chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Polysubstance dependence including opioid type drug, episodic abuse, with delirium - Patient was transferred to our facility due to need for Precedex and concerned that the patient may have some other significant problems.  Patient was continued on Precedex because of agitation initially.  The patient eventually was weaned off Precedex and switched to oral medications.  He was seen in consultation by psychiatry.  The patient has been given both combination of Haldol plus Seroquel. Discharged home but then returned to ED  3 days later for acute psychosis. Treated and recommended for inpatient mental health services. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Approx 90 seconds after the first injection my daughter became faint and passed out, she then began having a seizure, the entire episode lasted approx 2 minutes. After being treated and stabilized at the clinic, we saw our family DR approx one hour later. She had multiple xrays due to the injuries when she fainted, she has a mild concussion with slight dilation of the left pupil. She has a lingering headache, (we are sure this is at least in part due to the facial injuries from the fall to the tile floor). There is significant pain at the injection site which is being treated with ice packs and extra strength Tylenol (no Motrin allowed due to the high level of bruising) after seeing our family DR she has referred us to a Neurologist to rule out any underlying factors leading to the fainting and seizures that our daughter experienced today.  7/29/09 Consultant records received DOS 6/11/09. Assessment "faint" vasovagal Patient felt dizzy, passed out, loss of consciousness, posturing, incontinence, hit (R) face, (R) hip, (R) knee, some jerking.  Presents with erythema (R) cheek / skin / (R) Hip and knee. Contusion (R) hip (R) knee (R) face. Face and knee feel sore. (L) pupil > (R) properly responding. Auditory canal blocked with wax.
This spontaneous report was received from a Registered nurse (RN) and refers to an unspecified amount of patients (ages and gender unknown). Medical history and concomitant medications were not provided. On an unspecified date, the patients received RECOMBIVAX HB (lot # M041384; expiration 07-JUL-2019. On 23-JUN-2017, the vaccine underwent a temperature excursion and an unknown number of patients may have been vaccinated with this product. Total time in the range 47 degrees F to 77 degrees F: 47.1 degrees F for six minutes. A data logger was involved. The outcome was unknown. Additional information has been requested.
She fell asleep for 4 hours after the vaccines were administered. Immediately upon awakening she had intermittent periods of high-pitched, inconsolable screaming and lethargy. When she would stop screaming for a minute, I would try to speak to her to get her to interact with me as she had been doing in the weeks before the vaccines, but it was like the lights were on, but nobody was home. No response, no eye contact - nothing. I tried to nurse her, but she was unable to stop crying long enough to latch on. So, I took her back to see her pediatrician. We arrived at his office at 4:20 PM. He said she also had a temperature of 100F under the arm, which is uncommon at that age. The crying upon waking lasted about 24 hours. The lethargy and fever lasted 2 days.
Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 16-SEP-2010, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and he subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2014, the patient was treated at a medical Center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 22-JUL-2014, the patient sought further treatment at physician office, for continued and worsening shingles-related symptoms, which was diagnosed as post-herpetic trigeminal neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient has been prescribed FAMVIR, PERCOCET, ELAVIL, gabapentin, and lidocaine for management of his painful and persistent symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
I don't necessarily know if my adverse event was vaccine-related but since the number 1 serious adverse event reported in clinical trials was appendicitis, I figured I should notify you. The COVID-19 vaccine is so new. It's hard to know if appendicitis is truly a consequence of the vaccine. The only way you will ever know is if people report the adverse event and you see there is a trend of increased incidence of appendicitis in vaccinated individuals. Once again I don't know if the appendicitis was truly related to COVID-19 vaccine, but I figured I would report my case and you can use the information. I figure the more information you get the better for these new vaccines.
Recvd immun 130PM on 12SEP91 given APAP when immun given & every 4 hrs x 2 more doses; didn't want to eat supper @ 530; slept till 11PM; fever 103 AX & inconsolable crying for 4 hrs; Shaking observed but mom felt was from fever;
Immediately became lethargic and fell asleep while being put in the car -she couldn't hold her head up or respond. Within a few hours, she developed a high fever which reached 104 within the next 24 hours and lasted a few days. She remained lethargic, less responsive, and upset for those 3 days.
Loose stools, gas and bloating for two weeks (resolved), feeling of hot flash in head/chest with slight sweating, lab evidence of kidney transplant rejection
This spontaneous report as received from a physician refers to a 64 year old male patient with none pertinent medical history and drug reactions or allergies. On 07-JUN-2013 the dialysis patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (first dose, route not provided) (lot number, expire date not provided). It was reported that there was a numerous unspecified concomitant medication. On 08-JUN-2013 the patient was found to be positive for hepatitis B surface antigen. The patient was following up on test results (it was reported that on 17-JUN-2013 more test will be done) and sought medical attention. The outcome of hepatitis B surface antigen was unknown. Additional information has been requested.
