chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she denied further AE; She reported that VAQTA was administered to a patiient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 05-OCT-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date on 03-DEC-2021 (conflicting information also reported as 13-DEC-2021) 0.5 milliliter, for prophylaxis (strength, route of administration and anatomical location were not reported).   Vaccine was administered after experiencing a temperature excursion (product storage error); it was stored at 50.5°F during a time frame of 0 hours and 30 minutes. There was no previous temperature excursions and further Adverse Event (AE) were denied (no adverse event).  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316: US-009507513-2110USA007379: US-009507513-2110USA007269: US-009507513-2110USA007007: US-009507513-2110USA007272:
very bad dry cough; her back and chest hurts and also is experiencing some cold coming up; her back and chest hurts and also is experiencing some cold coming up; experiencing some cold coming up; This is a spontaneous report from via Regulatory Authority Support. A contactable female consumer (patient) of an unspecified age reported for herself that she patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Consumer took her second shot of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021 and had experienced a very bad dry cough for the first 7 days after getting the shot. She also mentioned that her back and chest hurts and also experienced some cold coming up. The cough was still there up to the date of report. Talked with her physician and was prescribed, Codeine at night and Mucinex in the morning to manage that. Caller wanted to know if they had any data on the clinical trials about that. The outcome of event very bad dry cough was not recovered while the outcome of other events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation.  The most recent COVID-19 vaccine was administered at Hospital. Medical history was none.  No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.
Patient reported that she started having tightness in her chest and shortness of breath the next day after getting the vaccine...
Case number PHEH2013US023756 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 54-year-old male patient. He was vaccinated with an expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient (respiratory therapist) of an unspecified age received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 16Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He lost the sense of smell on 28Dec2020 and later tested positive in Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Headache, Arthralgia, FATIGUE, PAIN/SWELL INJ SITE Narrative:
Moderna Dose 1 2/25/21 (041L20A) Moderna Dose 2 3/25/21 (011M20A) COVID Positive 5/10/2021  5/10/21: Presented to ED. 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough.  Patient reports symptoms started about 1 week ago with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea.  He was treated with Z-Pak but symptoms continued and he presented to the emergency room, found to be hypoxic requiring up to 6 L nasal cannula oxygen  Patient also had fever no chills or rigors. Reports he has received both shots of COVID-19 vaccine.  In the emergency room patient was hypotensive which was responsive to IV fluids and  received levofloxacin.  Chest x-ray showed bilateral pneumonia.  WBC 15.5, lactic acid 2.8 and the creatinine 2 which is patient's baseline.  5/13/21: 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week prior to hospitalization with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Treated with dexamethasone and levofloxacin. With not a candidate for remdesivir based on poor renal function and ID consulted and did not believe patient qualifies for Actemra. Subsequently shortness of breath and hypoxia resolved and he was deemed stable for discharge and will complete 7 days steroid taper.  Liver transplant team at pain clinic was consulted, recommended holding sirolimus while patient is on dexamethasone.  I have clearly communicated to the patient and his wife to resume sirolimus after 1 week.  On discharge patient was a febrile and hemodynamically stable.  He was discharged home.
Information has been received from a physician concerning a 4 month old male with a pertinent medical history who was vaccinated PO with his second dose of ROTATEQ (lot# not provided). subsequently the patient experienced diarrhea. The patient was treated for diarrhea but nothing helped so the patient was hospitalized. While hospitalized the patient was diagnosed with SCID immune disorder. It was unknown if the patient was still hospitalized. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.  5/13/2008 MR received for DOS 3/16-5/1/2008 with D/C DX: Severe Combined Immunodeficiency s/p haploidentical stem cell transplant.  Rotavirus, Rhinovirus, Adenovirus, Giardia and PCP pneumonia, feeding intolerance, torticollis. Pt presented to local hospital on 3/13/08 with 1 week hx of diarrhea, one episode of emesis, and on the day of admission with lethargy, pallor, decreased responsiveness, and sunken eyes. TX with abx and IVF and transfered to current facility for management of dehydration. Upon admission infant had cool, mottled skin, a sunken anterior fontanelle, and poor tone. Shocky and in respiratory distress with labored breathing and metabolic acidosis.  Improved with fluid bolus, NaHCO3, and albumin. Pt intubated and extubated on 3/26/08. Stable on RA. Pt had a stem cell transplant on 4/07/2008 and started on Rotavirus and Adenovirus Immunoglobulins PO as well as abx, antifungals and antiparasitics. Some motor developmental delays 2' to long hospital stay. By d/c most cultures/titres were (-) or decreasing. D/C home with NG tube for feeds. Found to have a mild disaccharidase deficiency.
