chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 05-JUL-2017 from a registered nurse who was reporting on a 13 month old male patient. No medical history or concomitant mediations were reported. On 05-JUL-2017, the patient was administered an expired dose of MMRII (lot L024266, expired 01-JUL-2017)(site, dose and route not reported) for prophylaxis. This was supported by post-expiry memo. No temperature excursions and no adverse effects reported. No additional information was reported. Additional information has been requested.
itching; This case was reported by a physician via sales rep and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient complained that site reaction of itching that took almost 3 weeks to dissipate.  The reporter contacted Agency and the patient spoke to them to get additional information on 2nd dose of Shingrix and whether site reaction would be any different. The reporter did not agree to follow up with GlaxoSmithKline.
Bedridden for 9 days. Chills high fever loss of appetite. Hospitalized for 10 days on oxygen remdesivir and antibiotics
already had the virus with minimal symptoms; already had the virus with minimal symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (already had the virus with minimal symptoms) and ILL-DEFINED DISORDER (already had the virus with minimal symptoms) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (already had the virus with minimal symptoms) and ILL-DEFINED DISORDER (already had the virus with minimal symptoms). At the time of the report, COVID-19 (already had the virus with minimal symptoms) and ILL-DEFINED DISORDER (already had the virus with minimal symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Information has been received from a nurse concerning an approximately 19 month old patient who in September 2010, was vaccinated with a dose of PROQUAD (Merck) (Lot# unknown). In approximately September 2010, the patient experienced swelling at injection site, fever, vomiting, crying, screaming and fussiness. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. The nurse said that the office no longer gave the first dose of PROQUAD (Merck) in the younger patients, they only gave it to 4-6 year old patients now. this is one of several reports from the same source. Additional information is not expected.
Patient stated today she was having a lot of swelling and pain in her arm. She was having difficulty raising her arm and was unable to raise her arm over her head.
Didn't get  2nd dose within 6 months window; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-Feb-2023. Reporter's Comment: On an unknown date, the patient did not receive the 2nd dose of Shingrix. Pharmacist stated she had a lot of patients that called in and asked if they need to restart Shingrix series if they do not get the second dose within 6 months of first dose. Pharmacist does not have any specific patient information, just that there were multiple patients who have gone past the 6 month window. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination.
Experienced itching of right, forearm near elbow (non-injected arm) approximately 2 hours after receiving vaccine with no apparent external cause..  Also experienced weakness in the right hand that limited ability to firmly hold a pen.  Itching only lasted for a few minutes.  Weakness in hand lasted about 30 minutes, but experienced again the following morning (almost 24 hours since vaccination) that lasted for a few minutes.  No treatment was received for the itching or hand weakness.
Complained of low grade temp. 99.4, flu like symptoms, body aches, sore throat, and achy joints; The patient had a mild to moderate reaction to a Tdap
pt recv vax 18DEC97 &  19DEC97 pt devel diffuse papular erythematous rash;20DEC97 pt was seen in urgent care ctr for the rash;tx w/med;pt seen again by MD 30DEC97 c/o nasal congestion, coughing & nausea (no fever);
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was given COVID 19 vaccine and passed out. Patient appeared to be having difficulty breathing and passed out after vaccine. Epi-pen was adminmisted IM in Left Upper thigh and she was able to respond within a few seconds to commands. Patient was advised not to get a 2nd dose of vaccine. EMS was called and they checked patient and monitored her. Patient refused transport to ER.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt recvd 1st dose of Hep B vax in APR91 & devel joint pain; MAY91 recvd 2nd dose of vax & devel swelling in small joints of both hands accompanied by joint pain; By August sx subsided;
Second dose was administered at day at day 21 post first dose. No harm to the pt. Pt was notified; per guidance, no further action needed.
Approximately a week after I received Moderna Covid booster, I started experience sharp pains in my both feet. The pain developed into small fiber neuropathy like symptoms (burning feet, pain everywhere in feet, unusual and bothersome sensations in feet). A trip to a podiatrist resulted in the doctor's suggestion that I get a NVC/EMG tests. Both tests gave NORMAL results,  I have no preexisting conditions, and, unfortunately only now found out that my symptoms could've been caused by the Covid Vaccine.
