chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: Caller stated she took the first COVID 19 vaccine three weeks ago and tomorrow was three weeks. Caller stated the last time she called this number she was on hold and spoke to someone who said they would switch her to speak with medical information and the call got lost. Caller stated she was experiencing extreme fatigue and she was feeling concerned about getting the second shot because she does not feel like she has recovered from the first one. Other person on the line said they never got through they were put in the queue and got disconnected. The other person on the line said they spoke to someone like this DSU agent and took relevant information. Caller declined having a report reference number from the other report with the agent. Caller stated she also filed a report with Pfizer on the website. Caller declined receiving a confirmation email from the Pfizer website. The other person on the line stated she filled a report on two different websites (VAERS and Pfizer). The other person stated that they have done all of this and they got disconnected. The other person stated that was exactly what happened last time they were put on a brief hold and was given the  Regulatory Authority number the same one this agent just provided and was put back in the queue and was disconnected and that was the end of it. The other person stated that he wanted to take the survey. The other person stated they were going to get disconnected again and the same thing was going to happen and that it was a terrible system. The other person stated that they had waited for an hour and a half.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 68-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 17-APR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at the pharmacy, as prescribed by a healthcare provided for the long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX), the patient suffered a painful blistering rash and was diagnosed with herpes zoster and post herpetic neuralgia. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
A temperature excursion was discovered in our refrigerator, the high temp. was 48F
Within 2-3 days the development of urticaria, itching, involving face, chest, arms.  Shortness of breath noted by day 3 with wheezing. Then symptoms of CHF with orthopnea, dyspnea on exertion. Workup noted CHF of CXR, decreased systolic function of echocardiogram at 33% EF, and CHF meds started. Further workup for cardiomyopathy included perfectly clean coronary angiogram and a month later normal cardiac MRI. Still needing carvedilol, lisinopril and furosemide for CHF with class 2 symptoms, now starting to improve.
This spontaneous report as received from pharmacy student concerning a 60 year old female patient with allergy to clarithromycin (BIAXIN). On 01-NOV-2014 the patient was vaccinated with PNEUMOVAX23 (lot # J015868, expiration date 25-FEB-2015) 0.5 ml, intramuscular in the arm. Concomitant therapies included diclofenac, influenza vaccine (manufacturer unknown) administered on the same date of PNEUMOVAX23 in the opposite arm, allopurinol, metoprolol, AMBIEN and levothyroxine sodium (manufacturer unknown). On 02-NOV-2014, 2 days after onset of therapy the patient developed "big" bump that was about the size of a tennis ball at the injection site. She stated that the bump was red and itchy. She did not report any symptoms in the arm that the influenza virus vaccine was administered. No treatment was given. The patient sought medical attention called into the pharmacy on 04-NOV-2014. There were no laboratories diagnostic test performed. The outcome of red and itchy big bump at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Extreme injection site pain day 1. Nausea the same night and following morning with vomiting. Massive headaches and extreme fatigue. Injection site pain got worse throughout the day and now I?m having several rounds of diarrhea.
PASSED OUT; This spontaneous report received from a consumer 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, administered 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced passed out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210422259- Covid-19 vaccine ad26.cov2.s- passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Patient presented for office visit on 7/31/2008 for "rash". Patient stated onset was 2 weeks ago. Severity is mild. Location was right axilla and chest. Patient described it as erthematous and papular. It occurs continuously. The problem was improving. Denied aggravating factors. Associated factors included hyperlagesia of skin. Addition information: Antecedent paresthesias. Received Tdap on 7/15/2008. Symptoms developed on 7/16/2008.
Shortly after receiving the second dose, I began experiencing some soreness around the injection site in my left arm. This worsening throughout the day, and around 5:30pm that day I began to experience some cold-like symptoms (fatigue, soreness, chills). This continued into Sunday, and it tapered off until I felt relatively normal around 4pm.   I only treated this with some generic Nyquil.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in right arm, on 08Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 1" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: tested covid positive by PCR and home antigen 19Jun2022; (27Jun2022) Negative, notes: Home antigen negative 27Jun2022; (01Jul2022) Positive, notes: home antigen positive 01Jul2022; (19Jun2022) Positive, notes: tested covid positive by PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was product: Insulin, brand: Humalog and product: Fluoxetine, brand: Prozac. Paxlovid rebound: tested COVID positive by PCR and home antigen 19Jun2022. Started Paxlovid 19Jun2022 pm (diabetes risk factor), completed 24Jun2022 am. Home antigen negative 27Jun2022. Symptoms returned 30Jun2022, home antigen positive 01Jul2022. Patient received Paxlovid from 19Jun2022 to 24Jun2022 for COVID 19 treatment.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Information has been received from a registered nurse concerning an approximate 83-month-old female who on 31-JAN-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 649446/0651P). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
shingles; Information has been received from a lawyer regarding a case in litigation and refers to an elderly patient of unknown gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2017 (at approximately 68 years old), the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, route, lot # and expiration date were not reported) by a healthcare provider at a pharmacy. On an unknown date, the patient was treated by a health care provider at eye care for the injury resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of the event was unknown. The causality between the event and suspect vaccine was considered as related  by the lawyer.