Pt called and said that when pt was given the shot she felt like she was going to faint then later during the day she said she could not move the arm that the injection was given she said she took Advil and was feeling better and she could move her arm fine.
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor's recommendation.
Patient required hospitalization due to breakthrough infection. He received the Pfizer vaccine (2nd dose in series) on 03/25/2021. Hospitalized from 07/24/21 - 08/13/21 (death). Below is copied from his discharge (death) summary:  Cause of Death  Cardiac arrest Acute respiratory failure    Discharge Condition: Expired   Hospital Course:  87 y.o. male admitted on 7/24/2021 for evaluation of generalized weakness for the past day, loss of appetite, increased dyspnea. In the ED with diffuse rhonchi. Sats 88% on room air. Started on 5 L NC. Work up with COVID. Also AKI. Started on abx and steroid   AMS and confusion  Acute hypoxic respiratory failure on nasal cannula.  COVID pneumonia, present on admission. Asthma exacerbation improved. Sepsis, now resolved, secondary to COVID. Acute kidney injury likely prerenal dehydration, resolved. Hypertension well controlled. Benign prostatic hypertrophy. Bipolar/schizophrenia. Delirium ? Psychosis vs dementia, improved. SI s/p mental health act 08/04.  Patient had a very long hospitalization on the floor and in the ICU  Treated with IV abx, IVF and all COVID treatment  He was on HF but improved at some point and placed on RA then got worse again so abx restarted and speech reevaluated During the admission his mental status didn't improve and he was on restraints to avoid self-harm Psych, neuro and pulm followed during the admission  CTH no acute findings as well as MRI .      Druing my round today around 11.15-11.20a found the patient to be unresponsive when I stepped in his room. Pulse ox wasn't on his finger tried to place it but didn't work so called RN but we couldn't appreciate any pulse that time so we called code blue . Patient still unresponsive and very faint heart sounds on exam with no significant pulse .  Code staff/ICU team responded. Compressions , respiratory support , epi given as well trial of intubation since the pateint still listed as FULL code, but unfortunately didn't tolerate it and expired around 1138am    Discussed in details with the staff  Also called and discussed with his Care giver and empathy provided Patient has no family around and his care giver knows him and takes care of him for 20 years
fever & chills & myalgia 12 days post vax;rash & itching abd, arms, legs;
This case involves a 70-years old and unknown gender patient who had colds (nasopharyngitis), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious colds (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the event nasopharyngitis. Information on the batch number to be requested.
Patient reported redness that got worse over several days. Eventually the size of a saucer. Arm was swollen and sore and hot to the touch and had a knot in it
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 21-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Patient seen at urgent care center with complaints of redness and hot at injection site.  Left arm only.  Started on antibiotic for cellulitis.
Inability to stand up when trying to do so.  Tried several times and was able to stand up but with a tendency fo fall to the front and sideways -depending on my movement.   I stood up to walk but could not lift up feet adequately.  At she point managed to walk slowly leaning against a wall to avoid falling.  I could only drag my feet that seemed stuck to the floor.  I didn?t have this experience before.  I had fever (38.4 celsius), headache, neck ache and couldn?t feel my mind was clear.   This was too intense to be thought as ?stiffness?.   I kept walking and by half an hour later it was  better, I kept walking and was increasing the pace.  By two hours later the symptom was almost gone.  The vaccine was a ?Booster shot? .  Third Moderna vaccine after two doses in February and March 2021. Moderna
On Sat. 2/14/15 patient came back with red, swollen arm that was very painful, went to doctor and Dr said it was cellulitis.
This is a spontaneous report from a contactable nurse via a Pfizer Company representative. A female patient of an unspecified gender and race received the first dose of TRUMENBA at single dose for immunization. Medical history and concomitant medication were unknown. On unknown date the patient experienced a rash, along with redness, pain and swelling. The outcome of the events was unknown.
I95.9 HYPOTENSION 10/5/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE I95.9 HYPOTENSION 10/5/2021 DM 2 CONTROLLED BY DIET I95.9 HYPOTENSION 10/5/2021 HYPONATREMIA
R thighs with urticarial lession one on each side immediately next to injection site. L - Varicella/Flu. R - MMR/ HepA.
