chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored ZOSTAVAX 0.65 ml, subcutaneous. The reporter state that the patient received one of the following lots: lot # L000450, expiry date 09-MAR-2016 or lot # L012476, expiry date 10-JUL-2016. No adverse effects were reported. Additional information has been requested.
arm was sore for all 4; The lymph node under arm was a little irritated; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In May 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated). At the time of the report, PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated) outcome was unknown. No concomitant information were reported by the reporter.  Patient received the first and second dose in May of this year. Patient was thinking about getting the new bivalent vaccine. The second dose, how does that differ from the bivalent vaccine? Would it be to patient advantage to get the newest vaccine? was this vaccine approved?.  Patient received 4 doses of the Moderna Vaccine.  No treatment information were reported by the reporter.
On Feb 15th, I started getting very dizzy and couldn't hear out of my left ear. with extreme ringing and cricket sounds. The dizziness got so bad, my husband and daughter called 911 early Feb 16th to have an ambulance take me to the hospital. There, they took a cat scan of my head, and I was released that afternoon with Meniere, Tinnitus and Vertigo. I have a follow up ENT appointment with a Specialist on May 19th.
Initial non-serious report received from a healthcare professional on 19 October 2011 under the local reference number 11-0875. A 59-year-old female patient had received a dose of FLUZONE (batch number UT480AA) on 12 October 2011. The patient had no illness at time of vaccination. Route and anatomical site of vaccine administration were not reported. On 13 October 2011, the patient experienced nausea, headache, sore throat, general malaise and feeling dizzy. At the time of the report, the patient had not recovered.
On 2/21/2023, patient presented to the emergency department for evaluation of shortness of breath, malaise, and a positive COVID-19 test at her residential facility on 2/20/2023. In the emergency department, patient was given a COVID-19 antigen test which also resulted positive; Her chest x-ray showed bilateral interstitial opacities, new since 12/4/2022. Patient was afebrile but she was tachycardic and hypoxic; She was diagnosed with COVID-19 and new onset atrial fibrillation. Patient was started on diltiazem drip, IV fluid, given O2 and IV Decadron. However, when goals of care were discussed with the patient, she stated that she did not want aggressive treatment but instead wanted to be transitioned to hospice care. Patient was admitted to the hospital for further care and transition to hospice.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital:  Local Hospital,
started w/fever 101.6 ax (from Friday 730PM through Sunday 9AM); irritability, high pitched, unconsolable crying
she spiked a fever; lost grip in her hand; arm had swelling; arm was warm; tender to touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On 12-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. In SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced swelling arm (Verbatim: arm had swelling), extremities hot feeling of (Verbatim: arm was warm), pain in arm (Verbatim: tender to touch), fever (Verbatim: she spiked a fever) and grip strength decreased (Verbatim: lost grip in her hand).  The patient was treated with paracetamol (Tylenol). In SEP-2023, the outcome of the fever and grip strength decreased were resolved. The outcome of the swelling arm, extremities hot feeling of and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, pain in arm, fever and grip strength decreased to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm, extremities hot feeling of, pain in arm, fever and grip strength decreased to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-SEP-2023 The pharmacist reported an patient received Fluarix and after her arm had swelling, was warm and tender to touch. She spoke a fever which resolved with Tylenol.  She also temporarily lost grip in her hand but that has returned.  The patient thought it may have not been given in the right location but health care professional (HCP) stated there was no evidence of that. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
on 12/05/2006, the patient vomited 3 or 4 times and also had 3 episodes of diarrhea. 1 hour later, while in the office, he became lethargic, gray and needed stimulation and blow-by oxygen. He was transported by EMS to the emergency department.  03/27/2007 MR received for a 2 night hospital stay for c/o vomiting and diarrhea x4 as well as a parental report of turning blue.  Infant has has runny nose, congestion, and coughing x 2 weeks. PE: low grade fever, cough, runny nose, TMs dull and erythematous bilaterally, coarse breath sounds with good air movement, small rectal fissure. Txd with IVF and antibiotics.  Vomiting resolved, still had diarrhea upon D/C. Primary DX:  AGE. Secondary DX: leukocytosis.
