chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quadracel was given to infant with no reported adverse event; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant patient of unknown genger who was administered Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection (strength, dose, frequency, lot number and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient was with was administered Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] no reported adverse event (product administered to patient of inappropriate age) (latency: Same day).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Quadracel was given to infant with no reported adverse event).  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.
tested positive for covid-19 (home test); tested positive for covid-19 (home test); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 18:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: Jun2005, stop date: 20Nov2022; HUMIRA, start date: May2021, stop date: 12Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022 at 05:00, outcome "not recovered" and all described as "tested positive for covid-19 (home test)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive, notes: report positive test to Rheumatologist's office; (24Nov2022) Positive; (26Nov2022) Positive; (29Nov2022) Negative; (03Dec2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was currently on Humira (40mg/2 wks) and Methotrexate (20mg/wk). Symptoms of Covid-19 started 5:00 pm 22Nov2022-hoarseness, fever 100 deg.F, body aches, tiredness. 23Nov2022, 5:00 am, tested positive for Covid-19 (home test), report positive test to Rheumatologist's office, prescribed Paxlovid. Started Paxlovid at 12:00 pm 23Nov2022. At this time, Covid-19 symptoms were mild fever, mild body aches, tiredness. 24Nov2022, 12:00 pm, tested positive for Covid-19 (home test). Continued taking Paxlovid as prescribed. Covid-19 symptoms were very mild to non-existent. 25Nov2022-same. 26Nov2022, tested positive for Covid-19 (home test). 27Nov2022, all doses of Paxlovid were taken as prescribed. 29Nov2022 tested negative for Covid-19 (home test). 02Dec2022 symptoms; watery eyes, runny nose, hoarseness. 03Dec2022 tested positive for Covid-19. 04Dec2022 tested positive for Covid-19, symptoms are near non-existent.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-OCT-2010, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Received 1st COVID vaccine on June 29, 2021. On July 5, he started having blurry vision and seeing floaters. Described as if he is looking through a piece of glass with water flowing down the glass. This got worse after he received 2nd COVID vaccine on July 27.  Ophthalmology diagnosed him with central retinal vein occlusion with macular edema of the right eye. He received intravitreal injection of bevacizumab on Aug 6, 2021. Vision started improving after that and stabilized.
Influenza vaccine, pneumococcal polysaccharide both injections were not given on the left arm. 11/18/2010, Mom contacted physician at 8:01 PM. Pt. presented with a 3cm perfectly round, warm, non-painful with redness at site of injection. No fever, no chills. No systemic signs either. Dr. stated use ice, make margins around injection site. If worse in the morning, contact us.
started having itchy throat and strange taste in mouth about one hour after vaccination. Voice became hoarse, had some wheezing the following morning. Had some breaking out on her face along with small amount of injection site pain. Hasn't had any reactions in the past. Discussed based on timing and symptoms, likely was reaction to COVID vaccine. Little chance of anaphylaxis at this point but call 911 if this happens. Steroids and hydroxyzine prescribed.
Constant Fever despite taking Tylenol around the clock, 103.1. Chills, syncope, seizure, extreme fatigue, nausea, headache, loss of appetite.
Only the diluent portion of Shingrix was administered to the patient; Only the diluent portion of Shingrix was administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only the diluent portion of Shingrix was administered to the patient) and inappropriate dose of vaccine administered (Verbatim: Only the diluent portion of Shingrix was administered to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter reported that the patient received only the diluent portion of Shingrix. The reporter stated that she became aware of this a couple of weeks ago and the patient had no adverse effects.  The vaccine administration facility was the same as primary reporter. The reporter reported that the lot number provided was from the lyophilized portion, the vial for the diluent portion was discarded. The reporter did consent to follow up via postal. The reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
his son tested positive after receiving the 1st dose.; his son tested positive after receiving the 1st dose.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (son) who received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The reporter reported that his son tested positive after receiving the 1st dose. The patient underwent lab tests and procedures which included covid test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned an 80 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included the patient was bed bound. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported,1 total administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with suspected immunological vaccine failure (antibodies not created, vaccine did not worked). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure and bed bound was not reported This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191670.; Sender's Comments: V0. 20210900338-COVID-19 VACCINE AD26.COV2.S- Suspected immunological vaccine failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a medical assistant(also reported as office manager) referring to a 18 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 17-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Member developed erythema swelling and lymphedema on the upper arm at the injection site. He had severe pruritis. Symptoms started on 11 Mar. He was told to go home and take benedryl and motrin. He returned with worsening symptoms on the 12th. He was told to continue the benedryl and motrin. On recheck on Mar 19, 2009. He had total resolution of his symptoms
On day six post vaccination, pt awoke with conjunctival injection, itchiness and creamy yellow discharge from left eye. No ill contacts. No fever or any systemic symptoms. No allergies. denies touching vaccine site and eye. obtained optho consult and reported to MD and CDC.
Flu like symptoms, lasted 48 hours.  Now, a week later, I have pain, swelling, heat at injection site.
ITCHY SKIN . RAPIND HEART RATE.  ED VISIT OBSERVE.
