chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via other manufacturer and described the occurrence of anaphylaxis in a patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included chemotherapy. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician wanted to give Solu-Medrol (Pfizer) to the patient, however the patient had anaphylaxis to concentrated yeast. They had a reaction to chemotherapy and the Hepatitis B vaccine (names unknown).
This prospective pregnancy case was reported by a consumer (subject's father) and described the occurrence of fever in a 17-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified), seasonal influenza vaccine (non-gsk), MMR vaccine (non-gsk), meningitis vaccine and strain not specified (Meningococcal vaccine) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception. The conception was by normal method. On 10 October 2012 the subject received 2nd dose of Hepatitis B vaccine (unknown details) during approximately the 2nd trimester of pregnancy. In June 2012 the subject received the first dose of Hepatitis B vaccine (unknown details), a dose of Meningococcal vaccine (unknown details) and experienced vaccine exposure during approximately the first trimester of pregnancy. The gestational age at the times of vaccination exposures were not reported. The date of the last menstrual period was reported as May 2012. The estimated date of delivery was reported as February or March of 2013. The reporter stated that he "did not know the brand of the vaccines the patient received." The reporter stated that "he received [GSK's] number from a leaflet that he received at the clinic. [GSK's] number was listed along with other numbers and he did not know where to call to ask questions about receiving vaccines while being pregnant." In 2012, less than one year after vaccination with Hepatitis B vaccine, MMR vaccine (Non-GSK), Meningococcal vaccine and Seasonal influenza vaccine (Non-GSK), the subject experienced fever and muscle discomfort. In 2012, the events of fever and muscle soreness were resolved. At the time of reporting, the pregnancy was ongoing.
At 1:30 PM, patient received an IM of Boostrix to his Left Deltoid.  When he moved to the observation area and was seated in a student desk (within 1 - 2 minutes after IM) he slumped to his right side braced by a crossbar on the desk with his head/arms dangling.  He had jerking movements in the trunk of his body for about 10 seconds.  He was repositioned with his head and arms on the desktop and rested.  He began vomiting small amounts of clear liquid and was sweating.  He fully recovered within ~ 3 minutes.  Stated he hadn't eaten that day.
pt recvd vax;hyperpyrexia; n & v; rash, 2cm of induration;
This spontaneous report as received from a medical assistant and refers to 24 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot # of M031807 and an expiration date of 04-APR-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 5 Minutes: 9 grades centigrades. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved.This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014269: US-009507513-1701USA006026:
Chills; body aches; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 05:15 (Lot number: Ew6169) at the age of 15 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch No: Ew6169), administration date: 2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches"; MIGRAINE (non-serious) with onset 2021, outcome "recovered" (2021), described as "migraine". No follow-up attempts are possible. No further information is expected.
RIGHT HAND LOSS OF MOTOR CONTROL WRIST TO FINGERTIPS; RIGHT HAND LOSS OF SENSORY CONTROL WRIST TO  FINGERTIPS; COULD NOT SLEEP; SEVERE SHIVERING; SHAKING AS IF FEELING COLD COULD NOT GET WARM; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no other indication/ condition that may be related to the adverse symptom patient encountered. Patient is right hand dominant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced could not sleep. On 14-MAR-2021, the patient experienced severe shivering. On 14-MAR-2021, the patient experienced shaking as if feeling cold could not get warm. On 19-APR-2021, the patient experienced right hand loss of motor control wrist to fingertips. On 19-APR-2021, the patient experienced right hand loss of sensory control wrist to fingertips. On 01-SEP-2021, Laboratory data included: Cervical MRI (NR: not provided) Not provided. Laboratory data (dates unspecified) included: Grip strength (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand loss of motor control wrist to fingertips, and right hand loss of sensory control wrist to fingertips on 14-NOV-2021, and could not sleep, severe shivering, and shaking as if feeling cold could not get warm on 15-MAR-2021. This report was non-serious.
felt tired; This is a spontaneous report from a Pfizer-sponsored program COVID 19 Vaccine. A contactable consumer (patient's relative) reported that a male patient of an unspecified age received two doses of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated cousin's husband talked about his experience with the first and second doses, and how the second dose affected him a bit more. He did not have a temperature, but he felt tired and he said what he had taken. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Multiple bumps, resembling mosquito bites below torso on both extremities.  Large raised red area left thigh size of baseball with 1/8" elevation and warm to the touch radiating around calf and ankle.  Rash on right calf and ankle.  Temp 100 degree F 4:00 p.m. after nap first noticed.