Per mom complained of redness and swelling on right thigh post vaccination. Noticed in the a.m. Pt doing well today. MD. looked at the site and gave pt. Benadryl.
99.8 F Fever; Chills; Nausea; Headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site. . On an unknown date in 2021, the patient underwent lab tests and procedures, which included test for body temperature and the result was 99.8 degrees Fahrenheit. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
neutropenia; thombocytopenia/low platelets; Patient's lab work had stopped 'growing and restarted 'growing'.; concomitantly administered STERILE DILUENT Reconstituted PROQUAD instead of the Intended MMRII; Accidental overdose; This spontaneous report was received from a physician referring to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 28-SEP-2022, the patient was meant to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for prophylaxis (strength, dose, lot #, expiration date and route of administration were not provided) but the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (therapy type: rHA, lot #W004029, expiration date was unknown, but upon internal validation established as: 02-AUG-2023) for prophylaxis (strength, dose and route of administration were not provided) with concomitantly administered sterile diluent (manufacturer unknown) solution for injection/infusion (strength, dose, frequency, indication, lot# and expiration date and route of administration were not provided) instead of the intended measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). On the same date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U039722, expiration date: 15-DEC-2023) for prophylaxis (dose, strength, and route of administration were not provided) with concomitantly administered sterile diluent (manufacturer unknown) solution for injection/infusion (strength, dose, frequency, indication, lot# and expiration date and route of administration were not provided) (accidental overdose).  On unknown dates, the patient's lab work had stopped "growing" and restarted "growing" (laboratory test abnormal). On unknown dates, the patient experienced neutropenia and thombocytopenia/low platelets (thrombocytopenia). The outcome of all events was not reported. The action taken with all suspect therapies was not reported.  The causal relationship between all events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent (manufacturer unknown) was not reported. The causal relationship between events of laboratory test abnormal, neutropenia and thrombocytopenia and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not related.   Upon internal review, the events neutropenia and thrombocytopenia were determined to be medically significant.
This is a spontaneous case, initially received on 24-Jan-2018 from other health professional, concerning a 16-year-old, adolescent, male patient. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, reaching the highest temperature of 9.1 C (explicitly coded as incorrect product storage). On 21-Dec-2017, the patient was administered with FLUCELVAX QIV after the first temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (reported as right or left deltoid), batch number: 195228, expiry date: 31-May-2018) (explicitly coded as drug administration error). It was reported that, the patient did not developed any adverse event following vaccination. The reporter assessed the events (incorrect product storage and drug administration error) as non-serious. Significant case correction received with IRD 24-Jan-2018: Added start date of the event incorrect product storage as (unspecified date in Dec-2017) in the product tab.
3SEP97 constant crying had to hold child & try to console all day;febrile;temp unk;carried to ER 5SEP97 MD on call stated child ill & fussy throat was red;mom told to take child home & bring back if temp was 102;
Started symptoms on 12/14/2022 and on 12/16/2022 went to a clinic and tested positive for COVID-19. Diagnosed with acute bronchitis. I didn't not get rid of the cough until the end of January. I also still have headaches, but they are much less frequent.
