chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 7/17/2017, patient had an unresponsive episode followed by a tonic-clonic seizure at home and another upon arrival to the ER.  She had a thorough work up including labs, spinal tap, brain CT and  MRI, EEG. Stayed overnight in PICU. Treated with SOLUMEDROL and acyclovir empirically. Labs were all essentially normal including the EEG. She was sent home on no regular meds (just DIASTAT prn recurrent seizures) to follow up with Neurology. On 9/12/2017, patient had another unresponsive episode followed by a tonic-clonic seizure at home. Brought to ER. Given a dose of ATIVAN and started on Valproic Acid and admitted overnight again. EEG was again normal. She was discharged home on KEPPRA and follow up with Neurology arranged.
This spontaneous report has been received from a medical assistant and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M028552, expiration date 07-JUN-2018; lot # M031969, expiration date 30-JUN-2018 and lot # reported as M041079, expiration date 06-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 9 hours. There were no previous excursions reported. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011809: US-009507513-1703USA011810.
Had first injection on Feb 17,21 at Health Clinic had no problems at all. Had second injection 03/20/21 at the fire brigade Dept. Next day on Sunday about 8 PM I noticed a large swelling on the injection site. It was painful and very itchy from the inside out. I didn't have a fever but I did experience night sweats that were extreme to the point of my hairline being soaked. The area became spotted and bruised so i went to the hospital and then the Walk in Clinic.
Patient presented to ED due to worsening lethargy and low blood pressures.  Patiently did test positive for COVID within the last 10 days.  She has been intermittently requiring 2-4 L nasal cannula due to hypoxia.  Patient is a resident in long  term care facility.  History is limited due to patient's baseline mentation. 3/22 dc IV fluids 3/24 oral abx. Pt stable for dc back. Discharge Diagnoses: Pneumonia due to COVID-19 virus   Acute hypoxemic respiratory failure due to COVID-19 -improved   Acute metabolic encephalopathy   Acute encephalopathy - improved Hypernatemia - improved
Headache and fatigue immediately after the vaccine - for 24 hours. Then I noticed the enlarged lymph node a few days after my first vaccine. On my collarbone. Not painful. I went to Dr. and Dr. said to watch it. The doctor wanted follow up in a month. On May 14th, I followed up and had an ultrasound that day. Ultrasound report said it was reactive - and it gave the size of lymph node, etc. My doctor said we'd follow up in a month. I went back to her yesterday because I still have my lymph node. I will have an appt for a hematologist, a cancer doctor soon to see if a biopsy would be the next step. No treatment at this time. 2nd vaccine was 4/27/2021.
Patient has just turned 7 years old 6 days ago. Patient received Kinrix  instead of a single dose of DTap and IPV. No adverse events reported. Per provider, patient may come back for second dose 02/18/2024.
Two-fold: 1. Patient reports that upon receiving the shot, her throat felt itchy and scratchy.  Mild and subsided quickly same day. 2. Patient reports that 7 days after the shot, a large solitary hive developed over the injection site. It's itchy and cell picture does indeed show a large urticarial lesion over the left lateral deltoid area.
He has a chest congestion; his is a spontaneous report from contactable male consumer via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and guaifenesin (MUCINEX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. he took the vaccine on unspecified date hour and half an hour ago and he has a chest congestion on an unspecified date that's why he was asking if he can take the medication Mucinex. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt states had a nickle size,knot w/some redness;also had c/o body & joint aches for 72hr;
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored VAQTA (lot number/expiry date unknown) on unknown dates. No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 Minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 hours and 17 minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Temp 103 degree 6 days later - Chronic febrile seizure (Lasted less than 5 min - sent to ER via ambulance and recovered - Also diagnosed with B-OM (moderate)
Severe Left arm pain at the site to the point I could not move my arm. I required assistance to to get my arm in or out of a sleeve. Any movement at all was excruciating pain level 10 on (0-10) scale.  Chilling and fever occurred around 8pm highest temperature was 101.2F temporal. It came down after tylenol. Swelling of the injection site. Could barely see acromiom process. It is somewhat better this morning 11/14/2017 I can move the arm but still probably pain of 5 (0-10) scale. No fever today. Some swelling but improved.
High fever of 103 the night of the vaccine  Extremely painful headache two weeks following the vaccine.
Fever ,fast heartbeat, trouble breathing, passed out 3 times in less than 5 minutes. Got better by smelling alcohol, drinking water and taking Tylenol.
