chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ANA ELEVATED; INFLAMMATORY MARKERS ELEVATED; INVASIVE DUCTAL CARCINOMA; 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 medical history included: ductal carcinoma, double mastectomy, implantation, surgery on foot, artificial cartilage, broke ankle, persistent postural perceptual dizziness, head injury, and arthritis in big toe. Concurrent conditions included: juvenile arthritis, allergy to sulfa, alcohol user, and non smoker. The patient had no drug abuse or illicit use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), she had a little to no issue. In JUL-2021, she was feeling uncomfortable in the area. She visited to physician office and her plastic surgeon was suggested a magnetic resonance imaging (MRI). Later, her MRI, ultrasound and biopsy were performed (result not reported). In SEP-2021 (Last week or the week before the report), she was diagnosed with an invasive ductal carcinoma. On an unspecified date, her inflammatory markers (NR: not reported) and her antinuclear antibodies (ANA) (NR: not reported) was performed and found elevated. Her primary care provided (PCP) wanted to send her to a rheumatologist but she put them on hold because of the new finding. In next week of this report, her surgery was scheduled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of invasive ductal carcinoma, ANA elevated and inflammatory markers elevated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211017130-Covid-19 vaccine ad26.cov2.s- Invasive ductal carcinoma. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
petechiae on her right hand and forearm; Pain at injection site - left arm; Nausea; 102.4 fever; chills; severe body ache; sore throat; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (102.4 fever), CHILLS (chills), MYALGIA (severe body ache), OROPHARYNGEAL PAIN (sore throat) and PETECHIAE (petechiae on her right hand and forearm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL (ATACAND), SERTRALINE HYDROCHLORIDE (ZOLOFT), METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (102.4 fever), CHILLS (chills), MYALGIA (severe body ache) and OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced PETECHIAE (petechiae on her right hand and forearm), VACCINATION SITE PAIN (Pain at injection site - left arm) and NAUSEA (Nausea). On 07-Feb-2021, PYREXIA (102.4 fever), CHILLS (chills), MYALGIA (severe body ache) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, PETECHIAE (petechiae on her right hand and forearm), VACCINATION SITE PAIN (Pain at injection site - left arm) and NAUSEA (Nausea) outcome was unknown. Not Provided      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.   Treatment medications for the events included Tylenol, Motrin, Vicodin and Ambien 5mg.
Fever; body ache; cognitive disturbance; injection site pain; injection site swelling; injection site erythema; disorientation.  Information has been rec'd from a phys and a RN concerning a 56 yo pt who on 11/17/00 was vaccinated at 14:00 with pneumococcal vaccine 23 polyvalent (635898/0820K),IM. The RN reported that on 11/18/00 the pt experienced pain, swelling and redness in injection site and left arm, body aches and fever greater than 102F. The phys reported on 11/18/00, the pt experienced a swollen, painful arm, fever to 103F times 3 days. The phys reported that the pt was disoriented and experienced a  loss of cognition and saw specialist. The pt's white blood cell count was 11.2 (10-3/ul) on blood drawn 11/18/00. The pt was treated with Amoxicillin trihydrate (Amoxil) 500mg 3 times daily. The RN reported that the pt was feeling a little better. The phys reported hat the pt recovered from the swollen, painful arm, fever, disorientation and loss of cognition on 11/25/00. No further information is available.
Area at injection site was red, swollen, hot, and painful. The swollen area started out at aprrox 3 cm and by 11/06/09 had grown to approx tennis ball size. The doctor started my daughter on antibiotics to treat cellulitis.
2 inch diameter redness below injection site; A bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site) and VACCINATION SITE PAIN (A bit sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site). 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (A bit sore). At the time of the report, VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site) and VACCINATION SITE PAIN (A bit sore) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Patient woke up the morning following vaccine administration with numbness and weakness of his right arm and hand.  He later woke up from a nap that afternoon with numbness and weakness also in his right leg.
Fever  Narrative:  Employee woke with a 102.1 fever this morning. States she feels hot but no fever or chills or any other symptoms ofUpper Respiratory illness. Has not taken Ibuprofen or Tylenol.
(R) arm upper deltoid with swelling no increased redness 8-9 hours after immunization and hot. Sx 4x has helped but cont swelling with redness 24 hr after injections. Benadryl prn helping.
