chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Additional information provided patient demographics, dose details, suspect vaccine, test results, and outcome. Information regarding PREVNAR was received from a healthcare professional regarding a 4 month old male patient who experienced hives. A 4 months of age, the patient received a dose on 16 Mar 2010. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on 16 Mar 2010. Dose regimen was 1 dose (intramuscular). Additional suspect medication included HIBEST. Concomitant medications were not reported. The patient experienced hives on 27 Mar 2010. The patient recovered. No additional information was available at the time of this report. Physical examination (results: head circumference of 39.5 cm) was done on 25 Nov 2009. Physical examination (results: developmental milestones: with normal range) was done in Mar 2010. No additional information was available at the time of this report.
Information has been received from a registered nurse concerning a 16 month old patient who on 05-AUG-2010 was vaccinated SC with a 0.5 ml dose of PROQUAD (Merck upgrade process) (lot number 666746/0190Z) and with a 0.5 ml dose of VARIVAX (Merck) (MSD) (lot number 665908/1606Y) SC. The nurse reported that the patient received a dose of PROQUAD (Merck upgrade process) instead of a dose of MMR II. The patient was not experiencing any known symptoms. Follow up information has been received from a registered nurse. It was reported that the male patient with no pertinent medical history and no drug or allergies reactions was vaccinated with a dose of PROQUAD (Merck upgrade process) (expiration date 15-JUL-2011) SC in the right arm and with a dose of VARIVAX (Merck) (MSD) (expiration date 13-JUL-2010) SC in the left arm on 05-AUG-2010. There were no concomitant medications. The nurse reported that it was not until approximately 5-10 minutes after the patient had left the facility that the nurse who administered the vaccine realized her mistake and that the PROQUAD (Merck upgrade process) had indeed been given instead of MMR II. The nurse reported that she spoke to the patient's mother in the morning on 26-AUG-2010 and she stated that the child did not have any adverse reactions after his vaccinations. No further information is expected.
This spontaneous report was received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received VARIVAX (Merck) that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested. This is one of several reports received from the same source.
Approximately 20 seconds after the GARDASIL with no warning she passed out and became unresponsive for 10 seconds.  She was very pale, diaphoretic and had a heart rate of about 64.  When she came too she was unable to stand and had fully dilated pupils and so could not see.  I managed to get her to a room with a table and lay her down.  She gradually became fully responsive but had dilated pupils for about 7 minutes from the start of the reaction.  Being concerned about anaphylaxis I called 911 while she was not fully responsive, they came and checked vitals, BP 104/68, glucose 94.  At no time was her breathing compromised.  This whole episode lasted about 25 minutes, after which she fully recovered.
Child developed fever 4 hrs after vaccine administered.  She had a seizure 14 hrs after receiving the vaccine.  Seen in ER & did well.
A consumer report has been received. The report concerns a, consumer of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 26-Dec-2015. The patient experienced fever which started on 26-Dec-2015. The patient recovered from the event of fever on 27-Dec-2015. The reporter's description of the event was as follows: Unknown. The report was considered to be non-serious.
Patient fainted momentarily about 20 seconds. Recovered immediately, vitals were stable. Patient as given ginger ale.
Legs are very heavy severe difficulty walking just in the house; Ankles hurt, can't get out of bed without physically lifting up her legs; This is a spontaneous report received from a contactable consumer. A 84-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on the left arm on 26Feb2021(at the age of 84-year-old), at 09:00 as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration on the left arm, on 19Mar2021(at the age of 84-year-old), at 09:00 as a single dose for COVID-19 immunisation . The patients medical history consisted of chronic obstructive pulmonary disease (COPD) and was a cancer survivor. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 at 09:00, the patient experienced heaviness in legs and pain in ankle. It was reported that the patients legs were very heavy and had severe difficulty walking just in the house. Her ankles hurt and she could not get out of bed without physically lifting up her legs and this had started happening after the first vaccine was administered. The adverse events had resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events heaviness in legs and pain in ankle was not recovered at the time of this report.   No follow-up attempts are needed. No further information expected.