Immediatly after giving 4th injection (GARDASIL) client passed out...becoming unresponsive, limp, pale and jerking slightly. Was lowered from sitting position to floor with help of his mother. Became responsive very quickly after being laid down. Cool compress applied to forehead. 1:26 B/P 120/72 and apical pulse 72. Patient states the last thing he remembers was getting the last shot and then waking up on floor. 1:33  104/64  apical pulse 72 and regular, color had returned. 1:40 discharged in care of mother who is a Nurse Practitioner.
Fever last night/ red, swollen at injection site mom gave Benadryl and ice pack no fever, no pain at this time-
I have never had Tinnitus.  My ears started ringing after my first Phizer Covid vaccine which was administered on 3/12/21.  The ringing in my ears worsened 24 hrs after receiving my second dose of the Phizer Covid vaccine on 7/26/21.
The father took infant to see Mom where she worked and RN observed there that the infant was limp, lethargic and pale. She referred them to the ER. Pt was observed for 2 1/2 hours and discharged home.
Fainted; Tachycardia; Felt neck pain; Felt like electricity in body; Right eyebrow and eye inflamed.
Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Fatigue, headache, muscle aches, nausea, temperature of 99 degrees Fahrenheit.
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.  818 patients received dose from vials beyond 30-day use by date and refrigeration date is 07May2021   This case was linked to MOD-2021-363032, MOD-2021-363781, MOD-2021-363753 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-oct-2021 contain no new information .
High fever, body aches, headaches, chills, uncontrollable shaking, stiff joints, tired
Information has been received from a health professional concerning a patient who was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 641027/1051L). There were no concomitant medications. Subsequently the patient complained of arm swelling from shoulder to elbow with heat and erythema. One patient was hospitalized, treated for cellulitis with antibiotics and was resolved. The reporter expressed a concern regarding the lot number. The reporter stated that a second patient developed a reaction to pneumococcal vaccine 23 polyvalent (WAES0212USA00121). Additional information has been requested. Additional info is not expected. The follow up received on 12/17/02 states initial info has been received from a health professional and follow up info has been received from the physciian concerning a 70 year old male with increased lipids, hypertension NOS, prostatic specific antigen increased, panhypopituitarism, arteriosclerotic cardiovascular disease, diaphragmatic hernia NOS, benign prostatic hyperplasia, joint tenderness, raynauds, carpal tunnel syndrome and hormone replacement therapy and a history of smoking, pituitary tumor remova (Feb 1997), epistaxis, myocardial infarction and anxiety who on 11/15/02 at 14:00 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included Synthroid, prednisone, Androgel, DDAVF, lisinoprill, aspirin, vitamins, Lipitor, flomax and Kanax. On 11/15/02 at 18:00 the pt experienced arm swelling from shoulder to elbow, post injection chills and heat and erythema. The pt was admitted to the hospital on 11/17/02 for allergic reaction vs cellulitis. The pt's physical exam on 11/17/02 revealed that the pt was alert, and oriented x3 and was mildly anxious. Theh pt's temp was 37.0, pulse was 72, respiratory rate was 30, oxygen saturation was 98%. The pt's blood pressure was 130/72mnHg. An HEENT exam revealed S1 and S2, regular rate and rhythm.The lungs were clear to susculttion. The pt's abdomen was soft, nontender, and bowel sounds were positive, and no organomegaly and no rebound tenderness existed. There was no edema in the lower extremities. Thept's pulses were palpable. The pt's upper extremities revealed left upper arm erythema, warm to touch with left elbow swelling. The physician's impression was allergic reaction to pneumococcal vaccine 23 polyvalent vaccine vx cellulitis. Cellulitis, panhypopituitarism, hyperlipidemia, and hypertension. The pt was treated with Unasyn, and the pt's prednisone was increased to 10mg twice daily. Thept had an infectious disease and orthopedic consult. On 11/20/02 the pt recovered from arm swelling from shoulder to elbow, heat and erythema, cellulitis and post injection chills. Additional info is not expected.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot/batch#, expiration dates, dose, dose numbers and route of administration were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
She stated that a couple of days after receiving the second dose in the series that her legs became tired/weak and they are still feeling tired/weak. She is worried that she is going to go paralyzed.
