chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
This spontaneous report was received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with MMR II, injection (dose regimen unspecified). No concomitant medication was reported. On an unknown date medication error was reported that MMR II was exposed to 10 C (celsius) for 10 hours, and was administered to unspecified number of patients on unspecified dates. Reporter stated that she does not, nor will she ever have any patient specific information. She stated that she does not want to be contacted at all by our safety department. There was no product quality complaint involved. The outcome of the medication error is unknown. Additional information has been requested.
Gout flare within hours of receiving the vaccine. No gout flare in 6-8 years. No other changes in diet or lifestyle in recent weeks.
Localized swelling of thigh, increasing over 2 days. Improved within 5 days after immunization.
patient is on the lung transplant list; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG TRANSPLANT (medically significant), outcome "unknown", described as "patient is on the lung transplant list".  Clinical Course: The patient said that he had his first Pfizer shot in 2021 and he never got the second one. He said he had to get it immediately because he is on the lung transplant list. He said that he had to have this stuff done. The patient provided the information for vaccine appointment. The patient started ranting because we cannot provide the phone number and then he hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 15-20 min after vaccine - "felt funny, weird. Reported having a hard time swallowing (especially on right side of throat) ok with drinking juice. VSS 1009>120/80 75 20, 1022>122/82 62 16, 1045> 124/76 72 16, lungs clear at all checks; lips pink at all checks.
Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseous and faint. She passed out and was noted by her mother who is a RN to have a seizure. She remained out for several minutes  and then aroused. She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and has been on medications for this. Employee stated she has not has any seizure activity in over a year. She did not see medical attention due to recovering quickly from this.
Developed severe neck pain and cannot move her neck; went to chiropractor today who did adjust lumbar and thoracic spine did not adjust her neck.  Taken Aleve a couple times on 4/15/21 with no relief; also drinking electrolytes.
After pt and family left appt on 10/22/14, I was notified that the patient was administered the half-dose flu vaccine in error.  The MA who drew up the vaccines thought that the half-dose flu vaccine was part of normal 4-month vaccines.  A different MA administered the vaccines to the baby.   Called the mother to notify her of the error.  Stated that Azariah may develop fussiness or a low-grade temperature, which could be due to the flu vaccine or due to the other vaccines he received today.  Explained that we do not normally give the vaccine at 4 months predominantly because we dont expect the child to develop an immune response yet.  Notified her that there is an MD on call 24-hours for WFH, and should she have any concerns tonight, she can call the on-call physician to discuss them. .
?Pfizer-BioNTech COVID-19 Vaccine EUA?:  Drop in heart rate as low as 40 bpm, blurry vision, headache, throwing up - couldn't keep anything down for days, diarrhea,  lightheadedness.  Fatigue has continued to this date, June 23, 2021
Constant Diarrhea for almost 1 month since administering the rotavirus vaccine.
I BEGAN TO FEEL MILD EPIGASTRIC PAIN AT AROUND 3:30 PM WHILE DRIVING  FROM MY HOME ON DECEMBER 21, 2021. THE PAIN WENT AWAY SOON AFTER I TOOK AN ANTACID. THE PAIN RETURNED IN THE EVENING AROUND 9:00 PM AND WAS A LITTLE WORSE THAT TIME. I TOOK ANOTHER ANTACID, WHICH AGAIN SEEMED TO HELP THE PAIN. LATER THAT EVENING, I WENT TO SLEEP WITHOUT ANY DIFFICULTY. HOWEVER, AT AROUND 3:30 AM ON DECEMBER 22, 2021, I AGAIN EXPERIENCED EPIGASTRIC PAIN ALONG WITH PAIN THAT RADIATED AROUND MY UPPER BODY TO MY SHOULDER BLADES. THE PAIN WAS SEVERE, AND I WAS ALSO WEAK AND SWEATING. AT 5:00 AM ON DECEMBER 22, 2021, I WENT TO THE EMERGENCY ROOM AT THE MEDICAL CENTER, WHERE TESTS WERE PERFORMED. WHILE I WAS WAITING FOR THE TESTS, I BEGAN TO EXPERIENCE SEVERE STOMACH PAIN AS WELL AS NAUSEA WHICH CAUSED ME TO VOMIT. I WAS ADMITTED TO THE HOSPITAL AT AROUND 10:00 PM ON DECEMBER 22, 2021, AND I REMAINED IN THE HOSPITAL UNTIL MY DISCHARGE ON DECEMBER 24, 2021 AT AROUND 1:30 PM. I WAS DIAGNOSED WITH ACUTE PANCREATITIS AND A SMALL BLOOD CLOT IN A BRANCH OF THE PORTAL VEIN OF MY LIVER. WHILE IN THE HOSPITAL, I WAS GIVEN BLOOD THINNERS, ANTI-NAUSEA MEDICATION, AND PAIN MEDICINE. I WAS ALSO GIVEN IV FLUIDS AND DID NOT EAT UNTIL MY SYMPTOMS IMPROVED.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. Concomitant products included ACIPHEX, CELEBREX, fish oil, Multivitamin and Muscle Relaxant. On 22nd February 2018, the patient received SHINGRIX. On 22nd February 2018, less than a minute after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. The reporter considered the injection site pain and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's left arm was sore within a minute after vaccination. The soreness lasted 4 days, and was just beginning to improve. Injection site redness began at the site and spread down her arm about 4 inches. The redness started several hours after the vaccination. The patient denied to contact the physician.