received a 3rd dose of Shingrix; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provide are as follows: The case was reported by patent herself. The age at vaccination not reported. The patient inadvertently received 3rd dose of Shingrix 1 month after receiving her 2nd dose, which led to extra dose administered. The reporter asked were there any adverse side effects or reactions to be concerned about. The follow-up would not possible as no contact details were available.
Information has been received from a licensed practical nurse, concerning a patient who received the third dose of GARDASIL vaccine (yeast) on 18-Jun-2008 and passed out. The office reporting the adverse reaction was not the facility that administered the dose. The patient passed out after receiving the dose of GARDASIL vaccine (yeast) for a "short time". The patient received the first dose of GARDASIL vaccine (yeast) on 04-Jan-2008, the second dose on 07-Mar-2008 and the third dose on 18-Jun-2008. There was no concomitant therapies. All doses were administered at another facility. The patient recovered. No other information to report. There was no product quality complaint. No further information is available.
5 days after first dose, tips of toes on both feet and one finger on right hand started to develop petechiae. Red/purple raised blisters formed. Painful, cold to touch. Contacted a provider for video visit. Told this was " covid-toes" due to exposure or reaction to vaccine. Advised to use antibiotic ointment and wrap feet for warmth. Employer contacted at this time and told of symptoms. I was sent home, and swabbed nasally for testing. Covid -19 test was negative at this time. Returned to work. Condition worsened significantly after second dose of vaccine. Tips of toes turned blue, cold to touch and numbness started. blisters worsened. Painful to walk at this time. Had another video visit. Told this could be an auto immune disorder that was dormant triggered by vaccine, or reaction. Advised to elevate feet, wrap and wear socks continually for warmth. Go to ER is numbness continued. ER visit in my town at this time was very long and advised to go only if needed. Condition stayed the same for whole month of jan. Blisters healed beginning of feb. However red scars/left. Then tips of toes tuned blue. feet went numb for hours at at time. I kept a diary and pics of all events
One week after injection, pt. has had a patchy, dry, erythemous rash 1 cm. in circumference show up intermittently on trunk and extremities.  Rash  remits and recurs.  No history of rash.
Covid Arm.   My right upper arm is swollen just under (about 2" below) the injection site.   It is red and has a large lump that seems to be growing.   It is very tender and there is a red rash like spot in the middle.   Lump is approximately 4"x4" and the rash is just over 1"x1".  My first 2 doses of the vaccine were Pfiser.   This is my first Moderna shot.
R upper arm, swelling, erythema hot to touch extended from shoulder to antecubital region. Cellulitis treatment - Cephalexin 250 mg/5ml 10 ml BID x 7 days.
redness, some swelling @ site for 5 days;ice to be applied;aleve q 12 hr;
An initial report was received in the USA from a health care professional on 7/12/05. A nine year old male received YF-VAX, lot number UE449AA, SC in the right arm, TYPHIM VI, lot number Y0794, IM in the left deltoid on 7/11/05. Reportedly, 45 minutes post immunization, the patient experienced shortness of breath. Two to three hours later he broke out in hives at the YF-VAX injection site and other body areas not specified. He was taken to the emergency room where he received IV steroid and Benadryl. He was discharged with oral steroid and Benadryl prescriptions. Past medical history is significant for asthma and shellfish allergy but he denies egg allergy. Reportedly this patient has recovered. (OMIC) Follow-up information received on 30/Aug/2005 from a health care professional. It was reported that the patient was 19 years old, not nine as previously reported. The duration of the symptoms was several hours and the patient recovered the same day. No further information is expected.
4" X 3" cellulitis vs local reaction on left upper thigh. Cephalexin ordered.
