chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IPOL and PEDIARIX were inadvertently administered to a 4 years old patient, with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00414740) and transmitted to Sanofi on 04-Jan-2021.   This case involves a 4 years old male patient who was inadvertently administered a 0.5 ml dose of IPV (VERO) [IPOL] Dosage form: multi dose vial lot R1F971M, expiration date: 03-OCT-2021 via intramuscular route in the left vastus lateralis and PEDIARIX not produced by Sanofi Pasteur lot number and expiration date not reported via unknown route in unknown administration site on 07-Dec-2020 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for prophylactic vaccination.  This was an actual medication error case due to extra dose administered (latency same day).   Caller with question regarding safety/ adverse effects following administration of extra dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPV).  Adverse event symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the lot number of suspect vaccine PEDIARIX.
Pt had redness and swelling in their arm where the flu vaccine was given. Pt took BENADRYL and was okay per the pharmacist who was working on 10-3-16.
Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number J3TE5, expiry date 20th January 2023) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The pharmacist called to report the patient was administered the Shingrix and during administration link between the syringe and needle started leaking, so the patient received approximately half the dose of vaccine, which led to accidental underdose. The reporter consented to follow-up by email. No further information was reported at time of reporting.
duration of fatigue post injection; This case was reported by a physician via call center representative and described the occurrence of fatigue in a adult 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 fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient experienced fatigue post injection. The reporter wanted to give patient a clearer answer beyond probably a few days.  It was unclear whether patient had received Shingrix or not as no probing questions were asked prior to end of chat. The reporter did not consent to follow up.
perfectly well prior to immun @ 11AM; pt fussy & crying @ 1230PM-cried cont for > 3 hrs;
This spontaneous report as received from a nurse assistant refers to an unspecified number of patients of unknown age. The unspecified patients medical history was not provided. Since on an unknown date in August 2014, the unspecified patients were vaccinated with improperly stored GARDASIL (dose, frequency and lot # were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This case is linked to case # 1411USA010152 (same reporter link). Additional information has been requested.
w/in 8hrs had a bad case of the flu;had to stay in bed 2 1/2 days go to the MD;sick for about a wk
After vaccine patient became unresponsive and appeared to have a seizure not regaining consiousness for 10-15 seconds, was very pale after. 911 was called EMT arrived and evaluated the patient. He was taken to hospital but discharged after arrival saying that he was ok.
Had COVID Dec-2020, received Janseen vaccine in April-2021, fever of 101.5-103, weakness, difficulty walking, unable to control muscles in hands and arms, unable to speak words properly (slurred), confused, headache, dehydrated, low sodium, prescribed antibiotics by healthcare professional.
Fever of 103, Fast heart beat, Aches pains, Stomach ache, Lethargic, Cough, Runny nose.
COVID Breakthrough Case  Pfizer Dose 1 3/1/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) COVID Positive 9/29/21  10/7/21: Patient is a 79-year-old male who presents to the emergency department today with complaints of worsening shortness of breath.  Patient's accompanying symptoms include persistent cough, fatigue, decreased appetite, fevers, body aches.  Patient states the symptoms started about 2 weeks ago.  He tested positive for COVID-19 on 09/29/2021, received outpatient COVID-19 antibody infusion on 10/01/2021.  The patient states his symptoms have progressively gotten worse and today he felt as if he could not catch his breath which subsequently led his arrival to the emergency department.  The patient is vaccinated for COVID-19.  Patient has a past medical history significant for type 2 diabetes, hypothyroidism, anxiety, hypertension, hyperlipidemia.   Upon arrival to ED patient's temperature is 100.5°, heart rate 106, respirations 24, pulse ox 88% on room air, blood pressure 133/67.  Patient was placed on 4 L oxygen via nasal cannula to maintain O2 saturations greater than 90%. Patient received DuoNeb x1, Decadron 6 mg x1, 750 mg IV Levaquin x1, 1 L IV normal saline in ED.  chest x-ray reveals patchy bilateral airspace disease, concerning for multifocal pneumonia.  CT angio chest is negative for PE, scattered bilateral areas of airspace disease likely representing viral pneumonitis or multilobar pneumonia. Patient's laboratory findings are significant for hemoglobin 11.8, hematocrit 36.2, D-dimer 1.33, CRP 19.40, sodium 133, glucose 341, ALP 172, bili 1.3, albumin 3.1.   Patient was seen and examined at the bedside in the ED, patient is in mild respiratory distress.  The patient continues to complain of shortness of breath, fatigue, generalized illness.  Patient denies any alcohol abuse, tobacco use or illicit drug abuse.  10/12/21: 79-year-old man who presented worsening shortness of breath despite outpatient monoclonal antibody infusion following recent diagnosis of COVID-19 infection.  He presented to the emergency department where he was noted to be hypoxic, chest x-ray and CT pulmonary angiogram confirmed bilateral airspace disease without pulmonary embolism.  He was admitted to the hospitalist Service, treated with Actemra, IV steroids, empiric antibiotic therapy as well as antiviral therapy remdesivir.  Clinical response was favorable with progressive improvement in oxygen requirements, shortness of breath and other respiratory symptoms.  Oxygen walk for home determination prior to discharge was done, he was noted to require 3 liters/minute with activity and no supplemental oxygen at rest.  He was discharged in stable medical condition to continue outpatient follow-up.
