chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 24 month old female with no past medical history and no concurrent conditions who on 4/10/03, also reported as 4/10/02, was vaccinated IM in the left arm with a first 25u 0.5mL dose of hepatitis A virus vaccine inactivated (lot # 639847/0909L). There was no illness at the time of vaccination. There was no concomitant medication. On 4/12/03, two days later, the patient developed a fever. On 4/20/03, ten days later, the patient looked pale and lethargic. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. There were no adverse events following prior vaccinations of the patient or her siblings. Follow up information received from a physician indicated that on 4/12/03, 2 days after vaccination, the patient developed a fever. On 4/19/03, the child was pale and not herself. This was reported as still intermittent. Additional follow up information received from a physician indicated that on 4/12/03 the child started with the onset of the fever. The mother called on 4/19/02 to indicate that her child was very pale, looked sick, was fussy, her body was warm and her hands were cold, and she was not herself. The mother indicated that this had all occurred since shot last week. The mother called again on 5/19/02 and indicated that the child still appeared very pale to the mother, otherwise she was acting fine, indicating that she was playful, sleeping well, and had a good appetite. Laboratory data is listed below. Additional information has been requested.
RMA brought prepared Prevnar 13 vaccine into the exam room to administer to patient. Vaccine was prepped and she had attached the needle to the prefilled syringe. When she was taking the protective cover off the needle, the syringe snapped at the top of the syringe where the needle is attached. They syringe itself broke. The vaccine was not administered and another vaccine was obtained to complete the immunization without any difficulties. We have never encountered this type of syringe malfunction in the past at our clinic.
About 2.5 weeks after first shot, I started have joint pain and stiffness in my hip then about a week later it went down to my knee. It was painful to walk and painful sitting, I went to the Orthopedic Specialist walk in clinic and they didn't see much on xray, just called it a hip impingement and prescribed me anti-inflammatory when that didn't work they prescribed a steroid and when that didn't work, I started physical therapy which made it more painful so I stopped. I then went see my family doctor and did a rheumatoid panel and the RA factors inflammation levels came back positive but everything else for RA was negative. I then went back to the Orthopedic Specialist and did a MRI and they said I do have bursitis in the hip which is causing knee pain. I will be doing another round of anti-inflammatory medication
Symptom onset 11/15/22. Treatment includes: Paxlovid, Tylenol, PT/OT.
PSA scores showed an increase to 1.2; This is a spontaneous report from a contactable consumer. This 71-year-old male consumer reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation. Relevant history included prostate cancer which was previously diagnosed and was undergoing treatment. The patient received his 1st dose of the vaccine (BNT162B2) on 03Feb2021. Relevant concomitant drug was unknown. The patient noted that he had routine blood work done to check the PSA score for his prostate cancer, his previous PSA scores had been 0.1, 0.1, 0.3 respectively, however his most recent score from bloodwork done on 25Feb2021, showed an increase to 1.2. The patient asked if it was possible that the vaccine could have caused an increase or resulted in an incorrect number in his PSA score. The outcome of event was unknown.  Information on the lot/batch number has been requested.
vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-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 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No corrective treatment was provided.  28-Feb-2021, he was hospitalized for vertigo for 3 days.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time.  Further information has been requested.
Severe headache (migraine) started within a few hours and has continued with daily headaches since first vaccine.  Additional migraine after second dose, continued to have daily headaches since.
Patient is a 94 yo M who received his second dose of shingrix vaccine 6/14. The patient was at his baseline until yesterday afternoon (6/16) when he developed redness without itching on all parts of body face and his chest back and legs.  Patient with no evidence of any pruritus. The redness is mostly on the upper part of the body, not raised, not anaphylactic, no pain or itching. Pt is still red.
