chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details provided.; VARIVAX and PROQUAD inadvertently concomitantly administered to one patient; This spontaneous report was received from a office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 08-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD)(dosage regimen and route of administration were not reported), lot number W016355, expiration date 29-OCT-2023, administered as prophylaxis which was diluted with sterile diluent (dosage regimen, lot#, expiration date, and route of administration were not reported), and inadvertently concomitantly the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not reported) lot number T028304, expiration date 20-AUG-2022, administered as prophylaxis (Accidental overdose). No additional adverse events were reported (No adverse event).
Physician reported that patient received vaccine on 2/8/00, and approximately one week post immunization, she developed a lump at the injection site. This report was received from Aventis Pasteur (Ref. No. U2000-00357 (0)).
stomachache; dizziness; not puking but feels woozy; having trouble in standing up and sitting down; Caller added he felt kind of funny; Sick; shakiness; tiredness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2022 09:00 (Lot number: FK9729) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "one of his kidneys not functioning right" (ongoing), notes: Verbatim: one of his kidneys not functioning right. Concomitant medication(s) included: TAMSULOSIN taken for urinary tract disorder, start date: 2021. Vaccination history included: Bnt162b2 (Dose:01), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 2021, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 10Feb2022, outcome "not recovered", described as "stomachache"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "dizziness; not puking but feels woozy"; DYSSTASIA (non-serious) with onset 10Feb2022, outcome "not recovered", described as "having trouble in standing up and sitting down"; FEELING ABNORMAL (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Caller added he felt kind of funny"; TREMOR (non-serious) with onset 10Feb2022, outcome "not recovered", described as "shakiness"; FATIGUE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Headache"; ILLNESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Sick".  Additional information included: Patient's one of his kidneys was not functioning right and he has no idea when that medical condition began. The side effects did not start right away and began at 11:00am or after 11:00am.  No follow-up attempts are possible. No further information is expected.
This spontaneous report ws received from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinated with ROTATEQ (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one os several reports received from the same reporter. Additional information is not expected because no physician details were provided.
Patient was given the SHINGRIX vaccine subsutaneously and not IM. She suffered a red rash and some fluid build up which resolved in a couple days.
10 year old was given an extra dose of VARIVAX; This spontaneous report was received from a registered nurse referring to a 10-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 16-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter (lot number S021929 has been considered valid, expiration date reported and validated as 15-JUL-2021) for prophylaxis (frequency scheme, route of administration, and anatomical injection site were not reported). At the time of the administration, the patient did not have her vaccination records. Later, the clinic discovered that she was up to date on her vaccines, consequently, she received an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (extra dose administered).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA003848:
funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso
seizure activity 4 mos post 1st vax; had been irritable 2 wks post 1st vax but nl exam; no seizure noted;
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. He developed lower abdominal pain, diarrhea, nausea, chills and vomiting on ~ 4/9/21 . Patient presented to the ER on 4/11/21 and tested positive for COVID. Patient was admitted to the hospital for observation due to severe nausea and inability to take PO. COVID treatment was not started upon admission due to lack of respiratory symptoms.
Allergic reaction; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves child female patient (currently patient is 67-years-old) who experienced allergic reaction (hypersensitivity), while she received vaccine TETANUS TOXOID.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) on an unknown latency following the administration of TETANUS TOXOID.  Reporter stated that the patient had an allergic reaction before to an old tetanus vaccine when she was child and reporter did not know the name of the previous tetanus vaccine the patient received. Reporter wanted to ask if the Adacel contains horse blood extract and wanted to know if the Adacel has the same ingredient like old toxoid Tetanus.  Details of laboratory data was not reported.  Final diagnosis was allergic reaction.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of allergic reaction.  There will be no information available on the batch number for this case.
Body-wide, painful, burning hives that was treated with Prednisone.  Severe vaginal and throat pain. Hives were gone on 05/03/2021
Right side upper face and lip mild angioedema.  Lasted about 3-4 hours and resolved.  Then a week later  again in the early  morning mild upper face and LEFT lip milder angioedema lasted 2-3 hours and resolved.    Now today 4 days after second dose.  Very mild angioedema of lower central lip starting early in the morning and lasting only a couple of hours.
