chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received YF-VAX and had received another live vaccine 8 days earlier with no reported adverse event; Initial information received on 17-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who received Yellow Fever Vaccine  [Yf-Vax] and had received another live vaccine 8 days earlier with no reported adverse event and patient also received Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Typhoid Vaccine (Typhoid) for Prophylactic vaccination.  On 20-Mar-2023, the patient received an unknown dose of suspect MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) not produced by Sanofi Pasteur (with an unknown formulation, lot number, expiry date, strength)  via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 28-Mar-2023, the patient received 0.5 ml of suspect Yellow Fever Vaccine Solution for injection (lot number: UJ818AA; Expiry date: 18-Apr-2024) (Strength: Standard) (Frequency: once) via subcutaneous route in the left thigh for immunization.  On 28-Mar-2023, the patient received Yellow Fever Vaccine and had received another live vaccine (latency: 1 day)  earlier with no reported adverse event (inappropriate schedule of product administration) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE .   It was reported,  When not administered concomitantly, wait at least 4 weeks between administration of YF- Caller reporting a patient received YF-VAX and had received another live vaccine 8 days earlier. Caller with question on whether dose needs repeating. MMR administered on 20MAR2023 and YF-VAX administered on 28MAR2023.This situation is reported as a medication error due to not administering dose within guidelines on the PI in regard to waiting 4 weeks between administering Live vaccines.  Action taken: not applicable for both the vaccines  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DTP/OPV/MMR given 18Feb @ 1000am;PE-nl,nasal congestion;pt had previous hx of febrile seizures,but no prior hx of adverse outcome to vax.Morning of 19Feb91,pt developed T,had seizure of undetermined length seen @ER;DX:RLL bronchitis on Xray
Passed out twice a few minutes after receiving the vaccine; started convulsing; foaming at the mouth; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 31Aug2021 11:00 (Batch/Lot Number: EW0217) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history, no known. There were no concomitant medications; no other medications in two weeks and no other vaccine in four weeks. Patient had no COVID prior to vaccination. On 31Aug2021 11:15 AM,  the patient passed out twice a few minutes after receiving the vaccine, started convulsing, and foaming at the mouth. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Outcome of events was recovering. Patient was not COVID tested post vaccination. Events were reported as non-serious.  Follow-up attempts are completed. No further information is expected.
LIGHTHEADEDNESS; SWEATING; VOMITING; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021; 10:40 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced lightheadedness. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: mepyramine maleate/pamabrom/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and had not recovered from nausea, lightheadedness, sweating, and vomiting. This report was non-serious.
My throat almost closed up / upper airway swelling; This case was reported by a consumer via interactive digital media and described the occurrence of throat swelling in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown.   It was unknown if the reporter considered the throat swelling to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient's throat almost closed up when he/she took it in college. The patient later read the manufacturer's insert and it said that upper airway swelling was a side effect.
soreness at sight of injections, including a knot 2+ days after without relief sudden feeling of something being off upon waking, increasing nausea after rising 11/5/2021 sudden tiredness after 8 hours sleep AM of 11/5/2021 stiff/soreness at back of neck 11/5/2021 went to school, had to leave and go home before the bell rang due to increasing feelings of something being wrong 11/5/2021
received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingrix. On 22nd August 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: 26-AUG-2022 Reporter's Comment: The reporter reported that, a patient received only the adjuvant (AS01B) portion of Shingrix without reconstituting in the right deltoid. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received only the adjuvant (AS01B) portion of Shingrix without reconstituting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
t104 x 3-4 days measle-like rash x 3 dasy measles all over body head to toe, muscle weakness legs/soreness, lethargic, fatigue, somnolence x 2 days, diarrhea x 2 days @ end of illness rxn, loss of appetite;
reports rash on back of R hand that started on 12/23 and spread to L hand, face, breast area by 12/26, went to urgent care on 12/26, dx with hives, placed on prednisone, advised to f/u with PCP to document.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 04-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
A nurse reported that a 25 year old male received Pnu-Imune 23 and Menomune A/C/Y/W-135 vaccines on 3/21/00. The next day, he developed a fever of 103F and redness at the site of Pnu-Imune 23 injection. The next evening, the pt developed a cold. He recovered.
slight headache; low grade fever; muscle pain at shot location; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, fever and injection site muscle pain. On an unknown date, the outcome of the headache, fever and injection site muscle pain were unknown.   It was unknown if the reporter considered the headache, fever and injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced a slight headache, low grade fever, muscle pain at shot location. The patient reported that it was some listed side effect. The patient wanted to know what appear to be the listed side effects? The patient was advised to follow up with physician for side effects.
