chrisvoncsefalvay/vaers-outcomes huggingface dataset:
still testing positive; still testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 25Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 66 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity until recent weight loss (dieting); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: My first "negative" test had a very faint line; positive, notes: I am still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received Paxlovid from 18Jul2022 to 23Jul2022 as COVID 19 treatment. Bounce-back after Paxlovid. Her first "negative" test had a very faint line, and now on day 14 of her infection (first symptom was day 0) The patient still testing positive. Original symptoms were runny nose and sore throat, only symptom now is sore throat, mild. From 17Jul2022 to 19Jul2022, the patient received other medication in 2 weeks product Cold and Flu, brand= Up & Up start date=17Jul2022 stop date=19Jul2022 and lot number was P108452. The patient known allergies: sulfa drugs and other medical history: obesity until recent weight loss (dieting).  No follow-up attempts are possible. No further information is expected.
Patient was seen for 4 yr physical on 1-6-15 was given 4yr vaccine. (MMR, varicella, DTAP and IPV). Mother states had swelling and redness immediately after injection to right upper arm with MMR. Patient was seen today 1-9-15 and was givne cefdinir 250mg/5mL q 12 x 10 days. Patient to follow up next week.
DEBILITATING HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced debilitating headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating headache. This report was non-serious.
3 minutes post vaccine with syncopal episode.   Diaphoretic and pale and cool to the touch.  BP 98/68, 69bpm, 96% RA,  No signs of anaphylaxis.  Patient awake alert oriented but slow to answer.  Given juice po.  No hx of DM.  Hx of COVID with increasing exertional SOB according to girlfriend not reported before vaccine.  Discussed patient history and ongoing VS including O2 sat that falls into the 80s when resting and returns to 90s when reminded to take a deep breath.  Discussed with Dr. (Name).  EMS called on his advice.  Arrived 533pm.  Patient refuses to go to  the Medical Center.  Signed refusal forms and will seek PCP care. Released to girlfriend by EMS.
Patient's arm was red, swollen, itching with blisters and progressively got worse the next day.  Patient still having problems with itching.
Patient developed morbilliform diffuse maculopapular rash from trunk to extremities, sparing face, palms, soles, groin area.
On Dec 28,2020 Patient was receiving the Fluarix Quadrivalent influenza vaccine Lot #B223P Exp. 06/30/21 for first time to (L) deltoid at 14:36. Pt was educated on signs and symptoms to report after vaccine administered. Pt instructed to wait 15min for observation afterwards and pt. verbalized understanding and agreed. While retrieving pt. immunization record, I heard pt. yelled out "Nurse I don't feel good!". when I turned around I saw pt. on floor on his stomach, unresponsive. I then called out for help from 2nd RN who immediately came to assist with pt. and helped turn pt. on his side while calling other staff for assistance. 911 was called at 14:37 by RN. Pt aroused 14:38 a bit confused and pt. was assisted to chair with feet elevated. Epinephrine 0.3mg was then given at 14:38 in pt. (R) thigh. Cold compress was then placed on pt. forehead and neck. Pt then verbalized that he was starting to feel much better and EMS arrived on scene at 14:45. Pt vitals taken by EMS were: FS 100, BP standing 121/76, Sat 100%. and departed with EMS at 15:00 to  Hospital for further evaluation.  On the scene was Supervisor, Agent, RN's.  Pt wife was also by his side throughout incident.
After receiving my third dose and I had the same immediate reaction as my second dose. I had flu like symptoms, a sore arm and chills for about 24 hours. I went to my doctor two weeks ago for my annual physical. It was discovered there that I had a UTI. The strange part is that I really didn't have symptoms of a UTI. I did have a foggy feeling in my head. I was given antibiotics and I have lost that foggy brained feeling. I believe I had a UTI for the past couple of weeks but did not realize that.
pt reports breaking out in a rash from head to toe along with severe itching. started approximately 2 days after receiving the flu vaccine on 10/9/19 at pharmacy. she has received flu vaccines in the past with no adverse reactions.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
This case was reported by a consumer and described the occurrence of headache in an adult female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKlilne). A physician or other health care professional has not verified this report. The subject's medical history included diverticulitis (but she has not had any issue with it for 2 or 3 years). Concurrent medical conditions included allergy, allergy to DEMEROL and PERCOCET. Concurrent vaccination included Tetanus Toxoid vaccine; manufacturer unspecified; given in March 2014 a few days before ENGERIX B adult. On 31 March 2014, the subject received 2nd dose of ENGERIX B adult (1 ml, unknown route and injection site) which had expired on 22 March 2014. On 31 March 2014, few hours of vaccination with ENGERIX B adult, the subject experienced headache and exhaustion. The subject stated that the headaches may be related to her allergies. At the time of reporting the headache was unresolved and the outcome of exhaustion was resolved.
