chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had a fever of 101.3, chills, headache, redness around injection site and hot to the touch, and swollen lymph node
Began menses the morning of 12/23 prior to receiving vaccine. Had my vaccine and menses became unusually heavy, with more cramps than usual lasting a full 8 days when normally my cycle is 2-3 days total. This has never happened to me before. Also, had headaches daily (frontal, ache) for 4 days beginning on day two or three.
pt recv vax 5/18/99 & woke up w/severe abd cramps noticed difficulty w/breathing & swallowing, itchy bottom of feet & diff sleeping;also exp SOB & chest tightness;sc cont for @ least 1wk;low grade fever;
The patient was administered an expired Pentacel/no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (Reference number- 00642478 and 00645476) and transmitted to Sanofi on 15-Jun-2021.  This case involves a 2 months old male patient who was administered 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ326AAA, expiry date: 13-Jun-2021) via unknown route in the right thigh for prophylactic vaccination on 15-Jun-2021 (Expired product administered)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  The caller was calling back to report they had administered an expired Pentacel and asked what should be done regarding the expired dose that was given.   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.
itching everywhere-- nose,head, hands, vagina and "just everywhere"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching everywhere-- nose,head, hands, vagina and "just everywhere") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (The patient reported that for years, every year in April she gets shingles. In 2021, she got shingles in the early part of march (08-Mar-2021)). Previously administered products included for Herpes zoster: Shingles (September/ October 2020.) in October 2019.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-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 PRURITUS (itching everywhere-- nose,head, hands, vagina and "just everywhere"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching everywhere-- nose,head, hands, vagina and "just everywhere") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative (tests were done twice, both negative).         Concomitant medications were not reported. On 03-Apr-2021, it was reported that the patient experienced itching, which started out as mild and then worsened. She reported that the she never had history of prior itching like the present which lasted so long. The patient reported that she did not have rash.   This case was linked to US-MODERNATX, INC.-MOD-2021-069795 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: E-mail received includes no new information On 17-May-2021: Email received and included confirmation of previously reported event," itching" after the second dose of vaccine administration, outcome of event that it lasted for one week, doctor visit for medicines, no history of covid-19 infection with two negative Covid-19 tests. On 20-May-2021: Follow up was received  included event was resolved. On 25-Jun-2021: Follow up received and added shingles shot date in medical history and treatment received yes for event itching; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069795:CROSS LINKED WITH DOSE 1
Seven days after receiving my 2nd dose, I developed a painful lump near the injection site.  The skin was red and very warm to the touch. It continued to grow and get darker red, but I believe it has stopped growing now and I think that the color is lighter.  the lump seems smaller, also. It still hurts (much like the original vaccine) and it is still warm. It has been two days since I first noticed it.
No further AE details provided.; HCP called to report that a dose of PROQUAD was administered to a patient after a TE.; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 08-JUN-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once as prophylaxis (W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, route and anatomical location of administration were not reported), in combination with a sterile diluent. The administered dose underwent a temperature excursion via data logger of 12.8 degrees Fahrenheit for 25 minutes. There was a no previous temperature excursion reported (product storage error).   No additional adverse effect was reported.   This case was determined to be non-valid due to the lack patient's identifiers.  This is one of three reports from the same reporter.  Follow-up information was received from the nurse on 25-JUL-2023.  The report concerns to a 4-year-old female patient.  The vaccine was administered subcutaneosly in the left thigh.   It was reported that on 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, temperature excursion occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Data Logger (previously reported that temperature excursion was via Data Logger, conflicting information). The vaccine was administered by a heathcare professional and according to the instruction leaflet and it was not available for return/evaluation. On 11-JUL-2023, the vaccine was properly reported to manufacturer and seemed safe for use. The patient did not experience medical adverse events as a result of temperature excursion. The vaccine was no  longer in stock.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002433: US-009507513-2308USA001000:
