chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes that come up on my chest; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES VIRUS INFECTION (herpes that come up on my chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (herpes that come up on my chest). At the time of the report, HERPES VIRUS INFECTION (herpes that come up on my chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been prescribed with an antiviral drug for herpes. No concomitant medications were provided by the reporter. Patient wanted to get the booster on the day of reporting.   Reporter did not allow further contact
no adverse effects; patient received one improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  Since 12-JUL-2019, vaccines had a temperature excursion.  On 14-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot number S008570 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 5 degrees Celsius (C)  for more than 30 days. The excursion ended on 05-SEP-2019. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
This spontaneous report was received from a pharmacist concerning to a neonate (term baby) male patient who was born on 29-MAY-2013 to a Hepatitis B positive mother. On 29-MAY-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml in the arm (route, lot number and expiration date were not provided). With the 12 hours of the first dose, the patient was re-vaccinated with the second dose of RECOMBIVAX HB. Other suspect therapies included H-BIG. Concomitant therapies included erythromycin as part of routine protocols for delivery. No adverse effect reported. The pharmacist reported that the neonate patient received RECOMBIVAX HB concomitantly with H-BIG and in the same area on the body (in the same arm). It was also reported by a physician that these two injections were supposed to be given in contralateral deltoid muscles. A Vaccine Specialist advised to revaccinate the child with RECOMBIVAX HB. This second dose was given within 12 hours of the first dose. The physician also reported that H-BIG alone provides 3 to 6 months of passive immunization against perinatal Hepatitis B even if the birth vaccine dose was not immunogenic. He also reported that he instructed the pharmacist not to give the second dose of RECOMBIVAX HB, but rather to wait for the first month and six months dose which would complete the appropriate 3 dose series. After 6 months, Hepatitis B antibodies should be measured. If the child is a non-responder, repeating a 3 dose series could be possible with the 6 doses being the maximum. Unfortunately, the neonate received 2 doses of RECOMBIVAX HB 12 hours apart on their first day of life. The physician was instructed to tell the mother to observe for fever, rash, excessive irritability or lethargy. At the time of reporting, the outcome of the events was unknown. At the time of the report, the patient was still in the hospital. Additional information has been requested.
PT C/O HEADACHE AND NAUSEA 10 MINUTES AFTER BEING VACCINATED WITH INACTIVATED H1N1. HEADACHE GOT PROGRESSIVELY WORSE TO A 7.5/10. PT REPORTED TO THE MEDICAL TREATMENT FACILITY AT 10:52 AM FOR TREATMENT WAS EVALUATED BY THE PHYSICIAN ON DUTY AND GIVEN ACETAMINOPHEN PO 325MG TABLETS TO TAKE 1-2 BY MOUTH EVERY 4-6 HOURS PRN FOR PAIN. PT WAS GIVEN 48 HOURS SICK TIME (SIQ).
Narrative:  After received his Pfizer covid shot, he got sweaty and symptoms improved quickly, refused to go to ER.
Pt broke out with hives the evening after his shots were given. He had small hives over the right upper thigh, that then spread to and thru his groin area. He was brought to the office the next day. He was given Zyrtec syrup and mom was instructed to give him tylenol or motrin for the next 2-3 days. Pt is to return to the office on 9-7-07 for a follow-up appt.
This spontaneous report was received from a female patient of unknown age, regarding on herself. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 20-NOV-2018, also reported as on 29-NOV-2018 (conflicting information as it was also reported as the onset date of the event), the patient was vaccinated with PNEUMOVAX 23 subcutaneous injection, lot number R009408, expiry date 07-MAR-2020 (strength, dose and frequency were not reported) for immunization for the prevention of pneumococcal disease. On 29-NOV-2018, the patient experienced an "anaphylaxis reaction" (unspecified). The outcome of anaphylaxis reaction was reported as not recovered. The causality assessment between with PNEUMOVAX 23 and the aforementioned event was not provided. Upon internal review anaphylaxis reaction was determined to be serious due to medically significant.
