chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 59-year-old patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure, whooping cough and pain were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and pain to be related to DTP vaccine. Additional details were provided as follows: This case was reported by a consumer via Interactive Digital Media. This case was reported by the patient for themselves. The age at vaccination was not reported. The patient had all the available vaccinations when they were kid, including the DPT dosages. Two years before the date of reporting at the age of 59, the patient experienced whooping cough. The patient was under the mistaken impression that being vaccinated as a kid meant was protected for life. This was so not the case. The pain and agony from having whooping cough was far worse than any bout of pneumonia had all their life. The patient asked that all must be re-vaccinated every 10 years and did not put it off, all have no idea that how horrible it was. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for pertussis were not provided.
After I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. Then it happened again the next cycle; After I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. Then it happened again the next cycle; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. No medical history was included. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6198), dose 1 administered at arm left on 03Mar2021 at 14:30 as DOSE 1 for covid-19 immunisation. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that, "after I received my second dose. I couldn't ovulate on my own and was having unexplained spotting for a month. then it happened again the next cycle on 15Apr2021. Checked with my doctor and he couldn't fond anything wrong with my body". Outcome of the event was not recovered.  No additional details provided. Information about batch/lot number has been requested.
This spontaneous prospective pregnancy report was received from a resident concerning to a 19 years old female patient with no pertinent medical history and no known drug reactions or allergies. The patient's history of previous pregnancies and live births was not provided. On 15-JUL-2008, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). No other co-suspects were reported. There was no concomitant medication. On 21-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # were not provided). On 22-AUG-2012, the patient found to be pregnant with an LMP (Last menstrual period) of 16-JUL-2012 and an EDD (estimated delivery date) of 22-APR-2013. Initial exposure to GARDASIL was at 5 week(s). The patient was exposed to GARDASIL during trimester 1. Urine pregnancy test was performed on 22-AUG-2012. No adverse event reported (other than the pregnancy). The patient did not received treatment for the adverse event. The patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning a 16 year old female with schizophrenia. On 31-JAN-2007, the patient was vaccinated with the first dose of Gardasil. Concomitant therapy included LEXAPRO and ABILIFY. On 31-JAN-2007, the patient's schizophrenia symptoms became worse. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.
HIGH BLOOD PRESSURE; NO APPETITE; SWOLLEN ARM; PALPITATION; PAIN; HEADACHE; This spontaneous report received from a physician concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included tendon surgery on the right limb, and concurrent conditions included COPD (chronic obstructive pulmonary disorder), non alcohol user, non smoker, thyroid, diabetic, no drug abuse or illicit drug usage, and hysterectomy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 05-MAY-2021, the patient experienced high blood pressure, no appetite, swollen arm, pain, palpitation and headache, and was hospitalized for same. On 06-May-2021, the patient was discharged. Laboratory data included: Blood pressure high (NR: not provided) 140/126, 159/156, 172/111.  Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, headache, no appetite, and swollen arm, and the outcome of palpitation and pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210516972-JANSSEN COVID-19 VACCINE-High blood pressure ,no appetite, swollen arm, palpitations, pain - This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) 20210516972-JANSSEN COVID-19 VACCINE- Headache. This event(s) is labeled per RSI and is therefore considered potentially related.
This spontaneous report as received from a health care worker refers  to an unspecified patients of unknown age and gender. It was reported that since 03-FEB-2014, the patients was vaccinated with ROTATEQ (dose and route was unknown) which was improperly stored. No adverse effects were reported. No product quality complaint (PC) was involved. No additional information was provided by this reporter. Additional information is not expected.
pt was vaxed just a/420PM; mom noted a hive on rt arm; mom checked rest of pt body & found patches of small red spots hives; pt devel a barky cough & waspy breathing; mom took pt to hos;
1 day after patient received immunizations, she would not walk.  She was taken to the ER, discharged home in stable condition.  5 weeks later, on 3/21/08, she was admitted to Hospital with transverse myelitis C-3-T-3. Treated with Prednisone. Patient now amulatory with AFOs. 9/19/08-records received for DOS 3/21-3/26/08-DC DX: Longitudinal myelitis with positive ANA and double-stranded DNA. On 3/19/08 began to fall backwards, then shaking upper extremities and not able to walk upright. Older sibling while carrying child slipped and fell, sister landed on top of patient. Seen in ER all findings normal.Presented with C/O bilateral leg weakness.  Bladder dysfunction, catheterization. At time of discharge moving lower extremities but unable to stand. Transferred to rehab facility.
