chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female patient of unknown age referring to herself. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unknown date, the patient received both the PNEUMOVAX 23 (indication: prophylaxis; strength, dose, frequency, route, lot # and expiration date were not reported) and PREVNAR 13 concomitantly (overdose). No adverse effects were reported at the time of the call.
Two hours after I received the vaccine I started feeling really sick, nausea and headache. And my skin would get really hot and feverish.
6-8 minutes after the shot felt a sensation from left shoulder slowly sweeping across body, going into face and neck to the inside of left eye. Face had a weird feeling also.  Headache, tonged tingling. Left and went to the car. Face was red and swollen all over. Skin looked like she was skiing in the middle of winter.  She went back inside the hospital to her department on the 5th floor and stayed about 30 minutes. Then she went home. Half bottom lip was swollen, Both eyes got itchy, glassy, watery.  Behind sinuses hurt really bad. Next day pain in hips both knees. Took 2 full days for the redness to go away from face. Had dark circles under eyes.  Took Claritin. Hair has been shedding, sever brain fog at work.  Her employer told her to take some time off from work .  Upper teeth hurt.
chest tightness; Chills; Fever; Body Aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 33-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 12:00 hours as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included nebivolol hydrochloride (Bystolic) and fluoxetine hydrochloride (Prozac) (both taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination. On 17Feb2021, at 15:45 hours, patient had fever, chills, body aches, headache, and chest tightness. On 17Feb2021, patient had been tested for COVID-19 (qualitative polymerase chain reaction) post vaccination using nasal swab, rapid test and result was negative. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for the events. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Vaccine administered on 7/21, pt began to itch and have rash on stomach, groin and lower legs on 7/26. Visited MD on 7/28 received prednisone shot and was taking BENADRYL. On 8/2 - went back to MD - received pred pack and cream (topical) - per pt spouse MD thought allergic rxn then a viral rxn at 2nd visit.
Approximately ten minutes after immunization, patient presented with "itching". Upon examination there was a red area warm to touch (~1.5 in diameter). Patient was given BENADRYL 25mg (TQ6 hours). At 7pm patient reported no itching and no redness.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the tiredness and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow up with her physician on an unknown date. Consented to follow up was provided. This case linked with US2019GSK018566, reported by same reporter for the same patient.
Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).; Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 12:00 as dose 1, single (Lot number: HGH628) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Oct2023 at 10:00, outcome "not recovered" and all described as "Vaccine failure to prevent COVID19 infection; tested positive on 11Oct with symptoms (flu-like).". Clinical course details: the patient had no Covid prior vaccination and tested for Covid after vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
shaking movements-whole body x 2 seconds 2 day p/vax + 2nd episode, just leg; 3rd episode 2 days later just head; all lasted 2 seconds; EEG & neuro consult pending;
01/21/22 presents to EC ED for "SOB". PMHx of "HTN, DM, HLD, PVD, CVD, hyperthyroid, COPD no home O2, CHF s/p ICD, COVID ++ 1/6"
Pt recvd vax 11SEP92 & exp flu-like sx, sore throat, fever, h/a, malaise; also neck stiffness, vertigo;
HIVES!!  with both shots - Developed hives within hours of receiving the Covid 19 vaccine on my lower extremities, feet, ankles, shins, calves, thighs and buttox.  More severe with 2nd shot and still developing  more in the last 48 hours.  They will last at lease 4 days.  I was also freezing cold the day after the shot (all day) and had a headache.
Arm immediately swelled up with the injection.  Became a hard painful lump.  Stayed swollen and hot for several days.  The bruise is still visible 18 days after vaccination.  Created a large bruise 3-4 inches in circumference.
ACUTE NON ST ELEVATION MI 4/18/2023 ABNL LIVER ENZYMES ACUTE NON ST ELEVATION MI 4/18/2023 ACUTE NON ST ELEVATION MI
p/vax pt c/o whole body weakness; lt arm swelling & discoloration approx 6'' down from inj site; also c/o dizziness & bed ridden for 2-3 days;
I tested positive for Covid-19 on March 3, 2023 my symptoms were a fever of 100.0, headache, body aches, I was prescribed PAXLOVID for my symptoms.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 10/30/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
DATE OF ADMISSION:  10/17/2022   DATE OF DISCHARGE:  10/20/2022     DISCHARGE DIAGNOSIS: 1. Fever and shortness of breath due to COVID.  2. Coronary artery disease with history of cardiac cath and stenting.  3. Uncontrolled hypertension.  4. History of cerebrovascular accident and paroxysmal atrial fibrillation.  5. Chronic dizziness.
arm turned very red, hot to touch and extreme painful, the next day Oct 20th  she developed a fever  with flu like aches and pains all day.    she was all day in bed due to nausea. entire arm has red rash, warm to touch but less painful. Wednesday and Thursday she felt exhausted and dehydrated which kept her in bed. Friday she felt well. I called her today and she said she is all well.
