chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Pediatric Bivalent vaccine for age group 5-11 was administered to a 2 year old.
Did not notify employer, posted on Facebook that she had heart palpitations and shortness of breath that started 16 hours after vaccination, but also stated that she had similar episodes two weeks prior to vaccine.
Sunday  after administration, pt stated she started to feel  her hear racing when going to bed, woke up with her heart racing in the am.  Pt stated to experience tingling and burning in her feet that later traveled to her hands.  Pt has a history of PVCs but noted an increase in the PVC frequency.  Chest pain that was intermittent but lasted for 4-5 days.     Continues to experience twitches and tingling feet to this day.
This spontaneous report as received from a Licensed practical nurse (LPN) refers to a patient (unknown age and gender). On 25-JAN-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB 2 doses of pediatric (0.5 ml doses) equal an adult dose but the doses had expired (lot # 666806/0732Z and exp date 10-NOV-2012) (route not reported) and on 25-FEB-2013 vaccinated with the second dose of RECOMBIVAX HB 2 doses of pediatric (0.5 ml doses) equal an adult dose but the doses had expired (lot # 666806/0732Z and exp date 10-NOV-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medication was reported. The patient was not experiencing any known symptoms. Additional information has been requested.
Quadracel was given inadvertently to a 13 month old who has not been vaccinated before.
NAUSEA; LOSS OF APPETITE; TASTE WAS OFF; CHILLS AROUND 11-12 PM AT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 130 pounds, and height was 67 inches. The patient's concurrent conditions included egg allergy, sulfa drugs allergy, and anaphylactic to pcn/sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug use. For antibiotics, she can only take zpack/ erythromycin due to reported allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered at around 16:15 on left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced chills around 11-12 pm at night. On 18-MAR-2021, the subject experienced loss of appetite. On 18-MAR-2021, the subject experienced taste was off. On 18-MAR-2021 08:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 18-MAR-2021, and was recovering from chills around 11-12 pm at night, loss of appetite, and taste was off. This report was non-serious.
This case was reported by a pharmacist and described the occurrence of inappropriate dose of drug administration in a 16-year-old subject of unspecified gender who was vaccinated with Havrix for prophylaxis. On an unspecified date the subject received primary course of Havrix (1440 ELISA units, unknown). This was considered to be an inappropriate dose of drug administered. The 16 year old subject should have received a 720 ELISA unit dose of Havrix as indicated. The pharmacist considered the event was clinically significant (or requiring intervention). No adverse events were reported.
Sinus completely clogged up for over one month immediately following vaccination. Patient couldn?t breath through nose during sleep. He has to open his mouth to sleep causing heavy snoring and sleep apnea.
4-5 hrs p/vax pt had 5-6 episodes of sz-like activity-darting of eyes back & forth lasting about 30 seconds ea time; pt taken to MD then admitted to hosp; EEG & bloodwork neg;
pt recvd vax 21MAY93 & started crying 9PM that day-high pitched squeal for 1 hr given APAP; slept thru noc woke up 5AM on 22MAY; started high pitched screams again; gave APAp & fell asleep again about 1 hr later, cried about 1 hr-unconsolal
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient said on 10/17 he had itching and hives that began in the axillary region of injected arm that eventually spread down and across his entire body. He said he experienced swelling of hands and hives all over trunk of body and into the inguinal area which prompted him to seek care at an urgent care. Within the next day it was flaring up again and he went to the emergency room on 10/19/22. He received additional care and the hospital doctors advised him to call us.
Discharge Provider: MD, PhD Primary Care Physician at Discharge: MD  Admission Date: 9/21/2022  Date of Death: 10/8/22 Time of Death:  6:47 AM Preliminary Cause of Death: Cardiopulmonary arrest (HCC)  Patient 82 year old with an extensive PMH, HTN, Afib on Eliquis, diastolic heart failure, COPD, OSA w/Cpap, CKD stage 3, GERD, gastric ulcer, diverticulosis, anxiety/depression, fibromyalgia, and MRSA that presents 9/21/2022 with an Intracranial Hemorrhage. To review, the patient was last known well at 2 pm today when her daughter arrived home from work. The patient was in her normal state of health, complained of new onset nausea that she attributed to her potato chips. She got up and went to the bathroom, proceeded back to her bed. Her daughter heard a loud grunting noise, found her half out of bed and nonverbal. EMS was called. Upon arrival to ER that patients blood pressure was 137/94, on exam she had right sided weakness, facial droop, right gaze deviation. Head CT was completed that revealed a  Large left frontal ICH, mild surrounding edema, 1-2 mm MLS. CTA head/neck with area of active extravasation in the hematoma, cannot rule out vascular fragility/rupture, underlying vascular malformation, or mass. Accordingly, she was given Fieba for reversal of her Eliquis, and started on nicardipine to maintain SBP < 160. She was transferred to the NICU for close monitoring. Upon arrival she was awake, nonverbal, forced right gaze not crossing midline, right sided H/H, Right side with some noted spontaneous movement to RUE. With concern for ongoing bleeding a repeat head CT was obtained with progression of her hemorrhage. Neurosurgery was bedside to evaluate patient, will hold off on OR for now and repeat HCT in AM. Nicardipine infusion restarted to achieve new blood pressure goal of < 140. Family at bedside for history taking, discussed plan of action, all questions answered.