I developed a pain in my right calf and tingliness after 7 1/2 hours after the shot.  Woke up next morning very sick as to be expected after already having covid.  achey, very tired, headache, runny nose, chills and fever of 101.3,  skin is sensative to the touch, nausea diharea, throat is tight, tightness in chest and shortness of breath. at 6:30pm fever goes to 102.3 and my fingers from the 2nd knuckle up turned white, cold and numb which has NEVER happened before. Next morning my fingers and hands are tingling. loose stools for 3 days and exhausted after 6 days.,
PATIENT REPORT MODERATE RASH AND SWOLLOWEN BUMP  ON NECK. I ADVICED PATIENT TO TAKE IBUPROFEN AND BENADRYL. I RECHECKED AFTER 2 HOURS AND PATIENT HAD IMPROVED IN SYMPTOMS
Immediate heart racing (about 10 minutes). Immediate Numbing/tingling lips (about 10 minutes) 5 minutes after severe itching in hand (1 1/2 hours). 2 days after injection Gland swelling (lasted about 2 weeks)
Mother states patient got a severe headache at 2pm following his flu shot at 9 am. Patient states he hears "boulders rolling down the hill crashing into each other" at night and in the mornings.
tachycardia, headache and chills beginning approx 12 hours post vaccine, rate as high as 130s by day 3, given beta blocker at outside hospital on day 3 (records not available)
This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 05-MAR-2004 the patient was vaccinated with a dose of VARIVAX for prophylaxis (route, lot # and expiration date were not reported). On 15-MAR-2007, the patient was vaccinated with another dose of VARIVAX for prophylaxis (route, lot # and expiration date were not reported). On 01-FEB-2017, the patient was diagnosed with herpes zoster. It was stated that the patient was prescribed with ALEVE as treatment for the adverse event. At the time of reporting, the outcome of herpes zoster was unknown. A product quality complaint was not involved. The causality assessment between the event and VARIVAX was not provided. Additional information has been requested.
5 Months Pregnant; Initial Report Received on 22-Jun-2023  A representative reported to the HEPLISAV-B pregnancy registry that a pregnant female patient resident (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while about 5 months pregnant.  No relevant medical history or concomitant medications were reported.   The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On an unspecified date in Jun-2023, the patient who was about 5 months pregnant, received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). No contact information or additional information was provided.  No further follow-up will be conducted by the Pregnancy Registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a pharmacist concerning a 42 year old male, who on 29-DEC-2006 completed the 3-dose series of RECOMBIVAX HB and his serology test done on 21-FEB-2007 was "inconsistent with immunity". Unspecified attention was sought. No other information was provided. Additional information has been requested.
persistent headache, extreme fatigue, nausea and loss of appetite for two weeks s/p vaccine
Patient given 0.5 mL from single dose vial. Informed later that the vial is labeled for single dose but must instead be taken for only 0.25 mL as advised for patient age group. Patient remained at baseline and did not require further treatment.
Four weeks after the 2nd dose I started to feel pain on my arm when I move it up. I went to my doctor thinking it was my rotators cuff and my doctor said it might be due to the vaccine.
SOB and difficulty breathing 10 minutes after injection given.  Epi was given and was transported to ER was given IV Benadryl and diagnosed with bronchial Spasm
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Thursday, 2/13/14 on lower left arm rash began, Started to travel up patient's arm. By Saturday morning patient had lower area about 7 inches long that was raised, inflamed, slightly swelled. Above that an injection site another area about 3 x 3 inches with nodule. Warm to touch no itching.
