chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cancer; illness; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant) and ILLNESS (illness). At the time of the report, NEOPLASM MALIGNANT (cancer) and ILLNESS (illness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 9-DEC-2022, Patient was scheduled to get the 3rd booster, but had to cancel it twice because of an illness. This illness was a recurrence of her cancer. Contact is a cancer patient and is wondering if this variant booster or previous boosters alter any CA-125 factors. One of doctors she has spoken to had mentioned that he had read an article that breast cancer patients who got the vaccine had elevated blood markers. She was now received  chemotherapy.   Treatment information was not provided.  Company Comment This spontaneous case concerns a 69-years-old female patient, with no medical history reported who experienced the unexpected events of neoplasm malignant (seriousness criterion medically significant) and illness unknown days after 4th.  dose of  mRNA- 1273 vaccine. This illness was a recurrence of her cancer; the patient is wondering if this dose or previous boosters alter any CA-125 factors. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 69-years-old female patient, with no medical history reported who experienced the unexpected events of neoplasm malignant (seriousness criterion medically significant) and illness unknown days after 4th.  dose of  mRNA- 1273 vaccine. This illness was a recurrence of her cancer; the patient is wondering if this dose or previous boosters alter any CA-125 factors. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Day after received vaccine developed stomach ache, low grade fever.  Later that day developed rash.  Red not raised and not itchy on hands, inner aspects of both arms, back of knees and then body/trunk.  Some sore throat as well. Next day (3/20/14) developed some vomiting which continued to 3/21/14. 3/22/14 felt tired and weak.  Family flew to another state for family trip. When arrived later that night went directly to ER because she vomited a number of times on the flight and mom noticed she looked yellow.  Also mom thought stools looked light in color (mom is a nurse). At ER: thought dehydrated. Blood work: mildly elevated liver enzymes, direct Bili and GTT. ER thought she had a "hypersensitivity" reaction to vaccine.  Ultrasound of liver normal. He was given IV fluids and IV steroids. Also diagnosed with UTI. After leaving ER 3/23/14 developed skin peeling starting with hands, then face, arms, legs and trunk which continued for 1 week. By 3/31/14 liver labs normal but still peeling.
Information has been received from a health professional concerning a 65 year old male with no known drug reactions or allergies who on 28 Nov 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included Zoloft. On 18 Dec 2006 the patient developed a unilateral vesicular rash with dermatonal distribution extending over his right hip. Unspecified medical attention was sought. As of 19 Dec 2006 the patient was recovering. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information indicated on 19-DEC-2006 the patient broke out in shingles. On 09-JAN-2007 the patient recovered. No additional information is expected.
Patient had rashes and fevers on and off since the vaccination.  I did not at the time realize that timeline.  On March 6, patient began falling to her right side and her right side of her body seemed week.  She would space out and not respond for up to 15 seconds at a time.  The symptoms were transient, coming and going with a low grade fever 100.8. We took her to the Emergency room and at that time her symptoms had stopped and neurological exam was normal.  We were told it was vestibular ataxia and told to follow up with pediatrician Her ears were totally clear in the that visit and every other visit after. Then she started walking on her toes and was unable to walk without assistance.  She then would go in and out of having balance issues,
BRUISING IN RIGHT ARM; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, bruising, and cough.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included citalopram for epilepsy, levetiracetam for epilepsy, and acetylsalicylic acid. On 12-APR-2021, the subject experienced slight headache. Treatment medications included: ibuprofen. On 13-APR-2021, the subject experienced bruising in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 12-APR-2021, and had not recovered from bruising in right arm. This report was non-serious.
