chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a office manager of a physician's office concerning a male pt, who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine and subsequently experienced cellulitis in his arm after receiving the vaccination. The office manager reported the pt had been in the ER for another reason; however, he received the dose of pneumococcal 23v polysaccharide vaccine, due to the state law that requires hospitals to offer it before a pt leaves the hospital. The pt was treated in the ER and the reporter noted that the pt's stay was prolonged. Hospitalized was noted. No further information was available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The reporter felt that cellulitis was an other important medical event (OMIC). Other business partner numbers included E200505558. Additional information is not expected.
About two months after getting the second dose of the vaccine I went to my Obstetrician because I had not had a period since I got the first dose of my vaccine. The doctor felt a mass and an Ultrasound confirmed a mass on my right Ovary. It was a very large mass that took up a large portion of my Pelvis. I had to have surgery to remove the mass. They also removed my Spleen, Appendix, and a portion of my Pancreas as well as the Omentum. I had a Radical Hysterectomy.
Patient was diaphoretic and became unresponive (fainted) about 5-7 minutes after his first dose of the Moderna COVID-19 vaccine. Blood pressure was 90/50 mm Hg, pulse 46, temperautre 97.8, respirations 16/minute, blood glucose 92 mg/dL. Patient reported chronic low blood pressure and feeling nervous about his vaccine. No food had been consumed prior to the vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This unspecified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 144, 31 and R; 48, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Had 2nd varicella vaccine June 21, 2010 at 0945. That evening arm became red and swollen. Area itches. On June 23, 2010 1130 area measures 7cm x 7cm.
Immediate pain at injection site. For six months post vaccine, pain is regularly felt at injection site. This pain is in the exact spot of the vaccine.
swelling on outside of earlobes anti helix. forming bulges on ears. moving upward, chills.slight headache, sharp pains in stomach,
Given Hepatits B shot in am on 01/24/2018, saw raised red dots on both upper arms the next morning while getting dressed. Coming home that night on 01/25/2018, she noticed hives had also gone to upper chest, nothing on breast or stomach area. Red dots also went up into the neck area, and when employee saw that, she went to the ER on 02/02/2018 @ 18:33pm.
None. Hib and Prevnar given before 28 days had passed since last doses where given. Found during chart audit.
Within 1 week following vaccination, R arm still sore, developed stiff neck and upper back discomfort.  "I may have injured myself exercising" but not aware of an injury.  Symptoms persist as of 12/19/19.  Advised MD appointment.
Fever of 102.after the 2nd dose; Have been throwing up after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102.after the 2nd dose) and VOMITING (Have been throwing up after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 102.after the 2nd dose) and VOMITING (Have been throwing up after the 2nd dose). At the time of the report, PYREXIA (Fever of 102.after the 2nd dose) and VOMITING (Have been throwing up after the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         No concomitant medications were reported.  No treatment medications were provided by the reporter.
Mom states pt devel rash & t102; 24 hrs p/shots were given;
BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media  concerned a patient of unspecified age, sex, race and ethnic origin. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after two months of vaccination, the patient died from blood clot. The reporter reported that, "A precious friend of mine died from a blood clot 2 months after and injection of your 'product'. There is no reason to take this fake vaxx". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220229023-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Red, pruritic, 2 mm papules on face and upper extremities. Mostly on right side though.
Pt fell on way to ER for her SBO and sustained femoral neck fx, she was then found to have COVID
fevers, intermittent with cold and clammy sweating, became very restless, and was waking from sleep crying and distressed with intense abdominal heat and continual thrashing,severe diarrhea,distressed, restless, continual screaming and crying,swelling at injection site, refused food, very thirsty, severe rash with red spots spreading over entire body,urine smelled of strong ammonia odor, purple discoloration on penis,could not maintain previous ability to walk, lost balance and fell down continually,back arching/muscle jerking/rigidity, "staring off into space",hyperactivity, irritability, and low frustration tolerance,inability to sleep, Chemical Sensitivities, which continues to this day                                               "Head banging" on a daily basis, which has now finally discontinued except for occasionally.                                     "Arm flapping", which has gradually reduced, but continues to this day. Failure to respond to his name, which continues to this day. Failure to respond to direction or "No", which continues to this day. Failure to "Look us in the eye", which has gradually improved, but continues to this day. "Staring off into space", which has gradually improved, but continues to this day. Failure to interact with us, which has gradually improved. "Walking on his tip toes", which has gradually improved, but continues to this day. "Separation anxiety", which continues to this day. Loss of language skills, which continues to this day.                                                TREATMENTS: Thus far have consisted of casein free gluten free diet, allergy avoidance diet, nutritional support, homeopathic remedies.  Next goal is to schedule for diagnosis regarding autism spectrum disorders. Lab testing has demonstrated malabsorption, lack of intestinal flora, and multiple food allergies.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 13:15 as dose 3 (booster), single (Lot number: ER8727), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: PREDNISONE, start date: 28Aug2022, stop date: 07Sep2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment received included Paxlovid (Treatment start date - 02Sep2022, Treatment stop date - 06Sep2022).
