It's making my job more difficult as reading/filling out forms and evaluating mammographic images for motion, etc. I'm on the computer off and on all day and that has become more difficult, as well as just trying to read a book at lunch time.
This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), seizures (serious criteria GSK medically significant and clinically significant/intervention required), nausea, lightheaded, sweating, shaky and product complaint. On an unknown date, the outcome of the hypoglycemia, seizures, nausea, lightheaded, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, seizures, nausea, lightheaded, sweating and shaky to be probably related to FLUVIRAL. Additional details received: Despite several attempts, the subject could not be contacted. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
Hyperventilation, collapsed on ground outside of car. Evaluated by EMS-Transported to emergency room/department or urgent care.
Patient is a 16 year old who was inadvertently administered with first dose of Moderna on 04/10/21 at  Medical Center.  Regulatory authority was contacted via telephone and email, please see e-mail below.  Per regulatory authority , patient can be administered with 2nd dose of Moderna.  Patient's mother agreed for patient to receive 2nd dose of Moderna and was scheduled for 07/12/21 here at facility.   Patient did not have any adverse reaction for first dose per mother.  Patient did not have any adverse reaction for 2nd dose while in clinic today. Patient was discharged in stable condition after office visit with provider and 2nd dose of Moderna.    Greetings,            Thank you for contacting the regulatory authority regarding Coronavirus Disease 2019 (COVID-19).         Vaccines   Type   Administration error/deviation   Interim recommendation     All currently authorized vaccines  (Pfizer-BioNTech Moderna, and Janssen COVID-19 vaccines)      Site/route  oIncorrect site (i.e., site other than the deltoid muscle [preferred site] or anterolateral thigh [alternate site])  oDo not repeat dose.* Inform the recipient of the potential for local and systemic adverse events.   oIncorrect route (e.g., subcutaneous)  oDo not repeat dose.* Inform the recipient of the potential for local and systemic adverse events.    Age  oUnauthorized age group  oIf received dose at age less than 12 years, do not give any additional dose at this time.? oIf age 12 to 17 years and a vaccine other than Pfizer-BioNTech was inadvertently administered:  ?If Moderna vaccine administered as the first dose, may administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group). ?If Janssen vaccine administered, do not repeat dose with Pfizer-BioNTech vaccine.                Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC
Patient admitted as observation on 5/24 due to pneumonia due to COVID-19 virus
severe body shakes for over a minute that he couldn't control, felt like something electrical was happening; pain in nerves; could hardly walk; slept from 2 pm through to the next morning; no energy/ energy hasn't come back; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe body shakes for over a minute that he couldn't control, felt like something electrical was happening), NEURALGIA (pain in nerves), GAIT INABILITY (could hardly walk), SOMNOLENCE (slept from 2 pm through to the next morning) and ASTHENIA (no energy/ energy hasn't come back) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-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 06-Apr-2021, the patient experienced TREMOR (severe body shakes for over a minute that he couldn't control, felt like something electrical was happening), NEURALGIA (pain in nerves), GAIT INABILITY (could hardly walk), SOMNOLENCE (slept from 2 pm through to the next morning), ASTHENIA (no energy/ energy hasn't come back) and LETHARGY (lethargic). At the time of the report, TREMOR (severe body shakes for over a minute that he couldn't control, felt like something electrical was happening), NEURALGIA (pain in nerves), GAIT INABILITY (could hardly walk), SOMNOLENCE (slept from 2 pm through to the next morning), ASTHENIA (no energy/ energy hasn't come back) and LETHARGY (lethargic) outcome was unknown. Not Provided          Concomitant medications were not provided. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Contact information updated for the reporter. On 21-Jun-2021: Follow up information received on 21-JUN-2021 contains no significant information On 01-Jul-2021: NNI
Right thigh where Hib and Prevnar were given induration and erythema of overlying skin.
Primary Diagnosis is likely hypersensitivity Reaction, or possible very early mild cellulitis caused by Vaccine around site area.
Exhaustion, lack of appetite, lack of focus, light headed meds - 4 days
Her husband is experiencing some of the same stuff he did, but not as bad.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.). At the time of the report, IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746763 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746763:Same reporter Wife case
Upon returning to vehicle to drive to work following vaccination, started to experience severe dizziness, tightening sensation in throat and chest and pounding heart.  Returned to clinic for evaluation.  Given dose of benadryl prior to transport to ER via ambulance. Treated and discharged with Medrol pack. Continues to experience symptoms disruptive to his life including daily panic attacks, feelings like his head is "cloudy" and has trouble breathing. He recently is experiencing numbness in his left cheek and left arm.  He has returned to the ER once and seen a physician an additional two times since the event.  He was prescribed and is taking daily doses of Xanax for the panic attacks and to function at work. He no longer is able to drink coffee as it overstimulates him. He has an appointment with his personal physician to be evaluated on 1/11/10.
Boostrix instead of Infanrix; Patient receiving Boostrix, 2 years old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The advisory service reported that a patient received dose of Boostrix vaccine instead of Infanrix. The HCP (health care professional) stated another advisory service reported the AE (adverse event), so did not provide any information about the situation, only wanted to know how to proceed.  Additional Supportive Information: The health care professional reported that a patient received Boostrix vaccine instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Follow up was not asked to HCP (health care professional). This case is linked with case US2022068741 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068741:Same reporter
This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, unspecified patients were vaccinated with an improperly stored dose of GARDASIL (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
side effects of shingrix; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had side effects.
About five minutes after receiving vaccine parent alerted staff to observe large red patches on babies face and left arm BENADRYL 5cc was administered.
pt recv vax 5MAR96 & the same day pt devel a non-pruritic rash which looks like vasculitis;the rxn did not respond to tx w/DPH;MD prescribed steroids (unspecified) & as of 12MAR96 pt had recovered;
Shoulder, neck and back pain. Rash consistent with shingles 1-3 days following. Currently receiving treatment.
Shortness of breath; Costochondritis/Need to take deep breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (Never smoked).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath). At the time of the report, DYSPNOEA (Shortness of breath) and COSTOCHONDRITIS (Costochondritis/Need to take deep breath) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   It was reported that the patient never had lung/breathing problems. No concomitant medications were reported. It was reported that after two-three weeks after the first dose, the patient had noticed a little shortness of breath. It was further reported by the patient that periodically felt would need to take deep breath and determined it was costochondritis (where ribs attach to the sternum). The patient was due to get the vaccine (second booster). No treatment medications were reported for events.   This case was linked to MOD-2022-546342, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up received includes no new information
DRESS syndrome also with STEMI and shock 2 weeks in the CCU, also developed ITP. Derm biopsy still pending. resolved with IVIG and steroids
Information has been received from a registered nurse concerning a pt who was vaccinated with varicella vaccine. One week post vaccination the pt developed a chickenpox like rash over whole body. Unspecified medical attention was sought.
Received flu shot at open clinic. Noticed small itchy isolated bumps first day, then larger hive-like patches in other areas appearing one section at a time for the next week.  Bumps turn red, ooze, break open and itch! Appears to look like shingles.  Benadryl and calamine eases itch and redness.