Rash, several inches in diameter at injections site. I woke up with it today. Deltoid still swollen and feels stuff/graded. Bruise that was already reported is still there too but has healed quite a bit.  Also, pain in left armpit that started 2/19. Cannot feel a lump but assuming this is likely a swollen lymph.
At about 11PM I could not get warm and started to shiver.  I fell asleep under a blanket, but woke up several times with muscle aches.  At 1AM I went to bed with an extra blanket, but could not get warm.  At 3AM I was still cold and achey, so I took 500mg generic extra strength Exedrin (acetaminophen & aspirin).   At 4AM I finally felt warm.  At 5AM my muscle aches subsided.
Bell's palsy; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or around April 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant. The event of Bell's palsy was considered to be disabling by the reporter.
Approximately 5 days after the vaccine was administered, the patient developed a red, circular area on the left thigh.  At the time of her well child check up on 10/13/21, the varicella vaccine was given in the left leg and the MMR and Hep A vaccines were given in right leg.  It may be an inflammatory reaction secondary to injection technique (suspicion that this vaccine may have been given IM instead of subcutaneous and that this may be the cause of this reaction). She presented for evaluation of this concern on 10/26/21. with her mother.  At that time, I had a low concern for cellulitis or abscess since she was afebrile and over the past several days, the area of redness/concern had not increased in size. We marked area on the left leg with a surgical pen to watch for spreading of the erythema. Advised that the family can use warm compresses to the area.  Also advised that they can use Zyrtec daily for itching.
Vaccine was administered after expiration date - no adverse events. Exp. date was 12/2/13.
11-1-06 call received from mother. Child temp 101.2. Left lower extremity hot and was providing Motrin regularly. Complained of left side shaking and thirst. Advised ER at ER temp 101.2, O2 Sat 99%, left thigh and face swollen. Upper arm some redness. Diagnosis: Acute allergic reaction to immunization with fever. Improved.
Seconds after receiving immunizations this child flew out of her chair at 3 feet away from the chair, bumping the right side forehead on the floor, causing a 1-1 1/2 inch bruise. Child alert to name , place and father and brother and sister. No complains of positions. (+) PERRLA, 3 mm pupils. BP 106/60, HR 60. Father told to get evaluation at the hospital.
Patient received a higher than recommended Pfizer vaccine (12+) formulation for the 1st dose. Patients parents were informed, side effects were reviewed with parents and a follow up phone call was done.  No adverse symptoms were felt.
After 2 minutes of vaccination, patient passed out and had an absent seizure. However, it lasted about 1 to 2 minutes, he was able to wake up by himself.
Arm still sore 2 weeks after shot - was going to urgent care for other issue and was supposed to call back w/update - no response.
On 4-16-09 Patient received DTaP #5 and Varicella #2 to the (R) Deltoid by RN and IPV #4 and MMR II #2 to (L) Deltoid. Family brought pt to clinic and stated pt had had some itching and hard red area 10" by 10" to the (R) deltoid area. No respiratory or other symptoms voiced. Localized reaction will be monitored. Pt eats eggs without incident and no reactions with past vaccinations.
Pt was wrestling with a Marine who had previously been inoculated with smallpox vaccine. Pt has zero symptoms at this time. Signs of papule lesions to the neck area and behind the left ear area. Tx: dry occlusive dressing applied to lesions follow-up for dressing changes PRN.
One day post anthrax shot # 2 member developed a facial rash and HSV lesion on lip. Rash also on frontal trunk area. Member denies fever. Benadryl taken with good effects.
Approximately 9 hours after being vaccinated patient reported awaking with heart palpitations.  She went to the Emergency Department and reports that she was diagnosed with Atrial Fibrillation.
Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea:  Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet
rash at the site; a little bit of headache; arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash at the site) and HEADACHE (a little bit of headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011CZ0A and 006MZ0A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (a little bit of headache). On 30-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the site). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash at the site) and HEADACHE (a little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided for first dose events   This case was linked to MOD-2021-057119.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Additional Information received and patient demographics updated
hx of 2 episodes of being pale & limp; no cyanosis but definite pallor; no stiffness, sz or fever noted; cry was weak, no irritability;
I administered her flu shot, and almost immediately she slumped over.  Her mom held her up so she didn't fall off the chair.  She regained consciousness after about five seconds.  I gave her water and her mom gave her a snack.  She said she felt ok.  She sat for a few minutes, then left with her mom.
ringing in the ears; muscle and joint pain; joint pain; nausea; chills; headache; back of his eye and his skin hurt; back of his eye and his skin hurt; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (back of his eye and his skin hurt), EYE PAIN (back of his eye and his skin hurt), TINNITUS (ringing in the ears), HEADACHE (headache) and MYALGIA (muscle and joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive) in July 2020.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 24-Mar-2021, the patient experienced SKIN DISCOMFORT (back of his eye and his skin hurt), EYE PAIN (back of his eye and his skin hurt), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced TINNITUS (ringing in the ears) and MYALGIA (muscle and joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN DISCOMFORT (back of his eye and his skin hurt), EYE PAIN (back of his eye and his skin hurt), MYALGIA (muscle and joint pain), NAUSEA (nausea) and CHILLS (chills) had resolved, TINNITUS (ringing in the ears) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-120806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: New adverse event was added and email id was received. Lab test and medical history were added.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-MAY-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical facility for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Pt had localized reaction to left deltoid, very red, swollen, warm to touch, mother advised cool wash clothes, Tylenol, Motrin or OTC Benadryl for itching at site.
Headache, NauseaVomiting, chills Narrative:  Per nursing report:  "2nd dose COVID 19 vaccine on 2/2/21. New symptoms of nausea, chills and headache."
Information has been received from a female who in November 2002, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23. In December 2007, the patient developed pneumonia. It was unspecified if the patient sought medical attention. Additional information has been requested.
Information has been received from a health professional concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies, who on 28-FEB-2008 was vaccinated with a 0.5 mL subcutaneous booster dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 657788/0719U). Concomitant vaccination included a dose of Menactra in the left arm. There was no concomitant medication. On 29-FEB-2008, the patient's mother phoned the physicians office to reported that the patient's left arm at the injection site was red, hot, tender to touch, and swollen to more than 5 centimeters. It was noted that the patient had also received a dose of Menactra in the same arm but at a different area. The patient was treated with ice and elevation. There were no laboratory or diagnostic studies performed. At the time of this report, the patient had not recovered. The patients vaccination history included on 27-MAY-1998, a first subcutaneous dose of varicella virus vaccine live (Oka/Merck). A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Follow up information from the health professional indicated that on 29-FEB-2009, the patient developed a local reaction with a 5 cm, large red welt-hot.  Current patient status was not reported.  This is one of two reports from the same source.  Additional information is not expected.
IM right deltoid region. Right shoulder pain after receiving injection that has progressively worsened since. Difficulty with abduction/internal rotation of the right shoulder. Suspect injection placed into subacromial space.
Redness, swelling of (L) upper arm; about 2.5" x 2.5" surrounding the point of injection. (+) warmth, non tender, no induration.
Administration issue Used Baksnap syringe 23g 1.5 ml, safety not depressed in pt arm, small portion (est 0.02 to 0.04 ml) remained in syringe.
On 09/22/2000, the patient developed a varicella like rash on the chest and neck. The nurse was unsure of the number of lesions and no fever was reported. Unspecified medical attention was sought. In follow up, the LPN reported that the patient had recovered. No further information is available.
dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised
Had a stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Covid-19 vaccine (primary immunization completed Unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had a stroke".  Clinical information: The patient received 3rd dose of vaccine and had a stroke. Dr. said that he believes the event was attributable to the vaccine. The event happened after his third dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and the event cerebrovascular accident cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse event,s. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Patient was vaccinated with 2nd dose too early. The vaccination card was dated as 05/10/21. However, both scribe and nurse read the card as 05/01/21. Both stated that the handwriting on the card was not clear and that the 0 looked like a dot. Pt was made aware. I spoke to the pt. He said he felt fine and normal. He provided me with his information and was discharged.