chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started to have a cough and my throat was hurting. I also had a bad headache. The following day my symptoms got worse. I was experience nausea and vomitting. i also had light diarrhea. When I would breath in I was wheezing.  I was having trouble swallowing so I decided to take a rapid test and it came back positive. On 04/13/2022 I went to Urgent Care. They advised to take Mucinex, rest and take fluids.
Information has been received from a licensed nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female pregnant patient (last menstrual period was 15-JUN-2010) with no known drug reactions, allergies or pertinent medical history who on 09-JUL-2010 was vaccinated IM with a first dose of GARDASIL (lot number 663559/1178Y). The nurse reported that an urine pregnancy test was performed but the positive pregnancy indicator was so light that it was missed and the dose of GARDASIL was given. No known adverse effects were reported. Estimated delivery date is 25-MAR-2011. Follow up information has been received from the nurse practitioner who reported that the patient decided to electively terminate the pregnancy. The nurse reported that the patient would be having the procedure done on 05-AUG-2010. The nurse also reported that the termination was not vaccine related. The nurse reported that the patient "just did not want the pregnancy".  At the time of the report that patient's outcome was unknown. Upon internal review "the patient decided to electively terminate the pregnancy" was considered to be an other important medical event. No further information is available.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:48 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 2:48 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported
Was in bouncy seat at home. Mom heard "unusual cry" and noted tonic/clonic movements/staring/head deviation. Lasted about 1 minute. Taken to ER. Sleepy & calm in ER. Admitted for observation x24 hours. Labs WNL.  EEG WNL. MRI WNL. CT WNL. No FH Sx's. Has neuro followup 9/13/11.
Extreme headache, fever, severe chills where I could not get warm and terrible bodyaches. Extremely tired.  The side effects started a few hours after the injection and lasted for 3 1/2 days.
Redness, pain, hardness, swelling, and body aches a week after receiving vaccination.
Shooting pain up right backside of neck to behind right ear; Shooting pain up right backside of neck to behind right ear; Psoriasis flare ups; Extreme joint pain; Fatigue; Fever; Chills; Swollen lymph nodes in neck.; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0175), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 at 15:15 (at the age of 33-years-old) as single for COVID-19 immunisation at hospital. The patient medical history included psoriasis. The patient had no known allergies. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 at 15:15 pm (at the age of 33-years-old) as single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 02Jun2021 at 02:30, the patient experienced shooting pain up right backside of neck to behind right ear, psoriasis flare ups, extreme joint pain, fatigue, fever, chills and swollen lymph nodes in neck. The patient was treated with Ibuprofen for the events. Outcome of all the events was resolved with sequelae in 2021.  Follow-up attempts are completed. No further information is expected.
Patient is a 74 y.o. male patient of, CNP with history of HTN presented to Hospital with N/V, weakness .   Covid-19 Virus Pneumonia Sepsis, due to COVID pneumonia, resolved  Date of onset of symptoms: 9/12 Symptoms present on admission: weakness, N/V, dyspnea Date of covid positive test: 9/17 Sepsis criteria: WBC 3,4100, platelet count 104,000, RR 24 Vaccination status: vaccinated Imaging: CXR with basilar infiltrate Medical therapy: remdesivir and dexamethasone started on admission  Anticipated special isolation end date: 9/19 Treated with oxygen support, remdesivir, dexamethasone Initially patient required supplemental oxygen, now his oxygen saturation is 96% on room air. Patient discharged in stable condition.   Deconditioned  Continue physical and Occupational Therapy   Leukopenia Thrombocytopenia White blood cell count 3.41, platelet count 120 Outpatient follow-up   CAD, native heart and coronary, without angina HTN, controlled Continue aspirin, atenolol, statin   DM2, controlled Hyperlipidemia On semaglutide, simvastatin at home A1c 5.8 (3/2023, records) Continue Lantus insulin and sliding scale coverage Continue statin Rheumatoid arthritis Chronic pain Continue Plaquenil and MS Contin Data reviewed   Goals of care Geriatric assessment Goals are somewhat rehabilitative, he would like to return home if possible DNRCCA no intubation Fall precautions, delirium prevention, oral thiamine
pain; hurt her neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK INJURY (hurt her neck) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced NECK INJURY (hurt her neck). On an unknown date, the patient experienced PAIN (pain). At the time of the report, NECK INJURY (hurt her neck) and PAIN (pain) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided.
Rash to site and rash to anterior trunk. Liquid Benadryl 37.5 mg given and sent to hospital.
c/o chills the same afternoon; @ 3PM had t103 (A) which came down w/APAP but was back up to 103 (A) by 7PM; during noc 15 hrs post vax c/o head twirling; mom noted breathing was shallow; t105 (A); site of inject was sore-not red or swollen;
patient reported bilateral rash under arms, red, denies itching, denies pain.  Did not treat, allowed it to clear on its own.  Said it lasted 3 weeks, did not report to us until today.
