chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SPEECH WAS BELLS PALSY SIMILAR TO A STROKE; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) in a 75-year-old male 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  It was unknown If patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  Company Comment: This spontaneous case concerns a 75-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the expected, serious (medically significant) AESI of Bell's palsy. The event occurred on an unspecified date in 2021 after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient experienced 'speech was Bell's palsy similar to a Stroke'. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The event was considered not related to the mRNA-1273 vaccine as per the reporter's assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the expected, serious (medically significant) AESI of Bell's palsy. The event occurred on an unspecified date in 2021 after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient experienced 'speech was Bell's palsy similar to a Stroke'. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The event was considered not related to the mRNA-1273 vaccine as per the reporter's assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Hives and Rashes broke out over entire body and have been  there for the past 3 days.
he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done; he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: My husband had test for the positive; Positive, notes: after 10 days continuously is, we just check it just if the test was still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Reporter stated, She asking about, the medication was Paxlovid. Her husband had test for the positive, Covid positive, so they got the Paxlovid, the medication, Pfizer's. After that, after 10 days continuously, They just check it just if the test was still positive. He does not have a lot of symptom but he still does had a lot of sputum was coming out and basically that was what it was. He pulped it out and spit them, he does not have fever, he does not have anything precise of whatsoever. She just wondering since he would test still positive, he was still contagious? Yes? He had all the Pfizer immunization, he had a booster two times, he had a vaccination two times (Later clarified as Pfizer COVID- 19 Vaccine), he got everything done. reporter just kind of wondering was that, can be possible if they ask about the urgent care doctor to ask about monoclonal antibody, was that a name or somebody says 'that Paxlovid may had possible' and even though he had Paxlovid, can they had another shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports new constipation unrelieved by OTC medications starting the same day she received her vaccinations. I told her we would report this as a possible adverse event. I encouraged her to reach out to a doctor office for help in getting some relief, but I also encouraged her to continue to drink plenty of water and to try Miralax. I also told her she could try magnesium citrate, but that it would cause a bit of abdominal cramping  and advised her to try other products first. She also reports generally feeling badly with occasional fevers. I assured her this is a normal response and that she can continue to take OTC medications for the fever.
Patient inadvertently received a dose of Vaxelis, instead of the ordered Fluzone High Dose QIV; product use in unapproved population; No Adverse Event; This non-serious case was received during the monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Patient inadvertently received a dose of VAXELIS, nurse accidentally pulled and administered VAXELIS, instead of the ordered FLUZONE HIGH DOSE QIV, with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 73-year-old male patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (Vaxelis), nurse accidentally pulled and administered vaxelis, instead of the ordered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization and suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and patient inadvertently received a dose of vaxelis, nurse accidentally pulled and administered vaxelis, instead of the ordered fluzone high dose qiv, with no reported adverse event (wrong product administered) (unknown latency). It was reported, ordering physicians ordered FLUZONE HIGH DOSE QIV for both patients. This situation is reported as a medication error due to a missed dose of FLUZONE HIGH DOSE QIV. As patient did not receive dose of ordered FLUZONE HIGH DOSE QIV on 07NOV2022. No further information provided by the reporter. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) and DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE) 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.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient inadvertently received a dose of Vaxelis, instead of the ordered Fluzone High Dose QIV", "No adverse event" and "product use in unapproved population".  No further information is expected.
Redness swelling hot to touch at and around injection site. Down to about halfway to elbow. Pt taking TYLENOL and will add some antihistamine and follow up with MD.
dizzy; nausea; threw up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CLONAZEPAM, HYOSCYAMINE and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up). On 04-Mar-2021, DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Contact Information Updated
Vaccine breakthrough, symptomatic.   Inpatient admit 9/3-9/8.
On day 8 my left arm swelled at the site it was red hot and itchy. Today I woke up with a ring of red around the injection site  and 6 quarter sized itchy red bumps under the site.
Unable to sleep  the night of the injection, felt poorly Next day (11/8) felt weak, nauseous (vomited 4x throughout the day), tired, headache, unable to eat, stayed in bed all day No pain or swelling at injection site 11/9 felt much better - almost back to normal
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Flu-like symptoms, fatigue, chest pain, headache, throat and ear pain, injection site irritation
Little sore arm after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm after the 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Glaucoma suspect), Food allergy, Seasonal allergy and Allergy to animals (Cat allergy). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, LATANOPROST (XALATAN) for Glaucoma.    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 VACCINATION SITE PAIN (Little sore arm after the 1st dose). At the time of the report, VACCINATION SITE PAIN (Little sore arm after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient felt fine with just a little sore arm. She did not have any Covid-19 diagnosis prior to or after getting the vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-535464 (Patient Link).
pt got the vaccine and walked away only to return a bit later and sit on the chair. Her husband stated she was feeling dizzy. I asked her to sit down and gave her bottled water to drink. They stated she had not eaten anything either so I gave her a protein bar . Shae ate that and drank the water. I asked her to take deep breaths and relax. During this time I was made aware that she gets this way just from the fear of needles as she goes through these episodes when she has blood drawn. After about 15 minutes I asked pt to stand for a bit and to look around. Then I asked her to walk a little. She looked fine and with the husbands permission let them go but to call us if any issues.
A rash appeared on her neck and back...worsening the next day and spreading down to buttocks with a small amount on stomach and left leg. Still there on 11/3/2009.  Made a doctor's appointment to have it checked this afternoon. 11/10/2009 MD record for 11/3/2009. Patient with c/o's papular rash on thorax and buttocks. PE normal. Tx: benadryl prn and observation. Dx allergic reaction.
Pt became pale,weak c/o dizziness and began vomiting after anthrax vaccination.
Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approximately 11:30am. She felt fine after the second vaccination, until about 1:30-1:45pm. Patient c/o a "heat rush", headache, and hives on BUE. Patient vitals were WNL except HR was slightly tachycardia at 107bpm. Respirations were baseline at 18. Patient denies sob/anaphylaxis. Benadryl administered orally, and monitored. No reaction was had with the first vaccine.
I took ibuprofen 15 minutes after the vaccine to minimize any reaction. 4 hours later my eyes started to feel like I had dirt under the eyelids. I also started to get a headache. Shortly thereafter I started to get an irritated throat and swelling at the back of my tongue. Next my sinus became so swollen that I couldn't breathe through my nose and my frontal sinuses became swollen as well. Next my lungs became involved and I started to have asthma symptoms.  I called the emergency triage nurse line for my clinic and as told to take more ibuprofen, an antihistamine and use my albuterol. If symptoms continued to get worse, I was to go to the ER. about 4-5 hours after the symptoms started, they stabilized and I was able to go to sleep. I wolk up this morning with aching muscles a headache ringing ears and a slightly swollen throat. I'm taking tylenol and ibuprofen to control the symptoms.  This is the first time I've ever reacted tot e flu vaccine. This is also the first high dose vaccine I've had. I do get serioius asthma symptoms with a cold or flu.
Headache, Myalgia & Fever Narrative: 3/12/2021: Woke with body aches, fever over 102, and swollen lymph nodes that lasted for most of day.
Patient returned to clinic 24 hours after vaccine was administered. Injection site red and swollen approximately 10cm x 10cm. Also with pain at injection site. Patient denies any itching, trouble breathing or mouth/tongue/throat swelling. No intervention required. Patient instructed to use ice and Tylenol or Ibuprofen as needed to help with pain. Patient to return as needed for any new symptoms.
1 to 2 days p/vax pt devel fever to 103;10FEB97 presented @ hosp w/bilat myositis in legs, w/o joint involvement;pt was unable to support weight;could not stand or walk;CPK was 1758 & considered to be risk for renal failure;
Pt. complained of difficulty breathing and shortness of breath. Vitals obtained: BP 130/80, Pulse 80, and resp. 20 (unlabored). No noted wheezing or stridor. No respiratory distress noted.
I have had fever, chills, headache, vomiting and diarrhea x 4 days.
POSSIBLE HALLUCINATION; This spontaneous report received from a consumer concerned an 87 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had his Janssen Covid-19 vaccination on 19-MAR-2021 and on 20-MAR-2021, the patient experienced possible hallucination and patient's son will be going to their house to investigate. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possible hallucination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210340686-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin, sulfa; "known allergies sulfa" (unspecified if ongoing), notes: known allergies penicillin, sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: it was unknown if other medication received in 2weeks. anti-viral details: product: COVID 19 Treatment, brand: Pfizer, treatment start date: 28May2022. treatment stop date: 02Jun2022. indication: Treatment of COVID-19. Patient experienced rebound covid on 07Jun2022. Patient did not received treatment. device timestamp: 08Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
it feels numb to her on the inside but she has pain at the same time; it feels numb to her on the inside but she has pain at the same time; she gained 20 pounds/usually stays at 135 pounds and got her Pfizer COVID Vaccine 1st dose on 25Mar2021 and 2nd dose on 16Apr2021 and she is now 153; This is a spontaneous report from a contactable consumer. A 31-year-old female consumer(patient) reported for herself.  A 31-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW1051, Expiration date: unknown), via unspecified route, administered in left arm on 16Apr2021 between 11:00am-11:30am (at the age of 31-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: ER8733, Expiration date: unknown), via unspecified route, administered in left arm on 25Mar2021 (at the age of 31-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  No vaccinations prior 4 weeks of vaccinations. On an unspecified date in Apr2021, after the vaccination, the patient experienced her right leg was felt like it is going to sleep and that happened about 4 days after the 2nd dose. Patient states she can stomp her leg and it kind of feels like painful but almost numb and she can feel it at the same time, and it feels numb to her on the inside, but she was in pain at the same time, and she can feel it when she pushes on her leg and her leg is almost asleep and it is a numbing pain of not waking up. states she has never had back or orthopaedic problems before this and takes no medications and does not go to the doctor unless she is sick or for her yearly check-up and is on no medicine. Patient was asking if this is normal and states she doesn't feel like her leg is going limp or she is losing control of her leg and it was going to sleep and won't wake up good. Caller states she gained 20 pounds and does not know why and usually stays at 135 pounds and got her Pfizer COVID Vaccine 1st dose on 25Mar2021 and 2nd dose on 16Apr2021 and she is now 153 pounds. Patient lab data includes pregnancy tests which was negative for three pregnancy tests she has done at morning noon and night and was not pregnant. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
This report was received from a nurse and prospectively described a 24 year old  female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis during the first trimester of pregnancy. The subject's medical history included allergy to Zyban. Concurrent medications were unknown. She experienced no adverse events following previous immunizations. On 11/6/02, the subject received her second injection of Engerix B (lot 5291A4). Unknown to the vaccine administor, the subject was pregnant at the time. Her last menstrual period was on 9/26/02. Additonal info was received on 12/10/02. On 11/16/02, the subject experienced a miscarriage at a gestatonal age of 5 weeks. The beta human chorionic gonadotrpin concentration was "never above 40 (units and reference range unspecified)." An ultrasound performed on 11/12/02 was "without fetal pole." The reporting nurse stated that the miscarriage was "probably not related" to Engerix B adminsistration because "cramping started before injection." Miscarriage is considered medically serious (OMIC). Therefore, this report has been reclassified as serious.