A 65 year old  female received Decavac (lot number U1704CA) on 12 December 2006. A day later she experienced at injection site erythema and itch and on 11 January 2007 it developed into a painful 2 cm nodule, which affected the movement of the arm. No treatment was reported. At the time of the report (11 January 2007) the nodule and redness persisted and the patient had not recovered. The patient's medical history included : Hypertension (HTN), severe osteoarthritis (OA), subclavian DVT (Deep vain thrombosis), depression and total abdominal hysterectomy (TAH). concomitant vaccines and prior exposure were not reported. The reporter is the same as in case 2006-00090.
Patient recieved Moderna Shot on 5/8/2021 and 6/6/2021. She had an abnormal mammogram on 7/8/2021 with a 6 mm spiculated mass. Diagnosed with invasive ductal carcinoma stage 1. Previous mammograms in 2019 and 2020 were normal
Redness at injection site, bruising. Approx 1-2 week after vaccine had nerve pain in legs, arms. Progressed to weakness and continued pain in bilateral legs, arms.
Mild itching - no signs of distress at discontinuation of monitoring - asked to f/u w/ PCP
Pt recvd 3 doses of Engerix-B vax & 26FEB92 titer results came back neg, pt did not respond;
Patient given a booster shot based on her last booster being given in December. It was found she received a dose in May, making the dose given to her an extra dose. She was not technically eligible for the booster dose given, as she had already received her 2nd booster.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 2 year old male patient. On 09-JAN-2014 at 12:17 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J005179, expiration date 03-NOV-2014, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Extreme pain at injection site near shoulder, all the way down my arm.  Pain lasted 2 days. Injection site red, inflamed and swollen. Aches and pains for two days all over body in muscles and joints.  Also fever for two days.
Became ill with fever one week post vaccination. Headache, Myalgia, Fever and Cough Wheeze.
patient received an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00702980) and transmitted to Sanofi on 29-Jul-2021.  This case involves a 3-year-old male patient received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  Medical history, medical treatment, vaccination and family history were not provided.  On 29-Jul-2021, the patient received a 0.5 mL first dose of suspect HIB (PRP/T) VACCINE [total, once, strength: standard, UJ358AA, expiry date: 27-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)   It was a case of actual medication error due to expired vaccine use.   It was reported that, "nurse practitioner asked for information regarding administration of expired dose".  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.
Apr ?21: Joint pain May ?21: Chronic fatigue, brain fog/cognitive impairment, light sensitivity Jul ?21: Abdominal bloating Aug ?21: Tachycardia upon standing, dizziness, back pain, swollen glands, decreased appetite, lightheadedness, disorientation, headaches, sweating, excess thirst/dry mouth, leg & glute pain Sep ?21: Hand tremors, finger/hand/arm pain, itchy/flaky ears & skin
Cold; shivering, Chills; fever ramped up all day long; horrible joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, #016B21A and #048F21A) for COVID-19 vaccination.     The patient's past medical history included Blood disorder NOS (that makes her susceptible to Deep vein thrombosis), Fever (from January until February) and Fatigue (from January until February). Concurrent medical conditions included Allergy to antibiotic (Allergic to tetracycline) and Allergy to antibiotic (Allergic to clindamycin). Concomitant products included VALSARTAN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain). On 13-Sep-2021, CHILLS (shivering, Chills) and ARTHRALGIA (horrible joint pain) had resolved. On 14-Sep-2021, PYREXIA (fever ramped up all day long) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information provided. It was reported that she might had COVID-19 in January 2021 but there were no available COVID-19 test that time.   This case was linked to MOD-2021-320892 (Patient Link).
Pt presented her left arm on 6/18/10 -> Thurs 6/17/10 pt saw no signs of reaction -  PC 6/18/10 AM - Pt noted a "silver dollar sized" bright red circle at injection site with slight inflammation. Rash still present, has not progressed.
pt recvd vax & 3 days later exp sore lymph nodes, legs, & abdo;
tendinitis; pain in his ears; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient of unknown age who experienced tendinitis (tendonitis) and pain in his ears (ear pain), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UT6657NA and expiry date: 20-Jun-2020 via unknown route in unknown administration site.  On an unknown date, (also reported as several hours after) following the vaccination the patient experienced tendinitis (tendonitis) and pain in his ears (ear pain). (Other relevant tests included no lab data.)  Final diagnosis was tendinitis and ear pain.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting. Events lasted for approximately 1 week.
