chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 17th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
5 days after vaccine. Went to walk in clinic with hives on back and armpits down to waist . Also upper groan area. spread from armpit to elbows. Patient also was really fatigue. Heart rate was dropping in the 40's at rest.
Pt recvd 1 dose of Engerix-B 15OCT91 & that same day exp sinus tachycardia, fever of 99.6 & sensation of numbness in arms & fingers; tx used were hot packs @ site of inject; events resolved;
severe thrombocytopenic purpura.; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On approximately 11-DEC-2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, on unknown date, the patient suffered and was diagnosed with severe thrombocytopenia purpura. The patient's symptoms resulted in physical limitations not present prior to using the Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient also sustained severe and permanent personal injuries, 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. At the time of the report, the patient's outcome was unknown, and the event of severe thrombocytopenia purpura was assessed as related.  Upon internal review, the event of thrombocytopenia purpura was considered medically significant.
Started bleeding on August 3rd somedays heavy bleeding occurred this was not the normal period, and was not close to time for cycle . I am still experiencing bleeding.
Same day post vax, the child began having a rash. Rash was described as being erythemic and slightly raised. Rash was on abdomen, trunk, and lower extremities. Child has not had any signs of itching, fever, shortness of breath or other problems. Pt also ingesting antibiotics and may be allergic to medication. Parent also reports a small lump at one of the injection sites on left leg.
Varicella Information has been received from a physician concerning a 6 year old male who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced very few chickenpox spots. He was not itching, no fever or complications were noted. It was reported that the patient had been exposed at school Additional information has been requested. 05/16/2007 Information has been received from a physician and a nurse concerning a 6 year old female (initially reported as male) who on 29-NOV-2001 was vaccinated with VARIVAX. On 15-MAR-2006 the patient had an onset of chicken pox breath thru with very few chicken pox spots (less than 50 lesions). She was not itching, and no fever or complications were noted. It was reported that the patient had been exposed at school. Subsequently the patient recovered. No treatment was necessary, just comfort measures as needed. The nurse also reported on two other patients who experienced adverse events after being vaccinated with VARIVAX (WAES # 0703USA05015 and #0703USA05016). Additional information is not expected.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: shortness of breath, pain in neck and back head, side face, ear all left sided-Mild, Systemic: Headache-Mild, Additional Details: left sided pressure and pain from neck to top of forehead on left side, side of administration.
In late February, I started feeling unwell. I initially experienced chills and body aches that included muscle and bone. On March 1, 2023, I felt worse. I had chills, body aches, joint pain, headache, and a cough. I felt feverish, but my thermometer did not give me an accurate reading. I tested positive for COVID-19 at home. The symptoms continued to get worse over the next day. By March 3, 2023, I went to urgent care. They repeated the COVID-19 test. The result came back positive. He prescribed PAXLOVID and one other medication that I can't name right now. He reduced my ELIQUIS to 2.5mg twice a day. I remained unwell for several more days with a lot of phlegm from my bronchial and from my sinuses. I started feeling better around March 08, 2023. I've improved every day since then. I also felt very exhausted for about 8 or 9 days. I continued to experience fatigue until about March 14, 2023.
Itchy rash, hives. Flush face. Erythema to back and arms. TX - steroid shot in office. OTC BENADRYL.
Moderna Covid-19 Vaccine EUA Vaccine found to be out of date after administration on 8/4/21.
could not get out of bed; very sick; could not eat; severe pain on her left side especially in her leg; nausea; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (could not get out of bed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease (Parkinson).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced IMMOBILE (could not get out of bed) (seriousness criterion medically significant), ILLNESS (very sick), FEEDING DISORDER (could not eat), PAIN IN EXTREMITY (severe pain on her left side especially in her leg) and NAUSEA (nausea). On 04-Apr-2021, IMMOBILE (could not get out of bed), ILLNESS (very sick), FEEDING DISORDER (could not eat), PAIN IN EXTREMITY (severe pain on her left side especially in her leg) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Company comment: This case concerns an 83-year-old female with Parkinson's disease, had a serious unexpected event of immobile, and non serious unexpected illness, feeding disorder, pain in extremity, and expected nausea. Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 83-year-old female with Parkinson's disease, had a serious unexpected event of immobile, and nonserious unexpected illness, feeding disorder, pain in extremity, and expected nausea. Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache and Stomachache; stomachache; Feeling sleepy , needs to sleep all the time; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0777027310) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time). At the time of the report, HEADACHE (Headache and Stomachache), ABDOMINAL PAIN UPPER (stomachache) and SOMNOLENCE (Feeling sleepy , needs to sleep all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications or treatment information provided.