Within 2 weeks, this triggered a genital herpes outbreak; Since then a genital and/or oral herpes outbreak has occurred at least every 2 months; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes and oral herpes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, within 2 weeks of receiving Pfizer COVID-19 vaccination, that triggered a genital herpes outbreak, and since then a genital and/or oral herpes outbreak had occurred at least every 2 months. The patient thought this would be of material interest regarding adverse events. She had never had outbreaks since her initial one 20 years ago. The patient thought Pfizer should know about this correlation with their vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab and the result was negative. Therapeutic measures were taken as a result of reported events which was unspecified. The clinical outcome of the event genital herpes outbreak and oral herpes outbreak was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in for 2nd pfizer shot at same time that we were doing a janssen Vaccine.  I inadvertently gave this patient a janssen dose  instead of his second pfizer.  I called cdc and they said not much info, but don't give any other covid shots.  His series is complete.  I informed patient he may experience flu like symptoms and to call if anything unusual happens . Since it just happened, I'm unsure of any reactions yet.
Flumist given at 10:30 am (1 spray each nostril).  Patient mother returned with a bloody nose. 1/2 to 1 cup blood overall.  Bloody nose began "15-20 minutes after".
Pt recv vax on 2/17/99; on 2/18/99 pt exp painful/ cold left arm, blue/ numb left hand; dx=dysfunction of nerve
Woke the morning of 9/25/2023 with c/o bilateral leg pain, fatigue, inability to stand/ambulate, and incontinent of urine. Later in the day had urinary retention.  Hospitalized. Treated with  Solu-medrol, Gabapentin, Azithromycin.  The child did have a cold 2-3 weeks prior to the neurological symptoms.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a non-hcp. This case involves a 71 years old female patient who experienced left arm pain, burning, warmth, swelling and raised site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UL030AA and Exp. Date 05-May-2019) via unknown route in the left arm. On an unknown date, the patient developed a non-serious left arm pain, burning, warmth, swelling and raised site (vaccination site inflammation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, on 17OCT2018 after receiving FLUZONE HD 2 days prior patient complaint for event. Details of lab data not provided. Final diagnosis was left arm pain, burning, warmth, swelling and raised site. The patient was treated with steroid shot, KEFLEX (oral 500 mg BID for 10 days) and OTC topical Cortisone cream. The event outcome was unknown. List of documents held by sender: none.
fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided.   Reporter did not allow further contact
Janssen Primary, Pfizer booster 12mins post vaccination pt c/o anxiety. Vitals: 11:18 126/58, 84, 99% -- > 11:30 120/64, 84, 99% Pt stable and released from the vaccination site.
Pressure in ears that started approximately 3 hours and 40 minutes after vaccination. Pressure is reported in both ears but more prominent in the left ear. Patient came back to immunization clinic under direct observation for additional 30 minutes after symptoms started. Symptoms still present.
Within 6 hours of vaccination, intense pain in the right arm - could not lift it overhead without pain.  This continued - and got worse on Friday morning.  The Friday morning event is what I am reporting.  I got up to shower; put shampoo in my hair and then conditioner. My right arm was hurting so badly that I was having trouble rinsing my hair. Then I felt faint and nauseous. Got out of the shower and fell onto the bed in the bedroom. Woke my husband to tell him that I was feeling badly - faint and the whole room was spinning. Then I felt my airway closing. He went down to get my levalbuterol (rescue inhaler); took one puff and that opened my airways.  I was still weak and he had to help me get dressed.  (BTW- I'm a competitive athlete/ swimmer.)  I held onto him going downstairs.  I was not hungry though did eat a bit.  I spent the day on the couch with the chills and the room spinning until early afternoon.  By Saturday I was starting to feel better.  The pain in my arm mostly subsided by Sunday and I went to swim practice.  It wiped me out for the entire day and I spent the rest of Sunday on the couch. It's now Monday morning. I am feeling a bit off but better.  I am concerned about getting the second shot.
Acute urticaria to left  outer upper arm  3 inches away from injection site and left cheek. Treated with 50 mg of liquid benedryl  po. Near complete resolution in 1 hour
Intense sting followedby bursted bloodvessels, 2 in right palm and 2 in right scalp. Also purplish fingers.
Information has been received from a nurse practitioner referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On an unknown date in the past, the patient received unspecified doses of VARIVAX (dose, batch/lot number and expiration date were not provided)  subcutaneously for prophylaxis. On an unknown date, the patient had an unspecified blood work performed, which indicated no immunity to varicella. The reporter said that the patient did have received at least one dose (therapy non-responder). The patient had sought medical attention  by seeing the nurse practitioner. The outcome of the event was unknown. The causality assessment was not reported.
Red area (5 inches across); soreness; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 11th June 2019, the patient received Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the pain was unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that the patient received 1st dose and reported red area of 5 inches, soreness, then red area shrunk to 3 inches a couple of days later. The pharmacy intern asked how to proceed in the future with 2nd dose.