chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially in ER for hip pain then 7/29/2021 1:43 PM  - had 5/10 chest pressure without shortness of breath, nausea, vomiting,, radiation or migration of the pain.  Pain resolved after 30 minutes and was gone by the time she notified staff.  She felt her throat was closing.  This has happened to her x2 this year, typically while she is falling asleep ACUTE NON ST ELEVATION MI    ACUTE PERICARDITIS, UNSPECIFIED
Extreme insomnia. Absolutely no ability to sleep even with sleep meds. No history of sleep issues or insomnia before the booster. Chronic brain fog and what feels like brain static.  Chronic fatigue - Exhausted after walking - was an athlete prior to booster. Limited ability to hold concentration. Was a presence coach and yoga instructor before booster. Onset of symptoms occurred within 24hrs of the booster and 5 months later I remain debilitated and unable to work or enjoy life.
This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021   at the age of 69-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included lisinopril taken for hypertension from an unspecified start date and ongoing; vitamin c [ascorbic acid] taken for supplementation therapy from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS [VITAMINS NOS]) taken for supplementation therapy, start and stop date were not reported; atenolol taken for an unspecified indication from an unspecified start date and ongoing. On 11Mar2021 the patient experienced took her temperature an hour or 2 later, it dropped to 93*f and that she never had a temperature that low as her normal temperature was 97-98*f/temperature was 93, 94, 95, 96, fluctuating , she was extremely tired, there was soreness in her arm. The patient underwent lab tests and procedures which included body temperature: 98.5 fahrenheit on 11Mar2021 her temperature went back to 98.5*F at 8pm , body temperature: 93 fahrenheit on 11Mar2021 Took her temperature an hour or 2 later, it dropped to 93*F and that she never had a temperature that low , body temperature: 97-98 fahrenheit on   normal temperature was 97-98*F , body temperature: 94 fahrenheit on 11Mar2021, body temperature: 96 fahrenheit on 11Mar2021. On 11MAR2021 the outcome of event took her temperature an hour or 2 later was recovered. On MAR2021 the outcome of event she was extremely tired  was recovered. On an unspecified date the patient experienced she was extremely tired was recovering. Information on the lot/batch number has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In March 2007, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. In 2007, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
COVID-19; COVID-19; Moderna, Dose: 3, 4 / Pfizer, Dose: 1, 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 24Apr2021 as dose 2, single (Lot number: EW0172) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 035C21A), in left arm and on 23Sep2022 as dose 4 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "Moderna, Dose: 3, 4 / Pfizer, Dose: 1, 2"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 23Aug2023 to 27Aug2023.
Narrative: No documentation of initial allergy in System beyond 2006, however it is reported that the allergy occurred in 2002. Notes documenting the allergy states variations of "allergic to influenza vaccine - skin rash." Logged as severe upon recent transition to facility, however without documentation of treatment. No documentation of a life-threatening reaction. No influenza vaccines reported in System.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients medical history, concurrent condition, drug and allergy history were not reported.  On 17-MAY-2017, the patient was vaccinated with an improperly storaged dose of M-M-R II lot # M032487, expiration date 05-JUL-2018,(strength, dose and route were not reported)for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent(manufacturer unknown) The patients concomitant therapies were not reported. On an unspecified date, the digital data logger registered a temperature of 9.6°Celsius (°C) during a time frame of five hours which was called by the data logger, with no previous temperature excursion. In addition, adverse effects were not reported. Additional information has been requested.
Chills started around 9pm the evening of the vaccine.  uncontrollable shivering until around 2am when the fever hit. Headache, body aches and  103 temperature when taken at 3:30 am.  took Tylenol and got the sweats around 6am.  Continued  the next full day not feeling well - headache, body aches and low grade fever.  went to bed on the night of the 13th with a 101 fever.  sweating throughout the night.  woke on the 14th feeling much better.
Medication indication/administration error. Patient is 14 years of age. No adverse outcomes noted 24 hours after administration by mother or patient. Will continue to monitor for any changes and report.
Erythema of arm (upper) deltoid 3 days post shot, continuing to be erythematous, decreasing in warmth when seen in office.