I started with a cough, sore throat which progressively worsened over the days. On 07-02-2021, I had a cough attack, cough spasms, felt very nauseated in which I tried to vomit but I could not and also my sore throat was getting worse. My blood pressure also went up and an ambulance was called to my home. I was admitted to the ER by 12:00pm and at the hospital, lab work was performed, did a Covid test which was negative. While in the hospital I had three episodes of spasmic cough attacks and I continued to feel nauseated, had chills, muscle aches and I was discharged at 11:30pm that day. A few days later I went to see my doctor who again performed lab work and my results came back normal. I also feel pain to the back of my knees, pain associated with a hot sensation that does not go away. Today I still continue with cough spasms and muscle aches and the hot sensation to the back of my knees. I do not have lot# to provide, 2nd dose.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # J014279, expiration date 16-SEP-2016, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Received half a dose of Jynneos due to arm movement; Jynneos was administered intradermally; First Jynneos dose was on 01-Sep-2022, second dose on 24-Oct-2022; Case reference number US-BN-2022-004657 is spontaneous case report initially received on 24-Oct-2022 from a nurse and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 01-Sep-2022, the patient was vaccinated with first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: unknown), at 0.1 mL, administered intradermally at an unknown anatomical location (explicitly coded as 'intradermal injection') for an unknown indication.   On 24-Oct-2022, 53 days after first dose, the patient was vaccinated with the second dose of Jynneos, (batch number: unknown), and only received about a half dose, intradermally due to arm movement (explicitly coded as underdose' and inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 11-Nov-2022 included confirmation of country of occurrence.; Reporter's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos vaccine intradermally and 53 days after first dose, was vaccinated with the second dose of Jynneos intradermally, and only received about a half dose due to arm movement, which is considered underdose and inappropriate schedule of vaccine administered. Intradermal injection, underdose and inappropriate schedule of vaccine administered are listed by convention. No associated adverse events have been reported. Intradermal injection, underdose and inappropriate schedule of vaccine administered have been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with first dose of Jynneos vaccine intradermally and 53 days after first dose, was vaccinated with the second dose of Jynneos intradermally, and only received about a half dose due to arm movement, which is considered underdose and inappropriate schedule of vaccine administered. Intradermal injection, underdose and inappropriate schedule of vaccine administered are listed by convention. No associated adverse events have been reported. Intradermal injection, underdose and inappropriate schedule of vaccine administered have been considered not related to the suspect product. The case is non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS), INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS), INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS). At the time of the report, JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) had resolved. No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Inappropriate schedule of product discontinuation, Joint stiffness, Pain in joint was assessed as Not related for cosuspect humira. No treatment medications were reported. Reporter did not allow further contact.
Reported body aches, low grade fever, inflammation, redness, fatigue. Self-treated with acetaminophen. Sought medical attention treated with antibiotics.
This medically confirmed spontaneous report (initial receipt: 18-May-2012) concerns a female patient. On an unknown date the patient received an unspecified flu vaccine (manufacturer unspecified) and experienced Guillain-Barre syndrome. The event outcome was not reported. No further information could be provided by the reporter.
Almost immediate fever to 102.1 within 5 minutes of vaccination and turned red -- no urticaria, no facial swelling, no difficulty breathing.
Information has been received from a physician concerning a pt who was vaccinated with varicella vaccine. It was noted that the physician "has seen zoster occuring in the same appendage at the vaccine was given." Unspecified medical attention was sought. Follow-up info has been received from a physician who states in the last year he has seen 3-4 cases of herpes zoster in children who have received varicella vaccine. He reports that they were all at the site of injection and that all of the children had uncomplicated recoveries from the herpes zoster. Additional info is expected.
