chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 27-JUL-2017 the patient was vaccinated with VARIVAX lot # N000683 with expiration date of 06-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On 27-JUL-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. It was stated that the vaccin underwent a temperature excursion of 6-14 degrees Fahrenheit for 6 hours. No previous temperature excursion was performed.  The call was because of a "data logger". Additional information has been requested.
On 29DEC mom noticed temp of 105; she gave APAP & took pt to clinic; temp of 103 @ clinic (1/2 hr later); to ER due to high temp; D/c home; Dx: fever secondary to DTP; pt smiling, playful, "looked great";
pt brought to ED with acute dyspnea, weakness; O2 sats 87% on RA; positive COVID test; admitted; O2 supplementation; Acute respiratory failure, metabolic acidosis, hyperkalemia; poor oral intake; given ABX, dexamethasone; pt expired in the hospital
Headache, Myalgia, NauseaVomiting, neck stiffness, chills Narrative:
pt recv vax 15DEC97 & 16DEC97 pt presented to Er w/swelling around eyes & face w/a rash across abd;
The client presented to the vaccination site today with his mother to receive his 2nd COVID vaccine Pfizer. The client reported an onset of chest pain on 06/15/21 in the morning after receiving the 1st COVID vaccine Pfizer. The client described the chest pain as "stabbing." The client stated the chest pain resolved after a few minutes. The client did not take any medications for the chest pain and did not seek any medical care regarding the chest pain on 06/15/21. The client denied any s/s of anaphylaxis following the 1st COVID vaccine Pfizer. The client denied any shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart. The client has no chronic conditions and is not currently taking any medications. The client has no known allergies. RN submitted a medical consult via text message. Approval to proceed with the 2nd COVID vaccine Pfizer was obtained. RN educated the client on s/s of anaphylaxis, pericarditis, and myocarditis. RN educated the client's mother on the s/s of anaphylaxis, pericarditis, and myocarditis. The client and his mother voiced understanding of this. RN also educated the client on when to seek EMS services and when to follow up with a primary care doctor, v-safe, and the recommended a 30 minute waiting period. The client voiced understanding of this. The client received the 2nd COVID vaccine Pfizer Lot#EW0191 at 1:50 PM. The client tolerated the vaccine well and did not report any symptoms to the EMT's during the observation period.
Initially pain in left limb, soreness in left arm, redness, swelling, pruritus at injection site; 9 days post vaccination (today) pain and soreness gone, but redness, pruritus, swelling at injection site persists; palpable area of swelling at injection site approximately 2" diameter, warm to touch; achiness at site
appears slightly pale; feeling lightheaded; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Mar2021 (Lot number: EN6208) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Patient usually takes Zoloft daily for anxiety but missed her dose that day. Concomitant medication(s) included: ZOLOFT taken for anxiety, stop date: 10Mar2021. Vaccination history included: Bnt162b2 (Product: COVID 19 , Brand: Pfizer, Lot number: EN6201, Lot unknown: False, Administration date: 16Feb2021, Administration route: Intramuscular, Vaccine location: Left arm, Dose number: 1, she always feels lightheaded after getting vaccines), administration date: 16Feb2021, when the patient was 29 years old, for Covid-19 immunisation, reaction(s): "she always feels lightheaded after getting vaccines". The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovering", described as "feeling lightheaded"; VISION BLURRED (non-serious) with onset 10Mar2021, outcome "recovering", described as "blurry vision"; PALLOR (non-serious), outcome "recovering", described as "appears slightly pale". Therapeutic measures were not taken as a result of dizziness, vision blurred, pallor.  No follow-up attempts are possible. No further information is expected.
inquiring if a patient can receive/second dose of shingrix/First dose was on oct 1st 2018.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st October 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired if the patient could received the delayed 2nd dose of Shingrix or if the series should be restarted. The reporter did not consent to follow up.  Notes:The patient's date of birth was reported as 28th November, which is later than 1st onset date (October 2018), hence date of birth is not captured in system raised for the same.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 21-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R003292, expiration date: 31-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032.
