chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102 degrees, body aches, chills, fatigue began the following day and lasted 14 hours. Treated with over the counter pain reliever and sleep. 2 days after vaccine had swollen neck and lymph node on side of injection.
3 - 5 minutes after GARDASIL injection given patient became lighthead & passed out - patient monitored for 45 minutes - recovered no problems rest and home w/parent.
This spontaneous report has been received from a pharmacist, concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 an expiration date 28-FEB-2018 (strength, dose number, route of administration and anatomical location were not provided) for prophylaxis, which was reconstituted with an sterile diluent (manufacturer unknown) lot #L006550 and expiration date 02-NOV-2017 or lot # L025374 and expiration date 27-MAR-2018. The reporter stated that while drawing ZOSTAVAX into plastic syringe, primary reporter reported that some of the vaccine was leaking out from the site where the needle was screwed into the plastic syringe. No adverse effect reported. There was no product quality complaint involved.
Patient is a 64 y.o. female patient of CNP with history of COPD on 4L NC chronically along with BiPAP at night time, paroxysmal AFib, chronic hypotension, hypothyroidism, and RLS presented with mental status changes in setting of likely unintentional overdose.   COVID-19 viral infection Tested positive on routine check for SNF placement delaying discharge for 10 days Completed course of steroids for ACOPDE Completed 10 days of isolation   Acute toxic metabolic encephalopathy, resolved In setting on unintentional overdose with hypercapnia and ACOPDE Regulate sleep/wake cycle  Continue management as below   Acute on chronic respiratory failure with hypoxia and hypercapnia COPD exacerbation Discharged on steroid taper following last admit; baseline O2 ~4L NC Significant expiratory wheezing on admission requiring BiPAP  Completed course of Azithromycin and steroids Bronchodilators (Symbicort and Spiriva), BiPAP HS and with naps Improved- on nasal cannula this morning   Overdose, unintentional Per hospice RN notes, pt appears to have taken ~24mg of Haldol between 3am and 7am Suspecting confusion due to hypercapnia lead patient taking more than indicated Evaluated by BH and cleared.    Anxiety  Likely multifactorial due to dyspnea and hospitalization  Started on Buspirone due to adverse events on Haldol (will be held at discharge) Morphine PRN   Epistaxis Noted to have right anterior epistaxis  ENT consulted. S/p FloSeal instilled in left nasal cavity due to prominent left caudal nasal vessel by Dr.. If re-rebleeds, apply 4-5 sparys of Afrin followed by nasal clamp for 20 mins.  Resolved  AKI, resolved Cr 1.2 on presentation Baseline creatinine wnl  Resolved with IV fluids   Atrial fibrillation Recent diagnosis for patient, rate controlled Continue home Toprol-XL, and Eliquis Diltiazem held this admission due to hypotension. Defer to PCP when safe to resume   Chronic HFrEF No evidence of volume overload on exam Takes Lasix PRN Continue Toprol-XL   Hypotension Chronic hypotension due to likely being on prolonged steroids Continue Florinef   RLS Takes Gabapentin 300mg HS PRN   Hypothyroidism Continue Synthroid   GERD Unclear as to why on both PPI and H2 blocker BID Continue Famotidine only at this time   Goals of care Given potential suicide attempt, code status was changed to full code briefly BH cleared of suicide precautions Changed code status back to DNR-CC after discussion with POA Goals are hospice
Patient reported local inflammation and hives on left arm and around the neck area.  Patient treated at home.
Severe swelling to the injection site. Muscle swollen and inflammed in an aprox. 6" square around injection site. Trouble walking (pain). Severe migraine. Stiff neck/shoulder (right side). High Temperature, as high as 102.5. Signs and Symptoms have lasted for 3 days and continue to persist. Tried to treat at home with aspirin, Excedrin migraine. Finally sought doctor care at an urgent care facility (date 11/23/12), given a toradol shot for pain and given butalbital/acetminophine/caffiene for headache. Having to take them every 4 hours to gain any relief.
