chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/21/2021 GANGRENE OF LEFT TOE I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/21/2021 GANGRENE OF LEFT TOE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 7/21/2021 GANGRENE OF LEFT TOE I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/21/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/21/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 7/21/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/21/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/21/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 7/21/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/21/2021 PERIPHERAL ARTERY DISEASE, UNSPECIFIED TYPE I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/21/2021 PERIPHERAL ARTERY DISEASE, UNSPECIFIED TYPE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 7/21/2021 PERIPHERAL ARTERY DISEASE, UNSPECIFIED TYPE
Information has been received from an RPh concerning a pt (demographics unknown) with asthma and some antibiotic allergies who was vaccinated with a dose of MMRII. Concomitant therapy included an unspecified "inhaled steroid". Subsequently, the pt had an unspecified reaction to MMRII. The pt sought unspecified medical attention. Additional information has been requested.
Strong inflammation near to the neck of a strongly inflamed nodule. I don't know if it's an artery. But it is getting worse and worse.
Information was received on 08DEC2014 from a female reporter regarding her female friend (the consumer/patient). The woman reported that her friend developed shingles after becoming sick after an unspecified period of time after she (the patient), had received ZOSTAVAX on an unspecified date. The patient did not wish to provided information. No further information was provided. Additional information is not expected.
Fever, chills, shakes, SOB, burning skin, achy bones - late pm.
Left testicle swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 08:30 (Lot number: ER 8729) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot number: ER2613 in left arm at 09:00 as dose 1, single), administration date: 19Mar2021, when the patient was 46 years old, for COVID-19 immunisation, reaction(s): "left testicle swollen", "left testicle sore". The following information was reported: TESTICULAR SWELLING (non-serious), outcome "not recovered", described as "Left testicle swollen". Therapeutic measures were not taken as a result of testicular swelling.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Fatigue; Pain/redness/lump at injection site,; Pain/redness/lump at injection site; Pain/redness/lump at injection site; Swollen/painful lymph nodes under right arm; Swollen/painful lymph nodes under right arm; Runny nose; Chills; Headache; Back ache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), doxazosin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all started on unknown dates and for unspecified indications. The Patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 12:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. On 03Apr2021, the patient experienced fatigue, pain/redness/lump at injection site, swollen/painful lymph nodes under right arm, runny nose, chills, headache and back ache. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fatigue, pain/redness/lump at injection site, swollen/painful lymph nodes under right arm, runny nose, chills, headache and back ache was recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 07-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
on day following routine vax pt became dyspneic & ashen in color; sunctioning of airways provided relief but episode re-curred; no sz activity or LOC; admitted to ER & hospitalized for work-up;
Fatigue  Muscle or body aches  Sore throat  Congestion or running nose
Slight fever, muscles sore, headache, mild red rash on cheeks and neck, feeling tired and sleepy.
Approx. 6" x 6" warm red patch on shoulder injected with PNEUMOVAX 23.
5 days & nights of 102.7 fever; Chills; Bursting headache; Muscle & joint pain; Muscle & joint pain; Patient lost all feeling in fingers and toes; Fatigue; Serious illness after traveling; This is a spontaneous report from a contactable consumer or non-health care professional (the patient). A patient with unspecified age and gender received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot number/Expiration date: not reported) via an unspecified route of administration on 27Apr2021 as second dose, single for COVID-19 immunisation. Patient medical history included pneumonia and unspecified viral or bacterial infection from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on an unspecified date via unspecified route of administration as first dose, single for covid-19 immunization. After patient being fully vaccinated on 27Apr2021 as second dose, he experienced serious illness on an unspecified after traveling to attend his father-in laws memorial on 28May2021 with unmasked. 12 days later, on an unspecified date in Jun2021 patient was endured with 5 days & nights of 102.7 fever, chills, bursting headache and muscle & joint pains which exceeding any of his past viral or bacterial infection 4 days and patient had lost all feeling in his fingers and toes. The fatigue after was similar to double pneumonia that he had decades ago. Not mild symptoms. The patient underwent lab tests which included body temperature results 102.7 degrees. Outcome of the event's serious illness, chills, bursting headache, had lost all feeling in his fingers and toes and fatigue was unknown. Fever, joint and muscle pains was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Client in office with mother, who's language is limited. Child said he and his sister need COVID vaccine. After the nurse gave the vaccine and observation were over she gave presented the CDC vaccine card to the parent. The mom goes in her purse and pull out a CDC vaccine card, which shows the children had already been fully vaccinated.
