chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that they administered 7 doses of an expired vial of Moderna COVID 19 Vaccine to 7 patients on 19 January 2022. The vial did not undergo any temperature excursions. It was reported that no adverse events were observed in any of the patients and no treatment was given to them. Patients were not under any concomitant or regular medication. The expiry date of vaccine was on 14 January 2022.
On 8/14/06 Father called to report that child had a rash around area where Immunizations were given and a few places of rash on other parts of the body.  Father was instructed by RN to contact the child's PCP to have rash evaluated and to determine if any adverse reaction had occurred.  On 8/14/06 received a call from the doctor that child had an adverse reaction to immunizations that were given on 8/8/06.  Requested a copy of the doctor's dictation to file in patient chart at Health Dept.  Child treated w/ Poly Hist PD liquid by PCP.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.
started having menstrual cycle every 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (started having menstrual cycle every 2 weeks) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Feb-2021, the patient experienced POLYMENORRHOEA (started having menstrual cycle every 2 weeks). At the time of the report, POLYMENORRHOEA (started having menstrual cycle every 2 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was Advil
Shingles; This is a spontaneous report from a contactable nurse. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Jun2021 at 09:03 (Batch/Lot Number: EW0180) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included Psoriatic arthritis, Psoriasis and an autoimmune disorder. Concomitant medication included secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 10May2021 at 10:16 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE for COVID-19 immunisation, and didn't have reaction with that shot. The patient had no prior vaccination within 4 weeks. The patient called to report that she got her second shot and it's not dangerous like threatening or death or anything like that, but she did come down with shingles after her second vaccination. When probed for permission to probe, the patient added that it was totally fine. She just wanted to make sure she reported it, because she thought it would probably be tracked for people with autoimmune issue. When asked regarding the causality, the nurse (patient) agreed that it is, but there was more to it than just that. She added that she was immunocompromised, she has an autoimmune disorder, and have psoriatic arthritis for which she is treated and at a higher risk for side effect. The nurse added that she did get a confirmation from her primary care doctor. She did guarantee the day before and did confirm it was shingles. Treatment for the adverse effects included some steroid. The patient added that she was on Nitropack (not clarified further) right, and on Acyclovir which has helped tremendously with the side effect. With regards to the lab test, the nurse stated that she didn't need any, they were able to look at it, and they were able to examine her. The blisters were very apparent that it was not psoriasis and that it was shingles because it looks very different from her psoriasis, and it follows the pattern which shingles does. The patient also stated that she just wanted to make sure that they get this information so that they can keep tracking more and more. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Whimpering, very sleepy - unable to wake. Arm would go out straight. Whole body would shake. Possible seizure.  11/17/08 Case closed w/medical records of 11/4-11/6/2008 that accompanied report. FINAL DX: seizure, probable DTaP vaccine induced Records reveal patient experienced good health on 11/3 w/concerns of constipation & possible hemangioma of arm.  Developed irritability, very sleepy, jerky shaking movements x overnight s/p vaccinations.  Seen by PCP, LP done & sent to ER.  Tx w/IV antibiotics.  Neuro consult done.  No further episodes & d/c to home w/recommendation to separate vaccines at 4mo.
Patient reported trouble swallowing and felt like her throat was closing up a few minutes after receiving the vaccine. I had someone call the paramedics and I gave her a dose of epinephrine (Epi-pen) 0.3mg. After a few minutes she was breathing easier. The paramedics came and checked her out and she spoke to her physician by text, who advised her to take a benadryl and famotidine. After about 45 minutes, the patient was comfortable enough for someone to drive her home.
overall malaise; could not lift arm beyond shoulder/couldn't take it from the down position; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature). At the time of the report, MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient states that his body was more used to the vaccine. No treatment medications were reported.   This case was linked to MOD-2022-642291, MOD-2022-642281 (Patient Link).
Seizure febrile, 2-3 days in hospital, fever very disoriented > signs, 930/1000 pm on 10/31/17 > time course. My daughter had her 15 month shots on 10/31/17 at around 930/1000 am and also a flu shot.... exactly 12 hrs later around 930/1000 pm at night she had a seizure and almost died in my arms!!!
Woke up next morning with rapid heart rate (200 bpm).  After 3 hours went to emergency
Patient exhibited fever, myalgia, chills, and  a rash in the upper torso, arm, and thigh that spread from one side to another. This occurred over a period of 2 days since the vaccination. Upon timing of call to facility, patient reported that rash was improving but not fully resolved while the other adverse effects fully resolved.
One day subsequent to receiving one dose of varicella virus vaccine live the pt experienced a varicella like rash. The physician noted the rash seemed consistent with summer itch.
FEVER; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 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 31-MAY-2021, the subject experienced fever. On 31-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and headaches. This report was non-serious.
Administration error: Pfizer Bivalent COVID-19 vaccine incorrectly administered without patient having received primary monovalent vaccine series. No adverse events noted from vaccine administration.
