chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; rash was mildly raised, warm; This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced raised rash and skin warm. On an unknown date, the outcome of the raised rash and skin warm were resolved with sequelae.   It was unknown if the reporter considered the raised rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed a localized rash on his upper arm soon after receiving the vaccine. The patient had rash which was mildly raised, warm and lasted 2 to 3 weeks and was approximately 2 x 4 inches. The patient wanted to get 2nd dose. The reporter asked if it is safe to give the second dose. The reporter consented to follow up.
Dose given after being in the syringe more than 6 hours. Contacted pfizer who stated dose should be repeated in opposite arm.  Contacted customer and instructed her to come back for repeated dose.
Patient received 0.5cc of Tetanus Toxoid inj IM (L) deltoid for dirty metal cut injury to RLE (leg) on 9 Aug 03.  On day 4, pt presented with 8 Cm of erythematous, inflammed area over on deltoid. Pt topical antibiotic and antiseptic agent for deltoid and oral antibiotic Keflex 250mg q6h x 7 days for RLE infection on 13 Aug. Pt recovering.
Student immediately passed out following the shot. Lowered her to the floor, while lowering her to the floor her respirations changed, she was snorting and gurgling slightly immediately aroused when laid on floor alert and oriented on arousal, frightened, crying, denies pain, SOB discomfort, "just scared us". VS 124/80, 68 , 14 speech clear no respiratory distress noted.
flu like symptoms; gelatinous bump over collar bone pretty inflamed; extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (gelatinous bump over collar bone pretty inflamed) and MYALGIA (extremely sore) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 002B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included PHENTERMINE for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (gelatinous bump over collar bone pretty inflamed) and MYALGIA (extremely sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (gelatinous bump over collar bone pretty inflamed) and MYALGIA (extremely sore) outcome was unknown.            Concomitant medications included Birth control medications.
Mother brought child back to Health Dept due to redness, swelling and fever to right thigh. Client received immunization to area 3/16/09. Mother applied ice to area. Suggested mother take child to MD.
Macular rash starting on trunk that spread to entire body. Confluent around the injection site on the R thigh. Fever up to 103 started the day after vaccine given.
9/13/14 Mom called, left arm has very large red, hot area, extremely itchy. 9/13/14 Pt seen. Lg. area (non-tender) erythema (L) deltoid local. AUGMENTIN Rx given.
Patient developed rash on 6/13/19 & a fever. Patient had white spots in mouth. Child said things tasted funny. Possible Thrush-given tx for Nystatin 100,000 unit/mL. Apply to white spots on tongue 4xdaily for 14 days. Given Benadryl for rash. Diffuse maculopapular rash face to feet, sparring palms & sole. Dept. of Health was called and Rapid Flu test - Negative. Mom advised patient needed testing for measles. The patients mom refused any testing and was very upset. She took her children and left the building w/out finishing the visit. Dept. of Health stated they would take it from here and follow up w/the patients parents.
Normal resting heart rate is 70 and starting approximately 4 hours later resting heart rate was 110 and if i would get out of bed it would go up to 140.  This lasted approximately 36 hours .
Referred to urgent care for constant crying, the day after receiving 4 mo immunizations. Exam was nml. Baby cried > 3 hrs. Mild rxn, cranky, gassy, spitting up, appetite decreased. Gave Tylenol. Pt fine after 1-1 1/2 days, per mom.
This spontaneous report as received from a licensed practical nurse refers to a 5 year old patient of unknown gender. The nurse reported that a 5 year old was vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscular on 04-APR-2013. The nurse reported that the order for the patient was for poliovirus vaccine inactivated (IPV) and was misread or interpreted as Human papillomavirus (HPV) vaccine. No product confusion was discovered. No adverse event reported. Additional information has been requested.
