chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Syndrome (tingling, heat, sharp electrical-like pains started in both feet in the morning); Pains eventually attacked my lower stomach; This a spontaneous report from a contactable consumer (patient herself).   This 46-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0173), via an unknown route of administration in the left arm, on 08May2021 09:30 AM (at the age of 46-year-old female) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route in the left arm, on 17Apr2021 09:30 AM (at the age of 46-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. The patient did not have relevant medical history and concomitant medications. On 13May2021 07:00 AM, she had tingling, heat, and sharp electrical-like pains started in both feet. By afternoon it had traveled up both legs. It eventually attacked both legs and her lower stomach. The patient visited the emergency room (ER) where doctor diagnosed Guillain Barre Syndrome. The patient was treated with gabapentin and pain meds. In May2021, computerized tomogram (CT) scans and lumbar puncture were done but results were not provided. The patient is currently recovering from the events.
Vomiting, headache, severe body aches, chills, fever 101.6 at highest
I have itchy red bumps on my lower legs and knees and on the tops of my feet I have red spots the size of silver dollars that are light red in the middle and dark red on the edges. annular demarcation. it's worse on my left foot. my legs feel much colder than the rest of me. I applied a steroid cream and it seems to be getting much better.
Seizure 3-4 days after his one year old immunizations. 4 more seizure episodes after that. Last one 1 year ago. 06/01/06-10 pages of office notes received from dates of service range from 8/20/02 through 8/24/05-note for 4/22/04 documents intractable N/V and moderate dehydration, with subsequent admission to hospital, a note of 8/24/05 documented febrile seizure history x2 and 1 afebrile seizure-last seizure 8 months prior to 8/24/05 visit. Referral for Neuro consult to MD.  06/06/06-6 page ED reports for dates of service 11/06/03 (date of vaccine), 11/07/03(8pages),11/08/03 (6 pages) and 11/25/03 (6 pages) received from Hospital. Notes document temp of 104.9 on 11/06/03 with c/o fever and vomiting and cough. RX with Rocephin 600 mg, Tylenol and Phenergan. DX of otitis media, viral gastritis with secondary diagnosis of s/p vaccine. ED note of 11/07/03 documents mother stated had apparent siezure and vomiting, temp of 103.1 and RX with Rocephin 600mg. DC instructions return on 11/08/03 for additional Rocephin. DC DX Fever, Febrile seizure and secondary diagnosis of otitis media. ED report 11/08/03 documents temp of 100.4 RX with Rocephin 400 mg IV. DC DX febrile seizure. ED report 11/25/03 documents temp of 98.8 with c/o fever times 2 days and seizures from fever. DC DX Right otitis media. DC instructions included f/u with family practice physician. Notes from Clinic document that the next visit occurred on 02/26/04 for well baby visit.
Tachycardia HR 111 with itchy throat 25mg of Benadryl po given made pt wait 30 minutes instead of 15 minutes
This spontaneous report as received from a medical assistant refers to a 5 year old male patient. The patient was vaccinated with the first doses of VARIVAX and MMR II on an unspecified date in his infancy. On 25-APR-2013 the patient was vaccinated with the recommended second dose of VARIVAX and MMR II. The medical assistant reported that on 06-AUG-2013 this patient was administered another dose of VARIVAX (0.5ml subcutaneously, lot number and expiration date not reported and MMR II (0.5ml subcutaneously, lot number and expiration date not reported). No adverse event was reported. The patient's outcome was not provided. Additional information has been requested.