This 82  year old female received the Covid shot on  2/16/21    and went to the ED on 5/3/21     and was admitted  on 5/3/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome)
I was preparing two doses of Abrysvo for two patients. I injected the sterile water through the provided adapter as usual (and recommended in product labeling), gently swirled the vials, and let the vials stand while I prepared the other immunization supplies. When I prepared to draw the reconstituted vaccine into the syringe, I noticed something in the liquid. I thought it was air bubbles at first, but I held the vials up to light and gently tilted them back and forth and confirmed that there was indeed particulate matter in the vaccine following reconstitution. The vials had been sitting reconstituted for about five minutes by now and all other Abrysvo doses I have prepared have dissolved very readily and I have never had issues with particulates. I repeated this with another two doses and the same thing happened. (This looked like anything from very tiny grains of sand to flakes resembling white paint). I tried again and finally got two vials that allowed complete dissolution. I let the four vials with particulates sit at room temperature since about 2:30-3PM (Currently 8:22PM) and just checked them and one appears to have some small particulate matter remaining even after sitting for hours. Two vials have potentials particulate matter 00 if they do, it's very small. One vial seems to have cleared up. All vials are from the same lot number and have the same expiration date. They came from different boxes but all have been store appropriately. (Lot HF5014 Ex[ 02-2025 for the vaccine and Lot GY5655 Ex[ 02-2025 for the sterile water diluent) I am not sure if the particulate matter was simply undissolved powder or if it was something else. The issue seems to have somewhat resolved but it took longer than the time to reconstituted vaccine can sit before administration.
This spontaneous report as received from a from pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Hospitalization for COVID pneumonia 12/14/21-12/17/21. Treated with Rocephin,  dexamethasone, baricitinib and Remdesivir.
Received my injection on Wednesday and had a deep tissue massage on Friday. My back broke out in welts but stayed on my back and shoulder area. Clinician did not use anything different when working on me. Itchy rash has remained now for 4 days and is about 50% resolved.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was reported. No treatment medication was provided by reporter. Reporter did not allow further contact
Received - Flu vaccine "non-allergic/latex free type. Developed puffy, reddened eyes, tighten in chest and moderate." Itching approx 7 hrs s/p injection. Medicated with BENADRYL 25mg PO.
He also stated his arm was sore after both injections; Arm soreness worse after second injection making it hard to sleep; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that a caller on the line who just disconnected that stated he completed both of the COVID vaccines. He wanted to know if there was an blood test to check for antibody for immunity. He also stated his arm was sore after both injections. It was worse after the second injection, making it more difficult for him to sleep. She provided him with Medical Information's number. Caller disconnected prior to transfer. Reporter confirmed he was on the line today, 28Jan2021. He said his wife had it at the same time and did not have any problems. The outcome of the event arm was sore after both injections was not recovered and unknown for other event.  Information on the lot/batch number has been requested.
Extreme soreness at site of injection  that has continued into third day.  Pain worst the second day and is waning, but use of arm is still painful.  Experienced lightheadedness shortly after injection, but with no bad effects.  Like being high.  Painful body aches began at end of day of injection and continued for 36 hours, with highest intensity after 24 hours.  Body aches diminishing on third day, but arm soreness still quite evident
I received  my first COVID 19 Pfizer Vaccination on Jan. 21, 2021 from clinic about 2:30 pm. I am age 94.  My wife brought me home about 3:30 pm and I was tired and went to bed and to sleep. I slept soundly until about 8 pm, and my wife awoke me to eat.  I was too weak to sit up or stand, my legs felt like rubber.  I didn?t feel like eating, and I couldn?t answer her questions coherently.  My wife was worried and called the 911. They checked me and found my vital signs were normal, so they helped my wife get me settled in bed. The next few days I still felt weak and had to use a cane or walker.  My second dose is scheduled for February 11, 2021 at 2 pm.  Will I likely have worse side affects?  What precautions should I take.
