chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced sickness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and weakness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she had called previously in December or January and noted that she did not receive her 2nd dose of SHINGRIX, which led to incomplete course of vaccination. She also noted she was sick and weak for a week after the 1st dose. The caller disconnected abruptly, no additional information was gathered. The caller clarified name spelling but unable to locate caller in sale force database.
Symptoms started a few hours after getting vaccine.  Patient got fever 102.2 and lasted off/on for 2 days, emesis x 2 episodes, diarrhea x 1 day, feels sweaty sometimes throughout the day - usually in the morning which is new for him, urine is very bubbly.  He also feels quite fatigued and tired.  His currently s/sx are fatigue and bubbly urine.
admitted to Hospital on 1/5/2022 for an apneic episode. Vital signs on admission showed the patient to be afebrile and hemodynamically stable and breathing well on room air.  Labs on admission were notable for WBC 10.1, hemoglobin 10.0, platelets 67.  Sodium and potassium were normal creatinine and BUN were elevated at 4.16 and 42.  D-dimer was negative.  Lactate was negative.  EKG showed atrial fibrillation.  CXR showed no acute findings. apneic episode during her dialysis run.  She was noted to be cyanotic but began breathing on her own following jaw thrust on sternal rub. Patient had a similar occurrence at a prior dialysis session about 2 days prior to hospitalization.  Patient was found to be Covid positive.  She had a dialysis session on 1/7 which she tolerated.  Nephrology and pulmonary consulted during this hospital stay. The etiology of her symptoms remained unclear, though she tolerated HD well during her stay.  From COVID standpoint, patient was weaned off 02 by time of discharge.   Apneic episodes on dialysis  -Unclear etiology, could possibly be related to COVID-19 infection  -Basic labs, EKG, and CXR on admission relatively unremarkable.  -She tolerated dialysis on 1/7, 1/10 -switched ativan to xanax 0.25mg MWF w/ HD   COVID 19 PNA Patient found to be positive for COVID 19. Was hypoxic to 84%. She has been weaned off oxygen. Started on decadron which was stopped at discharge     ESRD on HD -Typically dialyzes MWF.  Her primary nephrologist is Dr.   She has not recently missed any HD.   Mdodrine prior to HD. Her PTA ativan was switched to xanax 0.25mg -Nephrology following, appreciate cares and recommendations - Avoid nephrotoxic agents -renal secured COVID HD chair on d/c   Atrial fibrillation w/ RVR History of CVA History of CAD Hypertension -She is not on any blood thinners in the setting of her prior GI bleed, hemorrhagic stroke, and increased fall risk.   -Not on rhythm control PTA.  On 1/7, had RVR to 130s started on metoprolol 12.5mg BID -Heart rates currently in the 80s to 90s   History of tracheal stenosis, vocal cord dysfunction -Secondary to previous intubations and tracheostomy.  She has undergone multiple dilations. -Appreciate pulmonary recommendations   History of GI bleed -continue PTA on omeprazole 20 mg twice daily   Anemia of chronic disease: Hemoglobin on admission of 10.0, baseline appears to be 9-10. - Transfuse for hemoglobin <7   Thrombocytopenia: Platelets on admission of 67, baseline appears to be 75-98. Thrombocytopenia likely secondary to chronic renal failure.  No active signs of bleeding noted. Improved to 110
Client had swelling of the face and upper body.  Was seen at Urgent Care and treated with steroids and antihistimines.  Client started having swelling of the extremities a few days later and was seen back in Urgent Care.  Given a pill for the "fluid" that she was retaining and released.  Client said that the Dr. told her that it was caused by the H1N1 shot and that he had seen several cases.  Fluid pills are helping per client.
On the 3rd day following vax pt felt very ill; went to hosp; LP pos for GBS; pt hospitalized; discharged & transferred to rehab unit;
Started with bad pain in right side and trouble breathing. Went to Emergency Room where CAT scan was done and was told Heart was enlarged, Liver was enlarged, Thyroid was enlarged, Lympnodes were enlarged and found Nodes and something that looks like glass in Lung. Second scan was done with Nuclear Medicine and then told to seek Hematology Oncology Specialist, Pulmanary Specialist and need more Scans done. HAve seen Primary Doctor on 6/4/2021
Patient was here to receive his 2nd Covid-19 vaccine. He did not have his card. The person at the check in table looked him up in database to verify date of first shot He wrote on sticky note and gave to patient. Patient proceeded to nurse to get vaccine. He told her he was there for 2nd Moderna Vaccine. Vaccine was given  and after that it was noticed that the name on the paper was not the same.  The person who was scribing brought it to my attention that  the date was too early for patient. When verifying the date I noticed that  it was documented that he had received a Pfizer Vaccine on 03/29/2021. I instructed hi that our records show that he received the Pfizer Vaccine on 03/29/2021. He still states he received the Moderna Vaccine. I instructed him to send me a picture of his card he states was at home.  He sent a picture on 03/18/2021 which showed he did receive the Pfizer vaccine on 03/29/2021 . He states his arm was sore. I followed up with him on 03/19/2021 and his arm was better. I instructed him that he did not  have to repeat either one of the vaccines at this time.
