chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my ears are like red, my chest is like not a rash but you can tell that it is red; ears are itchy; palm of my hand is real itchy; my cheeks are like swollen; rubbing my hands and my face, I mean it's itchy; nauseated; bad headache; my hand was hurting a little bit; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced ears are like red, ears are itchy and palm of her hand was real itchy and her face, when she rub her nose (incomplete sentence), her cheeks were like swollen and chest was like not a rash but you can tell that it was red, rubbing my hands and my face, she meant it's itchy nauseated, bad headache and allergic reaction. The patient stated that got the shot between 5 or 6 (Clarification unknown) and then she started noticing like oh my god, she just waited for like 2-3 minutes and then noticed her hand was hurting a little bit but not as bad and then it wasn't event 2-3 hours that she started itching. It was reported that the patient got her shot received at about 10 something in the Pharmacy and the problem was her ears are like red, ears are itchy and palm of her hand was real itchy, her face, it was like when I rub her nose (incomplete sentence), her cheeks were like swollen and chest was like not a rash but you can tell that it was red. When they were on the car for home, she told her brother that she needs air. She felt like she was car sick and it anyway 'she doubted' (Clarification unknown) about the allergic reaction and she was laying down and watching TV but still kept rubbing her hands and face, she meant it's itchy. She was nauseated earlier, she not now just had a bad headache. She asked would the itching go away and if she should take a hot shower and it will just stop, should she just wait to see if this goes away. When asked about lot number, she replied that the number they gave on the card. , that Pharmacy would be. Was not on the vaccination card. That was the only number on the card, and then call hung abruptly. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This infant had erythema 2" diameter with induration and puncture wound in the center anterior left thigh. Cellulitis left thigh, local reaction Prevnar injection. Augmentin 200 mg Bid x 5 -10 days.
Pt recvd a series of 3 doses of Engerix-B on 20FEB91, 20MAR91, & 20AUG91 & 20SEP91 pt was pos (having high titers); coverage from Engerix-B was checked (screened) on 18OCT91 & was neg;
None.  Pt was given vaccine that had been stored in conventional freezer since 1/5/22 (expired since 1/19/22).
Paresthesia to left shoulder and arm after 2nd dose that has persisted. Paresthesia of left side of face after 1st dose.
Apatient received last year flu vaccine/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from an Other healthcare professional via Global Media Information (under reference- 00825023) and transmitted to Sanofi on 22-Oct-2021.  This case is linked to case 2021SA356217 and 2021SA356045.  This case involves a five-year-old male patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] by mistake with no adverse event (Expired product used).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 22-Oct-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ562AA and expiry date 30-Jun-2021] via intramuscular route in the left thigh for prophylactic vaccination.  It was reported "3 patients received last years flu vaccine by mistake and would like to know how to proceed?"  First time product used: Yes. Still using product: No. Was Device Used: Yes.  It was a case of actual medication error due Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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 by the regulatory authority. 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.
Patient received one dose of Janssen on  April 8 and May 6.  Was asked three times if he had another Covid vaccine , he denied each time.  Signed consent and completed registration.
DIED; GOT REAL SICK; This spontaneous report received from a consumer via social media (J&J corporate) via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient also received booster of covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced real sickness after his first booster and died (Dose number in series 2). The date of death and cause of death was not reported. It was unknown if an autopsy was performed or not. The reporter stated that "My Son in Laws Dad got real sick after his first booster and died. No wonder they call it the death jab." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of got real sick was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221147290.; Sender's Comments: V0: 20221149115- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Rash, swelling and stinging sensation on the right lower arm and wrist. Vaccine given in left arm. No itching, no difficulty breathing.  Sent to ED for evaluation and treatment.
Twelve minutes after second vaccination patient C/O Headache, Dizziness, slow to respond and "Felling disoriented" per patients husband. Pt encouraged to lie down on stretcher to see if conditions would improve. Concerns for anxiety versus reaction. Patient was oriented to name, day of week, year, and current President. Per patient's Husband, patient has a history of POTS, and under the care of a cardiologist, and is on a beta-blocker. Per physician on duty it was recommendation to call EMS and pt transport to ER for further evaluation. Pt treated and released from ER at 1505
Client reported to parent at 5 am 3/19/14 c/o dizzy, stomach pain, plugged ears, sore throat, fever. Parent reports fever 101 degrees orally, child slept all day - extreme fatigue. 3/20/14 fever 100 degrees, continue c/o sore throat and HA. Request advice. Recommend evaluation by MD. Discontinue oral typhoid, RTC after s/s resolve for immunization with TYPHIM Vi. T/C to Crucell, cust service- agrees with this plan. Dad, in agreement with this plan.