pt recv vax 19NOV98 & had been taking amoxicillin 5 days for cold;mom denies any fever during this time;child devel a rash on face, chest, arms & buttocks on 20NOV98;T98 aux rash is red, raised macular appearing;mom gave med for cold;
6.5 x 12 cm area of erythema, induration, hot to the touch, and sharply demarcated. Patient complained of pain... tender to touch.Patient had a low grade temperature of 99.6
The day after and the next day were filled with extreme exhaustion, dizziness, joint pain, and headache.  I started to feel better until Jan 11, where I had extreme exhaustion, worse joint pain, extreme muscle aches and stiffness, worse headache, and the worst nausea.  Since Jan 11, I haven't been able to eat much.  The V-safe check in skipped the worst days so far.
no adverse event; A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721464, US-MODERNATX, INC.-MOD-2023-721466, US-MODERNATX, INC.-MOD-2023-721467, US-MODERNATX, INC.-MOD-2023-721468, US-MODERNATX, INC.-MOD-2023-721471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721471:Patient 6 US-MODERNATX, INC.-MOD-2023-721468:Patient 5 US-MODERNATX, INC.-MOD-2023-721466:Patient 3 US-MODERNATX, INC.-MOD-2023-721464:Patient 2 US-MODERNATX, INC.-MOD-2023-721467:Patient 4
Patient complaint of itching  throat 15 minutes post getting vaccine.  Redness noted right forehead  Treatment 50 mg benadryl given right deltoid 5:48pm. Symptoms resolved in 10 minutes.
On 8/6/21 I got a severe, deep bruise on my right calf that was much worse than the injury I sustained seemed to warrant.  After monitoring it through a bruises typical phases of healing, I scheduled a doctor appointment on 12/1/21 to have my leg checked for a blood clot.  On 12/2/2021 I was able to get an ultrasound that in fact resulted in the diagnosis of a deep vein thrombosis (DVT) in my right calf.  I was immediately put on a blood thinner (Eliquis) daily to prevent further DVTs or a pulmonary embolism (PE).   On 12/20/21 my personal care physician ordered additional blood tests; the results on 12/25/21 indicated I have the genetic Factor V Leiden mutation (hererozygous for G1691A mutation).
Swelling in Bicep, Extended to entire arm, shoulder and swollen clavical.
I came with COVID-19. I felt very sick that night, Wed I took a home COVID-19 test, and it was Positive; next morning I have telehealth call with the doctor. 100.5 fever, sinus, congestion, Doctor prescribed Paxlovid. Within 12 hours of taking, it I felt better. After 5 days I was sick again, the same mode, tire, headache, sinus, congestion for 2 weeks, I still tested Positive until the 3rd week.
This case was reported by a consumer and described the occurrence of arm weakness in a 30-year-old female subject who was vaccinated with TWINRIX for prophylaxis. A physician or other health care professional has not verified this report. On 14 September 2005 the subject received 1st dose of TWINRIX (lot not specified) to the right arm. On 14 September 2005, less than one day after vaccination with TWINRIX, the subject experienced arm weakness and soreness in the right arm. The subject required unspecified medical attention at the physician's office. At the time of reporting the events were improved.
Patient still has a red slightly raised itchy and painful bump where vaccine was administered 5 days after the dose.
