chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
Off label dosing frequency; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Off label dosing frequency) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label dosing frequency). At the time of the report, OFF LABEL USE (Off label dosing frequency) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.
My lip on the outside started itching the my face started swell and it cause my low jaw to go numb. My throat started to close.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (fibral myalgia) and Rheumatoid arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Left arm, swollen and warm to the touch, treated with Doxycline HCL 100mg Take 1 capsule(s) twice a day by oral route with meals not MILK.#20 for 10 days. Patient reported event today during a nurse visit.
nose bleeding; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 18Feb2021 (age at vaccination: 72-years) as single dose for COVID-19 immunisation. The patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient experienced nose bleeding on 20Feb2021. The patient had his first dose of the vaccine last Thursday (18Feb2021) and since then he had 2 different episodes of nose bleeding. The patient stated that the 1st incident was 2 days after getting the vaccine and the 2nd incident was on Sunday. He mentioned that it wasn't that significant since he experienced bleeding on only 1 nostril and thought he had cut himself at first. When he noticed that it was coming from his nose, he tilted his head and put ice over it and 15 minutes later the bleeding stopped. He also added that he has not experienced this for 30-45 years now and what a coincidence it was that he had nose bleed again 2 days after getting the vaccine. He wants to know if there had been any reports of nose bleeding as a side effect of the vaccine because he wanted to call and check first before he calls and makes an appointment with his doctor. Therapeutic measures were taken as a result of nose bleeding. The outcome of the event was recovered on 22Feb2021.  No follow-up attempts are possible. No further information is expected.
On Jan 26th she received the shot, 3 days later she experienced some respiratory distress and the following Tuesday she experienced vision loss. She was diagnosed with viral induced asthma and encephalitis which also affected the optic nerve which caused the vision loss. She has luckily recovered and has regained her vision, but her doctors advised her to contact facility to see what the vaccine was composed of so she knows what to stay away from in the future. She has received the seasonal flu vaccine in the past.
Headache, Myalgia, fatigue, lethargy Narrative:  headache and fatigue still comes and goes, was able to work remotely on 1/12 or would have to stay home, couldn't drive due to muscle aches, left an hour early on 1/13
Swollen, itchy left eye Blurred vision in left eye Itchy left hand  Itchy left foot
There are no symptoms to report, however the temperature not working or the data logger were not working for the Month of October 2018 due to the temperatures not being logged for the month all vials of immunizations were deemed unviable.
extremely weak; dizzy; Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker; extremely sharp pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sharp pain in her legs), ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D12L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROPINIROLE, PROPRANOLOL, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]), PRAVASTATIN, PHENAZOPYRIDINE, MULTIVITAMIN [VITAMINS NOS], METFORMIN, MAGNESIUM OXIDE, LINAGLIPTIN (TRADJENTA), HYDROXYZINE, GABAPENTIN, DOCUSATE SODIUM (DOK), COLECALCIFEROL (CHOLECALCIFEROL), ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE BESILATE (NORVASC) and TECHNETIUM TC 99M APCITIDE (ACUTECT) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sharp pain in her legs). On an unknown date, the patient experienced ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker). At the time of the report, PAIN IN EXTREMITY (extremely sharp pain in her legs), ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was vitamin D12. The treatment information was unknown.
Symptoms: light headed , nauseous, and vomiting Vitals: BP 120/60, RR 16 Pulse 65 O2 95% Intervention/treatment: assess vitals signs, gave her apple juice and water
Client started sneezing right after vaccines administered but no other problems, about 10 minutes after vaccines administered, clients father called the health department and was transferred to a nurse and he stated he was still in the parking lot and his son was wheezing and unable to walk to the car, the nurse instructed the dad to bring client back in and at the time the client was given some oxygen and 911 was called, the client was being monitored by nurses at the health department until EMS arrived and took child to ER.
