chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and skin red. On an unknown date, the outcome of the pain and skin red were unknown. It was unknown if the reporter considered the pain and skin red to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced wide sore red patch 4 inches below the vaccine. The reporter asked GlaxoSmithKline was it normal to. The follow-up would not possible as no contact details were available.
contract the virus / COVID-19; passed away; This serious spontaneous report was reported to Amgen on 10/AUG/2022 by a consumer from a commercial program and involves a female patient (sister) who passed away [PT: death], contracted the virus/COVID-19 [PT: COVID-19] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient contracted the Coronavirus disease 2019 (COVID-19) after receiving the vaccine while concurrently taking Enbrel. Shortly after on an unknown date in OCT/2021, the patient had passed away. The cause of death was unknown. It was unknown if an autopsy was done. No treatment information was received. The outcome of the event COVID-19 was reported as unknown. Action taken with Enbrel was reported as unknown for the event COVID-19. The causal relationship between the events death, COVID-19 and Enbrel was not provided by the consumer. Follow up has been requested.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  ENBREL is under agreement with Amgen.; Reported Cause(s) of Death: Unknown cause of death
Patient broke out in fever and blisters over body 8 days after receiving the varicella vaccine.
Vial was stored about 20 hours post puncture; Received expired Booster dose about 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2022 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Number of doses/vials: 1 vial / 2 doses. The vial was initially stored in the refrigerator on 02-JUN-2022. The vial was first punctured on 23-JUN-2022 at 1:14PM. The vial was stored in Refrigerator post puncture. The vial does not undergone any temperature excursions. Post punctured the vial was stored in the refrigerator approximately for under 20 hours. The vial exposed to room temperature for >24 hours: Less than 24 hours.  No treatment medications was reported.
I am a 75 year old female with severe Cardiomyopathy with an ejection fraction of less than 20% and an implanted defibrillator. I had my first COVID vaccine on Sunday, February 28.  I had had sinus problems with a little runny nose the week before...no fever, no chills, normal temperature.  Other than my arm being a little sore, i took two Tylenol the night of the vaccine and had no problems until Tuesday afternoon, March 2, 2021. i felt perfectly Sunday after =noon, all day Monday and Tuesday.  However while shopping at a nearby store as I got to the checkout counter I started having shortness of breath, It was hard for me to walk and I was very shaky.  I have an apple watch so I was able to check my heart rate.  The heart rate was anywhere from 58BPM to 177BPM and all over place in between,  i got in my car, trying to calm myself then called the EMTs.  They took me to hospital to the Emergency Room.  Several tests(see below) were performed.  The final diagnosis was hear palpitations.  They did a COVID test and I did test positive for the Rhino virus.  The doctors didn't know if my incident was related to receive the COVID vaccine and my defibrillator was checked, and a test was run that indicated it wasn't bad enough to activate the defibrillator.
10/16/08 Pain/ tenderness at site left deltoid. Redness at site- 10/17/08 Increasing redness + warmth at site.  c/o nausea 10/16/08 in PM No emesis- appetite decreased.  Facial redness and warm feeling.  -> instructed by ED physician- apply ice/increase fluid intake.  10/19/08 No further complaints.
Extreme arm pain to the point I was not able to utilize my arm for 2 consecutive days without extreme pain and still experiencing some pain with movement on day 3 but improved from day 1 and 2
The patient reported a small lump in the injection area along with redness/ rash down the arm. Area totaled about 5 inches in length down the arm, towards the elbow.  There was no pain and no numbness in the arm or fingers   She started to take 25mg Benadryl  during the day and 50mg at bedtime along with the use of ice.  On 7/16/2020 the patient reported less swelling and redness in at the injection site and the lump was smaller. There were no other reported complications and patient was informed to continue the same treatment for the next 24 hours. On 7/17/2020 the swollen area was significantly smaller than on 7/15/2020 and the redness was about 3 inches down the arm. The patient reported that it was not worsening and no other complications. Advised to continue the same treatment of Benadryl and to contact primary care provider if area worsens or other symptoms arise.
Within a few hours the arm started getting very sore for approximately one week after the second dose in left arm.  There were two days when the pain started to dissipate but then the pain intensified for the next four weeks.  The should exhibited loss in range of motion, cracking, popping, and locking in place.  Pain started to dissipate but a loss in range of motion with continued cracking and popping in shoulder.  Increased level of warm sensation and tingling inside joint.  On 08/23/2021 met with orthopedic surgeon that did previous shoulder surgery.  Advised to wait an additional four weeks and if pain or loss in range of motion persists will require an image of the shoulder.  Recommended any future moderna shots not in or around either shoulder.  Recommended any future booster shot in buttocks.
tinnitus since about 2 months after first injection through today. loud ringing bilaterally. nothing helps it.
