chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN LYMPH GLANDS TO THE LEFT ARMPIT; TENDER  LYMPH GLANDS TO THE LEFT ARMPIT; BALANCE ISSUES; TROUBLE WALKING STRAIGHT LINE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included prior vertigo from ear infection, cardiac arrest, and ear infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: TPH1802070, and expiry: 09-JUL-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced balance issues. On 13-APR-2021, the subject experienced trouble walking straight line. On 16-APR-2021, the subject experienced swollen lymph glands to the left armpit. On 16-APR-2021, the subject experienced tender lymph glands to the left armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from balance issues, and trouble walking straight line on 25-JUN-2021, and had not recovered from swollen lymph glands to the left armpit, and tender lymph glands to the left armpit. This report was non-serious.
large area of redness and swelling around injection site.  patient reports sore and warm to touch
Burning feeling at site of injection at right deltoid, going down arm to hand, with tingling of hand. Rash noted 8 hours later from site of injection down to mid forearm; it looked like hives.
Stomach pain, nausea, loss of appetite, weight loss. I day after and ongoing for 2 months
This spontaneous report was received from a Registered Nurse referring to a 15 year old female patient. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L018351 dose 2 in the right arm. Concomitant therapies included: poliovirus vaccine (unspecified), hepatitis a virus vaccine (unspecified), meningococcal vaccine (unspecified), MMR I, hepatitis b virus vaccine (unspecified) and Tdap vaccine (unspecified), tetanus toxoid. No adverse events were reported. This is one of two reports from the same source. Additional information has been requested.
COVID SSX BEGAN 9/22/21 WHILE PATIENT INCARCERATED. TRANSFERRED TO HOSPITAL DUE TO WORSENING SHORTNESS OF BREATH. ADMITTED TO ICU, PUT ON PRESSORS. INTUBATED ON 10/4/21. DEVELOPED WORSENING KIDNEY FAILURE AND BLOOD CULTURES + FOR SALMONELLA. MAXED OUT ON VENT AND PRESSORS. PATIENT MADE DNR BY FAMILY, CODED & DIED 10/12/2021.
flu like symptoms; fever that left them in bed for 1-2 days; aches/pain; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to 2019SA290955 (same reporter).  This case involves a 75 years old male patient who experienced flu like symptoms, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on concomitant therapy.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AA via intramuscular route in the arm upper.  On an unknown date, The patient developed a non-serious flu like symptoms(influenza like illness), fever that left them in bed for 1-2 days (pyrexia) and aches/pain (pain) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was flu like symptoms, fever and pain.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved on an unknown date for the events.
Client fell on the floor. He stated he did not lose consciousness but suddenly felt very weak. Father said that he did not eat breakfast or lunch. Apple juice was given and client stated that he felt nauseated. Offered a chair to sit on until he felt better. He left with the father at 2:05 PM with a steady gait.
sprained her ankle and it is a little swollen, not so much; sprained her ankle and it is a little swollen, not so much; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: EN6204, Expiration Date: Jun2021) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIGAMENT SPRAIN (non-serious), outcome "unknown", JOINT SWELLING (non-serious), outcome "recovering" and all described as "sprained her ankle and it is a little swollen, not so much". Additional information- Patient stated that  she had her 1st dose of the vaccine and Monday she would to have her 2nd one. States last Monday she sprained her ankle and it is a little swollen, not so much. States she has been reading so much and she is scared and wanted to know if she had the sprain that was a little swollen could it be a problem if she got her next dose, was there any inconvenience because it is swollen. Stated  she had read about thrombosis that can be caused through the vaccine and the swelling is not too much, it is getting better.    No follow-up attempts are possible. No further information is expected.
I received my second vaccine dose on Friday, 4/16. At the time I was 6 weeks and 4 days pregnant. I woke up at three o'clock in the morning on Saturday, 4/17 sweating with chills, body aches and a headache. When I went to the bathroom at six o'clock AM I noticed that I was bleeding. I called my doctor and she told me to monitor the bleeding over the weekend and to call first thing Monday morning for an ultrasound. I continued bleeding throughout the weekend and yesterday (4/19) my doctor confirmed that I was experience a miscarriage.
I had soreness and redness at injection site, around the first of March I started having left foot pain, the doctors think it's gout or maybe something else they're looking for, but I've never had anything like this before. I had horrible pain in my left foot that didn't have before. Still in pain, wearing a boot and the leg is swollen from the knee down the whole foot.