This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose), VACCINATION COMPLICATION (COVID arm/It was pretty bad, it looked bad, it felt bad), MIGRAINE (almost a migraine headache), NECK PAIN (pain went into my neck) and MALAISE (just didn't feel well) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose). On 16-Aug-2021, the patient experienced VACCINATION COMPLICATION (COVID arm/It was pretty bad, it looked bad, it felt bad), MIGRAINE (almost a migraine headache), NECK PAIN (pain went into my neck) and ARTHRALGIA (pain went into my shoulder). On 17-Aug-2021, the patient experienced MALAISE (just didn't feel well), TENSION HEADACHE (tightness in her head) and HYPERHIDROSIS (broke out in perspiration in my scalp and face). On 20-Aug-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (a little fever). The patient was treated with LORATADINE (CLARITINE) on 19-Aug-2021 at an unspecified dose and frequency. On 15-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose) had resolved, FATIGUE (tired) had resolved. At the time of the report, VACCINATION COMPLICATION (COVID arm/It was pretty bad, it looked bad, it felt bad), MIGRAINE (almost a migraine headache), NECK PAIN (pain went into my neck), MALAISE (just didn't feel well), TENSION HEADACHE (tightness in her head), HYPERHIDROSIS (broke out in perspiration in my scalp and face), ARTHRALGIA (pain went into my shoulder) and PYREXIA (a little fever) outcome was unknown.            This case was linked to MOD-2021-293599 (Patient Link).
After administration of vaccine patient walked to our parking area and stated he felt "very dizzy" and vomited. His mother brought him back into the office. Skin was hot and clammy. B/p was low initially. Cold compresses were given and he was checked by doctor. After 20 minutes he stated he felt better. B/p was normal and he was allowed to leave.
Severe chills; Fever; Nausea; Dizziness; Unsteady gait; Severe vertigo; This is a spontaneous report from a contactable nurse, the patient. A 77-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) and HCTZ (hydrochlorothiazide) (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first  dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 16:00, the patient experienced severe chills, fever, nausea, dizziness which remained after 3 days also. She also experienced unsteady gait, severe vertigo and it was the worst feeling of her life. The patient was a nurse and cared for herself but could not drive and lived alone. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events severe chills, fever, nausea, dizziness, unsteady gait and severe vertigo were 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.
flushing, itching /burning of ears, tightness of throat, cough, generalized itching
Information has been received from a certified medical assistant concerning a 59 year old female with cluster headache, memory loss, hearing aid user, depression, hypertension and rosacea, and drug reactions/allergies to penicillin (unspecified), hydrochlorothiazide ("hydrochlorothiazide"), and esomeprazole magnesium (NEXIUM), who on 31-JUL-2006 was vaccinated subcutaneously in the left arm with a first dose of Pneumovax 23 vaccine (Lot # 651374/0485F) (0.5 ml). Concomitant therapy included acitretin (SORIATANE), fluocinonide (LIDEX), albuterol (VENTOLIN (albuterol)), propranolol HCl, paroxetine HCl (PAXIL), amlodipine besylate (NORVASC), lisinopril (LISINOPRIL-BC), aspirin, omega-3 marine triglycerides and vitamins (unspecified). The medical assistant reported that the patient experienced an adverse reaction after being vaccinated. The patient called the clinic 2 days later, and reported that her arm was red and swollen at the injection site and down past the elbow. The patient happened to see her dermatologist the next day and he placed her on antibiotics (unspecified). Additional information received from the certified medical assistant indicated that the patient's experience were considered other important medical events since the patient required antibiotics. The medical assistant indicated that the experiences were serious enough to require medication but was not sure if they would have been life threatening or would have required hospitalization without the antibiotic treatment, although at the time of reporting she felt that way. The medical assistant stated that patient's symptoms had been diagnosed as cellulitis. No product quality complaint was involved. The patient's experiences were considered to be other important medical events. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date sicne 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # J005078, expiration date: 20-SEP-2015) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
