chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her husband was unable to receive his second dose because he had a brain surgery; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Her husband was unable to receive his second dose because he had a brain surgery) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain operation (brain surgery).    On 16-Mar-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 PRODUCT DOSE OMISSION ISSUE (Her husband was unable to receive his second dose because he had a brain surgery). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Her husband was unable to receive his second dose because he had a brain surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.
pain in her right rib; Arm Stiffness on Injection Site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Headache; Cold sweats; Sore arm; lightheaded; This case was reported by a consumer via call center representative and described the occurrence of headache in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In June 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache, cold sweat, pain in arm and light headedness. On an unknown date, the outcome of the headache, cold sweat, pain in arm and light headedness were unknown.   It was unknown if the reporter considered the headache, cold sweat, pain in arm and light headedness to be related to Bexsero and Bexsero 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 reported as follows: The case was reported by patient's parent. Lot and expiration date was not provided. The patient experienced sore arm, headache, cold sweats and was lightheaded. Not all information was provided.  No consent was provided.
Victim went to bed immediately upon returning  from the facility. He did not eat dinner because he was not feeling well. The next day he did not wake up until after noon and found he could no longer walk. He reported his legs burning as if they were on fire. He began to break out in a painful rash over two thirds of his body. He had pain in his back that would come and go. The burning pain in his body was intermittent and he was able to use a walker after a few days but he never recovered his strength like he was before he was vaccinated and he deteriorated further everyday and then began to exhibit memory and thinking problems. 29 days after the shot he became so weak he could not catch his breath and was taken to the emergency room and died within minutes after being put on the examination table. Cause of death was listed as heart failure. Prior to receiving the vaccine he was energetic and put in a full day everyday of home maintenance, gym workouts and exercise classes. He regular drove to social events and breakfast events and had not been sick with the flu for several years.
while administering the vaccine to the patient, the vaccine started "dripping from the bottom where the plunger is", no AE; Vaccine was leaking upon administering to a patient and patient received a partial dose of the vaccine, no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist in the United States.  This case involves a 59-year-old female patient who received a partial dose of the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (underdose) as the vaccine started dripping from the bottom where the plunger was (Syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccination.  On 21-Sep-2020, the patient received a partial dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7000CA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination. The patient was supposed to receive 0.5 ml.  It was a case of actual medication error due to Vaccine underdose (underdose) (same day latency). It was also the case of Syringe issue.   There was no sign of damage with the vial, plunger intact upon opening the carton, no difficulty pushing the plunger during administration. There was leaking around the plunger. PTC (product technical complaint) assessment was physical.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
10:35am- Pt arrived to clinic ambulatory with her Mom reporting allergic reaction after getting 2 vaccines at ~30 minutes ago. Pt immediately placed in treatment room. Generalized hives noted, worse on upper torso, upper back,  B thighs, B arms, Face, neck and scalp. Pt reports feeling Short of breath, but no stridor noted. Denies oral edema.  pulse ox 98% on RA, placed on 4L NC    1038 first dose of IM epi 0.3mg to R Lateral thigh given 1041 22g PIV to RAC with 1L NS bolus hung 1043 50mg benadryl given IV  no change in patient condition noted, also reporting abd cramping  1044 0.3mg epi given IM in L lateral thigh 1045 40mg IV Pepcid given 1046 100mg Solu-cortef given IV Pt reports starting to feel better, hives still present, but improved, ABC's intact, no stridor,  NP reports Clear breath sounds Bilateral 1051 0.3mg IM epi given in R lateral thigh   1055 hives decreased on face, Arms & legs, improved on back & torso, but still present. Pt reports feeling better, denies SOB,    1115- hives coming back on face, Arms, legs & pt reports pruritis increasing. Denies SOB, no oral edema noted, no stridor, no wheezing noted. 1120- Pt transported to ED via WC with RN & NP SBAR given to ED triage Attending, Dr. and ED triage RN
PATIENT HAD A NOSE BLEED ABOUT 10 MINUTES AFTER ADMINISTRATION
Patient came in 10/24 and showed a lot of swelling and bumps at site of injection which she got on 10/11. Patient was instructed to go to urgent care.
2/27/215 Pt. had approx. 6" round area - slightly reddened with small egg sized (oval) area (within the 6" area) that was darker shade of red. Entire area warm to touch and smaller area firm to touch. Pt. states area is tender and feels "itchy".
Same arm also received PNEUMOVAX. Pt. says area of vaccine blistered and became extremely sore. Use of arm became limited. Went to urgent care and received steroid injection. Pt now says she will need to see ortho.
