chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed an exanthem involving the trunk, arms, neck, legs within 12 hour of his last dose of 875mg Amoxacillin for tooth abscess on day ten post the first immunization for COVID-19 (Moderna). The rash was maculopapular and mildly itchy treated within a couple of hours post discovery (member awakened with rash this AM) with benadryl via urgent care, no major change after benadryl.
INJECTION SITE REACTION, LARGE RED/SWOLLEN AREA BIGGER THAN THE SIZE OF A QUARTER, TREATED WITH PREDNISONE AND RESOLVED QUICKLY
Pt recvd Engerix-B 10MAY91 & 1JUN91 & 22NOV91; In mid-MAR92 pt exp arthritis of the lower extremities; knees, groin; pt states event started out as a burning sensation in knees & groin; pain resumes on walking; burning sensation;
After administration of Zostavax, patients left arm turned red and warm. Three hours later, the back of the arm above the right elbow also turned red and warm. Patient was encouraged to go see a doctor. Cephalexin and cetirizine were prescribed for reaction. Day five following immunization, reaction on both arms went away. However, on day eight following immunization, patient noticed five red spots that itched on her right arm in the same spot the initial reaction was reported. Patient reported that reaction had fully resolved by the 10th day.
HEAVY HEAD; FEVER; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported 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 an unspecified date, the subject experienced heavy head, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever and heavy head was not reported. This report was non-serious.
Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast; chills; Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain). At the time of the report, CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-163250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant/ outcome unknown On 16-Jul-2021: Non-significant Follow-up
outbreak of shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2021, 29 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in right deltoid and had an outbreak of shingles. The patient was currently being treated by his health care professional. The reporter consented to follow-up.
About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling dizzy/ready to faint, unable to sleep, extreme exhaustion, general over all weakness lasting about 6-days.
pt recvd vax & had 6cm x 8cm flat red; slightly warm (blistering earlier) over inject site; tenderness positive;
Began with redness around injection site on 01/26/04.  On 01/27/04, tricep area was reddened and swollen; tender, warm to touch.  Today, school nurse noticed swelling down to elbow.  Family provided no treatment.  Recommended call physician, cool compress and pain relief approved by PMD.
26 yr old female with a right deltoid erythema, swelling and pain complaint. Received an ADACEL inj. 3 days ago. Initially significant red. Redness decreased but swelling increased.
I had priapism daily, with great intensity. I had to go out running for the pain to go away.
Stroke; Heart attack; High blood pressure; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Aug2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included sleep apnoea syndrome. The patient's concomitant medications were not reported. The patient experienced high blood pressure, stroke, heart attack on 19Aug2021 15:00. The patient was hospitalized for the events for 2 days. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events including medications. The patient underwent lab tests and procedures which included blood pressure measurement: high on 19Aug2021, Covid test (Nasal Swab): negative on 09Aug2021, Covid test (Nasal Swab): negative on 14Aug2021. The outcome of the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No adverse event.  First dose Pfizer vaccine administered 7/22/2022. Invalid follow up COVID-19 vaccine administered on 8/3/2022.
A couple days after vaccination, began having pain in the left thigh at the site a previous shingles outbreak approximately 5 years ago.  Pain progressed rapidly to the point of requiring a cane.