Arm numbness; pain everywhere; difficulty breathing; Stuffy Nose; This case was reported by a consumer via call center representative and described the occurrence of numbness of upper extremities in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness of upper extremities, pain, difficulty breathing and nasal stuffiness. On an unknown date, the outcome of the numbness of upper extremities, pain, difficulty breathing and nasal stuffiness were unknown.   It was unknown if the reporter considered the numbness of upper extremities, pain, difficulty breathing and nasal stuffiness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine 3 years or 3 months ago and has a stuffy nose, difficulty breathing, pain everywhere and entire arm numbness.  The reporter reported being in hospital and that she was dying. The reporter extremely difficult to understand and limited information was provided.  The reporter abruptly disconnected call and unable to confirm spelling for all demographic information. The reporter was unable to connect with caller after attempting to callback on caller ID number and phone number she provided during call.
Patient given influenza vaccine at place of work by outside group. Since a few days after injection patient has had redness, swelling, pain and nodule under skin at site of injection. Pain got worse so pt was put into contact with group whom gave injection by his place of employment. Was given Doxycycline 150mg bid x 4 weeks and Prednisone 10mg pack from outside group. Pt employer later posted a statement from Department for Public Health for numerous reactions like patient had. He was instructed by HR to contact his own PCP for follow up exam and testing. Pt seen in office 12/26/18 and given lab orders and referred to General Surgery. Was seen today and sent to ER for possible I&D.
Breakouts of hives / rashes all over body from head to toe intermittently.   Breathing is labored.  Taking  Benadryl every 4 hours and using steroid  cream.
Bilateral involuntary shoulder twitching, stomach ache, temperature of 99.1.
PATIENT REPORTED EXTREME HIGH BLOOD GLUCOSE LEVELS THAT WOULD NOT RESPOND TO RAPID ACTING INSULIN, WEAKNESS, FATIGUE AND MALIASE
Patient came in on 10/26/2021 to received 3rd dose immunocompromised Covid Vaccine. Patient should have received Moderna 0.5mL, however received 0.25mL booster dose. Informed patient of this error upon arrival today for their "booster" dose, spoke with medical director. Medical director gave permission to give their 0.5mL dose today and report to VAERS. Patient's father refused to get 0.5mL as he states he is not particularly an advocate for vaccines and would prefer to just receive another half dose (0.25mL). I informed him that this is not recommended by the CDC for immunocompromised patients but he states a little bit is better than none or be given to much.
Blood Vomitings, Nausua , knee pains, Chills, fever, headache, dizzyness, uncomfort.. 6 hours of sickness, next day body pains and uncomfort.
Erythema, Edema, and decreased ROM left arm with Palp left Axillary Lymph Nodes
Vaccine given at 0930 on 10/27. By 1130 patient had loss of bladder control, blinding headache, vomiting, photophobia, dizziness. Diffuse, painful rash to injection site erupted 10/28. Patient has no hx of migraines.
pt phoned c/o spiking fever, flushed, hot dizziness instructed to go to ER; 345PM spoke to pt-states @ work drank a coke & started feeling better about 1-1 1/2 hrs later; states still feels a little hot & dizzy
Information has been received from a physician concerning a 5 year old patient who on 13-AUG-2007 was vaccinated with a second dose of PROQUAD (Lot # 658187/0790U) in the left leg. Concomitant vaccine administered on the same location, left leg, included hepatitis A virus vaccine (manufacturer unspecified). The left leg became swollen, red and itchy at the injection site and the area measured approximately 5-6 centimeters. The physician reported that the reaction was most likely due to the PROQUAD. The patient was given ATARAX syrup, manufacturer unknown. No further information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Death  5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia  2. Bilateral Covid-19 Pneumonia  3. Covid-19 disease  4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure
Woke up at 11:30 with croup like cough, headache, low grade temp, sore legs and then vomiting
Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided
Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Episodes of vertigo, myalgias, vacillating BP and pulse occur 5-20 times per day, lasting for 5 minutes to a few hours. Symptoms began after receiving immunizations in 2002. His trainee immunizations were repeated at the same time because his immunization record was lost. Upon arriving, he was hospitalized for 12 days for a lung condition. Since then multiple specialists and workups have not yielded a diagnosis. He is under care. He was to provide a record of his immunizations, but has not as yet.