all joints in my body ached, headache, fever 102, full body rash, itching, diahreah, all started on the 13th.  next day after shot.  went to hospital on 04/22/2021 and released on 04/28/2021
Information has been received from a 73 year old male patient with diabetes and with no known drug reactions/allergies who on 16-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) injecting in his arm. Concomitant therapy included WARFARIN, metoprolol, TRICOR and LIPITOR. On 16-JUN-2008, after receiving the ZOSTAVAX (Oka/Merck), the patient experienced extreme dizziness, nausea and vertigo on his way home. He did make it home, but one he got into the house he could not function due to the dizziness and he felt like he was going to vomit. The room was just spinning. He was kept hospitalized for 4 days. A magnetic resonance imaging (MRI), unspecified scans and blood work were performed but no result was provided. The patient's extreme dizziness and nausea and vertigo persisted. Additional information has been requested.8/18/08-records received for DOS 6/17-6/20/08-DC DX: Acute dizziness, possibly a cerebellar versus midbrain small infarct versus acute vestibular neuronitis. Presented to ED with C/O acute vertiginous attack, dizziness and diaphoresis.  Gait disturbance. 1/25/2010 Follow up: I have not felt real well since I took the vaccine, I now get more dizzy spells than before I took the vaccine.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccinations 4 weeks prior to the COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Information has been received from an investigator concerning an 11 month old male patient (AN#81318) with no concurrent conditions or medical history who entered a study. On 22-OCT-2012, consent was obtained. On 25-OCT-2012, the patient was randomized and was vaccinated with the first dose of MK-V419 STUDY dose 1, intramuscularly 2, 4, and 11 to 12 months of age. Other suspect therapies included first dose of rotavirus vaccine, oral and first dose of PREVENAR 13, intramuscularly on 25-OCT-2013 to complete the childhood immunization series. On 11-Dec-2012 the subject was vaccinated intramuscularly with the second dose (0.5ml) of MK-V419 STUDY. The subject was also vaccinated with the second dose (2.0ml) of rotavirus vaccine, oral and the second dose intramuscularly (0.5 ml) of PREVENAR 13 to complete the childhood immunization series. On 10-JAN-2013, the patient was vaccinated orally with the third dose of rotavirus vaccine to complete the childhood immunization series. On 15-JUL-2013, the patient was vaccinated intramuscularly with the third dose of MK-V419 STUDY. The patient was also vaccinated orally with the third dose intramuscularly with PREVENAR 13 to complete the childhood immunization series. There was no concomitant therapy, no secondary suspect therapy and no previous therapy history. On 13-AUG-2013, the patient experienced abscess on left thigh of severe intensity and was hospitalized on 24-SEP-2013. An ultrasound was done on the day of admission. Results showed liquid bubble of 12 mm of diameter, resembling pus, surrounded by edematous tissue sized 15x12x19mm. Other tests done on that date were: p-CRP-O, which was below 5mg/L; and normal, negative bacterial staining, culture and NhO (to be clarified). The abscess was drained under general anesthesia. A single dose of pre-operative intravenous cefuroxime (dose unknown) was administered. On 25-SEP-2013, the patient recovered from abscess on left thigh and was discharged from the hospital. The action taken with study therapy was none. The reporting investigator considered that abscess on left thigh was related to the third injection of blinded therapy, since the abscess was located on the injection site. The investigator is of the opinion that the event could have been induced either by the vaccine or the procedure. The investigator considered abscess on left thigh to be not related to PREVENAR 13 and rotavirus vaccine, oral. Additional information is expected. Follow-up information was received on 08-Oct-2013 from the investigator. Causality assessment was changed and rationale was provided. Injection cycles were provided complete. Weight, age at onset of event, intensity of event, diagnostic tests and treatment of event were also added. SAE stop date was confirmed. The record for this patient was unblinded on 11-Oct-2013.
Woke up the next morning early with the worst headache of my life. Achy sides especially my right side. Significant pain in my joints worsening over 3 days. Shortness of breath, chest pain, and heart speeding up and slowing down. I get a little better but then it returns in waves. After 5 days my pain level in my joints is less but I am stiff. But my chest pain and difficulty breathing has not diminished significantly. Just pain everywhere and extreme tiredness. I am significantly worse than when I had a Covid months prior. I felt perfectly healthy before but have been wrecked since the day after my vaccine.