FLU SHOT 10/12/2020:  the following is per phone call with patient on 10/13/2020  ; Patient received Flucelvax vaccine (Fluad oos)  on 10/12/2020 and 45 minutes later while shopping fainted ; ambulance was called and patient went to hospital for observation ; pt has hx of orthostatic hypotension, was found to be dehydrated, and had low O2 saturation ; pt reported no arm pain or trouble breathing post vaccine but had a "funny feeling" immediately after vaccine administration (which was not reported to RGA until follow up phone call) ; patient didnt think the vaccine was the direct cause of the fainting but may have "put her over the top for the day" ; advised patient to get flu shot at provider's office next year so she can be monitored (if vaccine is without event said she could resume vaccinations with our pharmacy)
Patient came in for both the flu and shingles vaccines and had mild flu like symptoms the following day according to her daughter. On the 6th night (8/17) patient woke up and her legs felt like "jello" since she was unable to move them. The daughter said she was admitted into the ED that night. The patient progressively got worst as now she is unable to move her arms and her speech is now being affected. Her daughter said the providers ran tests to figure out what the cause was and perform a Guillain-Barre syndrome exam which came back positive
Severe headache; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3249), via an unspecified route of administration on 14Jan2021 05:15 at single dose on left arm for COVID-19 immunisation. Medical history included diabetes. Patient had no known allergies to medications, food, or other products. The patient's concomitant medications included metformin.  The patient experienced severe headache on 14Jan2021 with outcome of unknown. No treatment was received for the event. Since the vaccination, the patient had been tested for COVID-19 on 14Jan2021 with unknown result. This case was reported as non-serious.
This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ by oral route, lot # K013410, expiration date 27-FEB-2016 (dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
flu like aches and pain; swelling of feet and legs; rash all over lower legs; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (flu like aches and pain), PERIPHERAL SWELLING (swelling of feet and legs), RASH (rash all over lower legs) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema (lympademia in remission). Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Swelling.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (flu like aches and pain), PERIPHERAL SWELLING (swelling of feet and legs), RASH (rash all over lower legs) and PYREXIA (fever). At the time of the report, PAIN (flu like aches and pain), PERIPHERAL SWELLING (swelling of feet and legs), RASH (rash all over lower legs) and PYREXIA (fever) outcome was unknown.            The patient's lymphedema was in remission but came on with swelling of feet and legs. As treatment the patient increased furosemide and was in therapy to reduce swell. No concomitant medications were reported.
Pain at injection site, helped by ibuprofen.  Delayed onset of dizziness, muscle pain, nausea on or around 9-26-13 continuing through 10-5-13.  Muscle tension, nausea, dizziness ongoing and hoping it gets better!!!
10/5/21 at 10pm-sore arm at injection site  10/6/21 at 2:30am-shivering 10/6/21 at ~8am- headache, muscle aches and low grade fever -took Tylenol 650mg at 8am which seemed to help for a few hrs but muscle aches and headache never went away. -too ibuprofen 400mg at 4pm which also helped but muscle aches and headache never went away.
14AUG91 t103-104, pain, swelling of rt leg, screaming p/immun; had sz 22AUG91 ER visit seen by MD to have EEG & follow up w/MD;
chickenpox; itchy rash primarily on the "trunk" of her body, armpits, left leg / spread to her inner thighs and pubic area; "little" white pin-sized heads on it; rash is seen along with white spots and itching/body, armpits, left leg.; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st on 26th August 2019).   On 24th January 2020, the patient received the 2nd dose of Shingrix. On 23rd May 2020, 120 days after receiving Shingrix, the patient experienced diarrhea. On 24th May 2020, the patient experienced chickenpox, itchy rash, blister and skin discoloration. On an unknown date, the outcome of the chickenpox was unknown and the outcome of the diarrhea was recovered/resolved and the outcome of the itchy rash and blister were not recovered/not resolved and the outcome of the skin discoloration was recovering/resolving.   It was unknown if the reporter considered the chickenpox, diarrhea, itchy rash, blister and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe diarrhea. The patient still had diarrhea but also developed an itchy rash primarily on the trunk of her body, armpits, left leg.  She went to see her physician who she stated was not sure but thought it might be chickenpox.   The caller also stated that the itchy rash spread to her inner thighs and pubic area and had little white pin-sized heads on it.   The diarrhea has stopped but she still has areas where the rash was seen along with white spots and itching. The reporter consented to follow up.
On 2-28, I started having tinnitus after never having it before the shot.  It was extra loud suddenly on 3-1-21 about 1:00 PM.   On 3-26-21,  7:00 PM,  it was extra loud in right ear and has been louder (in both ears) ever since.  It is louder sometimes than others.