Patient reports having an outbreak of small red non pustular bumps on face and scalp 2 days after receiving the first shingles shot. Patient denies outbreak anywhere else on the body. Not accompanied by any other symptoms.
Mark on arm since August 2021 with INDENTATION increasing. Burning sensation since its been probed over the lat couple weeks
He developed a rash with coughing, sneezing, drowsiness and vomiting shortly after vaccines given today with left arm swelling and redness noted first.
I have whole long UTI or bladder infection/Bladder or urinary infection; I have a full grown infection; It really hurts; I have whole long UTI or bladder infection/Bladder or urinary infection; I have a full grown infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jun2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. It was reported that the patient had second vaccination on 02Jun2021 and prior to that and during that time, patient had no urinary tract infection symptoms or bladder irritation of any kind and now had whole long urinary tract infection or bladder infection on an unspecified date in Jun2021. The patient wondering because now had a full-grown infection. The patient asked was that a side effect anyone had reported previously. The patient wanted to find out if that was associated. The patient stated that need to get taken care of because it really hurts. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt recvd vax & dx w/Bell's palsy 10 day later by MD;
On the 6th day post vaccination, my daughter had some hives on her body, later in the day they spread from head to toe as an itchy rash.  Hives were multiple sizes and shapes.  Skin was red surrounding the hives.  For this I gave her Benadryl and hives subsided.  Soon after, I noticed a raised dark red dots on her torso and chest which resembled the measles.  These spots lasted for a few days. and hives came and went periodically.  For the next 4 days, she had a constant fever and was lethargic.  Fever was treated with alternating Tylenol and Motrin every there hours, but a fever of 102-103 always lingered. She went to the pediatrician to be seen and I was consulted numerous times over the phone with them as to what to do to help her.  By the third day the fever reached 104, by the fourth day in the afternoon, fever went up to 105.6 and my daughter was convulsing and was very uncomfortable.  An ambulance came and took her to the hospital where multiple tests were done to rule out anything else that may be causing this reaction.  It was concluded with my pediatricians and ER doctors that this was a reaction to the MMR vaccine.  Later that night my daughter's fever broke, she was sweating and felt warm to the touch and rectal temperature was 96.7.  I kept her warm all night with blankets so that her temperature would rise.  By the fifth day she was symptom free and started to recover after this agonizing and scary episode.
Chills; headache; muscle pain; chest pain from muscles; heartburn; fever not sure how high; hot flashes; body aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 15May2021 at 08:00 (AM) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunization. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing labetalol dosage lowered, and sulfa allergy. Concomitant medications included labetalol taken for high blood pressure; and buspirone. The patient previously took cabergoline for pituitary tumour but at time of report, was clear of cabergoline meds. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in right arm on 24Apr2021 at 08:00 (AM) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunization. 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 has not been tested for COVID-19. On 15May2021 at 16:00, the patient experienced chills, headache, muscle pain, chest pain from muscles, heartburn, fever not sure how high, hot flashes, body aches, and dizziness. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The adverse events were reported as non-serious. The patient did not receive treatment for the events. The patient was recovering from all the events.  Information about lot/batch number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a post-marketing evaluation program concerning a 5 month old female who was vaccinated PO with the first dose of Rotateq.  Subsequently 7 days post dose, the patient was brought to the office with complaints of vomiting, diarrhea, poor appetite.  The patient was admitted for exploratory laparotomy with reduction of partial volvulus, resection of Meckel's diverticulum and appendectomy and was hospitalized for 6 days.  The patient was discharged on day 6 with a diagnosis of ileocolic intussusception with partial volvulus.  Subsequently, the patient recovered.  The events were considered to be other important medical events (surgery) by the reporter.  Additional information has been requested.
R upper arm edema, redness, tenderness.  Pt reports first noted symptoms Tues, 12-2-08 at school approximately 9am.
8 hours after recieving vaccines, patient experienced chills and could not get warm. Experienced hives, swelling, redness, and heat at site of injections. Spoke with patient two days after receiving vaccines and said she had taking loratidine and used hydrocortisone cream; told her to take BENADRYL instead of the loratadine. Biggest issue at that time was still the swelling, heat, and pain at site of injection. Called her the next day and it had gotten better with use of BENADRYL but was still experiencing symptoms.