Increase in hot flashes especially at night. I am perimenopausal and have had occasional hot flashes, but now I am having hot flashes every night and sometime during the day.  Unsure if related to vaccine, but thought being it is a new vaccine I would report it.
he received an  infusion at a hospital ' to purify' the blood; pain in back; pain in back then  his ribs and then  travelled to his chest; pain in back then  his ribs and then  travelled to his chest; virus in his system from the virus as a result of the pfizer covid vaccine.; he was in a lot of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 77-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), (at the age of 77-years-old) via an unspecified route of administration on 06Apr2021 as dose 2 single for COVID-19 immunisation. The patient historical vaccine included received first dose of bnt162b2(Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 16Mar2021 as dose 1 single informed that no reaction on previous exposure to drug. The patient's medical history includes liver transplant about 10years ago. Patient concomitant medications were not reported. On an unspecified date, 3 days after the second shot he developed pain in back then his ribs and then travelled to his chest. He has been to Emergency twice, seen 6 or 7 different doctors; doing testing, had a CAT scan and an echogram. He told this morning that the doctor suspects he has a ' virus in his system from the virus' as a result of the pfizer covid vaccine. Caller asking if we know anything about this and wanting treatment recommendations. Caller unable to clarify what the hcp means. States before he received the vaccine, he was healthy other than a liver transplant about 10 years ago. States he was in a lot of pain-prescribed morphine but did not want to take it. Also states he received an infusion at a hospital to purify' the blood. He felt better after the infusion then 2 hours later it came right back (unclear if caller referring to pain). He was told by his hcp that everything was normal, and they can't find anything wrong. He said he read on the news that people were reporting aches and pains from the pfizer covid vaccine, but he was surprised how long it took for pfizer to acknowledge it. The outcome of the adverse events was unknown.  Information about lot/batch number has been requested.
sore throat and a cough; sore throat and a cough; mild regular cold symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 44-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore throat and a cough and mild regular cold symptoms on an unspecified date. She specified they have no fever, and were tested for COVID yesterday but they don't have the results yet on an unknown date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. Sometime on an unknown dates, when unspecified staff at her office draw up GARDASIL 9 from single dose vials to be administered (unspecified patients, unspecified dates), there was more than 0.5mll in vial. The reporter also stated some staff administered just 0.5 ml to the unspecified patients and other staff administered the total contents in the GARDASIL 9 vial which at times was more than 0.5 ml. Product Quality Complaint (PQC) was filed. No adverse effects reported. Additional information has been requested.
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, COPD, Anxiety and Tremor.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.            Concomitant medications included high blood pressure medication, COPD medication, anxiety medication, medication for tremors. No treatment medications were reported.   This case was linked to MOD-2021-325611 (Patient Link).
Additional information provided information regarding PREVNAR was  from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003.
0925 AMThroat light swelling, feels something back of throat, dysphagia, dyspnea. Recent sinus infection, 0928 Benadryl po  Last meal 1200am,Vital signs stable 0939am Feels better, still feels a lump in throat. 0955 Vital signs stable D/C
Developed rotavirus 1 day after vaccine was given (+ culture on 2/23/07) + C difficile.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 55 year old female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received an injection of LYMErix on 7/15/99 "according to the client." On 9/3/03, the pt's attorney alleged that the pt "suffered tingling of her legs, joint pain, fatigue, insomnia, difficulty walking, imbalance and headaches beginning the day after her vaccination according to the client." Upon follow-up received 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "tingling in her legs and feet, numbness of both legs, joint pain, fatigue, insomnia, difficulty walking, imbalance, and headaches." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a neurologist and received anti-inflammatory and other medications without relief of symptoms. On 15Sept04, the pt's attorney alleged that the pt, now 56 years old, experienced joint pain, numbness, tingling, headaches, neuropathy, insomnia, and gait disturbance with abnormal brain MRI. Time to onset treatment, and outcome were not reported. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
TO ED and admitted for shortness of breath, found have COVID 19. He was started on steroids, as well as Remdesivir, and did improve. He did not require any supplemental oxygen. Continuous blood pressure, adjustments were made to his blood pressure medications. He states his blood pressures always difficult to control. Is likely provoked by the Decadron. He will follow-up with his primary care physician within one week for medication adjustment. He was clear for discharge home
Vaccine given 8/11/15, mom noticed 8/13/15 at 8:30 am pt had red rash around the injection site, right thigh lesion about 2" c 2" in diameter that is red with some induration noted, temp 99.4, vomited once, fussy, flushed.
never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two years ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: A pharmacist called to asked for information about a patient who never received the second dose. The reporter asked if the patient had to start over with Shingrix vaccination (two doses).  The pharmacist did not provide the date of the first dose administration and the lot number of the first dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shngrix vaccine, which led to incomplete course of vaccination.
Pt states entire arm extremely painful since 1st day, after 2 days bacame red and swollen.
Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.
Fever, chills, body and joint aches, fatigue and lymph node enlargement and tenderness in the axilla on the shot side. Lasting 24 hours except for the lymph nodes which are still enlarged and painful.  Nosebleed x 2 on 9/5.
pt recv vax & dx meningitis 6NOV96 cult was negative but CSF antigen positive for Haemophilus influenza
feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
MINOR ACHES AND PAIN; ELEVATED RHR; INJECTION SITE IS A LITTLE SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced minor aches and pain, elevated rhr, and injection site is a little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor aches and pain, elevated rhr and injection site is a little sore was not reported. This report was non-serious.
Migrain and difficulty breathing onset. Pt. also had cold symptoms and thought that maybe the cold was the cause of the symptoms.
Her arm at the injection site is still swollen; Her arm at the injection hot and itchy.; injection site is  red; This is a spontaneous report from a contactable consumer (patient).. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration, in arm, on 06Apr2021 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced the injection site is still swollen, red, hot and itchy. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Janssen COVID-19 Vaccine EUA  a sharp series of pain in my abdomen on Monday, April 12. It was not severely persistent; I don?t believe it lasted for more than a few hours and it tapered on and off during that time, but initially it was sharp and made it difficult to move
2nd immun on 2/12 2pm.  Noted taste of blood in mouth on 2/14.   On Mondya 2/15 sent note to primary about adding a CBC for an already established appointment on Wed.  Lab appointment was wet for 2/16 am.  The evening of 2/15, my platelet condition worsened starting with profuse bleeding of gums following a waterpik session and subsequent identification of petechia on legs and blisters on month and tongue.  I called my hematologist's after hour service and agreed to stick with original testing plan