This case was reported by a pharmacist and described a 43 year old female patient who did not respond to the Hep-B vaccines immunization series.   On an unspecified date, the patient received the third dose of Energix-B.  Approximately two months after the third dose of Energix-B, on an unspecified date, a hepatitis B surface antibody titer indicted that the patient was "non-immune".  The reporting pharmacist considered the event to probably related to vaccination with Energix_b.  The pharmacist reported that the patient had begun the "second series" of immunization with Energix-B.
Information has been received from a nurse concerning an 82 year old female with chemotherapy who in June 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not reported). The reporter stated that the patient experienced shingles but only in the genital area on 25-OCT-2010 after having received ZOSTAVAX (Oka/Merck) in June of 2008. The rash had gone away, but still uncomfortable. The patient sought unspecified medical attention. Shingles in the genital area was considered to be disabling temporarily. Additional information has been requested.
non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional.   An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
nausea, fever, pain, swelling behind ear painful & tender, lymph nodes swollen;dx delayed hypersensitivity to vax;
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 08-SEP-2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on October 2013, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX.  The reporter considered the events to be disabling, life-threatening and medically significant.
Information has been received from a registered nurse concerning a 7 year old female with no allergies or medical history who on 12/03/1998 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  There was no concomitant medication and no illness at the time of vaccination.  On 01/22/2005, the patient experienced an itchy spot on the shoulder.  The next day the patient had a more diffuse rash on her belly, trunk, groin, and perineal area.  She was afebrile.  Unspecified medical attention was sought and she was diagnosed with chickenpox.  The rash lasted for 2 days and no treatment was required.  The nurse also indicated that there were many cases of the same at her school and the patient was exposed to these cases.  A product quality complaint was not involved.  Additional information has been received from the registered nurse who reported that on 02/11/2005, the mother called the physician's office to request a note be faxed to the patient's school regarding the fact that the child had an itchy rash on 01/22/2005 with vesicles.  The mother spoke with the on-call physician at the time who diagnosed presumed chickenpox via the phone.  The child was not seen to confirm secondary to inclement weather.  The rash lasted only 2 days and the patient recovered on 01/24/2005.  Neither the patient nor her sibling had any adverse events following prior vaccination.  No further information is expected.
Moderna covid vaccine given on 5/15/23 was a 0.2ml dose with the wrong vial (pink top Bivalent) but should have been 0.25ml with blue top. This change was implemented by CDC on 4/20/23 and we were unaware of the vial and dose change. Patient needs one more dose as she is currently now considered undervaccinated.
FLU LIKE SYMPTOMS/OVERALL SICK/ACHING/EXTREMELY TIRED; ALL HIT HER AT ONCE, LIKE A TON OF BRICKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 03-JUN-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced flu like symptoms/overall sick/aching/extremely tired. On 07-JUN-2021, the subject experienced all hit her at once, like a ton of bricks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms/overall sick/aching/extremely tired, and the outcome of all hit her at once, like a ton of bricks was not reported. This report was non-serious.
We do not know if the adverse affect happened with the first or second dose.  Patient was diagnosed with papilledema of both eyes.  Previous eye exams and dilated exam do not reflect papilledema.   Multiple specialists cannot uncover the cause.  The papilledema was first detected 10 days after second dose of pfizer covid-19 vaccine.  8 months later it has not resolved.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: No concomitant medication details provided. The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 the patient had chills and shivers that lasted for about half an hour and then completely resolved. The patient had a fever at approximately 2 AM. He described the fever as a temperature of 105. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, the patient had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. The patient had muscles soreness in his entire body for approximately 24 to 36 hours and then completely resolved, no additional information provided. On 6th March 2018, 1 day after receiving SHINGRIX, the patient had nausea that completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 6th March 2018, no additional details provided. The soreness was still present but has improved. He denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N031003), expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000587; US-009507513-1809USA000595; US-009507513-1809USA000596; US-009507513-1809USA000592; US-009507513-1809USA000593.
takes zyrtec for indoor and outdoor allergies; hive reaction; 3 pancake size areas on left arm; tingling lips; fever 102 degrees; body aches and chills; body aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees) and MYALGIA (body aches and chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills) and CHILLS (body aches and chills). On an unknown date, the patient experienced HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies). At the time of the report, URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills), CHILLS (body aches and chills) and HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
about 5 hrs p/vax mom noticed pt was pale & weak; status progressed to grey color especially in face; Pt did not move about as usual & had a whine like cry; Grey coloring started about 7 hrs p/vax & event lasted an addtl 3 hrs;
Patient had acute onset of highly uncomfortable peripheral neuropathy symptoms - specifically paresthesias with mild akesthesia (she is able to control it)
Shoulder where vaccination given sore; can't raise that arm above my head, pain when I try to lift it in other positions.
This case was reported by a physician via sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date, the subject received unspecified dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative was told that the physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796722A, A0796723A, and A0796724A.