Moderate pain and significant swelling of upper left arm. Unable to raise arm to shoulder level or higher without pain. Took 2 ibuprofen, and 2 more ibuprofen 6 hours later.  Swelling had resolved by following morning, and pain was decreased but still mild to moderate. Pain resolved completely by 3rd day.
left me sore arm; feel like got run over by a bus; achey everywhere; horrible feeling; This case was reported by a other health professional and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (mild case).   On an unknown date, the patient received the 2nd dose of Shingrix. On 6th June 2020, unknown after receiving Shingrix, the patient experienced malaise, general body pain and feeling abnormal. On an unknown date, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, malaise, general body pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, malaise, general body pain and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had sore arm, achey everywhere and felt run over by a bus.  The patient felt horrible . The patient received Tylenol iced and slept for 2 hrs that afternoon. No fever.  It was reported as this was a nasty vaccine.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX, lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the pharmacy the morning of 9/8 complaining of a rash that had developed on his right upper arm. This location is consistent with the administration site of the PNEUMOVAX shot administered a day previous on 9/7/18. Patient states that on 9/6/18 he was also given the tetanus shot by his physician in his right arm.
The day following vaccination the patient had chest pain and went to the hospital. labwork pending, suspected myocarditis. Patients mother is awaiting confirmation. The patient is still in the hospital as of 12/01/2021
Found apneic, blue, flaccid about 20hrs post inject; CPR performed taken to ER, intubated & bagged w/100% 02; Stabilized & was transferred to Hosp;
patient described swelling in her lower extremities on the third day after her second pfizer vaccination.  Patient was seen by her provider within the next day. Patient stated that she was diagnosed with a blood clot in her lungs that is allegedly inoperable and has been taking an anti-coagulant since that time. Patient just today reported this event to me.
The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022; No adverse event; Received expired first dose, after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022).    No concomitant medication was reported. Date the vial was initially stored in the refrigerator 27-JUN-2022. The vial does not undergone any temperature excursion. No treatment medication was reported.
Immunization given to a 5 year old on 07/12/2006. Seen in office 07/12/2006 with significant swelling, edema of left leg and large effusion of      . no fever and respiratory symptoms.
When probed for are the events worsened improved or still persisting consumer stated "Worsened"; Blood Sugar went up; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration on 28Jan2021 at single dose, and second dose (lot number: EN6200, expiry date not reported), via an unspecified route of administration on 19Feb2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement, hypothyroidism (low thyroid), and diabetes mellitus. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism and liothyronine. The patient's blood sugar went up on 02Feb2021. When probed if the event worsened improved or still persisting,  the consumer stated "worsened" on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement:high and thyroid function test: low. Clinical outcome of blood sugar went up was not recovered while unknown for the other event.  Information about lot/batch number has been obtained.
When I woke at 5:30am and went to get out of bed I experienced dizziness.  I had a couple more times this happened in the morning but since then it has stopped.   I have soreness in my muscle of my arm but No redness or rash.
Information has been received from a nurse concerning an 18 year old female with no known drug reactions or allergies who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur). The patient fainted 10 minutes after receiving her first dose of GARDASIL vaccine (yeast). There were no injuries. She was walking fairly soon after fainting. She did not say if she will discontinue the series. Unknown medical attention was sought with the doctor. Patient recovered on an unspecified date. Additional information has been requested.
Vaccine was administered on Friday 01/05/07, On Monday 1/8/07. Patient developed a rash and itching over trunk, back, behind knees. Mother administered Benadryl rash has subside. No fever.
Headache, Myalgia, Fever, NauseaVomiting, chills, fever, fatigue; Narrative:
This spontaneous case reported by a patient, describes the occurrence of illness (really sick from the second) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19) for immunization. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 1, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (really sick from the second). At the time of the report, illness (really sick from the second) outcome: unknown.  No concomitant medication or treatment information provided. This case linked to MOD-2022-585451 (patient link).
Pale pink blanching  macular rash to abdomen and chest, Calamine lotion 2-3 times a day
She  started with a fever of high 103.8 it did not respond to Ibuprofen or Tylenol and then broke out in full body hives .  This condition was diagnosed as Roseola.