3 min after receiving the vaccine pt verbalized feeling faint. Staff offered pt a cool pack for his neck. Patient accepted. Pt reported not having had breakfast and leaned back into the chair and became pale. PTA eyes were noted to be rolled into his head. Pts body became rigid. Staff assisted pt to the floor to a supine position. Staff obtained baseline vitals  (127/75, HR 66) while simultaneously dialing EMS. Pt a color retuned within approx 2 min and pt was talkative. Dad reports pt with fear of needles with hex of syncope in past. Pt reported feeling fine upon EMS arrival. Pt declined EMS transport. Tolerated water and muffin without difficulty. Pt without injury. Self ambulated out of clinic after additional 15 min observation period.
Pt had fever of 102-103 and a seizure occurred the same day as vaccine administration. No illness noted prior to vaccinations.
I administered the pt Proquad when he wasn't due for the combination shot until 4 years of age.  There was no adverse reactions reported at the time of me filling out the report.
Acute onset of pruritis dermatitis symptoms with onset within 24 hours of vaccination; I evaluated the patient approximately 6 weeks following vaccination and diagnosed her with presumed vasculitic urticaria.  She responded to treatment with a prednisone burst and taper.  Lab testing was negative for the autoimmune markers of vasculitis including ANCA. The patient was asymptomatic at follow up (12/30/2014).  The timing suggests an adverse reaction to the influenza vaccine. Details of the vaccination (lot, manufacture...) are not available.
Flu vaccine approved to give patient by Dr - mom stated she eats eggs with no problem. Patient developed red patchy rash and a few red bumps. Slight wheeze. Given 10ml BENADRYL and Albuterol 2.5mg/3m - neb. with good response.
Child was given the Pfizer COVID 19 vaccine 10mcg/0.2ml approved for ages 5 yrs and above. He was not 5 yrs old at the time
Patient received 1st dose with the adjuvant portion only; Patient received 1st dose with the adjuvant portion only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. On 5th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Pharmacist called to report that, a patient received a Shingrix first dose with the adjuvant portion only.  There was not data available about gender date of birth and lot number at the moment of the call. Did not consent to follow-up. Additional Supportive Information: The patient received Shingrix vaccine with the adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Ventricular tachycardia. Defibrillator paced me out of rhythm. I have had my ICD for 3 years. This is the first abnormal rhythm I have had where it delivered a therapy to abort it.
I had severe pain that night. When the doctor injected me I felt that it was too high on the shoulder, much higher than any of the flu shots I had ever received. Luckily, my son who also received the same flu shot did not experience any discomfort. I have limited range of motion, now after 13 days, in my right arm. It pains me to raise my arm up and rotate it in front of me. It is the worst at night and when I wake up in the morning.
There was no adverse reaction. He was given a peds dose when he should have received the Pfizer 12 and up. Father  was made aware of this miss dose. And an interpreter was also brought in to help parent understand. Parents were told that the state would notify them when we discussed it with the CDC to see what the next step needed to be done.
started screaming 45min @ time in afternoon evening only slept 5hrs in 37hrs;intermittent tremors;pt had no prior illness & has fully recovered;had some tenderness @ shot site;
This spontaneous report received from a medical assistant refers to unspecified number of patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB from lot # M032149 with expiry: 18-APR-2019 and lot # M032150 with expiry 21-APR-2019 (dose, route and anatomical location not reported), for prophylaxis. No adverse effects reported. The vaccine lots were exposed to a temperature excursion of 32 degree Fahrenheit and 36 degree Fahrenheit for 135 hours. The vaccine did not have previous temperature excursion. The temperature excursion was detected by digital data logger. No product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009721:
Severe chills with violent trembling, could hardly walk, used 7 blankets Achy Extreme fatigue for 3 days Headache, low fever Nausea OK after 5 days
The patient is a 24w3d male infant with pulmonary hemorrhage, cerebellar bleed, and bronchopulmonary dysplasia who was intubated at birth, with extubation on 8/10/23, however required re-intubation on 8/24/23 in the setting of apnea, bradycardia, and desaturation events. On 10/26/23, the patient was due for enteral rotavirus vaccine, which was ordered with the route as "oral" and "Give via NG tube" written in the administration instructions. However, administration was documented as being given via mouth that morning. Prior to vaccine administration, the patient's oxygen requirements appeared largely stable, with 52% oxygen documented the morning of 10/26/23. The patient experienced a clinical decompensation 10/26/23 afternoon, with coarse crackles noted in bilateral lung fields, oxygen requirements up to 100%, and initiation of sedation and paralysis. Empiric antibiotics were initiation on 10/26/23 as well for suspected sepsis. On 10/27/23, the patient was weaned back to 52% oxygen, and antibiotics were discontinued on 10/28/23 due to negative cultures, with notes indicating that the clinical exam was reassuring with more stable clinical status after the respiratory decompensation event. The patient was eventually transferred to another hospital for ongoing care on 11/6/23.
Fatigue, aching, fever, sweating, then in AM had swollen area, eyebrow & lower lip; time course 48 hrs; tx DPH & APAP;
LETHARGIC; TIRED; SLIGHT FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lethargic, tired, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, lethargic and slight fever was not reported. This report was non-serious.
