chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; GARDASIL 9 given to a 50 year old patient; This spontaneous report was received from a registered nurse referring to a 50 year old patient of unknown gender. The patient's concurrent conditions included diagnosis of precancerous moderate squamous dysplasia precancerous lesion in perianal area. No information was provided regarding the patient's medical history, drug reactions or allergies and concomitant medication.  On 10-APR-2019,  due to the diagnosis the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, lot number R026380 and expiration date of 23-JUN-2021, for prophylaxis (anatomical location was not reported). No adverse effects were reported
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Post procedural inflammation (FISSURE SURGERY WHICH WAS INFLAMMED) in 2017 and Surgery in 2017.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient was not feeling very well, went bathroom a lot and experienced blood/blood in stool and humira was not working. Patient had bad diarrhea, fever and blood in stool. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624833 (Patient Link).
Pt developed small wheal approximately 5 minutes after immunization on both legs at site of immunization. Wheal increased in size to approximately 5 cm by 20 minutes. No other signs of allergic reaction.
1/9th vaccination Eight days later, I woke up and felt my arm burning and itching. I went to the bathroom, it was a 2" diameter raised round circle; warm to the touch, risen part was opaque and surrounding was red. Could see where the injection site was. Burned, itch. Took Benadryl which knocked me out; slept 3 hours. Woke up, still raised, took another Benadryl. The next day it still burned, ached, it had spread to a reddish/purple area that grew in size to about 4" circle.  Monday; Surgeon in office marked it and measured it to monitor. It did not spread at that point.  * My arm is still discolored. Still get a ping of pain, at injection site. It is still itchy.  **2nd vaccination; still visible at injection site on both arms.
Patient experienced chest pain, starting within an hour of vaccination. Pain was focused on the sternum and primarily aching in the joints. Patient took aspirin and rest in the following days as the pain continued. During one night approximately 4-6 days after vaccination, the pain worsened, and included a burning sensation throughout the chest and feelings of pressure within the chest. Patient visited urgent care 1 week after vaccination for evaluation. EKG performed to screen for pericarditis/myocarditis; results were normal. Diagnosed with costochondritis. Patient had no prior history of this condition. Pain continued with little change in the following weeks. Patient visited a cardiologist approximately 5 weeks after vaccination for follow up screening. Stress echo was performed and found no issues. Chest pains slowly improved and were almost fully resolved 2-3 months after vaccination.
Patient had radiating pain during administration of FLUZONE vaccine. Her left shoulder, neck, and ear are affected. This has persisted for 20 days.
This spontaneous report as received from a currently 77 year old female consumer. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot, dose and route not reported). Possible concomitant therapies included atenolol (manufacturer unknown), multi-vit (manufacturer unknown), biotin (manufacturer unknown), vitamin D (manufacturer unknown), aspirin (manufacturer unknown), COLACE, MIRALAX, LEVAQUIN and sulfanilamide (manufacturer unknown). On an unknown date, the reporter mentioned that the patient experienced sick and weak after vaccination with PNEUMOVAX23. On an unknown date, the patient experienced lung cancer, leg surgery. The patient's medical history included leg problems and leg surgery as reaction of LEVAQUIN, rash as reaction to sulfas (manufacturer unknown). The outcome of the events was not reported. Upon internal review lung cancer and leg surgery were considered to be medically significant. The patient also experienced an adverse event while on therapy with MIRALAX (MARRS 1401USA013767). Additional information has been requested.
patient received 1st dose on COVID Moderna vaccine. She has history of peanut allergy/ carries epipen. About 5 minutes after receiving vaccine she experienced tongue swelling, feeling very warm and"just not right". she took 50 mg of her own benadryl that she had with her. throat swelling seemed to getting worse. It was decided she needed an epipen, pt self administered because she was familiar with using them . She began to improve almost immediately. Rescue was called and transported her to hospital.
