chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of GARDASIL 9 (lot# L004014, expiry date 04-MAR-2017; lot# L013429, expiry date 21-JUL-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
right thigh swelling, red, knot about 3x3 size. Per o/v on 05/06/05 with MD.
FLULAVAL given in left deltoid, next day presented w/circular rash, mild swelling and pain at injection site.
A small bump on left thumb 2 days ago, top just below the nail near knuckle.; Arthritis type swelling/pain in both thumbs, Left thumb swelling is still present; Pain in both thumbs; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced arthritis type swelling/pain in both thumbs. The left thumb swelling was still present, but right thumb affects was not currently present. On unknown date in Sep2021, the patient noticed a small bump on left thumb 2 days ago, top just below the nail near knuckle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arthritis type swelling/pain in both thumbs and small bump on left thumb was unknown at the time of this report.
This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old child of unknown gender. On 12-JUL-2010 the patient was vaccinated with a first dose of M-M-R II (rHA), (0.5 ml, subcutaneous, site of injection not reported). On 25-JUL-2013 the patient was vaccinated with expired dose of M-M-R II (rHA) (0.5 ml subcutaneous, site of injection not reported) (671438/1118AA, expiration date 12-JUL-2013) (second dose). No adverse effects reported. Additional information has been requested.
BODY ACHES; SHORTNESS OF BREATH; LOSS OF APPETITE; SORE ARM; HEADACHE; FEVER; NAUSEA; FEELS VACCINE WAS ADMINISTERED A  LITTLE HIGH ON THE SHOULDER; MORE PAINFUL SHOT THAN EXPECTED; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intra muscular and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:45 on left arm  for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feels vaccine was administered a little high on the shoulder. On 05-APR-2021, the subject experienced more painful shot than expected. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 05-APR-2021 20:00, the subject experienced body aches. On 05-APR-2021 20:00, the subject experienced shortness of breath. On 05-APR-2021 20:00, the subject experienced loss of appetite. On 05-APR-2021 20:00, the subject experienced sore arm. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 20:00, the subject experienced fever. On 05-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shortness of breath, loss of appetite, headache, fever, and nausea on 07-APR-2021 18:10, and more painful shot than expected on 05-APR-2021, was recovering from sore arm, and the outcome of feels vaccine was administered a little high on the shoulder was not reported. This report was non-serious.
Palpitations, had heart monitor which revealed premature heart beats in bigeminal pattern.  Episodes started 3 am morning after first vaccine, worsened after vaccine #2. Continued daily and throughout the day since initial vaccine.
Neck pain; back pain; pain in the glands behind the ear; chills; pounding on top of the head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (back pain), PAIN (pain in the glands behind the ear), CHILLS (chills) and HEADACHE (pounding on top of the head) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain), BACK PAIN (back pain), PAIN (pain in the glands behind the ear), CHILLS (chills) and HEADACHE (pounding on top of the head). At the time of the report, NECK PAIN (Neck pain), BACK PAIN (back pain), PAIN (pain in the glands behind the ear), CHILLS (chills) and HEADACHE (pounding on top of the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/31/2021 ABNL CBC J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/31/2021 ULCER OF BUTTOCK, UNSPECIFIED DEPTH J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/31/2021 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/31/2021 CKD STAGE 4 (GFR 15-29)
Pt was due for MMR and Varicella separately but a PROQUAD and Varicella was given.
This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received (BNT162B2), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVI-19 immunization. The medical history and concomitant medications were not reported. The patient experienced injection site pain and muscle pain, overall a feeling of being slightly unwell all on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10:45 AM on 11/4/15 - Patient had Grand Mal seizure activity for 2 minutes. Patient was postictal with confusion, lethargy, slurred and garbled speech until EMS arrived. Vitals 136/96, 108 pulse, Ox 100%, Blood sugar was 116 mg/dl.
On day 7 a large rash appeared on my arm at the site of the injection site.  Lasted for 5 days.  Red and blustery with a circumference of about 2 1/2 inches.
-Abdominal Headache, Fevers Chills, Feels warm, Painful rectal area when having Bowel movements.
2-17-2021 Received 1st Covid Vaccine around 11:30 am .Around 5pm same day site became very sore and throughout night awoken if rolled on this arm. 2-18-2021 Continued arm at site to remain sore around 7 pm a slight itchy checked site and experienced swelling and a ring of redness measuring 3 in width and approx. 2 inches in length - occasional chills.  2-19-2021 Remains red, swollen, and sore.  2-20-2021 Still swollen - slightly pink occasional itch and occasional chills During sleep if lie on it accidentally awaken from soreness. 2-21-2021 Still sore to touch and slight discoloration 2-22-2021 Discoloration and swelling almost gone; soreness slight. 2-23-2021 IMPROVING  Note: next dose scheduled for 3-17-2021
73 y/o female, BMI 32, PMHx of asthma, Afib, CKD, DM, hypercholesteremia, hyperlipidemia, HTN, admitted for weakness on 9/3/21. Chest X-ray shows pneumonia with pleural effusions. Covid treated with Decadron, Lovenox and supportive care. Pleural effusions treated with Lasix. Pt discharged to home on 9/7/21.