Pregnant female received Moderna Covid-19 Vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant female received Moderna Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.
TRANSIENT CEREBRAL ISCHEMIA 8/2/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/12/2021 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Patient Fainted after walking 15 feet or so from the pharmacy. She was very nervous and hyperventilating before hand. I laid her down on her back and put her feet up and gave her some water. She was fine after 5-10 minutes.
Patient is a 70 y.o. female with a history of multiple myeloma, DVT on Eliquis, COPD, chronic systolic CHF with EF of 40% who presented to ED with 7-day history of fevers, productive cough, sore throat, and myalgias and was found to have acute hypoxic respiratory failure due to COVID-19 pneumonia. She was transferred to facility 9/18/2023 for further care. There was an inability to rule out bacterial pneumonia and COPD exacerbation based on findings, so she was discharged with a course of antibiotics and steroids. She also had an AKI that improved with IVF and low normal BPs, so her antihypertensives were held on discharge.   1. Acute hypoxic respiratory failure: Not on home O2. Required up to 2 L on admit. Chest x-ray on admit with multifocal pneumonia. Likely due to COVID-19 and possible COPD exacerbation. Weaned to RA prior to discharge. 2. COVID-19 pneumonia, possible CAP: Recent travel history and productive cough. Chest x-ray on admit with multifocal pneumonia. Urine antigens negative, procalcitonin positive. Improved with steroids and antibiotics, discharged with 7 day total course. Held off on remdesivir given AKI and ultimately weaned to room air with rapid improvement in symptoms. 3. Possible COPD exacerbation: Due to above. S/p Solu-Medrol in the ED. Continued home inhalers. Steroids as above. 4. AKI: Creatinine normal at baseline. Creatinine up to 1.33 on admit.  Likely due to dehydration. Held home diuretics and ARB. Resolved with IV fluids. Resumed diuretic on discharge, but held ARB due to borderline low BP. Check BP and BMP and resume outpatient if appropriate. 5. Acute on chronic thrombocytopenia: baseline platelets 60-70.  Platelets 48 on admit. Likely due to above.  Trend. 6. Anemia of chronic disease: Hemoglobin baseline 10-11.  Hemoglobin 11.2 on admit.  Monitor. 7. Acute LLE DVT: Diagnosed 8/8/2023. Continued Eliquis 8. History of multiple myeloma: Follows with Dr. (oncology). Held home chemotherapy given active infection. Follow-up as outpatient 9. Chronic systolic CHF: Follows with Dr. (cardiology).  History of nonischemic cardiomyopathy.  TTE 11/16/2022 with EF of 42%.  Held ARB, beta-blocker and diuretics given AKI and soft blood pressures. Resumed BB and diuretic on discharge, resume ARB and HCTZ as able outpatient.
No additional AE; improperly stored vaccine administration; This spontaneous report as received from a nurse refers to patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 21-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1637651 was confirmed to be valid, expiration date 09-JUN-2022 (dose reported as "1", route of administration, vaccination site were not specified) for prophylaxis. The administered dose of the vaccine underwent a temperature excursion of 62 degrees Fahrenheit for 2 hours. There were no previous temperature excursions. Digital data logger was involved. No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA009775:
Client given Janssen when he should have been given Moderna as a second dose. The paperwork stated Moderna and the vaccine card also had Moderna sticker. The client was taken to a booth only administering Janssen and the nurse gave the wrong vaccine.  This mistake was found immediately. The client was talked to in person with an interpreter. He states understanding. All questions answered.