Large red circle around injection site. Pain down right arm where injection was administered. NOTE:  Red circle has lessened each day but still remains (much smaller) on 3/24/15.
Subcutaneous grape sized lump at the injection site, with baseball sized rash and intense itching.   Lump has subsided, rash and itching remain.  Treated with Hydro-cortizone cream for itch, and Aquaphor skin  care.
diagnosed with Shingles/zoster on 23Mar2021; Most concerning is the rash on upper right thigh. Began within 48 hours and has continued to spread. It is raised and sensitive to touch.; It began with fatigue within 3 hours of vaccination; Achy leg muscles.; Intense leg cramps began with in 36 hours; Achy lower back; progressed the achiness in right thigh, buttock and lower back; progressed the achiness in right thigh, buttock and lower back; This is a spontaneous report received from a contactable consumer (patient) and contactable Healthcare Care Professional. This Healthcare Care Professional reported in response to the HCP letter sent was processed together. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) via unspecified route on 18Mar2021 at 09:45 PM in the right arm at single dose for COVID-19 immunization. Patient's medical history included stem cell transplant 2 years ago and allergic to Lobster and Penicillin. On 26Feb2021 the patient received Hepatitis B vaccine, MMR and PPV23 in the right arm. Concomitant medication included levothyroxine. The patient did not experience COVID-19 prior or post vaccination. On 18Mar2021 at 01:00 PM, within three hours after vaccination the patient had fatigue and achy leg muscles progressed the achiness in right thigh, buttock and lower back. Also, within 48 hours the patient experienced rash on upper right thigh and has continued to spread. It was raised and sensitive to touch. Not itchy. Moderate to severe leg cramping within 36 hours, achy lower back mostly on right side, rash within 40 hours, shooting leg pain and worsening/spreading rash. The patient diagnosed with shingles/zoster on 23Mar2021. famciclovir and Tylenol was given as treatment. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
Pain at injection site right deltoid. No visible swelling or erythema. Ecchymotic area below area of vaccination. Advised to ice area and use NSAID over the counter.
Redness and induration 6" x 6" of right upper arm 1 week after shot was given. RO steroid have been given. Called on 07/03-recovered.
She feels dizzy and has been vomiting; She had no strength to walk; She falls down, she can't stand up, she can't stand on her foot,; She falls down, she can't stand up, she can't stand on her foot,; She has headaches, her head is spinning,; She has headaches, her head is spinning,; She feels dizzy and has been vomiting; Her head is spinning, "like a drunk person"; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via Medical information team.  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route on 12Jun2021 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient's medical history included diabetes. The patient's concomitant medications were not reported. On Saturday (12Jun2021), the patient was vaccinated and was fine till Wednesday (16Jun2021). On 17Jan2021 at 04:00, the patient started having symptoms when she attempted to reach the bathroom  she experienced no strength to walk, she falls down, she can't stand up, she can't stand on her foot, she has headaches, her head was spinning like a drunk person, she feels dizzy and has been vomiting. The outcome of the events was unknown.  Information on Lot/Batch number was requested.
Information has been received from a physician concerning a 20 year old female with a "fear of needles" who on 30-APR-2008 was vaccinated with Gardasil (lot# 0152X) 0.5mL IM in the left deltoid.  On 30-APR-2008 the patient experienced a seizure "about 45 seconds" after administration of Gardasil.  The seizure lasted less than one minute.  The patient rested on the exam table until stable but, when the patient stood up she experienced another seizure.  Unspecified medical attention was sought.  The physician stated that the patient recovered quickly and after resting in the office again she was able to leave the office fully recovered on the same day.  No medical treatment was required.  No further information was available.  Upon internal review convulsion was considered to be an Other Medical Event.  Additional information has been requested.
Injection site shoulder still extremely sore 2 weeks after vaccination. Started taking aleeve and icing, but no improvement. Extremely difficult to lift arm above head.
