chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt dizzy; heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing). On 05-Jan-2021, DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported.   No treatment medications were given  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.; Reporter'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.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored dose of VAQTA (lot# M038572, expiry date: 11-MAR-2018) (dosing details were not reported) for prophylaxis (incorrect product storage). Information regarding prior excursions was unknown. Temperature/Time Frame as follow: 32 Fahrenheit (F) to 35 F and 47 F to 77 F for 345 hours over a 90 day period. Call was not because of data logger. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014865: US-009507513-1705USA001549: US-009507513-1705USA001551:
We gave an expired vaccine to the patient on 9/10/21. The vaccine was punctured and left out at room temperature on accident. After 5.5 hours the patient was given the vaccine. We called her and followed up today and she is doing well. She had minor flu like symptoms on 9/11/21 but those have since resolved. Janssen had no studies to indicate what to do other than follow up with her and her provider. She declined having us do that for her.
Mild (noticed the pain) lower back pain that began 2 days after vaccination, and worsened on day 3 post vaccination. Bending down, squatting, lying on the back or stomach, and certain position sitting down become very painful, limiting positions for standing/sleeping/sitting. Limited mobility while working (work as a biomedical researcher).
Tested positive for COVID-19 after vaccination; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID-19 after vaccination) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after vaccination). At the time of the report, COVID-19 (Tested positive for COVID-19 after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Not sure. Concomitant medications reported were Not sure for drug use for unknown indication.
Exertional dyspnea, hypoxia, wheezing, low-grade fever, muscle pain
Patient received PEDIARIX vaccine and Tdap. Patient was to receive Tdap and Flu Vaccine. At the time of d/c, no adverse reaction was noted.
Immediately after receiving the Pfizer injection, I began to feel lightheaded and dizzy. Moments after that, I felt a general sense of unease and began feeling too hot. I was nauseated, sweating, shaking, experienced tingling in the hands and feet, tunnel vision, and temporary loss of hearing. Within 10 minutes, these had all subsided, and after my 15 minutes of waiting was up, I was allowed to leave with no further adverse reactions.
Patient experienced a 2 inch rash around injection site. The rash was raised with bumps and was itching.
Muscle was very sore; Arm was very sore; Lethargic; Slept a lot; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle soreness, pain in arm, lethargy and sleepiness. On an unknown date, the outcome of the muscle soreness, pain in arm, lethargy and sleepiness were unknown.   It was unknown if the reporter considered the muscle soreness, pain in arm, lethargy and sleepiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Reporter states that she got the injection during the evening and symptoms started the next morning. The patient received Shingrix 3 months ago and her arm was very sore, and the muscle was very sore. The patient was lethargic and slept a lot following that day for most of the week, like 3 to 5 days. The reporter asked are these side effects normal or abnormal. The reporter did not consent to follow up. Lot and expiration date were not requested.
Mother brought child into the clinic for PPD reading.  Stated that the school called her on Monday, 7 May 07, that the left upper arm was red and swollen, from the shoulder to the elbow.  Mother stated child complained of minimal pain but that the arm was warm to touch and itchy.  Child was seen by doctor and prescribed cool compresses to area and may use hydrocortisone for itchy as needed.  Follow up appointment made for 10 May 07 to observe site for increased swelling.
After 1st Anthrax, sought treatment on 1/11/91. On 1/21/91, I returned to the Medical Aid Station still complaining of throbbing pain in the lower left back to left testicle. On 1/22/91, I returned again, with lower left back pain and abdominal cramping. During the exam, the prostate felt burning on palpation and was boggy, 2-3cm. I was to return for a follow-up in 7 days. On 1/29/91, I received the Anthrax 2 vaccine. The next day, I returned for a follow-up. Doxycycline (known treatment for the side affects of P. B. pills and the Persian Gulf Syndrome) was still continued for 14 days. When each 1 of these exposures (Anthrax, environmental chemicals, warfare and P. B. pills) are administered individually, the toxicity levels have been reported to be bad enough! Being exposed to these exposures within a 3 week time span (exposure to some for longer periods), can reportedly multiply the toxicity level 25 to 35 times more! Given the known side affects of some exposures and the unknown long term affects of other exposures, combined with a cocktail of all these exposures, I feel it is safe to say that I acquired an unknown illness/Persian Gulf Syndrome! Dx's given in the past were just actual symptoms of an unknown illness/Persian Gulf Syndrome. The unknown illness/Persian Gulf Syndrome is a probable result of a series of exposures that I was exposed to, that have very little or no data on side affects, thus Undiagnosed Illness. I feel that I should be awarded 100% Service Connection since 4/3/98, when the MD signed a set of severe limitations in which he indicated that I was unable to do 98% of the physical requirements of my job, which eventually led to the termination of my job!. This is my complete statement of what happened to me. I have documentation to uphold this statement! Have been seeking treatment from VA since 10/96 until the present and ongoing treatment.  A follow up report received 04/11/2001 adds: (Current symptoms:) Numbness in fingers and toes, muscle cramps and spasms, muscle aches, joint pain and discomfort, back pain with lower back pain dominant, headaches, fatigue, sensitivity to light, abdominal cramps, chronic diarrhea and occasional burning sensation while urinating.
