chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus; It is about 140 (lbs.) and I know I am shrinking; bruising where the injection is done is ordinary; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number unknown (Booster), Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 10Dec2022, outcome "unknown", described as "bruising where the injection is done is ordinary"; TINNITUS (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "It is about 140 (lbs.) and I know I am shrinking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site bruising, tinnitus.  Additional information: Caller was asking if "bruising where the injection is done is ordinary" for "Pfizer COVID vaccine booster dose". "it was the second dose he had in 30Nov". I got a bruise from it. There is no pain. It is just a bruise. It is like a combination of black and blue and green." Other Conditions: No. Other Products: No. No prior vaccinations (within 4 weeks), Consumer stated the last one before that was 25May. That was well past 4 weeks. Treatment in response to adverse event: Consumer stated as No. Consumer stated, "I did go to the ear, nose and throat doctor at the (name withheld). That was for, to check, I have a tinnitus (Further clarification unknown. Hence not captured in tab). That has something to do with the hearing. It is in the left ear and that was about that. I mean I ended up getting an MRI done because they wanted to see if the tinnitus was caused by my brain or was it caused by tumor but they haven't gone back to me yet. So, I am assuming it was caused by the brain because first of all, it was only a 3 percent chance that it was caused by a tumor and it if it was caused by a tumor, I think they would have told me about it by now whereas if it was caused by brain, I mean I think they wouldn't have bothered telling me. You know it is one of those things, no news is good news, you know what I mean. They had to do an IV for that and if you know how an MRI works. I mean, I never had one done on my skull before. Saturday noticed he has a bruise where it was done.
Wrong Vaccine Administered, was supposed to receive bivalent booster and received monovalent vaccine. No side effects noted.
Symptoms Before Adverse Event: Pain on injection site (left arm) which started a few minutes after injection and got worse for the next 24 hours (later began subsiding after around 36 hours of injection). Fever (102 degrees Fahrenheit) and chills the night after receiving the vaccine (lasted around 6 to 8 hours). I had difficulty sleeping that night. I was uncomfortable and had muscle aches everywhere. I felt dehydrated and  got hungry in the middle of the night so I drank some water and ate two small bowls of Mac and Cheese before taking two tablets of 650mg Tylenol (to lower the fever because it was getting gradually getting higher). The following morning after waking up (I only slept for a few hours), I was sweating (fever was gone) and I got up to go to the bathroom. This is when the "adverse event" began.  Adverse Event: As I was standing in the bathroom getting ready to urinate, I started feeling a dizzy and my heart was pounding harder than usual (not faster or slower, but stronger beats). My vision got blurry and I started seeing white stars (white filling up my vision). I then felt this odd hollow, nauseating feeling in my stomach and began feeling too weak to properly focus. I started walking out of the bathroom to call for help and was helped to lay down on a bed. I felt like I was fainting (I have never fainted before but I am pretty certain that must be what it feels like to start to lose consciousness and the ability to move as you begin fainting).  Treatment and Outcome: As I was laying down, I fortunately started feeling like my energy was returning. My vision began reappearing and despite feeling extremely anxious during this incident, I was now feeling a bit more calm as it felt like I was getting better now. My parents where in the process of getting a phone to call ED to get help for the emergency but put that on hold as they helped me sit. I was not sure what had just happened and if I should go to the emergency room. I felt weak, scared, and kept grabbing my chest (I felt like I needed to feel my pulse and breathe deeply). I used Agency to call a doctor for advise on what to do. She mentioned that she believes that I had Orthostatic Hypotension as a result of the vaccine-related fever, being dehydrated, and getting up quickly. She told me that if I continued to feel sick then to go see a doctor in person but she said I didn't have to go to the emergency room now unless I felt like I had to or the incident reoccurs. I've felt weaker than usual since the incident (it's been 3 days since) and also somewhat nervous/anxious that it will occur again. I feel like I am getting a bit more agitated than usual (even when doing regular things like standing up from sitting or walking) and have had a lot of trouble sleeping at night (a bit of insomnia for the past few days).
Pt. came into the office for the 2nd day in a row trying to complete her school registration requirements for school. Employee Health Nurse had helped her yesterday and told her she had everything but the employee stated she needed new labs as school was rejecting her information. She had labs drawn and today pt. called back asking to get a booster so she could go ahead an register. Reporter prepared the form and had the vaccine and VIS out to be ready when she walked in. She said down and we started to discuss what she needed. I reviewed her documents again and said she had everything and didn't need the vaccine. Reporter showed her where she had a positive titer and just needed to upload that information. Pt. stated that the classes were already two days in and she just wanted the booster so she could get started. Reporter felt a little rushed and didn't take the time to go over the questions or have her complete the document first. Reporter  gave the vaccine since she was taking off her jacket. Reporter said, I really don't like to rush through these things. You aren't pregnant are you? She stopped and said yes. What are the side effects. I told her the side effects and told her she needs to go to her OB right away and bring me a note from the provider. I am attempting to complete the VEARS form but need information from the employee. me
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine was not applicable. The outcome of side effects was not reported. This report was non-serious.
