chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called 4/4/19 wondering about side effects of TDaP vaccine. Pt received ADACEL 4/3/19. Pt reported at about 9:00am on 4/4/19, he started to experience "bone aches," headaches, and shortness of breath. Pharmacist questioned him regarding his SOB. After questioning, pt stated he was not experiencing inflammation in the airway and he did not feel like his throat was closing off. The "shortness of breath" he reported was due to his low energy state he was experiencing (i.e. tiredness). He reported getting out of breathe sooner when he was active. It was harder for him to be active today (i.e. bending up and down during his painting job). Patient had no shortness of breath at rest. Pharmacist questioned patient regarding presence of rash or hives. Pt checked his body and reported no rash or hives. Allergy including anaphylaxis was not suspected by pharmacist. Pharmacist told patient he is welcome to see a physician, however I recommended patient to give it some time to see if he feels better over time. On the phone, patient stated he will give it some time to see if he feels better. Pharmacist told him I would call him tomorrow to see how he was feeling. Pharmacist also told patient if he ends up seeing a provider and it is determined that his symptoms were due to the vaccine, Pharmacy will "take care of him." I told him Pharmacy has insurance to cover anything corporate determines requires reimbursement. Patient decided to wait and see how he felt later on. Patient's wife called back later in the day and reported the patient was experiencing worsening headache, back pain, tiredness, rib pain and SOB. She stated patient was considering being seen by physician. He encouraged patient to be seen if patient thought he needed to seek treatment/diagnosis. He reiterated that Pharmacist will call tomorrow to see how patient is feeling. Wife did not state whether patient was or was not going to see a physician.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient called because she is concerned because her left arm is causing her severe pain (starting the night of the vaccine) and has progressively gotten worse with no improvement. I advised patient to contact her physician for a check up (heat/cool compress, tylenol/advil, etc)
About 10 days after the injection, I developed shingles on my left leg.  I showed the rash to a dermatologist on April 28 and was prescribed Valacyclovir.  I have never had shingles previously.  Note:  On April 22, two days before the eruption of shingles, I had a Moderna COVID second booster.
ILLNESS WITH HEADACHE, NAUSEA, VOMITING DIARRHEA AND FATIGUE FROM 4/8/07 - 4/13/07; RECEIVED GARDASIL VACCINATION ON 3/13/07; NO TREATMENT
Full body hives about 1-2 weeks after receiving the Moderna COVID-19 booster. The same reaction happened approximately 1-2 weeks after receiving the second dose of the Moderna COVID-19 vaccine. Symptoms include severely itchy skin, especially around the scalp, arms, groin, waist, buttocks, and antecubital and popliteal fossae. Itchiness is accompanied by red, raised urticaria that subsides after a few hours but reappears throughout the day. Levocetirizine (Xyzal) has been taken daily since the first occurrence after the second dose of the Moderna vaccine. Symptoms have mostly resolved after about 1 week on Levocetirizine qd, though some redness and itchiness remain.
As reported by Son - was not seen by doctor, but evaluated in ER.  Reported nausea, pain between shoulders and kidneys, tired, queasy.
Two days following the shot, I had swelling  and a lump in my right armpit. The following week, 7 or 8 days following my vaccination, I started experiencing chest discomfort to the left of my sternum.  This continued for 4 days and then seemed to start getting better by day 5 so I did not seek treatment but was concerned it could be heart or lung issue. A few days after I began to experience swelling  and tenderness in my left armpit which later went away.
red, itchy spot 3-4 inches down from the injection site; Itchy spot 3-4 inches down from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines were not reported.
Received vaccination the evening of 9/20/18 after waking up on 9/21/18 patient noticed she had a fever at 10:00am. Also was experiencing a headache that morning. Started developing redness and inflammation at the halfway point of the upper arm which eventually extended to just below the elbow. Still having redness and inflammation as of today but less than it was. The fever lasted till the night of 9/23/18 fluctuating between 99-104. Patient took IBU to treat the fever which lasted about 2 hours per dose. By the morning of 9/23/18 the headaches had resolved. Patient was also experiencing fatigue 9/21 thru 9/23/18.
Developed severe upper muscle pain in thighs. Hurt to stand up, sit down and walk. Had to have assistance to stand and sit for 2 days to help relieve pain associated with these activities.
ADMINISTRATION OF VACCINE POST 6 HOURS AFTER FIRST PUNCTURE (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 11-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On FEB-2022, the patient experienced incorrect product storage. On 11-FEB-2022, the patient experienced administration of vaccine post 6 hours after first puncture (out of specification product use). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine post 6 hours after first puncture (out of specification product use) and incorrect product storage was not reported. This report was non-serious.
around MN p/vax pt woke up w/a terrible h/a, shaking & diff breathing;around 10AM same day pt states lt arm & leg were tingling, terrible h/a chills, tongue felt numb & tingly, queezy, skin sensitive to touch;
pain in area of injection,  described as dull muscle ache.  Started within day after injection, continues to present time (5/29/20).  She mentioned the pain when 2nd dose was given 1/23/20, but she wanted 2nd dose in same arm.  2nd dose caused no pain, even as area where 1st dose pain persisted.  Patient denies any redness or swelling at any point after 1st injection.  Patient states that she has only had a couple of days in a row in the last month that she has not had any pain in the arm and she thought it was getting better. Pain returned with movement in a couple days.
