chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 07 May 2013 from an investigation participating in a study. A 86-year-old female subject was diagnosed with Bell's Palsy on 02 MAY 2013, i.e. 193 days after receiving the first dose of study vaccine (FLUZONE High Dose or FLUZONE) on 21 October 2012 (site and route of administration were not reported). The subject had medical history of bilateral cataracts, mild sinus problems, bilateral dry eyes, thyroid diease, blood clot near pituitary gland, hyperlipidemia, anemia, cholelithiasis, left inguinal hernia, osteoarthritis bilateral hands and right knee, pain bilateral knees, TIA, overactive bladder, Bjorgren's syndrome and polyclonal gammopathy. On the evening of 02 MAY 2013, the subject noticed that the left side of her face started sagging and she couldn't close her left eyelid. Subject went to the ER on 03 MAY 2013 and was diagnosed with Bell's Palsy. The event of Bell's palsy was other important medical event. The subject's complementary investigations were not reported. As per subject report, subject started on steroid and Prozac. The outcome of event Bell's palsy along with the symptom of left side of face sagging and unable to close left eyelid was not reported. According to the investigator, the event was not related to the study vaccine or trial procedures. The serious adverse event did not lead to the termination of the subject form the study.  List of documents held by sender: none.
SEVERE NAUSEA,VOMITING & DRY HEAVES WITH 99.1 TEMPERATURE LASTING 36 HOURS
LEFT FOREARM SWELLING LIKE A RAISED KNOT; REDNESS IN RIGHT FOREARM; ANKLE SWELLING; LEFT AND RIGHT ANKLE JOINT PAIN/LEFT WRIST PAIN; PAIN MOVED TO HER NECK; NECK STIFFNESS; PAIN IN SHOULDER AND UNDERARM AREA OF THE LEFT ARM/PAIN IN RIGHT FOREARM AND FOREARM SORE/LEFT AND RIGHT FOOT PAIN/PAIN IN LEFT FOREARM; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. Patient was not pregnant at the time of vaccination. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from MAR-2021 for severe headache. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm. On 15-MAR-2021, the subject experienced neck stiffness. On 15-MAR-2021, the subject experienced pain moved to her neck. On APR-2021, the subject experienced ankle swelling. On APR-2021, the subject experienced left and right ankle joint pain/left wrist pain. On 02-APR-2021, the subject experienced redness in right forearm. On 05-APR-2021, the subject experienced left forearm swelling like a raised knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck stiffness on 16-MAR-2021, redness in right forearm on APR-2021, and severe headache, and the outcome of pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm, ankle swelling, pain moved to her neck, left and right ankle joint pain/left wrist pain and left forearm swelling like a raised knot was not reported. This report was non-serious.
This case was received from a health professional on 08 November 2007. A male patient received a dose of Fluzone (lot number not reported) on an unknown date. He complained of weakness, and subsequently developed shingles. He was admitted to the hospital. The reporter did not have any additional information.
First symptom, the evening of  the  Vaccination, the left hand was burning.  2nd day top of feet had  burning sensation, right leg painful.  By 3-5 days face numb., hands numb and sometimes cold. Within a week after, left calf muscle felt unusual sensation when walking and both ankles were burning.  Face and hand symptoms improved first. Calf muscle and ankles nearly normal at three months. At four months, last symptom remaining is feet sometimes feel normal for a few days, but will burn again intermittently.
Fever of 100.4, achy right arn, swollen lymph nodes under right arm, elevated blood pressure 150/69, stiff neck. Patient felt better after Tylenol/advil. But glands were still a little swollen when she came in 7/14/2020
Severe chills/shivering - started 8pm on the same day, let up around 1am low grade fever, tiredness, achy muscles - throughout the second day, still experiencing these
Difficulty breathing (not wheezing, but unable to draw breath), extreme weakness, tingling, vomiting, dizzy, lower than normal blood pressure, fast heart rate, difficulty walking.
