chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had frequent sharp stabbing pain in my left upper arm where the shot was administered and in my left thigh, along with extreme pain from shoulder to shoulder and in my neck, along with constant ach/pain in all sites. These symptoms lasted for 9-10 days. Then the sharp stabbing pain in left arm & leg subsided, but the other ach/pain continued. Currently, a month later, I still have occasional sharp pain in my left arm along with the constant ach/pain in my left arm where the shot was administered.
Received FLUZONE QUADRIVALENT Adult vaccine on 10/20/14. From 10/21-10/23 patient experienced headache, tiredness and difficulty with vision focus. On 10/24 rash appeared on one side of face. Rash worsened over 10/25 and 10/26. On 10/27 patient visited dermatologist and was diagnosed with shingles.
H1N1 Vaccine was administrated on 11/9/2009. About two months later, left upper arm distal end of the deltoid shown muscle and fat tissue atrophy. Gradually, the above-mentioned atrophy became more apparent. Ortho consultation is in progress.
By 8 PM of the night of the shot on 4/13 I was very lethargic and was starting to run a fever, by the next morning 4/14 I had woken with chills, covered with two blankets and my skin was hurting, I had issues with holding my head up and every bone in my body ached terribly, by noon I guess the fever broke and I was in a puddle of sweat that required me to change all my sheets and take multiple showers and change my clothes multiple times as well.
Child received 5th dose of Dtap on 9/4/18 in left deltoid. Mother noted redness and swelling spreading to left forearm next. Afebrile. Child complains soreness in entire arm following day on 9/5/18. Per CDC, complained reaction is more common in 4th or 5th dose of Dtap, usually involving entire arm, may last from 1-7 days. Provider explained to mother about reaction, reassurance given. Warm compress to left arm. Tylenol for pain. Call if symptoms continue beyond 7 days without improvement or increase redness, swelling, and pain, or fever.
Patient called on 06/01/07 to report that he developed a rash on his right lower back on 05/28/07.  The rash is itchy but not painful.  He saw Dr. on 06/01/07 who diagnosed his with Shingles.  Patient was given Valtrex one gram twice a day po.
fever; nasal/head congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 63-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: Unknown) via an unspecified route of administration in the right arm on 02Mar2021 as a single dose for COVID-19 immunisation. Patients medical history included thyroid. Concomitant medications included levothyroxine 0.125 mcg qd, and baby ASA qd from unspecified date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination the patient underwent a COVID-19 virus test (spit test) on 08Mar2021, the result found to be negative. The patient experienced fever, nasal/head congestion on 06Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 10Mar2021.    No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
102.5 degrees F; freezing; 105 degree F fever; headache; chills; little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing), FATIGUE (little bit tired), PYREXIA (105 degree F fever), HEADACHE (headache) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Denied) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced FATIGUE (little bit tired). On 28-Feb-2021, the patient experienced FEELING COLD (freezing), PYREXIA (105 degree F fever), HEADACHE (headache) and CHILLS (chills). On 01-Mar-2021, the patient experienced PYREXIA (102.5 degrees F). On 01-Feb-2021, FATIGUE (little bit tired) had resolved. On 02-Mar-2021, FEELING COLD (freezing), PYREXIA (105 degree F fever), CHILLS (chills) and PYREXIA (102.5 degrees F) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Pt received a Typhoid vaccine about 3 hours after injection had pain in neck that radiated down arms. Also experience headache and diarrhea.
very sick; arm swoll up where I got the shot; Where I got the shot, it was sore for weeks; my nose clogged; hard for me to breath; when I blow my nose blood comes out; head hurts; feel dizzy; extremely tired; heart gets a funny feeling; my body will super hot, then sometimes my body will get real cold; I start shivering; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "very sick"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm swoll up where I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "Where I got the shot, it was sore for weeks"; NASAL CONGESTION (non-serious) with onset 2021, outcome "not recovered", described as "my nose clogged"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard for me to breath"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "when I blow my nose blood comes out"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "head hurts"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "feel dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extremely tired"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "heart gets a funny feeling"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "my body will super hot, then sometimes my body will get real cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "I start shivering"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The day after patient took vaccine he become very very sick. His arm swoll up where he got the shot, it was sore for weeks, nose clogged up and it still is 6 1/2 weeks after he took the vaccine and still counting. Its very hard for him to breath, when he blow nose blood comes out which is still going on head hurts, he feel dizzy, he be extremely tired everyday, heart gets a funny feeling when he breath in out, some times body will super hot to the point he start sweating then some times my body will get real cold and he start shivering. Something needs to be done about this because every since he took Covid-19 vaccine I have been sick. He asked for help because vaccine is slowly killing him.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever, aches, blurred vision, autonomic dysfunction (POTS), migraines and more.
