chrisvoncsefalvay/vaers-outcomes huggingface dataset:
37 years old patient received the first dose of Shingrix; redness in the injection site /Redness in the injection site after second dose; injection site, warm to touch / Warm to touch after second dose; huge lump in the injection site / Huge Lump in the injection site after second dose; pain that extended from the arm to the collarbone after second dose; severe chilling / Severe chilling after second dose; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 37-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on unown date, refer case US2020030286). Concurrent medical conditions included leukemia (when patient was younger).   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site lump, pain in arm and chills. On 17th February 2020, the patient experienced inappropriate age at vaccine administration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site warmth, pain in arm, chills and inappropriate age at vaccine administration were unknown and the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site lump, pain in arm and chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. On 17th February 2020, the patient received 2nd dose of vaccine which led to inappropriate age at vaccine administration. The patient experienced severe chilling, pain that extended from the arm to the collarbone, redness in the injection site, warm to touch and a huge lump in the injection site. The reported stated that patient was feeling better now but she still had the lump. This was medication error with harm. The reporter consented to follow up. This case had been linked to the case US2020030286, reported for same patient.
Redness and swelling in left arm, armpit and shoulder. Dizziness, headache, chills, nausea for 3 days. Lost feeling in arm off and on for 2 days.
Tightness in my chest and throat, SOB, swelling in my eyes. Fever, aches, chills, sweats, SOB and chest tightness lasted about 3 hrs, other symptoms until Monday 12/8
This spontaneous report was received from a registered nurse refers to a 4 month old male patient. On 27-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Hives in face within minutes of administration of PEDIARIX, Hib, PREVNAR (2nd doses) No treatment needed
Twitching (face, arms, legs, foot), Weakness/ numbness in hand and legs and arm, headache, heart palpitations, fatigue,  joint and neck pain, increased anxiety. (Symptoms have been off and on, not constant)
Laryngitis; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 05Apr2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021, the patient experienced laryngitis. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event laryngitis was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
No adverse effects; Administered improperly stored PROQUAD; This spontaneous report was received from a Medical Assistant referring to a 4-year-old patient. The patient's concurrent conditions, medical history and drug allergies/ reactions were not reported. On 07-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, formulation, dose/frequency and route were unknown) (lot # S009759, expiry date: 27-SE-2020, therapy type: recombinant human albumin (rHa)) for prophylaxis. The diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. On 07-SEP-2019, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product storage error). No adverse effects reported. The outcome of product storage error and no adverse event was unknown.
The patient received the vaccine in our counseling room and about 3 minutes after exiting the room the patient had slowly fainted and was caught by his parents prior to hitting the floor. The patient hasn't had this experience with flu shots in previous years, and patient's father has also experienced the same type of reaction after other vaccines. The patient and his parents declined to go seek medical care after leaving the store as patient stated he was feeling better and felt stable standing and walking on his own .
On 10/26/09 at approximately 4:15 PM, mother noticed that patient's speech was slurred and tongue quivering. Episode lasted approximately 30 minutes.
Extremely itchy Rash all over body. Started on lower abdomen as little spots in one area on right side of abdomen. Went to urgent care September 28ish and they have no idea where rash could have come from. Went to ER a week later(it is not covering whole stomach, and back and both arms, they gave me prednisone which cleared it while I was taking it.  Today 10/25 it is on my chest, inner thigh area, back of knees, and forearms and back ( where arms can reach)
Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy.  within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's.  Performance status declined.  Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.
Diarrhea; Chills; Body aches; Headache; Nausea; Vomiting; fatigue; Reflux; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received a dose of BNT162B2, (solution for injection, Batch/Lot Number: EM9809) via an unspecified route of administration, administered in right arm on 06Feb2021 10:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included asthma, high blood pressure, high cholesterol, Shellfish allergies and Iodine contrast allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medication included duloxetine DR, metoprolol tartrate, lisinopril. The patient had reflux, chills, body aches, headache, nausea, vomiting, diarrhea and fatigue. The patient was treated with ibuprofen, liquids as tolerated and suggested bed rest. The events occurred on 08Feb2021 at 22:30. The outcome of the events was recovered on an unspecified date of 2021.
