chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRUISING AT THE INJECTION SITE; SWOLLEN ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (SWOLLEN ARM AT INJECTION SITE) and VACCINATION SITE BRUISING (BRUISING AT THE INJECTION SITE) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (SWOLLEN ARM AT INJECTION SITE) and VACCINATION SITE BRUISING (BRUISING AT THE INJECTION SITE). At the time of the report, VACCINATION SITE SWELLING (SWOLLEN ARM AT INJECTION SITE) and VACCINATION SITE BRUISING (BRUISING AT THE INJECTION SITE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. treatment information was not provided.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. Patient was not pregnant a the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total administered on 21-MAY-2021 to right arm for prophylactic vaccination. Patient had no any booster dose of any kind. Age at time of vaccination 29 years old. No concomitant medications were reported.  On 27-MAY-2022, the patient experienced fever. On 28-MAY-2022, fever was resolved. On 30-MAY-2022, she experienced headache, cough, congestion, diarrhea, nausea, fatigue and lack of hunger. Laboratory data included: COVID-19 antigen test positive. Thus patient had suspected covid-19 infection and suspected clinical vaccination failure. On 02-JUN-2022, events headache, congestion, diarrhea, nausea, fatigue and lack of hunger was resolved. Patient was recovering from cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000237266.; Sender's Comments: V0:20220647743-Covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient was nervous about receiving vaccine, it is being mandated by college. He received vaccine at 3:20 pm. At 3:30 he asked for water and was very pale and sweaty. Gave patient water and sat with him. The were unresponsive for about 30 seconds while staring slouched in chair.  Patient stated he couldn't see for about 5 minutes and felt very light headed. EMT arrived shortly after and took patient to ambulance and took vitals.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 4/7/2021. Patient had a preoperative COVID-19 screening test performed on 9/6/2021 that resulted positive. On 9/8/2021 patient requested telemedicine visit due to relentless cough interfering with sleep and hemoptysis.  Also noted that wife and son are also COVID positive with symptoms. Patient was prescribed Casirivimab+Imdevimab which was administered on 9/10/2021, with a noted SpO2 of 98% on room air. On 9/13/2021 patient was transported to ED for evaluation of cardiac arrest. Patient had a witnessed arrest with CPR initiated while awaiting EMS. The treatment prior to presentation was 6mg Epinephrine, 450mg Amiodarone, 600 ml fluid, and 100 Fentanyl per EMS. The patient was shocked x2 before cardioverting. The patient was intubated by EMS. EMS states that the patient was taking a shower and started to feel "crummy" when he became unresponsive. This is when his wife started CPR and called EMS. Total CPR time per EMS was 30 minutes. Patient was initiated on therapeutic hypothermia and was unresponsive after his event. Unfortunately he experienced a recurrent cardiac arrest in the ER with Ventricular Fibrillation that was refractory to again prolonged CPR and resuscitative efforts. After prolonged efforts he was pronounced deceased in the ER by the ER physician on duty at 0354 on 9/14/2021.
After 2 weeks: Fever, cough, red throat, wheezing, ear infection, loss of language, self-injurious behavior, loss of eye contact, stopped responding to name, repetitive behaviors (running in circles, lining up toys), and general developmental delays. Treatment: Amoxicillin for 10 days starting on 3/6/2007.  Other treatments: Speech, physical and occupational therapy, child development sessions, floortime therapy, and special diet for multiple food allergies. Currently receiving multiple services for developmental delays.  5/16/08 Reviewed PCP office records of 3/9/2007-4/25/2008. On 3/9/07 was on antibiotic for wheezing, cough & fever.  Was improved.  Dx: probable pneumonitis.  Returned to office w/varicella 5/22/2007.  Returned 10/6/2007 for cough & fever x 3 days. Dx w/otitis.  Visit of 1/21/2008 states patient had been doing well until 5/2007 when began to lose speech & eye contact, repetitive play.  Was receiving speech therapy & was in early intervention program for autism.  Multiple food allergies were noted.  6/3/08 Reviewed consultant records from early intervention services for 8/2007-4/2008.   FINAL DX: developmental & speech delays Records reveal patient experienced language delays, tantrums, poor eye contact, head banging, perseveration w/toys & objects.  Receives PT/OT/ST, child development specialist, floor time, center based program & respite care.
