chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a clinic employee concerning her 18 year daughter who on an unspecified date was vaccinated intramuscularly with the third 0.5mL dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. The clinic employee said that in 2008, her daughter was diagnosed with mononucleosis "a couple months" after getting her third dose of GARDASIL". It was reported that after the mononucleosis "cleared up" the patient started having dizziness, blackouts and vomiting mostly in the morning. The patient sought unspecified medical attention and "blood work" was performed (results not reported). On an unspecified date, the patient recovered. It was noted that there was no adverse event reported after the first 2 doses. Follow-up information was received from the physician that reported that they did not have any record of a patient that had any reaction. Additional information is not expected. This is one of two reports received from the same source.
CAN HARDLY USE ELBOWS; This spontaneous report received from a patient concerned a 42 year old of unspecified sex. 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) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced can hardly use elbows. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can hardly use elbows was not reported. This report was non-serious.
Information has been received from a physician concerning a 5 year old female patient who in 2005 was vaccinated with the first dose of VARIVAX (Merck). On 09-JUN-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) 0.5 ml subcutaneous. She developed an injection site reaction and a dozen papules scattered over her body. She was taken to an emergency room and given acyclovir and hydrocortisone cream. She presented in the office on 11-JUN-2009 with worsening at the injection site. The area affected was 8cm warm, red, tender with induration. She was afebrile. The patient had not recovered at the time of reporting. Additional information has been requested.
Swollen right eye; Rash under the eye; Fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative.  A 33-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was administered the Pfizer Covid19 vaccine on 01Mar2021 and experienced a swollen right eye with a rash under the eye. He also said he experienced fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
VACCINE GIVEN TO PATIENT 17 YEARS OF AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 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: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 20-JUN-2021, the subject experienced vaccine given to subject 17 years of age. On 20-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given to patient 17 years of age and off label use was not reported. This report was non-serious.
Erythema induration and TIP at (R) deltoid. Noted 3/9/2017. Advised pt. warm compresses, NSAIDs, ED precautions. Sx began approximately 24hrs. after immun.
Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relative to rash. Rash location on arms, legs, chest, back, feet, hands, head. Rash was raised and red. Developed within 24h of COVID vaccine dose. Treated at home with scheduled diphenhydramine, Tylenol,  hydrocortisone topical cream, and Pepcid. After two visits to PCP office, eventually treated with intramuscular steroid injection.
Hands peeling/Fingers and tip of nose peeling; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Hands peeling/Fingers and tip of nose peeling) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (Hands peeling/Fingers and tip of nose peeling). At the time of the report, SKIN EXFOLIATION (Hands peeling/Fingers and tip of nose peeling) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment medication included vitamin E lotion.
pt recv vax & w/in 12-24 hrs exp an urticarial rxn, laryngeal swelling, & secondary painful lt conjunctivitis; pt was seen by MD the next day & was treated w/IM inj of Decadron LA & antihistamine; all sx resolved w/in 48 hrs;
Lymph nodes in armpit of injected arm were swolen and painful for 3 days. Pain successfully managed by 400mg Ibuprofen twice per day.
post-herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On or about 25-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided) On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered outbreak of shingles and post-herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and at the time of the report, the patient was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles and post-herpetic neuralgia were considered to be disabling.
Patient received Pfizer COVID-19 vaccine beyond the manufacturer recommended 31 days at refrigerated temperature. Organization has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range, which is supported by the above data. No known adverse outcome.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 16-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28 MAY 2016, dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Cervical pain. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise). On 31-Jan-2021, CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise) had resolved. 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. Concomitant medications included pain medications for chronic cervical pain management. No treatment information was provided.
