chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Postmenopausal bleeding; Dizziness; Confused; Slurring words; Went onto ground, Crashed onto left arm; Head flashes; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial biopsy (Failed endometrial linining biopsy due to scar tissue from a previous cerclage placed in 2004) on 21-Apr-2021, Hysteroscopy (Waiting on lab results) on 07-May-2021 and Uterine dilation and curettage (Waiting on lab results) on 07-May-2021. Concurrent medical conditions included Penicillin allergy, Food allergy (mango, pineapple, avocado, shrimp, watermelon, pomegranate, kiwi, cantaloupe) and Drug allergy (opioids, narcotics).   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo). On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown and DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: abnormal (abnormal) 102/73. On 21-Apr-2021, Biopsy endometrium: failed (Inconclusive) failed. On 07-May-2021, Hysteroscopy: unknown (Inconclusive) unknown. On 07-May-2021, Uterine dilation and curettage: unknown (Inconclusive) unknown.         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 case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Person younger than 18 years old received the Moderna Covid 19 vaccine.; son received the Moderna Covid 19 vaccine as the first dose and then he received the Pfizer vaccine as the second dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 years old received the Moderna Covid 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (son received the Moderna Covid 19 vaccine as the first dose and then he received the Pfizer vaccine as the second dose) in a 5-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 years old received the Moderna Covid 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (son received the Moderna Covid 19 vaccine as the first dose and then he received the Pfizer vaccine as the second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 years old received the Moderna Covid 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (son received the Moderna Covid 19 vaccine as the first dose and then he received the Pfizer vaccine as the second dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Narrative:  Patient received Moderna covid vaccine #1 on 2/27/21 and #2 on 3/27/21. On 4/16/21, he was admitted at a another facility and treated for sepsis/pneumonia with vancomycin and Zosyn. Of note, history of metastatic stage II melanoma and that same day he had just returned from medical facility where he received a study drug through a clinical trial for melanoma. He was discharged home on 4/19/21 on oral levofloxacin. On 5/1/21, he was readmitted to that same facility with hypotension, dizziness and weakness and reported at that time he had discontinued the clinical trial and treatments for his cancer. On 5/2/21, he discharge home with home hospice services. There were 42 days from second vaccine to date of death. No autopsy report available.
Loss of vision in left eye, stroke in eye caused by retinal vein occlusion. 3 weeks. Injection in left eye once a month for 6 month, not guaranteed to bring back vision.
Information has been received from a RN concerning a 19 week old Hispanic female who on 03-FEB-2001 was vaccinated with a second dose in the right thigh of Comvax. On 04-FEB-2001, the pt developed a lump at the injection site. It was reported that the lump was still observable 3 weeks later. On an unknown date the pt recovered. it was noted that the pt had no prior adverse reactions. It was reported that 4 other pts had similar experiences following exposure to Comvax.
Sore shoulder 1 inch lump where vaccine administered, pain moved to same side within 2 days. 3rd day pain moved to same side upper thigh very tender sore stiffness.
Nausea, arm, neck, wrist, leg pain, fever, chills, decreased limb mobility.
On May 21, 1999, the pt received the first (IM-left deltoid) dose of Lymerix for prevention of Lyme disease.  Two days later on May 23, 1999, the pt experienced dizziness and aching.   The most recent information received on June 23, 1999 reports the condition of the pt as resolved.
under the age of 65 receive fluzone high dose in error, with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA448810(CLUSTER).  This case involves Adult and unknown gender patient who is under the age of 65 received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient under the age of 65 received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT7729BA; Expiration Date: 30-Jun-2023) via unknown route in unknown administration site for immunization in error with no reported adverse event (product administered to patient of inappropriate age).  Action taken: not applicable.  Outcome: Unknown.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received vaccines past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 3:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 3:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. No treatment medication was reported by reporter.   This case was linked to MOD22-011-6773, MOD-2022-542869.
