chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HEADACHE (bad headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (bad headache) outcome was unknown.            The patient reported he experienced dizziness and bad headache within 11 hours of vaccination.   Reporter did not allow further contact
Fever of 102 degrees F, muscle and joint pain, sharp headache, fatigue.  Lasted 48 hours.  Patient was too tired to get out of bed for the first 36 hours.  No noticeable reaction to the first dose of Covid vaccine.  No history of noticeable reactions to any vaccines in the past.
12/24 Vaccine 12/30 malaise, increase temp to 99.7 (usually 96/97), fatigue, nausea, episode of vomiting, massive chills, flu like symptoms. 'life having the flu for 4-6 hours' 1/6/2021 14 days after vaccine; extreme episode of severe chills lasted approximately 2/3rd of the day
some blood came out of his arm; This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a 43-year-old male patient who received TWINRIX for prophylaxis.   On an unknown date, the patient received the 2nd dose of TWINRIX (intramuscular). On an unknown date, less than a day after receiving TWINRIX, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to TWINRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX about a week ago and reported when he got home after receipt of the vaccine and removed the band-aid and some blood came out of his arm. The patient then bled a little more and was worried he may not have gotten a proper dose of the vaccine.
Initial and follow-up information has been received from a registered nurse concerning a 7 year old male who was vaccinated on 01-MAR-2001 with varicella virus vaccine live (Oka/Merck) (Lot #635449/1141K) 0.5 mL SQ in the left arm. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and hepatitis B virus vaccine (manufacturer unspecified). On 04-DEC-2007 the patient developed a chicken pox rash with more than 50 lesions all over his body and a fever of 104 F after receiving varicella virus vaccine live. The nurse reported that she spoke to the mother on 17-DEC-2007 and was told the patient had fully recovered from all symptoms. Additional information is not expected.
Pt recv vax on 3/5/99; on 3/11/99 pt exp vesicular rash
Developed Henoch-Schonlein-Purpura 4/6/07. Received Hepatitis A vaccine, HPV, & MVC-4 vaccine on 3/20/07. 05/15/07-records received for DOS 4/14/17-Henoch-Schonlein purpura. Myalgia in calves painful with palpation. Mild edema around joints. No fever no signs of DIC. 4+ hemoglobin in urine. PMH: PPD positive. 9/04/-07 progress note received DX Henoch-Schonlein purpura
Inconsolable crying within the week following shots. Decline of social/communication skills from this time forward. Odd behaviors. Loss of speech by 3rd year of life.
Headache, Myalgia, Arthralgia & Fever Narrative:  Employee c/o fever, H.A. body aches, chills. She was unable to sleep on 1/20/21 due to reaction. She called in sick today 1/21/21 due to her reaction to the second vaccination.
High fever, seizure, and stopped speech. Seizures continued until age 6, and speech returned strained, and slowly.
TRANSVERSE MYELITIS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced transverse myelitis, a post-infectious or post-vaccine autoimmune phenomenon, in which the body's immune system mistakenly attacks the body's own tissue while responding to the infection. The patient was hospitalized (date unspecified) and the duration of hospitalization was not reported. She was still in need of medical treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210450559-COVID-19 VACCINE AD26.COV2.S-transverse myelitis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt had Tdap on 5/26/11. Another one was given on 10/10/11. No complaints were noted by patient.
On 3/8/99, the pt experienced a respiratory infection and was treated with antihistamines. On 3/15/99, the pt was seen again with an erythematous, scaly red rash and was again treated symptomatically. On 3/29/99, the child developed full - blown chickenpox all over his body with vesicles and itching. No fever was noted. Subsequently the pt recovered. No futher in formation is available.
This spontaneous report as received from a pharmacist refers to a 70 year old female (additional information was received directly from the patient who was also an Audiologist). The patient's pertinent medical history and drug reactions or allergies were unspecified. On 20-DEC-2014, the patient was vaccinated with ZOSTAVAX (lot # reported as J49842, expiration date: 31-MAR-2016) 0.65 ml, subcutaneous. Concomitant medications were unspecified. On 26-DEC-2014, the patient experienced sudden hearing loss, 40% in her right ear after receiving ZOSTAVAX. On 27-DEC-2014, the patient tested her hearing herself. The patient sought medical attention by visiting otolaryngologist (ENT physician). The patient was treated with ten, two hour, hyperbaric chamber treatments, with steroid therapy and FAMVIR. It was also reported that, at the time of report, the patient was still on steroid therapy that would be completed on 13-JAN-2015. The patient would have two more hearing tests completed on an unspecified dates. At the time of the report the outcome of the events was reported as recovering. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Upon internal review the event of sudden hearing loss in right ear was considered to be medically significant. Lot number J49842 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
a itchy red rash started around the site of the injection and the over the course of the next 48 hours has spread across her chest and neck, although is better now at this writing than it was this am.  Still itchy, but "drying up" per mom.
