chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few hours after receiving the second dose, I was overcome by uncontrollable emotions. This involved spontaneous crying that lasted for over 2 hours. This is not typical behavior for me and the only thing that was different was that I received my second dose of the vaccine. This situation could be a disaster for someone who is less aware of their condition and symptoms. The emotions were so intense that there was the potential for self-harm.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. It was reported that an unspecified number of patients have received improperly stored doses of PEDVAXHIB (lot #, expiration date, strength, dose and route of administration were not reported) on 15-OCT-2014. No symptoms reported. This is one of several reports received from the same reporter. Follow up information has been received from a medical assistant on 24-OCT-2014 concerning 2 months old patient of an unknown gender. On 29-SEP-2014, the patient received improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
lethargy; Tired; This is a spontaneous report from a non-contactable consumer. An 80-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, about 2 to 3 days after vaccination, the patient experienced lethargy and tiredness which stayed for about 2 to 3 days. The events outcome was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
FRIDAY: Unusual tiredness began approximately 10 hours after injection (at bedtime). Woke up in middle of night with mild headache, feeling of dehydration and having chills.  SATURDAY: Throughout the following day, mild headache off and on, fever of up to 102* and extreme sleepiness continued. I could stay awake no more than an hour without an overwhelming need to sleep.  Virtually no appetite but I was thirsty.  I took Tylenol a couple of times but otherwise let things run their course. By the end of the day, a small appetite returned. Chills during the 2nd night were there, but lessened.  SUNDAY: The following morning (approx 44 hours after injection), I felt better, less exhausted but continued to have a low grade fever (100*) for a few more hours. I did not nap the entire day but was extremely low on energy and had to rest several times. Splotchy rash developed on upper arm of the injected arm (right). MONDAY: Tiredness continued into the next day but no longer had a fever.  Rash worsened but not to the degree of the rash that developed on the left arm (1st injection).  Rash resolved after a couple of days. Somewhat itchy.
Immediately Dizzy, feeling faint, after 24 hours fever, fatigue, achy
Abdominal pain, diarrhea, vomiting, lasted about 5 hours.
This spontaneous report as received from a other refers to a female patient of unknown age. The patient was vaccinated with, 1 DF ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced hypersensitivity. No treatment information was reported. The outcome of hypersensitivity is unknown. The relatedness for hypersensitivity is unknown for ZOSTAVAX. No further information is available.
Upper arm became red, swollen, painful approximately 12 hours after admin. of flu vaccine. Improved with BENADRYL PO. Also given PNEUMOVXA in the same arm.
4/13/21 Started to become fatigued by 5pm on date of vaccine..by 8 pm I was in extreme pain,  all my joints hurt, by 2 am developed a very large lump underneath my left armpit.  I?m assuming it?s my lymph nodes..I was unable to lift my arm until  4/16/21.. Pain subsided on 4/15-4/16..With lingering fatigue.  4/16..lump underneath armpit is still there and tender to touch.
Pt woke up from 5-10 min nap- shaking whole body- (screamed out prior to episode- stiffened arms straight out & legs. Episode lasted approx. 10 seconds- Event occurred 4 hours after administration of vaccines.) Pt was sent to local ER.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22  HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.  DISCHARGE DIAGNOSES 1. COVID-19 2.  Acute renal failure on CKD stage 3-resolved 3. Acute metabolic encephalopathy-resolved 4. Transaminitis-resolved 5. Vestibular schwannoma status post resection 6. BPH 7. Chronic obstructive pulmonary disease 8. Coronary artery disease status post stenting 9. Hypertension 10. OSA
Patient experienced expected side effects, but robust, including sore arm and fatigue.  On administration, patient had almost immediate discomfort in deltoid area.    Additionally, she had waves of nausea and an episode of diarrhea.  She also experienced hot flashes and cold spells.  On Tuesday, the day after the vaccine, she experienced a cold sore on the exterior of her mouth in addition to a sore inside the mouth.   Patient had had immunizations in that same arm  within the last 4 weeks.  3 small red raised areas appeared in this are.
Patient fainted shortly after administering vaccine.  Patient lost consciousness about 2 minutes following the vaccine.  Patient regained consciousness and then felt like they were going to faint again.  Pt reported some chest tightness and then chills after regaining consciousness.
Cellulitis at site where immunization given (erythema from glenohumeral joint down to lateral upper arm, circles around biceps to medial). ROCEPHIN IM, cephalexin PO.