Vaccine was exposed to storage temperature outside the recommended ranges. Patient did not need any treatment and did not have any symptoms.
WE WERE REPORTED THE FOLLOWING INFO BY HER FRIEND BEGINNING 3/29/21:  Monday               Patient collapsed at work and was taken to hospital.  She was intubated and sedated.  They did a CAT scan and labs and ruled out heart attack and stroke.  Her blood sugar was also fine. Doctors did not know what caused this and started to lean towards stroke again and scheduled a MRI for Tuesday.     Tuesday               She was taken off sedation but has not regained consciousness and she is breathing 70% on her own w 30% oxygen supplement.  MRI was done and again ruled out stroke.  Lumbar puncture was done and came back clear for meningitis and West Nile viruses. EEG was done and waiting on results.   They did a reflex test and she responded well.  She does have random eye opening and hand movements just not on command.     Wednesday        She ran fever during the night and they were able to control it.  Waiting on EEG results.                          Dr is going to repeat all tests especially for stroke, said her heart is weak but it?s functioning.
Itching and hives reported by patient, outside urgent care evaluated 8/22/2021 documented normal skin exam but diagnosed hives.
mom calins poor memory for details 9MAY 6-630 anorexia, T103, fussy, irritable gave APAP, diarrhea, no appetite & did not move for 2 days;did not always verbally respond;hard to awaken, groggy @ times, sleepmore than usual
I can't get the second dose; I had allergic reaction/ My reaction started probably little bit at after the 15 minute more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Verbatim: Overweight; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "I can't get the second dose"; HYPERSENSITIVITY (non-serious) with onset 26Oct2021, outcome "unknown", described as "I had allergic reaction/ My reaction started probably little bit at after the 15 minute more". Therapeutic measures were not taken as a result of hypersensitivity.  Clinical Course: Consumer stated, "I need to know if I am allergic to the Covid19 Vaccine because I had allergic reaction. What kind of proof do I need to show the people in the future that I can't get the second dose and was informed about the role of Pfizer Drug Safety and about Pfizer Medical Information for the concern and was provided the contact, Option 3, Monday to Friday, 8am-20:00pm. Consumer confirmed the product as first dose of Pfizer Covid19 Vaccine LOT.  "I can't find my vaccine card. It is probably in the car or something. I don't know where it is. I don't have it on hand. Weight: "Weight I don't know. I am about 277 or something. Other Medical Conditions: "A lot of things is wrong with me those are just the major ones." (Further clarification unknown) "My reaction started probably little bit at after the 15 minute more. What do you want to know? "When clarified, consumer stated, "withheld pharmacy." No, I didn't have other shots this year and don't have any of the information. The pharmacy will have all that. I went home, and I just waited that it would go away. "The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of widespread rash in a 49-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 15th February 2018, the patient received SHINGRIX. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced widespread rash (serious criteria disability). On 16th February 2018, the patient experienced fever. On an unknown date, the outcome of the widespread rash and fever were unknown. It was unknown if the reporter considered the widespread rash and fever to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient received a dose of SHINGRIX the day before the date of reporting and experienced diffuse rash later that evening. On 16th February 2018, 1 day after vaccination, the patient experienced fever. The patient's body temperature was recorded as 102 degree F. The patient was on their way in for an office visit. No further information was reported regarding the event.
Jaw pain; Tastebuds were off; Sick; Chills; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw pain), AGEUSIA (Tastebuds were off), VACCINATION COMPLICATION (Sick), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN JAW (Jaw pain), AGEUSIA (Tastebuds were off), VACCINATION COMPLICATION (Sick), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN JAW (Jaw pain), AGEUSIA (Tastebuds were off), VACCINATION COMPLICATION (Sick), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event was not provided.; 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.
I experienced terrible joint pain in my knees, hips and rib cage.  Felt like I had been beat up.  By 8PM on the 31 was shaking so hard with chills sat in truck with heater running full blast in 82 degree outside temp.  Profuse sweating followed through out the night along with waves of chills and nausea.  Dry heaved a few times.  Had nothing to eat for two days  Also a terrible headache accompanied this.  Daughter was going to call 911 at 1:30 AM on August 1 but didn't.  She found on site a reference to Tylenol and asked my Primary care id I could take it.  The answer came back it was ok to take.  This helped some.  Too until Friday 08/02 AM when reactions seemed to quit.  Nothing since.