Gradual decline in speech and eye contact 2 months prior to this date.. was admitted to ER for uncontrollable vomiting and fever..
tonight have a fever not a big one 100 and a half; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (tonight have a fever not a big one 100 and a half) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced PYREXIA (tonight have a fever not a big one 100 and a half). At the time of the report, PYREXIA (tonight have a fever not a big one 100 and a half) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2022, Body temperature: 100 fever not a big one 100 and a half.         Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient tested PCR positive for COVID on 5/20/2021. He is asymptomatic and was fully vaccinated  for 8 days prior to test. Test was conducted  pre-procedure.
Felt like a very bad cold.  Coughed a lot, extremely achy.  Had a temprature around 100-101 for 2 days.  After day 5 felt better. Stayed home from work for 5 days + the weekend.
Patient was given the 5-11 year old dose (10mcg) instead of the age appropriate 12 & up 30 mcg dose.
pt tested positive for COVID on 10/24/21; 10/25/21 family brought pt to hosp requesting care, stating they were unable to care for him any longer; dx with COVID pneumonia; some dyspnea but not requiring O2 supplementation; started on ABX; began to prepare to transition him to hospice care; DNR; 10/29/21 dc'd pt to Hospice where he passed away; DC and med records sent to vaers website
36 hours of: 100.2 fever  Shivers  Dizziness  Fainted at the 30 hour mark
itching / believes it is due to administering the Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   The reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported the case about the patient who was a pharmacist. The patient had been experiencing some itching and believed it was due to administration of the Shingrix vaccine. The itching was ongoing till the time of reporting. The reporter consented to follow up.
The location of the shot created a hard lump. It?s hot and swollen and sore. I?ve taken Tylenol to help for the first day. I took it on Wednesday but it?s Saturday now and it?s still there.
woke up very tired; developed fever in the afternoon of that same day that reached 101.5 and remained this high for approximately 5 hours (6-11 pm); mild headache; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: Unknown), via an unspecified route of administration on 10Jun2021 as unknown, single dose for covid-19 immunisation. The patient's medical history included arthritis reactive from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 10Jun2021, Thursday, on the day of vaccination, the patient experienced mild headache on the day of vaccination. The patient woke up very tired the following day on 11Jun2021 and stayed home. He developed fever in the afternoon of that same day that reached 101.5 and remained this high for approximately 5 hours (6-11 pm) despite the use of paracetamol. The patient was able to sleep through the night and woke up feeling fine today 12Jun2021, which was the second day after vaccination. The received treatment with paracetamol for fever. The outcome of the events was recovered on 12Jun2021.  Information related to batch/Lot no. was requested.
Suspected vaccination failure; Keep getting as well; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Keep getting as well). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient's child via  interactive digital media. The patient kept getting shingles as well.  They patient was bullied by his doctor as well.  The reporter asked that how much dollar he got for each shingles shot. That was a conflict of interest (for your information).  The patient fired his doctors as did many of his clients.  The reporter stated that most doctors were drug pushers now and just sad.  The reporter further stated that selling your soul for dollar never ended well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR050706 and US2023AMR050711, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR050706:Same reporter - Batch report US-GSK-US2023AMR050711:Same reporter - Female patient case
Pt recvd 1 dose of Engerix-B & had an allergic reaction, swelling, red, hot, painful @ inject site; also had burning sensation in spine, chills, sweating & pain in jaw; seen by MD who prescribed rest & fluid; sx subsided in about 3 days;
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed) and BACK PAIN (lower back was hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), PYREXIA (low fever 99.3), CHILLS (chills) and FATIGUE (tired). On 22-Apr-2021, the patient experienced DIZZINESS (light headed), BACK PAIN (lower back was hurting) and ARTHRALGIA (all the joints in her body hurt (ongoing)). On 23-Apr-2021, the patient experienced AGEUSIA (noticed couldn't taste my food (ongoing).). At the time of the report, ASTHENIA (felt a little weak), PILOERECTION (she started to have goose bumps), PERIPHERAL SWELLING (noticed that her hands were swelling and the next day they were more swollen), DIZZINESS (light headed), BACK PAIN (lower back was hurting), AGEUSIA (noticed couldn't taste my food (ongoing).), PYREXIA (low fever 99.3), CHILLS (chills), FATIGUE (tired) and ARTHRALGIA (all the joints in her body hurt (ongoing)) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (abnormal) Low fever 99.3. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment- iced cold patch and panadol 500 mg
As per dad they noticed redness on 3/16/09 (L) upper deltoid & swollen. Today I notice a little redness around the vaccine area. No swollen no induration he said no fever & it last only for one day (3/14/09)
constant pain at injection site; radiating through my deltoid as well as the same pain; deep ache in both thighs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hep b, for Immunization; Flu vaccine, for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "not recovered", described as "constant pain at injection site"; PAIN (non-serious) with onset May2021, outcome "not recovered", described as "radiating through my deltoid as well as the same pain"; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "not recovered", described as "deep ache in both thighs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pain, pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.