Patient states only had soreness for a few days with the first administration of shingrix...upon receiving the second shot she states her arm has been sore for 58 days ..."at first radiating down to her elbow and then up into her neck"  does not report any range of motion issue     She has not sought medical services for this issue    She states it is now gradually feeling better, but wanted us to report her experience
My doctor gave me a machine to monitor my heart rate. I noticed that my heart rate was irregular after the booster. I also started to get weak in my arms, I used to be very active but now I can barely move my arm. My doctor said that if I keep exercising that it should help. However when I would take the lightest weight possible I could barely move it around. After about 30 mins I would gain some strength back. My doctor put me through stress testing at at that point my EKG was settling down. Right now everything is fine and I haven't had to self monitor my EKG in a while.
Follow up in office afternoon after receiving Tdap and GARDASIL 9 in left arm. Swelling, redness and induration.
Pt recvd DTP/OPV approx 4PM @ clinic; approx 8PM pt started w/high pitched crying x 2-3 hrs (constant w/no relief); Denies any high fever; mom called MD-no rx necessary;
Patient received immunization and reported feeling faint. Incident witnessed by mom. Mom reports LOC for "a few seconds". Patient experiencing tightening of bilateral upper extremities with numbness and tingling of hands. Patient alert and oriented upon assessment. Vitals stable. Numbness, tingling, and tightening resolved soon after. Patient discharged after visit.
Trouble breathing; Sore throat; Headache; Aches all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and MYALGIA (Aches all over) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced DYSPNOEA (Trouble breathing), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and MYALGIA (Aches all over). At the time of the report, DYSPNOEA (Trouble breathing) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown and HEADACHE (Headache) and MYALGIA (Aches all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  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.   This case was linked to MOD-2021-121550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 11 MAY 2021 has Event outcome and hospitalization reported.; Sender'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.
T 103.7, constant screaming for 3 hrs, limp, sponge bath & antibiotic. Seen for MD next day, antibiotic D/C'd
dizzy; triped fell hard; I brused my whole torso; so sick; vomiting; massive headaches; weakness; vision problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: DIZZINESS (hospitalization) with onset Aug2021, outcome "not recovered", described as "dizzy"; FALL (hospitalization) with onset Aug2021, outcome "unknown", described as "triped fell hard"; INJURY (hospitalization) with onset Aug2021, outcome "unknown", described as "I brused my whole torso"; ILLNESS (non-serious) with onset Aug2021, outcome "not recovered", described as "so sick"; VOMITING (non-serious) with onset Aug2021, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "massive headaches"; ASTHENIA (non-serious) with onset Aug2021, outcome "not recovered", described as "weakness"; VISUAL IMPAIRMENT (non-serious) with onset Aug2021, outcome "not recovered", described as "vision problems".  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Profound weakness, sweating, upper respiratory infection, gastrointestinal infection, poor sleeping, body aches throughout. Rx: fluticasone, ZYRTEC, SUDAFED, TYLENOL.
Early morning low grade fever less than 100.  Onset of vomiting around 10AM, followed by a febrile seizure and a spike in fever to around 102.  Patient was taken to the emergency room, tested for possible ailments (all tests were negative) and was released with an ongoing fever.
Started having chest pain and shortness of breath approx. 10 hours after injection. Symptoms kept Worsening. Taken to the ER. Cardiac workup performed. It was negative. Diagnosed with Pleurisy.
Right deltoid warm to touch, swollen, redden area, rash, small nodule at injection site.
Patient was given a monovalent Pfizer COVID-19 vaccine for their third dose instead of the bivalent Pfizer vaccine.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that she was talking with her pharmacist and her pharmacist had a patient who had a reaction to SHINGRIX. This case was reported for 2nd patient. This is one of five cases, reported by the same reporter.