Pt recvd vax & reporter indicated that 45 mins p/vax pt devel a rash, hives & exp a dec in BP; pt was treated w/DPH/Epi;
Pt received vaccine sat down in recovery  complained of "feeling woozy". Pt became diaphoretic, pale, had near syncable episode. no LOC, Alert to verbal. brought to recovery to lie down and elevate feet. Put ice pack to back of neck and forehead. no shortness of breath. Left deltoid site benign no redness, no swelling. MD assessed summized as vaso vagal episode.  VS taken 108/80, hr 60,  reg strong, resps 16 reg  non labored. father at side, stated "this happened when he had blood drawn" Changed to monitor for 30 min, gave water to hydrate. pt stated he felt much better after lying down 10 min.  Provided reassurance  paleness and diaphoresis subsided. OK'd to exit after 30 min. Exited with father.
no additional adverse events reported; a dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report was received from a vaccine coordinator with the health department and refers to a 15 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-JUL-2021, the patient was administered a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5ml, lot # S022598, expiration date 25-FEB-2022; route of administration and anatomical location were not provided) for prophylaxis.   The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had underwent a temperature excursion of 35.3 Fahrenheit degrees (F) for 195 hours and 38 minutes. There were no previous excursions reported. No additional adverse event was reported.
shingles after / a Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In April 2021, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided are as follows: The reporter informed that the patient got shingles after she had been administered with a Shingrix vaccine. The reporter did not consent to follow-up.
Erythema - up to 4cm from the site of injection persisting up to 2 days after injection.
Headache, Diarrhea, seeing floaters in left eye; sore arm Narrative:
10/30/21 0200 SpO2 88% 2at 1L via nasal cannula, rr 32, increased moaning/facial grimacing with HS care. LS dim with occasional congested cough. Repositioned in mid Fowler's position; PRN Oxycodone administrated per order with good relief. RR 20, O2 94% at 2L n/c.. Rapid Covid test negative. 11/1 Continued with decline, desat 80s 2.5 l oxygen via n.c, labored resp, audible congested cough and secretions. res repositioned, large amount of dark yellow/brown mucus from mouth.. skin pale, nail beds dusky, res lethargic. afebrile. o2 placed 3l. Daughter updated, wants comfort care here. Dr. updated. new order Rocephin 1gm IM x7 days. duo nebs tid x7 days as res unable to use scheduled inhalers. cbc, bmp and chest x ray in am. Rocephin 1gm IM administered to l glut. daughter ok with plan. wants f/u palliative. 11/1 MD updated on elevated WBC and Na level and aware of overall condition with hospice referral pending. New orders obtaine to d/c rocephin 1 gram, start zosyn 3.375g Q6hr x7 days and start 1/2 NS @75cc/hr continuous for now, CBC/BMP in AM. Daughter updated and consents to current plan of care at this time. Plan for admit to Hospice Services. Iv started and infusing for additional hydration and comfort. 11/2 Admitted to Hospice. 11/2 Comfort maintained throughout the day with family at bedside.Resident hospice today, 02 stats dropping into 80s today. Family and MD updated, family in for visits throughout the day. N.O morphine started this morning. No s/s of pain or discomfort noted. PRN morphine given this morning for SOB. Resident resting comfortably throughout the shift, family at bedside. Priest called in for visit. Hospice nurse in for eval see n.o., 02 at 93% on oxygen via n.c. Mouth care provided throughout the shift, reposistioned throughout the morning throughout the shift. Currently family sitting bed side. 1500 11/2:increase on overall decline this AM. Oxygen saturation <90% on 4L, tachypnea, increase congestion. Family notified by floor nurse. MD updated on resident status, new order for morphine sulfate 20mg/ml 5mg PO Q4HRS PRN for pan/dyspnea, d/c oxycodone, change PRN Tylenol to suppository for elevated temp, and CMO. Hospice Nurse in shortly after with new recommendations and discontinuation of non essential medications, MD aware, see new orders. Family updated on new orders and consent to POC. Reverend in to provide sacrament of the sick. Resident resting comfortably at this time with family at bedside. 11/2 1410-Passed away with family at bedside.
I got headache, body pain, fatigue, and rash on arm for 4 days.
Vaccine reconstituted with incorrect diluent. No adverse event to report. Immunization needs to be repeated per CDC.
Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 mL dose of GARDADIL (lot #653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES0620USA04384, WAES0610USA04385 and WAES0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA03730). Additional information is not expected.
Patient collapsed onto floor 10min s/p Pfizer vaccination  patient stated feeling dizzy and not realizing she fell. Patient has history of fainting after shots but did not advice anyone.  Patient got quarter of an in laceration on forehead. Vital signs stable, cleaned and wrapped laceration and sent with paramedics to ER.
