chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and medications were reported. On 16-Oct2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions Unfortunately 16 doses were given on 29Oct2021 in the pharmacy. It was possible that more people got doses from vials with this lot number in another pharmacy of the same chain. But HCP did not have information on that.
"Fever, dizzy, chest and stomach pain, hurts everywhere, bad headache." "Started approx 2 hrs after injection" per pt.
itched; Rash about 4 inches long by the time it stopped; red; hot; developed covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm). At the time of the report, PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Hives, swollen eyelid, administered Epi pen x 1 Benadryl 1 1/2 tsp PO.
Patient recieved flu shot and a few minutes after walking away from vaccination area after injection felt dizzy and faint and slowly sank to the groun while holding on to her mom
feels like she has covid again; arm is sore; body aches; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to sulfa drug). Concomitant products included HYDROXYCHLOROQUINE and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has covid again), PAIN IN EXTREMITY (arm is sore), PAIN (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore, painful and swelling aroubd injection site.  Painful  lump  in right armpit.
Patient states that 24 hours after her vaccine, she noticed redness and swelling at the injection site that worsened over the next 24 hours.
This case was reported by a consumer (patient's friend) via call center representative and described the occurrence of rash zosteriform in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown. It was unknown if the reporter considered the rash zosteriform to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX last week from reporting date and at the time of reporting, the patient had rash on his side that looked like zoster. The reporter wanted to know if that rash was from SHINGRIX vaccine.
7JUL94 pc from mom reporting sz w/fever 103 to 106 intermittently x 2 days; 1 wk p/vax 24JUN93 pt was taken to ER on 2JUL93 w/fever; t103 & sz x 1; pt also being treated @ that time for probable OM; started 1JUL94 w/rash on bottom; also te;
nausea, vomiting, fever t101.8 x 2 days; abdo pain, h/a, pallor, lethargy, gait unsteady & disoriented; treated @ home; full recovery;
Patient presented to emergency services, found to be hypoxic requiring supplemental oxygen. rhabdomylosis , diagnosed with acute hypoxic respiratory failure secondary to COVID-19 pneumonia and subsequently hospitalized. Patient remains hospitalized at time of VAERS submission.
Approximately 10 hours after receiving vaccine patient felt muscle cramps in legs, eye twitching, red ears, and developed blisters on hands and soles of feet. He took BENADRYL which seemed to help and reported to health center two days after.
Stroke; Unconscious; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) in an 88-year-old female patient 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable consumer on behalf of son, from a Pfizer-sponsored program. A male child patient (son) of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unknown date at a single dose for immunization. Medical history included that he suffered from ear infections to the serious point of possibly needing his ears tubed. The patient's concomitant medications were not reported. On an unknown date, less than two weeks after pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) the patient developed type 1 diabetes. The consumer reported that the patient was currently a 22-year-old and was using an insulin pump so he did not have to use needles every day. The clinical outcome of the event, type 1 diabetes, was not recovered. No follow-up attempts are possible. No further information is expected.
On 6/5/2017 Mom of client called to report that the child started a rash on 6/2/2017, time of onset unknown. She took her to the Emergency room on 6/4/2017 where they told the mother that it might be strep or a reaction to her vaccines. No testing was done and they told her to follow up with her doctor. When she talked to me on 6/5/2017 I also told her to follow up with her doctor. The mother called me back later on the afternoon of 6/5/2017 and reported that she saw a doctor and he told her that it was a rash related to the MMR vaccine. Mom reports that the child is covered head to toe in a rash but that no other signs or symptoms are present, denies any fevers. The doctor that she saw told her that it would go away and that no treatment was necessary. Mother of child also reports the child only having 1 set of vaccines in January 2017 at a free clinic, unable to obtain records.