inconsolable crying x 48hr;nl comfort measures administered by parent, APAP;sx resolved;mom informed MD @ 9mo well child visit;did not seek care/advice during episode;
I began feeling joint pain and stiffness all over my body in June of 1997 and in addition to that, I always felt like I was on the verge of getting the flu. I toughed it out until Spring of 1998, when my knees became ver swollen and doubled in size after going up and down a ladder a few times. I went to the doctor on 06/02/98. He prescribed 1000 mg daily of Naproxen and that reduced the swelling in my joints as long as I kept taking it. Over the next month, I felt a little better and the flu like symptoms finally subsided after a year, as long as I kept taking the Naproxen. I was still very stiff and sore so I went to an Osteopathic doctor on 07/20/1998. He diagnosed the severe stiffness, soreness joint pain and flu like symptoms as fibromyalgia. He prescribed physical therapy on 07/29/98 and continued treatment until 09/09/98. I currently have been changed from Naproxen to 20 mg daily of Bextra to relieve the fibromyalgia symptoms. As long as I continue the Bextra I can tolerate most normal activity.
"I got my flu shot last month at drill weekend (November). I am still having pain from it. When I lift my arm above my head it shoots pain down my arm. Also, when I wake up in the morning it is super sore. There is still a mark from where I got the shot, it?s a scar."
The vaccine was given without the saline diluent added, so patient received 0.3mL of straight vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Penicillin allergy" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LISINOPRIL; HCTZ; LIPITOR; ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 320308D, Location of injection: Arm Right), administration date: 19Oct2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 04Feb2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), PYREXIA (non-serious), HEADACHE (non-serious), DIARRHOEA (non-serious) all with onset 14May2022 at 19:00, outcome "recovered" (2022) and all described as "Severe body aches, mild fever, headache, diarrhea starting ~12 hours after vaccine and lasting several days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, pyrexia, headache, diarrhea. Additional information: It was reported the patient did not receive other vaccine within four weeks. The patient took Metoprolol, Lisinopril, HCTZ, Lipitor, Advil, Tylenol in two weeks. Adverse events included severe body aches, mild fever, headache, diarrhea starting 12 hours after vaccine and lasted for several days. The patient did not receive any treatment for the events. No covid prior vaccination. Covid tested negative post vaccination. No follow-up attempts are possible. No further information is expected.
This case was reported by a physician and described the occurrence of influenza in 74-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Unknown (Unspecified medications). On 3 October 2007, the subject received unspecified dose of Fluarix (.5 ml, subcutaneous, unknown). The reporting physician believed the subject's dose of Fluarix was "inadvertenly administered subcutaneously rather than intramuscularly and thus was not effective". At an unspecified time after vaccination with Fluarix, the subject experienced two occurrences of influenza and lack of efficacy. The subject did not require any treatment. At the time of reporting the outcome of the events were unspecified.
Temp of 102 and it lasted for 24 hours, had a warm patch about 5"x6".
asymptomatic- tested positive on binax rapid antigen test 10/10/2022- has completed primary series plus 1 monovalent booster- all Moderna
She had Pfizer vaccines on 4/22/21 and 5/13/21. She was diagnosed with COVID at an outpatient lab on 8/30/21. She was seen by her PCP and given steroids. However, SOB, cough, and wheezing got worse, so she came to ED and admitted at Hospital on 9/8/21. Hosptal day 2.
Chills; Fever; Headache; Fatigue; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any concomitant medications.  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 07Apr2021 at 03:00, the patient experienced chills, fever, headache and fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, headache and fatigue were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient received his varicella vaccine on 2-21-08 and on the morning of 2-22-08 developed a 6cm x 6cm raised, warm, erythematous circular area, pruritic, on his R deltoid area.
It started the following day of getting the vaccine. So, I got chills, low grade fever, headache, and then it got worse. Sunday I got a 102 temp and my headache got worse. I suffered with it the following next week. On 1/24/2022 I had a tele-health visit and that doctor told me that it was no way it was the vaccine and that I should get a COVID-19 and Flu test done. The next evening 1/26/2022 I notice that I was having shortness of breath, pain in my right calf, and a pain in my upper back for about  three days. So I went to the ER that same evening and they said I still was having fever. They ran a lot of test and they all were negative. The fever has been intermitted on and off. I work from home and I still don't feel 100%. I also had a very bad case of COVID-19 and Pneumonia November 2020. My kidneys started shutting down and I had no appetite, not thirsty at all. I also had an anti body test in October 2021 and my body showed high anti-body and I didn't have to get it. I only took the COVID-19 because I knew that I have a lot of vacations and I didn't want to get sick.
Superficial thrombophlebitis in the right arm following IV for appendectomy.  I previously had no blood clotting issues from IV sticks.
patient wanted Johnson & Johnson?s Janssen COVID19 vaccine but was accidentally given Pfizer vaccine instead