This spontaneous report was received from a male patient of unknown age via Poison & Drug Center and refers to himself. The patient's past medical and drug history included receiving PREVNAR 13 a couple of years before the report with no reaction. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscularly in the left deltoid, one time (dose, lot # and expiration date were not provided). The patient's concomitant medications were unknown. On 29-NOV-2016, the patient experienced arm swelling, rash, pain, burning, redness and itching in his left arm. The patient reported the left arm had swelled up really bad and is "50 percent bigger" than his right arm. The patient experienced he was not experiencing trouble breathing or anything like that where he needed to call an ambulance or anything but the symptoms were getting worse every few minutes. Laboratory data was unknown. At the time of the report, it was unknown if the patient continued to receive PNEUMOVAX23. The patient continued to experience worsening symptoms of arm swelling, rash, pain, burning, redness and itching in his left arm (outcome of the events was considered as not recovered). The causality was not reported. Additional information has been requested.
Bell's Palsy - symptom of pain behind ear started 11/30/11. Eye edema numbness, tingling of face 12/1/11. 12/2/11 seen in E.D., acyclovir and prednisone admin. Recovering - still has mouth -eye drooping.
Pt reports several hours after the vaccine he developed fever, chills,  right arm pain then severe shortness of breath. It resolved within 24 hours. He did not seek care during this event.  Reported event 4 days later with a routine follow up
Patient stated she has had pain in her left shoulder and in her left lower arm since receiving the flu vaccine 2/5/09. No redness, swelling or induration at injection site.
Swelling, redness, skin tightness, pain and fever at injection site for 24 hours after injection.
Severe HA, myalgias, back pain, LE pain/neck pain, paresthesias, N&V, diarrhea.  7/23/09 Hospital records received DOS 6/21/09 to 6/22/09. Assessment: Acute dehydration, viral syndrome, dermatitis, paronychia chronic and incidental. Patient presented with a febrile illness with associated myalgias, sore throat, stiff neck. Abdomen tender.
pt was warm when came to clinic, but nurse did not feel had a fever;3PM fever, was climbing & by 515PM t105 taken to hosp ER & given motrin & APAP;pt fussy & dec appetite, cranky, tired, flushed;urine output dec, po intake dec
lightheaded, sweating, feeling like passing out, put in wheelchair, brought to observation, juice given, symptoms improved
BODYACHE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal for red blood cells (RBCs) and white blood cells (WBCs), and Polymerase chain reaction (NR: not provided) Negative. On 07-APR-2021, the subject experienced bodyache. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bodyache, tiredness and headache was not reported. This report was non-serious.
On 3/30/02, pt broke out in diffuse multiforme rash on upper trunk, especially on neck, face and into hair line. Lymph nodes were swollen behind ears and along neck. Had tightness and "swelling feeling" in face and throat. Also had sore throat. Temperature was 98.4F. Lung sounds were clear and sharp; no wheezing. Took Benadryl 25mg po tid with extra 25mg at bedtime if needed. On 4/3/02, no rash present and lymph node swelling decreased.
I had pre-term rupture of membranes. At June 18th - 33 weeks and three days gestation. Admitted (19th) until the delivery of baby at 34 weeks and four days gestation. My baby is healthy and fine. Did have to spend 2 weeks in Neonatal  unit.- Baby fine now. Pregnancy history: Prior to this pregnancy- 2 previous pregnancies - both ended miscarriages. This baby was conceived by IVF. June 26th was the actual date of birth for this baby. Baby was discharged July 8th. I had one doctor's appt to take out my stitches. 6 week postpartum on the 12th of August.