Had the same thing-losing weight; Could not taste or smell anything; Could not taste or smell anything; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had the same thing-losing weight"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Could not taste or smell anything"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional Information: I was losing weight, I could not taste or smell anything, I had a raging fever and it was spiking back and forth and I said I do not get a fever very frequently actually."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
- 3:00 pm  Headache - 5:00 pm  Stomach pain + diarrhea - 8:00 pm  Chills + fever, muscle and joint pain - 10:00 pm  Uncontrollable chills                   and fever of 103.4, only treatment Advil                                               swelling + pain in joints                                               continues.
Approximately 12 hours post vax, the pt developed a severe headache, became short of breath and felt like she was having a heart attack. Additionally, the pt experienced itchy arms although she had no rash.  Follow up information from a physician reported that the pt did not seek medical treatment and that approximately 1 1/2 hours later the symptoms resolved with the severe symptoms lasting about 45 minutes.
Pt recvd 3 doses of Engerix-B & 25SEP90, 25OCT90 & APR91 & it was determined that pt was a non responder;
Congested, nasal drip, coughing (dry), pleuritic chest pain.
This solicited report as received from the patient's mother refers to a female patient of unknown age enrolled in a Market Research. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #,  dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient began having problems (unspecified). The outcome of problems was unknown. The relatedness between the problems and GARDASIL was unknown. Additional information is not expected as the reporter is not willing to be contacted to discuss further.
pt recv vax; reported to er w/in 48 hr p/ vax;fever 105; fever dec to 101 following day;
had shingrix vax 7/20/20  woke up that night w nausea, vomit, body aches, muscle aches, ha. came in next day w severe sx. L arm sore at inj site wo redness. no nasal congestion or cough. does have lupus and is on plaquenil. This was her first of shingrix series. she denies any ill contacts. she did have a mild cold earlier this month.  we gave her toradol and promethazine in clinic and tramadol.  symptoms lasted for about 5 days and pt was so ill was unable to leave her house
Initial information received from another manufacturer (service request number 1-53634398510 on 03 August 2012. The information was originally provided from a healthcare professional (Nurse). Cluster of three patients (individual patient details were not provided), whose medical history and concomitant medications were not reported, had received MENACTRA Sanofi Pasteur ltd. (lot number, route of administration, and anatomical site of administration were not reported) on unspecified date. On unspecified date, the patient experienced almost fainted and become "flushed" after vaccination. The reporter stated that the patients had no loss of consciousness. The events of fainting and flushing had recovered on unspecified date. Corrective treatment was not reported. List of documents held by the sender: None.
Pt was given Proquad in error.  He was also given Varicella.  He was supposed to get MMR II and Varicella.  Proquad was given instead of MMR II
11/17 approximately 3 days after vaccines pt dev. rash on hands and feet, mom called re: rash on 11/18. Seen in office 11/20 with diffuse rash C/W Urticarial Multiforme no other S/S Tx with ZYRTEC resolved after 2-3 weeks.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Since 09-OCT-2014 the patients were vaccinated with doses of VARIVAX (Merck) (lot#, expiration date, route and dose were unknown) which were exposed to a supported temperature out of range. No adverse events have been observed or reported. Additional information has been requested.
Cold sweat, says tongue felt thick; Patient was given Benadryl 50 mg and monitored; Patient was observed for over an hour and was allowed to leave, feeling fine
2 erythematous patches on her chest 10 min post vaccine; Denies any itchiness, admits pain; Applied ice to rash, mild improvement; It's possible these are bug bites and were there before the injection; Denied any shortness of breath, face swelling, palpitations or dizziness
Pregnancy = 16 weeks EDD: 7/15/21 Swollen axillary node on 2/2/21- still present on 2/4. Developed 2x2 area of erythema at injection site on 2/4/21
This spontaneous report was received from a consumer regarding his wife of 53 years old. The patient's medical history, concurrent conditions were not reported. The patient's concomitant medications included unspecified menopause medications. On an unknown date in June 2018, the patient was vaccinated with ZOSTAVAX, 1 injection (strength, frequency, route, lot# and expiry were not reported) for prevention of shingles. On an unknown date in June 2018, the patient developed a bump that is several inches long underneath the injection site (vaccination site mass). Patient sought medical attention from doctor. No laboratory diagnostics or studies were performed. Outcome of the event vaccination site mass was reported as not recovered. Causality assessment was not reported. No product quality complaint was involved.