a stiff neck on the right side and has not gone away/Stiffness muscle; muscle pain/Its not excruciating pain.  Its just right there, mild pain; the area of what would be the trapezius muscle and confirms the area on his right side is what is sore, feels swollen, stiff, and tense; the area of what would be the trapezius muscle and confirms the area on his right side is what is sore, feels swollen, stiff, and tense; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03May2021 11:30 (Lot number: EN0175) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "food allergy" (unspecified if ongoing), notes: Allergy to egg. Family history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04May2021, outcome "not recovered", described as "a stiff neck on the right side and has not gone away/Stiffness muscle"; MYALGIA (non-serious) with onset May2021, outcome "unknown", described as "muscle pain/Its not excruciating pain. Its just right there, mild pain"; MUSCLE SWELLING (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset May2021, outcome "unknown" and all described as "the area of what would be the trapezius muscle and confirms the area on his right side is what is sore, feels swollen, stiff, and tense". Therapeutic measures were taken as a result of myalgia, muscle swelling, muscle tightness.  Additional information: Further stated that, patient described the area of what would be the trapezius muscle and confirms the area on his right side was what was sore, feels swollen, stiff, and tense. "It feels more tense when his wife massages it. It feels like it needs to loosen up but like its tightening." Ice and heat make it feel better. It was not excruciating pain. It was just right there, mild pain. It was not stopping me from my daily routine. It was annoying and the length of it scares me. Would it have anything to do with soft pillows or sleeping in a certain position."He says he had heard side effects should go away after a couple of days. Caller received a call from his doctors office and asked this agent to hold while he took the call. I was unable to hear and capture all details patient gave the physician but I was able to hear him describe some of the same symptoms and said he had used Bengay. When caller returned to the call, he said "The doctor says its probably not to do with the vaccine and the pain was not related to the vaccine but from how I was sleeping." He told him to take a pain killer and to massage it if it hurts. If it gets worse he can come in and they would do x-rays. He had tried ibuprofen, icy hot, and ben gay to relieve the pain from the muscles, it was not lessening though.   No follow-up attempts are possible. No further information is expected.
Pt. initially received Moderna as her first dose; she received Pfizer as second dose today.
pt recv vax in 1983 & pt exp elevated liver function studies & became ill immed;
Shingles; itchy throat; poor balance; scalp pain/painful skin on neck and ear; numbness; bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Thyroid cancer (Patient had radioactive iodine therapy). Concomitant products included clopidogrel bisulfate (Plavix).   In July 2022, the patient received the 1st dose of Shingrix (intramuscular). In July 2022, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, scalp pain and papular rash were not recovered/not resolved and the outcome of the itchy throat, balance difficulty and numbness in leg were recovered/resolved.   It was unknown if the reporter considered the shingles, itchy throat, balance difficulty, scalp pain, numbness in leg and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comments: This case was reported by the patient. He received Shingrix dose about 2 weeks ago. While the patient was walking 3 mile walk his leg and feet became numb and he had poor balance. His wife had to assist his walking. The numbness and poor balance lasted a few minutes. At that time he also noticed that he had scalp pain and painful skin on his neck and ear. Even the wind blowing through his hair was painful. After he had returned from his walk, he noticed about 20 bumps on his ear and side of his neck. The patient thought that the bumps were mosquito bites or hives.  The patient saw the doctor on the day before reporting and was diagnosed with shingles. The patient was treated with Valacyclovir 1 gram tid for 7 days. The reporter consented to follow-up.
leg was swollen, lot of pain, and could not walk; leg was swollen, lot of pain, and could not walk; leg was swollen, lot of pain, and could not walk; This spontaneous report was received from a consumer referring to a 4 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 02-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported).   On the same day, the patient's leg was swollen, lot of pain, and she could not walk. The patient's health care professional (HCP) who administered the vaccine was notified, and the HCP advised to give the patient diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN) for the symptoms. It was reported that the patient's allergist had told them it was OK to receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the reporting time, the outcome of the events was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all the events was not reported.
4.5 cm X 5 cm cystic fullness right supraclavicular area found 2 days after injection. Fullness still present 2 months later. Also noted brief discomfort in mid portion  of supraclavicular fossa if turns head.
Red, splotchy, raised rash on interior aspect of upper left arm and also has some red spots scattered over chest area.