Swollen underarm and collar bone lymph node; appendicitis; This is a spontaneous report from a contactable consumer reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0161/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8734/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 1:30pm (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at 3:00pm, the patient experienced swollen underarm and collar bone lymph node and appendicitis. The events required an emergency room visit and the patient was admitted to the hospital. The patient received treatment for these events swollen underarm and collar bone lymph node and appendicitis which included an appendectomy. The outcome of the events swollen underarm and collar bone lymph node and appendicitis was recovering. Since the vaccination, the patient has been tested for COVID-19, test type nasal swab on 24Apr2021 with result negative.
Pt. states having lightheaded sx with blurry vision 2 Min after Anthrax Vaccination. Pulse about 82 BPM, breathing 20/ min. Pt states having no difficulty breathing. no food x 12 hours, patient received about 1 hr ago Yellow fever and Menningococcial Vaccines. All vaccines were given in Left Arm. Pt deferred from smallpox for 30 days.
Patient experienced intense itching, redness & white raised patch waist up all over her body the next day of vaccination. She took Benadryl for several days & tried Zyrtec at last. Zyrtec gave her longer relief.
fibroids on uterus; extremely heavy bleeding; intermittent bleeding; This is a spontaneous report from a contactable consumer(patient).  The 38-years-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 at her 38-years-old (Lot Number: EL3249) as dose 2, single for covid-19 immunisation.  The patient medical history includes did not menstruate monthly. Concomitant medication included levonorgestrel (MIRENA) taken for did not menstruate monthly, start and stop date were not reported. Historical Vaccine included first dose bnt162b2(dose 1, lot number=EN6201 on Left arm) for COVID-19 immunization on 22Jan2021 at her 38-years-old and experienced menstruating heavily and intermittent bleeding. No other vaccine in four weeks. The patient experienced fibroids on uterus, extremely heavy bleeding, intermittent bleeding and on Feb2021.  The patient underwent lab tests and procedures which included Nasal Swab: negative on unknown date, ultrasound scan: fibroids on uterus on unknown date.  AEs resulted in Emergency Room Visit and Physician Office Visit. Treatment received for all events included Surgery. No Covid prior vaccination. Covid had been tested post vaccination via Nasal Swab with negative result. The clinical course was reported as follows: None of these problems happened prior to getting the first dose of the COVID vaccine. She did not menstruate monthly because of prescription Mirena. She had the first dose of COVID-19 vaccine on 22Jan2021, and 24 hours after the first shot, she began menstruating heavily. She subsequently was intermittingly bleeding every day. On 15Feb2021, she had second dose of COVID-19 vaccine. 24 hours after the second shot, she had very heavy bleeding and in the days after, she had intermittent bleeding that did not stop. She was very concerned because she typically do not have this happened, so she scheduled an appointment with OBGYN for an exam. She had an ultrasound done, found out she had fibroids on uterus. She had to have surgery On 18Aug2021 to try and stop the bleeding. The fibroids were too dense and could not be removed. On 03Nov2021, she ended up in the emergency room for extremely heavy bleeding. She will likely have to have a standard hysterectomy to fix this problem. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101555770 Same reporter/RA, similiar events, Different dose
3/13 - vaccine 3/13. 3/15 - noted redness over vaccine sites R thigh ant Lat. C/O pain, no fever. 3/16 seen at clinic, Less erythema.
