chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over the body; dermatagraphism; chronic spontaneous urticaria; runny nose in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives all over the body). November 2021, the patient experienced MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from November 2021 for Hives and Dermatographism, at a dose of 2 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from November 2021 for Hives and Dermatographism, at a dose of UNK, qd. At the time of the report, URTICARIA (Hives all over the body), MECHANICAL URTICARIA (dermatagraphism), CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) and RHINORRHOEA (runny nose in the beginning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Histamine level: high (High) high histamine levels..         Concomitant product use was not provided by the reporter.  Patient stated that  8 days later after the booster shot, patient had hives all over the body and visited a dermatologist who said she was having dermatagraphism for which she took oral antihistamines and stated that it was a month long thing now. Patient was taking two  Zyrtec per day and one  Benadryl in the evening.
Hospitalized;  COVID-19 positive 8.25.21 (fully vaccinated); Admission Date: 8/25/2021; Discharge Date: 8/29/2021; DISCHARGE DIAGNOSES 1. COVID-19 Pneumonia 2. Paroxysmal Atrial Fibrillation 3. Anxiety 4. HTN 5. GERD 6 COPD; DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 83 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease who presented with cough, fatigue, chills, body aches, and shortness of breath.  She noted that a couple of days ago she initially felt very chilled and fatigued.  She had a cough. Her baseline oxygen in 4 L   She is fully vaccinated against COVID-19. Patient was admitted and treated with Decadron 6 mg daily. She was also a candidate for Remdesivir and got  5 doses before her discharge.  Patient was stable on her baseline oxygen of 4 L NC. Of note patient was confused the day after her admission. She could not remember why or how she got to the hospital. She kept insisting she was at her home. The following day the patient was back to her baseline and she was aware of her previous confusion. She was given steroids in the ED which could have contributed to the confusion. Patient was alert and oriented x4 at the  time of discharge.
After vaccination patient in observation line, stated he felt 7/10 stabbing and shooting chest pain. Vitals 1:23 PM: 141/87 blood pressure, 75 heart rate, 18 respirations, 98% O2. Patient was A&O x4, talking without difficulty, color was good. Denies dizziness, shortness of breath, nausea or vomiting, numbness or tingling. Patient stated he had a history of chest pain within the last 6 months, had not seen a Dr yet and pain today was worse. At 1:30 pm vitals were: 127/78 blood presssure, 76 heart rate, 18 respirations, 97% O2; at this time patient rated pain 3/10 and was feeling better. Advised patient to see Dr about recurring chest pain, and side effects that may arise and he would need to go to the ER for. Patient expressed understanding to these issues and left the vaccination site in car with his parents and no pain.
Left arm cellulitis x 2 weeks spreading to neck, scapula, and breast. Treated with Doxycyline x 2 weeks. Already reported.  Drooping of right upper outer eyelid with visual changes. 4 days after vaccine. Recently diagnosed with Posterior Vitreous Detachment, no retinal detachment, tears, or holes. Could not explain the drooping.
Repeated myoclonic spasms occurring 14 hrs post 3rd DTP/HBOC; Spasms lasted for 4-6 hrs;
This case was reported by a consumer via call center representative and described the occurrence of wheezing in a adult male patient who received Influenza vaccine Quadrivalent unspecified season. Previously administered products included Influenza vaccine Quadrivalent unspecified season (Every year from past several years). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wheezing and pollen allergy. On an unknown date, the outcome of the wheezing and pollen allergy were unknown. It was unknown if the reporter considered the wheezing and pollen allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. Later, as pollen was strong, patient developed some wheezing which the physician associated with allergies. Patient was hard to understand and hard to pin down whether the event was reportable.
No further information is available; patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a 2 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 02-SEP-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # S009234, expiration date 24-JAN-2022; strength, route and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures were 14.2 Celsius degrees for 3 hours 15 minutes. Previous temperature excursion were 17.5 Celsius degrees for 8 hours and 1.9 Celsius degrees for 3 hours. No product quality complaint (PQC) was reported. No further information was available.
acute local reaction of left deltoid. Deltoid area was red, warm and pruritic.
Starting on 3/14 had fever (101-102) for 2 days, reaction at the injection site on thigh and faint red spotty rash
Sore arm near site, fever(temp elevated up and down), chills, headache, couldn't lift left arm, nausea, vomiting, diarrhea
Information has been received from a health care professional concerning a pt who was vaccinated with MMR and subsequently, experienced a fever, post vax. The pt sought unspecified medical treatment. Additional information has been requested.
