chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness; Hot to touch; Erythema; Swollen; Fever; local reaction to immunization; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced pain, feeling hot, erythema, swelling, fever and local reaction. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain, feeling hot, erythema, swelling and local reaction were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain, feeling hot, erythema, swelling, fever and local reaction to be related to Shingrix.  Additional information received were as follows: This case was reported by medical assistant or immunization program coordinator on the line. The patient received Shingrix on right deltoid. On 21th August 2019, the patient reported to the clinic. The patient site was swollen, red, and hot to touch. On the reporting date, the patient again came back in and has erythema that grew to 15 by 13 cm, with warmth. The diagnosis was local reaction to immunization. The patient was given prednisone oral two 20 mg tablets once daily for 5 days and instructed to elevate and ice 4 times a day. The provider drew a border around the erthyema. The patient also reported soreness and fever. When the patient came into the clinic, the fever was controlled. The fever has resolved, but all other events were ongoing. No details were available regarding start date. The reporter consented to follow up.
1/18/22 13 yr/o child with no significant past medical history who presents with acute onset of diffculty breathing and chest pain. He tested positive for COVID 1/16/2022 and results came back earlier today, he has had no significant sick symptoms. Per mom, he was watching a movie in his room with girlfriend and other friends when his sister came down the stairs and told mom he was having trouble breathing and chest pain. He has never had symptoms like this before, he is an active kid who wrestles and plays other sports. No history of anxiety, no significant family hx of heart disease, bleeding or clotting disorders.   Review of Systems  Constitutional: Negative for fatigue and fever.  HENT: Negative for congestion 1/18/22  Review of Systems  Constitutional: Negative for fatigue and fever.  HENT: Negative for congestion and rhinorrhea.   Eyes: Negative for redness.  Respiratory: Positive for chest tightness and shortness of breath.   Cardiovascular: Positive for chest pain.  Gastrointestinal: Positive for abdominal pain. Negative for nausea and vomiting.  Musculoskeletal: Negative for arthralgias and myalgias.  Skin: Negative for rash.  Neurological: Negative for light-headedness, numbness and headaches.
3/15/06 seen in clinic prescription for oral typhoid called to pharmacy 3/17/06. Took 1st pill on empty stomach. 3/18/06 at 3am started having nausea and vomiting. Later am 3/18/06 ate breakfast. 3/18/06 noon got abdominal pain and nausea. Took ranitidine on advise of pharmacist. Did not take any more typhoid pills. 3/19/06 bloating uneasy discomfort continued. 3/20/06 symptom free. 3/24/06 reported event to clinic.
7SEP pt recvd vax & 8SEP called parent to see how pt doing p/vax parent reported crying, high pitched, would last 1hr, would calm down x 1/2hr then high pitched crying would began;t106 ax;pt fussy afeb;20SEP seen by MD some loss of motor
Erythematous papules and plaques to face, torso and legs with mild facial swelling L > R after 24-48 hours.
about 15 min after vaccination patient complained of itching at injection site, felt warm around neck. She appeared flushed and blotchy around site. SHe was kept for 15 min more. Denied chest or throat tightness. She complained of feelling warmth down left leg. BP 106/70 pulse 74 O2 sat 99%. Patient had not mentioned any hx of bee allergy during consultation, only that she felt faint/sick after receiving Hepatitis A vaccine before.
Fatigue; Upset stomach; Fever; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fatigue, upset stomach, fever and muscle pain. On an unknown date, the outcome of the fatigue, upset stomach, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, upset stomach, fever and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter stated that the patient received 1st dose of vaccine in unknown arm, four months prior to the reporting. The reporter stated that after received Shingrix vaccine the patient experienced muscle pain, fever, upset stomach and fatigue. The reporter had nothing else to report. Follow-up would not possible as no contact details were available.
She has a spot about the size of a baseball around the injection site that is red, swollen, hard, and hot to the touch.
Three days after administration patient presented with a red, warm & swollen rash on and around the area of administration. Within the week had blistered, pt visited MD received KEFLEX rx and is now recovering with minor scarring from the scab.
Pt was given vaccine on 6/28 and called 7-2-16 stating his arm was swollen down to above elbow and hard and red. Pt did not come in for eval.
Pressure in chest; difficulty breathing; fast heartbeat; dizziness; shakiness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on arm right on 19Mar2021 04:15 AM (age at vaccination: 57 years) as DOSE 1, SINGLE for COVID-19 immunisation at Hospital. The patient medical history included Asthma and trouble sleeping. The patient had known allergies to Compazine. Other vaccine in four weeks was reported as no. Covid prior vaccination and covid tested post vaccination was reported as no. The patient Concomitant medications were not reported. On 19Mar2021 05:00 PM, the patient experienced Pressure in chest, difficulty breathing, fast heartbeat, dizziness, shakiness. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for all events and treatment included as Xanax for trouble sleeping. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Started coughing within 2.5 hours of vaccine administration. Sounded like seal bark. Visual swelling on neck and mouth/cheeks by next morning.