Fever, nausea, chills, headache, body aches.  11:30 pm until present time
Dizziness, Headache, Arthralgia, Fever, NauseaVomiting, chills, urinary frequency Narrative:
Did not begin symptoms until 10 days after injection.  Began with body aches on 10th day.  On 11th day most severe:  Extreme chills, all over body aches, fever, stomach pain, fatigue, nausea, severe headache.  Days 12 - 14:  Body aches, fever, stomach pain, fatigue, nausea, headache, sweats.  Day 15 and day 16: (today) Tired, mild headache, fatigue, diarrhea.
Sore arm; Slight fever; This is a spontaneous report from a non-contactable consumer (patient). This 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration on 25Jan2021 at 16:00 (at the age of 59-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient had allergies to cashews and iodine. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen from an unknown date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient experienced sore arm and slight fever on 26Jan2021 at 9:00. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The reporter's overall assessment of the events was non-serious. The outcomes of sore arm and fever were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
EXTREME injection site burning, stinging, throbbing pain, headache, EXTREME joint pain, zero energy, chills, elevated heart rate, unable to sleep, oxicodone and methocarbomol (muscle relaxer) required to cut pain,  extreme symptoms  lasted from 8:00pm to 6:00am and lesser symptoms continued throughout the following day.
Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue
Balance was off; Was feeling really loopy; felt drunk; lost balance over half a dozen times; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times). At the time of the report, BALANCE DISORDER (Balance was off), ABNORMAL BEHAVIOUR (Was feeling really loopy), FEELING DRUNK (felt drunk) and BALANCE DISORDER (lost balance over half a dozen times) outcome was unknown.        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 medication include clonazepam for anxiety & PTSD.  No treatment information was provided   This case was linked to MOD-2021-102218 (Patient Link).
Aching Fever Nausea Chills Sweats Felt much like the flu Lasted about 32 hours
Fever highest 103.7, body joint aches, headache, itchy and painful injection site, injection site red, swollen hard 10" x 6" area.
pt recvd vax & exp severe allergic response & was seen by MD; responsible MD indicates pt has been skin tested to thiomersal & found to be pos;
Admitted as a direct admit with fall, sustaining R lateral, posterior scalp laceration (was stapled) and R hip pain. Two RN skin check Bilateral LE are ruddy, intact.  Found to to Asymptomatic COVID positive upon admission.
Blood clot in arm, severe back pain that spreads to chest area, blood work shows high inflammation markers, has been referred to see a rheumatologist.
fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 015M20A and 011D21A) for COVID-19 vaccination.     The patient had no allergy.  The patient had no mentioned AE and both acute and chronic illness at the time of vaccination.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, PYREXIA (fever) and CHILLS (chills) had resolved.            The height was 175.25 cm (5 feet9 inch).  The patient had episodes of fever and chills after each administered dose. The episodes of fever and chills occurred 36 hours of the first dose .On 23-Feb-2021, during 24 hours of the second dose, the patient had fever and chills and the events recovered on 24-Feb-2021. On 10-Dec-2021, during 24 hours of the first booster dose, the patient  had fever and chills and the events recovered on 11-Dec-2021.  Patient had not received other vaccines within one month prior to moderna covid-19 vaccine. The patient had not seek any medical care because of adverse event. Also patient had no similar events in the past.   This case was linked to MOD-2022-656373 (Patient Link).
Day after had following symptoms : Severe chills Weakness Fever as high as 100.6 for 4 days Headache and dizziness Severe fatique Loose movements and frequent  Constant need to urinate but did not need to go  (was tested for UTI but it came back negative).   Started to feel better on 6th day.   Went to urgent care and they advised it was from the Covid vaccine.
Given 1.Flu shot 2. Pneumonia shot at same time, which cause an asthma attack, and had to go to ER. at hospital.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced decreased appetite and widespread rash. The patient received a dose in Oct-2008. The patient experienced decreased appetite and widespread rash in Oct-2008. On 09-Oct-2008, the patient was examined by a physician and prescribed BENADRYL. The patient recovery status was unknown. No additional information was available at the time of this report.
Patient fainted and proceeded to feel nauseous. Patient was in chair when the mother asked for help and the patients head was slumped over. Patient was put in cot and counties to feel headache and dizzy.
