chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to our office for his one month health check. Post check up Provider ordered the second dose of Hep B. Medical Assistant administered the flu vaccine by error thinking that it was the Hep B. Medical Assistant as soon as she recognized her error she informed the provider of the incident. Provider spoke to patient's mom and explained to her what happened. She advised patient's mom to please keep a close eye on patient and if she saw any changes in his behavior to please bring him back to the facility or call 911 and go to the nearest ER if nothing occurred then to please come back in 48 hours for recheck. Patient's mother stated that she understood the instructions given to her.   10/19/2018: Samuel and his mother returned to the clinic Provider examined Samuel and stated that Samuel was cryful but comfortable, no redness or induration noted to the site of vaccine. Mom was asked to return in 10 days for follow up.
Patient, "Starting just hours after the vaccine I felt exhausted. I slept for a long time and woke up the following day with the standard arm pain but I also had extreme fatigue and a headache as well as a productive cough. That lasted for over 48 hours. On the third day I had fatigue, cough, body aches and a headache. I received a rapid  covid test on the 31st that was negative and the nurse practitioner said that she believed that I was either having a bad reaction to the vaccine or bronchitis or pneumonia. Last night I had all of the same symptoms as days prior as well as tightness in my chest and a obvious upper respiratory infection."
Information has been received from a registered nurse concerning a 14 week old male who was vaccinated with a first dose of Rotateq. No adverse symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Little rashes over my body like on the wrist and my legs.; lot of itching; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left arm by the shoulder) on 30Jan2021 (age at vaccination was 76 years) as dose 1, single for COVID-19 immunization. The patient's medical history included cholesterol and blood pressure both were controlled. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced little rashes over his body like on the wrist and his legs and lot of itching. The patient stated that he did not really know the start date of rashes. Maybe 5 days after the shot. The patient experienced them because they didn't go away. It was one on the wrist, one on the leg and one on the arm and it was not all over his body. It has lot of itching on his skin specifically. The patient asked if that was one of the side effects. The patient received treatment with over the counter anti-itch cream. The outcome of the events was not resolving.   Follow-up attempts completed. No further information expected.
This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6206, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 as dose 2, single for COVID-19 immunisation. Medical history included hypertension (High Blood Pressure managed by medication) and known allergies to Penicillin and Sulphur Drugs. Concomitant medications included Losartan at 100mg and Hydrochlorothiazide 25mg tablets taken for hypertension. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 09:45 as dose 1, single for COVID-19 immunisation. On 18Mar2021 22:30, patient experienced, on the night of the second shot she woke up with fever. On 18Mar2021, patient experienced headache, ache and chills which they say can happen. On 20Mar2021, the patient experienced, on sunday patient woke up with like a rash on her neck and part of her face and she did not like the way it looked. On 21Mar2021, the patient experienced several quarter size hives on her neck. On an unspecified date patient experienced shingles. Patient did not received treatment till she went to doctor. The outcome of the events fever, chills, headache was recovering, for the events several quarter size hives on her neck and itchy was not recovered and rash on my neck and part of my face, ache, shingles was unknown. No follow-up attempts are possible. No further information is expected.
nausea; headache; chills; balance problems; weakness; I became extremely fatigued which continued through my second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 12:30 (Lot number: EP8730) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Date: 10Mar2021, Time: 10:15 , Anatomical Site of injection: Left arm, Batch/Lot number: EN6199), administration date: 10Mar2021, when the patient was 70 years old, for Covid-19 Immunization, reaction(s): "Extremely fatigued". The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; BALANCE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "balance problems"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I became extremely fatigued which continued through my second vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of balance disorder, asthenia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. After my first vaccine 10Mar2021 I became extremely fatigued which continued through my second vaccine on 07Apr2021. After second vaccine symptoms of nausea, headaches, chills, balance problems, weakness in legs became more severe. I now use a walker for balance and because of weakness I use it for support outside of my home. In closing hopefully this will provide some insight to others who are experiencing similar symptoms.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer and described the occurrence of rash in a 48-year-old female subject who was vaccinated with Engerix B for prophylaxis.  A physician or other health care professional has not verified this report.  In 1997 the subject received 3rd dose of Engerix B (unknown).  In October 2006, 9 years after vaccination with Engerix B, the subject developed a rash on her back, arms, chest, legs and sometimes her face.  The symptoms were described as a "red sunburn" with bumps that itch.  The subject was treated with topical steroids, xipamide (Aquaphor), allegra-d (Allegra D) and diphenhydramine hydrochloride (Benadryl) which helped the symptoms.  At the time of reporting the events were said to be worsening.  Follow-up information was received on 20 April 2007 via the consumer.  According to the subject, her allergist stated that any reaction to the vaccine would have been localized to the injection site.  The subject reported that she has eczema which is "completely unrelated" to the use of Engerix B.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, or drug allergies were not reported. On unspecified dates, patients were vaccinated with improperly stored doses of PROQUAD injection (dose and route of administration were not reported) lot number M042501, expiration date 17-APR-2018, for prophylaxis. According to the reporter, PROQUAD doses were exposed to the following temperature excursions: between -9 degrees Celsius (C) and 8C for an undetermined time frame. Previous temperature excursion was -9.5C  for 1 hour and 6 minutes. The suspect vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Nine erythema spots approximately 1 inch diameter that are raised and feel hard, spread throughout upper torso. Surfaced approximately 1 day after vaccine.