a couple side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (a couple side effects) 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, the patient experienced ADVERSE REACTION (a couple side effects). At the time of the report, ADVERSE REACTION (a couple side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VARIVAX (lot # M000760, expiration date 01-JUN-2018, lot # M003441, expiration date 19-JAN-2018, lot # M019643, expiration date 20-APR-2018; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported feeling faint after the vaccination. Patient fainted for about a minute. Her blood pressure was low for about 10 minutes. She stated she didn't have any issues with nausea or difficulty breathing. We watched patient for about half an hour. Her blood pressure returned to normal. Patient reported she fainted sometimes with immunizations.
the most painful injection I have ever had; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got his/her 1st shingles shot 3 days before reporting and stated that it was the most painful injection he/she had ever had. The patient stated that he/she would get the 2nd shot because he/she does not want shingles. The patient asked if others found the shots to be painful. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
her arm hurt; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that she received the first dose of vaccine, her arm hurt and then went away in one day. The patient was recovered from the event in 2021.  Information about lot/batch number has been requested.
I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2.  It's so loud, I have difficulty concentrating and sleeping.   I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer  vaccine.
Skin Lesion - Information has been received from a health care professional concerning an approximately 4-5 year old female with no significant medical history who on 03 Apr 2000 was vaccianted sc with one dose of varicella virus vaccine live (site unknown).  On 13 Apr 1000 the patient developed approximatley 10 pox like lesions around her waist  a pox like rash, not herpes zoster.  The lesions were noted to have gone away and every few days she breaks out with a few more which subsequently disappear.  The patient sought unspecified medical treatment.  Additional information has been requested.
Muscle aches (myalgia), fever, headache. Seen in ER 8/23/17, IV fluids, TORADOL; TYLENOL. Dschgd 8/23/17 PM.
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth.  She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Smallpox vaccine received 24MAR2009.  Symptoms began 13APR2009 with lesions on arms, legs, face, and trunk with clear discharge.  Biopsy was sent to Medical University and tested positive of Vaccinia.  Pt was treated with SELENIUM Sulfide.  Lesions have scabbed over and Pt is no longer considered contagious.  Vaccine was administered on Military base.
Injection site developed red bull's eye type rash, minor muscular pain  in arm similar to after the vaccine, skin is warm to the touch.
Person identified need for J&J/Janssen Booster.  After primary series complete.  However, it was discovered after the person received their dose that this was their second booster as he then reported having received 2 J&J already and not just the primary dose.  No untoward events Just reporting as CDC Standards are the third dose is mRNA based and no Janssen
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #20 of 32, a 28 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 28 year old female on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included typhoid vaccine (unspecified). Seven days after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthralgia, erythema nodusum and fever. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02344, WAES # 1004USA02346 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Additionally, she's reported on behalf of others in her community:  "I know several people who have had severe reactions and I've had severe reactions. It's clear now that the vaccine does not keep you from getting covid, it doesn't keep you from passing it on to someone else.  Some friends have been boosted twice, 8 members in their family have covid now.  Sometimes the vaccine will cause more harm than good, there's so many variants out there now, so it's not preventing you from passing it on". "I also know people who have gotten it and died from the vaccine, who were young and no other medical problems and just died. Several people in our family have died of the vaccine. They contacted attorneys because they've been so sick and they have so many medical problems now from taking it and some people have died.  This has been 25-30 people right in one area.  I think Pfizer needs to be aware of it. And other, Moderna some have had that and had problems, it's not just all Pfizer that's done it, but most of them had the Pfizer vaccine because it was safer to take it... my pharmacist and doctor said that would be the best one [Pfizer]."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Mild anaphylaxis; This case was reported by a nurse via sales rep and described the occurrence of anaphylaxis in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 7923K, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 7th October 2020, 1 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the patient experienced . On an unknown date, the outcome of the anaphylaxis and  were unknown.   The reporter considered the anaphylaxis to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received Fluarix and experienced mild anaphylaxis on the next day after vaccination.  The patient went to Emergency Room and was out of work for the day.  Reporter and Emergency Room's doctor believed that the event was related to the vaccine. The reporter consented to follow-up.