chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for the pregnancy registry for VARIVAX (Merck) concerning a 28 year old female patient with no allergies or drug reaction history who on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the patient was 10 weeks pregnant, Approximated LMP: 26-JAN-2011. EDD: 02-NOV-2011. The nurse mentioned that the nurse who gave the vaccines asked the patient through the help of a "language line", if the patient was pregnant and the patient denied being pregnant. The patient sought unspecified medical attention. The patient did not receive any treatment. The nurse reported that blood work was performed (no results were provided). At the time of the report the outcome of the patient was unknown. Follow up information has been received from a registered nurse. It was reported that the patient with a history of 1 pregnancy and 1 full term delivery, no stillbirths or miscarriages was vaccinated on 06-APR-2011 with a 0.5 ml dose of VARIVAX (Merck) (lot number 668455/1310Z). The patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck). The patient did not have a local reaction at vaccination site or any varicella or herpes zoster symptoms post vaccination. Follow up information has been received via pregnancy Questionnaire from a registered nurse concerning the 28 year old female patient that was pregnant. The physician reported that on 20-APR-2011, 17-AUG-2011, 01-NOV-2011 and 20-NOV-2011 an ultrasounds were performed which showed normal, normal breast size and "datas", anatomic "survey" and right position. It was reported that on 10-MAY-2011, the patient started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth a healthy baby boy with no any feature of congenital varicella zoster syndrome. No complications were reported during pregnancy and during labor/delivery. No diagnostic tests were performed and no infections or illness were reported during pregnancy. No concurrent conditions were reported. Follow up information was received from medical records. The patient delivered a baby on 20-NOV-2011 via C-section. Upon internal review, C-section was considered to be an other important medical event. The baby's experience has been captured in WAES1104USA01360B1. Additional information has been requested. All available medical records will be provided upon request.
I feel a numbness like at the dentist from the lower corner of my left eye to my left ear.  slowing decreasing in intensity. muscle soreness at injection site
SORE ARM; TIRED AS HELL; This spontaneous report received from a patient via social media (Facebook) from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously received covid-19 vaccine ad26. cov2. s (form of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The patient did not have any adverse event following covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore arm, and was "tired as hell" for a day. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired as hell, and the outcome of sore arm was not reported. This report was non-serious.
Fever, chills, body aches, sore arm with red spot larger than a quarter.
Patient given peds hep A, not adult. Will be given adult in 6 mos.
Case number PHEH2015US026880, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 66 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016 into left deltoid on 08 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP.
Patient's mom stated that her daughter got infected with bacteria now on antibiotic after getting boostrix at pharmacy. Also per patient, she told us she went to ER and ER Dept md put her on antibiotic drips Vancomycin, did CT scan same day with oRal antibiotic Bactrim DS on 8/20/19, we spoke to the patient to follow up to make sure she is doing fine. Per patient, she confirmed she is doing fine.
This spontaneous report was received from a 80 year old male patient reporting on himself. The patient was not taking any concomitant medication, had no pertinent medical history, known drug reactions or allergies. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot # and expiry date were not reported) for prevention from shingles. On the following day (02-DEC-2016), the patient began to experience flu-like symptoms that were getting worse as of the date of this report. The patient did not seek medical attention. No lab diagnostics studies were performed. The patient did not receive any treatment for this event. Product quality complaint (PQC) was not involved. At the reporting time, the patient still had the flu like symptoms. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
The vial was stored in fridge post puncture.; administered vaccines to patients >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 1st patient (female) as described by the reporter.  No concomitant medications information was reported.  The vial was initially stored in the refrigerator was 21-Jul-2022. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. It was unknown  for how long the vial was exposed to room temperature but it was not greater than 24 hours. Reporter told that patient was fine.  No treatment medications were provided.   This case was linked to MOD-2022-615202 (Patient Link).
rash kinrix injection site measuring 3'' x 3'' red, warm to the touch . Parent gave Tylenol , ice compress & benedryl/ topical  cream.
WRONG IMMUNIZATIONS GIVEN.  Patient was given PedvaxHIB and Vaqta at 6 month well child instead of Vaxelis and RotaTeq that was needed. No adverse reaction occurred, patient is doing fine without issue.,
24hr p/vax became nauseated, lightheaded, rash on chest, weakness;48hr p/vax muscle & joint discomfort, weakness;72hr p/vax swollen fingers progressing to all joints seen by MD;
Vaccines administered 9/8, onset 9/9 malaise, body ache, fever to 100.2.
On 7/3/13 arm red and swollen starting at site and then swelling increased going from armpit down to elbow with increase redness, swelling and pain saw doctor received ROCEPHIN injection and po antibiotics on 7/5/13.
Had the shot, then had them worse/Suspected vaccination failure; Had them worse 2nd time (shingles); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot, then had them worse/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had them worse 2nd time (shingles)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot, then had shingles worst the second time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Friday night through Sunday afternoon had spiking fevers up to 102.1 degrees, chills, nauseas, headaches.  Sunday afternoon through Monday afternoon fevers spiking to 99.4 , tired and body aches.  Monday afternoon through Tuesday very tired and very nauseas.
arm is sore; she almost passed out; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous) in an 87-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous). On 10-Oct-2023, PAIN IN EXTREMITY (arm is sore) and NAUSEA (nauseous) had resolved. At the time of the report, PRESYNCOPE (she almost passed out) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It had been reported that patient arm was sore and she was a little nauseous at morning once she got breakfast but patient was ok at the time of reporting but she almost passed out. Treatment information was not provided.