Information has been received from a physician concerning a 42 month old male pt who on 9/28/00 was vaccinated with a dose of MMR II (lot 636402/0999K). Subsequently, the pt was diagnosed with an expressive language delay within the spectrum of autism. It was reported that the father of the child believes "thimerosal" in the vaccine could have caused his son's condition. Upon internal review the pt's autism was determined to be an other important medical event (OMIC). Additional info has been requested. The follow up received on 1/22/03 states there was no illness at the time of the vaccination. On 9/28/00, the pt developed a fever and had cold symptoms that lasted for 2 weeks. On 9/28/00, behavioral changes were noted that were reported as ongoing. The pt was evaluated by several professionals. Subsequently, the pt was diagnosed with an expressive language delay within the spectrum of autism. It was reported that the father of the child believes "thimerosal" in the vaccine could have caused his son's condition The father reported that there were no issues prior to the pt's firsth birthday nor prior to this vaccination. The autism was considered to be disabling. No further info is expected.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter made an inquiry about how long do the shivering last after vaccination with Shingrix.
Patient came on 10/24/2018 and notified that she had arm stiffness, pain, and could not raise her arm after she was immunized on 09/18/2018. She said today, 10/24/2018, that she did notice improvement today. Advised patient to follow up with primary doctor. Patient stated that her daughter is a doctor and she spoke with her and that she thinks she will be ok.
5 to 6 days after each shot i got irisitis frst in my left then second shot in my right. I hae been on eye steroid since to this day. When i finish the 4 weeks of drops eyes get re inflamed.  Next week i will finish this latest treatment of eye drops and hope after 5 months it goes away. I worry because the eye drops can cause cataracts and blindness if taken too much, but untreated irisitis can also cause blindness.
Following first injection on 3/13/21. pt had 2 days of headache starting that night.  Following the second shot on 4/10/21, headache returned but was severe starting 24 hrs following injection.  Nausea and severe headache noted during this time.  Took Tylenol, but took 1 week to resolve.  Since this time, pt had marked increase in frequency of headaches, with need to start Elatriptan in June.  Headaches continued despite this medication.  Pt seen in ER 10/7 for intractable headache.  ER workup negative for acute changes.  Noted hair falling out, fatigue and weight loss in August, dropping her BMI to 19.5.  Pt had w/u and has ANA antibodies and possible diagnosis of scleroderma per Rheumatology.
Pt recvd series of 3 Engerix-B vax (0, 1, 6 months schedule) given deltoid; Testing 2 months p/3rd dose indicated titer was borderline (low titer of Anti-Hbs detected); 2 boosters given 1 mo apart.
Information has been received from a physician concerning a 37 yr old white male with no known allergies or medical history, who on 11Nov04 at 15:00 was vaccinated SC with a first dose of pneumococcal 23v polysaccharide vaccine (lot number 646078/0257N). The pt denied illness at the time of vaccination. On 12Nov04 the pt experienced a localized site reaction that included redness and warm to the touch. On 16Nov04 the pt stated that the doctor told him to call to report that his reaction was an infection related to a multidose vial. It was reported that the vial was discarded. No diagnostic studies were performed. The pt was treated with an unnamed antibiotic. Subsequently, the pt recovered. No product quality complaint was involved. It was also reported that a female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA03801). The vaccine was from the same lot number but a different vial. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released.
Patient received vaccine on Monday 5/20/19 in the afternoon. Later on that day the injection site became sore and red and swollen. It started at the site and went down her arm (almost to elbow) and up towards her shoulder blade on her back. This was confirmed by pictures she showed me. She did not come to the pharmacy until today, Sunday 5/26/19 and it was still a little red. The redness was surrounded by a bright white border. She said it was not itchy, just sore and painful.
Information has been received from a health professional concerning a 5 year old white male with no medical history or allergies who on 25-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657650/0716U). Concomitant therapy included a fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), a fourth dose of poliovirus vaccine (manufacturer unknown) and a second dose of measles virus live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). There was no illness at the time of vaccination. On 28-JUL-2007 the patient broke out with chickenpox while on vaccination. No serious reaction was seen but it was reported that he could have been exposed to numerous people at attractions. The patient returned home and went to physician's office and was told it was a pretty bad case for having had both vaccines. At the time of report the patient was recovered. No diagnostic laboratory tests were undertaken. No medical attention was sought. Follow-up information received states that no real adverse reaction occurred, just that the vaccine did not protect from the disease. The patient received 2 immunizations but got chickenpox 6 weeks after the last immunization (also reported as 28-JUL-2007). Additional information has been requested.