Narrative: Pt is a 74 y/o male with PMH of HTN, HepC, HLD, GERD, metastatic prostate cancer had received first dose of Moderna COVID-19 vaccine on 1/19/21. Pt fell 1/29 and starting vomiting 2/1. Pt expired 2/4 22:05 and the cause of death is cardiopulmonary arrest.
Information has been received from a registered nurse concerning a 21 year old female patient with no pertinent medical history and penicillin allergy who "4 years ago" in January 2007, was vaccinated with the first dose of GARDASIL (Lot # and expire date not reported), intramuscularly. On 12-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 663454/0672Y and expire date 19-SEP-2011), intramuscularly. On 29-DEC-2010, the patient was vaccinated with the third dose of GARDASIL (Lot # and expire date not reported), intramuscularly. Concomitant therapy included "birth control pills". The registered nurse stated that after the second dose on 12-OCT-2010, the patient became pale, sweaty and felt lightheaded. Registered nurse also stated that this resolved after giving the patient a ginger ale and crackers shortly thereafter. There were no laboratory diagnostics studies performed. On 12-OCT-2010, the patient recovered. The patient sought unspecified medical attention. Follow up information received from a registered nurse indicated that the student female patient with no illness at the time of vaccination was vaccinated on 12-OCT-2010 at 14:00 PM, with the second dose of GARDASIL intramuscularly in the left deltoid. It was reported that 10 minutes after vaccination, the patient became lightheaded, pale and sweaty. The patient did not seek medical attention. Additional information is not expected.
4/9/2023: CHIEF COMPLAINT: Chest pain  DIAGNOSES: -Acute hypoxic respiratory failure -Community-acquired pneumonia versus aspiration pneumonia -Decompensated heart failure -History of severe AS  Presented with complaints of chest pain, SOB, congestion and nonproductive cough for which he was prescribed Augmentin by an outpatient provider in the prior week. Found to be hypoxemic and in respiratory distress. BiPAP was attempted in the ED, however patient refused to continue wearing the mask. On arrival to the ICU, patient more lethargic, though still following some commands. He did reiterate that he would not want to be intubated, as he has stated in prior admissions and during this ED visit. Intervention: 15 L OxyMask, IV Lasix 20 mg, BiPAP attempted  Pertinent background -Admitted 2/23/2023 - 3/2/202 3 for acute hypoxic respiratory failure/CHF exacerbation; he was discharged to a SAR but reportedly left 6 days earlier. Neuro #Acute encephalopathy -evidence of respiratory acidosis in addition to acute infection likely leading to altered mental status. IV antibiotics and diuresis for slight volume overload. ? Delirium precautions - trial BiPAP if mentation improves - IV antibiotics and infectious per ID section -If no improvement, could consider meningitis and obtain LP CV  #Acute on chronic decompensated heart failure #History of severe aortic stenosis, Mild volume overload based on POCUS exam. -- diurese with IV diuretics. -IV Lasix 20 mg x 1 -Continue losartan 25 mg, goal SBP 120-140  #CAD s/p MV PCI (06/2007)-Continue ASA 81 mg daily - Continue statin  Pulm #Acute hypoxemic respiratory failure #Acute on chronic hypercapnic respiratory failure #Aspiration pneumonia-- Increased work of breathing in the setting of hypoxemia, cough associated with congestion, and high risk for aspiration concerning for pneumonia as etiology. Unable to clear secretions, high risk for NIV. Updated son who plans on coming in to discuss further GOC. Patient has been consistent with DNI. -Continue Optiflow, if mentation improves could consider BiPAP -Airway clearance: DuoNeb + Mucomyst every 4 hours, CoughAssist, frequent suctioning -IV antibiotics per ID section -Gentle diuresis for volume overload ID #Aspiration pneumonia --treat for CAP, RT for airway clearance. -Obtain MRSA nares, urine Legionella and strep pneumo -obtain respiratory culture -Monitor daily CBC - Anti-Infective therapy: ? Ceftriaxone ? Azithromycin Date and Time of death: 4/12/23 at 12:30
acute peri myocarditis.  Pt presented with chest pain, dyspnea, fever, nausea, malaise.  EKG with diffuse ST elevation, troponin and BNP elevation.  Cath clear.  admitted overnight.