arrhythmia; tingling in left side of face that proceeded down left side of neck, and down into left leg; heart palpitations; 6 Abnormal EKG's; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 19Mar2021 15:45 (at the age of 64-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There were no Medical history and concomitant medications. The patient experienced arrhythmia (medically significant and hospitalization), tingling in left side of face that proceeded down left side of neck, and down into left leg (hospitalization), heart palpitations (hospitalization), 6 abnormal EKG's (hospitalization), all on 30Mar2021 08:00. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. All events received treatment. The patient was hospitalized for 1 days. Immediately experienced tingling in left side of face that proceeded down left side of neck, and down into left leg. Tingling sensation subsided 9:30pm. Within 10 days she began experiencing severe heart palpitations all day, every day. 6 Abnormal EKG's. Numerous tests revealed no heart disease. Cardiologist determined Covid Vaccine related arrhythmia. EKG's, Bloodwork, Nitroglycerin Stress Test. The patient was received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 09Apr2021 09:45 (at the age of 65-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient underwent lab tests and procedures which included: Blood work and Nitroglycerin Stress Test: Unknown results; Numerous tests: no heart disease; EKG's: 6 Abnormal EKG's on 30Mar2021; Covid test: Negative on 29Jul2021. The outcome of the event Paraesthesia was recovered on 30Mar2021 21:30, others were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt describes/reports, allergic rxn and VARIVAX shot- (R) arm itchy redness swelling, above and below the shot injection site prescribed BENADRYL, Medrol Dose Pack, PEPCID, Keflex.
No additional AEs or PQC reported; vaccine administered after temperature excursion occurred; This spontaneous report was received from a registered Medical Assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 01-FEB-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #T037957 was confirmed to be valid, expiration date 09-MAY-2022 (albumin status rHA), administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion was 9.9 degrees Fahrenheit (F) for 13 hours. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001996: US-009507513-2203USA001996:
Immediate pain in left shoulder and bicep.  Unable to move arm for 2 days.  After 1 month of no relief, contact primary doctor's office.  Talked to the nurse who advised I should see a specialist as I would be referred to one.
Patient reports shortly after receiving the vaccines he experienced pain and tingling below the injection site. The pain continued to increase and he was seen by his primary care physician. His physician believed his nerve may have been struck by one of the immunizations. He was told by his primary care to take over the counter medications. The pain continued and he was referred to a neurologist. According to the patient, the neurologist's tests were inconclusive.
This initial spontaneous case, was received from other health professional (nurse) on 05-Oct-2017, concerning a 60-year-old adult male patient. The patient's medical history was not reported. The patient concomitant medication included Lisinopril and APRISO for an unknown indication. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195221, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient received vaccine that underwent temperature excursion (less than 32.54-degree F for about 25 hours) (explicitly coded as incorrect product storage and drug administration error). It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The reporter assessed the events as non-serious. Follow-up report received on 24-Oct-2017: The route of administration (intramuscular) and anatomical location (right deltoid) were updated. It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The narrative was amended accordingly.
p/vax pt exp 2 ecchymotic areas over lt thigh, 12x8cms & lt arm 2x2cms; general malaise; joint aches; . continue evaluation. seen by allergist Per follow-up: Ring in ears continues (Tinitis). Energy level still low. Frequent chest congestion and colds, URI. Prolonged period of fatigue. Sore muscles and painful joints, mental fog and impaired concentration as well as items listed to the right, I feel this anthrax shot has damaged my overall health and immune system.
Fevers 103-104 12 hrs post inject, myalgias, n,v, dizziness, h/a, sore arm @ inject site, mild swelling;
On the day following the injection, I began feeling feverish, quite tired, sleepy, with achy muscles. That lasted until the next morning. It is now three days after I received the vaccine and my arm is still dark red, swollen, and hot.
MDM-43-year-old man presents wit syncope versus near-syncope. Differential diagnosis includes vasovagal reaction versus dehydration versus anxiety versus arrhythmia.
Varicella #2 given 4-4-07. 4-5-07 pt with swelling and redness at site. Painful. On 4-6-07 in office to have site evaluated. Redness, swelling, pain and warm to touch. Measurements 7.5 cm x 7.0 cm induration 10x9 cm redness. No streaks.
Rec'd flu inj. at 11:30 AM. Had delayed reaction at 8 PM same day - 3" red area with 21 cm central induration. Swollen area started as separate welts and fused together. BENADRYL and MOTRIN eased itch and discomfort.
received the pentacel vaccine today instead of the tetanus shot with no reported adverse event; 74 years old took Pantacel vaccine with no reported adverse event; Initial information was received on 03-Mar-2022 regarding an unsolicited non-valid non-serious case received from a health professional via call center.   This case involves a 74 years old female patient who reported that received the pentacel vaccine today instead of the tetanus shot with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Mar-2022, the patient received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine suspension for injection(strength: unknown)at dose of 0.5ml (lot UJ523AA and expiry date:22-jul-2022) via intramuscular route in the right deltoid for immunization.  On 03-MAR-2022, a 74years old patient reported that she received the pentacel vaccine today instead of the tetanus shot with no reported adverse event (incorrect dose administered)and (product administered to patient of inappropriate age) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken:not applicable.  At time of reporting, the outcome was unknown for the event incorrect dose administration and product administered to patient of inappropriate age.    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.