0.5ml Moderna Covid vaccine was given instead of the 0.25mll CDC recommended dose
right eye IV nerve palsy; vertical diplopia/double vision; soreness in arm; scalp tenderness; headache; pain and soreness in the area of the right superior nasal orbital rim; This case was reported by a consumer and described the occurrence of ivth nerve palsy in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 2 months ago and had about the normal soreness in his arm, refer case US2022AMR060953).   On 1st April 2022, the patient received the 2nd dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced ivth nerve palsy (serious criteria GSK medically significant) and double vision. In April 2022, the patient experienced pain in arm, scalp tenderness, headache and nasal pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain were unknown.   It was unknown if the reporter considered the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR060953   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: The patient received a dose of Shingrix and 1 day after vaccination, the patient woke up with double vision.  The reporter's wife was a licensed OD and she was able to determine that he had vertical diplopia from a right eye IV nerve palsy. Less than a week, after receiving the vaccination, the patient also experienced some right sided scalp tenderness, a headache, as well as pain and soreness in the area of the right superior nasal orbital rim. The patient asked if a fourth nerve palsy been reported as an adverse side effect after any other Shingrix vaccinations. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060953:Same patient/reporter
no energy; extreme fatigue; painful right arm; jawbone and teeth pain on left side; discomfort; stabbing ear pain; jawbone and teeth pain on left side; Head ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Aug2021 12:20 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing); "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, start date: May2017 (ongoing); CALCIUM taken for osteoporosis, start date: Jan2020 (ongoing); VITAMIN A D taken for osteoporosis, start date: Nov2018 (ongoing); MULTI VIT (ongoing). The following information was reported: FATIGUE (non-serious) with onset 05Aug2021 13:00, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), described as "painful right arm"; HEADACHE (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021), described as "Head ache"; TOOTHACHE (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), EAR PAIN (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021) and all described as "stabbing ear pain"; PAIN IN JAW (non-serious) with onset 05Aug2021 12:35, outcome "recovered", described as "jawbone and teeth pain on left side"; DISCOMFORT (non-serious) with onset 05Aug2021 12:45, outcome "recovered", described as "discomfort"; ASTHENIA (non-serious), outcome "recovered", described as "no energy". The events "extreme fatigue", "painful right arm", "head ache", "jawbone and teeth pain on left side", "stabbing ear pain", "jawbone and teeth pain on left side" and "discomfort" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, pain in extremity, headache, toothache, ear pain, pain in jaw, discomfort.  Additional information: Extreme fatigue came on fast and lasted 3 to 4 days. Head ache and fatigue occurred within 1 hour of injection, the jaw/ear issue 24 hours later and lasting 2 to 3 weeks easing in discomfort w/n that time. The second shot sore arm and tiredness for a couple of days. There was no patient medical history and no family medical history relevant to adverse event. Vaccination facility types pharmacy or drug store. There was no vaccination administered at military facility. No treatment for AE, no known allergy, no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Upon awakening 11/28/21 (6 days after Covid Moderna booster administration), I experienced  intermittent double vision (Diplopia)., and diziness/haziness. Over the next couple of weeks, Diplopia became permanent. I saw my primary care doctor and my eye doctor. Lenses were administered to help correct the vision and a CT was ordered. CT showed no abnormalities. Referral was then made to a neurologist who ordered an MRI. Once again, nothing abnormal. Myasthenia Gravis (MG) was then expected as the cause, so antibody tests were conducted which showed no signs of antibodies for MG. I was then referred to another Dr who performed an optical evaluation. He did not think the cause was MG, so we ordered the blood tests again which came back showing no antibodies associated with MG. I then saw a retina specialist, and underwent a single fiber EMG test for MG. That test also shows no signs of MG. As of 11/8/2022, there is no diagnosis of why sudden onset Diplopia occurred, other than the Covid vaccine booster being administered 6 days prior to the onset.
At about 7PM, patient reported having chills, site of shot was red, swollen, hot and painful to touch.
the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration; the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (RA).  A 15-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Lot number: GK0928, Expiration Date: 31Aug2024) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SINGULAIR. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "the product expired last night at 10:32pm and the patient received a dose at 9:22am. Product was diluted and had went past the dilution expiration".  Additional information: Transferring agent stated, "I have an adverse event to report, I have a caller on the phone that needs to report an adverse event. She is a Licensed practical nurse. The product is the Pfizer BioNTech COVID-19 Vaccine Bivalent for 12 years and older. So, the product was diluted at 10:32 AM yesterday, stored in a refrigerator and would have expired last night at 10:32 PM however a patient was given a dose of that product this morning at 9:22 AM today."