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer
MUSCLE TREMORS; MEDICATION ERROR; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 29-OCT-2021, the patient experienced muscle tremors. On 29-OCT-2021, the patient experienced medication error. On 29-OCT-2021, the patient experienced headache. On 29-OCT-2021, the patient experienced fever. On 29-OCT-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and fatigue, had not recovered from headache, and muscle tremors, and the outcome of medication error was not reported. This report was non-serious.
Was really bad; Could hardly walk; Very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy). At the time of the report, FEELING ABNORMAL (Was really bad), GAIT DISTURBANCE (Could hardly walk) and DIZZINESS (Very dizzy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient had no problems with any previous Covid doses.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650982 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650982:Male case
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, 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 experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Patient had already been on Qulipta for 7 days and had 1 to 2 headaches since taking it. Patient had taken 60 mg. Does not have the lot number.  No concomitant medication details were provided.  No treatment medication details were provided.
The patient was given Prevnar 20 in error. MD was notified, no adverse effects or symptoms were observed or reported by patient.  The correct vaccine ordered by MD was then given (Menquadfi) No adverse effects or symptoms were observed or reported by patient.
Fever, body aches, chills, sweats, "fight or flight" symptoms, severe exhaustion, pain and heat at the site of injection. Symptoms began 30 minutes after and 2 hours after the vaccine was given.
Information has been received from a physician concerning a 4 year old female with no history of recent exposure to Chicken pox who on 05-JUN-2005 was vaccinated with a first dose of VARIVAX (Merck) (route not reported) on her left upper lateral thigh.  Concomitant therapy included MMR II (Wistar RA 27/3) (MSD), PREVNAR and PURIVAX.  On 04-JUN-2008 the patient developed shingles on her left upper lateral thigh where originally the vaccine was given.  No other systemic symptoms were noted.  The patient sought medical attention.  Additional information has been requested.
Fever noted this AM measured 101.5ax; lump noted @ DTP site today; rt thigh 28x30mm induration, not well defined; esentially non-tender; not hot or red; Doubt vax as cause of fever;
Reported chills, arm pain, fever 100F, nausea, body aches.
Noticed today 12/19/02, 7cm hard knot; area painful/itched right arm.
Flu; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 68 years old female patient who experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Lung disorder.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for influenza at the time of reporting.  There will be no information available on lot number for this case.
I had the first dose (Moderna, Lot 030L20A, Left Arm on 1/31/2021). The same side effect happened for both doses.  I am 18 weeks, 5 day pregnant. Pregnancy is normal, 1 baby, no issues thus far.  During the 24-48 hours post vaccine administration, I have had an increase of depression/self harm thoughts. I was diagnosed with mild depression and generalized anxiety disorder over 15 years ago, but have not experienced a major episode in over 5-7 years and have been able to manage these conditions without medication for over 10 years. With in the time frame given for both shots I have been extremely depressed, angry and had hurtful thoughts. I have done the necessary things to keep myself safe and to curb the thoughts, but I found it more than a coincidence to happen both times after the shot.   Normal side effects that occurred that I did anticipate - Sore arm, overall body fatigue.
Patient with complaints of feeling flush and hot.   Also with complaints of an odd taste in mouth.  Offered water and observed.  BP 120/70, HR 82 Pulse-Ox 97.  Patient appears a bit flushed in upper arms and chest.  States she sometimes has menopausal hot flashes.  Advised the patient to stay to be observed an extra 15 minutes.  Also advised to seek medical attention if symptoms become worse.  In check before leaving patient states she feel good. Less flushed..
With first 3 doses patient only experienced a little pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059F22A, 015M20A and 030L20A) for COVID-19 vaccination.     It was unknown whether patient had allergies and any history relating to mentioned adverse event. It was unknown whether patient had received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown whether patient ever had COVID positive test or diagnosis.  Concurrent medical conditions included Cholesterol. Concomitant products included EZETIMIBE for Cholesterol, VITAMINS NOS for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm). At the time of the report, PAIN IN EXTREMITY (With first 3 doses patient only experienced a little pain in the arm) had resolved.            It was reported that with first 3 doses and experienced a little pain in the arm which was lasted for 1 day.  No treatment medications were provided.   This case was linked to MOD-2022-664515 (Patient Link).
This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of ROTATEQ (route oral, dose, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
tested positive for COVID-19 5/5/22 (rapid antigen at-home test)  symptoms: very mild congestion, dry cough from post-nasal drip.  Symptoms lasted two days, then disappeared.  Negative antigen test 5 days later (at-home test) No lingering symptoms