We left the exam room and stood at the counter to make his next appointment. He complained that he didn't feel well, said his stomach felt sick. He was shaking his head slowly from side to side and sagging against the wall. Then he just fell to the floor. Staff rushed out to help him back into the exam room to lie down. They have him some apple juice and within 20-30 minutes he was feeling better. I chose not to take him to school afterward. By noon, he had what appeared to be a large mosquito bite at the injection site. The area was raised, red and warm. He complained that it was sore and itched a bit. It was about 1.5 inches in diameter. We returned to the doctor's office the next day to have the area seen. We were told the reactions was normal. The area remained this way for several days and faded over the course of the following week.
This spontaneous report was received from medical assistant and refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of M-M-R II (lot # M034387, expiry date: 19-JUL-2018 and M037096, expiry date: 23-AUG-2018) for prophylaxis. Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (°F) to 35°F for 8 hours and between 47 °F to 77 °F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 hours. The call was because of a data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This case was cross-referenced with 1706USA011420, 1707USA001306, 1707USA001304 and 1707USA001305 (same reporter). Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015 09:56, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 14.4 (5 hours 37 mins) and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Within a few minutes after receiving vaccination I started to experience tingling in the lips and then it spread to my tongue and after a few minutes of that it started to get numb. It has now been a couple of hours after my shot and I have a flushed face, and my neck and chest is itchy and have a headache.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Apr2021 at 16:00 as dose 1, single (Lot number: ER8731), in left arm and on 04May2021 at 11:00 as dose 2, single (Lot number: EW0170) at the age of 61 years, in left arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Irritable Bowel", start date: 2007 (ongoing); "Pancreatic exocrine insufficiency" (ongoing), notes: Onset Date:; "Mast cell Activation Syndrome", start date: 2021 (ongoing), notes: Diagnosis not completely confirmed.; "Neuropathy" (unspecified if ongoing); "Colon Spasms" (unspecified if ongoing); "Anti histaminic" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for neuropathy peripheral, start date: 2017, stop date: 2021; GABAPENTIN taken for neuropathy peripheral, start date: 2017, stop date: 2021; PANCREAZE [AMYLASE; LIPASE; PROTEASE NOS] taken for pancreatic failure, start date: 2020 (ongoing); CHLORDIAZEPOXIDE; CLIDINIUM taken for gastrointestinal pain, start date: 2019, stop date: 2021; HYDROXYZINE taken for antiallergic therapy, start date: 2021, stop date: 2022. The following information was reported: DEAFNESS (medically significant, medically significant) with onset 01May2021, outcome "not recovered", described as "hearing loss"; TINNITUS (non-serious) with onset 2021, outcome "not recovered"; COLONOSCOPY (non-serious) with onset 10Dec2021 at 09:00, outcome "recovered"; EAR DISORDER (non-serious), outcome "unknown", described as "felt like moisture in my ears". The events "hearing loss" and "colonoscopy" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (06Dec2021) Loss of hearing, notes: Lost more in right ear; Colonoscopy: (10Dec2021) Normal. Therapeutic measures were not taken as a result of deafness, colonoscopy. Clinical course: May to Jun2021, tinnitus. Felt like moisture in my ears. Ear popping and liquid-like sound when moving my head. Took several months to see ENT doctor. He performed a hearing test and exam. No fluid in ears and no physical abnormalities. Hearing test indicated hearing loss both ears with more loss in the right ear. Tinnitus continues. I am happy to provide the records if needed. Just ask. No follow-up attempts are possible. No further information is expected.
patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication provided.  Nurses administered 0.25ml doses to 5 patients all patients were employees of the prison.  This report refers to a case of incorrect dose administered for mRNA-1273, lot # 017B21Awith no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 017B21Awith no associated AEs.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-JAN-2018 and 31-JUL-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020; lot# N022728 and expiration date 31-MAY-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
COVID Vaccine Breakthrough Case  J&J dose 7/27/21 (1808980) COVID Positive 10/11/21  10/15/21: History is obtained from patient as well as a personal review of records.  Patient is 47-year-old lady with known history of asthma, obesity pre diabetes and other medical problems.  She lives with her husband and 2 sons.  All 3 of them had COVID-19 in recent past.  Patient started having nasal congestion, chills and cough on 10/7/2021.  Symptoms have become worse in last 2 days.  She is coughing out sputum. Tan and pink in color.  Also reported back pain getting worse with cough and deep breathing.  Patient was advised by primary care provider to go to emergency department. She had test done for  SARS-CoV-2 on 10/11/2021.  It is positive.  She reports getting J&J vaccine.  10/17/21: Patient is a 47-year-old female who originally arrived to the emergency room secondary to some increasing nasal congestion, chills and cough as well as some increasing shortness of breath.  Patient was found to be COVID positive and is noted to have a history of being appropriately vaccinated.  Patient did briefly require some oxygen which ranges anywhere between 2-3 L via nasal cannula.  Patient was started on treatment for COVID-19 with remdesivir, steroids, antibiotics, vitamin-C, vitamin-D and zinc.  Patient did improve.  Patient also received nebulizers and dexamethasone.  On the morning of 10/17/2021 the patient was feeling better and was otherwise felt stable for discharge.  Patient's questions were answered to the best of my abilities and we did discuss review her medications, vital signs, laboratory studies, imaging studies and plan of care as well as the plan for follow-up.
Patient was given 3 GARDASIL vaccines in 2008 by her PMD. PAP smear results on 3/4/09 shows LGSIL with HPV changes.
tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 24Feb2021 at 01:00 PM (Lot Number: EL9263) at the age of 34-year-old as single dose for COVID-19 immunization. Medical history included asthma. Known allergies included erythromycin, shellfish and flu vaccine. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received flu vaccine, the erythromycin and experienced erythromycin allergies. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on left arm on 03Feb2021 at 02:00 PM (Lot Number: EL8982) at the age of 34-year-old as single dose for COVID-19 immunization. On 24Feb2021 at  01:30 AM, the patient experienced tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life. The events resulted in emergency room/department or urgent care. Treatment was received for events included epi, Benadryl, steroids and cardiac monitoring. The outcome of events was resolved with sequel.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events memory impairment, tachycardia, pharyngeal swelling, myalgia, arthralgia and the suspect drug "BNT162B2"  annot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received Pfizer vaccine at 1145 am after 15 minutes c/o feeling dizzy and hot . Vital sign checked , patient stated he didn't eat  provided with a orange and water . B/P 99/57  Hr 57 O2 sat 97% room air temp 97.1,  Rechecked B/P was 74/53 manual .Pt continue to c/o of feeling dizzy . 911 was called. EMS arrived  and checked blood glucose level was 141.  . Patient was observed for 60 mins and refused EMS ride to hospital.  Patient blood pressure recovered 130/72 standing HR 72 sats 98% room air  was able to ambulate without assiatnce.
Dyspnea (progressive shortness of breath) on exertion with chest and back discomfort.
This spontaneous report has been received from a 67 years old female patient referring to herself. Information about medical history, and concurrent conditions was not provided. The patient's concomitant therapy included PROLIA. On 30-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 (1 x 0.5 mL dose, route of administration and anatomical location were not reported) for prophylaxis. On 01-DEC-2018, 2 days after onset of therapy the patient experienced "soreness at injection site and in the front and back of her left shoulder and the pain ran down to her fingers". The patient's also turned bright red, like a sunburn, she also had a fever. Unspecified treatment was given for the events. No laboratory studies performed. At the time of this report, the outcome of all the event was recovered on unspecified dates. The causality between the events and PNEUMOVAX 23 was not provided.
Patient vaccinated 5/13/2021, 4/22/2021. Hospitalized COVID positive 12/26/21
rashes due to skin lupus have disappeared; achiness; Fever; Nausea; fatigue; headache; rash on the side of injection, which was already present before the vaccine; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on the side of injection, which was already present before the vaccine), THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever) and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash (Patient has had a rash for years on ankles and upper arms) and Cutaneous lupus erythematosus.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on the side of injection, which was already present before the vaccine), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared). At the time of the report, RASH (rash on the side of injection, which was already present before the vaccine) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.