Pt recvd 3rd dose of vax 30DEC92 & in JAN93 exp leg twitches; FEB93 exp resting tremors in rt thigh & cramps in lt thigh & back pain inc;
The patient's mom called and stated that the child developed a rash on face, chest, back, legs, and private area.  Mom states that "he feels like he has a fever but we don't have a thermometer."  Mom states that Ibuprofen has been given for "fever."  Rash started on 11/7/19.  States that child is eating and drinking ok.
side effect of blood sugar; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267, expiry date not reported), via an unspecified route of administration at the right arm on 17Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension (blood pressure high) from Jan2019 and diabetes mellitus (diabetic) from Apr2019. The patient experienced side effect of blood sugar on 17Feb2021. Patient said he tested his blood sugar before he got the vaccine in the morning before breakfast it was 95, which was normal for him, then his blood sugar was lower than normal after breakfast which he got at a restaurant he goes to regularly so he knew how it usually would be, by 30 points. He said that he keeps good enough records to tell that after lunch, which was a meal he eats regularly so he should know what his sugar usually is, and his sugar was 65 points higher, then after his evening meal it was 10 points higher. He clarified that he got his first dose of the vaccine before he ate breakfast. Clinical outcome of the event was unknown.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored RECOMBIVAX HB lot # K012875, expiry date 27-JUL-2016 on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received half-volume of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine). On 26-Dec-2021, ACCIDENTAL UNDERDOSE (Patient received half-volume of Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
day after the shot patient described pain in feet and behind knee and notice a bruise behind  and below the left knee on 1/16/22 around 3:30pm no change when contacted this evening at 7pm (1/17/22)
Covid-19 vaccines reported to VAERS  due to temperature excursion.  VAERS report
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Headache" (unspecified if ongoing), notes: Headache; "Migraine" (unspecified if ongoing), notes: Migraine. Concomitant medication(s) included: AIMOVIG taken for migraine. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "Body aches through out the night"; CHILLS (non-serious) with onset 04Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 04Jun2022, outcome "unknown" and all described as "He had a migraine, headache which he normally gets". Therapeutic measures were taken as a result of migraine. Additional information: NDC number and UPC number of COVID-19 vaccine: Unknown. Prior vaccinations (4 weeks) reporter was not aware. They got the 4th booster shot of Pfizer yesterday morning and by evening time they had typical symptoms. The patient had a migraine, headache which he normally gets and takes Amovig for. He had chills, fever and body aches through out the night." Other medication the only one they know was for migraines Aimovig, it's a monthly injection. Not aware about Lab test. Treatment: just migraine medicine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nurse case manager picked up vaccine at vaccine clinic site, took to wrong patient and administered dose at 14 days to patient listed in this report.  She was scheduled to deliver this dose to a male patient who was due for his second dose this day.   Patient did not suffer any adverse affects.   Error discovered during paperwork reconciliation
PATIENT FELT UNWELL AT 1230, BP 124/82, HR 73, RR28 1237 GAVE 25MG BENADRYL IM 1245 PATIENT STARTED TO SHAKE, INCREASED RESPIRATORY RATE, STARTED TO HAVE AIRWAY CLOSURE 1245 EPI PEN GIVEN IN LEFT LEG IN RESPONSE TO SOB, REPORTED NUMBNESS AND SWELLING IN THROAT, INCREASED RESPIRATORY RATE.   1246 PATIENT ABLE TO BREATHE BETTER AFTER EPI 1247 PATIENT TRANSPORTED TO ED FOR OBSERVATION 1257 EMS TRANSPORT TO ED
Initial report received on 05 October 2009 from a consumer. A 49 year old female patient with no reported past medical history developed a bruise at the injection site one day after she received FLUZONE (lot number not reported) on 26 September 2009 at 11:30 AM. The patient did not note any swelling. At the time of the report the patient had not recovered. Follow-up was received from the consumer on 20 October 2009. The bruise at the injection site resolved by 12 October 2009. FLUZONE lot number is unknown. The patient indicated that she had previously received yearly flu vaccinations for the past six or seven years. It was not reported if the patient had experienced any adverse events following those prior vaccinations. List of Documents held by Sender: none.