No adverse event; Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster).    The concomitant medication was not reported by reporter. No AEs were reported. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662377, US-MODERNATX, INC.-MOD-2022-662382, US-MODERNATX, INC.-MOD-2022-662383, US-MODERNATX, INC.-MOD-2022-662384, US-MODERNATX, INC.-MOD-2022-662386, US-MODERNATX, INC.-MOD-2022-662387, US-MODERNATX, INC.-MOD-2022-662389 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662377:same reporter US-MODERNATX, INC.-MOD-2022-662382:same reporter US-MODERNATX, INC.-MOD-2022-662383:same reporter US-MODERNATX, INC.-MOD-2022-662384:same reporter US-MODERNATX, INC.-MOD-2022-662386:same reporter US-MODERNATX, INC.-MOD-2022-662387:same reporter US-MODERNATX, INC.-MOD-2022-662389:same reporter
The patient pulled his arm away after the needle was inserted into the muscle. 0.1 mL of the vaccine was still in the syringe and a significant amount of spilled vaccine was visible on the patient's skin. The patient received less than half of the dosage (dose: 0.2 mL). The dose was repeated immediately per CDC guidelines and with the parent's consent. The patient was monitored in the office for 15 minutes after injection. The patient was asymptomatic. The parent was instructed to call the clinic if needed.
have had a headache since May 1, 2021 and still have it today May 6, 2021. Had nausea for 4 days. was rired for 4 days. achy for 2 days
I have been experiencing hives that are severally itchy all over my body since Sunday.  I have taken Benadryl and Zyrtec daily, but it appears that the Zyrtec has stopped working and they have continued before the medicine wears off.
This spontaneous report was received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 10-DEC-2015, the patient was vaccinated with ZOSTAVAX. On 10-OCT-2016, patient inadvertently received another dose of ZOSTAVAX lot # M003486/ expiration date- 27-MAR-2017 (inappropriate schedule of drug administration). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Had nasal mist then went to lunch. C/o sick stomach at lunch, drank milk then began throwing up. No elevated temp B/P 110/70, pale. Desired to lie down on floor & went to sleep. Teacher came to to take fever.
swelling of arm; fatigue; joint pain for months after incident; fever; brain fog; inflammation
Multiple cysts; severe lower abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right on 02Apr2021 at 10:45 am (Batch/Lot Number: ER8735) as dose 1, single for covid-19 immunization (at the age of 43-years-old). The patient medical history was none. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. It was reported by the patient that after receiving the first shot of vaccine within one week on 09Apr2021 at 12:00 pm she experienced severe lower abdominal pain in which she visited her doctor, emergency care doctors, received an ultrasound and CT scan to find what was causing the issue but have still not received a diagnosis. She stated that every month since receiving the vaccine she has had extreme lower abdomen pain for at least a week prior to and during her menstrual cycle that also bothers her intermittently all month long and stated that there is a definite link between the vaccine date and the beginning of this pain/issue. She also stated that on 21Apr2021 the vaginal ultrasound showed a multiple cyst. The adverse events resulted in the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 27Apr2021 gastroenterologist suggested that need to get colonoscopy endoscopy. The patient underwent lab tests and procedures which included antibiotic level which showed pain (to treat pain w/ urination, clear antibiotics for pain in lower pelvic region) on 15Apr2021, urine analysis showed urine culture on 20Apr2021, ultrasound scan vagina showed multiple cysts on 21Apr2021, CT scan (computerised tomogram) and ultrasound abdomen (received an ultrasound and CT scan to find what was causing the issue) which results was unknown on an unspecified date in 2021. The patient was treated with antibiotics and birth control and dicyclomine and ultrasound to monitor cysts 3 months later and need to get colonoscopy and endoscopy. Patient received second dose of BNT162B2 via intramuscular route of administration on 02Apr2021 at 11:15 am (Batch/Lot Number: EW0161) as dose 2, single for covid-19 immunization. The patient was not recovered from the events.   Follow-up attempts are completed. No further information is expected.
