chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; By Sunday night we took him to hospital due to fluid build up around his chest and severe pain.; Complained of arm soreness on Saturday but not at injection site, under armpit.; He started oral antibiotics due to a perceived infection/ reaction.; mild swelling at infection site but mostly the fluid build up is at lymph node under arm.; redness and swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: AXILLARY PAIN (medically significant), outcome "unknown", described as "Complained of arm soreness on Saturday but not at injection site, under armpit."; PLEURAL EFFUSION (hospitalization, medically significant), CHEST PAIN (hospitalization, medically significant), outcome "unknown" and all described as "By Sunday night we took him to hospital due to fluid build up around his chest and severe pain."; INFECTION (medically significant), outcome "unknown", described as "He started oral antibiotics due to a perceived infection/ reaction."; SWELLING (medically significant), outcome "unknown", described as "mild swelling at infection site but mostly the fluid build up is at lymph node under arm."; ERYTHEMA (medically significant), outcome "unknown", described as "redness and swelling". Therapeutic measures were taken as a result of pleural effusion, chest pain, infection.  Clinical course: Patient received booster shot on Friday at 2pm. Complained of arm soreness on Saturday but not at injection site, under armpit. By Sunday night we took him to hospital due to fluid build up around his chest and severe pain. He started oral antibiotics due to a perceived infection/ reaction. No underlying conditions. Did not react this way with first two doses. He does have mild swelling at infection site but mostly the fluid build up is at lymph node under arm. The redness and swelling is about 8 inches wide.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Erythema and swelling at injection site. Treatment: Cephalexin and sma/tmp.
My symptoms started on March 23, 2021, a day after my first shot.  Around 11:00am I experience very bad chills, body aching, weak, left arm very sore swollen at the site and a knot.  I was so I weak I couldn't get out the bed.  Almost like having the flu.  On 3/24/2021 around 8:00am the symptoms were gone.
I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected; I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I received both base Pfizer covid vaccines and a Pfizer booster shot. I contracted covid last week and am currently infected". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt returned to vaccination site post vaccine and 30 min wait r/t Hives on her face.  Two hives noted on face one to her left eye brow an d one to the right of her lips.  Pt c/o itchiness, Benadryl 50 MG PO provided. Pt felt better post medication and had her GF with her who drove her home. Pt and GF educated on when to call MD for an appt and when to call 911 both parties verbalized understanding.
Broke out in hives, eyes swollen, feet swollen, nausea and vomiting, chills, temp, skin burning and itching.Pt was hospitalized.Pt was tx w/ fluids and a low dose of steriods.
I fainted 5 different times through out the day starting in morning and last spell was 9 pm at night.
Following administration of vax pt cried unconsolable for 45 mins & for following 24 hrs pt was listless;
The incident occured when  (pharmacy technician) administered the injection (0.3ml of air) into  left deltoid region. He noticed that it was empty after he injected the syringe into her arm. The patient didn't have any immediate symptoms so the went and agreed to get another shot in the other arm (right arm). After about 15-20mins she noticed some tingling on her left arm and hands.  I , made sure to monitor her and ask how she felt at this time and she noticed that the tingling didn't get any worse and was fine overall.  I made sure to leave my personal cell with the patient to have her call if at any point her condition changes or gets worse. She agreed to leave because there was no further changes to her symptoms besides some soreness and tingling on her left arm.
Immediate redness/flushing of arm that received the injection. The neck then turned red and the patient had difficulty breathing. An itchy throat and some peripheral swelling were experienced. Patient was given 50 mg of BENADRYL 5 minutes after injection. Emergency services were called and patient was taken to the Emergency Room via ambulance. She was observed for several hours over which time the symptoms subsided.
Patient passed out at home after being uncomfortable and "whimpering" all day in pain. His right leg turned fire engine red and he fell to the floor in the bathroom. Wife couldn't get him up, called 911 and he spent 5 days in the hospital on IV antibiotics for a mystery infection in his leg later deemed to be a bone infection from a 2 decade old titanium rod. Blisters have been coming and going, very large and uncomfortable. On 8/25 he went to drive his dog to the park and couldn't leave because he noticed he was seeing double. The doctor diagnosed him with a 6th cranial nerve Palsy. They are trying to rule out infection as a cause.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (strength, route unspecified) lot # L002871, expiration date 27-JAN-2017. No adverse symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to cases 1507USA008507, 1507USA004977 via same reporter link. Additional information has been requested.
Vertigo for the past six days slowly improving on it's own. No prior history of vertigo outside of motion sickness.
Headache Chills Narrative:  Per nursing report: "took 2nd Moderna vaccine yesterday. C/o chills and headache last night [2/3] and this morning [2/4]."
On 4/10/2021 awoke went to get out of bed and fell to the floor. Unable to walk ambulance transported patient to local hospital where he was admitted with Covid and remained until June 3rd, 2021. On June 3rd patient was transported to a Rehab where he remained until July 17th. 2021.