Pt. developed pain in RUQ of abdomen on 08-01-10 then developed a rash with 2 small blisters in the same area on 08-08-10 that crusted over. At the time of this report (8-11-10) pt. states pain is resolving.
Pt experienced numbness of left arm and left leg lasting for 3 days after immunization. Pt also experienced an intermittent stomach cramps for 3 days.
71 year old male with PMH CAD, AFib s/p PPM, HF, HTN, seizure disorder presents following a syncopal episode which occurred while driving. He states he passed out and got into a minor car accident. States he has been feeling generally unwell and fatigued for the past week. Reports progressive shortness of breath over the past several months, worse with exertion. He was found to be COVID-19 positive in the ED. No known exposures.
Shingles, right torso, 4th outbreak; 4-5 blisters which are uncomfortable; uncomfortable; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, blister, discomfort and incomplete course of vaccination. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the blister and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister and discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: The patient got the Shingrix vaccine in July 2021 and within 7 days patient got shingles for the first time on right torso.  The patient's physician said to go ahead and get the second shot as the vaccine might lessen the severity of any future outbreaks. Now patient was experiencing the 4th outbreak of about 4 to 5 blisters which were uncomfortable.  The patient had the anti-viral pills to lessen the time. The patient knew did not report this data back to you, so the patient was. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Note: Incomplete course event was coded as 6 months' timeline was extended for 2nd dose and nowhere said that due to the reported event vaccine was not administered.
patient stated a few days after had vaccine developed some "freckles" on skin of both forarms and face but has since resolved for the most part
Patient described redness at site of injection and pain. This pain within 48 hours has extended to elbow and continued to cause discomfort in left hand. Patient described numbness and tingling.
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient administered the vaccine from 10Dec2021-13Dec2021. Concomitant medication was not provided. Treatment information was not provided.
Aches; FEVER; Vomiting; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporte
BODY ACHE; INJECTION SITE LITTLE HARD (ON RIGHT ARM); CHILLS; NAUSEA; 101 F FEVER; FATIGUE; NO ENERGY; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: hernia, and concurrent conditions included: irritable bowel syndrome, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A20A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for irritable bowel syndrome. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced injection site little hard (on right arm). On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced 101 f fever. On 10-SEP-2021, the patient experienced fatigue. On 10-SEP-2021, the patient experienced no energy. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, nausea, 101 f fever, chills, fatigue, no energy, and injection site little hard (on right arm). This report was non-serious.
Patient called our onsite nurse on 17MAR21 to report injection site pain, swelling and redness (left deltoid).
Started having itching on December 10th at around 1800, went to sleep and then woke up at 0400 on December 11th and noted to have hives all over my body including my face, took OTC Benadryl and the hives subsided but itching remained throughout the day. Supplemented with OTC Allegra later in the day and continued to monitor. Woke up on December 12th at 0233am and noted to have severe swelling on my face, left eyelid almost closed shut, right eyelid starting to swell up as well. Hives noted all over my body. Took another benadryl and slept again. Woke up at 9am with the symptoms unresolved. Informed my PCP and got prescribed and medrol dose pack. Started taking this on December 12th at noon. Over the next several hours the facial swelling subsided but the hives remained and appeared in various portions of my body intermittently. Over the next several days there was no more swelling/angioedema and the hives have gone away but still getting intermittent red rashes and still continue to itch. As of Dec 20th at 1700, still noted to have intermittent itching and rashes sporadically on my extremities / face and have been managing symptoms with OTC allegra and OTC famotidine.
cried for many hr p/vax 3 1/2-4;no tx;
Friday night he reports that his heart felt like it was exploding out of his chest. Saturday his left arm started aching and he felt tiredness. By Sunday night, symptoms were resolved.
Mother reported that pt had dizziness, grogginess, and headache during the evening after a tetanus  vaccine.  Resolved by next morning.
UTI; may have a bladder infection as she has some symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (may have a bladder infection as she has some symptoms) and URINARY TRACT INFECTION (UTI) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced CYSTITIS (may have a bladder infection as she has some symptoms). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with AZITHROMYCIN (AZO) for Adverse event, at an unspecified dose and frequency. At the time of the report, CYSTITIS (may have a bladder infection as she has some symptoms) and URINARY TRACT INFECTION (UTI) outcome was unknown.        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.   No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up information received on 31-Jul-2021 and included Event UTI added with outcome. Treatment medication also added that was not included from original source document.
inadvertent administration & fatigue are reported in a pt who recvd 2nd dose of fluogen instead of a pneumonia vax on 21OCT93; pt had previously recvd fluogen on 7OCT93; pt recovered;
9 patients received MENACTRA post-excursion at negative 0.7 degree Celsius for 5 minutes/ no AE;Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00750950) and transmitted to Sanofi on 01-Sep-2021.   This case is linked to case Id: 2021SA293642 (CLUSTER).  This case involves 9 patients (unknown demographics) who had received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6951AA, expiry date 06-Jun-2022) post-excursion at negative 0.7 degree Celsius for 5 minutes (product storage error) via unknown route at an unknown administration site on 25-Aug-2021 for prophylactic vaccination.  It was a case of potential medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event reported.  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.