Breakthrough case admission after 4 vaccines Moderna 2/25/21 Lot# 031L20A;  Moderna 3/25/21 Lot# 045A21A;  Moderna 11/6/21 Lot# 939906;  Moderna 4/19/22 Lot# 033K21-2A
Got the shot and was talking to the pharmacist for a minute or two.  Began coughing and having trouble breathing.  Could not speak coughing so much.  Used my rescue inhaler (Proair HFA) multiple times, all the while thinking, "She is a pharmacist, she has an epi pen! " Gradually my coughing stopped and breathing returned to normal.  I did not get a shot of an epi pen.  Somehow I stayed calm during all this, but afterwards was glad they were out of the Pfizer vaccine and only had the J & J so I would not be required to have another shot. I am too afraid to get a booster!  (I take allergy shots every week.)
Constant scream occurred 1 hr p/vax given lasted for 2-3 hrs;
Client received Moderna (1st dose) on 1/29/21 and received Pfizer (2nd dose) on 8/7/21.  Monitored for 15 minutes and no adverse reaction noted.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 77-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 31 May 2011 the subject received a dose of BOOSTRIX (details unknown). On an unspecified date in 2011, less than one year after vaccination with BOOSTRIX, the subject experienced injection site redness (within 2 to 3 centimeters of the injection site), injection site pain and injection site pruritus. The subject was treated with Antibiotic cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported 3 subjects who experienced adverse events following BOOSTRIX vaccination. This is case 3 of 3; see cases A0933920A and A0933923A for details of the other reports.
sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark; diagnosed with mastitis; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), dose 1, via an unspecified route of administration, administered in right arm on 01Mar2021 12:00 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with Covid-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and did not receive any other medications within 2 weeks of vaccination. The Wednesday after the vaccine, on 03Mar2021 05:30 (also reported as about 36 hours later), patient woke up with a sore right breast. As the day progressed, patient had the chills, body aches, and a fever of 102.6. Patient also noticed more soreness in right breast and a red mark. Patient spoke to OB and was diagnosed with mastitis. The patient was tested for covid post vaccination reported as results of tests and procedures for investigation of the patient on 12Mar2021 as nasal swab: negative. Therapeutic measures were taken as a result of the events reported which included antibiotic. The events were reported as recovered in Mar2021.   Information on the lot/batch number has been requested.
This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax & exp intense pain of the back, neck, & rt arm;the day following vax pt was unable to move rt shoulder;upon the advice of MD took DPH & advil;
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medications provided. No treatment information provided.
No adverse event reported; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse event reported) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event reported). At the time of the report, NO ADVERSE EVENT (No adverse event reported) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list  was not provided. No treatment information was provided. Reporter contact details were updated.
Information has been received from a licensed practical nurse concerning a patient (gender and age not reported) who was vaccinated in error with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka/Merck). No adverse events were reported. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. All attempts to obtain follow up information have been unsuccesful. No further information available.
Three days after vaccine, patient's mother brings her back to clinic reporting for the past 2 nights, fevers to 104 degrees F taken at home. Temp at clinic 99 degrees F(otic). (Possibly temperature could have been 2 hours to viral illness as mother developed fatigue and apthous stomatitis).
dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIZZINESS (dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RITUXIMAB, PREDNISONE, LISINOPRIL, CITALOPRAM and LORAZEPAM (ATIVAN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided
Information has been received from a Doctors of Pharmacy concerning a newborn infant female patient who on 19-AUG-2009 at overnight - early morning was vaccinate with a pediatric dose of HEP B vaccine (manufacturer unknown). Doctor of Pharmacy reported it was not product confusion it was related to the orders. The child did not show any adverse effects. The patient sought medical attention on site. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Patient felt lightheaded and then passed out face first on ground- some bruising and bleeding on nose/forehead/cheek. Patient was seem by EMS (911 called) and refused to go to the hospital. EMS cleared him and he stayed an additional 30 min then left-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium
Nausea, tingling arms/hands/face, pallor, brain fog, confusion, lethargy, axillary and right cervical lymphadenopathy developed 40 hours after injection
Patient stated that she started to feel light headed.  Felt faint and that things were spinning .
This spontaneous report was received from medical assistant, concerning to a patient of unknown age and gender, the patient's pertinent medical history, dug reactions/allergies were not provided. On unknown date, sometime in the past, the patient was vaccinated inadvertently with a dose of PROQUAD (Merck) (total dose, route and lot number were not provided), instead of a dose of VARIVAX (Merck) (total dose, route and lot number were not provided). This is one of several reports received from the same source. Additional information has been requested.