Feeling flu like symptoms until next day but daily fatigue that I have that I did not have previous to vaccine. I get through my daily activities with a feeling of fatigue. Have to take a break to manage.
slight numbness in the left side of the face; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot #; EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 09:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took naldecon [carbinoxamine maleate;paracetamol;phenylephrine hydrochloride] and experienced drug hypersensitivity. On 26Feb2021 11:15, the patient experienced slight numbness in the left side of the face. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
On 6/10/00 the pt developed a fever of 103, was limp and staring. This lasted about 3-5 minutes. The pt vomited one time. For a period of 20 minutes afterwards the pt couldn't stand, limbs were rigid had difficulty lifting and straightening head. Was seen in the ER.
Pt states 1st day hot hot, hard & itchy and 2nd day hives under L axilla and spread to breast & legs. 3rd day arm very swollen, could not bend, hot to touch and very red. Went to ER 12/1/01. Given Benadryl, Solumedrol, Prednisone packet and cortisone cream. Instructed pt to call her family Dr to make him aware, and not to get flu vaccine in the future. Pt stated she has had flu vaccine for 10 yrs except for last year when there was a shortage.
Left arm began to get sore, where injection was given, pain increased as time went on, noticed pain around 9 P.M.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSVERSE MYELITIS GUILLAIN BARRE SYNDROME HYPOTENSION
Friday 11/12/2021 at approximate 3:30PM- patient noted facial drooping.  Seen at ED by ED physician.  Dx Bell's Palsy and steroids prescribed.  Patients states has had Bell's Palsy in past.
severe pain in the left foot, especially on the left big toe; toenail is bluish in color; severe pain and numbness in toe, feet and chest; severe pain and numbness in toe, feet and chest; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Left on 11Aug2021 15:15 (at the age of 42 years old) as dose 2, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not reported. 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 received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: FH6780 OR FN6780) on 21Jul2021 at 13:30 for covid-19 immunisation. The patient experienced severe pain in the left foot, especially on the left big toe, toenail is bluish in colour, severe pain and numbness in toe, feet and chest, on 12Aug2021. Caller mentioned that "this morning, he woke up with severe pain in the left foot, especially on the left big toe, his toenail is bluish in colour. Caller mentioned that he experienced numbness, "very numb" big toe after experiencing pain on it. when he walks or stands, he has pain on the left foot going to the calf. Agent states the patient got second dose yesterday, 11Aug2021, states he is having severe pain on his feet and toe, also on the chest. toenail is bluish in colour, also not having much feeling on his feet, a reduced sense of feeling. Wants to know if this is a normal side effect or if he needs to go to the doctor. Caller clarifies he got the Pfizer Covid vaccines, clarifies it is his left foot that is affected, states he had the injection in left shoulder, states the pain is especially in his big left toe, states he noticing the nail is looking like a bluish colour, states there is a lot of numbness in the big toe toward the tip of the toe and when walking or standing it causes pain from toe into foot and up into the left calf. Severe pain and numbness in toe, feet and chest and toenail is a bluish color were reported as worsened. AE(s) does not require a visit to Emergency Room or Physician Office. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Symptoms of confusion and hypoglycemia associated with poor oral intake associated with acute illness with positive COVID-19 PCR test 6 days previously prompted presentation to hospital emergency department. Diagnoses included acute hypoxemic respiratory insufficiency, acute on chronic CKD,  diarrhea, deep vein thrombosis, and failure to thrive in setting of increased inflammatory markers. in addition to antidiabetic medication management, patient received remdesivir, dexamethasone, and anticoagulation X 4 days. Patient was discharged medically stable to his routine home care.
diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing blindness legally blind, ongoing hypersensitivity neuropathy peripheral. The patient's concomitant medications were not reported. The patient previously took klonopin and experienced coma, flu. It was reported that, the patient experienced diarrhoea on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: no results on blood test: no results on ophthalmological examination: no results. Therapeutic measures were taken as a result of diarrhoea (diarrhoea).  No follow-up attempts are needed. No further information is expected.