HISTORY OF PRESENT ILLNESS: Patient is a 20 y.o. female with a PMH of  has no past medical history on file. is being called today for a vaccine reaction    Pt received Pfizer vaccine on 4/6/21.  3-4 hours following the injection - started experiencing itchy raised wheel shaped lesions to arm. Hives gradually spread to both arms, face, neck and are now diffuse to these areas.    Denies difficulty breathing, swelling of the face, tongue, or lips, dizziness, increased drooling.  No GI or other systemic symptoms.    COVID-19 Vaccine Adverse Reaction Screening Flowsheet completed   She has been taking Benadryl Q6-8 in addition to Claritin 10 mg daily. Added topical steroids hydrocortisone 2.5% with mild improvements in itching.    States that hives have continued to expand despite antihistamines and topicals. Would like guidance re: current management and 2nd dose of vaccine.    She does have a hs of hives - triggered by heat. Treated with antihistamine.     Also with many seasonal allergies and some food allergies. No known drug or vaccine allergies in the past    Takes Claritin 10 mg daily for seasonal allergies  No Known Allergies Current Medications Current Outpatient Medications Medication Sig Dispense Refill ? cetirizine (ZYRTEC) 10 mg tablet Take 10 mg by mouth daily.     ? ibuprofen (ADVIL,MOTRIN) 600 MG tablet Take 1 tablet (600 mg total) by mouth every 6 (six) hours as needed.. 60 tablet   ROS: Per HPI   VITAL SIGNS are unavailable for this phone visit.  BP Readings from Last 3 Encounters: 04/09/18 103/67   PHYSICAL EXAM is unavailable for the phone visit. Patient was calm. Voice was clear. No signs of respiratory distress, anxiety, or depression. Speech organized.    DATA REVIEWED:    ASSESSMENT / PLAN Patient was seen today for allergic reaction.   Diagnoses and all orders for this visit:   Urticaria, acute - Spoke with PCP. Agreed with plan for oral steroids although this is likely to decrease immune response of vaccine    Urgent referral to allergy placed    RETURN VISIT:  As needed I spent 25 minutes with the patient, of which 25 minutes were spent reviewing data, counseling and coordination of care. Specifically we discussed my impression of the etiology of the patient's symptoms, interpretation of test results, management plan, and acute symptoms for which to seek immediate medical attention.   I have counseled about COVID19 ? specifically advising on social distancing, hand washing, staying home when sick. I also provided them with the campus resource line   Electronically Signed by APRN, April 9, 2021
PATIENT INDICATED BLOOD GLUCOSE WAS 500, TREMORS, FEVER, SWOLLEN FEET, DIFFICULTY BREATHING, BRUISES IN ARMS AND THIGHS
He had a slight relapse in his multiple sclerosis condition, he started with tingling in his face, vision problems, dizziness, motor problems.
Initial information received from a health care professional on 18 November 2013. A 73-year-old female patient had received first dose of FLUZONE HD (batch number: U4173AA) intramuscularly in the right deltoid on 12 September 2013. The patient was not ill at the time of vaccination . The patient had history of pacemaker, hypertension and was concomitantly taking anti-arrhythmic drugs. On an unspecified date after vaccination, the patient complained of pian and limited range of motion of her right arm. There ws inflammation at the injection site and was prescribed naprosyn (naproxen). Lab investigations were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not have any known allergies. Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date-19Jul2023, Treatment stop date-23Jul2023, Indication-Treatment of COVID-19, Administrator Route-Oral.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 and the reported events Covid-19, drug ineffective cannot be excluded.
Severe arm pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe arm pain". Additional information: Patient experiencing severe arm pain for 10 days after receiving Prevnar 20. The physician confirmed that the event took place after use of product.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as "Motrin for allergies". On 19 Dec 2006, the patient was vaccinated intramuscularly with the firs "single dose vial" of Gardasil (Lot # 653938/0954F). Concomitant therapy included Motrin, Desogen, Allegra and Zantac. On 19 Dec 2006, "almost immediately after vaccination", the patient became a little flushed in the face and had to take a minute to sit and gather herself together. The patient was noted to have a blood pressure of 101/65 mmHg (date unknown). The patient sought unspecified medical attention. It was reported that the patient" improved within seconds". On 19 Dec 2006, the patient had recovered from the event. The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI". Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as MOTRIN for allergies" and no illness at the time of vaccination.  On 19-Dec-2006, the patient was vaccinated intramuscularly with the first "single dose vial" of GARDASIL (Lot # 653938/0954F).  Concomitant therapy included MOTRIN, DESOGEN, ALLEGRA and ZANTAC.  On 19-DEC-2006, "almost immediately after vaccination", the patient became a little flushed in the face, experienced dizziness, and had to take a minute to sit and gather herself together.  The patient was noted to have a blood pressure of 101/65 mmHg (date unknown).  Vital signs taken were very similar to those taken during the exam.  It was reported that the patient "improved within seconds".  On 19-DEC-2006, the patient had recovered from the event and left the office without further incident.  The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI".  No additional information is expected.
started to have rash, ithcy, pain around injection area one week after the shot. tried otc antihistamine, itchy improved, but still have redness, swelling and pain. ,
? febrile seizure vs BRUE in afternoon after event. Was unresponsive approx 30s not breathing required layperson CPR. EMS was called and transported child and stayed in ER several hours for observation. Child was d/c that evening.
All started within 15 min patient started itching all over body throat went numb, started coughing with vomiting trouble breathing - pt was seen and ordered & given SOLU-MEDROL 40mg IM and was kept in office 1 hr before she was taken home feeling better.