when administering the vaccine in the left deltoid, the syringe/needle started to leak.  since dose provided was undetermined, pt was given a new dose in the Right deltoid
85-year-old female was referred to the ED from her primary physician's office after she tested positive for the COVID-19 infection.  The patient was assessed promptly upon arrival and lab tests and imaging studies were ordered.  I reviewed all the lab test results and chest x-ray findings.  The imaging studies revealed an infiltrate in the lower lobe of the left lung.  The CRP was elevated at 84.5.  The patient needed supplemental oxygen to keep the oxygen saturation above 90%.  It was decided to admit the patient for further care. CTA of the chest was ordered in view of the low oxygen saturation.
Anaphylactic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that on an unspecified date, she had a severe anaphylactic reaction to pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein), had a rash, severe side reactions and she ended up in the hospital. She wanted to know if any of the ingredients on the Prevnar 13 are the same as the ones on the Covid 19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I started to develop shingles around 10 days following my second dose of the Pfizer covid vaccine. A skin rash originating under my right arm gradually spread horizontally in both directions to my chest and back. Over the course of six days, the rash became extensive and painful. A week after symptoms started, I consulted a doctor who diagnosed the shingles. Her assessment was that my immune response to the vaccine reactivated chicken pox cells in my body, resulting in shingles. Valtrex and Prednisone were prescribed to treat the condition. I am currently taking these meds and seeing improvement.
Information has been received from a MD concerning a normally healthy 3 year old white female with no significant medical history or known immunosuppression who, 5 days post vax, developed a right arm rash. The pt was dx'd at an urgent care facility as having poison ivy and was treated with 1 dose of IV dexamethasone and diphenhydramine (Benadryl). The following day, the pt developed right arm eschar and papular vesicular lesions which were noted as very painful and pruritic. The pt was seen by a MD and was dx'd with herpes zoster with cellulitis secondary to a bacterial infection. The herpes were primarily on her right arm and in a dermature pattern and subsequently she developed lesions on her mid-chest, right scapula and anterior thighs. The pt was hospitalized for 72 hours and treated with IV Zithromax and Tylenol with codeine phosphate. On an unspecified date, the pt fully recovered and was discharged from the hospital. It was noted that the parents of the pt denied any previous chickenpox exposure. On 5/15/2000, the pt was noted to be fully recovered. No further information is expected.
thrombotic thrombocytopenic purpura leading to a placental abruption, emergency c-section at 35 weeks of pregnancy. birth weight was 4lb 4.1oz.  Pt received several units of platelets, several days of plasmapheresis. Diagnosed with central serous retinopathy.
Patient reported a fever and rash that developed shortly after vaccine was administered and lasted 3 to 5 days
Significant constipation, moderate nausea (no vomiting), mild headache (I never get headaches), moderate fatigue and weakness.
Strong night terrors, hallucination, sleep walking - started that night and have continued every few nights since the shot. Usually last about 20 minutes.
severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expected to confirm Sweet's Syndrome.
This spontaneous report as received from a consumer refers to a friend (age and gender were not reported). On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date, patient lost sight in one eye for a while (recovered). Patient still had itching, and possible inflammation in the brain, with subsequent memory loss (not recovered). The relationship between ZOSTAVAX and the events was not reported. Upon internal review lost sight in one eye and inflammation in the brain, were considered to be medically significant. This case is linked to case 1308USA003078 via same reporter link. Additional information has been requested.
Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 1/6/2021    Patient is a 60 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   No previous hx of vaccine reactions.     ALLERGY REVIEW OF SYSTEMS:  All other systems negative          Objective    Vitals Vitals:   01/06/21 1705 01/06/21 1720 01/06/21 1724 BP: 134/82 (!) 145/84 134/72 Pulse: 94 80 77 SpO2: 97% 99% 100%       Physical Exam Vitals signs and nursing note reviewed.  Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.         Assessment/Plan  Treatment included: antihistamines and benadryl. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Diphenhydramine 25 mg given at 5:15   Pt dismissed at 5:25.
severe muscle cramps of both calf muscles w/vesiculation; may have also had tingling & spasm in rt thumb, but not evident on exam now; Is a postal carrier & bitten in rt calf by dog or dogs; had some vomiting & dec appetite;
LYMPH NODE IN ARMPIT BECAME PAINFUL AND SEVERELY SWOLLEN. WITHIN A FEW HOURS IT WAS THE SIZE OF A GRAPEFRUIT. OTHER NODES IN SURROUNDING AREA ALSO ENLARGED AND VERY TENDER. FEVER.