This spontaneous report was received from a registered nurse reporting on a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Influenza (Fluzone) High Dose Quadrivalent was given to 59 patients under the age of 65 at multiple offices, no adverse events were reported. This was discovered during a routine internal flu vaccine audit and has been reviewed by vaccine coordinator and director of clinical services.
Resident returned to the memory support unit at 1500.  Resident was than toileted and transferred in to bed per his request.  At 1515 resident was observed face down beside bed, resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro Checks with in normal limes Vital signs: 100/52, 100, 97.2, 28.  Resident sent to ED for further medical evaluation via EMS.
MMR 4/2/07. 4/25/07 woke up with  swelling R Parotid gland. Temp 99 Axillary
Member complains of "severe" itching head-to-toe. Member given BENADRYL & CLARITIN by doctor.
Lightheaded, general weakness; transported to ED via EMS due to inability to ambulate properly; given fluids and meclizine
Severe shaking, shivering and teeth chattering. Full body aches. Severe headache. Symptoms started approximately 16 hrs after receipt of dose. Shaking lasted around an hour. I was unable to get  to a thermometer to check temp at the time.  Several hours later I took Tylenol and checked temp which was 103.5 F. at that time. I alternated Tylenol and Motrin and temperature subsided in about 8 hours.  Headache and body aches lasted another 24 hours.
Muscle aches and pain all over body, headache, nausea, weakness, exhaustion
Pt. stating after getting infection, she got infection at the site of injection. She had to go to MD to get treated.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 11:06 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
on the 8th i had an itching rash  all over my body. I had not eaten or taken anything out of the normal.. Called 911 and they sent EMA to come out and they gave me a shot of Benadryl 50 mg . I stayed awake all night. after a while the itching did stop. When i got up the next morning the rash was gone.
12 hours after the vaccines had fever around 41 degrees and when it went up to 41.7 C had convulsions.  After controlling the fever a rash appeared all over body.  He still is complaining of earaches.
While in observation @ 1125 c/o of not able to breath,  headache and chest discomfort right side.  Placed in WC back to med eval.  VS taken 166/101, sat 99%RA, HR 106 and respiration 20.  Mask removed and fluids offered.  Anxious and holding her chest.  Pt speaks Spanish interpreter line used for translation.  EKG done by EMS .  VS monitored, friend speaks no English for support.  Resting in chair VS repeated after no further headache and decrease in chest pressure.  BP 146/101.  Pt history of DM and asthma.  Lung sounds clear, inhaler present and not needed.  Pt declines any further work up or transport to hospital.  Reviewed with pt need to call PMD regarding events with post vaccine and to discuss 2nd dose with PMD.  Pt to bring someone to drive with 2nd dose and her inhaler with her.  Verbalized understanding to call 911 for any difficulty breathing, hives or continued chest pressure.  Discharged ambulatory @ 1205 with friend with no further chest pressure or headache.  RS, NP
Hair loss, globs and globs of hair loss; Fever for 5 days; Facial numbness; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 17Feb2021 at 09:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hypothyroidism, anxiety and arthritis. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), labetalol (MANUFACTURER UNKNOWN), furosemide (LASIX) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 00:00, the patient experienced hair loss, globs and globs of hair loss, fever for five days and facial numbness. The events resulted into doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was recovered on 23Feb2021, while that of the event- hair loss, globs and globs of hair loss and facial numbness were unknown at the time of this report.
Slight fever; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and PYREXIA (Slight fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131020A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (Cough). On 15-Jan-2021, the patient experienced PYREXIA (Slight fever). At the time of the report, COUGH (Cough) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that, he might have COVID-19 because his wife was diagnosed with COVID-19 on 11 Jan 2021. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hives all over from 1 week after 2nd dose and lasting 6 weeks so far.
Racing thoughts/Hallucinations.  15 minutes of feeling as if dreaming while conscious.  No history of this prior.
Child spent the night at paternal grandmother's house on 5/23, mom saw him on 5/24 and noticed redness.  Redness has decreased over time.  No fever or pain.  He is using the arm normally.  Mom contacted Pediatrics, my office,  at 14:06 on 5/27/20 and was scheduled for a Telemedicine video appointment on the same day.  Dr. did the visit at around 16:40.  Mom is aware a VAERS report is being made.
