chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; Felt flu-like; white pale hands; Dizzy spells; blood pressure shot up; Body aches; chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired). The patient was treated with MAGNESIUM at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Dizziness, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included fluids, Magnesium drip
Initial unsolicited report received from nurse on 25-Oct-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV and PNEUMOVAX (Batch number, expiration date, dose, route was not reported) in arm on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced severe swelling and cellulitis that was warm to touch and elbow to shoulder area was swollen. Lab data was not reported. The patient received corrective treatment with antibiotics. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198), on 21Mar2021 as dose 2, single (Lot number: ER2613), on 22Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "pulmonary endometriosis" (unspecified if ongoing); "SVT" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Oct2018; METOPROLOL, start date: Aug2020; POTASSIUM CHLORIDE, start date: May2020; LASIX [FUROSEMIDE], start date: May2020; KELNOR, start date: Jan2007; FAMOTIDINE, start date: Jan2019. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Pneumovax, reaction(s): "Known allergies: Pneumovax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Product=COVID 19 Treatment, brand=Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Completed 5 day treatment with Paxlovid. Felt good and was returning to normal routine. Four (4) days after completing the 5 day course of treatment, symptoms began to return. General malaise, runny nose, scratchy throat, body aches, wet cough. All the same symptoms as initial indication plus a strange headache not present in the initial encounter.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 4 times with the Pfizer product, having received vaccine on 01/28/2021, 02/18/2021, 08/26/2021 and 06/01/2022. They presented to emergency department on 09/01/2022 for shoulder pain and were discharged with medication. They presented to emergency department again on 09/02/2022 via EMS for fever and change in mental status/new confusion. They tested positive for COVID-19 on 09/02/2022 (upon hospital admission). They had a highly complex medical history and were on chemotherapy for multiple metastasized cancer. They were found to be septic due to Enterobacter and in acute renal failure. They also had suffered a non-ST elevated myocardial infarction. The individual was revised to DNR due to poor prognosis and they died in hospital on 09/04/2022.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (The patient had breast cancer 3 years ago).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) (seriousness criterion medically significant). At the time of the report, BREAST CANCER RECURRENT (Recurrence of her Breast Cancer/got my biopsy result and it says that my cancer is back) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: cancer (abnormal) Patient cancer is back.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not 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 event, a causal relationship cannot be excluded. Previous medical history of Breast Cancer is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Previous medical history of Breast Cancer is a confounder.
Patient has a renal transplant; developed fever and seen in Emergency Ctr.; tested positive for COVID.
Customer received the vaccination, sat with wife and vaccine administrator to drink a soda due to the patient knowing that he has previous experience with receiving vaccines and passing out. When patient stood up, he passed out and pharmacist on duty was notified. Patient was given a bottle of water and sat in waiting area after waking up.
Day after the flu shot I got a scratchy throat, the day after that I had a stuffy nose for the next two days, now the fourth day after I'm coming down with a cough. I took the shot b/c I have a newborn and now she's sick too. 5 weeks old.
An unspecified number of pts were vaccinated with the first and second doses of varicella virus vaccine live.  Subsequent laboratory evaluation revealed a lack of response. There were no adverse experiences.
Fatigue, stiffness in left arm and fingers, diarrhea, severe dizziness (unable to stand for a bit), headache, fever, chills, upper back soreness, injection site and lymph node swollen   Unable to sleep due once it all hit around 11:30pm  Diarrhea and dizziness began at 5am
3 hours after I received the H1N1 vaccine I had the onset of left foot pain, non weightbearing, numbness, tingling, swelling, fluid, now bone loss. Left hand slight numbness, left groin discomfort. Have doctored for 2.5 years now, Clinic, etc. Clinics, Podiatrists, Orthos,  NO ONE knows what is causing this problem with my foot. They acknowledge there is a problem but say it is a mystery. When I ask about the H1N1 Vaccine they all reply, "We don't know enough about that or avoid the subject all together. I did 18 months on crutches, I now walk with a cane and live in pain daily. Last Dr. visit It was suggested it may be something I'll just have to live with.