second day aches all day, severe chills lasted 1 hour then chills remainder of day and chills aches next.  Day 3 chills and aches during day then 101 temp at night. Day 4 chills and aches stopped, unable to urinate sitting but could standing
Writer was in RM 2 with pt, about to give menactra and men b vaccines. Pt stated he was nervous. Writer gave pt menactra, pt had no issue. Writer gave pt Men B in R arm, as soon as writer gave pt the injection, pt turned gray, eyes rolled in the back of his head, pt started sweating, shaking and becoming extremely stiff. Pt slid down the chair and leaned on Dad. Pt was rocking back and forth, shaking from side to side. Writer had dad hold pt, while writer went to door and asked for help. LPN came in the room to assist, Dr. came in as patient was coming too and evaluated pt and had pt sit in chair, while writer gave pt water. Pt sat to recover. After 20 minutes pt stated he was extremely exhausted, but felt a little better. Dad informed LPN that pt has had seizures in the past and did pass out last year when given an injection. Dad then told writer patient had a history of seizures and had been air lifted to the hospital in the past from seizures. Pt and Dad checked out.
Hives, called HD nurse. Mother took baby to ER. Benadryl given and prescribed for 24 hours at home.
Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter
Headache, sore arm, nausea, vomiting, diarrhea, nervous feeling, burning, chest tightness, not feeling well overall.
Patient noticed pain, redness and swelling the day after the shot, which progressively worsened.  Patient was seen in clinic on 6-2-22 and was diagnosed with cellulitis of her upper left arm.
Injection site pain, aches, chills, fever, headache, lose of appetite, diarrhea, fatigue, nausea.
pt recvd vax 16JUL93 devel swelling, erythema over lt deltoid area; on 18JUL inc swelling & multiple bullae over central area of erythema; minimal tenderness x/where skin open;
hives on face; rash on face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives on face) and RASH (rash on face) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on face) and RASH (rash on face). At the time of the report, URTICARIA (hives on face) and RASH (rash on face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was reported.
Minor patient received Pfizer booster dose. About 5 minutes after vaccine, she became pale, hot, dizzy, sweaty, and had vision changes. I checked her blood pressure and it was 96/50.   I placed I cold pack on the back of her neck. She was given water and apple juice.  Store management reported incident. I checked her blood pressure 2-3 more times. Incident lasted about 15 minutes overall. Patient started feeling better (color tone back to normal, vision back to normal, no longer dizzy or hot). Final blood pressure reading was 116/64.
feeling small shock like pain in my thighs; feeling small shock like pain in my thighs. Ever since it's moved to random places all over my body; Like piercing stabbing pain in muscles; feels sometimes like in my veins; This is a spontaneous report from a contactable consumer (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number unknown due to unable to locate or read the details) via an unspecified route of administration, administered in Arm Left on 14Aug2021 15:45 at age of 52-year-old at single dose for COVID-19 immunisation. Medical history included Sjogrens, penicillin allergy and sulfa drugs allergy. The patient had no COVID-19 prior vaccination. No COVID tested post vaccination. Concomitant medications included unspecified drugs. It reported the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As she walked out she began feeling small shock like pain in her thighs. Ever since it's moved to random places all over her body. Like piercing stabbing pain in muscles and felt sometimes like in her veins. The events onset date was reported as 14Aug2021 15:45. No treatment received for the events. The outcome of the events was not recovered.   The lot number for BNT162B was not provided and will be requested during follow up.
Lost hearing in my right ear; This is a spontaneous report from a contactable consumer, the patient.  A 77-years-old non-pregnant female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration from  in the left arm on 23Jan2021 at 15:00 (at the age of 77-years-old) as a single dose, for COVID-19 vaccination The patient medical history and concomitant medications were not reported. The patient had no known  allergies.  On 12Feb2021 at 18:00, The patient experienced lost hearing in my right ear (medically significant).  No treatment was given for the event. The clinical outcome of the event lost hearing in right ear was not recovered.  Information on Lot number was requested.
Swollen glands under right arm starting 2 Weeks after vaccine 2/22/21. Still swollen and hurting  today 2/25/21.
Dizziness; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIZZINESS (Light headedness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (Light headedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: follow -up received on 09-JUL-2021,Non-Significant Follow-up, Patients contact information updated.
