chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner, concerning a female patient, who on 17-FEB-2007 was vaccinated with the first dose of Gardasil and on 27-MAR-2007 was vaccinated with the second dose of Gardasil. The nurse practitioner stated that the patient was not able to get her second dose on 17-MAR-2007 because she developed Bell's palsy (date not specified). The reporter stated that Bell's palsy was not related to therapy with Gardasil. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to reports previously submitted on 4/13/2007. Initial and follow up information has been received from a nurse practitioner, concerning a 21 year old female stundent, who on 17-JAN-2007 previously reported as 17-FEB2-2007 was vaccinated IM in the left deltoid, with the first dose of GARDASIL (Lot #655619/1427F). Following the vaccination, the patient had a "recent viral infection" (date unspecified), that was followed on 17-MAR-2007, with the development of bells palsy. The primary care physician was consulted, and approved for the patient to receive her second dose of the vaccine although she had bell's palsy. The NP clarified that on 21-MAR-2007 at 1:00pm (previously reported as 27-MAR-2007, the patient was vaccinated IM in the left deltoid, with the second dose of GARDASIL (Lot #656050/0245U). The reporter stated that Bell's palsy. was not related to therapy with GARDASIL. At the time of this report, it was unknown if the patient had recovered from the viral infection or the Bell's palsy. The patient sought unspecified medical attention. Additional information has been requested.
Sudden striking pain going through right leg about 7:30 that morning  , I was at work at time, but as day went by it finally went away unit my daughter messaged  me about the Janssen Vaccine clothing and I started to worry if I was having some symptoms, No now it's April 4/14/21 I'm having same issues now both legs I'm having some striking pain going through legs, I hope not issues. I hope to hear from some one soon, Do I need to see my Doctor?
THIS CASE MEETS CRITERIA FOR VACCINE BREAKTHROUGH REVIEW. SXS INCLUDE SOB, COUGH, ONGOING ILLNESS FOR 2+ WEEKS.
Temperature of 99 degrees; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep) and PYREXIA (Temperature of 99 degrees) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Couldn't sleep). On 16-Mar-2021, the patient experienced PYREXIA (Temperature of 99 degrees). On 16-Mar-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, PYREXIA (Temperature of 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99 (High) 99 degrees.         No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-058176 (Patient Link).
This spontaneous report was received from a physician assistant refers to a currently 24 years old no pregnant female patient without pertinent medical history. Drug reactions include dizziness and palpitations with codeine (date unknown). On 05-MAY-2015, the patient was vaccinated with the first dose of GARDASIL, strength reported as 120 Y, (dose, route and anatomical location were not reported), (lot # K011138 with expiration date: 08-APR-2017). Concomitant therapies included hormonal contraceptives (unspecified) described as birth control pill. On an unknown date 2015 after the vaccination with GARDASIL, the patient experienced trismus described as "lock jaw like symptoms", fatigue and headache. The patient sought medical attention through seeing the physician assistant on an unknown date. It was unspecified if treatment was given for the adverse events and there was no laboratory diagnostics studies performed. The outcome of trismus, fatigue and headache was reported as recovered/resolved on an unknown date in 2015. The relatedness between trismus, fatigue and headache and therapy with GARDASIL was not reported. Additional information has been requested.
"Patient with 3 COVID vaccines who admitted to hospital and had a COVID detected test.  Provider d/c note:  ""90 yo F presented to the ER for altered mental status admitted for acute metabolic encephalopathy in the setting of COVID and severe symptomatic hyponatremia.  Stroke was ruled out with MRI with urine studies consistent with SIADH picture, so fluid restriction initially started along with amitriptyline discontinuation.  Echocardiogram was done showing significant reduced ejection fraction around 30%, new as compared to previous.  Given the latter, hyponatremic likely further complicated by hypovolemic component.  Given lack of response of hyponatremia to fluid restriction and medication optimization, nephrology was consulted with initiation of salt tablets with further transition to urea packets in addition of furosemide with good, steady improvement in hyponatremia.  Discussed with family regarding new cardiomyopathy with reduced ejection fraction, and elected for medical optimization prior to discharge with outpatient cardiology follow-up with consideration of ischemic workup.  She was discharged in a stable condition with appropriate follow-up.
This is a spontaneous report obtained from a contactable medical assistant through a Pfizer sales representative. This medical assistant reported for her son. A male patient of an unspecified age, race and ethnicity received the first dose of TRUMENBA, (NDC number: 00005-0100) 0.5 ml, single dose, on an unknown date, in Aug2016, for immunization. Relevant medical history and concomitant medications were unknown.  On an unspecified date, in Aug2016, the patient's thighs were swollen for almost for three days. The patient completely recovered from the event on an unknown date, in Aug2016.
Extreme headache within a day that has never let up. Persistent Cough, body aches, wheezing, runny nose started by afternoon. It's Tuesday and I'm still sick in bed. Had negative covid test  done on Sunday so not from exposure prior to second vaccination.