Received the vaccine in the morning. By evening had severe arm pain, unable to lift arm at all. Low grade fever, chills, muscle pain, nausea, migraine, fatigue.
Information was received on 01-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age who was inoculated with a dose of ZOSTAVAX vaccine on or about 25-APR-2014 at a Medical Center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During May of 2016, the patient was treated at the Medical Center for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to 1 or 2 patients of unknown age and gender. There was no information about pertinent medical history reported. The patient's concomitant therapies included sterile diluent. In 2017 after June 2017, the patients were vaccinated with an improperly stored dose of ZOSTAVAX lot number M035147 with expiration date 25-OCT-2017 (dose, route and anatomical location were not reported) for prophylaxis. The ZOSTAVAX temperature was reported as 15 F (Fahrenheit) for 2 hours and 15 minutes. There was no previous temperature excursion and digital data logger was filled. No symptoms were reported. Lot number M035147 has been verified to be a valid lot number for ZOSTAVAX.
Pt arrived at the hospital on 2/22 due to shortness of breath and was admitted for heart failure and known coronary artery disease.  On 2/24 the pt was tested for COVID due to requiring a TEE and the test was positive.
Pt recv vax on 2/23/99; 30 min post vax pt exp fussiness, sleep pattern change, unconsolable, not eating, runny nose, constipation, fever (100.2), congestion, cough; dx=viral syndrome
Patient loss consciousness for a few seconds, vomited, hot to the touch at first then cool to the touch.  911 was called and vitals were checked by the paramedics. Patient did not go to the hospital and vitals were within range.
Very sore arm the morning following injection. Two hours after awakening mild flu like symptoms (headache, lethargy). Normal routine interrupted by intermittent sleep. Headache remained through the day. Later the evening following injection major flu like symptoms appeared including significant headache. Delirium interrupted sleep for 12 hours. Hot and cold sweats. Awakened next morning somewhat improved, still have minor headache with sharp pain when I cough. Injection site pain substantially improved, no external signs present (rash, etc.).
Approximately 3 days after the vaccines he developed an itchy rash on his back, hands and feet.   They do not recall what the rash looked like.  Mom says during the middle of the night he complained of his heart feeling weird.  Mom says he developed swelling of his elbows, followed by hands, then knees and then feet.  There are unsure how quickly the swelling developed (8 to 12 hours between joint involvement).  The hands remained swollen for several days. The other joints did not remain swollen.  He had pain with walking for about 2 days.  He was taken to the ED and given steroids and antihistamines.  Mom does not recall if it helped significantly.  He also had lip swelling at some point during the course.  They do not recall how long his lips were swollen - maybe 6 to 8 hours.
After immunizations were administered, baby cried immediately and was handed to mom. Patient arched back and then appeared to have had a breath holding spell. Baby was handed to nurse and within seconds baby started to breath spontaneously. Was slightly pale after episode.  Baby was smiling and alert. Dr. called to bedside to assess pt.
No additional adverse events; an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a healthcare worker (also reported: vaccine coordinator) referring to a 12 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 09-JUL-2021 the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029515, expiration date 08-JUL-2021, 0.5 milliliter; route was not reported) for prophylaxis (expired product administered). This dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was found supported by memo with no temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Drug ineffective; COVID-19; fell sick with COVID-19; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received both doses of vaccine, however before the second dose could achieve full efficacy he fell sick with COVID-19. Now since the second vaccine likely could attain it's full efficacy before getting COVID-19. The reporter asked "what is the recommendation for his vaccine schedule? Should he get 1 more dose, redo the whole schedule of two doses, or no doses? What are you recommending for patients who get COVID-19 despite receiving all two doses and allowing time for immunity? We do not have titers available". The outcome of event was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the strong temporal association and known safety profile of the vaccine, the event COVID-19 is considered related to the vaccine BNT162B2.