PAIN IN HANDS DUE TO RHEUMATOID ARTHRITIS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced pain in hands due to rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from pain in hands due to rheumatoid arthritis. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
6/12/07: Vomiting and Fever 6/13/07: Hematemesis, Melena, Fever, Lethargy. (10 AM) 6/13/07: (6 PM) Ileocolic Intussusception diagnosed with gastrograffin enema; reduced by hydrostatics and laproscopy. 7/5/07-ER records from receiving hospital for DOS 6/14/07-HX of vomiting began yesterday. Number of episodes of vomiting became coffee ground in appearance this morning. Lethargic. No diarrhea. No stool at all since yesterday morning. PE: Pale, abdomen soft with diminished bowel sounds and does not appear grossly distended.  7/13/07-records from receiving hospital.DX: Ileo-ileo intussusception. Laparoscopic reduction of ileo-ileo-colic intusssusception. DOS 6/13-6/15/07. Barium enema parially reduction.
Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6200), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (24Apr2022) Positive; (25Apr2022) Negative; (26Apr2022) Negative; (29Apr2022) Positive; SARS-CoV-2 test: (18Apr2022) Positive, notes: Got COVID - PCR positive; (26Apr2022) Negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient appear to have Paxlovid rebound. Got covid - PCR positive on 18Apr2022 and started Paxlovid on 19Apr2022 (Lot number: FY4422) for treatment of COVID-19, finished it on 23Apr2022. Currently not experiencing symptoms.  Follow-up attempts are completed. No further information is expected.
PT WENT TO LOBBY TO SIT AND WAIT 15 MIN. PT HAD APPARENT SEIZURE WHILE SITTING IN CHAIR. HIS EYES ROLLED BACK, CLENCHED FIST WITH ARMS SLIGHTLY MOVING. HIS FACE BECAME RED, THEN SUDDENLY WENT VERY ASHEN IN COLOR, LIPS PALE. PULSE VERY FAINT. PT INCONTINENT OF URINE. 911 CALLED . AFTER ASSESSMENT, THEY STARTED IV AND TRANSPORTED TO ER. PER EMT, BP WAS 68 WITH UNHEARABLE LOWER NUMBER.
I had the injection in the morning around 8 a.m. on a Friday. About 4 hours after the injection, the injection site became slightly red and very sore. About 12 hours after the initial injection (which would be Friday Evening), I developed a moderate level headache, mild nausea, general lethargy and overall achiness. 24 hours after the initial injection (which would have been Saturday Morning) the injection site became extremely red and warm to the touch along with general lethargy and the continuation of the moderate headache, nausea and overall achiness. Sunday Morning I felt a little bit better but still had mild side effects as listed above. By Monday morning, which would have been 72 hours later, pretty much all symptoms had disappeared and on Tuesday morning I was back to normal.
The pt experienced tachypnea, sick, fever of 103 - 104 for several days.
Blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization), outcome "unknown", described as "Blood clots".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I got my second shot on May 1st, on May 18th I experienced a lot of hair loss, it just stopped a week ago, now I have 90% less hair than before the vaccine. The doctor prescribed Minoxidil now my face is swillen.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not provided; lot # L046884, expiration date: 23-NOV-2017; lot# M025865, expiration date: 24-MAY-2018). The reporting nurse stated, that sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) used to reconstitute the vaccines was properly stored. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25.7 degrees Fahrenheit for 1.5 hours and 8.8 Fahrenheit for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013690.
Patient presented to the Clinic on 10/08/2013 with reports of redness and heat of her left arm following her flu vaccination Sunday 10/6/2013. Her flu vaccination was given in the deltoid muscle of her left arm and the area of erythema and warmth is beneath the injection site with clearly defined margins. She reports that on 10/06/2013 her arm felt hot but the redness and swelling did not develop until 10/08/2013. She denies fever/chills. I told her that she likely has a delayed reaction to the flu vaccination and that she should mark the margins of erythema and if it spread, worsened or she began to run a fever she should be seen at urgent care for possible treatment of cellulitis. She was offered an appointment to be seen by me today or referral to urgent care for further evaluation and treatment but declined.
Nausea, tension headache, abdominal cramping, diarrhea, fatigue. Over the counter stomach acid reducer taken. Symptoms have been ongoing for 10 days.
Post vax, pt was drowsy-went home and slept. The next day the pt awoke with arm swollen and red. Arm is still a little swollen and red. Pt took some Benadryl and that seemed to help.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Dec-2011. On 22-Dec-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 23-Apr-2012 and incorporated into the narrative: No late occurring adverse events.