Unsure - dad reported patient brought to ER for abdominal pain and was diagnosed with intussusception and had it surgically repaired at facility reported. Patient never seen here for that04/24/07-records received from facility for DOS 03/14-03/15/07. DC DX: Intussusception Ileocolic. HX of emesis and bloody stools. Gastrografin enema water soluble attempt unsuccessful. Exploratory laparotomy with manual reduction of intussusception. Incidental appendectomy.  problem.
lupus like rash on right arm. Onset was 9/20/22 morning. Patient was fatigued lethargic for two days and rash got larger until saturday 9/24/22.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a unspecified history of allergies and drug reactions on October 2012 (above 1 month ago), the patient was vaccinated subcutaneously with ZOSTAVAX (dose and lot # not reported). No concomitant medications were reported. The pharmacist stated that patient, who was administered ZOSTAVAX 1 month ago, was recently diagnosed (approximately in 2012) with genital herpes simplex lesions after an evaluation with her unspecified physician. At the time of the report the patient's outcome of genital herpes simplex lesions was reported as not recovered/resolved. The relatedness for genital herpes simplex lesions was unknown for ZOSTAVAX. Additional information is not expected.
Patient was under age requirment for moderna vaccine booster. No treatment required. No adverse treatment taken place.
Patient states 3 weeks after getting vaccine she got muscle weakness and got shingles for 4 weeks. She asked her md and he stated it was probably from the vaccine.
The shingles vaccine gave me shingles.  I never had a shingles outbreak prior to the vaccine.  Approximately one week after the vaccination, I broke into a shingles rash on my upper left thigh, anterior portion.  The doctor confirmed it is shingles.  I still have the eruptions.
16 year old son got the Moderna Covid-19 Vaccine accidentally; sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally) and MYALGIA (sore arm) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son got the Moderna Covid-19 Vaccine accidentally) and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.
Pt reported when arriving for dose 2 that during dose 1 she had hives within a few hours of receiving Covid  vaccine  dose 1.  She was instructed by her physician to take diphenhydramine every 4 hours around the clock until hives resolved.  She stated this helped.  She was also planning to do this when she took dose 2.
1 day after receiving the 2nd Moderna shot I began to experience severe nausea & vomiting precipitated by intense vertigo. The vertigo was so severe that I had visual disturbances, severe headaches, loss of balance, poor concentration including memory problems, and ringing in the ears that precluded these attacks. These events occurred 1-2 times a day. It has devastated my life.  These episodes take 1-3 hours to overcome and their is no specific time of day they happen. I had to be hospitalized for 2 days exactly 1 week post vaccination. The healthcare providers can not agree that these events are directly caused by this vaccine. I've been told it's central nervous inflammation caused by my immune system over reacting from the vaccine. I have no history of vertigo or really migraine headaches. The neurologists say these symptoms are vestibular migraines or vestibular vertigo (positional).  It's now almost 3 months and I'm still struggling with these symptoms but thankfully not as severe and debilitating.  Shot 1/27/21, first day of symptoms 1/28 and hospitalized 2/3 to 2/5.
Pt was brought to the pharmacy at the local hospital to receive the covid-19 booster.  This is his 3rd shot. I was the pharmacist that was asked to administer the vaccine due to another pharmacist not available.  Due to my normal work duties, I have not drawn up vaccines for almost a year. I had ask one of the immunization technicians to help me make sure I got the right materials and vials.  After giving an HPV vaccine to the pt's sister, I then went back to the work station to draw up the covid-19 booster dose.  The tech had left the vial and diluent out for me.  I drew up the diluent to dilute the covid vaccine vial.  Due to my lack of experience, I had looked at the covid vial and saw that very little fluid was in the vial and I incorrectly assumed that this was the last dose in the vial and did not inject the diluent.  I drew up 0.2 mls of the covid vaccine and administered this to the pt.   After the pt left and I discovered my error, I quickly reached out to a Immunization pharmacy manager and explained my mistake. They directed me to document the error and to contact the parent.  I contacted the mother and explained that their child received a dose too high based on the pt.'s age but that it was the right medication. I instructed her to watch for signs and symptoms of fever and more stiffness/soreness of the arm than usual.  I aslo let her know that if there are any issues that are of concern to bring him to the emergency room.  Mother was understanding and had no concerns or questions.  At this time, there has been no adverse effects for the patient.
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in their ears) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Visual impairment and Heart disorder. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TINNITUS (ringing in their ears). At the time of the report, TINNITUS (ringing in their ears) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications reported included unspecified blood pressure medication. No treatment medications were reported. This case was linked to MOD-2021-437088 (Patient Link).