I felt numbness in the lower half of my body. I noticed it in my feet, then the anal/genital area. I have received a course of steroids for treatment.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/11/21 (EN6205) Pfizer Dose 2 4/8/21 (EN6208) Pfizer Dose 3 10/15/21 (FF2588) COVID Positive 12/29/21  12/28/21: 76-year-old female patient with a history of bowel obstruction 3 times and subsequently had exploratory laparotomy for lysis of adhesions which were extensive. This surgery was performed on 10/17/2021 per Dr. at Hospital.  Subsequently the patient was discharged to the Hospital for further care for the wound care.  The patient was discharged with an open abdominal wound as this could not be closed.  The patient's family was unhappy with the care provided to the patient and the Hospital and hence she was transferred to another location.  And this location, the family again and noticed that due patient was covered completely in her stool and there was significant excoriation of the skin around the open wound.  The patient was then brought into the hospital today for admission. The patient could not be admitted at the first Hospital as  Dr. is available but due to the inavailability of the beds, the patient is admitted here. The emergency room physician spoke with this surgeon on-call Dr. who agreed to follow the patient here but no surgery will be performed at present.  Dr. was also called who recommended only TPN and no acute need for surgery. The patient has no history of fevers, chills, nausea or vomiting.  The patient was unfortunately fed at the hospital and hence her drainage was getting worse.  The patient has no other complaints at this point.  1/7/22: 76-year-old female patient with a history of bowel obstruction 3 times and subsequently had exploratory laparotomy for lysis of adhesions which were extensive. This surgery was performed on 10/17/2021 per Dr. at Hospital.  Subsequently the patient was discharged to the Hospital for further care for the wound care.  The patient was discharged with an open abdominal wound as this could not be closed.  The patient's family was unhappy with the care provided to the patient at the Hospital and hence she was transferred to another location.  At this location, the family again  noticed that patient was covered completely in her stool and there was significant excoriation of the skin around the open wound.  The patient was then brought into the hospital for admission.  The patient could not be admitted at the first Hospital as  Dr. is available but due to the lack of the beds, the patient was admitted here.   Patient was noted to be positive for the SARS-CoV-2 virus infection.  She was totally asymptomatic did not have any fevers or hypoxia.  The wound nurse was consulted who had the patient with the wound VAC and also surgery consultation was obtained.  The patient was also started on TPN.  Education and instructions given to the family with regards to Accuchecks and TPN administration.  Patient will see the surgeon 1st prior to being discharged home at his clinic.  Patient will have visiting nurses services.  All questions answered at the time of discharge.  Patient will follow up with PCP in 1 week.
Feel like fainting; difficulty to breath; heart beating fast and strong; pressure in my chest; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feel like fainting), DYSPNOEA (difficulty to breath), HEART RATE INCREASED (heart beating fast and strong) and CHEST DISCOMFORT (pressure in my chest) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 02-Jun-2021, the patient experienced DIZZINESS (Feel like fainting), DYSPNOEA (difficulty to breath), HEART RATE INCREASED (heart beating fast and strong) and CHEST DISCOMFORT (pressure in my chest). At the time of the report, DIZZINESS (Feel like fainting), DYSPNOEA (difficulty to breath), HEART RATE INCREASED (heart beating fast and strong) and CHEST DISCOMFORT (pressure in my chest) had not resolved.            Patient reported she still had the side effects, it was a pressure in chest, heart was beating fast and strong, every time she try to get up from beat or stay standing up she felt like fainting. She had difficulty to breath, like she don't have enough air to breath.  No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Tdap vaccine was administered on 7/13/16. Provider reports localized swelling and tenderness. No abscess, fluctuance or redness. TYLENOL/ibuprofen. Cold compress to area.
Sudden onset difficulty breathing within about one minute of vaccine administration, tingling in head, pain in throat area.  Another pharmacist on duty dialed 911 while I administered one dose of Epipen within about one minute after patient started to experience symptoms.  After about one minute after Epipen was admistered, patient started to breathe normally again and was able to talk.  EMS arrived on site within ~3 mintues after 911 call was completed.  The patient was then transported to the hospital for further monitoring.