Information has been received from a health professional concerning an approximately 48 year old female patient with condyloma with mild to moderate dysplasia who on 31 Oct 2006 was vaccinated IM into the deltoid with a second 0.5mL dose of Gardasil (yeast) (lot # 653978/0955F). Concomitant therapy included aspirin. It was reported that after the nurse gave the injection blood immediately ran out of the site and it was hard and lumpy. It was reported that the nurse used proper placement technique and a standard 1 inch needle (not the prefilled device). The patient had no problems with the first dose. The patient did not report any discomfort from the hard and lumpy area. The patient sought unspecified medical attention. Additional information has been requested.
PT WAS ADMINISTERED AN INCOMPLETE DOSE OF THE VACCINE. THE INTERN THAT ADMINISTERED THE VACCINE APPROXIMATED THAT 1/4 OF THE DOSE LEAKED OUT OF THE SYRINGE DURING INJECTION AND WAS NOT ADMINISTERED TO THE PT. THE SYRINGE FROM THE MANUFACTURER MAY HAVE BEEN COMPROMISED BEFORE ADMISTRATION. THE PHARMACIST INFORMED THE PT THEY WOULD CONTACT THE MANUFACTURER TO DETERMINE IF ANOTHER DOSE WOULD BE NEEDED.
appendicitis; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 15:30 (Batch/Lot Number: ER8736) at the age of 16-years-old as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Clinic. Medical history included allergy to peanuts, tree nuts. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; dexmethylphenidate, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: W0158) on 13Apr2021 15:30 (at the age of 16-years-old) in Left arm for covid-19 immunisation. The patient experienced appendicitis (hospitalization, disability) on 30May2021 08:00. The patient was hospitalized for appendicitis for 2 days. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of appendicitis included Appendectomy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was recovering.
Initially presented with shingles around  T7, travelled from spine to sternum. Since resolution, an unresolved atopic dermatitis has been present and severe in conjunction with vaccine administration. The dermatitis relents approx 6 months following each of the last two administrations. The dermatitis is present on upper limbs and groin. Topical steroids provide little to no relief. Currently taking gabapentin to quell nerves in the affected areas.
pt devel anaphylactic shock 5min p/vax;cyanotic above waistline; red rashes on lower extremities;signs of difficulty breathing, tachypnea;
Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, 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 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023).    Concomitant drugs were not reported. Pharmacist stated that perhaps 5 doses of the bivalent vaccine which was expired on 06-Jun-2023 were administered. Vial size was reported as 2.5ML. Date the vial was initially stored in the refrigerator was 7Jun2023. Dates of administration of vaccine was reported as 1 dose on 7Jun2023 and 4 doses on 8Jun2023.  The vial had not undergone any temperature excursions.  Treatment medications were not provided. The case corresponds to 5th out of 5 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:Master case
Patient had vaccine on 01/06/2021 and reported she woke up early in the am on 01/07/2021. She wanted to go to the bathroom but had severe dizziness and needed help from her husband to get back in bed. She also experienced nausea and vomited 3 times. Also had extreme soreness. Was followed up in office on 01/08/2021 when she continued to report severe pain in L arm where she had the injection. No nausea or vomiting for past 24 hours.
Pt experienced soreness at the site that progressed over the week after the vaccine was given.  She has not been able to lift her arm above her head without pain since the shot was given.  She has taken Ibuprofen and Tylenol as needed daily and has applied moist heat to the site.  She did see her physician about it, but no further treatment was reccomended.  There was never any redness or swelling to the site.
felt like she had Covid again; sweating; chills; headache; been sick; felt all the aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (been sick), HYPERHIDROSIS (sweating), SYMPTOM RECURRENCE (felt like she had Covid again), MYALGIA (felt all the aches) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced ILLNESS (been sick) and MYALGIA (felt all the aches). On 22-Jun-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headache). On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (felt like she had Covid again). At the time of the report, ILLNESS (been sick), HYPERHIDROSIS (sweating), SYMPTOM RECURRENCE (felt like she had Covid again), MYALGIA (felt all the aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Body temperature: 100.6f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.
massive joint pain, loosening of joints, bursitis, inflammation of all joints Diagnosed with RA. Enbrel for treatment MRI disclosed bursitis in hips
S/P first set of immunizations deveolped fever and fine red rash x2 days.S/P second set of immunizations began to develope fine red rash within 20 mins. of immunizations. Given Benadryl 1/4 tsp in office with resolution of rash. Rash didnot return but had fever x48 hours again, peaked @102.0 with Tylenol
Sore arm, nighttime chills during sleep, headache, fever (99.7).  Sore arm started 3 hours after shot and the others about 15 hours after shot.