6" x 4" redness, 4" x 4" swelling left upper thigh.
2nd dose given 18MAY92 approx 24 hrs later presented w/blotchy type flushing of face, neck, upper chest & arms; felt burning inside; BP 142/98, P72, R20, T96.8; felt very weak; DPH & EPi given;
Patient received a dose of J&J vaccine and came in to get the Moderna booster.  Communication we received from corporate looked like those who received the J&J shot would get the full 0.5ml dose of the Moderna booster so that is what this patient got.  Much later that evening, we learned that everyone gets 0.25ml of the Moderna booster with the exception of those who are immunocompromised.  Spoke to patient to inform her that she received the full 0.5ml dose and she was actually very happy about it.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received form a mother regarding her 21 month old female daughter who experienced irritability post vaccination, loss of appetite, restless sleeping, and significant congestion with runny nose, the pt received the third dose on 08/13/2004. Event Details: within 3 days of administration, the child experienced irritability, loss of appetite, and restless sleeping, which has continued for the last 11 days. The pt is a fraternal twin,  her twin sister experienced a similar reaction including a fever of 103.8 degrees Fahrenheit. which lasted for 3 days (see case ID HQWYE510024AUG04). The mother also reported that  one twin during this period of time, developed significant congestion (nasal) with a runny nose. No addiotonal information was available at the time of this report.
Sore throat, swollen lymph notes, cough, congestion and tightness in chest.
Initially presented to emergent care on 4/8/21 for left arm pain, SOB on exertion, and intractable headache. Headache had been ongoing for 12 days. It was throbbing and in the frontal region with nausea. No phonophobia. No weakness. No vision loss. No speech impediment.  She was somewhat less active given her severe headache. She was found to have a DVT in the left arm and bilateral PE with heart strain. Referred to Hospital and admitted. Started on lovenox 1 mg/kg every 12 hrs and elected to be transition to coumadin since her sister had another blood clot on Eliquis.  Neurology started her on gabapentin. She was discharged and told to follow-up with hematology and warfarin clinic. Presented to the ER on 4/27/21 with SOB at night that had been worsening the past 2 nights. Denied dyspnea or chest pain. Sx were thought to be due to anxiety given her hx of panic attacks. She was discharged home and saw hematology the following day. Hematologist noted that her SOB was gradually improving and her left arm swelling and vascular changes had resolved. Repeat CT showed improvement in clotting burden and stable pulmonary and hepatic nodules.
Inappropriate schedule of vaccine administered; did not sleep good; pain pain/severe pain/so much pain/pain in shoulder; shoulder where got the injection; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (did not sleep good), ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder), VACCINATION SITE PAIN (shoulder where got the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced POOR QUALITY SLEEP (did not sleep good), ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder), VACCINATION SITE PAIN (shoulder where got the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, POOR QUALITY SLEEP (did not sleep good) outcome was unknown and ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder) and VACCINATION SITE PAIN (shoulder where got the injection) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  The patient received primary series from Pfizer COVID19 Vaccine on 20Mar2021 and 20Apr2021. He had no problem with them.
This 15 year old female subject was enrolled in a blinded study for the prophylaxis of genital herpes disease and herpes simplex virus type 2 infection in healthy pre-teen and adolescent females. The subject received single dose IM injection of blinded study vaccine in the left deltoid on 8/4/04, 8/30/04, and on 1/10/05. Lot numbers were not provided. The subject had been randomized to receive the active control in this study, a marketed formulation of Havrix vaccine containing 320 ELISA units of hepatitis A antigen + 0.25mg aluminum in 0.5ml. On 2/16/05, this 15 year old female presented to the emergency room reporting symptoms of a possible sexually transmitted disease. All tests for STD's were negative. A urine pregnancy test was positive. Subject's last menstrual period was on 1/20/05 and the estimated date of delivery was 10/28/05. On 2/26/05, 47 days after the third investigational product, the subject experienced bad cramping and vaginal bleeding. She was taken to a nearby clinic where spontaneous abortion was diagnosed. The spontaneous abortion was considered to be medically significant (OMIC). A dilatation and curettage was performed under anesthesia. The gestation age at the time of the spontaneous abortion was four weeks. She was discharged home with prescriptions for unspecified antibiotics, pain medication, and a laxative. The events resolved on 2/26/05 after 1 day. On 3/7/05, subject had follow up visit at clinic and underwent dilatation and curettage. Subject's mother reported she was fully recovered. The investigator considered there was reasonable possibility that the spontaneous abortion may have been caused by investigational product. The investigator also considered the event to be possibly associated with a natural history of early pregnancies.
