chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Physician assistant concerning a 14 weeks old male patient who his on 27-APR-2011 was vaccinated with the first dose of ROTATEQ oral (lot. Dose not provided). On 23-MAY-2011, patient was vaccinated with the second dose of ROTATEQ oral (lot. Dose not provided). On 27-OCT-2011, the patient was vaccinated with the third dose of ROTATEQ oral (lot. Dose not provided). No adverse event reported. Additional information has been requested.
Had flu shot on wed. (Dec 1) and the next sat I was very sick, chills, tight cough, headache, muscle aches in my whole body. Two day had loose stools. It is a week later today a still not feeling better.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 3:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 3:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a ethnicity. The patient had received the vaccine dose number booster. No concomitant medications were reported. It was reported that a series of an approximately 540 patients had received lot number of 066H21A in past and had an its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No treatment medications were reported.
On 10/28/2022 1 week after my 4th dose I started feeling facial numbness, tingling and numbing in my left arm down to my left leg. I went to the ER where I was checked for Diabetes and that was normal. I also had an MRI and CT scan which were both normal as well. I still have tingling and numbness sporadically.
Patient experienced redness/edema at the injections sites, pain, and vomiting. Patient was seed at the ER and was prescribed prednisone and antibiotic. Patient feeling better today.
Information has been received from a licensed practical nurse concerning 4 females (ages not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL due to a nursing error. Each patient received 0.25 mL dose of GARDASIL given subcutaneously near the wrist on 17-OCT-2007. The person who administered the doses split a 0.5mL dose of GARDASIL equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN that one vial of PPD was delivered to one office one day. On the following day one vial of GARDASIL was delivered to the same office. The medical assistant who was located in the office, in error draw the medication that would be used for the PPD test from the GARDASIL vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccination would only be administered at another office and not in the current office to assure that this error would not occur again. The patient that received GARDASIL was treated with cold/warm compresses and recovered. Additional information is not expected.
Pt recvd 2 doses of Hep B vax on 8MAY92 & on 15MAY92 pt devel malaise, t99, nasal drainage & productive cough; upper resp drainage & occasional dry cough; nasal drainage & productive cough;
got positive after getting the vaccine; got positive after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for herself and for her husband. This report for her husband. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer mentioned that she and her husband had the first dose of the vaccine on 11Mar2021 and got positive after getting the vaccine. The patient tested positive on an unspecified date in Mar2021. The consumer would like to know if they can still get the second dose of vaccine on 05Apr2021 (more than 21 days). At the time of reporting outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328790 same reporter/product/event, different patient
13DEC94 4mm area of redness lt deltoid, applied ice 14DEC94 7x8mm area of redness-warm to touch; MD advised warm packs & Voltaren;
17 yo patient received Moderna Vaccine 1/23/21. Pt also received dose 2 Moderna 2/20/21.
Got My covid pizer shot on Wednesday. Two Days later horrible rash on face one spot on right side of cheek. Next day rash appeared on both forearms and at crease of fold of arms to my forearme Stillby?redrewstill there as of 8-13-21. No pus, infectionn or dr ju5 from rash nor contagious
Chickenpox outbreak 5/21/06 (outbreak @ daycare). H/o vaccination @ age 12 mos.
consumer did not get Imovax at all on day 3 but another manufacturers rabies vaccine with no reported adverse event; Initial information received on 21-May-2021 regarding an unsolicited valid non-serious case from a pharmacists.  This case involves a 69-year-old female patient who received first day zero dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) but on day 3 received another manufacturers RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] (lot ARBA651B, expiry date-01-Mar-2023) via unknown route in unknown administration site for post exposure immunization on 17-May-2021 (interchange of vaccine products).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of interchange of vaccine products (same day).  It was reported that, the patient is scheduled for a 4-series vaccination. Also, the reporter had query if the entire post exposure series of Imovax needs to be performed if the consumer did not receive a dose on Day 3.  At the time of report, no adverse event was reported.  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.  There will be no information available on the lot number for this case.
Hypothyroid turned into hyperthyroid. Racing heart, weight loss, gritty eyes, double vision, tremor, nightmares. All began after January 25.   Although TSH level was high, endocrinologist cut back synthroid because of symptoms. Now, 4 weeks later, I feel better, but labs are still strange.
