chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED LESS THAN  0.5 ML BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered (dose number in series was 2) on 01-DEC-2021 on left arm for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL"  (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event received less than 0.5 ml booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210067, 20211209551, 20211210058, 20211209679, 20211209706, 20211209775, 20211209782, 20211209798, 20211209874, 20211209880, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210112, 20211210133, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210555, 20211210585, 20211210590, 20211210610, 20211210662, 20211210670, 20211210684, 20211210197, 20211210733, 20211209816, 20211212088, 20211212082, 20211210588, 20211209740, 20211209843, 20211209976, 20211209884, 20211210549 and 20211210733.
The day of my vaccine I had itchiness at the injection site and soreness. About 3 weeks (around the 1st of December) after my booster shot I got a pain in my shoulder by the left side of my neck. On December 8th I went to the emergency room due to the pain in my chest, severe headache, and pressure in my neck and into the back of my shoulder.  They did a chest x-ray and a CT scan and blood clots in my lungs. I was hospitalized for 1 night. The doctor increased Eliquis to 10mg per day, the pain continued for 2 weeks and then went away.  I am still getting headaches and vertigo.  I have gone to PT for that and it's still there.  I also have brain fog and I can't really think sometimes.
Local swelling approx 5 cm at site of DTaP injected-started within hours of shot lasted 48-72 hr
Uticaria/ hives on face, around eyes, neck, chest, trunk/around bra line, underarms. With systemic itching and redness. Symptoms presented between 830pm and 915pm. Unrelieved/no improvement with Benadryl  PO. After consulting with nurse line from local hospital, per instructions I went to the emergency department and was diagnosed with uticaria/hives and treated with IV Solumedrol and IV famotadine. I was discharged with a 5 day course of PO prednisone  and to take over the counter Benadryl and PO famotadine until symptoms resolved. The hives resolved by 1/28, though additionally, I had moderate to severe side effects from the prednisone on 1/28 (2nd dose). I was unable to go to work 1/27 and had to leave work 2 hours into shift on 1/28 due to side effects from the prednisone.
Patient came in for 28 week ob visit and was due for TDAP vaccine. Patient has a latex allergy and was given the pre-filled vial of TDAP. Patient tolerated vaccine well. Patient is pregnant and pregnancy is normal. Estimated delivery date is 07/06/2022
After about 20 minutes, I noticed some mild numbness in the face, similar to getting a light dose of Novocain at the dentist. It stated to go away, but never fully dissipated. The next morning while getting ready for work, I noticed I could not taste anything, and mouth felt a bit numb. Also had some residual facial numbness.
This is a spontaneous report from a contactable pharmacist.  A 76-year-old female patient received PREVNAR 13 Lot N47827, NDC number 00005197102, Expiry Date Nov2017, via an unspecified route of administration in left arm, on 14Nov2016 13:00 at 0.5 ml, single for immunisation.  Medical history included ongoing blood cholesterol.  Concomitant medication included pitavastatin calcium (LIVALO), and escitalopram (at least since 2015).  The patient experienced 1 inch in diameter knot at injection site, red and warm at injection site on 20Nov2016 with outcome of not recovered.
Left side of lip swollen and hard. Swelling extends to approximately the midcheek region
Pt inadvertently received COVID-19, mRNA, LNP-S, PF 5yrs-11yrs (Pfizer-BioNTech, Tris-sucrose) vaccine instead of intended Fluarix vaccine. Pt was under the minimum age to receive this vaccine. No symptoms noted during 15 minute observation period post administration.
This spontaneous report as received from a consumers mother refers to a female patient of unknown age with asthma. The patient has no drug allergies. Approximately on an unknown date in  2011(reported as about two year ago), the patient  had received three shot series of GARDASIL (product circular number was reported as 9883616). On 07-FEB-2013 the patient was given an additional dose of GARDASIL in error by an unspecified physician at an unspecified clinic. Since receiving the additional dose of vaccine(07-FEB-2013), the patient had developed a headache, soreness around the injection site and lack of appetite. The patient has been using MOTRIN to alleviate the symptoms but has not sought medical attention. The outcome of lack of appetite, soreness around the injection site and headache was reported as recovering/resolving. Additional information is not expected.
Erythematous papular/pustular-generalized with ? concentration in groin/chest areas where he has shaved hair.
Lower back pain, very sore. Hard to stand up straight. Painful to sit or stand or walk.  Feels like Sciatica, but both sides of lower back.
Pt recvd 3 doses of Engerix-B vax on 18JUL90, 22AUG90, & 17JAN91 & was found to be a non-responder;
This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive for COVID. 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. No concomitant medications were mentioned. No treatment details were reported. Company comment: This case concerns a patient of unknown age and gender, with no medical history reported in this case, who experienced the non-serious AESI of SARS-CoV-2 test positive. The event occurred on an unknown date after the administration of an unknown dose of the mRNA-1273 vaccine, in a patient with an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported in this case, who experienced the non-serious AESI of SARS-CoV-2 test positive. The event occurred on an unknown date after the administration of an unknown dose of the mRNA-1273 vaccine, in a patient with an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Significant swelling in armpit region of injection arm (- Approximately size of golf ball).  Began upon waking morning after injection, and still present at this time (72 hours later).  Area is tender to touch.