Initial information has been received from a whole sale representative, as told by a customer, and follow up information has been received from a healthcare worker, concerning a 87 year old male, with unknown medical history, who on 25-JUL-2006 was vaccinated (route unknown) with a second dose (0.5 mL) of Pneumovax 23 (Lot # 651328/1046P. Concomitant therapy may have included ROCEPHIN. Initial information received from the whole sale representative reported that the customer indicated that "we heard the patient reacted to Pneumovax 23 and that the patient had a rash." Initially the clinical outcome of the patient was not provided. Follow up information from the healthcare worker indicated that the same day, on 25-JUL-2006, the patient called the office because his arm was swollen. He started to treat the arm with warm compresses but the arm became swollen from the shoulder to the fingers with a "blood collection" at the end of the arm. The patient was treated with KEFLEX and injections of DEPO-MEDROL. The patient recovered on 31-JUL-2006. The reporter indicated that all serious criteria was no. However, she requested that a lot check be done on the lot, because she was not using it on any other patients. She also noted that she was "afraid this might happen to other patients". A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Information has been received from a nurse concerning a 16 year old 96 lb. 61 1/4 in. female who on 31-JUL-2007, was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no reported illness at the time of vaccination. Follow up information form the nurse indicated that on 01-AUG-2007, the patient developed in the arm at the injection site, "baseball size", warm to touch, and tender for 3 days. Medical attention sought was not reported. There were no relevant diagnostic tests or laboratory data. As of 03-AUG-2007, the patient had recovered. The patient's vaccination history included on 20-OCT-1992, varicella virus vaccine live (Oka/Merck). A product quality complaint was not reported. Follow up information indicated that the office "did not feel the event met the criteria of an adverse event". Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 5 / Moderna, Dose: 1, 2, 3, 4, 6; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 22Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Swiss cheese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2022 at 12:00, outcome "recovered", described as "Pfizer, Dose: 5 / Moderna, Dose: 1, 2, 3, 4, 6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 2 days of negative tests for COVID, now testing positive again; Positive, notes: After 2 days of negative tests for COVID, now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181192 same reporter/patient, different product/AE;
Fever 99F and diarrhea approx 12 hrs post first dose of oral typhoid(10-12 stools in a 12 hr period. Took Lomitil and took 2nd dose at the appropriate time with same symptoms occuring about 12 hrs later.  Became weak and dehydrated.  No further oral typhoid taken .  Has scheduled a typhoid injection.
Patient had a vasovagal attack in office. EMTs were called but patient denied to go to hospital as she was feeling fine and patient was monitored in office for half an hour.
administered pentacel to an 18 month old patient, but it was seven days expired with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18-months-old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)], but it was seven days expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine (Pneumococcal); and influenza vaccine (Flu Vaccine VII) for Immunisation.  On 25-Sep-2023 at around 16:30 hours, the patient received 0.5 mL Dose 4 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/  IPV  (vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once ) (batch number: U774BA; expiry date: 18-Sep-2023) via intramuscular route in the left thigh for Immunization but it was seven days expired with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
My arm was somewhat sore for a couple of weeks, but then it got out of control. The pain was excruciating. My doctor took an X-ray on August 20th and saw a shadow around my rotator cuff. He feels that the serum was stuck in the bursa at the rotator cuff. I was given a MEDROL DOSEPAK and sent for physical therapy for my shoulder.
Patient received Menctra in his right arm. Then Tdap was administered in his left arm. He became unconscious after Tdap was given for approximately 10-15 seconds. He aroused and was stable following incident. He has a history of vasovagal events.
pt recvd vax in er;was discharged fr er; 30 mis later, pt devel sz characterized by "rolling back of the eyes, foaming at the mouth & jerking all ber";also H/A; sz activity has ceased by time pt returned to er;tx w/ dextrose,doxycycline po;
Arm sore Low grade fever Chills Rashes on both thighs - moved from upper thigh to side of knees. This lasted for about an hour
Initial report received from a healthcare professional on 17 September 2012. A female patient of unspecified age, whose concomitant medications and medical history was not reported, had received dose of FLUZONE HD vaccine (Lot number, Route, anatomical site of vaccination were not reported) on unspecified date. It was reported that the patient was standing 6 feet way when the dose was adminsitered and the safety shield was activated. After 5 hours of administering the vaccine i.e. on 10 September 2012, the patient had burning sensation in her eyes and thought that the vaccine must have gone into her eyes. The reporter advised the patient to flush her eye and the burning sensation in eyes had resolved on unspecified date. Corrective treatment was not reported. List of documents held by the sender none.
Extreme pain in shoulder where vaccine was administered. Still painful to move after 5 weeks. Hurts when lifting arm, sleeping on left side & lifting arm over head or across body.
Patient reported that she received her first Pfizer Covid vaccine on 2/24/21 and on 3/30/21 she went to the hospital and was diagnosed with a Pulmonary Embolism. She stayed overnight.
Looking for / financial assistance with / second dose / had the first dose years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient had been told by her PCP (primary care physician) that she needs the 2nd dose and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was looking for information concerning financial assistance with getting her 2nd dose. The reporter consented to follow up.