has had numbness in her arm and now does not have any feeling down her entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001228 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "has had numbness in her arm and now does not have any feeling down her entire left arm". Additional information: On 26Sep2023, it was reported that a patient (Age: 65, units not specified) started treatment on unreported date with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 immunization. It was reported that since her injections, the patient has had numbness in her arm and now does not have any feeling down her entire left arm.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168694 Same patient/event, different dose;US-PFIZER INC-PV202300168695 Same patient/event, different dose;
COULDN'T GET OUT OF BED; TIREDNESS; EXTREME SLEEPY; HEAVINESS; This spontaneous report received from a patient concerned an elderly 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: Unk) dose was not reported, administered on 12-MAR-2021 08:00 at left deltoid for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 12-MAR-2021, the subject experienced extreme sleepy. On 12-MAR-2021, the subject experienced heaviness. On 12-MAR-2021, the subject experienced tiredness. On 16-MAR-2021, the subject experienced couldn't get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme sleepy, tiredness, heaviness, and couldn't get out of bed. This report was non-serious.
pt presented to ER on 7/31 w/vomiting & diarrhea. dx on 8/1 w/intussusception. pt had bloody stools and diarrhea
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and received IV fluids and Zofran, monitored and discharged to home.
Extreme fatigue & lethargy. Unable to do much at all.  Stated she didn't know she would feel this bad or would not have taken vax.  Really felt "terrible".
1 hour after receiving vaccination - and since this time - he has been having hot flashes (cannot cool off), generalized body aches, weakness, intermittent dizziness and nausea/vomiting.
This initial spontaneous case, was received on 27-Oct-2017, from a nurse, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number, expiry date: not reported). On an unspecified date in Aug-2017 (reported as 2 days post-vaccination), the patient had bursitis and difficulty in raising arm. The patient had not taken any treatment. At the time of the report, the patient had not recovered from the events. The reporter assessed the events as non-serious.
Father stated that child started with rash on face approximately 4pm on 03/03/04.  Went to E.R. and rash spread over body.  Temp on admit 103.1 to ER/  Made full admit to hospital on 03/04/04 at1430.  Discharged from hospital on 03/05/04.  Father stated that doctor thought rash was related to MMR and child possibly had viral infection.  Father stated rash gone after 3 days.  Admit dx: rash viral exantham
body aches; chills; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included cyanocobalamin; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); desogestrel, ethinylestradiol (ISIBLOOM) and topiramate taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 11:15 as dose 1, single for COVID-19 immunization and experienced fatigue, headache, sore arm. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, low grade fever and headache on an unspecified date. The clinical outcome of all the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Severe joint pain, knee's, elbow, TMJ, missed periods. Pt has seen an oral surgeon and is now being treated by a TMJ specialist as well as a Rheumatologist to try to figure out what is going on. All these issues started after the vaccinations began.  9/29/2008 PCP records received from 1/7/2008 to present.  16 yr WCC with normal exam 1/7/08. Seen 3/21/08 for URI sx, head pressure, tooth pain, feeling faint, and vaginal d/c. Assessment:  vaginitis.  sinusitis. Seen 6/23/08 for c/o knee pain R>L x 2 weeks with no injury.  PE WNL. F/U 8/8/08 with joint pain in elbows, knees and cracking shoulder. Hurts to swallow.  Diminished energy over past few months. Weight loss. Assess:  Wt loss, joint aches and pains, increasing over past 2-3 months. ? rheum issue or r/t Topamax. Will refer to Rheum.
Patient received Pfizer COVID 19 vaccine at 8:42am. This was patient's first dose. He was observed in clinic for 18 minutes afterwards without concern and left approximately 9:00am. Patient returned to clinic at 9:28am with complaints of sweating, nausea and lightheadedness. RN took patient to private observation room and started assessment. VS 9:30am O2 100%, BP 147/78, HR 50. Patient is laid back on bed with head at 45 degrees and legs elevated. Patient was given 6oz of water and neurological assessment completed. Patient alert and oriented without changes. Patient denies SOB, scratchy or tight throat, hoarse voice, trouble swallowing or itching. VS 9:40am O2 100%, BP 151/77, HR 54. Patient given another 6 oz of water and continues to lie back with feet elevated. Patient took clonidine, sertraline, propranolol, Adderall and vraylar this AM. He ate breakfast. Is not a diabetic. Patient states his lightheadedness has subsided, still complains of sweating and nausea but states he is "feeling better and ready to go home". Patient has a ride and is going home to his parent's house where they will both stay with him all day. VS 9:45 O2 100%, BP 143/81, HR 61. Patient appears more comfortable, less anxious and HR has risen. States his nausea is lessening. Patient would like to leave. RN educated patient on emergency signs to seek 911 for and they include SOB, throat swelling, sudden emesis, increased lightheadedness or nausea, fainting, new dizziness or any other sudden change in condition. He voices understanding; plans to go home with parents, have toast for lunch, push fluids and rest. Patient escorted to the door and visualized entering vehicle with family.
