chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old granddaughter with a history of attention deficit/hyperactivity disorder (ADHD) and no drug reactions or allergies who was vaccinated with the first and second dose of GARDASIL (Lot# not reported) in approximately 2010 (reported as "about a year ago") and on 20-OCT-2011 (reported as "2 weeks ago"), respectively (lot# and route not reported). Concomitant therapy included medroxyprogesterone acetate. After the patient received her second shot of GARDASIL and had just found out that she was pregnant. On an unspecified day she had 3 urine tests performed and only one of them came back positive for pregnancy. The patient also had ultrasound performed (result not reported). Therapy with GARDASIL had been discontinued by the given physician. On 04-NOV-2011 the patient would go to the OB/GYN office to seek medical attention. The patient's last menstrual period (LMP) was on 22-JUN-2011 and her estimate delivery date (EDD) was on 08-MAR-2012. Follow up information has been received from a physician concerning the patient who was seen for an initial obstetric visit at her organization on 01-NOV-2011. The physician had reviewed the patient's medical chart. Prior to 01-NOV-2011, the patient had never been seen here. The physician's office had not administered any vaccines for this patient as of 01-NOV-2011. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients was vaccinated with improperly stored RECOMBIVAX HB (lot # L038018, expiration date reported as 13-SEP-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
From 5:30-11:30pm: fever, severe chills, breaking out in sweats, could not form fist with hand and severe mental fogginess. 11:30-7:30am: migraine, breaking out in sweats 7:30-8:00pm: migraine, major GI issues, stomach hurt to the touch, mental fogginess
Breakthrough case admission after 2 vaccines Moderna 4/23/21 Lot# 006C21A; Moderna 5/21/21 Lot# 005C21A
around 11/01/2021 in the evening I began ear pain/pressure and sever headache.  Saw PA on 11/03/2021 and I believe dx was otitis media.  I was afebrile at that time.  Pseudofed and OTC nasal spray recommended and started.  During the onset and up to 11/06/2021 the ear pain/pressure, stabbing headache persisted. On 11/06/2021 in the a.m.  Bell's Palsy  started with facial paralysis.  The ear ache/pain, headache, and most of the classic s/s of Bell's Palsy still persist. On 11/06/2021 reported to PA, steroids and antiviral added to medications. Gabapentin 300mg added at hs  for sever headache. Flonase nasal added and OTC stopped .   The 60 mg x5 , 40mg x 2  , 20mg x 2 prednisone completed,  the 1 gm antiviral daily completed.
I became very feverish, 101 degrees, with chills and headache, confusion and very fatigued.  I had severe sweating in the early mornings.  This lasted for two days.  The injection site is hot, inflamed and red.  My husband had Covid at the same time as me and received the same first dose of the vaccine at the same time that I did at the same place.  His symptoms are exactly the same as mine, his fever was higher at 102 degrees.  Today we are feeling a bit better and able to work.  Our arms are still inflamed and hot.  We are afraid to get the second dose of the vaccine and don't know what to do.
Pain in right arm from shoulder to wrist; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 00:00 (at the age of 88-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 09Apr2021, the patient experienced pain in right arm from shoulder to wrist which was present at the time of reporting (18Apr2021). The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event pain in right arm from shoulder to wrist was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Insomnia Narrative: Night of vaccine had insomnia, went to work the following day, had body aches and bit of a headache. Felt warm but his temperature was normal.
Pt recvd 1st dose of Hep B vax on 24JUL92 approx 4-5 h rs following vax devel flu-like synd characterized by pharyngitis, h/a, sweating, arthralgia, myalgia, fatigue; also exp nausea, aches, & malaise;
Face and neck on right side of face,  Became red, burning and itching feeling. Skin on that side now has small bumps on it.   Primary Dr via phone call,  recommended benadryl.  Took that last night and have started applying a benedryl cream.