Sore throat with peeling tongue and rash sore on bilateral legs and arms. Called PCP on 3/18 was told to go to urgent care. Went to  urgent care 3-19/21
Vaccine administered without correct liquid; Vaccine administered without correct liquid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine administered without correct liquid) and inappropriate dose of vaccine administered (Verbatim: Vaccine administered without correct liquid). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The clinic had a vial of Menveo liquid left over.  When they find the patient that had the incorrect dosing, would that dose need to be repeated and how much time did the patient need to wait between doses. Upon callback to health care professional (HCP), she stated she was informed yesterday and it discovered wednesday.  They were still researching. The lot or expiry date not available but gave consent for follow up to obtain this info at a later time. The reporter consented to follow up. The patient had Menveo vaccine administered without correct liquid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Acute Urticaria - No Dyspnea. No Dysphagia. Area of redness @ injection site 4 cm diameter.
Patient woke up on the morning of 08/03/17 complaining of fatigue, throat tightness, chest heaviness, and nausea. The symptoms persisted and patient was seen in the office and examined by MD around 12PM.
During the 1st dose on 3/3/2021, about a week later I notice that had a few hives spots on my body.  During the 2nd dose on 5/3/2021,  after the shot on 5/5/2021 I broke out in a really mild case of hives all over my body.  I had to take Zyrtec and the symptoms went away after an hour or so.  I also contacted  Dr. on 5/5/2021 about my hives.
Patient given vaccine on 6/14/21.  Expiration date listed on vaccine 12/07/20. -Patient  administered vaccine 6 months beyond stated expiration date. Patient informed subsequently on 6/16/21.  She stated that no arm discomfort which was different from initial vaccine dose.  No other ill effects.  Plans to come for Dose #3 in September.
Mother called to report child scratching ~ 1030am area of injection at school. Noted reddened area "size of silver dollar" with lump; parent was advised to apply cold compresses and give Benadryl for itching. Swelling decreased, less reddened at 150pm reports mother.
Palpitations developed 3 to 4 hours after vaccine, associated with lightheaded.
injection site lump size of a quarter; slight sore throat; injection site soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) outcome was unknown.            Patient stated that she received her second shot on 23Apr2021 (Lot # 001C21A) and now she experiencing injection site soreness and a lump at the injection site, the size of a quarter. Caller also had a headache and slight sore throat.
Information has been received from a pharmacist referring to a newborn (numbered 85). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 times each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 10-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 54 year old female patient. It was reported that the patient was not ill at the time of vaccination and did not have any pre-existing allergies or medical conditions. The patient's concomitant therapies were not reported. On an unknown date, a registered nurse picked up the wrong vaccine, she got PROQUAD instead of M-M-R II and the patient was vaccinated with a dose of PROQUAD first dose, subcutaneously, in the left arm, lot # N010245, for prophylaxis (strength and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). The patient contacted the reporter on 05-OCT-2017 and referred that, on an unknown date, her "arm was 'stiff'" and she "felt tired" (source document difficult to read). The patient contacted the reporter on 10-OCT-2017, and referred that her "arm was still same" and she did not have other complains (source document difficult to read); however, the outcome of fatigue and musculoskeletal stiffness was reported as unknown. The causality between fatigue and musculoskeletal stiffness with PROQUAD was not reported.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with no drug allergies and irregular menses and a history of abnormal "low grade squamous" pap in February 2008, who on 03-FEB-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). There was no concomitant medication. On 16-FEB-2009 the patient sought medical attention for prenatal care at physician's office for a confirmed pregnancy. On 19-MAR-2009 the patient phoned physician's office and complained of bleeding. Therefore a quantitative Human Chorionic Gonadotropin (HCG) was drawn with a result was "61, 811". On 21-MAR-2009 the patient had a repeat quantitative Human Chorionic Gonadotropin (HCG) level drawn with a result of "46, 393". On 23-MAR-2009 the patient went to her primary care physician's office and had a "cytotech" procedure performed there for a miscarriage. On 04-APR-2009 the patient visited an emergency room for complaints of cramping and bleeding following the "cytotech" procedure. On 14-APR-2009 the patient came to physician's office and complained of dizziness. On 21-APR-2009 the patient met with the nurse practitioner at physician's office when her second dose of GARDASIL was due, but it was not given at that time. On 28-DEC-2010 the patient came to physician's office and received the second dose of GARDASIL (therapy route and lot # not provided) late. At the time of reporting, the patient's status was recovered. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Sore arm, headaches, dry cough, shortness of breath, dizziness, weak.