Body rash appeared within a few days lasted about a week then on 8/31/14 extreme fatigue set in so bad that he had to quit sports and be on 504 plan at school. Neurologist did sleep study and said he has Idiopathic Hypersomnia hypothesizing by the HPV vaccine. He also has dizziness, muscle malaise, and depression.
no AE; patient was administered PEDV AXHIB after a temperature excursion; This spontaneous report was received from a HBP to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T037650 verified to be valid with expiration date: 21-JUL-2023) in dose 0 .5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccine was exposed was 47.29 degrees of Fahrenheit (F) and the time frame was reported as 3 hours 22 minutes.. It was unknown if a digital data logger was involved. No adverse symptoms were reported.
Area of redness, tenderness, warmth, slight induration at site of injection (upper outer left arm) 24 hours after vaccine given, increased to 4cm x 8cm size by 48 hours, with fever 101. Headache. No body aches. PE otherwise normal.
Information has been received from a physician concerning a 5 year old male with asthma who on 01-FEB-2002 was vaccinated in the right arm with a 0.5 mL IM first dose of Varivax (lot # 640090/1147L). There was no illness at the time of vaccination. On 10-APR-2006 the patient developed shingles at the injection site on the right arm. A doctors visit was required. On approximately 10-APR-2006 a CBC was performed, the patient's MCH was low at 25.8 pg. A strep test was negative. A urinalysis was performed, the results were not reported. The patient was treated with acyclovir (ZOVIRAX). On 17-APR-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
legs pain; felt sick for 3 days; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs pain), MALAISE (felt sick for 3 days), PYREXIA (fever) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (legs pain), MALAISE (felt sick for 3 days), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (legs pain), MALAISE (felt sick for 3 days), PYREXIA (fever) and CHILLS (chills) had resolved.            No relevant concomitant details was reported.  No medical history was provided by the reporter.  No treatment details was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-030645 (Patient Link).
Erythema, swelling, site of influenza immunization given 09/21/2005, reported 09/23/2005.
This spontaneous report as received from a pharmacy intern refers to a patient  of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, an unspecified  patient may have been vaccinated with improperly stored dose of ZOSTAVAX 19400 PFU lot # N012493, expiration 17-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Sterile diluent used to reconstitute the vaccine did not undergo a temperature excursion.  Temperature: 15 degrees Fahrenheit (°F) to 46°F Time Frame: 12 hours 19 minutes No previous temperature excursion Digital Data logger report was involved. No additional information was reported. Additional information has been requested.
Light headed, feeling of vertigo, tired, fatigue, sore throat lasted  a few days.
Four months after first Covid19 (03/1/21) vaccination with Pfizer postural tachycardia and orthostatic hypotension developed. These symptoms have continued and worsened over time. They have lead to multiple ER visits as well as continued disability. Symptoms associated with the tachycardia and hypotension include dizziness, shortness of breath, fatigue, headaches, left calf pain, generalized pain, and malaise. I can only stand or walk for short periods of time (5-15 minutes) and can only be upright for a few hours at a time. No treatments have had substantial impact on symptoms or functioning. Treatments include; increase in salt and water intake, cardiac rehabilitation program, and IV fluids.   3 days after 4th dose a sinus infection developed and lead to bronchitis and an asthma flare. Multiple rounds of antibiotics, oral steroids, and rescue asthma medications were needed. Addition of inhaled cortiocosteriod Advair did not improve results. Symbicort with Spiriva was added and asthma is now controlled again.
stopped getting flu shots patient stopped getting sick. Had not been sick in years; Initial information was received on 17-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCINE.  Past medical history, medical treatment(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient stopped getting flu shots patient stopped getting sick. Had not been sick in years (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Noted swelling/redness around injection site on 5/3/00, progressively more. No fever or irritability. Mild bump on 5/4/00. On exam, had 10cm X 10cm swelling/redness on antero/medial left thigh with mild tenderness and ? fluctuance; no pustule, no drainage. Seen back on 5/5/00 and legs were red, swelling more medial. Treated with cool compresses and Motrin. On 5/17/00, still minimal swelling and warmth/redness.