swollen lymph nodes; This is a spontaneous report from a contactable consumer from a lay media report reporting events for 3 patients. This is patient 3 of 3. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included bone cancer. The patient's concomitant medications were not reported. On an unspecified date the patient experienced swollen lymph nodes. The outcome of event was unknown. The patient underwent lab tests and procedures which included chest CT scan performed : swollen lymph nodes in one armpit on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021845045 Same article / same event / different patient;US-PFIZER INC-2021845051 Same article / same event / different patient
can hardly walk, he has to drag his feet; His arm has been sore since he got the vaccine; This is a spontaneous report. A contactable consumer (the patient) reported for himself. A male patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via unspecified route of administration, in the arm, on an unspecified date, as dose number unknown, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that, he was having some side effects from the Pfizer Covid vaccine. Patient said, he can hardly walk, he has to drag his feet and his arm has been sore since he got the vaccine. Outcome of the events was unknown.   Information on lot/batch number has been requested.
Severe soreness in shoulder around area of vaccine administration.  Has continued for almost 3 weeks now.
Headache, dizziness 20 mins. after having the vaccine. Advil 400 mg p.o. once.
pain @ inj site w/fever;pt was seen @ urgent care following evening p/vax;
This spontaneous case, was initially received from a pharmacist on 24-Jan-2018, concerning a 29-year-old adult female pregnant patient. The patient's maternal and paternal (hereditary disease only) medical history, including previous pregnancies, birth defect or congenital anomaly occurred during pregnancy was not reported. The patient did not have spontaneous abortion or still birth in the past. It was unknown whether the patient was taking any medications prior, during pregnancy and received by the father prior to conception. The patient's last menstrual period (LMP), estimated date of delivery (EDD) was unknown. On 24-Jan-2018, the pregnant woman was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195242, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded as vaccine exposure during pregnancy). The reporter assessed the event vaccine exposure during pregnancy as non-serious. Non-significant follow-up received from the reporter on 09-Mar-2018: The reporter informed that the patient neither had any adverse event nor any details of LMP, EDD, medical history. Narrative was amended accordingly.
Headache; This spontaneous case was reported by an other health care professional 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications were not provided by reporter.
My psoriasis inflamed; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (My psoriasis inflamed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis.    In August 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (My psoriasis inflamed). At the time of the report, PSORIASIS (My psoriasis inflamed) had not resolved.            Concomitant medications were not reported.  The patient received the booster and it was patient's 4th shot. Patient's psoriasis inflamed and won't go away. The patient received the shot back in August and the doctors and patient's dermatologist had been giving patient creams and pills to try to get the inflammation down. The patient wanted to know what patient can do to counter act it. It was itching and was driving patient crazy.
Aura migraine without headache, decreased visual acuity, numbness in upper and lower left extremity and left-side of face on 11/20/2021. All symptoms recurred on 12/11/2021. I went to emergency room assuming stroke, which was not detected. Symptoms persisted. I have been undergoing various treatments for migraine since (supplements and now Effexor). Still experiencing periodic migraines.
10x8 cm red, slightly raised rash left arm .  Warm and firm to touch.  Mild itching and tenderness.  Not resolved as of today.
severe muscle aches all over, severe chills with no fever, headache, nausea, fatigue, Severe symptoms lasted until about 4 am 12/14/2021. All symptoms are still active just not severe
Muscle fatigue was noticed around 5pm, took a 500mg Tylenol and laid down.  Went to sleep.  Muscle fatigue continued throughout the night and into next day (FR 3/19/21), continued to take 500mg Tylenol every 6 hours, slept through Noon on Friday, felt better laying down throughout rest of Friday/Friday night.  Symptoms gone about 2:30am SA 3/20/21
pt recvd vax & exp considerable lt arm soreness; pt reports that was unable to raise arm more than a few inches or to reach around rt side of back w/o pain; also unable to sleep more than 3-4 hrs @ noc due to aching & hurting;
Felt fine no symptoms besides arm pain. About 28 hours later I was very nauseous and threw up. Feel better after throwing up.