SLE diagnosed 10/2010 months ago admitted with progressive weakness, numbness, and tingling in her lower extremities for last 2 weeks prior to admission. 1.  Acute infective demyelinating polyneuropathy, likely Guillain-Barre syndrome.  Patient gave a history of progressive weakness, numbness, and tingling following a bout of gastroenteritis.  She stated that her symptoms had gotten progressively worse for 2 weeks and was having difficulty with walking. Extensive workup including MRI, CT scan, as well as lumbar puncture.  A lumbar puncture did not show any evidence of infection.  MRI showed no evidence of infarction.  CT brain was negative.  MRI of the spine showed abnormal thickening and enhancement of the ventral and dorsal cauda equina nerve roots, likely compatible with Guillain-Barre syndrome.   Patient was started on 5 doses IVIG therapy with the last dose on 4/22/2011.   EMG and nerve conduction studies on 4/15, and the EP findings were consistent with acute severe infective demyelinating polyneuropathy consistent with possible Guillain-Barre syndrome.  Patient never had any plasmapheresis done.  Started on Solu-Medrol, which was later changed to prednisone.  Her FVC was maintained at greater than 2 L always, and it was checked every shift. Patient still continues to have some lower extremity weakness. To TIRR for therapies  2.  Acute renal failure, likely secondary to lupus nephritis.  During the hospital course, she was noted to have acute renal failure around 4/17/2011.  Her kidney function worsened, and she underwent a renal biopsy on 4/20/2011, which showed class 5 membranous acute glomerulonephritis consistent with lupus nephritis, as well as marked acute tubular injury.  Patient was started on dialysis, and she later had a Perm-A-Cath placed and continues to be on hemodialysis. 3.  Acute blood loss anemia, likely secondary to retroperitoneal hematoma from Bipsy site plus bleeding from femoral catheter site after removal plus anemia of chronic disease, given iron study showing elevated ferritin.  Following the kidney biopsy, patient was noted to have a significant drop in hemoglobin.  She was noted to have developed right renal hematoma, for which she was managed symptomatically. Also, she had iron studies, which showed elevated ferritin consistent with anemia of chronic disease, and renal is on board for the same. 4.  SLE.  Patient was diagnosed with SLE about 6 months ago, and her anti-ANA, anti-Smith/anti-RNP, as well as anti-double stranded DNA along with anti-SSA/anti-SSB antibody positive.  Rheumatology has been on board throughout the hospitalization, and her hydroxychloroquine was continued.  Solu-Medrol was later changed to prednisone as per rheumatology recommendations, and patient will continue prednisone 60 mg daily, and rheumatology will see her at TIRR and adjust dose accordingly.  Patient has not been restarted on CellCept, which was held given her worsening renal function.  Rheumatology will follow up at TIRR regarding the same. 7.  Hypertriglyceride:pt started on niacin 8.  Hypertension.  blood pressures were noted to be elevated and placed on Norvasc and appear to be better controlled now.
ED COURSE & MEDICAL DECISION MAKING Patient is a 20 y.o. male who presents emergency department for evaluation of fevers, chills, nausea, and shortness of breath.  Symptoms occurred approximately 3 to 4 hours after his Covid vaccination today.  He has not felt symptomatic for symptoms related to COVID-19 prior to his vaccination.  Nausea was noted without vomiting and he was given Zofran prior to arrival.  No objective evidence of anaphylaxis or angioedema was noted at urgent care nor was this noted on physical examination.  He does have a fever on arrival with Tylenol taken a little more then an hour prior to arrival.   Chest x-ray negative for findings of COVID-19.  There was no evidence of pneumonia.  His blood counts were otherwise reasonable though he did have relative lymphopenia that can be described in COVID-19 infection.  Metabolic profile was otherwise benign.  Differential diagnosis of his fever include the possibility of a vaccine reaction though the timing is rather quick for this reaction.  Certainly this remains in his differential.  His he has history of asthma and felt short of breath he was given Solu-Medrol.  He was given Toradol with improvement of symptoms as well as IV fluid.  With differential diagnostic considerations that he may have Covid, he was swabbed and tested at bedside.  With his well appearance he was ambulatory in the emergency department.  He was discharged stable condition with recommendations for Tylenol and ibuprofen in the short-term.     Procedures MDM     CHIEF COMPLAINT Fever and Chills     HPI The history is provided by the patient, medical records and the EMS personnel.      Patient is a 20 y.o. male who presents emergency department with fevers, nausea, and shortness of breath.  He has generally not felt well over the course of the last 8 hours after receiving his first Covid vaccination this morning at 9 AM.  Fevers have been noted.  He took Tylenol with 2 tablets an hour prior to arrival.  He has had shortness of breath with a history of asthma.  He denies productive cough, or chest pain.  He denies abdominal pain, or diarrhea.  He denies dysuria or frequency or hematuria.  Seasonal allergies are noted without significant medication allergies.  He denies a sensation of throat closing.  He denies tongue or lip swelling.  He was seen in urgent care and sent to the emergency department for further evaluation.
pt arm became sore also shoulder & neck 9OCT PM felt had temp did not take ?100; 11NOV92 seen by MD CXR done; inflamed lt side chest; eratic heart, inc BP;
Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine). The patient was treated with Surgery (Uterine fibroid removal surgery) for Uterine leiomyoma. At the time of the report, UTERINE LEIOMYOMA (Patient diagnosed with uterine fibroids after second dose of Moderna COVID-19 vaccine) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient took booster dose on 15 Dec 2021.   Reporter did not allow further contact
Headache started evening of 2/11. Waking up hourly on 2/12 starting at 1:30am. Headache, chills, body aches, fever, loss of appetite, and fatigue throughout 2/12.  2/13 - slow heart rate
Numbness and tingly down both arms starting June/July 2021 that transitioned to small joint aches in elbows, hands, fingers, and toes starting Sept/Oct 2021 that continue to this day (09/2023). Aches include joint stiffness, swelling, tingling, sharp aches from use, excessive heat and redness and loss of strength.   Vaccine was received while pregnant in 04/2021. Pregnancy was through with birth of healthy baby boy (8lbs 6oz). Please note that the inflammatory antibodies have persisted with little to no relief since 2021. Second child born (4lbs 3oz) and died 06/03/2023 due to Neonatal Hemochromatosis.