Patient started developing swelling at the site of injection the same day of vaccination. The affected area got red, hot and painful. Patient saw doctor the next day, she was prescribed doxycycline for 7 days for suspected infection. Patient started feeling better the day after starting the antibiotic (2 days after receiving vaccination).
Rapid heart rate 110 in bed at 3:00 am, fever, extreme headache, nausea, cramps, violent vomiting, agitation, muscle ache.  Unable to keep fluids down resulting in dehydration. Went to urgent care at when symptoms would not abate.  arrived at urgent care at 1:30 pm.  the doctor evaluated my condition.  He gave me a sublingual medication for nausea, Zofran, I began to vomit again within 15 minutes.  He checked urine and found Keto in urine.  He then administered 25 mg IV Promethazine into hand IV port followed by 1Litre of saline solution.  The nausea was finally finished but severe headache persisted.  Much agitation due to the promethazine and including involuntary muscle spasms.  Finally,  able to leave Urgent Care at 4:45pm.
Coughing up excessive amounts of foamy phlegm tinged with blood, blowing out thick nasal secretions tinged with blood, full body muscle aches, joint pain, fatigue and tiredness, hot flashes and cold chills.
Hospitalized 10/23/2021; COVID-19 positive 10/23/2021; fully vaccinated  BRIEF OVERVIEW:   Admission Date: 10/23/2021 Discharge Date: 10/28/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01] COVID-19 virus infection [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   Patient is a wonderful 92 y/o man admitted for confusion related to COVID19 pneumonia as well as UTI/prostatitis.  He has a past medical history significant for NPH, hypertension, AAA status post stenting, history of melanoma status post resection.   Patient presented with AMS and was found to be covid positive and was started on dexamethasone and remdesivir and had rapid resolution of acute respiratory failure with hypoxia.  UA was positive as well raising concern for UTI and was started on ceftriaxone.  Mental status changes resolved.  UC ultimately grew Klebsiella and staph hemolyticus and imaging raised concern for prostatitis as well severe bladder infection or neoplasm and so ID and urology were consulted.  Urology recommended outpatient cystoscopy with resolution of COVID19 and UTI.  ID recommended changing antibiotic to bactrim with course dictated by etiology of imaging findings - 2 week minimum course with course extension as long as 6 weeks if imaging findings were secondary to infection rather than neoplasm.     Above CT imaging was actually obtained as part of vascular workup - patient complained of leg pain and had difficult to palpate pulses.  CT imaging of thorax showed 4.8cm descending thoracic aortic aneurysm w/ likely prior old dissection, CT angio of aorta and lower extremities showed multiple occlusions in both lower extremities with reconstitution and ABIs showed at least moderate disease in both legs.  Vascular surgery evaluated patient and recommended outpatient f/u post completion of treatment of infectious as patient didn't have signs or findings to suggest critical limb ischemia.  Patient was started on ASA/statin.   Patient was seen by PT/OT who recommended SAR however COVID19 infection made placement very difficult so ultimately patient returned to his facility with additional family support and home care.  He will need close f/u with PCP, repeat BMP in 1 week and weekly thereafter while on bactrim, f/u with urology, and f/u with vascular surgery.
unspecified problems; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated during telephone conversation that he had been seen thousands of patients over the years that, had reported many, unspecified problems after getting a flu vaccine. The reporter facility required that patients get the flu vaccine, so a patient could be dying of sepsis, but they had to get the flu vaccine in the emergency department. No other details provided, given, or available other than what was documented, at time of initial reporting. The reporter consented to follow up. This is 1 of the 3 linked cases reported by the same reporter.
No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Left lateral thigh, 5 x 6 cm slight redden swollen site. Patient occasionally scratching at site. No drainage. Treatment: Benadryl, warm compresses, Motrin
10/22/02 had DTaP #$ and Hib #4. 10/23/02 mom noted red, firm, bump near imm. injection and fussy. 10/25/02 we saw her.
Weakeness, loss of strength, some pain, tingling. DX; Parsonage-Aldren Turner Syndrome.