Hyperventilating. Evaluated by EMS- Transported to Emergency room/department or urgent care.
feeling dizzie/ light head / every time they move their head they feel dizzie; weakness all over; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MINOCYCLINE, OMEPRAZOLE, MAGNESIUM OXIDE, DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]), CALCIUM, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), PREGABALIN (LYRICA), ESCITALOPRAM OXALATE (LEXAPRO), ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM, ERGOCALCIFEROL (VITAMIN D2), NADOLOL, TERBUTALINE and HYDROMORPHONE for an unknown indication.   On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over). At the time of the report, DIZZINESS (feeling dizzie/ light head / every time they move their head they feel dizzie) and ASTHENIA (weakness all over) outcome was unknown.            Tourmaline 300 mg twice a day and proguard, Sulphate, Bath lysine  and Tomalin were concomitant drugs used and no treatment drugs were provided.  Every time the patient sound more sleepy and less and less coherent.   This case was linked to MOD-2021-079363 (Patient Link).
eyes are watery and his nose is red like it's swollen around his mouth too. Scratching his throat and having a hard time breathing; almost grunting sounding
Fever of 104.9, tachycardia to the 130s, weakness, fatigue, chills.
Large body hives that come and go all over my trunk, arms, legs, shoulders , back of neck, and feet. They are very itchy. I break out when I have dairy products, fruits, some flavored drink packets, or sometimes just wearing my watch. I have never been allergic to any of those things. Sometimes I break out in the middle of the night if my bed gets a little warm. I never had problems with any of those things before the shots.
crohn's disease flare up; bruising on genital area; bruising on neck; hives on neck and genital area; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4334132-00.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158187) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovering", described as "crohn's disease flare up"; GENITAL CONTUSION (non-serious), outcome "recovering", described as "bruising on genital area"; CONTUSION (non-serious), outcome "recovering", described as "bruising on neck"; URTICARIA (non-serious), outcome "recovering", described as "hives on neck and genital area". The action taken for adalimumab was unknown.  Clinical information: It was reported that, on an unknown dates, the patient experienced bruising on genital area, bruising on Neck, crohn's disease flare up and hives on neck and genital area. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of bruising on genital area, bruising on neck and hives on neck and genital area with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of crohn's disease flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of bruising on genital area, bruising on neck and hives on neck and genital area Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was possible. The reporter's causality for the event(s) of crohn's disease flare up with Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was not reported. Concomitant drugs and dates of administration was not reported. Other relevant history was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: magnetized-Medium, Additional Details: Patient states after her vaccine her arms became magnetized 4 days post shot. Noticed her left arm was actually more magnetized then her right although shot was on the right arm. Right neck area also noticed some magnetism. Patient states magnetism still occuring
Osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included CELECOXIB (CELEBREX) and ASPIRIN [ACETYLSALICYLIC ACID] for Osteoarthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis). At the time of the report, OSTEOARTHRITIS (Osteoarthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that aspirin and celebrax for osteoarthritis prior to taking the second shot of his Moderna COVID-19 vaccine which is scheduled for next Wednesday 17Mar2021. No Treatment information was provided.   Reporter did not allow further contact
about 10 days after the shot my arm feels warm, has a large red ring around the injection site and feels itchy on and off.
Child was suppose to receive MMR and received MENACTRA instead. This was done in error by the M.A. Dr. has reported this to our local health Dept. Child has had no adverse reaction. Except Diarrhea due to gastroenteritis.
Fever cough emesis after got vaccination today at clinic. Discharged on ibuprofen and Zofran.
Wanted to sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Wanted to sleep all day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Feb-2021, the patient experienced SOMNOLENCE (Wanted to sleep all day). At the time of the report, SOMNOLENCE (Wanted to sleep all day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SOMNOLENCE (Wanted to sleep all day) to be related.    No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624127, MOD-2021-624136 (Patient Link).