Pain; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and ERYTHEMA (Redness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN (Pain) and ERYTHEMA (Redness). At the time of the report, PAIN (Pain) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Flu-like symptoms, shaking, chills, body aches, headache  in temples. Patient reports to use Tylenol or Ibuprofen
sudden sharp pains on the left side of her head close to her ear. They then began moving all over her head; had left leg pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Dec2021 18:45 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 18:55, outcome "recovered" (2021), described as "had left leg pain"; HEADACHE (non-serious) with onset 01Dec2021 19:05, outcome "not recovered", described as "sudden sharp pains on the left side of her head close to her ear. They then began moving all over her head".  Additional information: Patient had left leg pain 10 minutes after being vaccinated . Stated that after five minutes that she had sudden sharp pains on her head. . when she got home that she had shooting head pain that kept going every 20-30 minutes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA. Vaccine given at 2040 and waited 15 minutes before leaving site. On my drive home, between 2100-2110 started feeling tingly and numb around mouth and it spread to entire face. Tongue and inside of cheeks also felt tingly/numb.  No visual swelling of face and breathing was ok. I didn't feel any airway obstruction.  Heart rate also increased. I continued driving to the nearest store to get Benadryl (about an additional 20-25 minutes).  Took 50mg at approximately 2145 and my symptoms slowly got better. As of today (02/16/2021) my face does not still feel 100% back to normal, very minimal numbness/tingly but more so on the left side which was also the same side as injection. I have had no facial drooping.
21 yr old who recieved the following shots today;  on right arm Hep A and IPV;  on Left Typhoid and YF along with PPD;  pt about 1 hr after getting the vaccines started to feel itchy in left arm;  that became generalized to body;  no hives, no dif. breathing, no chest pain, no nausea, no problems with walking;  pt went to facility and was sent there;  pt walked to Health clinic without a problem;  never had similar reaction in past;  no rashes;  Recommendations for future;  pt should not get all of the listed vaccines at the same time;  VAERs form done;  did not put as allergic reaction because pt is doing well with no signs of analph.  no hives;  Benadryl prn;  f/u with PCM in morning as needed;  pt needs to be with roommate tonight;  volunteer drove pt back to dorms  Medication(s):   -DIPHENHYDRAMINE--PO 25MG CAP - T1 CAP PO Q6H FOR 24 HRS #30 RF0 Qt: 30 Rf: 0
Clenching of fists and rolling of the eyes; lasted about 20 minutes after 26 hours of immunization.
Shortly after receiving the Moderna covid vaccine, patient complained of tingling of tongue, itchy throat, numbness and coldness of left side.  Patient was given 1cc (50mg) of Benadryl IM.  Patient started feeling better 5-10 minutes after administration.  Her symptoms had subsided however, she started complaining of a little dizziness.  Her BP was monitored with no signs of hypotension.  Patient has a history of allergies, migraines and usually takes allegra for allergies.  Eventually, the patient with her husband also monitoring her condition, agreed that she was feeling better and felt ok to go home.
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot),  lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
Broke out in Hives on my arms legs and my thighs on the 3 day; extreme itching; Had no problems a little sore arm; This is a spontaneous report from a contactable Consumer (Patient). An 68-year-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL0140, expiration date: Mar2021) via unspecified route of administration, on left arm, at 16:30 on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included multi vitamins, Calcium, biotin and omeprazole. The patient had no problems a little sore arm on 15Jan2021. The patient reported 'she broke out in hives, it was on her arms, on her legs, her thighs on the 3 day evening (on 18Jan2021). Not really on the top of her body, not on her chest and also had extreme itching. Itching went away in about 12 hours. It was reported that hives returned days 4-9. The hives would go away and return. It was reported that when patient first time visited the local doctor the hives gone and by next morning it was completely gone and again appeared evening about the same time for seven days. The patient took pictures and finally visited local doctor. The doctor gave a shot of steroid injection (treatment) and prescribed Zyrtec and Pepcid and advised not to take second dose of vaccine. The patient reported that she never had a reaction to medications. The patient guessed that she was not going to be able to take the second vaccine and wanted to confirm it. It was reported that patient was very healthy and had no allergies. The patient had no COVID prior and post vaccination. The outcome of the event broke out in hives on my arms legs and my thighs on the 3 day was recovered on an unknown date in 2021; extreme itching was recovered on an unknown date in Jan2021 while for the event had no problems a little sore arm was unknown.