Pt presented with 24hr of chest pain and SOB, found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at hospital after finding positive cardiac markers. Treated with Motrin and Colchicine with improvement after 4 days.
Swelling, redness, pain about 1 inch below bottom injection site. Fever.
Received KINRIX vaccine IM in left upper arm 3/17 developed redness, heat and swelling in left arm from elbow to shoulder. Resolved in 2 days. Hx cow's milk allergy-hives, peanut-swelling. Received PEDITRIX and INFANRIX same reaction.
COVID-19 VACCINE - Patient received 1st dose of Moderna on 2/2/21.   Was scheduled to receive 2nd dose on 3/3/21.   Pfizer vaccine was administered in error on 3/3/21 as second dose.       No symptoms reported by patient's husband on 3/5/21.
Myocarditis; Heart rate increased; Blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased). At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications provided by the reporter.   The patient asked if he was reporting a side effect to the vaccine; to which he stated not sure of myocarditis. Also, experienced increased blood pressure and increased heart rate although not significant enough to require hospital.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;
COULD NOT DRIVE; UNABLE TO GO TO WORK; SICK AT NIGHT/ ILL; This spontaneous report received from a vaccine facility concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced sick at night/ ill. On 22-MAR-2021, the subject experienced could not drive. On 22-MAR-2021, the subject experienced unable to go to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick at night/ ill, could not drive and unable to go to work was not reported. This report was non-serious.
Burning sensation underneath the skin of her left face and nostril; A spontaneous casewas reported by a consumer  concerning about  his friend, 41 years old female patient and describes the occurrence of burning sensation underneath the skin of her left face and nostril  who received mRNA-1273 (Moderna COVID-19 Vaccine) injection for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27 Jan,2021 the patient started mRNA-1273  COVID-19 Vaccine at an unspecified dose. On the same day after one hour,  the patient experienced burning sensation underneath the skin of her left face and nostril.   At the time of the report, burning sensation underneath the skin of her left face and nostril had not resolved.  Action taken with mRNA-1273 in response to events was not provided.
Pain, induration & rash noted on 3rd day post vax; medial to inject site 6 cm;
warm on arm of injection; itchy on arm of injection; rash on arm of injection; swollen on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, METOPROLOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), GLIMEPIRIDE, METFORMIN, ESCITALOPRAM and ATORVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection). At the time of the report, VACCINATION SITE WARMTH (warm on arm of injection), VACCINATION SITE PRURITUS (itchy on arm of injection), VACCINATION SITE RASH (rash on arm of injection) and VACCINATION SITE SWELLING (swollen on arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 3000 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received first dose administered through deltoid muscle. No concomitant medication was reported. No treatment medication was reported.
On 5/5/01 she had 4 seizures and was hospitalized for 5 days. On 04/24/2002, child was diagnosed with bronchitis and treated with Zithromax. After a rash developed, the Zithromax was discontinued on approximately 04/30/2002 and Benadryl prescribed. Rash abated. (Above information is in addition to seizures previously reported for 05/05/2001)On May 5th 2001 she had four seizures and was hospitalized for five days.
Chest Discomfort, Constipation, headaches, body pain, day sweats, sore throat, felling feverish, sluggish, weakness & tiredness.
Approximately 45 minutes after receiving vaccine patient developed urticaria.  This progress over one hour to swelling of the throat, difficulty breathing, dizziness.  Patient self treated with epinephrine (Epi-Pen) which she keeps for known peanut allergy.  Had excellent response to epinephrine.  She called EMS and was transported to Emergency Room. Observed overnight with minimal symptoms (itchy rash) on night of 4-16-07.  Only treatment in ER/hospital was Benedryl 50 mg IV.  Discharged on 4-17-07 and had no further symptoms until morning of 4-18-07 when awoke with swollen lips, itching of face and ears, dizziness, nausea, mild abdominal pain. Came to Student Heatlh Service for evaluation.  Developed throat swelling while at Student Health.  Treated with .3 mg epinephrine sq. with good response.  Infectious Disease consultant recommended close inpatient observation until steroids or other treatment could be initiated to stop reaction.  05/09/2007 Mr received for 2 ER o/n admits (4/16-1707 and 4/18-19/07) for c/o allergic reaction to JE vaccine.  Pt reports 2 hours after vaccine she developed a "choking" sensation, difficulty breathing, and trouble swallowing with rash.  Self-injected with epi-pen with relief and evaluated in ER.  Discharge DX;  Allergic reaction/anaphylaxis status post JE vaccination.  Pulmonary stenosis. Returned to ER 1 day after D/C with c/o facial swelling (lips and tongue).  Used Epi-pen and Benadryl en route to hospital with some resolution.  Admitted for observation. Discharge DX:  Resolved angioedema, allergic reaction/anaphylaxis related japanese Encephalitis vaccination immunization. Doing well.  No symptons at this reaction since May 2007.  Last seen by my office on 4-14-08 for an unrelated problem.