3/29 11pm: severe chills, body aches began 3/30 3am: ** syncopal episode, loss of consciousness, ground level fall - pt ambulated to bathroom independently, became dizzy, lost consciousness, fell to the ground, total loss of consciousness approx 30 seconds, aroused easily by family member 3/30 continued all day - chills, body aches, fatigue, nausea, headache, dizziness, "brain fog", overall malaise and weakness,  ** 1:00pm another syncopal episode and loss of consciousness 3/31 and 4/1 continued fatigue, overall malaise weakness, dizziness, brain fog 4/2 no symptoms 4/3 symptoms recur - significant fatigue, malaise, generalized weakness, nausea, brain fog 4/4 no symptoms
pt had high fever, irritability p/1st Hep B shot; pt had sz like activity w/clonic movements, head back, eyes rolled back x few seconds assoc w/fever;  Hep series will be delayed;
Patient received Hep B vaccine at place of employment. Approximately 15 minutes later patient began complaining of nausea and feeling shaky. Within 10 minutes she stated she vomited. Shortly after she began having trouble breathing, and EMS was contacted. Patient refused transport and patient was released from duty. Patient states she did not seek any further medical attention.
Initial unsolicited information received from a nurse on 17-May-2018. This case involves a patient (age and gender not reported) who was administered with 0.4 percent diluent of ACT-HIB (batch number, expiry date, dose, route and site of administration were not reported). It was a case of actual medication error due to inappropriate reconstitution technique. 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. List of documents held by sender: none.
Body rash to left side of body,"hives", to left arm (one bump) and to left leg (8 bumps); the patient was seen in Occupational Health clinic; unable to rule out rash associated with vaccine.
Patient stated flushing, redness to face and arms with nausea. Pt came to lobby of clinic at 3:00pm Dr. to room shortly after, vital signs taken, Benadryl given and pt. monitored, finger stick glucose taken read at 89. Dr and I monitored pt until driver arrived and pt.'s symptoms resloved.  Inst. to go to ER if she has breathing problems.
red, raised rash, warm to touch;rx DPH, heat, hydrocortisone;
8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".). At the time of the report, INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to a patient of unknown age and gender. On an unknown date the patient received improperly stored RECOMBIVAX HB (lot#, strength, dose, frequency, route unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever and shivering and that these had resolved. The reporter did not consent to follow up. This case linked with US2020026930, reported for patient's wife.
This non-serious spontaneous case, was initially received on 14-Sep-2017 from other Health Professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one (temperature excursion). On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion (explicitly coded as drug administration error) recommended the vaccines to be discarded. No adverse events were reported after the second excursion of vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow-up report received on 20-Sep-2017: No adverse events were reported after the second excursion of vaccine administered. Amended narrative accordingly. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
Exactly one week from the date of vaccination, my daughter developed a fever and cold symptoms,  and did not eat or drink well for about 24 hours.  Her symptoms began the morning of September 6, 2002.  By that afternoon, I decided to schedule her an appointment as she was somewhat lethargic and I couldn't get her fever to break.  Her fever at the doctor's office was documented at 102.7.  While waiting for the pediatrician to evaluate her, she developed a brief tonic-clonic seizure and went into respiratory arrest.  It's disputed whether or not she went into cardiac arrest as well.  One staff member says she did, one says she didn't.  CPR was administered and she was revived shortly thereafter.  She was sent to local ER, and upon arrival, her blood sugar levels are also disputed, as the glucometer reading read below 30, while the labwork showed a glucose of 90. She was given a chest x-ray, which showed no abnormalities.  She was then transferred by ambulance to the hospital for overnight observation, due to her possible cardiac arrest.  Upon arrival, I was advised by staff that if her fever didn't break by morning, she would have a spinal tap done to test for meningitis.  However, her fever broke sometime during the early morning hours of September 7, 2002, and no spinal tap was performed.  She did have an EKG done, which was normal.  She was discharged around 4 P.M. that day with a diagnosis of febrile seizures, and a strong suspicion of medium chain acyl-coA dehydrogenase deficiency (MCADD).    My daughter is now almost 3, and shows some neurological deficit as she has hyperreflexia in both legs, mild spasticity in her right ankle, and her right foot shows moderate intoeing.  She also had a speech delay, which has greatly improved with speech therapy to the point where she doesn't qualify for therapy any longer, according to the state requirements.  She had her genetics testing a week or two after her seizure, and all of the results came back normal. She was evaluated by a neurologist in August 2003, and had an EEG and a MRI of her spine, both of which were normal.  She goes back to be re-evaluated by both the geneticist and the neurologist in April, 2004. Discharge summary on 04/28/04 states nothing new to report. Follow up medical record on 05/14/04 states: completed.