No adverse effects.; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 14-OCT-2019, a patient administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460 and expiration date 20-MAY-2021; strength, dose and frequency were not reported) subcutaneously for prophylaxis (product storage error) with sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not reported). It could not be determined if the sterile diluent was properly stored. No adverse effects were reported. The vaccine underwent the temperature of -11.5 Celsius for a duration of 76 hours. There was no previous temperature excursion and the call was because of data logger.
Shortly after receiving the pediatric COVID vaccine patient got extremely light headed. He sat down and started sweating and lost color in his face. He threw up within the next 2 minutes. Patient stated 2 minutes later that he felt better and did regain color in his face. EMT arrived at scene a few minutes later and spoke to mom.
Pain/soreness in lymph nodes in armpit of left arm(injection arm) 12 hours after injection.; Moderate soreness around injection site; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the upper left arm on 29Mar2021 at 15:15 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, obesity and pre-diabetes. The patient was allergic to tree nuts. Concomitant medications included cetirizine hydrochloride (ZYRTEC), phentermine hydrochloride (PHENTERAMINE), levothyroxine and liothyronine (NP THYROID) and multivitamin (MANUFACTURER UNKNOWN). The patient previously took codeine experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 06:00, the patient experienced pain/soreness in lymph nodes in armpit of left arm (injection arm) 12 hours after injection which remained painful after 2.5 days, and moderate soreness around injection site. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for pain/soreness in lymph nodes in armpit of left arm and moderate soreness around injection site. The clinical outcomes of the events pain/soreness in lymph nodes in armpit of left arm and moderate soreness around injection site were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
11 doses were administered today to 11 patients from one vial after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (11 doses were administered today to 11 patients from one vial after excursion) outcome was unknown. Not Provided      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.   No concomitant medications was reported Treatment information was not provided
headache, chills, fever, vomitting, diarareah, joint aches ibuprofen, sleep, alka seltzer
Child presented to clinic for flu vaccination.  following immunization, child complained of feeling faint.  Head was placed between knees.  Child then jumped up, arched back and was assisted to the floor. He regained consciousness within one minute.
Headaches passing out and now 2 years laters seizures started occurring 01/01/2010, leg shaking, personality changes, depression, restless sleep
IPOL at a low of 1.6C out of range for 26 minutes with no adverse event; IPOL at a low of 1.6C out of range for 26 minutes and administered post excursion with no adverse event; Initial information received on 13-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA082834.  This case involves a 16-year-old male patient to whom IPV (VERO) [IPOL] at a low of 1.6c out of range for 26 minutes and administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and meningitis.  On an unknown date IPOL was at a low of 1.6c out of range for 26 minutes with no adverse event (product storage error).  On 14-Feb-2023, the patient received a suspect IPV (VERO) suspension for injection at a dose of 0.5 ml once (lot V1A121M, expiry date: 15-Feb-2024) via intramuscular route in the right deltoid for immunization.  On 14-Feb-2023 the patient developed a non-serious ipol at a low of 1.6c out of range for 26 minutes and administered post excursion with no adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the 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 the guidelines. 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.
Pt recvd 2nd dose of MMR on 18MAR91; 1st vax given 1981 @ age of 15mos, on 25MAR91, pt noted to have change in personality; Had been very assertive became passive, submissive, & apologetic w/spasmodic smile;Jun91 exam rev "affective" change
This spontaneous report as received from a medical assistant who administered vaccines refers to a patient of unknown age. On 31-DEC-2012, the patient was administered a dose of GARDASIL (lot # reported as H013977; expired date; 15-MAR-2015) intramuscularly that was exposed to an unsupported temperature excursion (58 degrees Fahrenheit for 106 hours). It was not specified if this was the first, second, or third dose of GARDASIL this patient had been administered. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Influenza vaccine administered in right deltoid at 13:30. Patient stated that he felt as though the room was closing in and then everything went black. Patient fell to the floor and blacked out for a split second.  Patient's color had drained out of him and he was diaphoretic. Patient was awake, alert and talking. Given a piece of candy. Color returned to normal. Patient given a lollipop and water and layed on the floor for 15-20 minutes. Then sat in chair for 5 minutes. Made complete recovery.