I had the Moderna Vaccine as suggested by providers since I had ongoing side effects and issues from Pfizer. We delayed me getting the 2nd vaccine for a long time in hopes that this would not be an issue again. My side effects from the first one were improved at this time although not resolved and I was still taking increased Omeprazole and Diltiazem to control the ongoing cough and esophageal spasms. I had the vaccine and felt ok for the first few days with just the same ongoing cough and esophageal spasms. On day 5, I woke up and took a drink of my warm coffee and it felt like my esophagus was on fire. This initiated extreme spasms in my esophagus that were extremely painful, the loss of my voice, increased cough like after the 1st vaccine.  These issues are ongoing. The burning is improved now as long as I don't drink anything hot. I can drink warm things.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 19:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tenseness at injection site"; DIZZINESS (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "waves of faintness"; FATIGUE (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tiredness"; OROPHARYNGEAL PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "red sore throat"; RHINORRHOEA (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "runny/stuffy nose". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, dizziness, fatigue, oropharyngeal pain, rhinorrhoea. Additional information: Other medications in two weeks: multivitamin, meloxicam. No other vaccine was administered in four weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 19 year old female with anaemia who on 02-JAN-2008 was intramuscularly vaccinated with her first dose of Gardasil (lot # 659437/1266U).  On 13-JAN-2008 the patient experienced syncope.  She went to the ER and was found to be slightly anemic.  On 19-JAN-2008 the patient had an office visit and experienced shortness of breath and generally did not feel well.  Subsequently, the patient recovered from syncope but not from the shortness of breath.  Additional information has been requested. 02/10/2010 In follow up report from the doctor's office and medical record it was indicated that patient had diagnosis of sycope/near syncope on admission to ER. It occured while she was standing after taking a shower. She became nausous, dizzy and then she passed out. She had no prior history of similar problems. Her discharge diagnoses from teh mergency room was syncope vasovagal. In the emergency room laboratroy result revealed her hemoglobin was 10.9 which was low. Her blood pressure meausrment was 110/60, heart reate was 77, repiration was 10 and oral temperature as 97.3 F. She had no pain and pulse oximety was 100% in room air. Head computed axial tomographyic of brain showed no caute intracranial abnormality. Electrcardiogram showed normal sinus rhythm and was sent to her physician. All other laboratory results were within normal range. No other information was avaiable.
received TENIVAC instead of ADACEL WITH NO REPORTED ADVERSE EVENT; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 36 year old female patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) instead of adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Feb-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult vaccine once (lot U6831AA, expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination instead of Adacel (wrong product administered, latency: same day). The reporter was questioning on how long the patient needed to wait until administration of adacel.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (received tenivac instead of adacel with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received tenivac instead of adacel with no reported adverse event.  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 guidelines. 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.
This spontaneous report as received from a certified medical assistant refers to a 14 year old female patient with no known pertinent medical history or drug allergies/ reactions. On 15-OCT-2013, the patient was vaccinated with her first and only dose of GARDASIL (lot # J008423; exp. Date: 21-JAN-2013) (dose not provided) intramuscular. There was no concomitant medication. On an unspecified date, on approximately October 2013, the patient broke out in a rash. The patient sought medical attention, the patient's mother called the office. No laboratory tests were performed. The patient was treated with Benadryl. On an unknown date, in 2013, the patient recovered, "the rash cleared up fine". Additional information has been requested.
Headache; 12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Latex allergy and Drug allergy (demerol). Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth) and VOMITING (vomiting). 05-Apr-2021, the patient experienced NAUSEA (Nausea). On 11-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) (oral) ongoing since an unknown date for Allergy, at an unspecified dose and frequency; MONTELUKAST (oral) at a dose of 10 mg once a day and FAMOTIDINE (PEPCID AC) (oral) at an unspecified dose and frequency. On 07-Apr-2021, NAUSEA (Nausea) and VOMITING (vomiting) had resolved. At the time of the report, URTICARIA (12 hours after vaccination she broke out in hives everywhere/she could fell them down in her esophaus(hives)/ hives on the scalp/ hives on neck, eyes, inside throatand  shoulders, back,legs, hands, feet/ hives on the inside of eyelids, mouth) and HEADACHE (Headache) had not resolved.            Treatment activities for event was also done with steroid for 5 days and allegra. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-071161.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received and the reporter information, patient demographics, concomitant medication, treatment medication and new event were updated.