Anaphylactic reaction, chest tightness, SOB, spO2 dropped to 64 %. 0.3 mg epinephrine and 25 mg Benadryl given. Onset of symptoms occurred approx 5 minutes post injection of Fluzone. 911 was called Pt was transported to hospital for observation.
Redness at injection site; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and chills. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the injection site erythema and chills to be related to Shingrix.  Additional details were provided as follows: The caller was patient. The age at vaccination was not reported. The patient received her first dose of the Shingrix vaccine and experiencing redness at the injection site and chills.   The reporter asked how long do these symptoms last after receiving the vaccine.   The reporter declined to provide demographic information. The reporter did not consent to follow-up. No additional details provided by reporter.
Right now her fever only about 100; she is shivering and freezing; vomiting; she is shivering and freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "semi-okay"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever". The following information was reported: PYREXIA (non-serious) with onset 22Oct2022, outcome "unknown", described as "Right now her fever only about 100"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 22Oct2022, outcome "unknown" and all described as "she is shivering and freezing"; VOMITING (non-serious) with onset 22Oct2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: reporter stated that we got the Omicron, my girlfriend and I got the Omicron shot, here it says shot at 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she is shivering and freezing and it has been since last few hours and vomiting too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253010 same product, patient, different AEs, different dose;US-PFIZER INC-202201253011 same product, patient, different AEs, different dose;US-PFIZER INC-202201253008 same product, patient, different AEs, different dose;US-PFIZER INC-202201253009 same product, patient, different AEs, different dose;
Narrative:  Patient presented to hospital with generalized weakness, failure to thrive, severe anemia, limited cardiac reserves and progressive declined in setting of progressive right heart failure (significant pleural effusion requiring drainage every 2-4 weeks). Patient also noted to have pericardial effusion. Unknown hemoglobin pathology as patient's fingers appear purple and hemoglobin untestable due to the presence of cold agglutinins. Daughter reports patient progressively weak over last three months onset after 1st COVID vaccine. Patient previously used cane for assistance now using walker last three months. Daughters noticed rapid decline since week prior to admission after a fall. Patient previously had symptomatic improvement with pleural fluid drainage but patient did not improve after last drainage (5/27/21). Patient very weak and fragile with increased work of breathing and very low exertion tolerance. Hospice consult. Patient converted to hospice/comfort care. Discharged from hospital for end of life/hospice care. Patient's family expressed concern about timeframe corresponding to post-vaccinations series. Provider wonders if cold agglutinin disease could have been triggered by vaccine. Patient died 6/26/21.
Her arm was very sore, got large lump in armpit area, arm got red.  Occured the evening of the injection.  Put warm compresses on it.
Started 05/18/2022, I started getting pain. I called the doctor the next day and they prescribed a MEDROL dose pack. It did not help me and I called them again and they put me on a high dose of prednisone and instructed me to also take ibuprofen or ALEVE. It helped with the pain but didn't resolve the numbness I was feeling in my right foot up through my knee. I went in and was advised to get an MRI scan to see how to treat it. Unfortunately, due to my insurance they will not approve an MRI until I have had at least 6 weeks of conservative treatment. After the 6 weeks passed (06/30/2022), I went back into the office and they requested the MRI again. Last Friday, 07/07/2022, I was approved for the MRI and I am scheduled to have one done tomorrow (07/15/2022). I have a follow up with a Dr. on 07/28/2022 to interpret the MRI. When the prednisone ran out, I was prescribed gabapentin and I have been taking that twice daily along with ALEVE. When I wake up in the morning, the numbness and pain are worse. The medicine helps the pain but not the numbness. Also, I am experiencing edema in the ankle that is worse at night. Within the last week, I have been wearing compression socks and that is helping slightly for swelling during the day.