burning is more in left arm than right arm; Burning is all the way down arm and hand and where she got injected; whole left arm and hand was tingling; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Lot number: EW981) at the age of 34 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's", start date: 2019 (ongoing), notes: Taking Levothyroxine in the meaning since 2019; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for autoimmune thyroiditis, thyroid disorder, start date: 2019 (ongoing); VITAMIN D [VITAMIN D NOS] (ongoing). Vaccination history included: Flu shot (She always got flu vaccine). The following information was reported: PARAESTHESIA (non-serious) with onset 14Jul2021, outcome "recovered" (14Jul2021), described as "whole left arm and hand was tingling"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning is more in left arm than right arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Burning is all the way down arm and hand and where she got injected".  Additional information: This report is not related to a study or programme. Patient stated that, she as an RN she always got flu vaccine. She was normal healthy person. She never had a problem with any vaccines before. She never got Covid and never got sick and she was healthy and feeling good and happy to get vaccine. She wanted to get vaccine to protect her family and son and thought she was doing the right thing. No additional vaccines administered on same date of the Pfizer suspect. Didn't get flu vaccine and got every year as a nurse. AE(s) following prior vaccinations or Family Medical History Relevant to AE(s) included none. Vaccination facility type was Pharmacy or drug store. Vaccine was not administered at private Facility. Vaccine administration Time (24hrs) was stated as sometimes in the morning (did not remember the time). No prior vaccination (within 4 weeks). Patient experienced burning more in left arm than right arm. Burning is all the way down arm and hand and where she got injected. Immediately after the first dose of vaccine was administered, patient whole left arm and hand was tingling that only lasted a few minutes, no other side effects. Patient stated first dose of vaccine was fine. Events Causality was not provided.
Approximately two to three weeks after date of vaccination, itchy hives developed all over body. Oral antihistamine Zyrtec 10mg pill was taken and relieved by the symptoms for approximately 24-36 hours. Afterwards, dermatographia has developed and now persists until another dose of Zyrtec is taken.
On 11/4/2020, she received Menveo #2 and Bexsero #1. The next day had arm pain on left arm, which lasted a whole week. On the 6th, had numbness on anterior right lateral calf, which lasted about a day. Overnight and into the next day, she developed nausea and globus sensation.  On Sunday the 8th, went to restaurant and after eating, she was feeling increasingly nauseous but didn't throw up. Felt like she couldn't breathe. No one else was sick. Once at home, she kept gagging. Dizzy. ED: ibuprofen and nausea meds ODT (has used a few, but they didn't help at all). Had had blood work drawn the same day Broke out in a rash around the same time- seen here and Dx Urticaria. Never took the cetirizine because rash self-resolved after about 1 week of intermittent coming and going. No rash for past 2 weeks.  Seen here on 11/12. Urgent Care visit on either the 17th/18th who recommended PMD follow-up. Last Thursday 11/19 called, but never got a call back. So Mom came by yesterday to get this appointment.  At this time, she continues to have spitting up - clear - no blood, occasionally feels like a luggie is stuck in throat and can't cough it up. Denies abdominal or chest pain. Diarrhea started around same time as spitting and ongoing with TID BMs that are liquid - no blood.  Dizziness happening at random and worse when standing up. Drinking water (about 2 cups/day) and juice (about 1 cup/day). Also not eating well initially because of globus sensation, which has resolved, so now feels like she can eat again. In middle of drinking, she'll get hit with sensation to spit up.
Left sided neck/ supraclavicular pain w/ swollen lymph nodes are palpable can feel #2 of them.
Fatigue; fever; cough; diarrhea; body aches; chills; headaches; nausea; and it all lasted about 5 days. First thing that came on with the cough. Cough lingered for another week or so. No treatment for it. A couple of weeks ago, I had stomach issues but I was not the only one and I think it was food poisoning.
Patient had a reaction to the Pfizer Covid-19 vaccine. While waiting for 15 minutes after the shot, patient had a 'seizure' according to patient's mom. She was flapping her hands, staring, and sliding down the chair. 911 was called. Patient was pale and calm but responding to the immunizer (technician) and pharmacist. Patient said she was fine. EMS came and checked the patient and said patient is fine. Patient said she was fine again. EMS left without the patient since she was fine.
I have been suffering from chronic hives for months. I am on a lot of medications. Being treated by an allergist.  They are even in my throat.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 2013, a healthcare provider administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot number not provided). On or about 26-NOV-2016, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
left hand, left leg numbness; This is a spontaneous report from a contactable consumer or other non hcp reported for patient. A 33-years-old male patient received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 21Apr2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced left hand, left leg numbness on an unspecified date. The reporter asked if should see HCP or Emergency. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
accidently administered expired dose of Bexsero; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number abxc06aa, expiry date 31-MAR-2023) for prophylaxis.   On 11-MAY-2023, the patient received Bexsero. On 11-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: accidently administered expired dose of Bexsero). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.