chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in the arm at the site of injection; really tired; weak; Nausea; feeling unwell; Diarrhea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: EW0175) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the arm at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "really tired"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; HEADACHE (non-serious) with onset 20May2021, outcome "recovered", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, asthenia, headache, nausea, malaise, diarrhoea.  Additional information: The reporter stated that his son got his first shot yesterday and so far he of course has pain in the arm at the site of injection but he is really tired and rather weak he had minor headache this morning, he has diarrhea and little bit nausea and generally just feeling unwell, he does not have a fever but she thought maybe she should report that just because this was his first shot and she thought normally it start getting that's stuff on the second shot. The headache was gone away he was still very tired, and the diarrhea was recent.  No follow-up attempts are possible. No further information is expected.
Pentacel was not reconstituted prior to administration,  only the vial containing liquid was administered.  Patient's mother was informed about error and to receive correct vaccination at upcoming appointment with the health department.
Did not dilute the vial prior to administration so patient got more then what she should have gotten.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Twinrix and Twinrix 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: 25-JAN-2023 Reporter's Comments: Nurse reported that a male patient received a dose of Twinrix, administered by a different nurse, which had an expiration date of 16th March 2022.   This was the patient's third dose in the series.   At the time of reporting, the patient had not been revaccinated. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Twinrix which was already expired on 16th March 2022.
Itchy lips and mouth "dissipating now" Vital Signs:  B/P: 120/70 HR: 62 O2sat: 97% BS: 69 Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath sounds clear Bilaterally Treatment: Juice for low blood sugar Repeat Assessment @ 14:10 Vitals: B/P: 120/80 HR:  60 Resp.: 10 O2sat:96 % Blood Sugar: 105 Skin signs: warm and dry Circulation: Cap refill <2sec Resp.: Clear Bilaterally Patient clear to go home
Strong reaction to vaccine.  Feels like I have the flu combined with feeling like I have been in an auto accident.  I have had a fever ranging from 99.0-99.6 and I normally have low body temp of 96.8 due to my connective tissue disease, EDS so a "low grade fever" for most is more significant for me.  I also have had non-stop issues with my asthma and normally I only have to use it when I have a virus.  I feel like this vaccine has caused system wide inflamation.  Pain is not stopping, nausea, diarrhea, severe fatigue, wide spread body pain, not sleeping well, increased anxiety, 9 days post vaccine it is not letting up.  Woke this morning with a migraine that did not respond to any medications.  I was afraid to get this vaccine and now it seems I had good reason to be afraid of it.  This needs to be studied more in those who have genetic mutation, I have MANY.
Fever; Body ache; chills; body ache; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (body ache) and PAIN (Body ache). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) outcome was unknown. Not Provided          No treatment information provided.
PATIENT DEVELOPED ERYTHEMA, DIFFUSE PRURITUS, AND ITCHINESS  WITHIN THE 20 MINUTE POST INJECTION. SHE RECEIVED 50 MG OF BENADRYL IM, AND 20 MG OF FAMOTIDIN ORAL, AND AFTER 30 MINUTE TREATMENT, THE REACTION SUBSIDED.
2 DAYS AFTER VAX, PT EXPER URTICARIA. TREATMENT OF BENADRYL, SELDANE.
patient was given a Moderna vaccine booster injection of 0.25 mL from a vial that expired on 11/06/2021; no adverse event reported
Tinnitus as a result. It has not gone away. Nonstop tinnitus for 4+ months. Ringing is a high pitch sound. Sound level is a 7-8. Very loud, never goes away.
Awoke 9/24/2009 w/scattered red 2-3 mm papules on face, trunk, extremities some. Vesicular-none crusted. New ones coming out rapidly.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated intramuscularly with improperly stored doses of VARIVAX lot # L020002, expiry date 02-JUN-2017, lot # L046887, expiry date 23-NOV-2017 and Lot# reported as M000757, expiry date 06-JAN-2018, frequency reported as once (dose not reported). No adverse events were reported. The therapy was not discontinued. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I had a persistent cough, and my throat was really sore. I tested positive for COVID-19 on 02/20/2023. I contacted my doctor and was given the prescription PAXLOVID. I had diarrhea once after taking PAXLOID but was able to get to the bathroom without any difficulty. I also had a foggy brain for a few days while taking PAXLOVID.
The patient stated that he called 911 Saturday evening due to severe shoulder/arm pain and severe swelling / discoloration of the entire arm, down to the finger tips.  The patient went back to the ER again Monday for treatment for continued pain, inflammation, swelling, and discoloration.  The patient stated that the dr said the immunization may have been given too high and into the joint.  Patient was treated with meloxicam, an IM injection of toradol, and tramadol per the discharge papers.