Arm was very sore which is normal I'm sure but I Felt it going up my neck and then within a few hours my jaw, cheek were numb to my ear. It was numb and strange feeling for about 72 hours after the shot. I have not been to the doctor but will speak to a doctor before considering getting a second dose.
skin itching/ skin itches; skin break out/ rash that spread in both arms; knot in the arm (hard ball) on the administration site; nauseous/sick to her stomach; upset stomach described as almost killing her; felt very Sleepy/ she is just in a sleepy mode; have to run back in forth popping all the time (diarrhea).; swollen administration site; felt very drain; got headaches like shot pain on the temporal on the right side; she has not been able to eat; Not feeling well/feel sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182; Expiration Date: Jul2021), via an unspecified route of administration on 18May2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Apr2021 (patient provided the numbers 1887 but could not read rest) (at the age of 63-year-old) as a single dose for COVID-19 immunisation. It was reported that patient had skin itching/skin itches and skin break out on 18May2021, knot in the arm (hard ball) on the administration site, swollen administration site, nauseous, upset stomach described as almost killing her, felt very drain, felt very sleepy/she was just in a sleepy mode, have to run back in forth popping all the time (diarrhea) all in 2021. She also additionally mentioned that she got headaches like shot pain on the temporal on the right side and she even have a rash that spread in both arms in 2021. She added that she had used Cortisone but that didn't worked. she mentions her stomach was nauseous, she hasn't been able to eat, and her skin was all broke out from the 2nd vaccine and it itches in 2021. Her arms have been itching as soon as she got the vaccine. Her skin broke out after she had the shot on 18May2021, she states she was still itchy and still broken out. She started putting cortisone on her arms and it did not work. patient clarified that was was a maximum strength cortisone 10 cream with aloe. patient verifies that the itching has not improved and was persisting. While probing the caller for event details she stated that all these questions were making her feel sick and sick to her stomach in 2021. patient states that she really was not feeling well in 2021. The outcome of the events pruritus and rash was reported as not recovered. The outcome of all other events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Adverse effect of vaccine, initial encounter. Vaccine reaction; suspect allergic/inflammatory and less likely infection given improving spontaneously. Area of reaction outlined with marker; call if extending beyond margins or if any worsening symptoms like increased redness, swelling, pain, or fevers. Apply cool compress or ice pack (not directly to skin) for 15-20 minutes several times/day BENADRYL 25-50 mg every 4-6 hours x 24 hours, then prn. Off work today F/u if symptoms worsen or do not improve as expected.
barely able to move; body is aching; affecting her ability to walk; lymph nodes hurt; lymph nodes are swollen; neck is hurting; spine achy; patient imagine arthritis feels; ribs are achy; joints hurts and pain in elbow; Initial information regarding an unsolicited valid serious case was received from a consumer or non-health care professional via Health Authority (Reference number- 00328232) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 53-years-old female patient who experienced barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment,  concomitant medication and family history were not provided.   no other vaccines given.  On 12-Oct-2020, the patient received a once 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength: standard, lot UJ463AA and expiry date: 19-Mar-2021) via an intramuscular route in the right arm  for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain) one day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory details were not reported.   No corrective treatment was received.  The event outcome was unknown for all events.
arm swollen, red, warm to touch, periphery of redness is blotchy;started 2-3hr p/vax given;last tetanus given 8yr ago, no rxn;c/o itching in reddened area;
Large lump slowly appear at site of injection and approximately 2 inches to the left of injection site. Slight bruise around injection site. Gave 2 BENADRYL. No lightheaded, no trouble breathing. Feeling okay, able to stand/walk normally. No pain.
Ache all over, low fever, nausea, short of breath, short attention span, just exhausted
pt recvd vax for prophylaxis; 1 wk later p/ dose 2, exp psoriasis over entire body