allergy; itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy"; PRURITUS (non-serious), outcome "unknown", described as "itching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt admit 2/16 with angioedema after receiving Moderna COVID-19 vaccine 2/4/21 given at store. He was treated with benadryl, pepcid and solu-medrol and symptoms improved. 2/17 solu-medrol dose decreased from 60mg bid to 40mg daily. ADR admitted to VAERs and Moderna. Pt discharged in stable condition.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with doses of PEDVAXHIB (dose, route of administration, anatomical location, lot# and exp.date were not reported) that were improperly stored. No adverse effects were reported. The outcome of the event was unkonwn. This is one of several reports received from the same source. Additional information has been requested.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 NICOTINE DEPENDENCE I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 NICOTINE DEPENDENCE I95.9 HYPOTENSION 1/4/2022 NICOTINE DEPENDENCE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 NICOTINE DEPENDENCE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 NICOTINE DEPENDENCE R09.02 HYPOXEMIA 11/21/2021 NICOTINE DEPENDENCE I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 ACUTE PULMONARY EMBOLISM I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 ACUTE PULMONARY EMBOLISM I95.9 HYPOTENSION 1/4/2022 ACUTE PULMONARY EMBOLISM J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 ACUTE PULMONARY EMBOLISM J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 ACUTE PULMONARY EMBOLISM R09.02 HYPOXEMIA 11/21/2021 ACUTE PULMONARY EMBOLISM I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 PLEURAL EFFUSION I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 PLEURAL EFFUSION I95.9 HYPOTENSION 1/4/2022 PLEURAL EFFUSION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 PLEURAL EFFUSION J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 PLEURAL EFFUSION R09.02 HYPOXEMIA 11/21/2021 PLEURAL EFFUSION I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 MALIGNANT PLEURAL EFFUSION I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 MALIGNANT PLEURAL EFFUSION I95.9 HYPOTENSION 1/4/2022 MALIGNANT PLEURAL EFFUSION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 MALIGNANT PLEURAL EFFUSION J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 MALIGNANT PLEURAL EFFUSION R09.02 HYPOXEMIA 11/21/2021 MALIGNANT PLEURAL EFFUSION I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I95.9 HYPOTENSION 1/4/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXEMIA 11/21/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/4/2022 ATRIAL TACHYCARDIA I82.453 ACUTE DVT OF BILAT PERONEAL VEINS 10/6/2021 ATRIAL TACHYCARDIA I95.9 HYPOTENSION 1/4/2022 ATRIAL TACHYCARDIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 ATRIAL TACHYCARDIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/4/2022 ATRIAL TACHYCARDIA R09.02 HYPOXEMIA 11/21/2021 ATRIAL TACHYCARDIA
I'm not sure if this connected to H1N1 but 2 1/2 weeks ago pt developed alopecia and hives. In past month I've had other pt develop urticaria  approximately 3 weeks after and one 4 yr develop shingles. Just curious if others seeing similar events.
I had a Ditrectomy on 02/16/2023 and I am also being treated for Afib. I was diagnosed on 03/30/2023. The doctor has me on Xarelto and amiodarone. I am scheduled to see my doctor again on 04/27/2023 to determine whether the medications are working or not.
Patient up to date on COVID vaccines who admitted to hospital within two weeks of positive COVID test.  Patient admitted with fluid overload and afib with RVR.  No respiratory complications (beyond what would be expected with CHF exacerbation) noted.  Provider discharge note below:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented with dyspnea found to be in atrial fibrillation rapid ventricular response and acute on chronic CHF exacerbation. He was treated initially with IV amiodarone and later IV to PO digoxin with good effect. For his heart failure he was given lasix with minimal urine output so metolazone added with great impact. He was discharged on his chronic O2 need back to nursing home with bmp/mag/digoxin level to be drawn in a week."
Patient complained that she had excessive bleeding, a bruise afterwards, inject site pain, and  soreness.
Patient received dose from a vial which was initially stored in the refrigerator and administered to patient after 30-day Use By Date; The patient administered the vaccine after the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator and administered to patient after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 33K212A) for COVID-19 prophylaxis.     Patient had not been diagnosed with/tested positive for COVID-19.    On 28-Apr-2022 at 11:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 27-May-2022 at 3:00 PM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator and administered to patient after 30-day Use By Date). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator and administered to patient after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Six vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. 10 vials of lot number 33K212Awas initially stored in the refrigerator on 28-Feb-2022.The vials did not undergo any temperature excursions.  It was unknown if the patient had any prescriptions, over the counter medication, dietary supplements or herbal remedies taken at the time of vaccination   The patients had not reported symptoms.   No additional doses, medications or treatments had been administered.