DIFFICULTY BREATHING; DIZZINESS; SEVERE HEADACHES; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included enlarged heart, and poor lung function. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headaches, dizziness and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Boostrix below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number J39HG, expiry date unknown) for prophylaxis.   On 27th April 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022.  The lowest temperature was 30.2F.  The readings were then ranging from 32.9F to 41.8F.  The duration was 7 hr. 45 min.  A dose was subsequently administered. The reporter did not have expiration date, or patient information aside from initials.  Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077005:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter
This case was reported by a healthcare professional and described a subject of unspecified age and gender who did not respond to immunizations with Twinrix for prophylaxis. On an unspecified date on or before 07 November 2006, the subject received unspecified dose of Twinrix. At an unspecified time after vaccination with Twinrix, on an unspecified date on or before 07 November 2006, serology tests for hepatitis A antibody and hepatitis B surface antibody were negative.
patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. Assessment performed respirations counted and were within normal limits, clear respiratory sounds. had patient sit near the door for cooler air, symptoms continued and Benadryl was given.  Paramedics arrived and further assessment was completed and she refused to received further treatment in the ambulance and was allowed to go home.  LVN and RN assessed further and patient stated symptoms no longer present 20 minutes after Benadryl was given.
Patient inadvertently administered first dose of Moderna cov 19 vaccine being under the age of 18.  Patient was administered 2nd dose of Moderna cov 19 vaccine on 3/5/2021 after being approved by Medical Chief and Medical Director Dr
Information has been received from a health professional concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. There was no product quality complaint. Additional information has been requested.
Patient has early onset Alzheimer's and during home visit found a suspect bag in patient's home counter.  Patient lives on her own but receives periodic home visits twice a week. Patient specified that she had no recollection of where bag originated and it was there since yesterday.  Patient left the bag alone since was not sure what it was about and did not want to touch it; patient had emptied the contents on sink. Reporter has no knowledge that patient requires a Typhoid vaccine.  The bag on the counter was white with green labeling. It had information about a Typhoid vaccine. Inside there were gloves, cotton balls with blood, one syringe with capped needle and another empty syringe wrapper with no needle and a used alcohol pad. There was a white plastic container with a lidlid was open--and reporter assumes items were in that container.  There were also clear fluid filled sheets of paper, and what could be bubble wrap or insulator.  There were no details on the bag as to the vaccine administrator. Reporter took photos of bag and contents and will submit them as follow-up; she then disposed items since did not want to leave it at patient's home.   Reporter not sure if patient received the vaccine.  Patient has no symptoms seemed perfectly fine during visit.  Patient takes daily walks with dog and could have picked up bag on the waybut that would be out of norm.  Please contact reporter if you have additional questions about incident or patient.
It started with wheezing that ive never had in my life, I started and coughing. I went to see the doctor and they put me on inhalers and other medications.
CLIENT COMPLAINED OF DIZZINESS, NAUSEA, MILD NUMBNESS TO TONGUE AFTER VACCINATION,  CLIENT HAD VOMITING EPISODE X1, REPORTS ANXIETY PRIOR TO VACCINATION, VITALS SIGNS STABLE, RESP EVEN AND UNLABORED , CLIENT SYMPTOMS RESOLVED AFTER 15 MIN OBSERVATION; RETURN TO BASELINE WITH NO FURTHER INCIDENT
Fever, muscle weakness and pain, sore throat,head-sinus pain, chills.
Fall resulting in a right radial head fracture Narrative: evaluated and treated for a right radial head fracture not requiring surgical intervention
I also got the flu shot that day in my other arm. I do not know any of the information about what influenza shot it was.  I was sick with lack of appetite, nausea, diarrhea, and high liver enzymes.  Anti-nausea medication and monitoring of liver status Antibiotics for the pneumonia
At first I had the expected side effects. Nothing too bad and that took about a week to feel better afterwards. Then on day 10 or 11 I noticed my arm was bothering me. I didn?t look at it until the next day (Sunday) and noticed what I at first thought might be cellulitis. I restarted the Claritin and used a hydrocortisone cream on it but it kept growing for several days taking up a large portion of my upper arm. I called my allergist (Dr) and reported what was going on and they said it?s ?covid arm?. It is mostly better now but I missed a Claritin dose and it?s coming back. On Friday I messaged my primary care Dr office (Dr in city,state) and they just called back today after looking at the photos and my dr called in antibiotics for cellulitis. Apparently multiple providers there have never heard of this delayed reaction ?covid arm? so it would be great if the CDC could provide more awareness about this.
Pt. states that after receiving the 1st dose of vaccine 04/07/2021, started experiencing symptoms 04/08/2021 of Vertigo, heart palpations, weakness, slurring words, dizziness. Low blood pressure, confusion, and neuropathy.  Electrical shock feeling in the top of the skull, Primary recommendation for Injecting Nerve Blockers. Loss of weight, bottom of feet redness, and continuing restless.
Employee had swelling and numbness to left arm and hand on 03-19-19. Employee was seen at Hospital on 03-20-19. Employee was prescribed BACTRIM DS BID x 7 days. She started the BACTRIM on 03-22-19. She states today that the numbness is gone and that there is just a little swelling around the nail beds of the fingers of the left hand.
Severe chills, aches, fever for 8 hours Next day- severe vomiting and headache for 8 hours