This spontaneous report as received from a healthcare worker/medical assistant refers to a patient of unknown age. On 09-OCT-2013 the patient was vaccinated with 0.5 ml once of M-M-R II (lot # was reported as 137AA, exp August 2013) subcutaneously. The expiration date of M-M-R II was August 2013. No adverse effects reported. Healthcare  worker/medical assistant stated patient had received at an unspecified time in the past "2 M-M-R II doses and requested another dose" and additionally stated "we have an immune titer for her."Additional information has been requested.
It was an administration error of the vaccine. The patient has a first dosis of Moderna. The second dosis administrated on January 28,2022 it was Pfizer instead of Moderna, so it is a mixed series. The patient didn?t present any symptoms at the moment of the vaccine administration.  Staff is given training to avoid errors in the handling of vaccines. Feedback is received from staff which is satisfactory to prevent this situation from happening again.
Pt called 9 AM on 4/11/08 c/o at 4" circular red, raised, itching vaccine site. Recommended Benadryl and Ibuprofen.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient 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, 1 total administered on unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, more than a month after vaccination, it was reported that the patient underwent COV-2 antibody IgG (Immunoglobulin G) test and the results were negative. It was also reported that on an unspecified date, the patient blood work were taken and had detected antibodies against SARS-CoV-2 spike protein including the receptor binding domain (RBD). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210521321- covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt. had PENTACEL and Hep B given in same leg at same time - came back to office 6/21/10 (about 6 days later) with quarter sized knot on (L) leg. Area tender/swollen. Cellulitis vs. allergic rxn - Pt tx with Augmentin and f/u one week.
Patient di not have adverse effect to vaccine given. Patient was administered Afluria flu vaccine instead of the pregnancy dose.
within 6 hours of getting rototeq, flu, pneumonia and Hib vaccines, my son developed very bad diarrhea. He had 10-14 dirty diapers a day. This lasted about 7 days. He then spiked temps 6 days after receiving the vaccinations. His temp was up to 104. Went to the doctors office and they could not tell me what was causing this reaction. He also had terrible diaper rash that required special cream to start to heal. On day 9 after the vaccinations he was all better.
3/23/04- Hives & itching all over was given Benadryl by mouth & cream.
Patient got flu shot during Employee Health clinic she went home and when she woke up and her lips was swollen and by 10:00 am she was having swollen eyelids and her face was red.
Patient had received 2 doses of J&J Covid vaccine previously on: 5/7/21 & 1/21/22. The nurse mistakenly gave a monovalent Pfizer dose today instead of the bivalent as a booster.
No adverse effects reported; that were improperly stored./ excursion occurred; This spontaneous report was received from a vaccine coordinator regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 21-JUL-2019, the patients were vaccinated with improperly doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) for prophylaxis, lot number N022727, expiration date 12-JUN-2020 (strength, dosage, frequency, and route of administration was not reported). No adverse effects reported.   The administered dose of vaccine experienced the temperature excursion on 25-AUG-2018 with 30 Celsius for 3 hours. Data logger was involved. There were no previous excursions reported.  This is one of four reports, received from the same reporter.; Sender's Comments:  US-009507513-1907USA016724: US-009507513-1907USA016723: US-009507513-1907USA016725:
coughing; my voice sounds scratchy...voice has changed; hard time breathing; chest is heavy; very bad cold; got the second dose 3 days earlier; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy), NASOPHARYNGITIS (very bad cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier). At the time of the report, COUGH (coughing), DYSPHONIA (my voice sounds scratchy..voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier) had resolved.            Concomitant medications were not provided.  The patient refused to provided any contact or demographic information and hung up the phone when her doctor called.  Treatment information was not provided.   Reporter did not allow further contact
one week after 2nd dose, tongue swelled and lesions underneath, week later, metallic taste of food, March 30 woke up with Tinnitus
Pt recvd vax & exp temp 106 & pt screamed hi pitched cry x 1 hr; 11FEB93 pt seen by practitioner & was told had UTI;
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 05-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 3 hrs. after receiving FLUZONE HD patient began to have trouble breathing. He went to visit his PCP. He was experiencing wheezing, nausea, vomiting, and irregular heartbeat per his PCP.
Giving my first monkeypox vaccine to Lab staff as PEP and because guidance stated deltoid I believed it to be an intramuscular dose, however the next day I realized it should have been given SQ.  Administration route error.  No adverse reaction reported by staff member.
Patient had vaccination 4/7/2021 and started having symptoms 04/25/2021 arrived at the ER today with hypoxia
Case number PHEH2013US024174 is an initial spontaneous report received from a consumer on 15 NOV 2013: This report refers to a 66-year-old male patient. He was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly on an undetermined date towards the end of OCT 2013. A couple of days after vaccination, he developed a red, itchy rash, hives and blisters all over his body. The reaction had not resolved completely at the time of report, although the consumer commented that it had started to clear up. No further information about seriousness and causality was reported.
Pt given DTP/OPV at 11:30AM, approx. 1-3PM pt screamed unconsolably. pt returned at 4-4:30pm, where exam revealed normal female infant. Infant required no treatment.