warm to touch; color is red turning yellow; inches wide pretty severe bruise; Arm soreness; A spontaneous report was received from a non-healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow.  No medical history was reported.  No concomitant medications was reported.    On 10-Jan-2021, prior to the onset of the events swelling of the arm/arm was swollen, arm was swollen under the injection site like a ball, arm was really itchy and arm was hot to the touch, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via an unknown route in left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, the patient experienced arm soreness, and on 08-Jan-2021 experienced inches wide pretty severe bruise, warm to touch and on an unknown dare experienced warm to touch and color is red turning yellow. Laboratory details were not provided.  No treatment medication included.  Action taken with mRNA-1273 in response to the events arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow was not provided.  The outcome of the events swelling of the arm/arm was swollen, arm was swollen under the injection site like a ball, arm was really itchy and arm was hot to the touch was not provided.  The reporter did not provide the assessment of the events arm soreness, inches wide pretty severe bruise, warm to touch and color is red turning yellow to study drug.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
2 1/2" diameter red/swollen/itchy patch x 8 days - no other symptoms, still existing.
Dose administered after improper storage and handling; Dose administered after improper storage and handling/ pre-drawn syringe that was; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was) had resolved.        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.   No concomitant medications were reported.  No treatment information was provided.  Reporter informed that one dose of the moderna vaccine was administered to an employee from a pre-drawn syringe that was left out for 24-36 hours. Dose administered after improper storage and handling.
Pt received 2nd dose Pfizer at clinic. Pt sat in observation room after vaccine administration. Pt began to cough. RN brought water and asked if pt was chocking on saliva. RN assessed pt's tongue and mouth. No swelling noted. Pt continued to cough. RN called charge RN. Charge RN came to assess. No visible swelling noted. Pt denies any history of allergic reactions. At 1556 Epi 0.3mg given IM in R thigh. Pt tolerated well. Vitals collected at 1600: Bp- 189/114, RR-18, O2-96% , HR-97. Pt reported feeling much better after EPI administration and coughing ceased. Charge RN called 911 per emergency protocol.
Information has been received from a school nurse concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live. The nurse reported that the child has been out of school for three weeks due to rashes that developed after being vaccinated. The child has been breaking out in "new crops" each week for three weeks. It was noted that therapy was "discontinued".  Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow up was received from the school nurse which indicated that she had no additional information. The nurse did indicate that the pt was attending school. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 2 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored PROQUAD (lot: N025928, expiry date: 18-MAR-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours, 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter. Sender's Comments: US-009507513-1804USA004755.
Vaccine given 10/6/08. Six days later got red bump at site of injection which has gradually increase in size. No fever. No exudate. Non-tender. Diameter of circumferential, erythematous macule is 2 cm.
Tired; Weak; Nauseous; Hot flash; Dizzy; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 03Aug2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Aug2021 at 11:45, the patient felt tired, weak, nauseous, hot flash, dizzy and had arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, weak, nauseous, hot flash, dizzy and arm pain were unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years 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 complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 24Dec2021, outcome "recovered" (08Jan2022). The patient was hospitalized for chest pain (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of chest pain.  Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 19Jul2022 to 23Jul2022. Admitted for chest pain for first booster. Had rebound covid from Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the causal association between the event Chest pain and the suspect drug BNT162b2 cannot be excluded completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Initial report received from a health care professional on 24 September 2007.  A 38 year old, female patient developed a large local reaction at the site of injection and was diagnosed with cellulitis, after she received Adacel (lot number C2771AA) in the right deltoid on 02 August 2007.  She did not have any illness at the time of the vaccination.  It was reported that patient recovered.  This case has the same reporter as cases 2007-02774 and 2007-03222.
Patient states she had bruising and swelling to left shoulder area which covered top of shoulder to mid deltoid area.  Pt also states numbness to right middle finger.  While swelling has resolved, numbness of right middle finger still persists.
Patient received vaccine in Administration clinic. During observation period, patient reported feeling nausea, lightheaded, and tightness in the back of head. Patient also reported vomiting in bathroom. RN remained with patient. Vital signs: 132/84; HR 99; 02 Sat 99%. Patient provided water, refused crackers. Remained with patient for emotional support. Vital signs retaken @ 3:52pm 111/75; HR 75; 02 Sat 100%. Remained with patient in observation room. 4pm patient reported feeling better and symptoms resolving. Vital signs at discharge: 137/77; HR 72; 02 Sat 100%.