Coughing, wheezing, weakness, fatigue, red swollen eyes, sore throat, vomiting occurred 4 hours after injection.
The patient experienced nausea, dizziness, and malaise. She had symptoms immediately after the injection when moving to the observation room. She was monitored for almost one hour and had normal vitals. She was able to leave on her own and sent confirmation when she arrived home and that evening to vaccinator.
lips turned blue, seemed confused; would not hold head up; body limp; difficult to arouse; this happened twice once @ 630pm & once @ 830PM: took pt to MD p/2nd episode;
had their second dose probably two months later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later) had resolved.            Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-375343 (Patient Link).
Symptoms began 3 days after shot and began with a fever of 100.5 F in the afternoon on the Thursday  following vaccination. Fever persisted for approximately 12 hours, despite taking an over the counter fever reducer.  After this, I developed nausea and was unable to eat much for approximately 4-5 days. Being worried that I had contracted COVID before the vaccine, I got a rapid test the day after symptoms began. The COVID test came back negative. On Friday I developed a red, stinging, itching rash on the injection arm. The rash lasted for several days. During this time I also developed joint pain and fatigue. An abnormal amount of fatigue lasted more than a week after the vaccine.
Information has been received from a Medical Assistant, concerning a patient of an unknown age and gender.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 05-MAY-2017, the patient was vaccinated with a dose of PROQUAD lot number M033908 with expiration date in 16-JAN-2018 (dose, anatomical location and route of administration were not provided), reconstituted with a sterile water diluent (DILUENT MRK INJ) for prophylaxis, instead of the scheduled vaccination with M-M-R II (dose, dose number, lot  number and expiration date were not provided) for prophylaxis. The medical assistant stated that it was a medication error in which she grabbed the wrong vial. No adverse effects reported. Additional information has been requested.
DOWN SYNDROME; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a foetus of unknown gender and age. The patient's mother was a 35 year old female enrolled in a non-company sponsored study. The patient's height, and weight were not reported. Maternal obstetrical history included 8 previous pregnancies: two ending in live babies, three in miscarriage and three in elective termination. Maternal first day of the last menstrual period (LMP) was reported to be 02-Jun-2021. The estimated delivery date (EDD) was calculated to be 09-Mar-2022.Type of pregnancy was reported as singleton. mother had history of tobacco, recreational use, alcohol, and e-cigarette, and concurrent conditions included: anxiety, bipolar disorder, depression, and migraine.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 20-MAY-2021 for covid-19 immunisation. Concomitant medications included minerals nos/vitamins nos, and paracetamol.  On 20-MAY-2021, the patient had foetal exposure during pregnancy. On 20-OCT-2021, the mother of the foetus underwent blood tests, such as cell-free DNA screening, alfa fetoprotein or the quad screen. The test detected Down syndrome. It was reported that, on an unspecified date in 2021, the mother of the foetus underwent amniocentesis and prenatal ultrasound. None of the tests showed any problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the down syndrome and foetal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and down syndrome as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy, down syndrome was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211135269- covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20211135269- covid-19 vaccine ad26.cov2.s Down's syndrome. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (Advanced maternal age)
Started almost immediately with sore arm where shot given.  Continued to hurt but just thought it was given in the muscle.  Started feeling "not well" around 1:00 pm with the aching and fevers starting around 4:00 pm.  My left arm hurt so bad I could not hardly lift it up.  It was swollen, red and hot.  My fever at home was about 102.5 and called the doctor.  Was advised to go to ER or Urgent Care.  Went to ER around 8:00 pm and was seen around 10:00 pm.  Fevers were still high, blood pressure was elevated, my body ached all over. My arm felt like it was heavy and I could not move it hardly at all. I was given the Pneumococcal Polysaccharide Vaccine.
Patient reported tachycardia the evening following vaccine administration in 12/07/2018 which resolved without treatment by the following day. The patient then reported the adverse event to pharmacy on 12/10/2018 and denies and further recurrence of the adverse event.
I had a full body rash on both arms, around my neck, on my face, on my torso and back. I took Benadryl every 4 hours. I emailed the doctor who told me to take this regimen. The full body rash lasted for about 3 days and then I had the rash on my neck and chin for the additional. The rash completely subsided after 7 days.