A few days after the vaccine, I woke up dizzy. Dizziness hasn't stopped since then and it has been over a month.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169), via an unspecified route of administration on 01Jun2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was unknown whether the patient receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Apr2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. On 05Jun2021, the patient experienced "a few days after the vaccine, I woke up dizzy. Dizziness hasn't stopped since then and it has been over a month". The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event which included treatment for vertigo but it did not solve. On 07May2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the event "a few days after the vaccine, I woke up dizzy. Dizziness hasn't stopped since then and it has been over a month" was not resolved at the time of reporting.
Received vaccines on 6/24/2013. Client states on 6/30/2013 after work, he had a swollen and painful area above rt. wrist. He had worn a reader, scanner wrist band at work. States didn't have injury to area. Client states wrist band at work was to tight and he moved it higher on arm. Area remains slightly swollen.
patient developed cellulitis at the injection site. went to emergency room an received antibiotic for the infection.
Subjective fever, chills, myalgias, lymphadenophathy, tachycardia, fatigue
Severe pain radiating down arm and up to neck, starting ondate of injection 10/22/02 to the present (6 weeks) weakness 20/0 pain with lifting.
Immediately after receiving her vaccination, she felt lightheaded. She requested to lay down on the floor, which she did. She does have a history of aversion to needles with similar symptoms in the past. She was taken to a private section of the arena and monitored come up with full resolution of her symptoms within 15 minutes.
Vasovagal syncope. Felt better after laying down for a while and then slowly drinking water and eating granola bar.
Having problems with hives a year or two ago after one the shots of Moderna.; He tested positive on Saturday; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.) and COVID-19 (He tested positive on Saturday) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 13-May-2023, the patient experienced COVID-19 (He tested positive on Saturday). On an unknown date, the patient experienced URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in May 2023 at an unspecified dose and frequency. At the time of the report, URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.) and COVID-19 (He tested positive on Saturday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. It was reported that patient went through a lot of trouble. He got tablets of Paxlovid and was feeling pretty good with the medication considering he was tested positive on Saturday.   Reporter did not allow further contact
pt. received influenza flu shot on 10/06/09 via a Public Health Flu Outreach at the Center. Flu shot manufactured by Sanofi Pasteur. Fluzone Lot #U3186AA Exp. June 30,2010. Pt. informed center administrator on 10/13/09 that his Rt. upper arm where he received the flu shot had bruised up more than usual. I am the Public Health Nurse in charge of that outreach that day so I called the pt. to find out what symptoms he was having.  Pt. c/o of right arm pain x 3 days, on a scale of 1-10, his pain was an 8.  He states that it hurt to elevate his arm but now 8 days after his pain is gone.  Pt. denied increased swelling, warmth,or pus at the site.  The senior center sent my a picture via my email.  The upper right arm appears with diffuse red/purple bruising approx 6-7 inches in length and approx 4 inches wide.  Pt.states he is on aspirin therapy.  Unable to obtain info. who gave him the shot d/t consent forms have been turned into the immunization program. Pt. is concerned about his bruising and will attempt to see his private doctor today 10/14/09. Rt. arm has no pain and pt. can move it without a problem.
After receiving shot pt started to feel lightheaded and started to sweat. He said he felt nauseous and I was unable to palpate a pulse. I had a technician call 911. EMT's came and administered fluids, verified pt's blood pressure (110/70) and treated the pt. After recovering pt refused to go to ER.
This spontaneous report as received from a nurse refers to a 62 year old male patient. The patient's medical history was not reported. On 22-SEP-2014 (reported as yesterday), the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (Dose: 0.5 ml, Route: subcutaneous in the left arm) (lot # K002927 and expiry date: 16-FEB-2016) instead of ZOSTAVAX. Staff error only. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is linked to 1409USA013863 (same repoter link). Additional information is not expected as the reporter did  not wish to contact.