Acute pericarditis; Atrial arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm, on 17Feb2021 10:45 (at the age of 74-year-old, not pregnant), at single dose, for Covid 19 (COVID-19 immunization). Medical history included allergies to alpha antibiotics. No COVID prior vaccination. Concomitant medications included atorvastatin, and bupropion. No other vaccine in four weeks. The patient previously took codeine and experienced allergies. The patient experienced acute pericarditis and atrial arrhythmia, both on 20Feb2021 15:00. Events resulted in emergency room/department or urgent care, and hospitalization (for 1 day). The patient underwent lab tests included COVID test (Nasal Swab/COVID 19 PCR) post vaccination on 21Feb2021, result was negative. Therapeutic measures were taken as a result of events and included treatment with multiple. The outcome of the events was recovering.
?seizure lasting 5 minutes starting 8PM evening of vax; pt hospitalized overnight to observe;
Ten days after my Moderna  booster, I broke out in hives and welts all over torso, back, and legs.   Also developed severe esophageal reflux.  My reaction to the Moderna vaccine and booster was swollen lymph nodes in my armpits.  The swelling was worse and lasted longer following the booster compared to the vaccine.  I was Covid+ in November of 2020. Symptoms were refractory to Benadryl, steroids, and antihistamines as well as topical treatments.    I had an EGD to confirm reflux and treated with 40mg pantoprazole BID.   GERD resolved in 2 weeks with medication.  My symptoms were most severe late afternoon into the night.   Tried elimination diets to rule out food allergy.   Familiar with mast cell disorders from my job.  Talked to my PCP and started Sodium Cromolyn 100mg 4x/day.  This worked for 2 weeks then increased to 200mg  4-5x/day depending schedule.  This is the only treatment that keeps my hives and welts away. Symptoms limited my ability to sleep, work, and participate in daily activities,
Was tested positive to Covid-19 twice; Was tested positive to Covid-19 twice; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 single dose for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient was scheduled to get her second shot for Pfizer vaccine on 09Mar2021 but she didn't want to take the Pfizer vaccine in the same facility where she had her first dose because it's too far and she mentioned that she was tested positive to Covid-19 twice. The event outcome was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K00696 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
A day after vaccine was administered.  Patient called to the office and notified staff she was pregnant. No information was given about pregnancy.
mom states vomited on the way home p/vax;c/o neck & back shoulder pain;unable to turn head or sleep @ noc;PMD visit 17JUL98;rx APAP & iron tabs;no RTC appt given;
(L) deltoid area red, swollen arm following the day vaccine given; no SOB, facial, lip or tongue swelling; went to hospital, rx'd with BENADRYL.
Patient was administered vaccine after 30-day Use By Date; Patient was administered vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known drug allergies. The patient had no chronic/acute illness and it was unknown if the patient tested positive/negative for COVID-19 within last month.     On 20-Apr-2022 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:11 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date) 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 number of doses/vials was 36. The vial was initially stored in the refrigerator on 25-Feb-2022 The vials did not undergo any temperature excursion. The frequency was reported as times per. The patient had not received any daily medications. The healthcare professional (HCP) wanted to know how to proceed with 36 patients that received a vaccine past the 30 day storage on the refrigerator. HCP confirmed that the patients were not experiencing any side effects yet.   No treatment medications were reported.
experienced random uncomfortableness; swollen lymph nodes under my arms; The swelling continued and only started subsiding until after the Booster; lymph node pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jan2022 17:00 (Lot number: FL3198) as dose 3 (booster), single, administered in arm left, administration date 25Apr2021 (Lot number: EW0170) as dose 2, single and administered in arm left, administration date 02Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2015 (ongoing); SIMVASTATIN taken for blood cholesterol, start date: 2020 (ongoing). The following information was reported: DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered", described as "experienced random uncomfortableness"; LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "swollen lymph nodes under my arms"; SWELLING (non-serious) with onset Apr2021, outcome "recovering", described as "The swelling continued and only started subsiding until after the Booster"; LYMPH NODE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "lymph node pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient had both of COVID vaccines back in April and have experienced random uncomfortableness from time to time because of swollen lymph nodes under my arms. Patient had ultrasounds that have confirmed the swelling and will be going for an MRI in a few weeks. Patient reluctant to go for my booster. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia was Unknown. Patient experienced lymph node pain after my first vaccine in April, the swelling continued and only started subsiding until after the Booster in Jan2022. At First, after the booster the swelling was worse for the first week, now the Discomfort is minimal, almost gone.  No follow-up attempts are possible. No further information is expected.  Follow-Up (23Feb2022): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist via a returned survey and refers to unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT episodes. The reporter found out about those events from a Food and Drug Administration (FDA) document from 2010. Since the pharmacist had a patient with congenital Long QT syndrome and the patient's family was unsure if GARDASIL was safe to give, the pharmacist wanted the same information for the most recent 6 years to make an educated assessment for the patient. The pharmacist complained that these serious events were not mentioned in the package insert, while that information was needed for the patient. The outcome of arrhythmogenic events and long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The reporter considered the events to be associated with GARDASIL. Additional information has been requested.