5AUG95 c/o aching in lt arm; felt tenderness @ site; 6AUG redness developing plus discomfort; 7AUG having all above s&s plus discomfort aching; 8AUG seen @ clinic whole upper lt arm edematous 3" reddened, very tender to lt upper arm
MUSCLE PAIN IN ARM OF SHOT; TIREDNESS; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 14:45 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced muscle pain in arm of shot. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain in arm of shot, and tiredness on 08-MAR-2021. This report was non-serious.
potential AE because of use against local labelling with no reported adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a 11 years old female patient who experienced potential AE because of use against local labelling with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine [Quadracel] and Measles vaccine, mumps vaccine, rubella vaccine [MMR].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking measles vaccine, mumps vaccine, rubella vaccine (strength, dose, route, formulation, batch number and expiry date: unknown) and diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine (strength, dose, route, formulation, batch number and expiry date: unknown) in unknown administration site all for Immunisation.  On an unknown date the patient developed a non-serious potential AE because of use against local labelling with no reported adverse event (off label use) (latency:unknown) following the first dose intake measles vaccine, mumps vaccine, rubella vaccine and diphtheria-15/tetanus/5 hybrid ac pertussis/IPV (MRC5) vaccine.  Action taken:unknown.  It was not reported if the patient received a corrective treatment for the event (off-label use).  At time of reporting, the outcome was Unknown for the event off-label use.
Patient called and stated about 11/24/21  , 9 days after receiving his booster dose of Moderna and his Flu shot he developed a rash on his back and arms. He still had the rash on 11/29/21 when he reported here were he got the vaccines.  He stated he has been taking OTC     antihistamines . At this time he had not seen his doctor , but did have an regular scheduled appointment in the next few days.
some in abdomen about three days after vaccination; The pain worsened each day, persistent; EKG was abnormal at urgent care; Developed burning sensation in chest & some in abdomen about three days after vaccination; Developed burning sensation in chest & some in abdomen about three days after vaccination; SHINGRIX administered on 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 55 years, on 30Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunization, (lot number: 58160-0823-11), first dose, single, on the left arm from 30Apr2021 to 30Apr2021; other medications the patient received within 2 weeks of vaccination were estradiol;estriol (Estriol/estradiol- 3/0.75mg/ml) and progesterone 75 mg taken for an unspecified indication, start and stop date were not reported. Patient previously took prednisone and erythromycin on unspecified dates for unspecified indications and experienced known allergies. Patient historically received first dose of BNT162B2 (Lot number:EW0162) on the right arm on 17Apr2021 at 09:30 AM for COVID-19 immunisation. Patient developed burning sensation in chest & some in abdomen about three days after vaccination (also reported as 04May2021). The pain worsened each day from 04May2021, persistent, sought advise with a virtual doctor on 02May2021 (as reported). Advised to have EKG ASAP. EKG was abnormal at urgent care on 04May2021. Sent to ER. Patient was seeing a cardiologist for more tests that are scheduled. Patient was not treated for the events. Adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Patient also underwent lab tests and procedures which includes blood and urine work up on 04Mar2021 with result of kidney, thyroid, liver, cortisol, glucose all optimal. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Adult Covid PFizer vial was mixed with 1.3 ml of saline and 0.2mg dose was used to inject instead of Covid Pfizer ped dose.
LOCAL REDNESS AT SITE OF INJECTION. WARM TO TOUCH. OVER 48 HOURS REDNESS SPREAD DOWN TO ELBOW. STEROIDS AND BENADRYL TAKEN AND TOTAL IMPROVEMENT BY 72 HOURS AFTER INJECTION.
Pt experienced hard time breathing that night. Went to ER and was seen by physician. Pt had elevated heart rate. Hasn't felt good since. Pt experiencing numbness in arm and headaches.
8/29/21 - Dry Cough; 8/30/21 Deeper cough, low grade fever, fatigue.  Outpatient visit with Dr. Performed Covid test and prescribed isolation and bed rest. Fully recovered by 10/3/21.
Hemoptysis - coughing blood up while swimming, stopped swimming and it went from bright red drops to red streaks in phlegm after about 2hrs .  Total blood loss about 10 ml.