Initially--fatigue, fever, muscle aches.  On day 4--parethesia  and numbness causing imbalance on left side.  lasted a brief time--less than 20 minute.   Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day.  Difficulty walking and using left side.  Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER.  MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
No adverse reactions. A 0.3 ml dose of the pediatric vaccine was administered to this adult and followed on the same day by 0.15ml of the adult RTU vaccine to complete a 30mcg dose
Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1ST, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=26Jun2021, Administration time=01:00 PM, Dose number=1), administration date: 26Jul2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: SINUS DISORDER (non-serious), FRONTAL SINUS OPERATION (non-serious), DIZZINESS (non-serious), OROPHARYNGEAL PAIN (non-serious), DYSPHONIA (non-serious) all with onset 25Aug2021, outcome "recovered with sequelae" (Aug2021) and all described as "Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat". The event "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat" and "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sinus disorder, frontal sinus operation, dizziness, oropharyngeal pain, dysphonia.  Additional information: No other vaccine in four weeks. AE treatment: Antibiotics and antihistamines. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received from a healthcare professional on 10/26/2004 regarding an adverse event occurring in the USA, it was reported that a 57 year old male patient received a TD ADS Adult vaccination, lot number U1282AA, administered intramuscularly in the left deltoid on 10/22/2004.  Reportedly within 24 hours the patient developed a large reddened area at the injection site that was warm to the touch.  The patient also had an oral temperature of 103 degrees.  No treatment was needed.  Reportedly the fever resolved but the redness persists.  Also, this patient had received a Fluzone vaccination on 10/15/2004, lot number, route and administration site not reported.
Patient blacked out for a moment. Was disoriented, felt dizzy, muscle stiffness and weakness - experienced difficulty walking.
Would this 8/4 L thigh swollen red + warm to touch,cover front of thigh + hurts to walk.
Stroke; Blindness; Double vision; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) (batch number XM22G, expiry date 31st August 2023) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix (intramuscular) and COVID-19 VACCINE MODERNA. In September 2022, 3 days after receiving Shingrix, the patient experienced stroke (serious criteria medically significant), blindness (serious criteria medically significant) and double vision. On an unknown date, the outcome of the stroke, blindness and double vision were unknown.   It was unknown if the reporter considered the stroke, blindness and double vision to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR149038   Additional Information: Receipt Date: 12-OCT-2022 Reporter's comments: The patient reported that on 12 September 2022, he had his first dose of Shingrix vaccine on the left arm. The patient had reported that on the same day he had the fourth Covid dose (Moderna Booster) in his right arm.  The patient had reported that 3 days after Covid 19 vaccination, he had a stroke, double vision and became blind. Not all information was available. The patient stated that he was told that, 1 % of patients taking the Shingrix vaccine developed strokes, double vision, and blindness. The patient stated that his lawyer would be contacting Agency regarding this. It was unknown if the reporter considered the stroke, blindness and double vision to be related to COVID-19 VACCINE MODERNA. Additional supportive information: This case was linked with US2022AMR149038 which was reported for same patient.; Sender's Comments:  US-GSK-US2022AMR149038:Same reporter
This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6294), via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 63 years). No vaccine took within 4 weeks. Medical history included Diabetes and Known allergies: Prednisone, Naproxen, Toradol, Levofloxacin. Concomitant medications included metformin; glipizide; venlafaxine; bupropion, Vitamins. The patient experienced severe itching from 24 hrs. post vaccination until day 4 on 10Mar2021, severe headache 2 hours post vaccination, malaise, nausea and fatigue on 09Mar2021 at 11:30. No covid tested post vaccination. No treatment received. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Second dose administered at <21 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was not applicable. Concomitant and Treatment medications were not provided.
No other AE; 17-year-old patient received a dose of PROQUAD; This spontaneous report was sent by a registered nurse and refers to a 17-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-MAR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human Albumin) (PROQUAD), 0.5 ml subcutaneously, once, lot number: U022726, expiration date 16-JAN-2023 (dose number and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age).   No other adverse events were reported.