Fever of 101, severe body aches. At 330 am post injection, incredibly stiff neck/spine. Could not turn head.  Went to er, evaluated ROM of neck, gave IV fluids and torodol, kept under observation for 1.5hrs. discharged bc ROM and pain improved. At home took 1000mg Tylenol every six hours for 12hrs following. Feverish at 1700 16Apr.
patient stated that she had fainted a while ago after gettin a shot. Today, after about 10 minutes patient began slumping in the chair. I gave her an ice pack to place on her stomach and some water, she did not want to lie down. Repeatedly checked on her, she left after 25-25minutes. Unknown amount of time passed, security came to get me because patient has collapsed in rest room, complaint of stomach cramping, a little leg cramping and then her legs felt like jelly and would not support her. We set her up in the baby nursing room with her feet up.
throat and tongue intching and slight swelling of tongue.  Moderately labored breathing within 10 minutes
patient received two Fluad vaccines on 9/7/2021 and on 10/8/2021
Left thigh with 14.5 by 15.5 centimeter erythematous, edematous area, non tender, positive warm to touch, fever.
In June of 2021, 3 months after my first shot in the left arm, I found a large diffuse b-cell lymphoma mass in my left breast. After pet scans, ultrasound it was found to be localized in my left breast, no lymph node involvement. The mass grew from the size of a pea to the size of an orange in 4 weeks.
Severe joint pain, very lethargic after a week from first vaccination; Severe joint pain, very lethargic after a week from first vaccination; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 (Batch/Lot number was unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia treated with savella. The patient's concomitant medications were not reported.  The patient experienced severe joint pain, very lethargic after a week from first vaccination with outcome of unknown. If other vaccine in four weeks: No. if treatment AE: Unknown. if Covid prior vaccination: No. if Covid tested post vaccination: No. Known allergies No.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer refers to her 17 year old son. On 09-MAY-1997 and 02-OCT-2013, the patient was vaccinated with the first and the second dose of VARIVAX (Merck), injection in the arm, (dose and strength were not reported). The concomitant therapy included MENACTRA was administered at the same time of dose 2. The consumer reported that within two hours of received both vaccines (on 02-OCT-2013), her son reported the sudden onset of severe testicular pain, occurred on both sides, but absent of swelling. The pain was described, "as if someone was squeezing them." His condition was treated with MOTRIN tablets and bedrest. Upon awaken the next morning (on 03-OCT-2013), the pain had subsided. The outcome of the event was recovered.  The patient sought medical attention through the way of make a phone call. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, route, anatomical location, lot # and expiration date were not reported). On 13-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, strength, route, anatomical location, lot # and expiration date were not reported). There were no known adverse effects.
Patient developed an erythematous patch in right thigh hours after shot was given. It got indented and bigger, with some induration, measures: 3x 1 cm induration.  - on the 8th day after shot was given, mom noted red spots in trunk. She was given antibiotic and BENADRYL.
1 of 3 nonresponders reported who recvd Engerix-B; Reporter stated 1 recvd in buttock; clarification is being sought;
1045AM found flat on back w/arms & legs extended;pale, cold (ax temp @ 11:30 95) flaccid, no movement, face was ashen, resp shallow;pt picked up & rubbed arms & legs, shouted @ pt p/eyes open cool cloth placed on face;gasped for air;
Blood clotting in lungs as shown by CT scan and D-dimer tests. Now on blood thinners. Chest pains, shortness of breath.
Pt.  had vaccine on Tues evening, by Wed evening had red, hard, hot circle like Pakman on left arm. No temp. Size 4-5cm.
09/08/22 presents to ED for "altered mental status". PMHx of "paroxysmal A. fib, coronary artery disease, hypertension, hyperlipidemia, pulmonary hypertension"
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old male patient. On 30-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Developed fever of above 101 (hard to control with Tylenol), which lasted about 24 hours. Massive headache, which made me sensitive to light. Headache lasted about 10 days but gradually diminished over time. Full body aches lasted about 24 hours. At the site of the injection, I developed a red, hot swelling, which progressively grew over the course of 3 days. Eventually it stretched from about the top of my shoulder, all the way down to my elbow, and wrapped about halfway around my arm.