12/29/22 presents to ED for "fever" "corona virus concern". PMHx of "multiple myeloma on chemo  and PE on anticoagulation"
About 3 weeks later I gradually started becoming weak.  I have stairs in my home and they became difficult to the point that I came down in the morning and did not go back up until bedtime.   I also experienced 3-4 falls during this time,  found getting up off the floor very difficult,  and even standing up from a chair was more strenuous and I began to consistently use my arms to help.  I attributed the weakness to the possible muscular dystrophy that runs in my family.  I saw my family Dr recently and told her that I thought perhaps I had inherited it and it was the source of my weakness.  After discussing this with her and leaving her office I gave it some more thought and realized that I had actually been getting my strength back so the MD wasn?t the source.  After talking to a friend about vaccines I realized it could have been related to receiving the vaccine as there is no other explanation and it was a significant amount of weakness that came on gradually, lasted about 6 months and resolved gradually.
7/19/05 at 4:30 PM pt had a physical examination performed by Dr who found redness to right deltoid measuring approx 3 inches. Site is a bit swollen and warm to the touch mother advised to keep monitoring site and if worse to come back for treatment. TDH to be notified.
NECK AND SHOULDER STIFFNESS, LOCAL REACTION(RASH) GETTING LARGER, ARM SWELLING DOWN TO ELBOW, HEADACHE AND FATIGUE SINCE INJECTION ON 8-29-18.
Headache present for approximately 2.5 days with mild to moderate ocular pressure for same time period. My sleep the first two nights was poor, negatively affected by headache and body temperature increase. Pain level fluctuated between 3 and 6 of 10 and seemed to be affected by blood pressure changes, i.e., pain and pressure would "surge" during certain movements (standing from seated position, walking upstairs or being active and bending over). Sensitivity to light during the next day and some the following day (Sept 3-4). I had to leave work the next day due to headache, ocular pressure, and sensitivity to light. Took acetaminophen 500mg once per day (AM) for two days and aspirin 81mg @ four times per day for two days. Did not take acetaminophen and aspirin together. Took aspirin for pain relief and to reduce possibility of blood clots. Acetaminophen helped some with headache and ocular pressure. I drank approximately 60-80 oz of water each day, the day of the vaccine and the following two days afterwards.
Developed rash on abdomen, generalized itching, pain, redness, swelling at injection site within 48 hrs of vaccine. KEFLEX started.
LOWER BLOOD PRESSURE; CHEST DISCOMFORT; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced lower blood pressure. On 16-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced chest discomfort. On 16-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower blood pressure, and chest discomfort on MAR-2021, and was recovering from fatigue, and muscle ache. This report was non-serious.
Itchy red swelling around 5x5 inches of arm treated with BENADRYL and ice. Given Abx incase of cellulitis duets spreading.
that an expired dose of Pediarix had been administered on 21Jun2022 to a 2 month old female patient.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK receipt date: 18-JUL-2022 Reporter's comment: The nurse administrator reported that upon performing inventory and review, she discovered that the patient was administered a dose of Infanrix, which had an expiration date of 29th May 2022 to a 2 month old patient. This was the patient's first dose in the series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Infanrix, which led to expired vaccine used.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with RECOMBIVAX HB (dose number, route, lot # and expiration date were not provided). In 2014, doses of RECOMBIVAX HB that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified dates, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant Medication use information was not provided by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns an adult male patient with concurrent condition of ankylosing spondylitis and reported non serious event of Therapeutic product effect decreased (reported as HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second and booster doses with the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with concurrent condition of ankylosing spondylitis and reported non serious event of Therapeutic product effect decreased (reported as HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second and booster doses with the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Nausea, Head cold, fever, chest sweats, morning leg pain, schizophrenic thoughts, loss of appetite, diarrhea.
DISCOMFORT; BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, discomfort, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and discomfort. This report was non-serious.
1 Inch below the actual injection site began a quarter size red, swollen, painful spot. By end of 5/13/21 had become the size 4 inch x 1.5 inch oval.  Went to Emergency Room to make sure was not a blood clot.  Doctor said was not a blood clot.  He also did ultrasound to make sure no abscess or other was present.  Nothing present.  Prescribed antibiotics for Cellulitis but I have not started that treatment.
BODY ACHES; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.5 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, body aches, and nausea. This report was non-serious.