Information has been received from a pharmacist concerning a "transplant patient" who on an unspecified date was vaccinated intramuscularly with 0.5ml PNEUMOVAX 23 (lot # not reported) for prophylaxis of pneumonia. Subsequently the patient experienced local redness and inflammation. It was unknown if this was the first dose of PNEUMOVAX 23. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 17 year old female who on 17-NOV-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot number 661528/0867X) in the right deltoid. On 18-NOV-2008 the patient experienced pain from the shoulder to the elbow. On 19-NOV-2008 the patient experienced pain, some edema and fever as high as 102.2. On 19-NOV-2008 the patient developed rash. On 20-NOV-2008 the patient went to see the physician. It was reported that the patient had an ERYTHEMATOUS rash on right upper forearm and mid forearm. The patient was given KENALOG 40 mg intramuscularly and was told to return as needed if the symptoms were not improved. At time of this report, the patient's events persisted. According to the reporter, the patient's events were considered to be other important medical events. Additional information is not expected.
Systemic: itchy throat about 10 minutes after dose-Mild, Additional Details: pt stated she had allergic rxn(itchy throat) to all 3 doses of pfizer. stated shes cant be given epinephrine due to heart condtion per dr.  At 3:35 pt was given moderna booster. at 3:50 pt had itchy throat, she was given 3 teaspoon of benadryl.  at 4:05 pt stated she felt better but slight itchy throat still present. she was given an additional 1 teaspoon (total given 4 teaspoon=50mg).pt left at 4:15 feeling good. called at 4:57 pt feels good!
Patient had unwitnessed seizure the day after administration of vaccines.  Associated with fever.  Subsequently had two more seizures, not associated with fever.  Third seizure was witnessed in ED.
Excessive muscle cramps resulting in excessive leg pain, generalized pain and weakness, chills and fever. Tylenol taken. Symptoms resolving  on 12/12/2021
Pain all over body, headache, ear pain, swollen tonsils, all dry phlegmy, constant sneezing, green and yellow mucus, chills.
12/6/13 - pt complained of swollen, red arm (did not state left or right) and fever. 12/7/13 - went to doctor with same complaint, was put on antibiotics. 12/8/13 patient was admitted to the hospital for adverse reaction to antibiotics. All information reported by LPN.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) from 06-Feb-2021 to 07-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Scarlet blisters in oval 3cm x 2.5 cm with clear exudate, crusting, itching, and sensations of pins and needles lasting x16 da; Larger edematous area 10 cm x 7 cm also 16 da; Headache x 1 da signs and symptoms were self-limiting, no treatment necessary.
Patient returned to the vaccine room on 15MAR21 at 0215 complaining of dizziness, nausea/vomiting.  She was evaluated and monitored by one of our registered nurses for 1 hour before going home at 0315.  She is to follow-up with our onsite nurse as needed.
Soreness at injection site within 2 hrs after injection and red rash developed at injection site on right arm and extended into arm pit.
11:39 am stated he was feeling sleepy , Vital sign were done  11:50 patient stated that his tongue felt different , experiencing nausea , clear emesis ,  Per Dr order , I gave patient benadryl 25 mg po. patient was alert . patient was left for further evaluation . 12:45 pm  the patient began to complain about  tightness off and on , nausea , emesis continue , whole body felt tingly. 12:47pm per Dr  order  , i administer the Epi Pen  was administer  . 911 was called . paramedics was transport to hospital .
right after I injected pt with vaccine he jumped out of his chair onto the floor hitting his head on the table, pt was bleeding, stayed with the patient and mother for about 25 minutes made sure patient was feeling ok to leave
I had 3 or 4 hives that were scarlet red. That disappeared after 3 or 4 days and I treated it with Cortisone and Benadryl cream. The hives lasted for about 14 days. I also had hives after my 2nd vaccine which was reported to VAERS. I have made a complete recovery.
This spontaneous report as received from a nurse via web page refers to a child patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unknown date (reported as yesterday), the nurse was ordered to vaccinate the patient with varicella virus vaccine live (manufacturer unknown) and M-M-R II. The patient received the varicella virus vaccine live (manufacturer unknown) as ordered but by a mistake he or she received PROQUAD instead of M-M-R II. No information on patient's concomitant medication was provided. This is one of the several reports from the same reporter. Additional information has been requested.
RN was administering pfizer vaccine during 04-27-21 clinic. RN reported to me (RPH on duty) as he injected patient, majority of vaccine came out of syringe attachment and went down patient's arm. I asked him to estimate how much he believes patient may have been injected with. Estimated less than 0.1ml. Using my clinical judgement, recommended to adminster another dose since patient received less than 50% of vaccine. Mother present and aware. Patient observed for 15 minutes. No adverse effects reported during that time.
This case involves a patient of (unknown demographics) who experienced got sick (illness), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. No additional laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on batch number for this case.