High fevers, Rashes, Horrible vocal and motor tics, Depression fits, OCD.
Headache began the day following the vaccine and has continued to present.  Severity fluctuates, but never completely goes away.
After 1 hour, student reported mild pain at the injection site. Later that afternoon, he reported to his mother that it hurt more. She examined the site and determined that it was red and slightly swollen. The swelling went down over the course of the school day, but the redness remained and grew in size. It seemed better after 24 hours, but then became more painful.
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB (dose, frequency, route, lot # and expiry date were not reported)(product storage error) for prophylaxis. No adverse effects reported. Temperature was reported as "29 point something". Time frame, previous temperature excursion, data logger involvement were unknown by reporter. No product quality complaint was involved.
Clients left deltoid has localized reaction, measured at 108mmx95mm. Arm was edematous, red, hot to touch, and client complained of itching. Per father vaccine given at 4PM notice reaction around 9PM 7/29/04. Pt given Tylenol per father. Nurse advise to use cold compress ever 20 min x 24 hours. Also advise to give Tylenol or Motrin to help with the swelling. Father advised if symptoms worsen to call private Dr or to go to ER.
After vaccine client complained of feeling "lightheaded" and dizzy.  After 30 minute observation, patient states completely resolved.   Called client @ 1610.    States she is still feeling better.
Reported due to vacination error.  Patient recieved first vacination of COVID-19 series at sister hospital.  Patient was given pfizer vaccine Lot # EK5730 at other hospital.  Patient was sick and did not make follow up vacination appointment and returned to regional campus to have second injection.  Unfortunately the second in the series was administered as moderna.  No ADR has occured at this point.
Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot number not reported). "A month and half ago", on approximately 11-JAN-2010 the patient experienced chickenpox. It was unknown if medical attention was sought. The outcome of the patient was not reported. The physician was the treating physician not the prescribing physician. Additional information has been requested.
I was post-menopause since 11/2018 Five days after my second Pfizer vaccine I had my period   After not having a period for almost 2 1/2 years
This spontaneous report was received from a nurse refers to a 34 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. It was reported that the patient was "very adamant" in receiving a dose of GARDASIL 9. The nurse stated that on 28-FEB-2018 (reported as today), the patient would most likely be administered with GARDASIL 9 injection (strength, dose and route of administration were not reported) (lot # N019103, expiration date: 03-FEB-2020) for prophylaxis (drug administered to patient of inappropriate age, circumstance or information capable of leading to medication error). No adverse effects were reported. There was no product quality complaint (PQC) reported.
After giving injection patient started to complain of dizziness, she felt better after 10 minutes and then home. 30 minutes after Mom called stated patient felt dizzy and nausea. Informed to put patient's legs up while laying down and kept patient hydrated. If symptoms persist and getting worse to take patient to ER. I called Mom the next day, she stated she took patient to ER. Per Mom would bring patient back if symptoms did not improved. Mom made an appointment for 4-25-18 and missed appointment.
administration error= wrong manufacturer Narrative: Administration error- Patient received Pfizer COVID-19 Vaccine on 3/20/21 without adverse event. Patient scheduled to received dose 2 of Pfizer on 4/10/21 but inadvertently administered Moderna COVID-19 Vaccine as the second dose on 4/9/21 instead. Series not restarted/patient did not received any additional doses per CDC guidance.
Left arm at injection site very sore.  Condition has not improved since then.  Arm still sore.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients of an unspecified date received improperly stored VAQTA (lot No, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
This is a 37 year old male who has been on stable HIV regimen of Truvada, Prezista & Norvir since 12/16/14.  Tdap was given in clinic on the left deltoid area on 01/21/15. The patient reported pruritic papules & wheals, first over the left then the right axillary and left inner forearm areas within 24 hours of the Tdap injection.  He called the clinic and sent pictures of the rash to the clinic on 01/22/15.  He was started on prednisone 40 mg QD x 5 days + Claritin on 01/22/15.  On these medications, the rash progressed to involve the back and leg areas on 01/24/15.  He reported lip swelling with no laryngeal symptoms on the morning of 01/24/15.  His prednisone was increased to 60 mg QD and he was sent to the local ER for evaluation & observation.  No epinephrine was administered at the ER.  He was sent home with a prescription for EpiPen.  Completing a 5 day course of prednisone (01/21/15 to 01/25/15), his Claritin was switched to Atarax 25 mg TID and Zantac 300 mg QD. His HIV medications were stopped - Prezista contains sulfa moiety. No rash or anaphylaxis symptoms were noted thereafter.  He was seen in clinic today 01/30/15 and he was asymptomatic.  He is now off prednisone but is still kept on Zantac and Atarax to prevent late reactions.  Re-start of HIV medications is planned in the week of 02/02/15 with a different HIV regimen (Stribild).
This spontaneous report as received from a physician refers to a 19 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with VAQTA, 25/0.5 DF injection, pediatric dose, for prophylaxis. No adverse event was reported.