Patient presented with vesicular rash in classic dermatomal distribution 5/26/08.  Patient had 2 doctoer visits. One urgent care visit 5/27/08 and one with primary MD 5/29/08
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # M035385, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011239: US-009507513-1708USA011240:US-009507513-1708USA004959:
Headache; Slight fever/ low grade fever; Nausea/ nauseated; Tiredness/ so tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, ESZOPICLONE (LUNESTA), IBUPROFEN and REPAGLINIDE (PRANDIN [REPAGLINIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired). At the time of the report, HEADACHE (Headache), PYREXIA (Slight fever/ low grade fever), NAUSEA (Nausea/ nauseated) and FATIGUE (Tiredness/ so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up received on 30-APR-2021 included: Patient declined further follow-up.
large hives, rash, swelling and itchiness initially on back and then spread to arms, legs and neck and belly.
Long stabbing when given shot. Unable to lift arm. Used ice and heat on arm with no effects. Arm is red and swollen after shot. Huge bruise on arm and red puffy streaks. Went to hospital and received Anaprox DS.
Dose #1: Acute reaction noticed upon standing (after waiting 30 min at center): tachycardia, heart fluttering, SOB.  Tried to ignore-thinking I might just be anxious, but worsened once home. Sx increased on standing (had to sit on stool to prepare dinner) - tachycardia, fluttering, low B/P.  Over next week: couldn't seem to get systolic B/P over 100 or HR under 100; symptoms worse on changing positions. (HR increased 15-20 bpm when standing; B/P dropped 10 mmHg ). I recognized this as possible POTS/dysautonomia, that I had seen a cardiologist for in 1988, but hadn't had much for symptoms since going on prednisone for adrenal insufficiency in 2005. The first week was the worst, but it took most of the month to improve. It got better, but never quite back to my normal. Other injections retriggered it since (Prolia, Evusheld) Dose #2: The B/P and HR symptoms were more mild, but 12 hours after injection had acute SOB/asthma response. Used inhaler (xopenex) and added prednisone pulse x 5 days
PT STATED THAT SHE WAS HAVING HOT FLUSHES AND PAPITATION , MD WAS NOTIFIED, VS WAS:163/65, T :99.6, \SAO@:97, p:87, r:18@3:15. PT WAS EVELATIED BY MD , FLUID WAS ENCOURAGED, MD ORDERED  CONTINUATION OF MONITORING PT , PT RESTED ON THE STRECHER FOR THE REMAING TIME, NO MORE DICOMFOORT COMPLAINTS FROM PT . VS CHECKE @3:30, BP :129/58, p :71, rr:18, SAO2:97. T: :99.5, VS CHECKED @3:58, \BP 131/58, p:82, \RR:18, SAO2:96, MD CAME TO CHECK ON PT @3:50, PT STATED THAT SHE FEELS FINE NOW , MD DIDD ANOTHER REEVALTION ON PT AND INSTRUCTED PT TO GO HOME , PT LEFT WITH HER AID NIA TAXI , NO MORE COMPLAINTS FROM PT.
Information has been received from a physician concerning a 22 year old female who on 11-Oct-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F) (0.5ml), intramuscularly. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 12-Oct-2006 the patient experienced "rash on her face and neck". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAY-2016 the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Event described by patient Daughter Dr. Patient had history of Echo in March and TEE in December, both were clear.  Now has asymptomatic Endocarditis that is aseptic with 3 vegetations on 2 valves recently after receiving 2nd dose of Moderna COVID-19 vaccine in February.  Daughter states patient was never diagnosed with COVID-19.