Body aches; Diarrhea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, WARFARIN, EZETIMIBE and WARFARIN SODIUM (JANTOVEN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This non-serious initial spontaneous case, was received on 22-Sep-2017, from other health professional concerning a 65-year-old elderly male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date: 31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose, less than 0.5 ml. The patient did not experience any adverse event. The reporter assessed the report as non-serious. Follow up received from health care professional on 25-Oct-2017: Added event no adverse event. Amended narrative accordingly.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On 01-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II subcutaneously (lot # H013040, Expiration Date: 17-JUL-2014) (dose was not reported). No adverse effects were reported. Additional information has been requested.
Arm was sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore for 3 days) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm was sore for 3 days). At the time of the report, MYALGIA (Arm was sore for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Covid Arm  swelled up about 3 inches on the 11 th day after first vaccine shot.  Red and swelled around injection site. Very worried
Patient woke up with bumps under the injection site arm, swollen lymph nodes and was in severe pain. Severe pain has subsided but patient still feels like something is pushing on the chest.
This morning I woke up and had a knot at the injection site, along with itchiness. We are 8 days out. I read online that it is considered delayed cutaneous hypersensitivity. I have had zero problems regarding the Moderna vaccine, and this isn?t an issue at all. It is just a small symptom. I figured you guys would be interested in hearing about it. I read that it was more prominent in women and was not that common. I am perfectly fine, like I said.
Since I got my first shot my periods had been getting worse, heavier than before. When i got my booster it all just came back again, I was in a lot of pain with heavier bleeding. The next month at my GYN I told them of my symptoms and they are working to get it under control because my birth control stopped providing the help that it was.
It started my Acute Arthritis skin legions open and bleeding. It is a on going symptoms and I have had this since the 1980's and the doctors have tried several different medications. The doctors said that they are running out of things to try. I have to have all of these bandages on my skin. It is very frustrating because I am having a lot of fatigue, joint discomfort, lost of range of motions, a lot of out breaks on my skin. This is autoimmune disorder of arthritis. Every since the second vaccine, I had notice that's when al of these symptoms have started all over again.
I have a rash that is red, very itchy, and all over my body.  It burns, tingles and itches. My doctor prescribed Zyrtec to help with the rash and itching.
First dose-sore arm. Flu like symptoms for about 36 hours SECOND dose-Sore arm. Real sick for 3 days.  Pretty much laid out.  Chills. Aches.  Nausea.  Felt real sick with lots of malaise.
The CMA of my office gave to a patient, a child, on October, today,  a 2-3 months expired immunization. I think it expired on June.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a child patient who received DTP (A or W not known) (DTP (A or W not known)) (expiry date JUN-2023) for prophylaxis.   On 25-OCT-2023, the patient received DTP (A or W not known). On 25-OCT-2023, an unknown time after receiving DTP (A or W not known), the patient experienced expired vaccine used (Verbatim: The CMA of my office gave to a patient, a child, on October, today,  a 2-3 months expired immunization. I think it expired on June.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 25-OCT-2023  A physician reported that a patient, on October, today, a 2-3 months expired immunization.  The reporter think it expired in June, what do you do. The reporter wanted to know do you repeat. HCP reported the vaccine name as "DTT" or "DPT".  MIS asked for clarification several times but unable to confirm brand name of the vaccine.  The patient received an expired dose of vaccine which led to expired vaccine used. The reporter consent to follow up.
No adverse event, person was given an  additional varicella dose.  Varivax and MMRV were given on 11/8/23. Error with MMRV, it was supposed to be MMR. MMR and varicella were supposed to given Seperately, but a Varivax and MMRV were administered. Provider is aware  and will inform patients parent of error.
Rash and blisters all over body, pain, weakness, swelling/inflammation, several urgent care/e.r. visits, 1 hospital stay for 4 days, diagnosed with vasculitis, prescribed steroids, antibiotics and pain meds.
Swollen Redish brown color at site itching swelling has gotten the size of her hand
Diaphoretic, chest pain, cold, clammy, 8-10 minutes after leaving store.