on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21  acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI.  1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility,  2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time
Pt recvd vax & devel fever which lasted a couple of days & an inject site reaction which included redness & swelling; pt recovered;
3:40pm: Patient reported tingling throughout the left side of her body, including her face and arm. Patient teary. No visible swelling in face or arm. Assisted patient to supine position w/ elevated feet. 3:45pm: VS taken. BP 110/58. Pulse 76 bpm. RR 12 breaths/min. (no temp or Sp02 taken). No visible changes or swelling in face or arm. Patient still teary. 3:50pm: Patient reported mild pain in left side of face w/ continued tingling in left arm and left face. 3:56pm: Assisted patient to sitting position. Repeated BP: 115/56. Still no visible changes or swelling to face or arm. Offered apple juice, patient drank a little.  4:15pm: Patient reported diminished hearing in left ear and some vision changes.
This spontaneous report as received from a medical assistant refers to a 17 years old female patient with allergy to mold. The patient's medical history included anxiety and rush. The patient was vaccinated with the first dose of 0.5 ml GARDASIL lot number 0214AE intramuscularly in left deltoid on 26-JUN-2012. No other co-suspects were reported. Concomitant medications included LAMICTAL. On 26-JUN-2012 the patient experienced pain at the injection site as the dose was being administered. Later that evening the patient developed a rash on her left forearm. The patient said it is the same type of rash she had gotten in the past when she came in contact with mold. The patient also developed "subjective weakness" of her left arm. There was no loss of strength according to the physician's notes. The patient had sought medical attention via an office visit. BENADRYL and ice were given as treatment for the events. No laboratory diagnostic studies were performed. The outcome was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Patient was prescribed Bactrim for an abscess on the left thigh, which mother noticed the day after the vaccines were given.
Lymph node swollen in groin area; the patient was administered with the Shingrix vaccine in glutes; This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 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 enlargement of lymph nodes and vaccine administered at inappropriate site. On an unknown date, the outcome of the enlargement of lymph nodes and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The reporter stated that the patient presented with swollen lymph node in the groin area after she was administered with the Shingrix vaccine in the glutes. The reporter consented to follow up. Additional Supportive Information: The patient was administered with the Shingrix vaccine in glutes, which led to vaccine administered at inappropriate site.
No adverse effects reported.; one dose of improperly stored MMR II  was inadvertently administered to the one patient on 10/3/2019.; Information has been received from a medical assistant, referring to an 18 months old patient of unknown gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.     On 03-OCT-2019, the patient was inadvertently vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) Albumin status rHA (recombinant Human albumin) (one dose, lot number R028003, expiration date 1-OCT-2020; route unknown) for prophylaxis (product storage error). The sterile diluent used to reconstitute the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) was stored properly. No adverse effect was reported, no product quality complaint (PQC) was involved. Temperature was above 47 Fahrenheit (52 Fahrenheit). Time frame was 10 hours. There was no previous temperature excursion. The call was because of a data logger.
Redness, pain, and swelling subsided 2-3 days after 1st dose, but on day #8, redness itching and  swelling of injection site returned along with  tingling in left arm, pain in left armpit area.
swollen lymph node; with dull pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) and VACCINATION SITE PAIN (with dull pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node) and VACCINATION SITE PAIN (with dull pain). At the time of the report, LYMPHADENOPATHY (swollen lymph node) and VACCINATION SITE PAIN (with dull pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported. No treatment was provided.
Soreness at injection site, nausea, chills, fever, dizziness,  sleepiness
Headache, fever, sore at injection site  Later severe Leg cramps and pain along with foot pain
Site: Redness at Injection Site-Medium, Systemic: Lymph Node Swelling-Severe, Additional Details: chest pain
Immediate itching of left arm; tightness of throat; difficulty swallowing; heart beating fast; This is a spontaneous report from a non-contactable consumer (patient herself). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6202), via an unspecified route of administration, administered in left arm on 05Mar2021 at 18:30 (age at vaccination: 53 years) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included asthma, pancreatitis, Kidney Stones, penicillin allergy and sesame oil allergy. Concomitant medications included pancreatin (CREON) and omeprazole (ZEGERID) and multi-vitamin. Patient previously took tetracycline, codeine, morphine, nitrofurantoin (MACROBID), and ciprofloxacin (CIPRO); had allergy with all these medications. The patient did not receive any other medications within four weeks of vaccination. On 05Mar2021 at 18:30, the patient experienced immediate itching of left arm, tightness of throat, difficulty swallowing and heart beating fast. The patient self-administered Benadryl for the treatment of the adverse events. The patient visited the physician's office for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report was received from a healthcare worker (medical assistant) and refers to a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 20-OCT-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscularly (lot#, exp.date and anatomical location were not provided). It was later learned that the patient was approximately 12 weeks pregnant at the time of vaccination (the estimated last menstrual date 28-JUL-2014, estimated due date: 04-MAY-2015). No adverse experience was reported. The outcome of the event was unknown. Additional information has been requested.
