chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M025563, expiration date 16-NOV-2017 orally (dose was not reported). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD, lot # K001854, expiration date 06-AUG-2015. On an unknown date, the patient received (Oka/Merck) PROQUAD that underwent an unsupported temperature excursion. No adverse experience was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Day after vaccination, began having watery-explosive diarrhea and vomiting.  Baby attempted to nurse but acted like she was in pain each time she tried.  Baby was irratable and crying more than usual.  Admitted to hospital for dehydration and subsequently had a seizure and required intubation.  After transfer to the intensive care unit baby was able to be extubated within 24 hours but remained hospitalized for diarrhea and inability to tolerate feeding.  Baby was started on TPN and eventually began feeding by mouth as tolerated.  04/08/2008 MR received for DOS 3/14-26/2008 with DX:  Dehydration, Hyponatremic Seizures, Diarrhea.  Pt presented to local hospital with 2 day hx of watery diarrhea and vomiting. Pt febrile and admitted for dehydration. Pt's weight had dropped from 11-13 to 10-5 on admission. Pt had poor feeding and became less responsive and ultimately began seizing, in which there were slow rhythmic leg movements and pt's eyes rolled back.  Valium was given and pt became apneic requiring intubation. Transfered to current facility for higher level of care.  Sodium levels normalized and pt was extubated and abx d/cd. Still having frequent, watery stool.  Trial of po feeds failed and TPN initiated. Transfered to regular peds floor on 3/17/08. Weaned from TPN when taking po well.
This case was reported by a pharmacist and described the occurrence of chronic inflammatory demyelinating polyneuritis in a 65 year old male who was vaccinated with Twinrix for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the pt received an injection of Twinrix (234A6). Approximately six to eight months post-immunization, the pt experienced chronic inflammatory demyelinating polyneuritis. The event was unresolved as of 6/4/03. Chronic inflammatory demyelinating polyneuritis is considered medically serious (OMIC).
Driving home from receiving first dose of Pfizer vaccine for Covid 19, So about 40 minutes after receiving the shot, I started to experience lip tingling and burning, heart palpitations/racing and a headache that started from out of no where. The burning and tingling would come and go, so I pulled over and took a Benadryl. I made it home and took some Advil. That evening, the heart racing continued with pressure,  it would come and go. I also developed a hive/sore on the inside of my upper lip that burned. I felt very tired but simultaneously I had a feeling of anxiousness at the same time. I took more Advil before bed. Day after the shot, I felt better, the hive on the inside of my lip was almost gone and I took Advil and Tylenol during the day when I started feeling not well.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.32.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician, via a company representative, concerning a 19 year old female patient who on 30-APR-2007 was vaccinated with the first dose of Gardasil. The physician reported that the patient "passed out immediately after receiving first dose of Gardasil; "she added that that patient had not eaten all day prior to receiving the vaccination. The patient recovered on 30-APR-2007, the same day of vaccination. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician and a healthcare worker, concerning a 20 year old (previously reported as 19 year old) female patient, with no known drug allergies, who on 30-APR-2007, at 11:45am, was vaccinated with the first dose of GARDASIL (Lot #656049/0187U). There was no illness at the time of vaccination. The physician originally reported that the patient "passed out immediately after receiving first dose of GARDASIL" but the healthcare worker (who administered the vaccination), clarified that at 11:55am, the patient "felt dizzy and complained of nausea, she dropped to the floor, but was conscious". The patient's blood pressure was reported as normal, and she was helped to a chair, given water, and was then okay. The physician added that the patient had not eaten all day prior to receiving the vaccination. The patient recovered on 30-APR-2007, the same day of vaccination. No further information is expected.
Pt felt nauseated post injection, became diaphoretic, and lost consciousness.  Pt became rigid for about 5 seconds, woke up, was unaware of where he was or what had happened.  Pt was extremely pale, profusely sweating. Ice pack applied to back of neck.  EMS was called.  Pt stated he couldn't hear well but resolved within a few minutes, had tingling in extremities, and pain felt in his teeth.  Pt continued to feel nauseated and extremely thirsty.  Pt BP 98/60 about 5 min after episode.  EMS arrived and took control of scene
Labored breathing.  Tightness in throat/lungs.  This became chills for 2hrs and hot flashes.  A fever of 101.5 was present for 1.5 days.