Migraine (2 days now) - started Ibuprofen  as needed Light sensitivity (1 day so far) while working from home Fatigue Injection site pain (1 day)
Rash on stomach, chest, neck. Rash looked like slightly raised red speckles. Did NOT itch. Resolved in 36 hours.
Information was received 13-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was alleged that on 26-FEB-2015 the plaintiff was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 03-OCT-2016 the plaintiff was treated by a physician at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. As a direct or proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Had numbness weakness on the entire right side head to toe. Head aches , could not concentrate on anything.
Subsequent to receiving vax, the pt developed a fever, irritability and fussiness. The mother reported that the pt would not take his bottle. He was treated with Tylenol. The fever resolved in 24 hours. A copy of this report was forwarded to Aventis Pasteur and Merck, Sharp & Dome, manufacturers of the concomitantly administered vaccines.
Sweat, lightheadedness, nausea, treat with rest, BENADRYL 50 mg IM at arm (deltoid). Pt had reaction to H1N1 inactivated flu shot. Nausea, sweating, lightheadedness. Vitals were taken, blood pressure was 102/64. RN was notified. Pt was brought by wheelchair to exam room. BENADRYL was administered IM. Pt was monitored by MA for 15 minutes.
Moderna Dose 1 6/17/21 (022C21A) Moderna Dose 2 7/14/21 (022C21A) Covid Positive 1/23/22  1/23/22: A 33-year-old gentleman presented to the emergency room with complaint of shortness of breath that started suddenly just 3 hours prior to arrival to the emergency department. Patient reports shortness of breath with activities.  He has also experienced some chest pain all over the chest.  Reports that he was at a game yesterday and was apparently normal after the game.  Reports subjective fever and has no other significant past medical history.  Of note, the patient was noted to be in SVT in the emergency room upon arrival.  He was given adenosine and has converted back to sinus rate.  1/27/22: The patient presented to the hospital with chest pain and palpitation, found to be in SVT received adenosin with abortion of his SVT, had shortness of breath and cough and his COVID-19 test came back positive, chest imaging show mild pneumonitis, he was not hypoxic and he did not require oxygenation during this admission.  His labs show elevated troponin, echocardiogram show EF 35% without significant valvular disease but the aortic valve was not visualized, the cardiologist consulted and recommend cardiac catheterization and the patient had cardiac catheterization and show clean coronary artery and EF about 50%, the cardiologist recommended angiogram to rule out aneurysm, CT chest angiogram show 4.8 centimetre aortic cured aneurysm involving the left sinus, discussed with the cardiologist Dr. and recommend beta-blocker and follow-up as an outpatient.  The patient most likely had viral myocarditis by COVID infection, will continue beta-blocker and losartan both low-dose due to borderline low blood pressure.  Discussed with the patient his wife his medical condition and the importance of compliance on stop smoking and make sure his blood pressure is well controlled and follow-up with the cardiologist with repeated scanning of his aneurysm every 6 month.  A medical report given to the patient to presented to his workplace.
Case completed primary Covid series in January 2021, and a booster on 8/16/21 (Pfizer BionTech Lot # EW0176, Left Deltoid), then was hospitalized for Covid on 9/29/2021. * Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Pt w/ acute hypoxemic respiratory failure due to covid-19 pneumonia. He is on day 5-7 of symptoms at admission. He is experiencing failure to thrive plus hypoxia and has bilateral pulmonary infiltrates seen on chest xray and CTPA. No PE seen. Was on 2-4 liters in ED. De-sats w/ activity. He is on Ocrevus (ocrelizumab) q6months (next dose November) which is a CD-20 targeting monoclonal antibody used for MS, it is considered an immunosuppressant. Unclear how it affects his ability to respond to covid-19.    Plan:  - dexamethasone 6mg daily for 10 days through discharge prescribed - remdesivir 200mg -> 100mg daily for 5 days total through 3/oct pm while inpatient - daily CMP while on remdes - discussed importance of avoiding atelectasis such as use of incentive spirometer, ambulation, sitting in chair, self prone    Severe sepsis  Assessment & Plan In the setting of strong physiologic response to covid-19 pneumonia which includes fever, tachypnea and tachycardia pt met severe sepsis criteria.