This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age reported as "in his 80's or 90's". Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown dates "for five consecutive years", the patient was vaccinated with one dose of PNEUMOVAX 23 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown dates "for five consecutive years", the patient was hospitalized for pneumonia and while he was still sick, received a dose of PNEUMOVAX 23 every time he was hospitalized. It was also mentioned, that the PNEUMOVAX 23 was ineffective in preventing pneumonia for the patient (drug ineffective). Subsequently, on an unknown date, the patient died from an unknown cause. It was not known if an autopsy was performed. At the reporting time, the outcome of pneumonia, drug ineffective and malaise were unknown. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1804USA004352: Reported Cause(s) of Death: Cause of death unknown.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Other medication in 2weeks: Yes. Anti-viral details: Product: COVID 19 Treatment. Brand: Paxlovid; Treatment start date: 29Apr2022; Treatment Stop date: 04May2022; Indication: Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Within 3-4 minutes of getting varicella vaccine pt began to c/o tummy ache & became flushed in face & cheeks.  Although no pain persisted he felt like he was going to throw up. He did not.  He coughed up a little bit of phlegm.  No wheezing exam remained stable - lungs clear.  Heart rate reg. rhythm reg. faint macular erythematous rash in the periumbilical area.  That was not there before.  Given 1 tsp. BENADRYL - flushing resolved.  Pt felt better.
5 days p/vax pt devel erythematous macules over legs;spreading to abd & trunk;the next day rapidly involving face & ears;lesions to lower extremities grew larger, devel target like appearance;morbilliform rash consistent w/erythema mult;
Fever, chills, headache, body aches 12hrs after vaccine administration.  Diarrhea 18hrs after administration.  Symptoms lasted 24hrs.
Here with father, follow up visit from ED visit on the 1st. Told symptoms secondary to flu vaccine. Received FLUMIST on the 31st. Developed stiff neck and fever on the 1st. Did not do LP, did rapid strep and culture, both negative. Temp to 101 yesterday. Sleeping well. Appetite decreased. Headache now is very mild. Nausea, no vomiting. Normal urination, history of UTIs. More frequent BMs but normal consistency.
He broke out into rash within 1 to 2 min after the immunizations, on my exam he has 2 wheals about 1/2 inch on Rt forearm, few macules on (L) arm & back & neck, he was not wheezing, no intercostal retraction, we gave him 1/2 tsp of VERIPRED 20 mg/5ml, mom was advised to stay in the room to watch for allergic reaction, mom left against medical advise.
Patient had PNEUMOVAX and flu this week. She states that she got a fever and pain that night. She states that she feels better today. Redness is decreasing but still warm. Arm ROM better.
62 y.o. female patient of, DO with history of HTN, DM, tobacco use, CAD, PAD, COPD. Presents with dyspnea and cough. Found to  be in acute hypoxic respiratory failure, requiring 2LNC 2/2 COVID and COPD exacerbation. Respiratory status initially improved with steroid therapy, but patient continues to require oxygen.    Acute Hypoxic Respiratory Failure Suspected 2/2 covid PNA vs COPD exacerbation  CTPA w/o PE, right upper lobe infilatrates, centrilobular emphysema Additional management as below Required continuous 2L NC oxygen on discharge    Covid 19 Infection Acute COPD exacerbation Positive test on admission, symptom onset 4/4 Completed vaccinations Continued dexamethasone and remdesivir for COVID Continued azithro for COPD exacerbation Duoneb q 4 hr scheduled, IS, mucinex   Hypokalemia - resolved K on admission 2.0 Monitored and repleted as needed   T2DM 4/10 A1c 9.5% Likely worsened hyperglycemia in setting of seroids Home meds: glipizide and metformin, held On day of discharge patient received 74u lantus and 54u SSI Will need close outpatient follow up for titration of medications PCP notified    Hypocalcemia Asymptomatic Ionized calcium 3.3 Phos 2.8, Mag 1.7 Repleted electrolytes PRN   Transaminitis, resolved ALT/AST 51/133, T bili 2.1 on admission Denied daily use of alcohol, no reported hx of w/d seizures Hepatitis panel negative Monitored for signs of w/d Daily CMP Macrocytosis MCV 103 on admission Appeared chronically elevated B12 1784, folate 6.4   HTN Chronic, elevated on admission 2/2 to poor med adherence Asymptomatic  Home medications: lisinopril, metoprolol, Continued metoprolol Held home lisinopril   CAD PAD Hx of SVT Continued home meds with ASA, plavix, atorvastatin  Continued home diltiazem for rate control   Tobacco Use Disorder Smokes 0.5 ppd NRT prn   Multinodular Goiter  Incidentally noted on CT scan  Recommend TSH and US in OP setting
Patient presented to pharmacy 12/27/21 reporting redness, swelling and pain in the right arm that occurred roughly 12 hours after patient received immunization. Patient received a flu shot in the left arm and a moderna additional dose (immunocomprimised) in the right arm. She said no mobility issues in the shoulder just soreness, swelling and redness. She has been managing with topical creams, acetaminophen and benadryl. As of today it is getting better started improving Sunday, worst she thought was Saturday 12/25/21 (Shots given Tuesday 12/21/21).