Pale, diaphoretic, hypertensive, wheezing, unable to breath. Epi was administered and symptoms subsided. 911 was contacted and patient signed off with paramedics.
Swollen lymph node under arm; Stiffness in neck and shoulder on same side of injectionarm.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 21Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient had no known allergies to medications, food and other products. On 23Apr2021 at 08:00, the patient experienced swollen lymph node under arm which was same arm that the shot was administered, headache and stiffness in neck and shoulder on same side of injection arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node under arm which was same arm that the shot was administered, headache and stiffness in neck and shoulder on same side of injection arm was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case, initially received from other health professional (nurse) on 09-Nov-2017, concerns a 58-year-old adult male patient. The patient's medical history includes BPH (benign prostatic hyperplasia), GERD (gastro esophageal reflux disease), high cholesterol and myalgia. The patient's concomitant medications included pravastatin, omeprazole and WELLBUTRIN. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018), which underwent at least one temperature excursion (explicitly coded as incorrect product  storage  and drug administration error). It was reported that, patient had not experienced any adverse event after the administration of the vaccine. The reporter assessed the events as non-serious. Non-significant follow up received on 11-Dec-2017: No new information received. Significant case correction received 09-Nov-2017: The event "No adverse event" was deleted. Added classification as "Special case with No AE" in relevant field.
Severe itching. Pt states that she felt disoriented, felt tired all the time & had experienced some slurred-speech and she ended up going to the ER on 9/27/11.
Information has been received from a physician concerning a baby who was vaccinated with the first dose of ROTATEQ at two months, the second dose was skipped and the third dose was administered at 31 weeks. Additional information has been requested.
Developed Guillain Barre Syndrome after multiple vaccines in basic training. Service member had pneumonia prior to hospitalization for GBS, but numbness in lower extremities started before respiratory sxs did. Received IVIG with improvement, but still has difficulty going up steps and with balance, cannot run, has pain in legs when squatting. Service member being discharged permanently from the military. Symptoms: Neuropathy, Gait abnormality, Hypo-reflexia, Sensation, decrease, Weakness, Paresthesia.  2/26/09 Clinical Summary received. Pt initiall presented  9/20/08 with c/o of ~10 day hx numbness of the toes  Initially thought numbness r/t boots and dismissed.  Returned with numbness now in both legs and productive cough -close contact w/ pneumonia.  Dx: Community Acquired Pneumonia and started on abx. Several days later developed tingling of the legs with painful cramping in the calves and now tingling fingertips. Unable to walk up stairs and having difficult due to arm weakness. Referred to hospital for further eval on 9/24/08. PE (+) for abnormal sensation, reduced motor strength , abnormal gait and stance, and diminished or absent DTRs.  DX with GBS following EMG/NCS. Tx with IVIG with some improvement.  able to walk with a walker. Still unable to run by 12/2008 with continued numbness, pain and spasm in arms and legs. Also significant fatigue.
Lower extremity rash with multiple papules with weeping vesicles. Started topical steroid 4/5/21. Treatment ongoing.
An order was placed for MMR and Varicella, patient was given Varicella and PROQUAD. Vials need to be more distinguishable to avoid confusion.
Very shaky feeling inside; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Very shaky feeling inside) in an 84-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:A number of allergies to medicines.  Previously administered products included for COVID-19 vaccination: Moderna (Dose 1: Lot number:004M20A , Expiry date: Unknown.) on 25-Jan-2021, Moderna (Dose 2: Lot number: 001A21A, expiry date was unknown.) on 23-Feb-2021, Moderna (Dose 3: Lot number: 020F21A, expiry date was unknown.) on 13-Sep-2021, Moderna (Dose 4: Lot number: AS7162B and expiry date was unknown.) on 01-Oct-2022; for an unreported indication: FLU VACCINE VII on 08-Sep-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Drug allergy.    On 22-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Very shaky feeling inside). At the time of the report, TREMOR (Very shaky feeling inside) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2023, SARS-CoV-2 antibody test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  After Administration of Spikevax, 3 days later the patient started having a very shaky felting inside, as if she had taken 10 cups of coffee. The felting was still there today. It's been a month; she was getting tired of felting this way. She did not feel better. As HCP suggested, she waited a little bit until doing any tests. The patient was wondering if it may be due to the vaccine received was so soon after having COVID. Nobody asked her in the pharmacy if she had COVID recently.
Have had a persistent headache (daily) since 1st vaccine.  No relief from Advil or Aleve.   Relief from Butalb-Acetamin-Caff.  50-325-40.
Vesicular/papular rash starting 8/10/13. Low grade fever on 1st day of rash.
Shortly after receiving vaccine, client experienced "excruciating episodes" of intense pain, tingling, and numbness.