Skin rash; This case was reported by a physician via interactive digital media and described the occurrence of skin rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced skin rash. On an unknown date, the outcome of the skin rash was unknown.   It was unknown if the reporter considered the skin rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: This case was reported via interactive digital media. The reporter stated that, had a patient called with skin rash 2 days after taking Shingrix. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Extreamly swollen thigh with a bump where vaccination was administered.  Over a month and a half still has a rash and has not gone away, swelling is still visible  but minor. Ichy at times.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 24-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received 1st dose of Pfizer vaccine and past out within 5 minutes. Patient awoke and EMT's were called. Patient was evaluated and released.
W/in 2 days p/immun, pt was seen in office & dx was cellulitis @ the DTP inject site; tx Ceclor & pediaprofen; No culture taken;
migraines headache, blurred vision, almost passed out, muscle weakness on Right arm and Right leg.She would fall down after taking a couple of steps, unable to write her name clearly. 11/03/09:  Vaccine record received, no update to VAERS indicated at this time  11/03 and 11/23/09  Medical records recieved for DOS 10/27009 Assessment: Difficulty walking, etiology unclear C/O weakness in legs, HA, blurred vision, diff forming words, diff walking. 1 week s/p vaccine. Refer to neuro. D/C to home. Not resolved.  ICD9 Codes: 719.7, V0481
Difficulty in breathing; Severe arm pain; Lump on the clavicle area on the same side of that vaccine was given; fever; Fatigue; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (Fatigue), HEADACHE (Bad headache), VACCINATION SITE MASS (Lump on the clavicle area on the same side of that vaccine was given) and PAIN IN EXTREMITY (Severe arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 031A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever), FATIGUE (Fatigue) and HEADACHE (Bad headache). On 13-Apr-2021, the patient experienced VACCINATION SITE MASS (Lump on the clavicle area on the same side of that vaccine was given). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain). On 15-Apr-2021, the patient experienced DYSPNOEA (Difficulty in breathing). On 13-Apr-2021, PYREXIA (fever), FATIGUE (Fatigue) and HEADACHE (Bad headache) outcome was unknown. At the time of the report, VACCINATION SITE MASS (Lump on the clavicle area on the same side of that vaccine was given), PAIN IN EXTREMITY (Severe arm pain) and DYSPNOEA (Difficulty in breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No additional AE; Nurse reported VARIVAX  was administered after TE; see TE case. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved VARIVAX X000532 1/4/2025        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications was not reported.  On an unspecified date, varicella virus vaccine live (Oka/Merck) (VARIVAX) injection experienced a temperature excursion (TE) (at 8.1 degrees Fahrenheit (°F) for a time frame of 3 hours). There was no previous TE.  On 28-SEP-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # X000532 has been verified to be a valid lot number, expiration date 04-JAN-2025) (strength, dose, dose number, route of administration and anatomical location were not provided) administered as prophylaxis. No adverse event was reported.
Fevers, facial swelling   Dx: Soft tissue swelling overlying the anterior maxilla, greater towards the left, consistent with cellulitis  secondary to odontogenic infection. Abscess overlying the facial side of the left anterior maxilla at the  level of the roots of the 1st and 2nd incisors measuring 0.7 x 0.4 x 1.3 cm. 1.4 x 0.8 cm periapical  cyst of the left maxillary 1st and 2nd incisors.
1-2 weeks prior to admission to hospital on 5/5/10 child had 5 days nausea, vomiting, and diarrhea. Day of admission 5/5/10 vomiting x 12 episodes and ended up with dehydration.
Fatigue,myalgias. Area of erythema and tenderness at injection site and pruritis. Treated with NSAIDs and antihistamines.
Pt. received vaccination last 8/12/10. Came back today (8/16/10) with a 1.5 cm x 1.5 cm bump on (R) thigh. (+) redness, tender to touch.
The skin on on my arms has been destroyed since my vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "The skin on on my arms has been destroyed since my vaccination".  Additional information: I was harmed by your Covid vaccine which received in Feb and Mar of 2021. The skin on my arms has been destroyed since my vaccination. It was suggested by a friend that I contact you about this. This supposedly save vaccine was not safe for me and thus far I have no remedy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Neck Pain, Shoulder Pain, Glutes pain, Calf Pain,  Hip Pain, Ankle Pain, Achillies Pain, Sweats, Dizziness (vertigo),  Fatigue,  redness below injection site, Redness was about the size of a racquet ball.   Treatment: 1000  mg  Acetaminophen every 6 hours for 2.5 days.  I felt better when I awoke on 10/7/2019.
Employee c/o pain like she had just gotten the vaccine. Difficult to lift arm vertical. Most pain happens at night with movement.
Pt stated 2 days after vaccine site became inflammed, painful, swollen, and purulent. Pt reported having a fever. Pt stated was better after a few days.
The vaccine given had a expiration of 3/18/22.  A stability report has been requested from Moderna.   The report from Moderna came back fine, showing full activity against COVID-19.   The patient reports zero adverse events with the booster.