Information has been received from a consumer concerning a female with no past medical history and no allergies who on 08/13/2001 was vaccinated with a dose of varicella vaccine and a dose of MMR vaccine. There were no other concomitant medications. The pt complained of muscle pains and itching. It was reported that the pt had become very irritable and anxious. The pt sought unspecified medical attention. Additional info has been requested.
1. About 5 minutes after the shot my left shoulder and left arm went numb.  Over the next 15 minutes, the numbing spread to my hands, left side of the face, left ear, and left side of the neck.  I met with the onsite ER doc who said it might be ulnar nerve syndrome, due to the numbness specifically in the pinky and ring finger.  One hour later I had full feeling in my face, ear, and neck.  Within 48 hours the numbness in my left fingers returned to normal. 2. 32 hours after the shot I had half a beer and reacted with an insane high like I was on laughing gas.  I was totally out of it laughing, giggling, and was just ridiculously not in a normal state of mind.  My family witnessed and said they had never seen me laugh so much in my life, and they could clearly see the side effects like being overdosed with laughing gas.  At that time, my left ear starting squealing and I tried popping it many times, like clearing your ears driving over high altitude passes or scuba diving.  No one else could hear the loud squealing and ringing that I could hear in my ears.   This dizzy, laughing, bringing episode lasted about half an hour and then stopped. 3. Now, every morning I wake to my ears ringing and squealing.  If I wake in the night, I hear it too.  When I am alone and it's quiet the ringing won't stop.  The tinnitus is not loud when I am around others but is noticeable when there is no other background noise.
pt recvd vax & approx 2 months later exp redness on lt cheek which was dx as Stevens-Johnson Synd; tx Nystatin lotion; wax & wane rash;
Pt developed gen rash approx 15 min following imm. 50 mg BENAFRYL PO given. Denied itching, diff breathing, throat swelling. Mother states same gen rash reaction following 1st GARDASIL imm. resolved with time and BENADRYL per mother.
hotness at the injection site; Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very; redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable; painful area where the shot was, felt like I got stung by a wasp; slight fever, never alarming; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very), ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable), VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) and PYREXIA (slight fever, never alarming) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very), ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable), VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) and PYREXIA (slight fever, never alarming). The patient was treated with IBUPROFEN for Swelling, at a dose of 800 mg. On 10-Jun-2021, PYREXIA (slight fever, never alarming) had resolved. On 12-Jun-2021, VACCINATION SITE PAIN (painful area where the shot was, felt like I got stung by a wasp) had resolved. On 13-Jun-2021, VACCINATION SITE WARMTH (hotness at the injection site), SWELLING (Severe Swelling,below the shot severe swelling and redness, swelling went all the way down to my elbow, very) and ERYTHEMA (redness,below the shot severe swelling and redness, swelling went all the way down to my elbow, very swollen and very uncomfortable) had resolved.            Patient has received the first dose on 09-Mar-2021,but has taken the second dose on 07-Jun-2021 according to patient's HCP's suggestion.  No concomitant medication were provided. .       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-Jun-2021 contains significant information including treatment and outcome of the event changed from unknown to recovered. Other information include updated primary reporter and patient details.
Sharp in left shoulder following injection . Pain is on and off . some muscle pain,. some clavicle pain.
Fever 101 24 hrs post injection; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247, patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 24Feb2021 at 02:00 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included migraine, penicillin allergy. Concomitant medication(s) included nicotinic acid (NIASPAN) taken within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. On 25Feb2021 at 06:30, the patient experienced fever 101 24 hrs. post injection. No seriousness criteria were reported. Patient received treatment for event with Naproxen. On 25Feb2021 at 06:30, the patient underwent lab test and procedure which included fever resulted as 101. The outcome of event was recovered on an unspecified date in 2021.  No follow up needed. No further information is expected.