Narrative:  84yo MALE with CAD s/p PCI x4 (2017), HFrEF (Echo 8/27/2021 with EF 15-20%,LVdd), HTN, HLD, R ICA 50-69% stenosis via atherosclerotic plaque, T2DM and Stage 3A male L breast Ca presented to the ED on 8/26 after episodes of chest pain while lying abed around 0200. Pt was admitted to agency hospital & diagnosed with NSTEMI and HFrEF exacerbation. renal fxn worsened on 8/31. He became cold and had continuing soft pressures and was transferred to ICU for suspected cariogenic shock on 9/1. Pt was then transfered to another hospital on 9/1/2021 for cardiac intervention procedure. On 9/2/21 patients condition deteriorated. His oxygen requirements went up and he was put on BiPAP. His pressures were dropping with MAP<65, hence levophed was started after consulting with his primary cardiologist andpatient was the transferred to the CCU for further work up and close monitoring.Patient was ultimately Intubated/Sedated. Patient then got Impella assisted PCI of LM into LAD on 9/2/2021. However, overnight patients condition deteriorated and his pressor requirements increased significantly. Family was updatedfrequently. Palliative care was consulted on 9/3/2021 and detailed discussion was done with the children. Children were aware of Patients poor prognosis. Reviewed code status. Children in agreement to revise code status to dnr Comfort care only. Chaplain at bedside to assist with spiritual support. Family Priest was also present. Patient passed away at 13:50 on 9/3/2021. Pt had received covid vaccines on 3/11/2021 & 2/8/2021. Pt's death is not related to covid vaccines.
pt recv vax & 30min post vax pt noted 4cm diameter red, hot, itchy area 24hr p/vax;pt still reports very warm, itchy raised reddened area described as approx 2 inches in diameter;
Patient states had allergic reaction to vaccine the next day with swelling in the arm at site of injection.
Red Hives; Swelling of arms and legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Mar2021 14:15 (Batch/Lot Number: 8733; Expiration Date: unknown) as 1ST DOSE, SINGLE for covid-19 immunisation administered in Hospital. The medical history included blood disorder, Penicillin, sulfa and gluten allergies. Concomitant medications included warfarin sodium (COUMADIN), escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID) and trazodone were received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had known allergies to Penicillin and sulfa gluten. The patient reported, red hives, swelling of arms and legs and itching on 27Mar2021. He had two Benadryl as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was unknown.
There were no pregnancy related adverse effects, as my son was born prior to me receiving the second dose of the vaccine (on 03/02). Baby? birth weight was 6 pounds 8 ounces. Baby was delivered at 39 weeks, 4 days via c-section. Apgar scores were 2, 5, and 8. He has collapsed lungs and is receiving ongoing care in the NICU. All of this appears to be unrelated to the shot, as he was born prior to receiving the second dose.  Side effects I experienced after the second dose:  1. Chills and inability to get warm within 12 hours of the second dose on 03/03 (middle of the night). 2. Itchy rash on my hands, feet, abdomen, breasts, and thighs, starting about 20 hours after the second dose (on 03/03).
The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech; Pain in the arm for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) and PAIN IN EXTREMITY (Pain in the arm for couple of days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (drug induced), Pneumonia (he was overdosed with antibiotics and had Pneumonia 5 times in last 10 years), Drug overdose (Antibiotics overdose), Drug overdose (Pharmaceutical products overdose) and Prostate surgery. Concurrent medical conditions included Gout, Hypertension, Immunocompromised and Grover's disease. Concomitant products included FEBUXOSTAT (ULORIC) for Gout, LOSARTAN and AMLODIPINE for Hypertension, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Prostate surgery.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) and PAIN IN EXTREMITY (Pain in the arm for couple of days). At the time of the report, TINNITUS (The volume of tinnitus tripled / pitch has changed from annoying screaming to high pitch screech) had not resolved and PAIN IN EXTREMITY (Pain in the arm for couple of days) had resolved.            The patient was immunocompromised which qualified him for 3rd dose. Patient stated many years ago he was overdosed with antibiotics and had Pneumonia 5 times in last 10 years, which made him immunocompromised. Patient reported that 15 years ago he was in surgery, where they overdosed him with pharmaceutical products which caused tinnitus. He states tinnitus was drug induced. But after the 3rd dose, the volume of tinnitus tripled and the pitch has changed from annoying screaming to high pitch screech.  Treatment information was not reported.   This case was linked to MOD-2022-550540 (Patient Link).
Starting the day after the vaccination, I was unable to use my entire left arm due to severe pain occurring with any movement - all I could do was hold it perfectly still.  While the pain in my whole arm has subsided, I have continuing sharp pain any time I move my left wrist.  After three months, that has not gone away.    (NOTE:  In November of 2020, I sprained my left wrist, but I had a series of physical therapy and acupuncture and wrist was back to normal.  And, never during that time period did I have the pain that I now have.)
undisclosed number of patients were given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.  Action taken with vaccine was not applicable.   Reporter did not allow further contact
Have had a vibration feeling off and on for two weeks.........have not seen a Doctor as of yet.   Spoke with a Neurologist friend who advised giving it a few more days before seeing my Doctor
I have had two Pfizer vaccines and a Pfizer booster for Covid19. Since several weeks following the second vaccine I have experienced  sob (shortness of breath) which comes and goes but never disappears. I've also experienced an unfamiliar fatigue that is with me always. I have never experienced either of these effects in a chronic way before. Today is 12/11/21 and I'm feeling short of breath and fatigued.
29Arm swelling around inject; red & itchy 4cm erythemia w/itch;