Shorty after receiving the vaccination, patient felt lightheaded, dizzy, and like she was about to faint. Patient also reported blurred vision
Initial report was received on 08 April 2014 from a non health care professional. A female patient (now 23 years of age and date of birth not reported) had received as a child DTaP (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an anaphylactic reaction to pertussis of the DTaP vaccine and was hospitalized for several days. According to the reporter, the individual was not a patient of their practice and they had no further information to provide regarding the situation and asked for no further contact regarding the situation. The patient's outcome was recovered. Documents held by sender: none.
Silver dollar sized area of pinkness that is blanchable and indurated but not warm to touch- (L) upper arm.
Case number PHEH2014US020451, is an initial spontaneous report from a nurse received on 08 OCT 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported He was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 015021A) intramuscularly on 08 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
no fever 30min p/vax pt devel dull h/a, photophobia, swelling around lt eye, lt hemiplegia (mild) & lt sided paresthesias;also vomited several times;nl mental status;no LOC;nl sensation;cranial nerve function nl;dx acute hemiplegic migraine
Arm where DTaP was given was red and swollen from top of arm to top of elbow. Ran temp of 99 degrees.
Very bad headache developed evening after his vaccine, several hours after vaccine per patient and parent. Headache resolved by the next day. Does not typically get headaches. Resolved by the next day. Note, also had a very sore arm for several days (known common vaccine reaction).
Day after injection patient started to experience pain in the injection arm. On a pain level scale of 1-10 she claims it is a level 8. It is swollen and red around the injection area. The pain is radiating down the arm and patient states it feels warm.
Pt was immunocompromised, and should have received a 0.5 ml dose, but received 0.25 ml dose .
Strong dizziness 15 minutes after getting the second vaccine, blurry vision. I also had diarrhea, fast heartbeat that comes and goes. Around 5:00pm I felt very weak and sleepy. The next day I woke up with pain and swelling in my legs and in the middle of my back.
COULDN'T GET OUT OF CHAIR FOR DAY (HOURS); FELT NUMB LIKE HAVING A STROKE; HEAD ACHE; This spontaneous report received from a patient via a company representative via media (J and J corporate concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced, red rash that covered arm (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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, it was reported that, "2nd covid shot felt numb, head ache, couldn't get out of chair for day (hours) felt numb like having a stroke (dose number in series 2). Won't get another shot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt numb like having a stroke, head ache and couldn't get out of chair for day (hours) was not reported. This report was non-serious. This case, involving the same patient is linked to 20220924365.
Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA
Patient was given KINRIX instead of MENACTRA on 04/07/17 around 11:30AM. Followed up with family on 04/11/17 and no adverse events reported.
patients who received 2 doses and ENGERIX-B and never got 3rd dose.; This case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st and 2nd dose received on an unknown date.).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date :01-NOV-2022 Reporters comment: The nurse reported that the several s patients received 2 doses and ENGERIX-B and did not received 3rd dose.  No additional adverse event reported.  No PQC reported.  No further information was provided. Additional Supportive information: Till the time of reporting, the patients did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. This case has been linked to the US2022158108 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022158108:same reporter
Extreme pain in left breast String sensitivity in my breast nipples Shooting pain in and around left breast Felt like an over inflated balloon was positioned under my left arm causing my muscle to feel as if it was tearing.  Electric shooting pain in my lower abdomen and vaginal/pelvic area
flu like symptoms. ADDITIONALLY, on February 16, 2021, patient broke out in hives on his body while at work.
7 minutes after her vaccine she complained of tongue numbness which progressed to swelling.  No wheezing,  no rash, no nausea no vomiting.  She was transferred to the ED for further management
varicella-type rash; fever; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unspecified age. The pt's concurrent conditions, concomitant medications and medical history were unknown. On or around 06-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 09-JAN-2015 (reported as three days after receiving zoster vaccine live (ZOSTAVAX) vaccine), she suffered fever and a rash on her upper right arm and was diagnosed with a varicella-type rash. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of fever and varicella-type rash was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of fever and varicella-type rash were considered as disabled by the lawyer.
Flublok vaccine was held in transition for to long. They did not received the email until the end of the day and 2 doses had already been with no adverse event; 2 doses had already been administered with no adverse event; Flublok vaccine was held in transition for to long. They did not received the email until the end of the day and 2 doses had already been with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 33 year old female patient for whom it was reported that INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was held in transition for too long and they did not received the email until the end of the day and 2 doses was administered of 0.5 mL (Extra dose administered, Product storage error and Product distribution issue) (lot number UJ509AA expiration date 05-Oct-2021) via intramuscular route in the left deltoid indication: prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a potential medication error due to incorrect product storage and Extra dose administered.  At the time of this report, no adverse event was 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 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.
Patient got Chicken Pox 20-30 papular/vesicles on cheek face and limbs Torso