Patient discharged denied any adverse affects, was turning to walk out of event and fell to the floor.  This was a witnessed fall, but he appeared to just bend at the knees and folded on to the floor without hitting head or losing total consciousness. Vital signs stable throughout observation,  cool cloths applied to forehead and neck, feet elevated A & O xs 3 at all times. Within 15 minutes patient was placed in a sitting position, given fluids and a complex carbohydrate.  Patient states he felt he was back at his baseline except for being tired. Patient remained for 45 minutes total, left with coworker with intent to return to supervisor and was going to go home.  Walked patient to his vehicle, gait was steady, patients friend drove the vehicle.  Pt advised to follow up with PCP if any symptoms return and to call 911 for an SOB, hives, chest pain or swelling of throat.  Pt verbalize teaching.
Seven days after vaccination a new, itchy, large erythematous patch appeared on the left arm around the site of vaccination and has not resolved currently.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and expired on 05-May-2022; second dose was adminstered after 2 months; Patient administered with expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired moderna vaccine), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and expired on 05-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and expired on 05-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired moderna vaccine), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and expired on 05-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 which was not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from the same lot more than 30 days after it was in the fridge). The vaccine was administered between 16-feb-2022 and 11-May-2022.Total number of doses/vials- HCP reported 84 doses  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patients had reported any adverse reactions  No treatment medication were provided.
we're really tired; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "we're really tired".  Additional information: Call shared how both her and husband got vaccine and her husband was tired the next day too. They were both laying around like really tired.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine administered 2/9/06. Exam 2/15/06 increased redness, swelling-warm compresses. 2/16/06 Continued increased redness, decreased swelling-6.5x7cm Keflex initiated 500 mg & PO Qtx10days warm compressed, and ointment.
bladder infection; This is a spontaneous report from a consumer (patient) to a Pfizer-sponsored Program . A female patient of an unspecified aged received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bladder infection. Therapeutic measures were taken as a result of bladder infection treatment included with medication Nitrofurantoin and patient wanted to know if it will affect the efficacy of the covid-19 vaccine. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Fever highest of 106 degrees F (lasting over 48hours), cold sweats at night (2 days of as today), swelling and pain of arm (hot to touch), redness and blotchiness on left arm near injection site, tiredness.
Arm hurt for 3 days, nausea and stomach/intestinal cramping started 24 hours later,  vomited once /24 hours after vaccine and spent the rest of the day in bed. Felt better 48 hours after vaccine.
I have had very infrequent nasolabial herpes in the past (about one minor episode every 1-2 years) easily treated w/ 1 course of Acyclovir 400mb/bid.  After the vaccine I got a severe case putting me in urgent care w/complication of infection.  The Acyclovir was ineffective and had to start higher doses and high dose prophylactic Acyclovir (800mg tid and bid if less severe).  I still broke thru prophylaxis w/ herpetic lesions and constantly have severe tingling prodrome in my nose and lip area. It took me awhile to associate w/my vaccine - started reading about other cases.  I am otherwise very healthy (no immune compromise, no diabetes or HTN, in good shape and weight, exercise, eat well - all of that). I have never experienced anything this severe and certainly not this long term before in my life. I strongly associate the severe herpes w/the COVID vaccine.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored VAQTA (lot # L004742, expiration date 18-AUG-2016). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt is a foster child that was seen in our office for well child exam and immunizations; MMR #1, varicella #1, Hib #4, and Hep A #1 were administered on 04/07/08.  On 04/16/08 pt was seen x fever, poor appetite and exanthema over legs x 12-24 hr duration.
fluzone quadrivalent given to pregnant with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30-year-old female patient, influenza quadrival A-B vaccine [Fluzone Quadrivalent] given to pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to Influenza quadrival A-B vaccine at 19 weeks of pregnancy.  The date of last menstrual period was reported as 09-May-2023. The estimated due date is 13-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 14-Sep-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine Suspension for injection (strength, expiry date: unknown) (lot: 4T80404A) via unknown route in unknown administration site for Prophylactic vaccination (immunization) and fluzone quadrivalent given to pregnant with no reported adverse event (maternal exposure timing unspecified) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: unknown.  Additionally, at time of reporting, the pregnancy was still ongoing.
Patient received first Pfizer vaccine 03Mar2021 days after that the patient tested positive for COVID-19; Patient received first Pfizer vaccine 03Mar2021 days after that the patient tested positive for COVID-19; This is a spontaneous report from a non-contactable other healthcare professional via regulatory authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, and days after receiving the first dose of vaccine, the patient was tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive, on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded.
Patient received second influenza dose on 12.4.21 when he had already received a first influenza dose on 9/22/21 - no adverse events reported by patient.