Per patient at injection site of right arm constant aching pain that does not go away, no relief by any rest or ibuprofen, patient states decreased right arm ROM, unable to extend posteriorly. started since given vaccine 3/5/2021
Pityriasis rosea; This is a spontaneous report from a contactable consumer (patient). This 29-year-old, non-pregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in left arm via an unspecified route of administration on 23Jan2021 at 10:00 am (Batch/Lot number was not reported; 29 years old at vaccination) as single dose for COVID-19 immunization. Medical history included an allergy to dairy. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks of the COVID-19 vaccine. Patient was not diagnosed with COVID-19 before vaccination and not tested for it since. The patient was diagnosed with pityriasis rosea which appeared after first shot on 30Jan2021 at 12:00 pm. Patient reported the event was not serious, it was not disabling or incapacitating, and it did not result in hospitalization. As a result the patient went for a doctor or other healthcare professional office/clinic visit and received treatment with corticosteroid. Patient received second dose of BNT162b2 on 13Feb2021 in left arm for COVID-19 immunization. Patient was not recovered from the pityriasis rosea.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Admitted to the hospital for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Tx w/steorids, abx, fluvoxamine, invermectin, O2. Pt refused O2 or home discharge.
Information has been received from a registered nurse concerning a 5 year old female with no relevant medical history and no allergies who in December 1999, at age 1.5 years was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 9/17/03, the patient developed shingles described as a few little bumps on her right arm which later spread. On 9/22/03, she was seen by her family physician with lesions on her right arm on the elbow, armpit, and fingers, following the dermatome, and was afebrile. On 9/22/03, a culture was sent and identified as shingles. The patient was treated with acetaminophen and hydroxyzine hydrochloride. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a four-years-old female patient who received a 0.5 ml dose of vaccine FLUBLOK QIV (lot number QFAA1831) via intramuscular route in the left deltoid on 18-Dec-2018 (reported as yesterday). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
tachycardia; This is a spontaneous report from a contactable physician via a sales representative. An adult female patient (cardiac nurse) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first COVID vaccine and had tachycardia for several hours immediately following the injection on an unspecified date. Patient planned to get second injection. Outcome of event was unknown.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The physician heard from one of his patients that 2 other girls developed bone tumors after receiving HPV. At the time of this report the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Pt recv vax on 12/2/98; on 12/3/98 pt exp fever (105.4F); tx=Ibuprofen & Tylenol
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route, dose and lot # were unknown). On an unknown date the patient complained of the injection "hurting" after receiving GARDASIL. The outcome of event was unknown. This is one of two reports received from the same source. Additional information is not expected.
I did not have anything right away. I do not considered this to be related to the vaccine but  I was diagnosed with shingles on 05/07/2021. I thought it was a bug bite but it was shingles. No medical tests. I took a picture and sent it to my doctor. They prescribed Valaciclovir.
since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; since vaccination, she developed a reaction "one inch below the injection site" where arm is "red, raised and very hot"; This spontaneous report was received from a pharmacist and refers to a 66 years old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, 0.5 milliliter once via intramuscular route (lot # S033516, expiration date: 29-JUN-2021) for pneumococcal prevention. On the same date, she developed a reaction one inch below the injection site where arm was red, raised and very hot. On 23-JUL-2020, she returned to pharmacy to consult pharmacist regarding the events. The patient was not hospitalized, she had no cancer or overdose. At the time of this report, the patient did not recover from the events. Causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
I have light bleeding in my nose; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration on the left arm on 28Mar2021(at the age of 33-year-old) at 14:15, as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included insulin lispro (HUMALOG). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19 and since the vaccination, the patient was not tested positive for COVID-19. On 29Mar2021 at 08:30, the patient experienced light nose bleed. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nose bleed was not unknown.  No follow-up attempts are needed. No further information is expected.