Approximately 30 minutes after administration, pt complained of leg weakness, stomachache, headache and vomited. Episode lasted approximately 10 minutes and was self resolved with rest and observation.
This is the fourth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
day after routine arm soreness &fatigue, but seemed to be improving in subsequent days. Then, on 1/28 noted feeling of fullness in L axilla and swelling in L arm. By 1/29 a 3" diameter bright red patch had appeared surrounding vaccine administration site (photo available if desired). Pruritic and warm. Took loratadine 10mg and then next days 5 mg. By Feb 2 erythema had largely subsided though was still pruritic and faint outline at circumference still visible. By 2/5 arm back to normal.  Wasn't sure this was reportable, but then heard about the article on "Covid arm" and realized that reporting would help establish frequency of this reaction which is definitely vaccine related given the location and interesting immunologically in that the reaction was delayed. Hence this report.
MD Notes: Chief Complaint This patient is a 91-year-old pleasant lady awake alert oriented x4 living independently in an apartment and assisted by 2 children high functioning cognitively physically was brought in after she was found to have been weak had loss of appetite cough fever and tested positive for COVID-19.  History of Present Illness This patient has cough, dyspnea acute hypoxia fever loss of appetite low energy loss of taste and diarrhea.  She has been having her children and caregivers provide food to her apartment.  She stated that  she has 2 children a son and a daughter.  One of her frequent visiting caregiver had tested positive for COVID-19.  She had symptoms of cough fever and diminished taste appetite diarrhea about 4 days ago.  She has been hypoxic and has dyspnea.  Outpatient testing came back positive for COVID-19.  She had worsening symptoms of acute hypoxia, atrial fibrillation with rapid ventricular rate and patient being symptomatic elderly 91-year-old was brought and admitted for further evaluation and management of acute hypoxia, newly diagnosed COVID-19 associated. She denies any chest pain shortness of breath.  She denies any orthopnea palpitations.  She is volume depleted. She has been evaluated in the emergency room now brought into telemetry unit.
Very swollen hands couldn't bend fingers or pick anything up. Also painful. Went to doctor and was given medrol prednisolone; series for 7 days. Swollen went down on day 8 but it is still very painful after a week later.
had two doses, still get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received two doses of Shingrix vaccine and still got shingles, fairly often. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
On 12/6 at 7am patient woke up with hives on her inner thighs, back of armpits, insides/backs of legs. The hives spread quickly to all of legs, arms, belly, hands, and face. We gave her Benedryl at 830am which did help the hives subside, but by 4pm they came back with increased amount. We brought her to urgent care at 5pm. The doctor evaluated her with no clear diagnosis, diagnosed uticaria and told to f/u with PCP. She has had upper respiratory s/s, fever, vomiting, and cold symptoms intermittently for the past 4-6 weeks, which I reported to the doctor. She was prescribed Prednisone, benadryl, and pepcid. Following day, PCP was called - we were advised to change benadryl to oral Zyrtec instead. We don't know if these hives are from one of the vaccines from 11/21/22 or from circulating Flu/RSV/viral illnesses in the community. Today, 12/8/22, she now has superficial bruising to her abdomen, legs, and buttocks. Her disposition and appetite are normal. She does not appear to be overtly itchy or uncomfortable.
Initial reported received from a health care professional on 18 June 2010. A 7-year-old female patient, with no medical history and no illness at the time of vaccination, received a left arm subcutaneous injection of YF VAX, lot number UF716AA, and a intramuscular right deltoid injection of TYPHIM VI, lot number D0412-1, on the 15 June 2010 and developed a temperature the night of and the day after the vaccination. As of the 18 June 2010 the patient was pale, lethargic, not eating, cold, clammy, but afebrile. The outcome was reported as not recovered. Documents held by sender: None.
Systemic: Chills-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt felt nauseated and had to the urge to vomit within 2-3 minutes of vaccination but never ended up vomiting. He also felt a slight headache and his temperature dropped from 98.7 F to 95.3 F within 10 minutes of vaccination. However, his temperature returned to 97.6 F approximately 9 minutes later and was monitored for total of 30 minutes with his temperature being 98 F when leaving the pharmacy. He felt normal with no symptoms upon leaving.
Seven days after the first vaccine, a large red, itchy  and hot rash appeared . I contacted my Dr and he said it?s common and to get the second shot. Second vaccine the first day my arm swelled quite a bit - it had a large lump and yesterday the rash started again. It?s only been two days so I am assuming it will grow like the last one (it took about a week for the last one to settle, but I still had a small pin prick rash on my arm when receiving the 2nd shot). This one is more painful and also very hot (my first rash never had swelling ).
BLOOD ABOUT THE SIZE OF A PENNY FROM NOSE; 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: Unk) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced blood about the size of a penny from nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood about the size of a penny from nose was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-JUN-2011, the patient was inoculated with ZOSTAVAX at a health center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JUN-2011, the patient was treated by a physician at the same health center for a blistering vesicular outbreak which was diagnosed as shingles. He was prescribed valacyclovir (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.