BLOOD CLOTS; UNABLE TO WALK/TEMPORARY DISABLED; This spontaneous report received from a source from a consumer via a company representative concerned a male of unspecified age. 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 administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The consumer reported that the patient on an unspecified date experienced blood clots and was unable to walk. The patient was under doctor care and was temporary disabled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, and unable to walk/temporary disabled. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: 20210502999-covid-19 vaccine ad26.cov2.s-Blood clots, unable to walk. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Moderna vaccine administered outside.  was 6/3/23 and vaccine given on 6/8/23.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN CHILDREN) for Fever, at an unspecified dose and frequency. On 14-Jan-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Lightheadedness was the first 2 days after the vaccine (arm discomfort).  Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later.  Numbness is improving at this time. Some fatigue.
My arm still aches from halfway to my elbow to halfway up my neck, accross my upper shoulder, and halfway to my breast.  Pain, pressure, sharp lightening strike pains, itching like numbing is coming out like a dentist visit or stitches site. For 2 months I had trouble lifting my arm. On May 23 I got a brown spider bite and it got  worse and has not gotten any better. My bra strap at night with shoulder against pillow hurts.  2 months after spider bite I worried there was a problem from that so I went to Dr  and had me do a round of Prednisone which did nothing. A week later did blood work and xrays. They showed nothing. I cannot find anywhere to see if anyone else has had these same issues. When I called CDC they did give me this site and another so I will check more.
have been running a low grade fever off and on since the second vaccine . I have one right now . I do not want to go to doctors so I am drinking tea, and water, and taking tylenol, the mortin off and on until it goes away again.
@ approx 2AM parents thought pt febrile; had approx 2 minutes tonic-clonic activity in dad's arms w/brief post-ictal period; t102 R p/event;
Chills, fever, body aches,  (flu like symptoms, all over malaise)  starting approximately 3 -4  hours after injection of Shingrix.    pain at injection site as well, and continuing .
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Sep2021 (Lot number: Ew0217) at the age of 34 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE; CETIRIZINE. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot no: EW0187), administration date: 12Aug2021, for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 24Feb2022, outcome "not recovered", described as "Bleeding 2 weeks after my last period". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Feb2022) negative, notes: Covid test name post vaccination Saliva. Therapeutic measures were not taken as a result of haemorrhage. Clinical course: I have been on birth control for 15 years with very regular periods, rare spotting in between periods on continuous method after no period for 3+ months. I am bleeding 2 weeks after my last period. Still on birth control and have always taken regularly with no problems in 15 years. Additional information: Patient was not received any other vaccine four weeks prior vaccination. Patient tested for COVID-19 after vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control, Pantoprazole, Cetirizine. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Haemorrhage cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had chest pain three epoxides.  I get felt like crushing pains on my left of my heart. I had SOB as well.  I took medicine that did not help.  I had numbness and tingling down my left arm.  I went to my cardiologist, and he stated that it was inflammatory issues.
Initially just a very sore arm, but the hardness and pain lasted a week.  After that I developed a rash and 2 days after the rash it turned into bright welts that are itchy and sore.
Information has been received from a pharmacist referring to a female patient of unknown age with tolerances to ACE inhibitors and tree nut allergies. The pharmacist noted the patient did take other medications but did not provide a list. On 21-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency was not provided), lot # N001007 with expiration date 19-SEP-2018 for prophylaxis. On 22-AUG-2017, the patient died suddenly with possible toxic shock syndrome. Autopsy was unknown. The causal relationship between PNEUMOVAX 23 and the death was not provided. Upon internal review, death was determined to be medically significant. Reported Cause(s) of Death: possible toxic shock syndrome.
feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  Additional information: Reporter mentioned feeling unwell for a day or two after being vaccinated.   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-202300180963 Same reporter/ drug/ event for different patients.;
Immediately after injection patient stated he felt dizzy, sweaty and faint - called paramedics.