Moderna COVID- 19 Vaccine EUA: Patient presents to clinic ten days after receiving  vaccine. Reports enlarged, painful right axiallary lymph node (size of a golf ball), fever, and chills one day after vaccination. Three days after vaccination symptoms improved but four days after vaccination noticed right arm bruising. Ten days after vaccination patient reports axiallary tenderness and soreness but lymphadenopathy has resolved per provider.  Vital signs all within normal ranges and patient discharged from clinic to home stable.
HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COVID19 vaccine in the left deltoid.  She states that immediately following vaccination, she felt a rushing feeling in the left side of her face, particularly the left ear, and left arm.  She further describes constant warmth, numbness and tingling in the left ear.  She denies muscle weakness, headache, changes in vision, and loss of consciousness.  She states she has never experienced these symptoms following a vaccination.  She also states she has not eaten this morning, but has drank water.  She affirms a history of childhood allergic reaction to sulfa drugs, however, she does not recall what the reaction was.  She denies a past medical history.  She denies taking medications on a regular basis.  She denies chest pain, difficulty breathing, difficulty swallowing, other skin changes/urticaria, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.     Exam: GEN: Alert and oriented x 4, NAD HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Erythema and warmth of the left pinnae.  No rashes, skin warm and dry.  No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Flushing of the left ear following vaccine administration.  Patient otherwise not displaying signs or symptoms of anaphylaxis.  Thorough neuro exam performed and was within normal limits.  Patient demonstrated the ability to adequately control the airway and secretions.  Vital signs stable.  Patient felt as if the sensations were decreasing by the end of the evaluation and felt comfortable driving home.   Instructed patient to consult their PCP regarding the post-vaccination reaction.  Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, difficulty swallowing,  muscle weakness, vision changes, adverse skin changes, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting.   Medications administered: None   Disposition:  Home
Severe arm pain- woke me from sleeping several times throughout the night.  Numbness in left side of body, especially in face -noticed the morning following the vaccine
Warm, maculopapular rash, non-pruritic. Advised treatment with ibuprofen and cool compresses to area. Rash noticed approximately 48 hours after vaccine administration.
Administered COVID vaccines dose age 5-11 yr instead of age 12 and up. No adverse events noted at the time of administration or reported by father on telephone interview on 12/14/2021.
Patient reported numbness in fingers (pins and needles sensation) that began approx. 30 minutes after receiving vaccine. Says it has mostly subsided now (12 hrs after vaccine) Immunization given appropriately in deltoid muscle. No numbness or pain in any other area of body except fingers of administration arm. Called pt. to follow-up about 12 hrs after first report of tingling. Pt. noted it has subsided saying maybe it felt a little numb if she pressed on the fingers but stated she was better. Informed her I would still proceed with VAERS reporting.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
To ER on 2/19/03 with seizure. Admitted to hospital. Abnormal EEG, normal MRI planned on distant 2.5 rectally for seizures. Home on 2/20/03.
Patient called on 16MAR21 to report injection site pain, swelling and redness (left deltoid).
Inconsolable crying for 12 hours. High Temperatures. Regression of communication and eye contact. Aggresive eczema developed to the point of bleeding. Treated with infant probiotics, infant DHA supplement and organic detoxifying diet.
Chills, distended stomach, nausea, abdominal pain, fever 101.5.
This spontaneous report as received from a registered nurse refers to "a lot of patients" with unknown ages. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular (dose and lot number were not reported). No concomitant medications were reported. On an unknown date, the reporting nurse, who oversees three offices, had seen a lot of patients passing out after receiving GARDASIL. She reported that at least one in every five patients passed out, with a drop in blood pressure, this usually occurs immediately or within a five minute period after vaccination. Additionally, at least three in five patients experienced feeling dizzy and light-headed after vaccination. Treatment protocol was all patients are required to remain in a safe position for 15 minutes after vaccination and if a patient passed out, nurse positioned patient on bed with feet up and monitors blood pressure, wand within a few minutes, patient was fine. The outcome of drop in blood pressure, feeling dizzy and light-headed after vaccination and passing out after receiving GARDASIL was unknown. This is one of several reports received from the same source (MARRS # 1310USA012759). Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-MAR-2015, the patient was vaccinated with a expired dose of ZOSTAVAX lot # reported as K00995, expiration date 06-MAR-2015 (dose and route were not reported). No co-suspect and concomitant therapies were reported. No adverse effects were noted. Additional information has been requested.
Patient received Moderna for first vaccine in Covid-19 vaccine series, patient received Pfizer for second vaccine.