chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 03-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 060H21A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was frozen and thawed on 29 Mar 2022 prior to administration to the patient.Patient have not reported any adverse reactions.Vial did not undergo any temperature excursions.  No treatment medications were provided.
Six days after receiving vaccine, she developed worsening hypoxemic respiratory failure and pneumonia requiring non-invasive vent support and bronchoscopy for pulmonary toilet.
Pt recvd flu vax 6 days later devel resp distress & was hospitalized; has been discharged from the hosp & still exp tightness in the chest & spasm of the vocal chords;
her brother is already fully vaccinated however he got covid; her brother is already fully vaccinated however he got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "her brother is already fully vaccinated however he got covid". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021561520 same reporter, different patient/AE
Patient received the vaccines at 0927 AM in the clinic for no adverse effects. Patient's mother called the clinic at 10:24 AM stating that the patient's eyes were swollen shut and he had developed hives. She was advised to seek immediate emergency care. When he arrived at the ER he had increased work of breathing and noisy breathing with increased secretions. He was given epinephrine and monitored for several hours for improved symptoms. He was discharged home from the ER in stable condition.
2 small patches of hair loss from the back/alopecia; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 15May2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21May2021, after receiving the first dose, there were 2 small patches of hair loss from the back, we noticed that within one week. The doctor stated that it was alopecia, the patient never had that and patch of hair loss was very evident now. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event 2 small patches of hair loss from the back/alopecia was not recovered at the time of this report.
This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on left arm on 26Jun2015 at 0.5 ml single dose. Medical history included cholesterol, diagnosed years ago and ongoing, asthma diagnosed 10 years ago and ongoing, blood pressure diagnosed in 1994-1995 (her blood pressure issues began because of the reflex sympathetic dystrophy diagnosed in 1994 or 1995) and ongoing, breast cancer diagnosed 20 years ago on right side, cardiac disorder, abdominal discomfort, ongoing calcium deficiency and ongoing gastric disorder. She received for immunization unspecified pneumococcal vaccine in 2005 and in 2010 and unspecified Influenza vaccine on an unknown date and did not have a problem. Concomitant medication included SPIRIVA 18 ug once a day in the morning since 2006 for asthma, FLOVENT at 220 mg since 2006 for asthma, ZETIA 10 mg, 1x/day since 2012 for cholesterol, Aspirin 325 once a day since 1998 for good heart, fish oil 1200 mg since 2014, 2x/day, Vitamin D 1000 mg 2x/day since 2010, famotidine 10 mg, 1x/day since 2014 for stomach; verapamil, 180 mg, 2x/day since 1997 for blood pressure, TUMS 1000 mg, 2x/day since 2000 for calcium deficiency, all ongoing. The patient experienced pneumonia in both lungs on 07Oct2015, coughing, the cough wakes her up during the night and chills, clear mucus on 15Oct2015 all with outcome of not recovered. The patient was hospitalized for pneumonia, cough and sleep disorder from an unspecified date in Oct 2015 (07Oct2015 or 09Oct2015) to 15Oct2015. While in the hospital, she received IV antibiotics, steroids, breathing treatments cough drops and a shot for blood clots. She also had to take insulin because blood sugar went up at least 3 times because of steroids. The patient underwent chest X-ray in Oct2015 which revealed pneumonia in both lungs and a sputum culture on an unknown date which revealed "Type of pneumonia from PREVNAR 13". Chest x-ray in Nov2015 was clear. The patient subsequently received unspecified allergy shots at the doctor's office. Follow-up (04Mar2016): New information from the same contactable consumer includes: lab data, vaccine history and vaccinations received after events onset. Follow-up (06Apr2016): New information from the same contactable consumer includes: onset date of the events and hospitalization dates modified; start date of concomitant medications.