Patient was inadvertently given Influenza Vaccine, Adjuvanted FLUAD Quadrivalent, 65+ vaccine.
She was given vaccine & came back to the office 2 days later with Redness (9cm) swelling, & Soreness. Was advised to use ice pack, Benadryl with IBU as needed.
Vaccine administered is approved for patients 18 years old and older. Patient is 16 years old.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored ROTATEQ oral (dose and lot # were not reported). It was reported that the vaccine was exposed to 1 degree C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness and swelling with some pain below injection site on left arm. Site warm to touch just above elbow. Swelling feels almost fluid filled.
Information has been received from a Certified Nurse Midwife concerning a female with a penicillin allergy who on 01-FEB-2008 was vaccinated IM with the first dose of GARDASIL. Subsequently the patient became pregnant. Her LMP is 14-JAN-2008. The patient received a PAP test and was positive for HPV. Follow up information was received from the C.N.W. who reported that the patient had terminated the pregnancy in March 2008. Upon internal review, pregnancy termination was considered to be an other important medical event. Additional information is not expected.
5/31/21 had back chest neck arm pain, went to medic, went into cardiac arrest, the did 18 minutes of CPR, got a heart rate, medivac?d me to Anchorage, AK spent 4 days in ICU, was told I had cardiac arrest due to  pulmonary embolus,.  Got a defibrillator installed in my chest.
This study case was received from the investigator in a trial on 12 November 2012. A 21 year-old male subject with no significant past medical history was found to have unspecified disease of the pericardium and non-specific myocarditis 14 and 10 days respectively after the subject had received on 16 July 2012 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory tests included an abnormal Troponin I recorded highest value of 01.91 on 28 July 2012, an abnormal ECG on 26 July 2012 and an abnormal echocardiogram on 27 July 2012. A Lumbar puncture and MRI of the brain, spinal cord and heart results were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Seizure with fever - 1/29/15. Seen at ER, fever, cough and congestion. Negative flu and strep.
facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On 1st October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The Glaxosmithkline sales professional called in stating that her colleague had already reported this adverse event but the Glaxosmithkline staff who was the reporter today got to speak to the physician. The patient experienced facial flushing, they felt faint and also had nausea and vomiting.  There were no hospitalizations. Additional information not provided.  The patient identifiers not available. The reporter consented to follow up. This case is 1 of the 5 linked cases, reported by the same reporter.
This case was reported in a literature article and described the occurrence of partial paralysis of abducent nerve in a 4-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject was born at 39 weeks of gestation by caesarean section due to prolonged labour following an uncomplicated pregnancy. There was no reported history of febrile illness or trauma and a photography from day 1 of life showed normal eye abduction. A maternal uncle had a history of strabismus. No further information on his medical, family history or concurrent medication was available. On an unspecified date, at 2-day of life, the subject received 1st dose of ENGERIX B (administration site and route unknown, batch number not provided). 2 days after vaccination with ENGERIX B, the subject experienced partial paralysis of abducent nerve and esotropia. This case was assessed as medically serious by GSK. On ophthalmological examination, he showed marked limitation of abduction in the right eye (-3) and full ductions in the left eye. This was consistent with right lateral rectus paralysis. He blinked to light with each eye. Dilated fundus examination was normal. His paediatrician performed a neurological examination that was notable only for the abducens nerve palsy. MRI of the brain and orbits, with and without contrast, was performed and T1- and T2-weighted fluid attenuation inversion recovery (FLAIR) and diffusion-weighted images with fat suppression revealed no abnormalities. Diagnosis was isolated abducens nerve palsy. The treatment consisted of part-time occlusion therapy of his left eye. Examination on day 30 of life revealed a 60 degree right esotropia in primary gaze at near. Cycloplegic refraction revealed +13.25 D spherical error for each eye. He maintained fixation in adduction in the right eye and had central, steady, and maintained fixation in his left eye. At 2 months of age the esotropia had resolved and he was orthotropic in primary gaze, with full abduction of the right eye. Patching was discontinued at this visit. Examinations at 4, 12, and 18 months of age revealed orthotropia in primary gaze, with no limitation of abduction of the right eye. His vision was 9.8 cycles per degree (20/60, within normal range) in each eye using teller acuity cards at the 18-month of age follow-up examination. The author's conclusion stated that they believed that his sixth nerve palsy was caused by the vaccination, although other, less likely, possibilities include cryptogenic or unreported trauma. Presumed postimmunization abducens nerve palsy typically resolves spontaneously within 6 months, although it was often associated with a recurrence.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   No ill effects noted or voiced.
About 4 or 5 hours after vaccine, I was covered in a red rash from head to toe. I went to the ER and got a shot of steroids and I was put on oral steroids for 5 days. Two days after, I had a full blown chest cold and flu like symptoms. I started antibiotics with breathing treatments. I'm better now. I've been sick for a good 10 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly GARDASIL. No adverse event was reported. The outcome was unknown. This is one of the 4 reports received from the same reporter. Additional information has been requested.