Employee was given Tdap by me (MN, RN) on 07/22/2009.  At the time of vaccine administration, I did not realize that he was beyond the age recommended for this vaccine.  He is 71 years old.  He reported no adverse event following vaccine administration.
Patient came to our clinic 4/20/21 to receive his second dose 3 weeks after the first dose.
Per patients description of event, pt received pneumonia vaccine and within minutes felt flushed and "strange". Per record became tachycardic, tachypnic, hypertensive with a temp of 103 F ax.
Telephone call from pt several hours, post vax, complaining of "feeling hot" and states face flushed which started <30 seconds, post vax. At work and no access to a thermometer. Referred to PMD if symptoms persist. Telephone call to client by provider 2 hours later. Client states "flushed look" abated, denies pain, fever, vertigo or headache. Encouraged to see PMD and call clinic if symptoms recur.
Diagnosed yesterday with Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included prednisone.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Fever over 103; body aches; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EK4176) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: EH9899), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever over 103"; PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received second covid vaccine (Pfizer)  on 3/31/2021 and patient reportedly had difficulty speaking and observed angioedema. Patient reported chest pain once arriving to the ED, unsure if it may have been due to epinephrine or COVID reaction. 3 mg epinephrine was administered and the patient taken to the ED. IV line was placed and labs were drawn. EKG taken after patient endorsed chest pain. Paitent was observed in the ED then discharged.
Pt recv vax on 10/21/98; 6 hr post vax pt exp sore/ lump at vax site, migraine headache, runny nose, sore throat, fever (99-101)
1715: Patient noted "dizziness" about 15 minutes post-injection. Denied respiratory distress. No abnormal skin presentations noted, oral mucosa moist, pink, no swelling noted. Patient B/P 95/77, HR 76, O2 sat 99%  on room air, lung sounds clear throughout. Bilateral grips weak, appeared to be trembling.   1718: Patient recline with legs elevated, took deep breaths and coughed. c/o worsening dizziness. Denied nausea. Temp 98.7  1730: Pt noted her throat felt tight and it was "hard to swallow." Pt stated it was "getting harder to take a breath."   No respiratory distress noted, lung sounds clear throughout, O2 sat 99% on RA. Nurse notified on-call physician, prepared to activate emergency response. Mother declined emergency intervention, patient stated she could "breathe fine" and stated her throat was not as tight as previously reported.  1745: Pt attempted to stand, legs began to shake and patient appeared unable to bear weight or walk. Nurse and mother assisted patient to sit.  Patient exhibited  slurred, slow speech. Pt eyes closed and head fell forward. When pt roused, she c/o headache, fatigue, and moderate to severe LLQ pain that was tender to palpation. Pt guarding (L) ABD. Temp 99.5. B/P 125/80, HR 80,  O2 sat 98% on RA, lung sounds remained clear throughout.   Nurse initiated emergency response.   1800: When EMT's arrived, pt was able yto ambulate with assistance, appeared weak, unsteady but able to bearweight. Pt A+O x 4. Mother accompanied patient to ambulance.  NOTE: Patient mother noted unusual tiredness and lethargy "over the last 2 days. It has been hard to wake her (patient) up."  Patient c/o intermittent stomach pain, LLQ, over past two days. Current nausea and headache.
SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.
The morning after the vaccine, my son woke up with several patches of hives (knees, forehead, cheek). These patches continued to come and go all day over various parts of his body, to include knees, feet, ankles, cheeks, forehead. He said they were itchy, and he was very uncomfortable, with an extremely poor appetite all day. He continued to have a few smaller patches of hives into the next day (02/15/2014).