Fever of 104.2 rectal at 00:26, chills, weakness, vomiting and diarrhea.
her throat got hard to swallow and tight; bottom of her left eye swelled and left side of her face swelled; bottom of her left eye swelled and left side of her face swelled; redness was there and on her chest; lightheaded/dizzy; redness on her arm at her injection site; chills; low-grade fevers; body aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (her throat got hard to swallow and tight), SWELLING FACE (bottom of her left eye swelled and left side of her face swelled), EYE SWELLING (bottom of her left eye swelled and left side of her face swelled), CHILLS (chills) and PYREXIA (low-grade fevers) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (low-grade fevers) and MYALGIA (body aches). On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness on her arm at her injection site). On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (her throat got hard to swallow and tight), SWELLING FACE (bottom of her left eye swelled and left side of her face swelled), EYE SWELLING (bottom of her left eye swelled and left side of her face swelled), ERYTHEMA (redness was there and on her chest) and DIZZINESS (lightheaded/dizzy). On 01-Apr-2021, THROAT TIGHTNESS (her throat got hard to swallow and tight), SWELLING FACE (bottom of her left eye swelled and left side of her face swelled), EYE SWELLING (bottom of her left eye swelled and left side of her face swelled), CHILLS (chills), PYREXIA (low-grade fevers), MYALGIA (body aches), VACCINATION SITE ERYTHEMA (redness on her arm at her injection site), ERYTHEMA (redness was there and on her chest) and DIZZINESS (lightheaded/dizzy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   .
Patient received her 1st Moderna Vaccine 4/9/21 at an estimated 12:30pm. By that evening at 09:30pm developed itchiness, fever, chills and vomiting. Woke up the following day 4/10/21 with a rash from neck down to feet. The rash subsided on 4/11/21 evening and her other symptoms went about on 4/12/21 midday. She reached out to her provider and was advised to not receive the second dose of the Moderna series.
Attendee received Johnson & Johnson vaccine at 13:49 in the left arm.  Lot# 204A21A. Attendee was directed to observation area.   At 13:52 voiced complaints of dizziness and lightheadedness.  Attendee's skin was warm and dry. Skin pale  13:53  Assisted to a wheelchair   13:55 -  HR:  77   BP:  110/72   RR:   12   O2Sat%:  99        13:57 - Attendee stated he felt better, pale.  Took a mint that mom had in her purse and a sip of water. HR:  75   BP:  110/80   RR:   12   O2Sat%:  96  14:01 -No voiced complaints- skin warm and dry.   HR:  76   BP:  110/90   RR:   12   O2Sat%:  95    14:06 -No voiced complaints- skin warm and dry.  No longer pale. HR:  88   BP:  112/90   RR:   10-12   O2Sat%:  96   14:10 -No voiced complaints- skin warm and dry.   HR:  75   BP:  120/86   RR:   10-12   O2Sat%:  98    14:20 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his family.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
Medical assistant calling to request stability information on RECOMBIVAX HB vaccine after it was administered one day post expiration; This spontaneous report was received from a certified medical assistant and refers to patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 01-NOV-2021, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) expiration date 31-OCT-2021, for prophylaxis (dose, lot #, route and site of administration were not reported). It was confirmed that the vaccine had never undergone temperature excursion.
No additional adverse symptoms were reported.; a dose of GARDASIL 9 was administered to a 2-month-old patient; This spontaneous report was received from a medical assistant and refers to a 10-week-old (reported as 2-month-old) patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-DEC-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose and route of administration were not reported) (lot# reported as BR1621929, confirmed to be not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiry date reported as 06-DEC-2021) for prophylaxis. No additional adverse symptoms were reported.
Modern a 2nd dose. Extremely high fever. Headache, body aches, chills, nausea
Redness, swelling, itching: lasted about 3 1/2 days. Morning after the shot woke feeling chills, aches: lasted approximately one day.
Received 3rd dose HPV vaccine in office this am, then went to school and within 1 hour developed severe HA.  Then complained could not see out of one eye and subsequently vomited.  Has been having migraine like HA since school started.  Pt pale on exam here but otherwise normal.
Redness & swelling of Arm. Full itching, redness developed of Arm as well as upper shoulder and nape of neck. Treated with Benadryl and ICE compress. Monitored for 30 minutes prior to discharge. Checked on pt 4hrs later and all sx resolved.
I developed Bells Palsy. When I went to the emergency room I was given steroids, and my doctor prescribed an antiviral for me. When I spoke with my primary doctor over the phone when I was out of town, I was prescribed another week of antiviral. So I had two weeks of antiviral and one week of steroids.
It was reported that a 45 year old female received Imovax IM on 8/12/99. The pt experienced redness at the injection site and 15-20 minutes, post vax, she felt pain and tingling in her fingers, from her hand to her elbow and also pain in the left side of her face. 12 days, post vax, she felt pain and tingling down the left arm. The pt was seen by HCP.
Body aches, arm sore , nauseated,  migraine was worse,  had fever on Friday 10th @ 8am it was 101.2,  then @ 11:30am it was 101.8, then @ 4pm it was 102.3 then @ 9pm it was 102.1  I took Tylenol & Ibuprofen.    When I woke up today  Saturday I am feeling better and I don't have a fever.
extremely sore left upper arm, large bruise too, cramping in muscles , occasional tingling in fingers of left hand