After recieving the shot, I waited the 15 minutes and felt okay then. Maybe a little nervous thinking I COULD possibley be unlucky few and have a bad adverse effect. However on the drive back home,  calmly singing along to my music, I all of a sudden felt an increase of heart rate. I could still drive fine, but my head had a radiating feeling and it's almost like I got a random adrenaline rush. My heart rate must've been 150+ bpm. It lasted for 20ish seconds and started to go away as I slowed my breathing. Not sure if it was a direct effect of the vaccine or my mind...as I had never gotten such effect on me.
Information has been received from a woman in a MD office concerning a 12 year old white female with no medical history who on 11/03/1997 was vaccinated SQ in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that on 01/21/05 the pt developed a fever and a rash. On 01/22/05 the pt was seen in the physicians office where a Dx of varicella was made. Supportive tx was ordered but no laboratory/diagnostics tests were performed. At the time of this report the outcome was unknown., Additional information has been requested.
I developed shingles within 72 hours.    I never had it before, and had chicken pox 55 years earlier.
PFIZER BTECH EW0173  I am 53 years old.  I have not had a menstrual cycle for more than one year and six months.  I received first dose of the vaccine on June 2, 2021.  Yesterday morning (June 20) at approximately 7:00 am I had terrible lower back pain.  I had light spotting at first.  Today on June 21 I am experiencing moderate amounts of bleeding.  I am confident that this is the result of this vaccination.
pt recvd vax on 2AUG93 & 25SEp93; 5OCT93 pt was dx w/cellulitus & bacteremia; lab eval of the blood & aspirate showed haemophilus influenzae type b;
Mom reported to ER child was down for a nap and body began to shake and eyes rolled back in childs head.  Mom reports woke child from sleep.
9 days after Varicella MMR admin. mom report onset of 101 deg temp. Next day fever subsided but rash started on legs and progressed to all extremities and few on face. Trunk clear. Playful.
Patient describes increased blood pressure, tachycardia, queezy feeling, tremors, tingling/numbness of the lips and eyes, and heavy feeling in tongue and jaw that started to develop ~15 minutes after vaccine administration and worsened overtime. Patient took Benadryl which provided minimal relief,  then presented to the ED.
fever, extreme chills, headache, nauseous, body aches, fatigue and pain in arm where shot was given.  Began in the night, lasted 2 days and treated with nyquil and rest.
Patient received DTaP-IPV component but did not receive the HIB component. DTaP-IPV was not mixed with HIB component.
The patient has a history of multivessel CAD s/p CABG, HFrEF, PE on apixaban, AAA s/p repair 2017, TIA, vascular dementia who presented to WBH on 8/15/2022 for left sided weakness.  Per chart review, the patient was noted to have sudden onset left sided weakness on 8/14/22 around 2300. Last seen at his baseline around 1900.  There is mention of seizure once EMS was called, but there is no description of what happened. Patient was hemodynamically stable, afebrile, on room air upon presentation to ED. EKG showed QTC prolongation at 527 with incomplete right bundle branch block and accelerated junctional rhythm.  His CT of the head showed a 5.2 x 2.2 cm right pericallosal white matter mass along with adjacent masses in both cerebral hemispheres involving the body of the corpus callosum.  There is also mention of remote infarcts of the cerebellum, left temporal occipital, right parietal, left frontal regions.  He was started on Decadron and given 1 g of IV Keppra and started on 500 mg IV Keppra twice daily.  Neurosurgery evaluated the patient and MRI of the brain plus minus gad was ordered. Patient is terminally ill with a life expectancy of six months or less if the illness runs its normal course with a diagnosis of brain mass.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022.; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported
Information has been received from a physician concerning a 5 year old female with asthma and allergies who on 23-JUL-2007 was vaccinated with her first 0.5mL IM dose of hepatitis A virus vaccine inactivated (Lot# 655090/0651F). Concomitant therapy included ADVAIR, FLOVENT and albuterol. On 26-JUL-2007, the patient developed a fever, anorexia, fatigue. The patient's hemoglobin level dropped from 13.1 g/dl to 10.8 g/dl within a 13 day period after the dose was administered. Unspecified medical attention was sought. Other lab tests included sedimentation rate, liver function tests, and test for "mono", results not provided. Subsequently, the patient was not recovered. There was no product quality complaint. Additional information has been requested.