painful joint pain in the neck; painful joint pain in arms, legs; painful joint pain in arms, legs and joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in the neck"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in arms, legs"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in arms, legs and joints".  Additional information: Caller mentions that on April 14th she got the second dose of the Pfizer Covid vaccine and almost 2 weeks after she is getting painful joint pain in the neck, arms, legs and joints. She just wants to know if this is normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red patch on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red patch on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red patch on her arm). At the time of the report, ERYTHEMA (red patch on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
shrugging tic and some eye rolling after 1st dose noticed Oct. 3rd, after 2nd dose shrugging was gone but the eye movement tic rolling eyes darting seemingly every few seconds on October 13th. I will be taking her to the doctors next week to be evaluated but wanted this reported. She had a reaction like this to Miralax in 2017 so I was very worried about giving her this vaccine. I called hospital with my concerns and decided it was safe to let her have the vaccine. Hopefully this goes away as the polyethylene glycol leaves her system, but if it doesn't I will be one upset mom. Imagine being a perfectly normal young girl to suddenly have everyone looking at your eyes moving darting around uncontrollably. It looks strange and thats not what you want as a teen with an extremely slim chance of dying of covid. Please think about what you are doing to these kids, anyone who has had any kind of adverse reaction to miralax not just anaphylaxis should not have this vaccine.
This medically confirmed spontaneous report (initial receipt: 20-Oct-2014) concerns a male patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed a blood clot in his eye. Initially, the patient experienced a loss of vision. The blood clot resolved and his vision was completely restored. Outcome was reported as recovered.
Vaccination location very sore. Pain continually worsened to the point where shoulder and upper arm muscle pained when used. Inability to lift arm over head or lift items with the vaccinated arm due to weakness. Three days after finishing a prescribed prednisone medication the pain in the upper arm and shoulder have returned.
Pt called 8/5/10 to report intense itching & tingling especially on soles of feet & palms of hands beginning about 6 hours after vaccination- intermittent every few hours. Advised MD appointment. 8/11 pt called, left message stating "95% better", took BENADRYL. Mess. to call re: follow-up.
CHILD DIAGNOSED WITH CELLULITIS AT THE SITE OF VACCINE ADMINISTRATION.  THE SITE WAS RED THEN DEVELOPED A PURPLE CENTER.  CHICKENPOX ALSO DIAGNOSED.  ONE WEEK LATER (04/13/2013) ANTIBIOTICS GIVEN, 3 LYMPH NODES ON NECK WERE SWOLLEN. AS OF 04/22/2013 CHILD WAS STILL ON ANTIBIOTICS. MOTHER SAID THAT CHILD WAS STILL NOT WELL.
I experienced a swollen lymph node under my left arm pit, my hands became swollen, pain in my wrist and tiredness.
Local site reaction to DTaP on the upper left thigh. the area is circular and red. There is minimal warmth. Local site reaction to DTaP on the upper left thigh. The area is circular and red. There is minimal warmth.
The second injection hurt really badly immediately, as I was getting the injection and in the moments after and continued hurting badly for almost two weeks after, and now I have this pain that feels like an overuse injury in my shoulder and it radiates into my collarbone and neck area and sometimes down into my arm as well.  I can?t sleep or carry bags on that side.  I don?t have insurance so I don?t know who to see about it but I?m worried that the needle missed the muscle and hit something in my shoulder.
I got my first shot I did have a very  fast heartbeat like my heart rate was racing for about 3 hours; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that on an unspecified date, the patient got first shot and did have a very fast heartbeat like patient heart rate was racing for about 3 hours. Patient was coming up for second shot, so it said to report any side effect that patient had but also had another question, shot was scheduled for the first for this Thursday (unspecified date) and patient who said cannot make appointment or reschedule it anywhere and asked how to reschedule second shot and should does need to get the second shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to an unspecified number of patient of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patient received improperly stored PEDVAXHIB (lot#, expiration date, strength, dose, frequency and route were unknown). The patients' concomitant medication was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 30AUG84 or 30SEP84 & 1OCT84 pt exp leg swelling from knee to hip;
This is a spontaneous report from a contactable nurse. A 1-year-old female patient received PREVNAR 13 at 0.5 ml single, polio vaccine (unknown manufacturer), hepatitis B vaccine (unknown manufacturer), rotavirus vaccine (unknown manufacturer), DTP (unknown manufacturer), Hib (unknown manufacturer) all administered in Jan2016. Relevant medical history and concomitant medications were not reported. The patient had no drug allergies. The patient reacted badly to a vaccine series of medications in Jan2016 and as result she was hospitalized. The nurse reported that the patient may have been hospitalized numerous times after this occurrence but she was unaware of exactly when. The patient was recovering from the event. The nurse reported that they could not determine which medication the patient reacted badly to however when she was at the hospital they were able to determine that she reacted specifically to the preservatives in multi-dose vials. They will now look for vaccines that are preservative free in the single dose vials.
Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to shock (shaking, rapid eye movements)
Moderna COVID-19 Vaccine EUA Began with headache and sweating around 9:45am, increased in intensity with generalized pain over the next hour. Intense migraine, nausea that lasted about 12 hours. Vomiting began about 6 hours in, two times. Received treximet for migraine and ondansetron for vomiting.
Few days after shot started with light headed ness/dizzy, which has come and go, then few weeks and my right side of face would go numb/tingly, then few weeks later my right arm would feel like asleep/heavy/burning sensation/numb/tingly, then few weeks started have burning sensation in torso on right side with something feeling as if it were squeezing me on right side, few more weeks spread down into calf and foot numb/burning/tight/tingling sensation, to right back spasm in shoulder blade with shooting pains down arm, another month went by now starting to have same sensation on left side arm/fingers/calf/foot as do on right, does come and go but most generally have symptoms every day now even have metallic taste in my mouth last few weeks
constant numbing pain running down R Arm/Arm pain 50 min after Shot; constant numbing pain running down R Arm/Arm pain 50 min after Shot; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; my R Arm is Messed up; feeling of being swollen; 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 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "my R Arm is Messed up"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "feeling of being swollen"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "not recovered", HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "unknown" and all described as "constant numbing pain running down R Arm/Arm pain 50 min after Shot"; MOVEMENT DISORDER (non-serious) with onset Nov2021, outcome "unknown", ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered" and all described as "Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder".  Additional information: Subject was patient assistance. Got Pfizer shot 1 on 15Nov2021 for fear of losing my jobs. Do not want shots. Work at home M-F. Since shot 1, patient R arm was messed up with feeling of being swollen, with constant numbing pain running down R arm. Unable to lift arm high enough to put bra on without help due to pain in shoulder. Arm pain 50 min after shot and had zero problems prior to shot. Still experiencing same level of arm and shoulder pain 4 weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Face swollen - esp around eyes - eyes almost completely closed - upper body scratching cough - nausea. Adrenaline - 2 mg/IM given.
Information has been received from a registered nurse concerning a 4 year old patient described as healthy who on approximately 02/01/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Within 24 hours of vaccination, on approximately 02/02/2005 the patient developed a rash with scattered bumps and itching.  Unspecified medical attention was sought.  Prescribed treatment included baths and diphenhydramine hydrochloride.  At the time of the report the patient had not yet recovered.  There was no product quality complaint involved.  Additional information has been requested.
shortly after receiving the vaccine, the patient reported shortness of breath, scratchy throat, and tingling of the face and lips for which she was administered an adult epipen and 50mg benadryl by mouth. Vital signs obtained simultaneously demonstrated normotension and oxygen saturation greater than 98%. Her symptoms improved, vital signs remained stable, and she was transferred to the local ED by EMS. At the ED, her symptoms did not recur and she was discharged from the ED. She followed up late in the afternoon in the base clinic and reported resolution of her previous symptoms with only a lingering headache.
Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 36 years old patient who received a dose of vaccine TENIVAC (lot U5525AA and expiration date 07-Jan-2019) via unknown route in the left deltoid on 15-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. Patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
burning foot pain, erythema, fever, chills, dizzy, nausea, headache, blood blister on face, fatigue, burning pain on back
Developed itching and hives for 24 hours. Took anti histamine for 48 hours.
Area of redness. Approximately 4x6 area of redness was warm to the touch. Denies any pain.
Muscle aches and severe shaking due to chills reported 8 hours after injection, fever of 102 and mild nausea reported 12 hours after injection, continued fever and muscle aches from 12 hours - 30 hours after injection, ocular pain and tenderness reported 30 hours after injection along with continued muscle aches
Severe hives; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 2016 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe hives (non-serious) on an unspecified date with outcome of unknown.    Information on lot batch number has been requested.
Vomiting multiple times with watery stools up to 7 times a day. Pt also with crying and apparent discomfort.