Patient discharged after (4) day inpatient admission.  Patient is a 55M  with PMHx significant for alcohol abuse who presents  from dextox center for acute alcohol withdrawal. He was hallucinating, reporting the walls are melting and he sees an old woman and a ship captain standing at the door.      In ED, admission labs significant for mag 1.3, potassium 3.0, pancytopenia with WBC 3.86, RBC 3.58, platelet 69. He was treated with IVF bolus, 20mEq of IV potassium, started on etoh withdrawal protocols and covid19 swab was found to be positive. Lipase was elevated but he denies abdominal pain. He  was treated with IV fluids and electrolyte replacement. He was seen by Psychiatry  and was placed on prn Ativan for acute withdrawals, thiamine and folic acid.    His electrolytes were monitored and replaced accordingly. His diet was advanced. Per patient and family request, he was re evaluated by psychiatry for anxiety. He agreed to start Cymbalta 30 mg daily   For his COVID 19, he is fully vaccinated and asymptomatic. He did not require treatment   PT/OT initially recommended acute rehab. PM and R recommended home with outpatient therapy and balance center   He also wanted to continue intensive outpatient therapy for his ETOH abuse. He was discharged to home in stable condition on 12/15/21
This spontaneous report was received from a nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, route, lot numbers and expiration dates were not provided). No adverse events reported. This is one of several reports from the same source. Additional information has been requested.
Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swallowing x 2 days (took ibuprofen)  Multiple fever blister outbreaks since receiving vaccine
she noticed a little nipple drainage after receiving both doses; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose (first dose); and then via an unspecified route of administration on an unspecified date at single dose (second dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she noticed a little nipple drainage on an unspecified date after receiving both doses of Covid-19 vaccine. The patient wanted to know if this was a side effect of the vaccine. The patient underwent a lab test and procedure which included an unspecified test which was normal on an unspecified date. Outcome of event was unknown.  Information on Lot/Batch number has been requested.
PATIENT EXPERIENCED SWELLING, TIGHTNESS AT INJECTION SITE.   WITHIN THE NEXT 24 HOURS HE EXPERIENCED ELEVATED PULSE RATE, ELEVATED GLUCOSE, NUMBNESS IN LEFT ARM, SLURRED SPEECH, AND DIZZINESS.  HE WENT TO THE HOSPITAL ON 7/6/19 AND WAS RELEASED.  HE IS TO FOLLOW UP WITH HIS PCP 7/9/19
PROFUSE SWEATING; RESTLESSNESS; MISERABLE; CHILLS; BAD NAUSEA; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 26-MAR-2021, the subject experienced profuse sweating. On 26-MAR-2021, the subject experienced restlessness. On 26-MAR-2021, the subject experienced miserable. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced bad nausea. On 26-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad nausea, chills, profuse sweating, bad headache, restlessness, and miserable. This report was non-serious.
fainted twice shortly after waking up/diagnosis was vasovagal syncope; fainted twice shortly after waking up/diagnosis was vasovagal syncope; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) on 31Mar2021 for COVID-19 immunization. Relevant medical history included a history of fainting on an unknown date in the past. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. It was unknown if the patient was tested for COVID-19 post vaccination. The morning after receiving the second vaccine dose, on 22Apr2021, the patient fainted twice shortly after waking up. The patient went to the emergency room (ER), and the diagnosis was vasovagal syncope. Vital signs were normal on an unspecified date. The adverse event (AE) resulted in an emergency room/department or urgent care. The patient did not receive any treatment for the AE. The patient recovered from the event on an unspecified date in 2021.  Information on the batch/lot number has been requested.
fussy x 10 days; rt thigh red swollen x 10 days per report of mom;
This spontaneous case reported by a consumer, describes the occurrence of headache, back pain (backache) and arthralgia (joint pains) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced headache, back pain (backache) and arthralgia (joint pains). At the time of the report, headache, back pain (backache) and arthralgia (joint pains) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Treatment included Tylenol.