After injection of Hep B and varicella in the left arm and then Gardasil in the right arm, patient became very pale and she lay back on the exam table and was nonresponsive.  Her eyes rolled back and her legs and arms stiffened.  Eyes remained open throughout the episode and she "came to" within 1 minute.  She continued to be pale for about 5 minutes but was oriented to person and place immediately upon "coming to".  She sat up after about 10 minutes, color slowly came back to her lips.
Information has been received from a nurse concerning a 9 month old patient with on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 17-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
7/15 Swelling arm worse; 7/17/19 - Admitted by oncology for further workup 7/20/19 - Arthrocentesis (-) infection - now w/ LUE Edema - DVT ruled out (arm where Shingrix given) - Prednisone 40g - responded well
Clinic received one box that contained 10 doses of Varicella Live Vaccine September 30, 2022. The Box and all but one vial are labelled LOT: WO18837, Expires 06/14/2024. Two of three vials had been administered before today. The label on the vial of Varicella administered today is reads LOT: SO20464, expires 2021July02. The box of Varicella was received through state program sealed. This Facility did not have any Varicella vaccine prior to receiving stock on September 30, 2022. Parent is being notified and given option to have another dose administered after 28 days. Patient has not shown adverse symptoms to this adverse event.
pt recv vax;devel rash on arm,leg & abd;following day,rash spread on face;
Mild pressure on her chest and shortness of breath on exertion. She denies shortness of breath at rest any localized or systemic vaccine reactions.
Pt developed tinnitus in Rt ear 4 days after vaccination. He had normal exam but also developed decreased hearing. He was evaluated by ENT and diagnosed with sensorineural hearing loss that has slightly improved with steroids.
Dermal fillers Jan 2020  in my lips and i had a lot of swelling in my lips the 2nd day. it has gone down a little but i have not done anything except call the person who  did my lips and they said to just wait it out.
Vaccine administration error.  mRNA vaccine mixed series error.  Patient was administered 1st dose of covid-19 vaccine, Pfizer.  Patient was then administered 2nd dose of covid-19 vaccine, Moderna, on 5-10-2021.
had shingles twice; Shingles hurt like heck; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received old vaccine of Shingles few years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received a Shingles vaccine few years ago other than Shingrix and had shingles. The patient then received 1st dose of Shingrix and again had shingles. The patient also reported that the shingles hurt like heck. Due to the reaction after 1st Shingrix shot the patient was not allowed to take the second shot. The patient said that the problem would have been worst if he/she had not taken any vaccine.
received the 1st dose of Shingrix about a year ago / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date one year ago prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms were was reported. The HCP stated that the patient received the vaccine at a different pharmacy just before the pandemic hit. The HCP does not have the lot and expiration date. The reporter consented to follow up. This case has been linked with US2021100491, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100491:same reporter
This spontaneous report was received from a pharmacist via field representative regarding a female patient of unknown age. The caregiver of patient reported to pharmacist regarding the patient. No medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose number and route of administration not specified) (lot number unknown). No concomitant therapy reported. On an unknown date, the patient experienced severe case of ophthalmic zoster above her eye and patient may go blind (disability and medically significant). The outcome of the events were unknown. The causality was unknown. NO PQC was involved. Upon internal review, event patient may go blind was considered medically significant. Additional information has been requested.
Information has been received from a physician concerning a 15 year old male who was vaccinated with his third dose of GARDASIL (Lot number not reported) on approximately on 02-JAN-2012. Subsequently, the patient experienced what appeared to be seizure-like activity. The physician stated that the patient lost consciousness and his body tensed; he might have "stopped breathing momentarily." The physician reported that he managed the patient accordingly, (intervention and monitored) and that the patient regained consciousness. Upon internal review seizure like activity was determined to be an other important medical event. This is one of the several reports received from the same source. Additional information has been requested.
On 3/22/2021, 7 days after I received the second shot, after supper at ~6:00 PM, I felt pain from right feet below the ankle. The pain got worse by 8:00 pm. I though I might somehow got it hurt somewhere.  I massage the pain area and place the foot and lower leg in a bucket   filled with warm water. Those did not help. I went to bed at ~8:30 pm and felt the whole right leg  very uncomfortable. The dull pain came from the foot and extended to the whole leg,  I felt the foot and leg were swelling but they were not. By 12:00 am the pain became less and totally gone by 7:00 am, I urinated four times over night and had severe sweating in the second half of the night.   I  feel alright the next day, just some kind joint/musel  uncomfortable.