This case was reported by a healthcare professional, via GSK representative, and described the occurrence of injection site redness in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) post-partum. Concurrent medical conditions included allergies, asthma, 6 weeks post-partum and rosacea. Concurrent medications included ZYRTEC and MAXAIR. On 8 June 2010 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 10 June 2010, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness and raised area injection site. The raised red area was 3-4 centimeters. The subject did not have fever. The subject was treated with cold compress. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
BLOOD PRESSURE DROPPED; HEADACHE; FATIGUE; BODY PAIN; BACK PAIN LIKE WHERE MY LUNG IS; IT HURTS WHEN I BREATHE; SWELLING OF MY FEET; VOICE CHANGES; DIZZINESS; HOT FEELING IN FEET; FELT LIKE CHEST WAS ACCELARATING; THROAT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced blood pressure dropped. On an unspecified date, the subject experienced body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, dizziness, hot feeling in feet, felt like chest was accelarating, throat pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like chest was accelarating, and headache, and the outcome of body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, fatigue, dizziness, hot feeling in feet, throat pain and blood pressure dropped was not reported. This report was non-serious.
the nurse gave pt a pediatric dose of the covid injection.  it should of been the adult dose as pt is 13 years old. no adverse reaction.
This spontaneous report was received from a pharmacist and refers to a 60 year old male patient with penicillin allergy. The patient's medical history included herpes simplex. On 21-APR-2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration were not reported). The patient did not use any concomitants. On 25-APR-2015, the patient developed a herpes simplex outbreak. The event was treated with 1 dose of VALTREX on 25-APR-2015 and 1 dose of VALTREX on 26-APR-2015. No lab tests were performed. The outcome of herpes simplex was reported as recovered on unknown date in 2015 (reported as "date unspecified). The patient sought medical attention, he called pharmacy. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as the reporter denied any further contact.
Pain on the injection site, the arm under the armpit and around the heart; I do had the booster shot; Dizzy; I already felt down; pain on the injection site, the arm under the armpit and around the heart; Feeling unwell; Muscle pain; Chills; Nausea; pain on the injection site, the arm under the armpit and around the heart; pain on the injection site, the arm under the armpit and around the heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiry date: unknown, NDC/UPC number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization; Bnt162b2 (2nd Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "Pain on the injection site, the arm under the armpit and around the heart"; IMMUNISATION (medically significant), outcome "unknown", described as "I do had the booster shot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I already felt down"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain on the injection site, the arm under the armpit and around the heart".   Clinical information: The patient wanted to know if the booster shot really was the right one or not. The patient was in a little bit in time pressure when requested for further information and was unwilling to complete the report. Regarding the lot number the patient thought of talking about it to medical info department. On request an attempt was made to transfer the call to Pfizer Medical Information Department however it was unsuccessful and call got hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient hospitalized on 12/12/21 and died 1on 2/13/21, after being diagnosed with COVID on 12/12/21.
I'm breastfeeding my 14-month old 3x a day. She had mild diarrhea and mild stomach upset on 5/6 and 5/7. Ruled out no change in diet. Diarrhea is not common for her
Swelling and itching at injection site, waking me up at 6AM, after work getting a Moderna booster at 11AM the day prior.  So swollen that it was difficult to move my arm much. It is slowly getting less swollen and itchy.  I did not have this reaction after my 2 doses of Moderna Covid vaccine
Moderna Covid Vaccine second dose Fever and chills Muscle aches Redness around injection site Sore eyes
I95.9 HYPOTENSION 9/16/2022 CANCER METASTATIC TO INTRATHORACIC LN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/24/2022 CANCER METASTATIC TO INTRATHORACIC LN I95.9 HYPOTENSION 9/16/2022 LUNG CANCER, RIGHT LOWER LOBE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/24/2022 LUNG CANCER, RIGHT LOWER LOBE
dizziness; continuing headache; vomiting; nausea; shivering; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizziness), HEADACHE (continuing headache), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037K20A) for COVID-19 vaccination.     No medical history was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (continuing headache), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Feb-2021, DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (shivering) had resolved. At the time of the report, HEADACHE (continuing headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-075039, MOD-2021-075081, MOD-2021-075123 (Patient Link).
Papular erythematous rash on left forearm with clear discharge. Rash is itchy. Started applying bacitracin, reports decreasing itchiness after 4 days of treatment, started on 02.22.21. Started on clindamycin, mupirocin ointment today for secondary bacterial infection on 02/26/21.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and axillary lymph nodes enlarged. On an unknown date, the outcome of the influenza-like symptoms and axillary lymph nodes enlarged were unknown. It was unknown if the reporter considered the influenza-like symptoms and axillary lymph nodes enlarged to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had flu like symptoms and axillary lymph node swelling. The reporter was unsure if the lymph node swelling was a side effect from the vaccine. The reporter agreed to provide follow up information.
Pain, swelling at injection site. Patient still has pain with lifting arm. Redness/swelling was subsided.