Myalgia TINGLING IN LEFT EAR AND NUMBNESS BELOW JAWLINE  Narrative:
Tightness in chest, shortness in breath, allergy-like symptoms, nose/eyes continuously running & watery, itchy throat, soreness, redness, itching muscle, joint aches, fatigue - seen doctor 1/29/03 - but released to work same day & prescribed Zyrtax (allergy medication) I did not work. Redness in eyes still remained, flu like symptoms present even after 2 wks from the 1st dose shot taken.
after vax pt exp l eye swollen shut in am, at 3pm rt eye swollen shut, temp; 6pm T103  both eyes swollen shut & joint pain both legs rash all over taken to er given med, unable to walk for 2 days, all blood test nl cont w/rash 4/30 nl
Patient is almost 2 months old, and was inadvertently administered a 0.5 mL dose of Fluzone Quadrivalent from the 5mL multi-dose vial today (14 Jan 2022).; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 58 days old female patient who is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022). while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ695AA via unknown route in unknown administration site.  On 14-JAN-2022 the patient developed a non-serious patient is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022). (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient is almost 2 months old, and was inadvertently administered a 0.5 mL dose of Fluzone Quadrivalent from the 5mL multi-dose vial today (14 Jan 2022).).  At time of reporting, the outcome was Unknown for the event patient is almost 2 months old, and was inadvertently administered a 0.5 ml dose of fluzone quadrivalent from the 5ml multi-dose vial today (14 jan 2022)..   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was given on Oct 31 2010 the Seasonal Flu vaccine as well as the H1N1 vaccine - FLUVIRIN MULTIDOSE vial at the pharmacy. The side effects are a skin rash itching, hot feeling and red pimples that burn and sting. Waking up in the night to the feeling of: burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as constipation with a black stool. I have pain in my stomach and continued digestive problems and a well as red rash. Which I have seen my primary care doctor to improve my condition. Which requires additional medicine and cost to myself and my family. The ill effect continue with a skin rash itching, hot feeling and red pimples that burn and sting. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as pain in my abdomen and stomach.
This is a spontaneous case, initially received on 27-Nov-2017, from Other Non-Health Professional, concerning a 68-year-old, elderly, female patient. It was reported that the patient does not have any medical history. The patient's concomitant medications included: ZOLOFT and XANAX for unknown indications. On 13-Nov-2017, the patient was administered with influenza vaccine (dose: full dose (as reported), anatomical location: upper muscle (shoulder), left arm, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On 15-Nov-2017, after 2 days of vaccination, the patient started sweating. After one week of vaccination, she had swelling at injection site and weakness. On an unspecified date, the patient felt shakiness, flashes on forehead and had sweating. The patient consulted the physician who stated that either the symptoms were probably due to the ZOLOFT (concomitant medication) or strong flu shot was administered. The pharmacist advised the patient to wait for one week for the symptoms to clear up. After a couple of days, the events sweating, and weakness were resolved. At the time of this report, the patient had recovered from the event, swelling at the injection site. The outcome of other events, inability to work, shaky and flashes on forehead was not reported. The reporter assessed the events as non-serious. Follow-up received on 28-Dec-2017: It was reported that the events injection site swelling, and weakness occurred after one week of vaccination. Sweating and weakness resolved after a couple days, hence the outcome was changed from not recovered to recovered. The patient felt shakiness, flashes on forehead and had sweating at the time of report. The physician reported that the patient received strong flu vaccine and the symptoms were probably due to the ZOLOFT. Patient's pharmacist advised to wait for one week for the symptoms to clear up. Added new events inability to work, shaky and flashes on forehead. Narrative was amended accordingly.
pt recv vax 20OCT97 & 6PM had red rash & itchy over upper torso (chest, back, arms, neck & face);rash cont till Thursday when it was replaced by discreet spots particularly on upper chest;rash & itching resolved by Saturday;
Patient reports acute onset of burning in anterior thighs and feet and difficulty with balance and ambulation.  He was also subsequently found to have a small pleural effusion adjacent to the right atrium after complaining of dyspnea on exertion which has been ongoing and preceded his booster shot.