Arrhythmia; BP  altered; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (BP  altered) and TACHYCARDIA (Tachycardia). At the time of the report, ARRHYTHMIA (Arrhythmia), BLOOD PRESSURE FLUCTUATION (BP  altered) and TACHYCARDIA (Tachycardia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment taken in response to the events was not provided. No more information was provided. The patient was Spanish speaking.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
23SEP98 pt was brought in w/rash c/w shingles (varicella zoster) on rt trunk & rt thigh;
This serious initial spontaneous case, was received from other non-health professional on 11-Dec-2017, concerning a 57-year-old, adult, female patient. It was reported that, the patient had never received flu shot in the past. The patient's historical condition included: had one seizure in 2009, but was told as TIA (transient ischemic attack). The patient was allergic to thiomersal. Concomitant medications included: Atenolol, Levothyroxine, Etodolac, Ocean, Calcium plus vitamin D, Omega 3 and COQ10 for unknown indication. On an unspecified date in Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On the same day, 10 minutes after receiving vaccine, patient had a seizure. One hour later, the patient had another seizure. The patient had additional episodes of seizures on unspecified dates in June and September. One week prior to this report, the patient had an episode of seizure. The patient was treated with an unspecified seizure medication. At the time of this report, the patient had not yet recovered from the event seizure.
Sore arm at injection site of flu vaccine, red, welts, warm to touch, with symptoms increasing in severity
pt did not have an adverse event, but did have chickenpox which broke out all over but more on legs;still has few scabs on 6/10/99;no other sx;
9 x 5.5 cm firm edema and erythema. Pain with ambulation; limping.
Very serious bacterial urinary tract infection; Rash; on face, underneath nose and underneath chin, aggravating rash; Bacterial infection; This is a spontaneous report from a contactable consumer (the patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 26Feb2021 (at the age of 91-years) as a single dose for COVID-19 immunization.  Medical history was none. There were no concomitant medications. The patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization.  The patient reported that she got her second COVID-19 vaccine Friday, and she has gotten a rash. It is just on her face, underneath her nose and underneath her chin. It is aggravating rash. She does not know what it is. She does not know what it could be or something else. The patient also reported "I had a very serious bacterial urinary tract infection, bacterial infection". The patient did not have any treatment for the rash. The clinical outcome of the events very serious bacterial urinary tract infection, Rash; on face, underneath nose and underneath chin, aggravating rash, and Bacterial infection was unknown.
Patient reports slight sore throat, dry cough, chest tightness & bloodshot eyes (redness) starting after work around 6 p.m. Patient didn't report to doctor until next morning.
Patient wasn't sure if allergic to Thimerosal. Patient was given PNEUMOVAX and 2 days later reported a rash to us on her arm. Patient was seen by MD and received Rx's (Prednisone).
In June 2021, several weeks after my second Moderna vaccine, I noticed that my hair was falling out in one spot. My hairdresser also commented about my hair loss in July. The hair loss continued and worsened and spread throughout the summer. I have had previous incidents of Alopecia Areata, but nothing to this extent. I am currently being treated with scalp steroid injections and topical treatments.
21APR98 pt exp 2.5 to 3cm diameter hyper pigmented areas w/dec SC tissue surrounded by papules;devel about 1wk p/vax w/o resolution on visit 29MAY98;
Information has been received from a licensed practical nurse concerning a female patient who on 26-JUL-2007, was vaccinated with a first dose of Gardasil. On an unknown date, the patient received a third dose of the vaccine only 7 weeks after her second dose. The patient also experienced injection site pain. At the time of this report, the patient recovered from injection site pain. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ, orally, lot # L013190 with expiration date 16-NOV-2016 and lot # L020861 with expiration date 25-JAN-2017 (dose was not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Eight days after the vaccine, I started to feel light headed and I thought I was just fatigued. I woke up at 3am and started to pass out and I couldn't see and falling down. I went to the ER and my pulse and blood pressure were low and I was mildly dehydrated. I had Sinus Bradycardia which they said may be transient. I have never had an unusual rhythm readings.  I experienced the lightheadedness for about a week. I did not drive or ride my bike because I might need to lay down.  Three weeks after the vaccine it seemed to get better a little a time and the events were less frequent. It has been four weeks and I feel fine now and I have resumed my normal activities.
On May 6th, 2 days after the second dose of the Pfizer vaccine, which was on May 4th, I started experiencing mild tightness in the throat and tingling of the mouth starting around 11 PM EST. The next morning, on May 7th, around 6 AM EST, I started experiencing itching all over my body, arms legs and face. Within 30 minutes my body was covered in hives and my bottom lip was very visibly swollen. Since doctor's office was not open, I decided to take 1 Cetirizine Hydrochloride tablet 10mg and 1 Diphenhydramine HCI 25 mg Antihistamine at the same time. Lip swelling went down and hives started to disappear within 90 minutes. Itching also stopped.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
extremely swollen lymph nodes on the side of my body where I got vaccinated. where it is visible for the first couple of days and then is just felt over the 1-3 months. I'm on my 3rd covid vaccine and each one has had this happen. I can feel a huge lump in my under arm and in my neck.