Covid pneumonia; Tired and gets tired going up the stairs; A spontaneous report was received from a consumer concerning a 57-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Covid pneumonia/ COVID-19 pneumonia and was tired/ fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Feb 2021, approximately few days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On an unspecified day in Mar 2021, the patient experienced a medically significant event of Covid pneumonia. On an unspecified day in Mar 2021, the patient experienced tiredness. Treatment for the event included antibiotics and the patient completed the course of prescribed antibiotics on 19 Mar 2021.  Laboratory details included had a CT scan done with contrast that showed the patient had multifocal pneumonia.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event Covid pneumonia was resolving. The outcome of the event, tired, was not resolved at the time of this report.; Reporter'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 except for the event of COVID pneumonia. The event of COVID pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing pneumonia.
Uvulitis, Treatment: cough drops, numbing throat spray. lasted 12 hours Rash and swelling at vaccine site, Treatment: Ice and heat, still present, reducing in size Fatigue, Treatment: Rest, Still present, but recovering Fever, Treatment: Fever reducer (Tylenol), lasted 48 hours
Fever of 103 Chills Aches Lost of appetite Headache  Weakness  All lasted about 24 hours - the symptoms were the worst 12 hours after receiving the vaccine
Shoulder and Neck Injury, symptoms started three days after the shot was administered.  Created adverse effects to C5 and C6 in neck spine, generated shoulder and neck injury to nerves.  Swelling/inflammation to the area between the C5 and C6 spine.  This has a related cause to the primary nerve being affected generating the shoulder injury.  Currently still under medical clinic care and no known future end date.
beginning w/in 12 hrs fever to 103.2, vomiting, appetite dec, fussy; devel rash-rash red/macpapular; MD felt was stomach virus;
PT. HERE WITH HEADACHE,  BLURRED VISION AND VOMITING FOR 2 DAYS. PT. STATES HIS WHOLE BODY ACHES AND HE DOES NOT FEEL WELL.  PT. HAD JANSSEN BOOSTER ON 12/13. PT. SLEEPING OK. DENIES ANY LEG PAIN  OR SHORTNESS OF BREATH. PT. REPORTS BLURRED VISION AND UNABLE TO FOCUS  TOO. PT. STATES HE VOMITED TWICE YESTERDAY WHILE GOING FROM WORK TO HIS  VEHICLE.
Pain in the armpit of the arm that had the shot; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was not known if the patient was pregnant at time of vaccination. The patient experienced pain in the armpit of the arm that had the shot on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
developed rt arm/chest/back nerve pain/rash. Then decreased muscle strength in rt arm and hand
pericarditis/ Tightness/heaviness in chest/ shallow breathing; booster; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 12:00 (Lot number: FH8030) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). The patient had not had COVID-19 and she was not diagnosed with COVID-19 prior vaccination. There were no concomitant medications received within two weeks of vaccination. Past drug history included: Amoxicillin, reaction: "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 03Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 13Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021 12:00, outcome "unknown", described as "booster"; PERICARDITIS (medically significant) with onset 09Dec2021 02:00, outcome "recovering", described as "pericarditis/ Tightness/heaviness in chest/ shallow breathing". The event "pericarditis/ tightness/heaviness in chest/ shallow breathing" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pericarditis and included prescription of indomethacin and colchicine. The patient had not been tested for COVID-19 since the vaccination. Clinical course: Tightness/heaviness in chest; shallow breathing. Diagnosed as pericarditis.  No follow-up attempts are possible. No further information is expected.
The PA-C who patient sees per daughter in law said the PA suspects the vaccine given 2/15/2021 may have caused the stroke that occurred on 3/12/2021.  Although, the patient had TIA three months prior.  The PA-C from the Clinic in the area.
eyes began itching approx 4hr p/vax;2PM 20OCT itching on face w/a few raised rash areas began evening 20OCT;eyes puffy w/facial itching 21OCTAM;pink macular pap rash areas on face & neck;raised area devel w/itching;
Pt vaccinated with MMR/OPV/TD mother describes facial tics, grimacing mouth, shrugging shoulders, jerking up neck reportedly started about 10 days after immuniz, disappear for several days, then recur.
Narrative: 57 yo male with PMH of CAD, vitamin D deficiency, nicotine dependence, irritability and anger, TIDM, cervical radiculopathy, CKD stage 3, depression, osteopenia, GERD, HLP, HTN, s/p BKA (right) was observed to have dizziness and headache during the observation period post vaccination of COVID19 vaccine. Patient complained of 1/10 dizziness and bilateral eyebrow tension following first dose of Covid-19 vaccination. Had patient wait an extra 15 minutes. BP 158/88, Hr 62, RR 17 , temp 98.0 and 98% O2. Denied chest pain, difficulty swallowing and shortness of breath. BP retake 131/77, HR 60. Denied worsening pain and dizziness upon leaving the Covid vaccination clinic. The patient denied any prior severe reaction to his vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy.
Following my flu shot I could not lift my right arm over my head. I struggled to get dressed, lift a cup of coffee, and carry anything heavy. I have been unable to reach things from a shelf.
Within a few hours arm turned purple from shoulder to elbow and was swollen.  Seen at a Urgent Care; had high fever and received Benadryl.
site of inj warm & red-rash began on trunk of body;advised by MD to get DPH;seen in ER nauseated, SOB, weak, rash over entire body;02 given;
Patient received a Shingrix vaccination and he developed a very large rash which is painful and warm. He feels it may be infected. He will see his doctor.
Itchy face then hives. Itchy face started 12 hours after vaccine. Hives started <24 hours following vaccine (responsive to Benadryl with hives resolved at time of contact). Phone visit completed with primary care office with indications for follow-up reviewed.
Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21).  She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot.  She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril.   Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68.  She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range.  On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am:  132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right  that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss.  She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.