5/14/2022 In the evening I started getting a sore throat and congestion. It concerned me a little, but I didn't feel like I was getting anything. I just assumed it was the dry air. The next morning my throat was hurting severely congestion was worse and I had body aches. On 5/15/2022 I tested positive for COVID. I slept a lot; I was super fatigued. The following day, I was feeling so ache and was running 100-degree temperature. I spoke to the doctor and she told me to stay hydrated. I should take warm showers, humidifiers for my congestion and lozenges and warm drinks for my throat and Tylenol for body aches as needed. Today I have still not recovered.
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S021326, which has been verified to be valid, expiration date reported and validated as 05-JAN-2021) as prophylaxis (product storage error). No further adverse event (AE) information provided.  The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.56F) for 50 minutes. There was a previous temperature excursion between 6F to 14F (8.47F) for 30 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000762:
floppy, unable to focus, clenched fists, initially, short term irritable cry, unable to sleep >=1hr intervals maintaining constant alert phase;
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with RECOMBIVAX HB lot # JB12567. expiration date: 30-JUN-2016 or lot # K014548, expiration date: 27-AUG-2017, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the J&J Covid vaccine I was awake all night with fever and chills, which I understand is completely normal.  However the next day my upper lip and lower nose swole up in an allergic reaction.  I took Benadryl and went to sleep and by the time I work up it had subsided.  Two days after that incident I woke up (this morning) and my left cheek was swollen from another allergic reaction.  During this time I had not eaten or taken anything out of the ordinary.
Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided .
Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2023, the patient received the 2nd dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Possible late 2nd dose of Shingrix). The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The physician reported possible late 2nd dose of Shingrix.  The vaccine administration facility was the same as primary reporter. The sales representative reported on behalf of physician.  No additional adverse event details available. The patient received possible late 2nd dose of Shingrix, which led to inappropriate schedule of vaccine administered.
Patient discharged after 2 days. Patient is a 58-year-old male admitted for COVID pneumonia.     Patient with past medical history of moderate chronic obstructive pulmonary disease with recent COVID infection.  Patient had been placed on prednisone in the outpatient setting.  Patient now presenting to the emergency department with worsening symptoms shortness of breath, cough and congestion.  Patient vaccinated including booster.  In the emergency department, patient was hemodynamically stable, with desaturations noted 87% with ambulation and was placed on 2 L nasal cannula.  Chest x-ray showed left basilar atelectasis versus scarring.  Labs with mild hyponatremia, otherwise unremarkable.  The patient was admitted for COVID pneumonia, with steroids increased dexamethasone 6 mg. Patient did well, remained stable on 2 L nasal cannula and was discharged home on home oxygen.  At time of discharge the patient had vital signs within normal limits, and was comfortable with discharge plan home.
Patient recevied her first Moderna, COVID-19 vaccine on 2/26/21.  She started feeling tired and sleepy about three hours later.  Over the next 48 hours she developed a rash that is now covering her entire trunk. She presented to our office on 03/03/21 and was given Solu-Medrol injection as well as oral prednisone taper. Rash persisted and was given another prednisone taper on 03/11/21. Presented to the office again on 03/18/21 for persistent reaction; rash still present with new areas appearing as well as continued fatigue and not feeling well.
About 5 minutes after giving the patient the shot, patient started feeling very dizzy, when asked if he would like an ambulance he refused. After a few more minutes, patient said he was feeling a little better. No trouble breathing or talking. After a few more minutes patient started holding his ear and said he was having trouble hearing and started seeing colors. We asked if patient would like an ambulance and patient agreed. Paramedics came and did some tests.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, 5 hrs after receiving SHINGRIX, the patient experienced fever, difficulty sleeping, chills, tremor and influenza-like symptoms. On an unknown date, the outcome of the fever, chills and tremor were recovered/resolved and the outcome of the difficulty sleeping and influenza-like symptoms were unknown. The reporter considered the fever, difficulty sleeping, chills, tremor and influenza-like symptoms to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced flu-like symptoms beginning the night of SHINGRIX vaccination and resolving by the following morning. The patient chills and shaking. The call with health care professional was disconnected during report and the conversation was unable to resume.