chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED VACCINE AT CLINIC ON 08/08/23. WAS EVALUATED BY OUR CLINIC ON 08/12/23 WITH COMPLAINT OF BREAKING OUT IN RASH AFTER RECEIVING HPV VACCINE. PATIENT HAD URTICARIA TO THE BILATERAL ARMS
Rapid heart rate at the time of vaccination of 146, heart rate back down to normal until 20 minutes post vaccine with heart rate spike of 138. Heart palpitations for 5 hours post vaccine. Symptoms resolved at 2:00pm on 01/28/21
Patient reported redness and tenderness with swelling to the injection site.   Warm compress recommended, observation of increase swelling and antibiotic given.
4 days later suffered Acute Myocardial Infarction involving the left anterior descending (LAD) coronary artery
high fever of 102.5, administered Tyelnol...fever came back, uncontrollable crying, lump in left leg where shots were recieved- massaged with cold compress, slept for long periods, not eating throughout day.  Fever came back that evening.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
diagnosed with Covid a few days after her first dose of IMOVAX; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age female patient who diagnosed with covid a few days after her first dose of imovax after receiving vaccine rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received a dose 1 dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On 13-SEP-2023 the patient diagnosed with covid a few days after her first dose of imovax (covid-19) 2 days following the administration of Rabies (HDC) Vaccine.  Reportedly, The Vet Techs are required to get pre-exposure rabies prophylaxis. A vet tech student was diagnosed with Covid a few days after her first dose of IMOVAX. HCP is asking if the tech can still receive her day 7 dose on schedule.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event diagnosed with Covid a few days after her first dose of IMOVAX.  At time of reporting, the outcome was Unknown for the event diagnosed with covid a few days after her first dose of imovax.
Per patient, "I don't know if you're aware, but after receiving my first dose of the Moderna vaccine this past Monday I had a weird reaction. About 10 minutes after the shot (in my Left arm) my left thigh started to go numb. The numbness then spread to the rest of my left leg, as well as my left arm, and my left cheek. I went to the hospital to ensure that it didn't get worse, and they checked my vitals and ran some blood tests, and they said everything looked normal, and my symptoms would hopefully go away. In the days after, most of the numbness has gone awa, my left leg has still felt kind of achy, but it is slowly disappearing ".
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild
PSORIASIS; CONDITION AGGRAVATED; COVID-19 RECURRENT; This spontaneous report received from a patient concerned an adult female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total (first dose, 1 in 1 once) administered on 21-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from JUL-2022 for an unspecified indication.   On an unspecified date, the patient had bad reaction to the covid vaccine, severe fatigue, fever, headache, muscle pain and felt like she had COVID-19 again  (covid-19 recurrent), limbs stiffness (psoriasis) and condition aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on JUL-2022. The patient had not recovered from condition aggravated, and the outcome of psoriasis and covid-19 recurrent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220901910- Covid-19 vaccine ad26.cov2.s- Psoriasis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed.            No concomitant medications information was reported.  No treatment medications were provided.  Patient had a stroke mid air and died.  Company comment: This case concerns a death of a male patient, of unknown age, with no medical history reported, who experienced the unexpected fetal event of cerebrovascular accident. The event occurred on an unknown date after a dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as event was fatal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a death of a male patient, of unknown age, with no medical history reported, who experienced the unexpected fetal event of cerebrovascular accident. The event occurred on an unknown date after a dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as event was fatal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: stroke
Neurological pain and weakness. Patient went to ER and was admitted to hospital as well for 2 days. Patient was treated with Gabapentin and Norco.
Mother noticed reaction on 7/13/04, same date vaccine was given but hours later. Shot area was covered with blisters. Arm circumference 28cm Right arm/21cm Left arm induration 17cm
MODERNA COVID19 Vaccine EUA I took my shot on Friday at 1:15pm I had tingling on the roof of my mouth for 2 hours starting about an hour after the shot; this resolved by itself w/o any medication. The tingling (and a bit of discomfort like my mouth had a sunburn) returned about 8 hours after the shot and was accompanied by mild throat swelling (no issues with breathing or any other symptoms). I did a tele-med visit and was instructed to self-medicate at home with Benadryl (50mg) which helped; I took benadryl to lesson the reaction for about 24 hours (q6 hr).   Other than these reactions, I was super tired until day 4  and had a slight discomfort where I had the shot on day two.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 91 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that the patient developed shingles about 3 months after receiving the first dose of the Shingrix series. The healthcare professional did not have any patient or vaccine information because the vaccine was given at a different pharmacy location.