chills; body aches/ pain all over her body; congestion; sneezing; headache; ear pain; she has a lot of mucus; her throat hurts; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunisation. The caller reported that, the patient was supposed to get the second dose on 28Aug2021, however the patient received second dose until Saturday 04Sep2021. On Sunday (05Sep2021), the patient started having chills, body aches, pain all over her body, congestion, sneezing, headache and ear pain, she has a lot of mucus and her throat hurts. The caller took the patient to a clinic but came back because the waiting list was 2 hours. The outcome of all the events as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red rash over body, Sent to dermatologist on 02/04/2010 and diagnosed with Urticaria, probably related to H1N1.  Treatment:  Benadryl and Hydocortisone prn
Information has been received from a physician concerning a 19 weeks old male with mild dilation of kidney and no drug allergies who on 20-JAN-2011 was vaccinated with the first dose of ROTATEQ (lot # 669073/1525Z). The reporter stated that the patient had a couple drops of red blood in his stool about 4 days ("24-JAN-2011") after vaccination with the first dose of ROTATEQ. The patient also had loose stool, fatigue, fever of 100 F and did not sleep well. This first dose was given at 16 weeks of age. On 25-JAN-2011 the patient recovered from a couple drops of red blood in his stool, loose stool, fatigue, fever of 100 F and did not sleep well. The patient was seen in office to seek medical attention. Upon internal review, a couple of drops of red blood in his stool was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Tinnitus - Five minutes after injection had ringing in both ears which subsided during the say.  Sunday was off and on.  Today (Monday) woke up to severe ringing.  Having problems concentrating with the loudness.
Wrong vaccines given to patient. I went to room and asked mother of patient if patient was pt whom vaccines were ordered for, mom replied "Yes". Vaccines (Pentacel, Prevnar, Rotarix) were given. When vaccine record was given back to mom she said "No, she is not this patient (pointing to vaccine record)." I asked again this is not patient and mom responded no. I apologized and informed provider immediately.
Pain shot up her neck while receiving the vaccine. Her arm became red and sore, the redness has spread down her arm 3 days later. Patient will go see her physician.
This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Hearing loss due to nerve damage; sudden and unexpected hearing loss in her left ear; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6200), via an unspecified route of administration on 22Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. There were no other vaccines administered within 4 weeks or on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263) on 01Feb2021 (at the age of 68-years-old) for COVID-19 immunization. On 08Mar2021, the patient had a cataract extraction in both eyes after which she started taking prednisolone acetate USP 1% (UPC: 6075811910, Lot: T0557, Expiry: Jun2023) steroid eye drops on approximately 10Mar2021 for an unspecified length of treatment. On 11Apr2021, the patient experienced sudden and unexpected hearing loss in the left ear only, which worsened. Per the appointment with the ear, nose, and throat (ENT) doctor, there was no reason for the unexpected hearing loss in her left ear, and the hearing loss was not related to anything medical. The ENT doctor started the patient on a steroid treatment (prednisone) for 10 days. On 20Apr2021, the patient had an abnormal hearing test which showed left ear hearing loss due to nerve damage (as of an unspecified date). The events did not require an emergency room visit. The clinical outcome of sudden and unexpected hearing loss in her left ear was not resolved, while of hearing loss due to nerve damage was unknown.
On 09/02/08, patient began fevers.  On 09/03/08, fevers became unmanageable, over 105 degrees.  Took patient to ER of local hospital.  She had chest x-ray, urinalysis, blood culture, all negative.  Rash began evening of 09/03/08.  Spread from neck area, down torso, back and face.  Fevers began to subside after rash appeared.  Was given Motrin and Tylenol for fevers.  Took patient to pediatrician on 09/05/08 who stated that in her 14 years, has only seen about 3 reactions similar to patient's but believes this all to be due to MMR vaccine.  Does not appear to be related to any illness, rash has appearance of measles.  Currently (09/06/08) patient seems to be feeling better although rash is still extremely apparent, all over face and body but not as pronounced on legs and feet.  Loss of appetite, loss of sleep, extreme fussiness, had to endure a chest x-ray (being placed in a tube to keep her from moving) as well as a catheter to obtain the urine sample and a needle stick for blood sample.  This ordeal has been extremely tough on my daughter as well as on myself and my other children as well as my lost time from work for hospital and doctor visits.  I was aware there could be a low grade fever or mild rash prior to receiving this vaccine however this was neither.  This reaction in my opinion is not worth the protection it provides.  I am hopeful that the worse is behind us.  I welcome any information you may have that you can provide to me.
Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that is an initial report. Information regarding PREVNAR 13 (syringe pre-filled) was received from a healthcare professional regarding a 4-year-old female patient who experienced swelling in thigh, pain in thigh and redness in thigh. The patient received a dose in Sep-2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered in Sep-2010. Dose regimen was 1 dose 1 time per day (subcutaneous). Unspecified flu vaccine on the same day as the PREVNAR vaccine (opposite thigh). CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced swelling in thigh, pain in thigh and redness in thigh in Sep-2010. Treatment included cold compresses to help relieve the pain from the reaction. Three days later, the events resolved. No additional information was available at the time of this report. Follow-up (17Nov2010): New information received from a contactable nurse. A 5-year-old female patient received PREVNAR 13 on 07Sep2010 in the right thigh. No pertinent medical history was reported. Relevant drug history included 4 doses of PREVNAR 7. Adverse event onset was 08Sep2010. Follow-up attempts completed. No further information expected.
RN gave Tdap instead of Flu vaccine, two Tdaps were given to patient in the same arm (Left deltoid.)
pt recvd vax & 25jan devel spells of staring to Lt & upwards; seen 26jan by pmd & referred to neurologist for evaluation & eeg; dx w/ myoclinic sz;
A 45-year-old female with no current illnesses had received a second dose of JE-VAX, lot number EJN222A, in the left deltoid, and a third dose of Twinrix , lot number AHABB058CA, in the left deltoid, on 21/Jul/2006. The patient experienced a half dollar sized area of redness, induration, warmth, and itching at the injections site, with loose stools and nausea five days post immunization, on 26/Jul/2006. Treatment and diagnostic testing were not reported. At the time of this report, the patient had not recovered. The patient had previously received on 14/Jul/2006, a first dose of JE-VAX and a second dose of Twinrix, in the left deltoid with no adverse reaction. The patient also received on 07/JUL/2006, a first dose of Twinrix, a dose of TD vaccine, a dose of Ipol and a dose of MMR vaccine. All of those vaccines were administered in the left deltoid with no reported adverse reactions. Follow up information received on 21/Aug/2006 from a health care professional. As of 15/Aug/2006, the patient was "feeling much better except for residual malaise. Concomitant medications had been added to the record.
aches and sore arm; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of bnt162b2 (Pfizer, Batch/Lot Number: Unknown), via an unspecified route of administration in left arm on 06Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Batch/Lot number was not reported) via an unspecified route of administration in left arm on 17Mar2021 as single dose for covid-19 immunization. The patient experienced aches and sore arm on 06Apr2021. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of event was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within days after receiving the new vaccine, my right big toe was numb and is still numb.
MMR given 09/14/2001 for negative titer (measles). Phone call to Employee Services 09/17/2001 with complaint of nausea and vomiting and URI symptoms. Seen in Employee Service 09/19/2001 and diagnosed pregnant (LMP 7/01). States didn't read consent. Follow up with OB-GYN 09/20/2001 regarding testing pt for fetal defects. OV to ES 09/26/2001 on medical leave, nausea, vomiting and abdominal cramps continue. Referred back to OB GYN. 11/12/2001 Note pt had elective TAB refusing appt for genetic counseling. Doing fine now.
Covid arm (large itchy swollen circle) so far just today. Not sure how long it will last