Injection site pain, fatigue, nausea, vomiting, diarrhea, headache, chills. My period started the next day too. It was 2 weeks early.  This never happens. It's always every 28 days.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a six-month-old female patient who was inadvertently vaccinated with an expired dose (third) of 0.5 ml PENTACEL (batch number: C5400AA, expiration date: 24-Jun-2018) via intramuscular in the left thigh on 25-Jun-2018. The patient's past vaccination(s) included PENTACEL on 07-FEB-2018 with at the age of 2 months and PENTACEL on 09-APR-2018 with at the age of 4 months. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; ROTAVIRUS VACCINE for Immunisation; and HEPATITIS B VACCINE for Immunisation (Batch number, expiry date, route and site of administration were not reported) on 25-Jun-2018. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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 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. List of documents held by sender: none.
It was an ear infection that I had. Mostly in my left ear but some in my right. I went to an urgent care clinic. They had me start on some antibiotics for a 10 day course as well as some nasal drops for about a month. That seem to help it decrease since then. They only did a Covid test, which was negative.
Dry cough and feeling of tight chest, especially on expiration, started on day 2, still continuing of day 5.   Occasionally feverish, max T 99.1, continuing fatigue.
chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated.         The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated.  Concomitant product use was not provided.Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
MD reports pt had outbreak of rash that formed pustules 4 days p/1st & 2nd injections of Engerix-B. First outbreak (following inject SEP90) resolved in one wk, while the second case (injection 11OCT90) (+ for pseudomonas) remains ongoing.
Administration of an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 22-MAY-2023, the patient received Engerix B. On 22-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter asked for recommendations on this situation. The reporter consented to follow up. The patient administered expired dose of Engerix-B, which led to expired vaccine used.
Client received the 1st COVID vaccine (Janssen Lot # 1822809 and expiration date 03/07/2022) at 10:47am. Client reported dizziness and feeling sweaty. PHN  and Nurse responded to incident. Client was sitting in chair when he commented "feeling dizzy and sweaty" at 11:00am. Client stated a health history of hypertension with a "baseline of 120s/76)" and took Losartan/Hydrochlorothiazide this morning. Client reports no allergies to medication but sensitive to amoxicillin, "causes upset stomach". At 11:03 vital signs were taken, blood pressure 140/98, heart rate: 44, respirations: 16, and oxygen saturation 98%. Heart rate was retaken reading at 70 beats per minute. Client stated "my baseline heart rate is in the 70's". Client is alert and oriented to place, person, and date. Client was given Gatorade, pretzels, water, and laid down on gravity chair. At 11:06am client began to shake, stating "dizziness and sweating has subside, just cold." Client denies, shortness of breath, chest pain, itchiness, difficulty swallowing or numbness. At 11:10am vital sign were taken, blood pressure 146/90, heart rate: 70 and oxygen saturation 96% and client stays denies any other symptom only reports shakiness. EMS services were provide to client at 11:10am, client refused EMS to be activated. At 11:15am vital sign were taken, blood pressure 137/85, heart rate: 72 and oxygen saturation 96%. Client's wife came in to facility to be with client at 11:20am, vital signs were taken again at that time, blood pressure: 140/83, heart rate: 66, respirations: 16, and oxygen saturation 96%. At 11:35am, PHN and Nurse  sat client up on gravity chair, client reported "shakiness is gone" at 11:42am. Last set of vital signs were taken at 11:55am, blood pressure: 144/98, heart rate: 78, respirations: 16, and oxygen saturation 96%. Client left facility at 12:00pm accompanied by wife, client physically  left facility with a steady gait and stated "I am okay to drive", wife of client stated "I will follow him home". Emergency Room precautions were provided to client and wife, such as; shortness of breath, chest pain, numbness or tinging or loss of consciousness, follow up with MD, and educated on the use of V-Safe.
numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.; hands were tingling; redness in the area where the shot was at; soreness; a little swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), SWELLING (a little swelling), HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.), PARAESTHESIA (hands were tingling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (soreness), SWELLING (a little swelling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.) and PARAESTHESIA (hands were tingling). At the time of the report, PAIN (soreness), SWELLING (a little swelling), HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.), PARAESTHESIA (hands were tingling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       no known allergies were reported. the concomitant history was not provided by the reporter.   This case was linked to MOD-2021-127972 (Patient Link).