Information has been received from a physician concerning a 19 year old male patient who on 31-MAR-1992 was vaccinated with the first dose of MMR II. On 25-SEP-1997, the patient was vaccinated with the second dose of MMR II. On 10-NOV-2009 the patient was diagnosed with mumps. Parotitis was on right side. The patient did not experience fever. Blood work was performed with a result of IgM<1:10, IgG 9.29 and serum amylase 725. At the time of the report, the patient's status was unknown. Additional information has been requested.
Information has been received from a registered nurse concerning several patients between the ages of 16 weeks and 6 months who were vaccinated with an initial dose of rotavirus reassortant vaccine live. No symptoms were known.  Unspecified medical attention was sought.  There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available. This is in follow-up to report (s) previously submitted on 1/16/2007.  Follow-up information from the registered nurse indicated that "so far" none of the children had reported any adverse experiences.  Additional information is not available.
middle ear congestion; ringing in the ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR CONGESTION (middle ear congestion) and TINNITUS (ringing in the ears) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Negative for past history of COVID-19 diagnosis).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced TINNITUS (ringing in the ears). On an unknown date, the patient experienced EAR CONGESTION (middle ear congestion). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Ear congestion, at an unspecified dose and frequency and PREDNISONE for Ear congestion, at an unspecified dose and frequency. At the time of the report, EAR CONGESTION (middle ear congestion) and TINNITUS (ringing in the ears) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: (Negative) negative for past history of COVID-19..         No concomitant medications were reported.  The patient reported ringing in one ear beginning on 31-Dec-2020 and second ear began ringing on 01-Jan-2021. The patient reports ringing in both ear continues until present (30-Mar-2021). The patient reported visiting her family physician and an ENT regarding her symptoms, was diagnosed with middle ear congestion and was prescribed prednisone and Flonase for 6 weeks.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Updated reporter address, patient demographics, suspect product details (second dose), new events and treatment information.
Customer reports redness, warmth, swelling that started below site of injection and has some signs of spreading which she noticed after she received the vaccination on 8/10/18.
I had 103 fever; flu-like symptoms: aches, chills, fatigue, headache. I was wiped out and felt overall malaise. The fever ran that high for a day. For a whole day, I felt really bad. And then it was low grade for 2 days and then I felt still like I had a flu but fever was 100. I took Tylenol and took plenty of fluids and rested. It was three days before it was better - each day was getting progressively better. By fourth day, I was fine.  I had almost no arm soreness at injection site with this vaccine. The first full day, it was a bit sore but then it went away. (The first Pfizer dose of vaccine, I had arm soreness - intense- for two weeks.)
This case reported by a consumer (the subject) and described the occurrence of upper respiratory infection in a 52-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included food allergy and seasonal allergy. On an unspecified date in 2010 the subject received a dose of Flu vaccine (details unknown). The subject reported that the flu vaccine was a GSK brand, but did not know whether it was FLUARIX or FLULAVAL. Within days of vaccination with Flu vaccine, the subject experienced upper respiratory infection, sore throat, hives all over and fatigue. The subject was treated with ZYRTEC, BENADRYL and prednisone. The subject reported that he had visited his physician soon after his reaction began, but the ZYRTEC prescribed did nothing. Upon his second visit, the subject was prescribed BENADRYL and prednisone. The course of prednisone was completed 9 days later, but the subject continued to develop new batches of hives everywhere. At the time of reporting the upper respiratory infection, sore throat and fatigue had resolved after more than a week duration. The hives all over were improved after being ongoing for more than 3 weeks.
24 hours after administration of seasonal influenza (TIV) and pneumovax, patient developed myalgias, chills, fatigue and developed progressively worsening hives the subsequent 4 days with some subjective symptoms of chest and throat tightness.  She saw her primary care doctor 2x and myself (allergist) 1x for these symptoms
This case was reported by a physician via sales rep and described the occurrence of generalized pruritus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: On an unknown date, two weeks ago the patient received a dose experienced Itching over entire body. The patient was itching till the date of reporting. He did not know if it was for sure linked to SHINGRIX but happened after she received dose.