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. It was unknown if data logger was involved or if previous excursions were reported. Additional information has been requested.
Patient received 2 doses of SinoPharm 05/31/2021 and 06/25/2021 - did not disclose at time of 09/03/2021 appointment.  Received Pfizer B1 09/03/2021 as indicated in this report.
Erythemic maculopapular rash trunk and face < 30 minutes after administration of vaccines. Given P.O. BENADRYL-rash faded, but did not resolve in clinic. Family sent home with BENADRYL and precautions.
Moderna vaccine was administered to individual  under the age of 18. Administration error was discovered in the course of a vaccine record review by the individual reporting event who is not associated with administering facility.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Adverse event (fainting) occured today at time of immunization. Pt fainted near immediately, regained consciousness in about 15-20 seconds, then seemed a bit dazed for several minutes. Pt stayed at the pharmacy for about 17-18 min and seemed to recover by the end and walked out with her parents. Parents noted that this is a normal reaction to vaccines, but this time did seem to be the most severe compared to past events.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient was light headed and dizzy. He was reclined and feet elevated. He also experience tingling in hands bilateral which radiated up both arms
Right now, it has almost been like 25 days, shoulder is in pain; This is a spontaneous report from a contactable consumer (patient) or other non-health professional.  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, on 03Apr2021 (at the age of 51-year-old), in arm right (right shoulder), as dose 2, single for COVID-19 immunization.Medical history included his leg is also broken from an unknown date and unknown if ongoing. There were no concomitant medications. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via an unspecified route of administration, on 11Mar2021 (at the age of 51-year-old), in left shoulder, as dose 1, single for COVID-19 immunization. On unspecified date patient experienced Right now, it has almost been like 25 days, shoulder is in pain. Patient had made an appointment with another Doctor to check out his shoulder and to take a picture with an X-ray. Right now, the patient's shoulder is in pain. Patient did not know what was going on with his shoulder, so he made an appointment with the doctor. Patient reported that something inside, but not too much pain. After two days, the pain was powering forward. Patient reported that his pain is a 6 on a 1-10 scale and almost like 25 days, not sure what day this began. Patient stated this is ongoing and he does not know if it has improved, is persisting or worsened. Patient clarified that his leg was broken prior to receiving either dose of the Pfizer Covid 19 Vaccine. On unspecified date the patient underwent lab tests and procedures which included pain assessment: 6, his pain is a 6 on a 1-10 scale. The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
11:29AM - NP notified of pt C/O SOB, chest pain. NP at car assessed pt noted with chest pain that she described as heaviness and SOB denies these symptoms prior to vaccine @ 11:35am. PT given 0'3 of epi to left thigh. EMS on scene PT BP 135/71, HR 78 , EKG NSR on monitor. PT reports history of blood clots, ulcers, strokes, z ta, seizure. TIA (2016 & 2018) taking Keppra, Eliquis daily 7 days. PT reports after 5mins  11:40am of chest pain & SOB subsiding. PT educated about the side affects of epi injection and the importance of being evaluated by the hospital.PT agreed and transported to Hospital by EMS.
ARM BECAME SORE WITHIN 2 HOURS OF ADMINISTRATION, CANT LIFT ARM, VERY PAINFUL STILL 3 WEEKS AFTER ADMINISTRATION
She was supposed to receive Bivalent vaccine for booster, but Comirnaty was given accidently.