Erythema, hot, edematous, hard area shoulder to elbow following injection. Given prednisone taper BENADRYL & ice packs at urgent care visit on 12/24/12.
Pt developed a diffuse nonspecific red maculo-papular rash covering entire body approx 1 wk after MMR. Had no fever, cough,V/D, URI sx. This rash resolved and was followed by another  bout of rash several days after onset of urticarial rash. The latter rash was localized to L thigh and was urticarial & confluent in appearance.
urticaria all over body; itching on hands; chills; nausea; swelling; fatigue; This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 4th March 2020, the patient received the 2nd dose of Shingrix. On 5th March 2020, 1 days after receiving Shingrix, the patient experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue. On an unknown date, the outcome of the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue were recovering/resolving.   It was unknown if the reporter considered the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient  experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue.  The reporter consented to follow up.
Moderna COVID-19 Vaccine EUA  8/24/21 Arm started getting very sore in evening 8/25/21 Woke up at 3am with chills and body aches. Very bad arm pain with redness, hot and swelling. Out of breath while moving                     about the house. Tiredness, Headache and Dizziness lasted all day. 8/26/21 Bad arm pain with redness, hot and swelling continued along with Tiredness and Dizziness. 8/27/21 Arm pain lessened but still red, hot and swollen.
Lips started tingling, Lips tingled more and roof of the mouth got tingling, ears itchy, throat itchy, throat felt slightly closed up Took a Claritin and sat for an hour til the symptoms cleared up. Took Benydril when I got home because the tingling started coming back in my lips. Symptoms were gone in another couple of hours.
Large inflamed wheal measuring approximately 2-3 inches in length at site of administration.  Large knot under skin slightly smaller than wheal.
No additional adverse events reported; an expired dose of V AQT A was administered today; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.   On 29-JUN-2021 (reported as today), the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (0.5 ml dose, lot# S037574, expiration date 10-APR-2021) intramuscularly for prophylaxis (Expired product administered). The dose was stored properly up through the time of administration. No additional adverse events reported. No product quality complaint. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
After receiving the vaccine, student's eyes rolled back in her head, her body postured for about 5 seconds. Once alert pt was pale and lightheaded for the next 10 minutes
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza. Past adverse reactions to the above products included No adverse event with influenza. Concurrent medical conditions included Hyperlipidemia, Mood disorder (Mood disorder of depressed type), Anxiety, Depression, Androgens increased, Cervical cancer, Cough, Acne vulgaris, Ovarian cancer, Osteoporosis, Breast cancer, Lung cancer, Skin cancer and Colon cancer. Concomitant products included SPIRONOLACTONE for Acne, METOPROLOL TARTRATE, BUPROPION HYDROCHLORIDE (BUPROPION HCL ER), BUPROPION HCL, VITAMIN D3, ASCORBIC ACID (VITAMIN C ACID), NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has Reactive airway disease problem. Lab exam  and physical exam  routine. Fish oil 1000 mg oral capsule orally once a day patient was taking. No treatment information provided.
Info has been received from a physician and a 36 year old female medical assistant who on 08/27/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L) intramuscularly in her left arm. Concomitant vaccination included a dose of influenza virus vaccine administered in the right arm. That night the pt developed swelling from her shoulder to her elbow. The injection site had an inner red circle that was surrounded by a larger wheal of redness. The physician reported that the pt experienced a severe local reaction; arthralgia and malaise. The pt also experienced severe arm pain and "heat". The pt immediately took acetaminophen (TYLENOL) and diphenhydramine HCl (BENADRYL). Subsequently, she was treated with diphenhydramine HCl (BENADRYL) 50 mg HS. On 09/05/2002 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other pts (WAES # 0209USA00030 and 0209USA01591 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Received first dosage of moderna on Friday Feb. 12, 2021. Monday Feb. 15th both knees ached and i had trouble walking. I had a knee replacement in my right knee and major arthritis in my left knee. by Tuesday, Feb. 13th my right knee was back to normal. My left knee is better, but still achy.
Site hard and red and swollen and warm and tender, oval area about size of 1/2 dollar. Later headache, neck/chest and cheeks have red blotches, arm ached to elbow and wrist.