Tingling and numbing feeling in the left and right feet and toes (4/9/2022 to 9/2/2022). Pins-and-needles and numbing feeling in the left and right legs (4/9/2022 to 9/2/2022). Pins-and-needles and numbing feeling in the middle section of body [front, sides, and back] (4/9/2022 to 9/2/2022). Joint and muscle pain (dull) in the right knee (4/9/2022-9/2/2022). Occasional muscle pain (dull) in the middle area of the lower back (4/9/2022-9/2/2022).
This patient had local swelling, and soreness at the injection site. Prescribed Benadryl.
Fever, Screeching cry, dazed, blotchy skin, restlessness.
an expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 21-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 15-month-old female, to whom an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination.  On 20-Mar-2023, the patient received a Booster dose at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (Strength: standard) (lot number: UJ665AA, expiry date: 11-Mar-2023) via intramuscular route in the left vastus lateralis for Immunization and on the same day an expired dose of acthib was administered to a patient with no reported adverse event (expired product administered).  It was reported, caller requesting validity and safety information.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  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.
Day of vaccination a bruise developed.  On day 9 (1-7-21)  @ 8:15 am  a localized reaction started.   The area started itching then became red, hard, sore and warm.  I put topical anti- itch cream on it twice during the first day.   The final size on day 10 was 6cm X 7cm.   I continue to apply anti itch cream and notify my HCP by telehealth.
Metal taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male 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 05Apr2021 at 14:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergy to any medications, food, or other products. The patient did not take any medications within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:15 the patient experienced metal taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event metal taste in mouth was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. has fever 99.0 - C/o SA last night, vomited x 2. Vomiting has stopped @ 4:00am 8/20/09.
flu like symptoms; injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 9th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced flu like symptoms and injection site pain after receiving her second dose of Shingrix.
w/in 45hr of vax pt presented w/hot, erythematous, edematous mid upper arm to elbow;pain @ upper arm radiating into axilla, dec ROM, chills, fever 102max, WB 13.7;
Syncope following immunization seconds after administering, then had brief convulsion causing him to fall to floor. No hitting of head or other injury. Patient finally became responsive to calling him by name and recovered quickly after. Directly monitored patient for about 5 minutes to assess symptoms and coherence. Only had some slight somnolence. Patient also informed me that he consumed cannabis "edibles" before coming in to curb anxiety to shots. Patient was instructed to remain in waiting area for 10 more minutes. Patient did not drive home; he had a ride to and from home with friends.
Pt. received Pfizer vaccine at 09:55 am to left arm on 4/16/21. At 10:10 AM patient started feeling dizzy, headache, light headed. Pt. then started feeling nauseous, then left arm started itching and feeling sore and red, then patient started vomiting. Pt. states that she is feeling light headed, having frontal headache 7/10. Pt. states that she still has a queasy feeling.
Initial and follow up information has been received from a registered nurse through the Merck pregnancy registry for GARDASIL concerning a 26 year old female with no previous pregnancies, no pertinent medical history, and no known allergies who on 27-JUL-2007 was vaccinated with her first dose of GARDASIL (Lot #658100/0525U) intramuscularly.  On 28-SEP-2007 the patient received her second dose of GARDASIL (Lot #658100/0525U) intramuscularly.  There was no concomitant medication.  On 28-SEP-2007, before the second dose, a urine pregnancy test was administered.  The result was negative for pregnancy.  The patient called the office stating that she was pregnant and an OB intake appointment was on 14-DEC-2007.  A urine pregnancy test was performed on this day with positive results.  On 27-DEC-2007 an ultrasound was performed, and on 24-JAN-2008 a maternal serum alphafeto protein was done, both tests were within normal limits.  The patients last menstrual period was 02-OCT-2007 and the estimated delivery date was 08-JUL-2008.  During the first trimester, the patient had complication of first trimester spotting.  On 10-JUL-2008, 41 weeks from the LMP, the patient delivered a normal live born female infant weighing 7lbs 14ozs and apgar of 9/9.  Additional information is not expected.