facial numbness changed locations, moving to below tongue and some of throat; facial numbness changed locations, moving to below tongue and some of throat; sporadic pain; headache; feeling of brain freeze; injection site pain; general fatigue; facial numbness; Had to stop lecturing due to facial muscles sore; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:15 hr (at the age of 36-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity, plantar fasciitis, sleep apnea from an unknown date and unknown if ongoing. Concomitant or other medications in two weeks, other vaccine in four weeks, COVID prior vaccination, if COVID tested post vaccination was reported as none. The patient previously took Sulfa drops and experienced hypersensitivity (known allergies). The patient experienced feeling of brain freeze, injection site pain, general fatigue, facial numbness on 26Feb2021, sporadic pain, headache on 27Feb2021, facial numbness changed locations, moving to below tongue and some of throat on 28Feb2021, had to stop lecturing due to facial muscles sore on unspecified date in Feb2021. Adverse events start time was reported as 08:30 hr on 26Feb2021. It was reported that adverse events on day 1 could be described as the feeling of brain freeze after drinking a smoothie too quickly about 20-25 minutes after injection, leading to injection site pain and general fatigue which has mostly continued and what could best be described as facial numbness. Day 2 most of face was numb, sporadic pain, injection site pain, fatigue, headache. Day3 facial numbness changed locations, moving to below tongue and some of throat, injection site pain and fatigue. Day 4-6 changing facial numbness and pain around face and top of head. Had to stop lecturing due to facial muscles sore (as if you hurt from laughing, but constant). Day 7 some fatigue and facial numbness and pain. There were no signs of stroke, no facial droop, nor uneven paralysis. No treatment was given for the events. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Parents states approx 1 wk following DTP began w/red raised rash lt thigh; continues  w/rash noted to be mainly on outer aspect lt thigh;
patient was administered only the adjuvant portion of Shingrix; patient was administered only the adjuvant portion of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Healthcare professional did not had time to give details about adverse event, and agreed to email follow up. The reporter consented to follow up.
4/21/2021 was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  numbing of lips and tongue and left arm.   Assessment : Time of assessment 1314. Alert and oriented and numbing to left arm, lips, and tongue.   Actions taken:  Vitals sign taken  EMS called at  1334. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1338.   VS at 1334- BP- 133/88, P- 88, O2- 97%, recheck at 1345- BP- 120/82, P- 74, O2- 98%   Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1314 and 1319. Administered by RN.   Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1338.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/21/2021 12:42 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc
The leg where immunization was given was "stiff", he won't bend the knee, and he couldn't walk straight. There's a little swelling noted by grandother. This has persisted for 2 full days.
Vaccine was in Tues. Sensitivity and fatigue and arm pain on weds. I felt normal all day on Thursday but on 3am on Friday I woke up with a fever , congestion,  loss of appetite without nausea, sore throat(7 on pain scale) and Sensitivity was back. I rested for 2 days with the fever reaching its peak at 101.7 and a cough starting on Saturday but the sore throat ending when the cough started. Oddly those 2 symptoms did not overlap. It's now Sunday.  Fever is down to 99.7 and I'm coughing up alot of flem but otherwise fine
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient continued to suffer ongoing injuries with mental and physical pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Diffuse macular rosy pink spots, trunk and arms, itchy                  tx w/po Benadryl 25mg.
6 days after receiving the 2nd Shingle vaccine - obtained a rash on the stomach area
Started on 1/16/21, noticed droopiness and slurring on the left side of her mouth, and the eyelid did not want to shut properly, could not raise the eyebrow on that side.  Stayed that way until yesterday, 1/28/21, was able to raise the left eyebrow and her lip was starting to normalize, but still having some droopiness from it.  Called her provider and looked it up on the internet, and was told she had Bell's Palsy.  Told her to keep an eye on it, and if anything else happened to go into the hospital to see if it was a stroke.  It did not affect her limbs or have any other stroke symptoms, just the left side of her face.
Itching and hives. Itching started 6 hrs after the shot and hives appeared 10 hrs after. Benadryl PO 12 hrs after with no relief. Located around waist and ankles.
53M with hypothyroidism, ulcerative colitis s/p remote colectomy, DM1 (on insulin pump), and GERD who presents with fever, poor appetite, nausea, cough and worsening SOB beginning on 8/7. Tested covid + on 8/10. Received pfizer vaccine series in march. Seen in ED 8/13 and given levaquin for CAP. After discharge he noted his O2 sats reading 84-89%.    COVID Pneumonia/Acute hypoxemic respiratory failure - he was treated with decadron 6mg daily for 4 days and remdesivir for 5 days. Supplemental O2 was successfully weaned from 2lpm to room air. In case he would require tocilizumab, screening labs were sent and returned negative except cocci which is pending.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  covid pneumonia
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with dose 1 VARIVAX (merck) (lot#, expiration date and route not reported) on unknown date in 1999. The patient did not receive his second dose of vaccine. No concomitant medications were reported. On an unknown date in 2010 the patient experienced shingles. The patient sought unspecified medical attention and unspecified treatment was given for adverse event. The outcome of shingles was unknown. The relatedness for shingles was unknown for VARIVAX (Merck). Additional information is not expected.
Insomnia; Racing thoughts; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included chronic migraines, high blood pressure, and known allergies to tree nuts. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021 at 16:00, the patient experienced insomnia and racing thoughts, which were assessed as non-serious. The patient did not receive any treatment for the adverse events (AE). The patient recovered from both the events on an unspecified date in Jan2021.  Information on the batch/lot number has been requested.
25 you M with vasovagal syncope after injection. Patient recovered. He had a companion drive home. He was evaluated by EMS on scene.
REDNESS AND ITCHING AT INJECTION SITE; VERY ITCHY; SLIGHTLY SWOLLEN, FEELS WARM TO TOUCH
6cm x 8cm area of swelling. Warmth and erythema on left anterior thigh. Pt given Keflex for 7 days and Benadryl QID.