only received the liquid portion with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who only received the liquid portion with no reported adverse event. (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 01-Nov-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ684AA and Expiration Date :16-Sep-2023)Strength: standard at a dose of 0.5 ml Total via intramuscular route in the left vastus lateralis for Immunization.  On an unknown date the patient only received the liquid portion with no reported adverse event (incorrect product formulation administered)(unknown latency).  Reportedly, stated 2 patients received PENTACEL. One patient received the full dose, the other only received the liquid portion. HCP isn't sure which patient received the full dose. Caller states that she has two patients that received Pentacel and realized that they had an extra Hib dose and only one was given. Caller states that she realized as she was providing the lot and expiation information that the second patients Pentacel were from the state vaccine and he received his full dose. Caller states that another patient did not receive a full dose of Pentacel because last month she 5 doses and now she has 3 and half.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
no AE; a patient received less than recommended dose of PROQUAD; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #U029325 verified as valid and expiration date: 19-MAR-2023, albumin status: rHA) (dose, route of administration, injection site were not provided) for prophylaxis. The patient received less than recommended dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Incorrect dose administered). No additional adverse events were reported (No adverse event).
2 days after vaccine administration a few itchy red bumps appeared. Worsened to redness, some pain and itchiness. Oral BENADRYL administered and oral prednisolone. An allergist referral was provided.
Had this Pfizer shot, I was lying down and realized that my heart started to do that same thing again and that reminded me of COVID; This is a spontaneous report from a contactable consumer (patient) or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced increased heart rate after having the first pfizer shot. The patient was lying down and realized that the heart started to do that same thing again and that reminded of covid on an unspecified date. The clinical course as follows, Consumer stated, "So, I received the first Pfizer shot vaccine on Monday, this 1st, so it's just a few days ago and I wanted to know I had a symptom in the evening that surprised me. So, I wanted to discuss it with you especially since you're a pharmacist because I wanted to know if it's common or uncommon or if it's something I should be concerned about. So, it's about the same. So, I had COVID a year ago, 19Mar was my first symptom." Consumer further stated, "So, I kind of knew, I had COVID and then I ended up having long term symptoms and it affected my heart as it does with other people. So, COVID affected my heart in a sense that I had these blurps and these out of control, not tachycardias but they were kind of like almost like an arrhythmia issue but not as tachycardia which is why it would like blurp and it lasted a long time on and off. And I actually went to a cardiologist and got a heart monitor to check it and they did verify and then it just kind of went away. And I did have one incident in the end of January and that was it, I've never experienced it again and my COVID symptoms lasted a long time but then they went away. And so, anyway I had this Pfizer shot on Monday and Monday night, I was lying down and just kind of watching a new show and I realized that my heart started to do that same thing again and that reminded me of COVID because that's what happened during COVID. It was like, it didn't seem like a coincident it lasted for about 2-3 minutes may be it was kind of a long time." The patient underwent lab tests and procedures which included increase in heart rate on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Fever, fatigue,  headache, sore-swollen-red rash on arm receiving injection.
extra dose of Menactra administered in error, as a booster dose was not indicated due to receipt of a first Menactra dose by this patient with no reported adverse.; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (MI) (Reference number- 00831432) and transmitted to Sanofi on 27-Oct-2021.  This case involves a 12-year-old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 27-Oct-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7190AA, expiry date: 16-Jan-2023) via an unknown route in the left arm for prophylactic vaccination.  It was an actual medication error due to extra dose administered (latency: same day).   It was reported "A 12 year old patient received a dose of Menactra today, 27Oct2021, in error, as a booster dose was not indicated due to receipt of a first Menactra dose by this patient in 2019."  At time of reporting, no adverse event 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.
I got my 1st dose, but missed my 2nd. What should I do?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment was provided.
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced hives. The patient did not come back for a follow-up visit and their outcome is unknown. Additional information has been requested.