This is a spontaneous report from two contactable consumer (Patient and patient's wife). A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 at 09:30 as dose 2, single (at the age of 84 years) for COVID-19 immunisation. Medical history included ongoing hypertension About 20 years, ongoing biliary obstruction started about 20 years ago (Bile ducts prone to being clogged), Sees a doctor every 3 months and has blood tests every 3 months, ongoing prostatomegaly about 10 years (prostate enlargement that has been for about 10 years.), ongoing pressure in eyes about 15 years and was on medicine for all of that. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiry Date: unknown), dose 1 via an unspecified route of administration in right arm on 26Jan2021 as dose 1, single (at the age of 84 years) for COVID-19 immunisation. On an unspecified date in 2021, reporter stated that patient had his blood pressure taken and it seems to be up. Patient has been on a high blood pressure medicine, and it just shot up. Reporter doesn't know when it first started. Patient went to the dentist and they took it there on 03May2021 and the dentist said it was a little bit high. Patient went to the doctor again this past Monday and it was up to 170. His appointment at the dentist was at 10:30, and the appointment at the doctor's office was at 14:30. They have also been taking his blood pressure several times a day. They increased his blood pressure medicine. When asked if it is ongoing, reporter said his blood pressure has been running between 140/79 and 164/89. Patient has some different medications, but nothing has changed. Patient mom had diabetes and passed away, and his dad had throat cancer. The patient underwent lab tests and procedures which included blood pressure measurement: between 140/79 and 164/89 on 03May2021, blood test: unknown on an unspecified date. He has had it for quite a long time, about 20 years. The outcome of event was unknown. Follow-up attempts are needed. Further information is expected.
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and presented to the ED w/ altered mental status on 2/18/21 after receiving COVID vaccine on 2/16/21. Patient was also previously admitted earlier that month for a retroperitoneal hemorrhage that had similar presentation of altered mental status. CT this admission showed a new CVA. He was eventually transferred to the ICU for nonconvulsive status epilepticus and eventually transitioned to hospice care after further decline in status. Wife elected to stop dialysis and he passed away on 3/23/21. Comorbidities include ESRD on dialysis, CVA, DM, prostate cancer.
vaccination liquid in eyes; A spontaneous report was received from a other healthcare professional concerning a 36 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination liquid in eye (Occupational exposure to product).   The patient's past medical history was not provided. Concomitant product use was not provided.    On 25-Mar-2021, prior to the onset of the events, the patient received dose of mRNA-1273 (batch no 016B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25-Mar-2021, the patient states their nurse was drawing up vaccination liquid to fill syringes. During this time the nurse got the vaccination liquid in her eyes.  Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccination liquid in her eyes, was unknown.; Reporter's Comments: This report refers to a case of Occupational exposure to product, for mRNA-1273, lot #: 016B21A , with no associated AEs.
Covid arm: red, hot, swollen, itchy circle around injection site.  Developed about 48 hours post injection.  Still lingering.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, in the left arm, on an unknown date in Mar 2021, at 15:45, single dose, for COVID-19 immunisation. Medical history included asthma and had a mini-stroke 30 years ago in 1991. The patient did not have any known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medication not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On Mar 6, 2021, at 17:00, patient experienced mono effects, leg/arm pain and significant fatigue. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has tested for COVID-19. On Mar 8, 2021, patient underwent a SARS-CoV-2 test (nasal swab test and the result: negative). The outcome of leg/arm pain and significant fatigue: recovering (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Client fainted following injections positioned onto floor feet elevated - eyes rolled back - several tremors extremities awake - did not know what happened & where she was - then oriented self to place & event maintained BP - P - because B.P. decreased once medics decided to transport - to be checked out B.P. 134/86 80 - 20 - 120/60 - 80 BP 100/70 90 standing 120/88 P 88.
1/14 am. General malaise and fever  shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
She did not receive the second dose yet,  It's been about 7 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months). In January 2021, PRODUCT DOSE OMISSION ISSUE (She did not receive the second dose yet,  It's been about 7 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information has provided.   Reporter did not allow further contact