I received the 2nd Moderna vaccination site has been itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching) 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching). At the time of the report, VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching) outcome was unknown.
sore lymph nodes; rash; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LYMPH NODE PAIN (sore lymph nodes), RASH (rash) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 26-Feb-2021, the patient experienced LYMPH NODE PAIN (sore lymph nodes) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (sore arm), LYMPH NODE PAIN (sore lymph nodes), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
onset of vaccine 0854 0900 onset of symptoms of "head spinning, headache, heart beating a million miles an hour" she started to go into a pseudoseizure, unresponsive to name, responsive to pain she was taken for evaluation:  BP 200/100 at 0912 BP 160/90 0920 HR at 84-90  given 25 mg Benadryl po at 0916 tolerated well at 0927, "feel fine, no headaches, no dizziness, no lightheadedness, ready to go home"  She refused transportation to hospital, signed refusal form discharged to home at 0935 with husband driving
Swollen lymph nodes in R armpit, generalized fatigue, 'fuzzy headedness'
Pain at injection site 2/22/21 at 11pm-2/13/21 at 6am Fatigue 2/11/21 at 5:30p through 8:30p on 2/12/21 Headache 2/11/21 starting at 1:30p through 2/13/21 at 6am Nausea intermittently on 2/11/21 at 1:30p through 2/12/21 at 8:30p Body chills intermittently 2/11/21 at 11:30p through 2/12/21 8:30p Joint pain intermittently 2/12/21 at 4:00a-2/12/21 at 8:30p
felt dizzy; diarrhea; No appetite; Headache; Nausea; A spontaneous report was received from a Consumer concerning a 53-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, nausea, felt dizzy, diarrhea and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The caller reported contracted COVID-19 on October 2020 it was mild, nothing terribly bad.  No relevant lab data was provided by the reporter.  On 25 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, nausea, felt dizzy, diarrhea, no appetite, The symptoms on the patient lasted longer, head ache and nausea affected the patient the most.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was unknown.; Reporter'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.
It was reported that a female patient received a TD Adult vaccination on 3 Jul 2000. Reportedly within 24 hours the patient developed pain at the injection site, fever, chills, headaches, and general malaise. Further information requested. From correspondence received 7 Aug 2000, it was reported that the patient recovered from this experience. Additional patient, vaccine, responsible physician and the vaccine administrator information were also provided.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (5 or 6 weeks) on 01-Feb-2020. Concurrent medical conditions included Low blood pressure (about the same) since 01-Jan-2006, Anemia (about the same, take iron medications) since 01-Jan-2006 and Drug allergy (Allergy to Sulfur). Concomitant products included IRON from 01-Sep-2020 to an unknown date for Anemia, Prenatal vitamins and supplements from 01-Jul-2020 to an unknown date for Pregnancy.   On 23-Jan-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 07-Apr-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred  on 30-Mar-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Estimated date of conception: 14-Jul-2020. On 23-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2020, Glucose tolerance test: normal normal (normal) normal. On 15-Jan-2020, Prenatal screening test: normal normal (normal) Week 10- normal. On 15-Jan-2020, Ultrasound abdomen: normal normal (normal) week 20 and next is week 32. On 27-Jul-2020, Pregnancy test: positive positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Past pregnancy included: Live, full term birth on 28-May-2015; Live, full term birth on 16-Aug-2017.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Updated delivery date, and suspect product dose details.
lightheaded Narrative:  Pt was sitting in observation area and started feeling "lightheaded, body feels heavy" 10 min after recieving her dose of Moderna.
Itchy and red day of, 14 days later hives on legs, arms, feet, hands, palm of hands, lips
A few minutes after receiving vaccine, patient experienced hot flashes, then chills, then pain in her back and down her left leg. After about 10 minutes the pain subsided and the hot flashes stopped. She was very shaky and had the chills.
Hives; and itching all over body; This is a spontaneous report received from a non-contactable consumer. A 88 years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at an age of 88-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified cholesterol medications from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On an unknown date in Mar2021, the patient experienced hives and itching all over the body. Therapeutic measures were taken as a result of the events and included treatment with steroids. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the hives and itching all over was resolving at the time of this report.   Information about lot number cannot be obtained. No further information expected.