This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
My shoulder joint began to hurt about four hours after my vaccination. I couldn't raise my left arm. My shoulder felt stiff and like it was out of joint. It was extremely painful to move it and I couldn't raise my left arm, I thought maybe the injection had been given too high on my arm and caused SIRVA
Case number PHHY2012US013541 is an initial literature report received on 14 Feb 2012 and a follow up report received on 09 Sep 2013. Authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a female patient (age not specified). She was vaccinated with influenza (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. She had an anaphylactic reaction after vaccination on an unspecified date. Authors concluded that the pregnant women who were vaccinated with H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes. The most common pregnancy specific adverse event was spontaneous abortion (SAB) and stillbirth, and more than a third of women who experienced SAB had at least one risk factor (advance maternal age). Seventy two percent of women who had stillbirth had at least one risk factor or had a pathological finding in the fetus or placenta, suggesting factor other than vaccination that may be contributed to the fetal demise. This suggested that women with higher risk were over represented in VAERS database. Follow up report received on 09 Sep 2013: The case was lost to follow up, as no response upon several follow up attempts.
pt broke out in rash on arm....notified us at te pharmacy 8/21/19 at which point rash was clearing
On May 16th, one week after second Covid vaccine, unknown anaphylactic system reaction to unknown trigger. Shortness of Breath, skin red patches, Heart rate: 129. First visit to allergist. On June 16th, similar anaphylactic reaction of unknown trigger. Second visit to allergist.
After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my head and giving me a headache. It eased up. About an hour later, I was getting itchy - arms; legs. Big welts on arms and legs and one my back. I took Benadryl hoping it would go away - took it for three days. It wasn't going away. I would scratch and every time I would scratch then hives would spread throughout the whole area that I scratched. Called my Dr's office - he told me to take Benadryl. By Saturday, I went to clinic. Was given steroid pills and prescription for Claritin or Zyrtec. No testing. The meds helped with the smaller hives but my welts still remained and by rubbing the welts I would still get hives around it and they get re-inflamed and they swell up - even it it's my clothes that rub against it. Still have dry patches but they are a little raised but as much as before. I was told to put some cortisone cream on them to help them go away.  I was advised not to get second shot.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 15Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 24Sep2021 as dose 3 (booster) single (Lot number: 30145BA) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) positive, notes: Tested positive for Covid; (28Jun2022) negative, notes: Tested negative for Covid; (01Jul2022) negative, notes: took home Covid tested which was negative; (04Jul2022) positive, notes: took home Covid test which was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 23Jun2022. Stop date of treatment for COVID-19 was 05Jul2022. The patient previously receive a COVID-19 Vaccine. Tested positive for COVID on 23Jun2022. Started Paxlovid 23Jun2022 evening and completed treatment as prescribed on 28Jun2022 morning. Tested negative for COVID 28Jun2022 and symptoms resolved. Congestion, headache on 01Jul2022 - took home COVID tested which was negative. Sore throat, congestion, fatigue, feverish on 04Jul2022 - took home Covid test which was positive. Symptoms continue on 05Jul2022. The patient received the fourth dose of BNT162B2 on 01Apr2022 (lot number: 027L21A) on right arm for COVID-19 immunization.
Patient reported feeling numbness in jaw and dizziness. Pt's lips, tongue, and skin were assessed while vital sigs were taken. She did not display swelling or discoloration in or around mouth or skin. The patient answered no when asked about difficulty breathing, itchiness, or shortness of breath. Initial vital signs were 160/107 HR 94 Sp02 98%. She reported a previous anaphylactic reaction to oxycodone and believes she was given IV epinephrine. Vitals were rechecked 5 minutes later and were 147/97 HR 92 Sp02 100%. Pt reported feeling numbness in chest and EMS was called at 1551. Pt was taken  via ambulance when EMS arrived.   Pt has a history of severe asthma and 2012 allergy testing was negative. Pt rec'd 2nd dose on 4/14/2021 with no known issues.
Patient has staring to develop a twitching in the left eye followed by pressure and a gritty feeling with redness.
Intermittent severe pain in lumbar spine and hip joints. I tried heat, ice, and OTC NSAIDs with no improvement. Hydrocodone (left over from knee surgery in 2018) relieves pain for 3-4 hours.