Sore (R) arm- approx 5x6 inch red non raised area.
the patient received Pediarix and Prevnar 13  in left thigh. The vaccine was not placed in the correct area which caused swelling with black and blue bruising. The patient did not have any other symptoms. The provider was able to touch the area. The parent were informed if the area does not improve to return to the office.
Rash, hives, and itchy rash on core body. Spread from neck down all the way to lower back. On both sides of core and front and back. Did not extend to arms or legs.  Hives lasted 72 hours despite taking Benadryl and Claritin.
5cm erythematous induration. Painful. Pt started on KEFLEX 20/5 10 ml PO BID x 10days.
Information has been received from a Healthcare worker concerning a 64 year old male with hypercholesterolemia and no drug reactions/allergies, who on 19-JAN-2011 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot #665707/1407Y, expiration date: 11-JUN-2012). Concomitant therapy included testosterone injection, lovastatin (manufacturer unknown) and lisinopril (manufacturer unknown). Healthcare worker reported that on 20-JAN-2011, the patient has developed "flu like symptoms" such as nausea, dizziness, achiness, fever and vomiting after receiving a dose of PNEUMOVAX 23. No lab diagnostic studies were performed. At the time of the report, the patient's flu like symptoms such as nausea, dizziness, achiness, fever and vomiting persisted. The patient phoned to seek for medical attention. Additional information has been requested.
Soreness at injection site for 3-4 days after shot (expected). Eight days after shot, red, warm, tender, irregular-shaped area (like hives, only just in injection area), 4-5" across.
No Symptoms.  No signs. After 3 weeks of second dose, negative test of antibodies.
Arm became very sore the day after the vaccine. Was fine, no pain the next day.
LEFT COLLAR BONE PAIN; NECK PAIN; SHINGLES (RIGHT EYE SCRATCHY LIKE SAND IN IT VERY SOON POST VACCINATION, SWOLLEN LEFT FACIAL LYMPH NODES AT LEFT JAW, RIGHT EYE PAIN AND PAIN PRESSURE BEHIND RIGHT EYE, LIPS AND EYE DEVELOPED BLISTERS AROUND THEM , LEFT FACIAL SWELLING); DIARRHEA; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, acid reflux, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: 25/MAR/2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shingles (right eye scratchy like sand in it very soon post vaccination, swollen left facial lymph nodes at left jaw, right eye pain and pain pressure behind right eye, lips and eye developed blisters around them, left facial swelling). On 09-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced left collar bone pain. On 10-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 10-MAR-2021, was recovering from left collar bone pain, and had not recovered from neck pain, and shingles (right eye scratchy like sand in it very soon post vaccination, swollen left facial lymph nodes at left jaw, right eye pain and pain pressure behind right eye, lips and eye developed blisters around them , left facial swelling). This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
polyneuropathy; post herpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, polyneuropathy, and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of herpes zoster, polyneuropathy and post herpetic neuralgia was not recovered. The reporter considered events to be related to zoster vaccine live (ZOSTAVAX). The lawyer assessed all events to be disabling.  Upon internal review, the event of polyneuropathy was determined to be medically significant.
Patient had already received High Dose Fluzone vaccine on 10/5/2023.  Today Flublok Quad was administered in error. No adverse events at this time.  Error was discussed with patient at the time of the incident.  Adverse effects are unlikely.
Event: Patient had 3 vaccines (flu, BOOSTRIX, and PNEUMOVAX) on 9/6/2017 around 4:30pm. At 8pm 9/6/17 patient called to report that her arm was swollen, itchy and red at the injection site. On 9/7/2017 at 9am, the pharmacist followed up with the patient again. The patient reported that the redness and swelling still persisted. The swelling was spreading from the injection site to her upper shoulder. Patient also reported dizziness and that she was not able to wake up and stand up from her bed. Treatments: The on-duty pharmacist recommended the patient to call 911 or seek medical attention should life threatening situation occurred. The pharmacist also recommended patient to take allergy medication, ibuprofen, and put ice pack on the injection site. Patient's husband was with the patient when the event was happening. The pharmacist will continue to call patient every 2-3 hrs by the end of 9/7/2017. Patient reported to her primary care provider as well. Outcomes: Around 2 pm 9/7/2017, the pharmacist called the patient again. The swelling and redness were still the same, but she could stand up, walk and eat. She said that she would be ok without going to the emergency room.