7 days post vaccine, swelling and a rash appeared at the injection site and through day 8 this was present at the injection site and within a 4 inch radius of the. Site of Injection. Exterior layer of skin was in tact and the swelling , redness and itchiness reduced within 72 hours of onset without taking any medication
Mom states pt gets himself worked up for shots. Gave vaccines and pt ok pt got up to leave and got about 20 feet. Got lightheaded and dizzy was put in chair, didn't feel better after about 4-5 min so took to lay down, laid down after 10-15 min was ok when left.
Information has been received from a physician concerning a 9 week old female with on medical history or allergies who on 11 Aug 2006 was vaccainted with a PO first dose of Rotavirus vaccine (lot 654248/0577F). Concomitant vaccination included a dose of Hib vaccine, a dose of Pediarix and a dose of Prevnar. On 11 Aug 2006, two hours after vaccination, the patient developed diarrhea. On 13 Oct 2006 she vomited once. The diarrhea continued to some degree to the present, however the child continued to gain weight. Medical attention was sought. She was negative for rotavirus, shigella, salmonella and Campylobacter coli. There was no product quality complaint involved. Additional information has been requested.
flu-like symptoms; nausea; vomiting; itchy all over her body; dizziness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On 21st December 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness. On an unknown date, the outcome of the influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on December 20th, 2019 at the doctor's office.  On 21st December 2019 Saturday, in morning she woke up with flu like symptoms, nausea, vomiting, itchy all over her body, dizziness.  The patient did not have a fever.  On 22nd December 2019, Sunday she felt better but not completely recovered.  The symptoms were gone at the time of reporting. The reporter consented to follow up.
Narrative: COVID infection following COVID vaccine series 06/11 Janssen, dose #1 10/05 pt admit to medicine cc: "LOW OXYGEN LEVEL" dx: COVID PNA LOS: 8 10/05 CXR impression: 1. Patchy opacities within the mid to lower lungs bilaterally, greatest in the right midlung, consistent with COVID-19 pneumonia 2. There is mild blunting of the left lateral costophrenic angle. Pleural effusions are atypical with cough and pneumonia. This blunting is nonspecific however could be related to other processes, including infarct. Consider CT as clinically indicated. 10/05 CTA PE Impression: 1. No evidence of pulmonary embolism. Pulmonary arterial hypertension. 2. Diffuse bilateral patchy groundglass airspace opacities in a distribution highly suggestive of COVID pneumonia versus alternate multifocal infections or inflammatory process. Follow-up to resolution recommended to exclude underlying malignancy after appropriate treatment. 3. Right hilar and mediastinal lymphadenopathy which may be reactive but also bears watching on follow-up to ensure resolution. 4. Upper Abdomen: See concurrently performed CT abdomen and pelvis report dictated separately. 10/05 COVID swab, result: detected 10/05 pt cc: loss of taste or smell, dyspnea, exposure: unknown 10/17 clinically resolved 11/05 CXR impression: No pulmonary embolus. Maturing pulmonary parenchymal findings due to the history of known COVID pneumonia. 11/08 CXR Impression: Unchanged patchy bilateral left greater than right airspace opacities.
got the shingles for 2 months; worse painful feeling; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and then 2 weeks later got the shingles for 2 months. The patient stated that he/she had the worse painful feeling.
Vaccine stored at room temperature greater than 24 hours after first puncture and then administered; Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture) and PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022 at 6:20 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022 at 6:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture) and PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was taken out of the freezer on 22-Apr-2022. Vial was taken out of refrigerator on 01-May-2022. The vial was stored at room temperature after it was first punctured on 01-May-2022, at 1:55 PM. Total time of vial at room temperature was around 28 Hours, 25 Minutes.  No treatment information was reported.
This vaccine is not approved for administration over the age of 6 years. This child was 7 years at the time of administration. No other adverse reaction has occurred due to this.
Patient reports that after she received second dose of Moderna vaccine she developed a ?racing heart rate, SOB and dizziness?. She was evaluated a injection site clinic but was advised to go to the ED for ongoing symptoms. She went to Paoli Hospital ED and was evaluated for dizziness. She was discharged to home Diagnostic test and lab results: CT Head ? no acute intracranial pathology CXR: no active disease EKG: NSR Labs: Troponin ? normal, CMP ? WNL, CBC w/ diff ? WNL
- Cellulitis @ injection site  - admitted for IV abx - discharged w/in 48hrs, improved quickly
HBIG given IM at 12:30 PM on 07/23/01, patient had hot rash over arms, chest and legs. Started at 3:00 PM on 07/23/01.