Mother reported redness/pain and swelling 4/14/07 10am; went to Night Lite Pediatrics - diagnosed with local immunization reaction with cellulitis - treated with Rocephin 750mg IM/Benadryl po/Motrin po and sent home with Omnicef po bid/Benadryl po bid; parents returned 4/15 with c/o worsening - treated with Rocephin 1gm IV/Solumedrol IV/ Benadryl IV and admitted to hospital. 5/17/07-DC Summary for DOS 4/15-4/17/07-DC DX:Left thigh cellulitis. treated with IV Clindamycin.
This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a health professional concerning and approximately 16 year old female with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine, intramuscularly. On unspecified dates, the patient was vaccinated with the second and third doses of GARDASIL vaccine. Secondary suspect therapy included VARIVAX. Other concomitant therapy included PPD TINE TEST). About two months after completing the GARDASIL Vaccine vaccination series, in approximately 2008, the patient developed arm pain near the injection site and on the opposite of the arm, in the triceps area. The pain is not constant but it does seem to get worse with use. The patient did not see medical attention. At the time of reporting the patient had not recovered. On an unspecified date, was performed to the patient an X-ray and an ultrasound, results for both were normal. Follow up information was received on 05-JAN-2009 from the nurse practitioner. It was reported that the female patient received the third dose of GARDASIL on 07-JUL-2008 (659968/0847X) intramuscularly in the left arm. ON 07-AUG-2008 the patient complained about arm pain. It was reported that the patient had a strain to weight lifting. The ultrasound and the Magnetic Resonance Imaging were negative. The patient recovered on 30-OCT-2008. Additional information has been requested.
This spontaneous report was received from a pharmacist who reported on them self. On 16-AUG-2017, the pharmacist was administrating a PNEUMOVAX 23 lot # N011305 for prophylaxis. On 16-AUG-2017, the pharmacist experienced occupational exposure to product, accidental exposure to product and product leakage. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA009458:
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
Started with fever 5/25/2019. Drooling increased. Woke with right thumb swollen over joint. Fussy. Had to be held. Seen 5/28/2019 seen in office. Walking ok and then would fall. But if touched feet would pull away and cry. 05/29/2019 mom called c/o muscle weakness. not wanting to walk or crawl. Mom had to leave work due to fussiness. Referred to ER. Xrays of hip, leg, and foot all normal. Sed rate, crp and wbc count normal. Dx septic arthritis and admitted. IV antibiotics started. MRI scheduled and ortho to consult.
did not receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2021 but the reporter was not sure).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: Age at vaccination was not applicable for this report. The pharmacist reported that a patient did not received the 2nd dose of Shingrix at appropriate time also not received till the time of reporting which led incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details were reported for 1st dose of Shingrix.
Patient received a first dose Moderna vaccine on 4/7/21. Following, patient scheduled an appointment for a first dose Pfizer vaccine. Patient was counseled and administered Pfizer on 4/26/21. Afterwards, patient mentioned he received a first dose Moderna. He was due for his second dose Moderna vaccine on 4/26/21. Additionally, the patient marked "no" on the immunization consent form to the question "have you ever received a dose of COVID-19 vaccine?"
Fever of 102.5 on day 4 followed by 200-300 blisters on hands and feet. Measles rash.
Dizziness. Couldn't move and get up. Muscle aches. Patient recovered within 3 days. Has not seen or called physician. Change to non-serious.
Information has been received from a clinical medical assistant referring to an unspecified number of patients of unknown age and gender. The patients'' pertinent medical history and drug reactions/allergies were not reported. Since 21-MAR-2016 the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L025738 with expiration date 14-AUG-2017, dose and route unknown). The temperature/time frame was 8.5 Celsius degree for 2.5 days (60 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.