Patient received the 2nd dose of the Pfizer Covid vaccine Monday 8/30/21,  and his face became swollen in the afternoon the day after receiving it (Tuesday 8/31/21).  His lips, and tongue were also swollen by this morning (Friday 9/3/21) and patient went to ER and was given prednisone and Epi-pen
Narrative: SORENESS, CHILLS, LETHARGY, FEVER BLISTER
Started feeling face tightness and numbness around lips and lower portion of face while driving home after getting the vaccine. Still feeling a lesser feeling of these symptoms, Thursday, 4 March 2021.
PATIENT HAS PAIN THAT STARTED RADIATING FROM INJECTION SITE TO BACK IN THE NECK
Began to be very weak, tired and extremely pale.  At 11:30 AM vomited in car seat and fell asleep immediately upon vomiting.  Vomited several more times that day.  Extremely weak and pale.  No one else in family became ill.
C/O chills and body shaking. Was very cold. Paramedics assessed and released about an hour later.
Severe lightheadedness/dizziness developed within the first 30 minutes after my 2nd vaccine. Additionally, the body aches began an hour after 2nd vaccine and the body aches that progressed into severe full body aches.  Took tylenol and drank a lot of fluid while resting.  Approximately 20 hours later the side effect were nearly gone.
pt recv vax 4AUG98 & on 7AUG98 pt exp peripheral sx which included arthralgia & photosensitivity of hand, feet & knee joints;pt exp serum sickness, levido reticularis, vasculitis & arthritis;
fever; chills; tired; arm red and swollenaround shot around,; arm red and swollenaround shot around,; swelling of armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0168) via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, the patient experienced fever, chills, tired, arm red and swollen around shot, swelling of armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills, tired, arm red and swollen around shot, swelling of armpit recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
patient received a first dose of Menactra December 24, 2010 and a second dose on December 26, 2010/second dose was too early and therefore invalid; patient received a first dose of Menactra December 24, 2010 and a second dose on December 26, 2010/second dose was too early and therefore invalid; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 41 years old patient of unknown gender who received first dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 24-Dec-2010 and second dose on 26-Dec-2010 (lot number not reported via unknown route at unknown sites for both doses).  The patient's past medical history included Asplenia.  The patient's past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was of actual medication error case due to Inappropriate schedule of vaccine administered and off-label use.  It was not reported whether adverse event was experienced or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
WARM TO TOUCH; BAD ITCHING; SUN-BURN LIKE; EXTREMELY TENDER; SKIN TENDER; SKIN SENSITIVE; INJECTION SITE REACTION; REDNESS GREW LARGER (SILVER DOLLAR SIZE); This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, and penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, once a total administered on 12-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride, and hydrocortisone. On 13-MAR-2021, the subject experienced warm to touch. On 13-MAR-2021, the subject experienced bad itching. On 13-MAR-2021, the subject experienced sun-burn like. On 13-MAR-2021, the subject experienced extremely tender. On 13-MAR-2021, the subject experienced skin tender. On 13-MAR-2021, the subject experienced skin sensitive. On 13-MAR-2021, the subject experienced injection site reaction. On 13-MAR-2021, the subject experienced redness grew larger (silver dollar size). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site reaction, redness grew larger (silver dollar size), warm to touch, bad itching, sun-burn like, and extremely tender, and the outcome of skin tender and skin sensitive was not reported. This report was non-serious.
REDNESS OF THE LEFT ARM; SWELLING OF THE LEFT ARM; ITCHINESS OF THE LEFT ARM; HOT LEFT ARM IN TOUCH; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included lymph node, and concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced redness of the left arm, swelling of the left arm, itchiness of the left arm, hot left arm in touch, and leg pain.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) everything clear, and Diagnostic ultrasound (NR: not provided) everything clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of the left arm, swelling of the left arm, itchiness of the left arm, and leg pain, and the outcome of hot left arm in touch was not reported. This report was non-serious.
numbness on the left side of her face; very stressed; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was having numbness on the left side of her face after receiving the first dose of the COVID-19 vaccine. She inquired about the symptoms in question and if Pfizer recommends receiving the second dose given her reaction to the first dose. She mentioned that she was very stressed about this symptom. The outcome of the events was unknown.   The following information on the batch/lot number has been requested.