Patient received vaccines at his well child visit. About 1-2 minutes after receiving the last vaccine, patient fainted. The MA assisted patient to a supine position on the exam room table and noticed some brief twitching just after the patient lost consciousness. Patient woke up after about 30-60 seconds. He was confused and nauseated. He has emesis x 1. We continued to assess patient's condition and monitor vital signs for the next 30 minutes. When patient returned to baseline he was sent home with his mother.
Within 2-3 minutes, weird sensation washes over my head. I have felt light headed and on the verge of fainting ever since. My arms and legs constantly feel very weak and as if my blood is cold. I have started to develop headaches.
About 7 days following her flu vaccine, noted muscle aches and developed vomiting, diarrhea and sweats. Went on sick call and instructed to increase po fluids. Sxs lasted approximately x 2 days. In late October 2003, started noting altered sensation in both feet and ankles. Had not experienced this sensation prior to October 2003. First instance was noted when she stood up and stumbled because she could not feel her feet. Since October, has experienced episodes of decreased sensation and numbness in both feet, but loss of sensation seems greater on left than right foot. Episodes occur approximately 2-3x/week. Has not noted an increase in frequency since November. Describes sensation as "numbness" with each episode resolving spontaneously after about 15-20 minutes. No change in character of sensation since onset. No associated sxs such as dizziness or clumsiness. Not triggered or associated with positioning. No back or lower extremity pain or weakness. Unable to identify precipitating or aggravating factors. Not sure if onset prior to or following influenza vaccine on October 22nd. Sought evaluation for this problem in early November, about 1 week after onset. Evaluated by neurologist on 11/11/003. EMG was completed and reported to be normal. A1C Harris' was told her vitamin B12 level was slightly low and she was started on Prenatal vitamins. Her blood glucose level was normal. Neurology evaluation is ongoing. Sxs: Numbness Start: 10/28/2003 Comment: altered sensation in both feet and ankles (decreased sensation and numbness).
Patient started having swelling in left arm the evening after injection. Patients entire arm from shoulder to fingertips is still extremely swollen 10 days post vaccination.
Bell's Palsy onset 5/3 at 6 pm. Sought treatment 5/4 left side face droop and paralysis. Given acyclovir and prednisone. Currently still taking. No improvement
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-month-old female patient received the fourth dose of PREVNAR 13 at single dose for immunization on unknown date. The patient had received three doses of the same vaccine on unknown dates. The patient had a medical history of recurrent respiratory infections under immunology w/u has low IgA not needing therapy. Concomitant medications were not reported. On unknown date the patient experienced antibody test abnormal. The patient is now on preventive 3 times a week Azithromycin.
Temp to 105; vomiting; p/vomiting temp began to dec; no emergency treatmnet required;
Within 1hr of receiving Fluviron dose (0.5ml) patient reports tingling of (L) finger and itching of (L) palm. Recommended Benadryl for itching and to notify patient's physician if tingling gets worse or spreads. Injection site is sore, normal reaction.
2 days after recieving vaccine I began to experience a mild cough, a "twitchy" feeling that didn't go away.  After appr. 12 days, I started to experience shortness of breath, severe fatigue, feeling like I had a moderate case of the flu, along with mild headache, dry cough, chest pain, sore eyes, muscle weakness,  and loss of appetite. A prescription for Z-Pack was called in, and I am on this medication at the present time.
24hr p/vax pt c/o pain @ site;@ 48hr pt was seen in clinic 6cm x 10cm cellulitis of lt deltoid;tx successfully w/oral antibiotics;
With  24  hours, shortness of breathe, migrane, itching, rash,  very swollen arm. The shortness of breath  and migrane lasted 24 hours. Swelling has gone gone. Itching and rash persist. Has made a doctor's appointment. Appointment is on 8/4/2021.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned an 18 year old male of unspecified ethnic origin and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure. It was reported that patient recently had titers checked and was found to be negative for antibodies. On an unspecified date, Laboratory data included: titer test (antibody test) (NR: not provided) negative for antibodies. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210830464-Covid-19 vaccine -SUSPECTED IMMUNOLOGICAL VACCINE FAILURE . 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
Elevated BP, was admitted to the hospital for hypertensive emergency, developed acute onset back pain and lower extremity weakness.