Pt stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. I ran to room. Patient face down on floor, I rolled him over. He was looking at me but unaware of surroundings & shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache & vision changes. Vision changes resolved about 1 hr. He threw up once 2-3 hr after event. He went home after 1 hour of observation.
Hematologist/Oncologist: MD  Primary Care Physician at Discharge: MD Admission Date: 7/10/2023 Discharge Date: 07/17/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired pneumonia of both lungs [J18.9] Acute respiratory failure [J96.00] Respiratory failure [J96.90]   HOSPITAL COURSE: This is a 70 y.o. patient with a past medical history significant for non-hodgkin's lymphoma, HTN, CAD, and HLD who presented to Hospital ER on 7/7 with symptoms of chills, fevers, cough and SOB. Pt reports contracting COVID in early June while on vacation. However his most recent COVID antigen test was negative. He felt he never fully recovered. He began having fevers and chills again on June 30 and presented to ER on 7/7 when his symptoms weren't improving. CTA of the thorax showed no PE but did show bilateral opacities. He was admitted to Hospital with bilateral CAP and treated with azithromycin and Rocephin until his transfer to different hospital for ID and pulmonology consults.  He did receive IVIG at Hospital prior to transfer.   Submitted ID and Pulmonary medicine was consulted and a bronchoscopy was performed on 07/11.  All workup was negative except for on the bronchoscopy did show that patient was COVID positive.  Unfortunately after the bronch on 07/11 patient had an episode of acute hypoxic respiratory failure and a RAP was called.  He was transferred to the intensive care unit and BiPAP was started.  Infectious disease recommended 5 days of remdesivir and steroids.  He was able to transfer out of the intensive care unit on 07/14.  He was very quickly weaned off of oxygen.  Initially pulmonary recommended a very long, approximately 8 week prednisone taper.  However the malignant heme attending was concerned about 18 for that long affecting his immune status.  I did reach out to Pulmonary Medicine on 07/17 to discuss shorter taper.  They were okay with an approximately 2 week taper.  Patient received his last dose of remdesivir and he was stable for discharge.  Above follow-up with Dr. was arranged.  He was discharged home in stable condition
itching; swelling; little bit of soreness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (little bit of soreness at the injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pain (soreness at injection site) on 09-Mar-2021, Itching on 09-Mar-2021 and Swelling (swelling at injection site). Concomitant products included BUPROPION, FLUOXETINE, LORAZEPAM and OMEPRAZOLE for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness at the injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling). On 22-Mar-2021, VACCINATION SITE PAIN (little bit of soreness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Treatment information provided
dose which expired was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) (batch number be554, expiry date 1st August 2021) for prophylaxis.   On 4th November 2021, the patient received the 1st dose of Havrix. On 4th November 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a pediatric dose of havrix which expired on 1st August 2021 was administered to the patient on 4th November 2021, which led to expired vaccine used. The reporter consented to follow up.
Information has been received from an 87 year old female patient, with Crohns disease, no drug reactions or allergies and a history of nerve damage to left leg after a hip replacement, who "approximately two to two and a half years ago" (in approximately May 2008), was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included "various" (unspecified medications). "A month ago" (on approximately 11-OCT-2010) the patient had shingles. The patient stated that the physician looked at them to determine that it was shingles. The patient had been using "SYCHOVIA ointment" (manufacturer unspecified) and "the medicine", but neither seemed to work. Additionally, the patient had very mild itching off and on, no pain, and something on the left side of her leg; but she had surgery on that part of the leg, she did not know if that is a result of that. It was not a very severe reaction. She thought she may have picked the shingles up at the hospital while she was having surgery on her left foot. It showed up while she was on rehabilitation at the hospital, right after the surgery. At the time of the report, the patient had not recovered; her condition had improved "very little". Additional information has been requested.
Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion
Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.
Pt came to clinic 6/24/12 with small skin reaction to Zoster vaccine. No fever or discomfort. Dr. advised warm soaks.