Very itchy. Not at shot site but all around it. Field gets bigger each day. First day about 2  inches of shot site.today  about 5 inches from shot site.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of ROTATEQ lot # L027719, exp. 28-APR-2017 and lot # L027726, exp. 10-MAY-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, photosensitivity, nausea, aches, chills for 10-12 hours day after vaccination.
Developed a rapidly progress rash about 9 pm. Given BENADRYL at home - did not help - when involved face > pt c/o was itchy Mom took her to ER. Given another dose of BENADRYL without improving then ZANTAC then steroids. No improved while being observed and rash worsen. Given epinephrine and rash resolved observed x 4-6 hrs. Sent home on PO prednisone x 5 days. Symptoms recurred 7 days after initial rxn.
FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included immune system is weak. 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 07-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Redness, itchiness. Local reaction. Tx with BENADRYL and ice.
Sore throat, runny nose. I felt feverish but never had one. I tested negative in 5 days, it was really quick for me. The doctor recommended I use MUCINEX and FLONASE.
Rash, body aches, tightness in chest, fever, chills, nausea, headache, light head, fatigue, elevated heart rate. Took Tylenol and Benadryl. Still has fever, headache, body aches, light headed, elevated heart rate, fatigue, nausea, tightness in chest. Spoke with Clinic and they told her that side effects were normal and treat them like a normal symptom.
Patient has c/o progressive weakness and loss of sensation since Flu vaccine administered in LUE 10-19-11.
Had left arm swelling, stiffness. Felt like she had swelling in LLE. ER did not report any documented LLE swelling.
PATIENT HAD PFIZER VACCINE DOSES ON 01/21/2021 and  02/11/2021, AND TESTED POSITIVE TO COVID.
On the first night, I had severe muscle pain in the left arm. The next day, I felt severely fatigued and had whole body muscle pain especially in my back and between my ribs. My left arm was still very sore and was hard to lift anything heavy with my left hand. The second day I woke up with numbness and tingling in the right half of my lower lip.
Pt reported hives that started within 10 minutes of vaccine and the start of difficulty breathing within 25 minutes of vaccine. Patient reported using a home dose of epinephrine injection that resolved symptoms. He did not seek further medical care. Pt reported no prior events with any vaccine.
The client became pale and dizzy and appeared to faint after the immunization. The client's mother and myself laid him down on the floor and called his name and he opened his eyes and started talking to us after a few seconds. The client then seemed fine and walked out the clinic a few minutes later with his mother. The client's mother called today (3-12-18) and stated that the client had been pale this weekend and had "passed out " two other times since the immunization on 3-8-18. I advised client's mother to call her Dr. and see about getting an appointment for follow up as soon as possible.
Patient had redness, swelling, and warm touch 3 days after injection. She approached the pharmacy on 8/23/17 about the signs of allergic reaction; she received the vaccine on 8/20/2017.
Information has been received from a nurse concerning premature 9 month old female twins with numerous medical problems who on 22-JAN-2008 were vaccinated with ROTATEQ. The nurse reported that the twins were born prematurely and have had lots of medical problems. The nurse reported that they put some of the vaccine on a preemie nipple and had the patient suck on it. One of the twins developed pneumonia and one developed bronchiolitis. On 24-JAN-2008 the patient bronchiolitis. Subsequently, the patient recovered from pneumonia. One of the twins was put on antibiotic and developed diarrhea. It was reported that the twins were given 4th month vaccination and were fine. Additional information has been requested.
Sore arm -> redness + swelling at the site of injection - measures 4.5 inches + 4.5 inches.
Day after received ADACEL vaccine (R) arm - arm began to be sore. Has continued to be sore since seen by MD 11/17/09 with no tx recommended. 12/14/09 pain not improved, taking ALEVE and applying ICY HOT to relieve. Often interrupts sleep. Another MD appt. recommended.