seen by dr wasserman 04/03/10 and told normal reaction to vaccine, seen 04/05/10 by Dr. So-skin-eythema-warm, right lateral thigh 9 x 13 cm and warm left anterior thigh 14 x 16cm, primary diagnosis: Cellulitis rx cephalexin , followup in 2 days
pt came down w/flu like sx 2wk p/vax;general malaise, herpes in throat & inability to concentrate cont x 6mo;dx mononucleosis;blood work showed no sign of EBV virus;no physical activity d/t enlarged spleen;
Child received a flu shot on 10/8 at the school flu clinic but had already had a flu vaccine at the health clinic on 10/5.  Mom stated child has some fever  after the 2nd vaccine but is fine now with no problems.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Arthralgia, Her left elbow remains painful since the first COVID 19 vaccination date, the pain has worsened since the second vaccination given.  Narrative: She c/o pain in left elbow starting after the first dose of COVID 19 vaccination give to her 12/29/20. She did not call to report this event, she could live with it and continued to work. After the second dose of vaccination given to her on 1/20/21 she stated her left elbow worsened in pain. She did not call the Agency to report , she though the pain would lessen, go away. This am the pain in her left elbow was so severe, she was unable to straighten her elbow with out pain. She has waited for one week for this pain to go away and it is not going away, she stated it has never gone since first dose 12/29/20, but only seems worse.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8277), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 07Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "Osteo Arthritis" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
On continuous ocp slynd and norethindrone not supposed to get menses.  Has had spotting since last wed. Has migranes and cramps also. Got covid booster Oct 9th. Had light menses cycle in oct and now spotting for a week this Nov cycle. She said this happened after previous covid vaccines also.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 10-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. On 27-Dec-2011, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt vaccinated with DTP had prolonged irritability, w/constant crying for 12 hrs.
Headache, chills, injection site pain. Tx: TYLENOL and Ice PRN. Pt instructed to call if symptoms persist or worsen.
~10mins post vaccination pt c/o dizziness and warmth on her leg.  BP 115/88, HR 96, RR 17. Pt symptoms improved and pt reported that she felt better.  Pt denies any abnormal s/sx and released from vaccination site.
This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUN-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (onset date not further specified), the patient suffered sudden intermittent blurred vision, with episodes of blurry vision occurring several times a day. On an unspecified date, the patient also suffered bilateral pneumonia requiring hospitalization and continued care and treatment. As a direct and proximate result of the Company's defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experiences mental and emotional distress due to resulting physician limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not resolved. Causality assessment was related. Sudden intermittent blurred vision, with episodes of blurry vision occurring several times a day and bilateral pneumonia were considered to be disabling. Upon internal review, bilateral pneumonia was considered to be a medically significant event. Additional information has been requested.
Started on 2/1/2021 with some shivering that seemed to amplify--or be amplified by--my parkinsonian tremor, which became much more pronounced. Then felt very weak. At night I could not sleep due to amplified tremor. At night I also had chills in lower half of body & got very hot in my head. Also a very occasional, intermittent, very weak dry cough. During the day on 2/2/2021 my temperature was 99.8.  I was also very weak and tired and could eat very little until dinnertime, when I could not finish my dinner. Slept a little the night of 2/2/2021 but often woke up and had a hard time fall asleep due to tremors.
8/3/2021- second dose- on 8/4/2021-body aches, fever, fatigue, bloody stools
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Jun-2022, the patient experienced COVID-19 (covid 19). On 06-Jun-2022, COVID-19 (covid 19) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had COVID twice. First time was before the booster and does not remember when the second time was. No treatment information was provided.
A few days following vaccination, I experienced an inflammatory cascade. I have pre-existing pernio and symptoms were exacerbated to the point of debilitation. Never before experienced, lesions on my feet and hands ulcerated and were excruciatingly painful. This disrupted ADL's and sleep. Symptoms have improved but not cleared entirely.   I also have left hip osteoarthritis. With the weather warming, symptoms had improved a lot prior to vaccination. But I experienced a flare alongside the pernio exacerbation.   Overall, this was an inflammatory cascade like none other.