high fever or 101.4; body aches; headaches; arm swollen and red at injection site; arm swollen and red at injection site; hard; inflammed; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Information has been received from a office manager concerning a 4 year old male patient with no pertinent medical history and no known drug allergies/drug reactions who on 12-DEC-2005 was vaccinated with a dose of MMR II (Lot # 649755/0380R). Secondary suspect vaccine given on the same day included VARIVAX (Lot # 646669/0626R). It was reported that a dose of hepatitis B virus vaccine rHBsAg (Lot # 647036/0958P) was administered on 12-JAN-2006. It was reported that on an unspecified date the patient developed an "autism disorder". The patient sought unspecified medical attention. It was reported that the patient had not recovered at the time of the report. Upon internal review "autism disorder" was considered to be an other important medical event. Other vaccines given in the past included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, hepatitis A vaccine (unspecified), Hib conj vaccine (manufacturer unknown), polio vaccine (unspecified), pneumococcal 23v polysaccharide vaccine (manufacturer unknown) and flu vaccine (unspecified). Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)) and other one of 104 hours with a lowest recorded temperature of 33 F (0.555555556 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
shortness of breath; Chest pain; I also haven't started my period and have been breaking out more than normal; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Aug2021 09:45 (at the age of 36-years-old) (Batch/Lot number and expiration date: was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 14Aug2021 22:00 the patient experienced shortness of breath followed by chest pain 4 days after receiving the first dose. Patient also stated she haven't started her period and had been breaking out more than normal. The patient did not receive treatment for the events but visited emergency room for the same. Patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The patient underwent lab tests and procedures which included blood test: unspecified on an unspecified date in Aug2021, chest x-ray: unspecified on an unspecified date in Aug2021. The outcome of all the events was not recovered.   Follow-up activities closed: Batch/lot number not available for [Vaccine, BNT162B2]
Information has been received from a Medical Assistant concerning a 61 year old female patient.  The patient had an allergy to sulfa drugs. She did not have a pertinent medical history.  Concomitant medication use was not provided. On 11-JUL-2017 the patient was vaccinated with PNEUMOVAX 23, 1 DF, intramuscular, for prophylaxis (lot # N005597, expiration date 19-OCT-2018). "A few hours later" the patient developed shortness of breath. The patient returned to the physician's office on 12-JUL-2018 complaining of nausea and shortness of breath and was treated with an unspecified medication (NOS). The outcome of shortness of breath and nausea was unknown. Additional information has been requested.
10 minutes after administering her flu shot she reported not feeling well. She stated to she felt sick and I had her sit down. After 20 minutes she stated that her head was severely aching and that her tongue felt like it was swelling. She then stated that she was having difficulty breathing. Her face looked red and at that point I gave her an EPIPEN injection and called 911.
Tingling & numbness in face, confusion & h/a are reported in pt who recvd flu vax; the day p/vax pt devel tingling & numbness in face which lasted 24 hrs & confusion which lasted 3 hrs; there were no apparent sequelae;
Patient experienced extreme increase of heart rate. Doctor verbally advised patient to take his carvedilol which he did. He felt better after 3 doses and about 3 hours later. He was not seen by a doctor for this.
SCREAMING AFTER WAKING, CRANKY, LETHARGIC AND GROGGY X 2 WEEKS AFTER ADMINISTRATION.  LEGS SWOLLEN UP TO 4 DAYS AFTER ADMINISTRATION.  FEVER OF 99.5F FOR FIRST 24 HOURS.  NOW INFANT IS BACK TO HIMSELF.  MOTHER STATES INFANT WAS "ZOMBIEFIED" FOR 2 WEEKS.
Headache  INJECTION SITE PAIN DURING AND POST ADMINISTRATION,  LETHARGY, SLEEPINESS, FEELING HEAVY HEAD AND ARM, FEELING HOT, EYES BURNING  Narrative:
My daughter had a combination vaccine given yesterday, Dtap and IPV, not sure the brand. This evening I noticed she started limping and complaining about pain and also her entire thigh, from knee up is visibly swollen, tender and sore.
Rash all over body with itching, hives, urticaria, steroids and antihistamine given by MD.
headache; Fogginess; weakness; Extreme Vertigo; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose number unknown, single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: known allergies: No, other medical history: No. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 18May2022 at 14:00, outcome "recovering", described as "Extreme Vertigo"; VOMITING (non-serious) with onset 18May2022 at 14:00, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 19May2022, outcome "recovering", described as "Fogginess"; HEADACHE (non-serious) with onset 19May2022, outcome "recovering"; ASTHENIA (non-serious) with onset 19May2022, outcome "recovering", described as "weakness". The events "extreme vertigo", "vomiting", "headache", "fogginess" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, vomiting, headache, feeling abnormal, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Extreme Vertigo causing vomiting approximately 2:00am Thursday 19May until approximately 8:00pm that night. Midnight 19May Extreme Vertigo subsided leaving headache and mild vertigo. Fogginess and weakness. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Meclizine and Ondansetron. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (as reported).  No follow-up attempts are possible. No further information is expected.
Mom called and said that pt had a "welt" and rashy area at injection site. Approx. 1 cm "welt" not itchy. No fever. No resp. issues. Happy playful. Discussed with Dr. Advised mom to give 12.5 mg Benadryl.  If "welt" worsens or rash spreads call PCP to be seen. If respiratory issues or trouble swallowing go to ER. Called mom 9/30/14 pt had a good night. Rash is gone. Small raised area still on arm. Mom wondering now if it could even be a bug bite and not a reaction at all.
MENACTRA was given to patient inadvertently with an expiration date of 24APR16. MENACTRA was ordered. LPN thought exp. date was April 16, 2024. No adverse effe cts reported.
Flu like symptoms, shortness of breath, cough, aches, pains for about 24 hours
Fever to 103.7, eight days after MMR, varicella, Comvax, influenza vaccines
Fever coming and going for over 24 hours up to 102.6 (rectal temp).
pt recv vax 17JUL97 & 22JUL97 pt exp hives, bronchospasms, lip edema & was seen by MD;pt recovered;