Pt reported to mom 3 convuls on 10JUL92 pt seen in ER;
Allergic event - "hives developed on rt thigh 12 hrs p/immun & proceeded to cover body w/in 15mins; Did not occur in throat but was promptly treated w/Benadryl; Seen in ER;
Vaccination was given at 8:25 and she began itching at 8:32. Itching that progressed from bilateral arms to trunk, bilateral legs and back. She felt wheezes starting. Given 50 mg. Benadryl po at 8:35. Symptoms were getting worse and RN gave Methprednisolone 125 mg. IM at 8:45.Alburteral Inhaler 2 puffs was given at 8:50. At 9:00 patient C/O upper lip tingling. Visual swelling observed. She was transported to ED by WC.  ED administered  Pepsid po and observed her for an hour. She was then discharged.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 12-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804097 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
This case was reported by a healthcare professional and described the occurrence of burning in a female subject of unspecified age who was vaccinated with TWINRIX. On an unspecified date, the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection with TWINRIX, the subject experienced burning and tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases included A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A732528A, A0732533A, A0732539A, A0732540A, A0732936A, A0732944A.
The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021; The patient received expired dose beyind expiratory date 03OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place stored in refrigerator was 16-Oct-2021. No temperature excursion occurred. No adverse event was reported.  No concomitant medication were provided No treatment details were provided
Within 12 hours post vax, the pt experienced headache, muscular spasms, and nausea. 24 hours post vax, the pt experienced heaviness in upper arm and flushing at night. 6 days later, pt developed erythema the size of a quarter at injection site. On 11/9, the pt had positive erythema with induration, clearly demarcated at injection site extending below site.
The patient came in today and I was able to check the injection site. She developed a rash near the injection site and she complained of itching.
Pt received Flu vaccine on 11/9/15 and around 12 noon pt experienced swelling at injection pain and the swelling and pain has spread down left arm around tricep area.
Per mom, patient was eating around 8am on 09/11/2021 and started shaking and his eyes rolled back and mouth shut tight.  She states that this lasted around 3 minutes.  Parents called 911 and when ambulance arrived, pt was alert and responsive and recommendation was to follow-up with PCP.  Pt was at PCP office on  09/13/2021 and exam was WNL.  Referred to neurology and an EEG was ordered.
Meningococcal MCV4 Lot# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Meningococcal MCV4 Lot# U3778AA Exp. 10/14/12 readministered: 8/12/11.
patient stated suspected myocarditis (sharp pain in chest, worse on inhale), started 1 week after 1st dose of COVID-19 Pfizer vaccine. Took ibuprofen over-the-counter and symptoms subsided
Since then, my fingertips have been numb. They turn white and there is no circulation in my fingertips.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had injection, appeared fine, moved to additional seating area and within 2 minutes had fainted. She regained conciousness immediately but we had her lay flat for approx 30 minutes. Her color returned, and she was talking and recovered. We told patient to report to MD her reaction and obtained pcp info to report as well. Parents advised if any additional interactions to take in to be seen.
numbness of left arm and tingling of left hand off and on (tingling of left 10 min after the shot in the evening of 1/27/10 intermittently)
The patient had a vasovagal response after the vaccine injection the patient stated after the injection that he always passes out at the sight of needles or blood. The response lasted five seconds and he became alert and oriented x4. All vital signs were within normal limits. The patient was seated at the time and there was no head trauma. The patient was monitored for 20 minutes after and ingested water juice and food. Upon departure the patient stated he felt much better.
Rhythmic Thumping noise in both ears and immediate headache. This is not constant, but comes and goes. Usually happens in the evening, but today it?s been all day long.
Patient came into the office with complaint of loss of balance when crawling (ataxia) since administration of immunizations approx 1 week ago. waking at night more often crying. emesis x1 last PM.
9/17 WAS LETHARGIC ONLY OPEING EYES BRIEFLY AND THEN FALLS BACK ASLEEP. NOT INTERESTED IN EATING. TOOK ONLY A SMALL AMOUNT WHICH IS NOT LIKE HIM NORMALLY TAKES 90-110ML PER FEED. CALLED PCP WHO ADVISED TO TAKE HIM TO ED. TOOK ANOTHER 80ML IN THE ED AND HE THEN SPIT UP CURDLED BREAKMILK. NO BLOOD OR BILE AND THIS IS NOT NORMAL FOR HIM AND HE IS MORE FUSSY THEN NORMAL. RIGHT BEFORE COMING TO THE HPSITAL HAD A LARGE STOOL MIXED WITH BLOOD AND MUCOS. ADMITTED TO THE HOSPOITAL FOR OBSERVATION AN ULTRASOUND DORDERD WHICH CONFIRMED INTUSSUSCEPTION
Headache Pain in muscles, legs, arms stabbing pain in ears. Back pain still some pain in back could not sleep all night TYLENOL 1:00AM ALEVE 900AM.
TIREDNESS; SMALL LOW GRADE FEVER; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced small low grade fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from tiredness, and small low grade fever on MAY-2021. This report was non-serious.