Tired, muscle pain, headache, shivering, nausea, redness & swelling at injection sight
No data provided.  60 day follow-up received on 10/13/00 provided a name change and stated that the pt did not recover.  Medical records stated child was admitted to hospital and had laproscopic surgery for adhesions and an appendectomy.  Also diagnosed with psychosomatic back pain.  Doc # 178811 do not provide the type of vaccine, but the name of the manufacturer and a date: Wyeth 06/2000.
Fever of 103-104, body aches, chills from about 4am-4pm 8/31/2021
Initial report received on 04 December 2009 from a consumer, who is the patient. A 54-year-old male patient had received four intramuscular doses for "post-exposure" of IMOVAX (lot number and site not reported) in November 2009. The exact day of vaccination was not reported. The patient had no concurrent illnesses at the time of vaccination. He has hypertension; is diabetic; and has chronic back pain. He currently takes concomitant medications of "GENOVIA", furosemide, NEBIVOLOL, clonidine; NUCYNTA, "AVENZIA, DIOVAN and "TETURNA". Three to four days after receiving the fourth dose of IMOVAX in November 2009, the patient began to experienced panic attacks lasting 3-4 hours. He reports not eating or sleeping well, is very nervous and can not sit still or lie down. These symptoms have been "going on for about 4 days to one week". The patient required a doctor visit, but no relevant diagnostic tests or laboratory data were completed. At the time of this report, the patient had not recovered. Documents held by sender: None.
06/07/2022 Covid-19 positive by Binax Now Covid-19 home test, iHealth Covid-19 test, PCR test at pharmacy Clinic         I had off of work this day. I reported my results to my nurse, who advised me on 5 days of isolation and 10 days of masking.        My symptoms were extreme nasal congestion and sneezing, cough, sore throat, joint pain, mild fever (under 100 F), fatigue (slept a lot more), loose stools, intestinal activity (not painful but unusually noisy), and on one day had some sharp pain in left side (went away within an hour).  06/08/2022 - 06/10/2022 Treated nasal symptoms with cetirizine HCL (10mg) and phenylephrine HCL (10mg). 06/10/2022 Felt better. 06/10/2022 Had virtual appointment with doctor. Discussed my symptoms and that Paxlovid did not seem to be necessary           at this time. 06/17/2022 Extreme primary symptoms entirely resolved. 08/01/2022 Still having occasional fatigue (usually in the afternoon). Still having loose stools frequently. These are not diarrhea and do not lead to dehydration, but they are noticeable. My sinuses and eyes (itching) are more sensitive to animal dander than before infection.
Case number PHEH2014US023522 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 27 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: A12014 and expiry date: Sep 2014), on 08 Nov 2014. No adverse event was reported following this administration error.
Tested positive for Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    .
75 days after COVID vaccination, I had a flu that was bad enough that I saw a doctor and tested positive for Influenza Type B.  I had not tested positive for COVID either with an at-home test nor with a doctor's office test at any time between vaccination and this episode of the flu.  Symptoms were overall fatigue, fever, coughing, and nasal congestion.  Treatment was a 5 day course of Tamiflu, also Flonase, and OTC cough suppressant (Mucinex 12-Hour).  Outcome was that the fever broke by 15-Dec-2022, coughing has been steadily reducing and is nearly effectively gone as of the date of this report.  NOTE: Both COVID19 and Flu vaccines on 28-Sep-2022 were administered at Pharmacy.  They probably have the flu vaccination records that were asked for, here.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) positive, notes: I still test positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 17Jun2022 to 21Jun2022 for treatment of COVID-19. The patient did not received other medication in 2weeks. It was reported that 5 days after completing Paxlovid course respiratory symptoms have recurred and I still test positive for Covid. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Yesterday between 16:00 - 17:00 started having pain and swelling, left bicep to shoulder. Redness noted at top of shoulder, no redness at injection site. Bicep area quite swollen. Denies fevers.
Case number PHEH2016US029892, is an initial spontaneous report received from a consumer on 10 Nov 2016. This report refers to a 64 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185285, expiry date: Apr 2017) intramuscularly on 06 Nov 2016. On 08 Nov 2016, the patient experienced itching all over with red patchy hives on shoulders and neck. The patient was treated with Hydrocortisone cream to treat hives. The outcome of the events itchy rash with hives was reported as condition unchanged and of the event itching all over with red patchy hives on shoulders and neck as condition improving as of 08 Nov 2016. The seriousness of the event itchy rash with hives was assessed as non serious by the consumer and of other events was not reported. The causality of the events was not reported.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated narrative.