The patient received a booster dose of 0.25mL of Moderna vaccine.  The patient is 15 years old and was therefore not eligible to receive the Moderna vaccine.  The pt also had her second dose of Pfizer on 7/10/21 making the time between her second dose and booster dose less than 6 months.
infection; suspected gout; huge pain at middle finger on right arm; A spontaneous report  received from a consumer who is 33-year-old male patient who received first dose of Moderna COVID-19 vaccine and experienced pain in middle finger of the opposite vaccine arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch #: 032L20A) intramuscularly in the left arm or prophylaxis of COVID-19 infection.   Patient stated that he received his 1st dose of the Moderna COVID-19 vaccine on 27 Jan 2021 in his left arm and had no soreness. The next morning, on 28 Jan 2021, he woke up with a huge pain in his middle finger on the right arm.  The doctor gave him antibiotics and suspected it was gout. Patient stated he went to his PCP and he asked him to go to emergency room.  The patient stated that he was given IV and antibiotics. The patient stated that they did a lot of blood work and blood culture (results not provided).  He stated that a 90 min surgery was performed, and he stayed in the hospital for three to four days.  The hospital lost the specimen, so he doesn't know what kind of infection he had.  The patient stated that he doesn't know if he should receive the 2nd dose of the Moderna COVID-19 vaccine or not.  Patient was treated with antibiotics and surgery.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
pain in my chest; inflammation; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151, patient was 57-year-old t the time of vaccination), via an unspecified route of administration, administered in Arm Right on 02Apr2021 at 14:15 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included systemic lupus. The patient previously took Celebrex and experienced allergy. The patient's concomitant medications were not reported. No other vaccine received in four weeks. It was reported that other vaccine received in two weeks. It was unknown if tested covid post vaccination. On 03Apr2021 at 08:00, the patient experienced pain in my chest, on 03Apr2021, the patient experienced inflammation. It was slight pain to begin with between my heart and lungs. After few days it did not go away. So today I went to Urgent Care. No seriousness criteria were reported. Adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pain in my chest, inflammation with injection of Depo-Medrol. The outcomes of events were unknown.   No follow up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: Ew0183) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 01Aug2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I took another at home rapid test and was positive again; (23Jun2022) Positive, notes: I tested positive by rapid test on 23Jun2022; (24Jun2022) Positive, notes: confirmed by PCR on 24Jun2022; (02Jul2022) Negative, notes: I tested negative by two rapid home tests on 02Jul2022; (02Jul2022) Negative, notes: I tested negative by two rapid home tests on 02Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient did not have any known allergies. Patient was treated with anti viral drug Paxlovid from 24Jun2022 to 29Jun2022, for COVID-19. Patient received other medication in 2 weeks. Patient tested positive by rapid test on 23Jun2022 and confirmed by PCR on 24Jun2022. Patient started paxlovid 5-day dose that evening. Patient tested negative by two rapid home tests on 02Jul2022 and ended her isolation with mild runny nose. She masked most of 02Jul and 03Jul, and her symptoms worsened the afternoon of 03Jul. Patient took another at home rapid test and was positive again.  No follow-up attempts are possible. No further information is expected.
Bell's palsy that affected left side of face.  Unable to smile symmetrically.  Numbness in my chin, around my eye, and into my forehead.  I was able to identify the issue and get an appointment same day.  Dr. , my PCP, started me on steroids for 10 days.  Symptoms lasted a total of 8 weeks.  After 4 weeks I could smile normal.  After 8 numbness in my cheek and chin ceased.
I don?t normally get my period being on the birth control shot, but after getting the vaccine I bled for 12 days.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219686, 20211219701, 20211219714, 20211219731, 20211219807, 20211219871, 20211219926, 20211219953, 20211220129, 20211220145, 20211220146, 20211220152, 20211220155, 20211220177, 20211220178, 20211220206, 20211220216 and 20211220527.
Shortness of breath and decreasing heart rate noticed in June 2022. Required pacemaker.  Inserted on 10/10/2022.  In recovery ongoing.
Muscle aches and pains all over body and fatigue.  Lasted approximately 2 days and resolved.  800mg Ibuprofen taken on 02/28/2013 and 03/01/2013.
Received first dose of Pfizer COVID-19 vaccine, 9 days ago, in left arm. Knot developed on arm at injection site, which has come and gone since then. Fatigue for 2 days after getting vaccine; back to normal now. Knot on arm is mildly tender. No fevers. Prior history of seizures, none in past 4 years. Stopped medicines 2 days ago. History of Tourette's (not on medicine). Mom noted increase of vocal and motor tics in the past week (they had been gone for a year or more).
14 minutes after the injection, within a 30 second time period, and lasting 8-10 minutes, I was overwhelmed with the following symptoms: Sever Shortness of Breath, Dizziness, Nausea, Blurred Vision, Sweating,  Muscle Fatigue, Elevated Heart Rate, and Body Aches. I was immediately monitored and administered a normal dose of Benadryl where I waited upwards of 1 hour for the symptoms to wear off. All remaining minor symptoms were gone by next day. I've developed pin-pointed neck pain limiting my range of motion within 2 days after the injection. Pain still persists today. No other symptoms. PCP recommended against getting the second dose of the vaccine.