chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a published literature article. This case concerns to 14 adult patients (10 males and 4 females). The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date, 4 unspecified patients were vaccinated with GARDASIL (dose, frequency, route, lot# and expiration date were not provided), and 10 unspecified patients were vaccinated with GARDASIL 9 (dose, frequency, route, lot# and expiration date were not provided), for recurrent respiratory papillomatosis (RRP). Two unspecified patients, received the first dose of GARDASIL but had not complete the series. There were no reported side effects due to vaccination. A copy of the published article is attached as further documentation of the patient's experience.
Patient reports: Received vaccine on Friday (4/15). On Saturday had pain and redness at site.  On Sunday the injection site was "red, hot, and hard" in an area about the size of her palm. Lymph nodes in her neck were swollen and she felt "really awful".  She went to the ED on Sunday were she was treated with IV fluids and Vancomycin, given a course of oral antibiotics to continue and discharged to home.  She called Employee Health to report this on Monday morning and was feeling better.
12 hours following vaccination experienced headache, body aches, fever, injection site pain, lethargy
Herpes Zoster, Cough, Pyrexia, Irritability, Diarrhea, Nasal Congestion, Pulmonary Congestion, Rhinorrhea Information has been received from a licensed practical nurse concerning a 20 month old white male with no pre-existing allergies, birth defects or medical conditions who on 12-MAY-2005 was vaccinated in the right thigh with a second dose of varicella virus vaccine live (Oka/Merck) (Lot #648942/0831P). There was no illness at the time of vaccination. No known history of varicella disease was noted. Concomitant therapy that day included a second dose of measles mumps rubella vaccine  (MSD) (Lot #648664/0992P). Other vaccinations included: the first, second, third and fourth doses of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (Daptacel) on 23-JUN-2004 (Batch #C1698AA) left thigh, 31-AUG-2004 (Batch #C1700aA left thigh) 25-OCT-2004 (Batch #C2044AA-left thigh) and 12-MAY-2005 (Batch #C2221AA-left thigh); the first, second and third doses of poliovirus vaccine inactivated (Vero) (IPOL) on 23-JUN-2004 (Batch #X0799-right thigh) 31-AUG-2004 (Batch #X1038 left thigh) and 05-OCT-2005 (Batch #Y0425-left thigh(, the first, second, third and fourth doses of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) on 23-JUN-2004 (Batch #495-300 right thigh) 31-AUG-2004 (Batch #495-707 right thigh) 25-OCT-2004 (Batch #A74399K left thigh) and 05-OCT-2004 (Batch #A74406P right thigh) and the first, second, third doses of HIB conj-hepatitis B Vaccine (MSD) on 23-JUN-2004 (Lot #647480/1288N left thigh) On 07-JAN-2006 the patient presented to the office with a rash on his mid thorax area extending around towards his back. The rash was vesicular and some bad scabs. He was diagnosed with shingles. The area was itchy with approximately 30-50 lesions. Some loose stools were noted. Information received contained the following adverse events: cough (11-NOV-2005) runny nose (11-NOV-2005) nasal congestion (11-NOV-2005) fever (11-NOV-2005), increased fussiness (11-NOV-2005), chest congestion (16-DEC-2005 and cough (16-DEC2005). Additional information has been requested.
Woke up Abruptly with vomiting, diarrhea, & body Aches at 0200 01/24/10 which lasted 24 hours. Then had nausea, body aches, restlessness, & "lack of concentration" with "cold sweats" for the next 2 - 3 days.
Cannot drive; Can hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Cannot drive) and GAIT DISTURBANCE (Can hardly walk) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21B and 032B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2021 and CABG. Concurrent medical conditions included Blood pressure, Acid reflux (esophageal) (Stomach acid reflux) and Anxiety. Concomitant products included METOPROLOL for Blood pressure, HYDROCODONE, ALBUTEROL [SALBUTAMOL], ACETYLSALICYLIC ACID (ASPIRINE), BUMETANIDE (BUMEX), BUMETANIDE, OMEPRAZOLE, CHOLESTEROL, THYROID and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication, VITAMINS NOS (MULTIVITAMINUM) for an unknown indication and an unknown indication.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced IMPAIRED DRIVING ABILITY (Cannot drive). 16-Jun-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk). At the time of the report, IMPAIRED DRIVING ABILITY (Cannot drive) and GAIT DISTURBANCE (Can hardly walk) outcome was unknown.            Isidolam - low dose for anxiety,Eye gel, 1 drop each eye 4x day and CABG blood pressure medication  No treatment medication was reported.   This case was linked to MOD-2022-465584 (Patient Link).
pt had 2nd dose of covid vaccine on 03/16  went home got something to eat  laid down- does not remember anything else for 2 days    was found on the floor by her bed  must have fell off of the bed  has lost urine  neighbor found her- call paramedics  declined to go to hosp   thinks she passed out for 1.5-2 days      daughter came to take care of her  had to drink from straw  couldn't eat  brain fog  feeling better now
Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 26-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), 0.5 ml, lot # L019996, expiration date 02-DEC-2016, subcutaneously. Concomitant drug was not reported. No adverse effects were reported. This was one of the two reports from the same reporter. Additional information has been requested.
approx 24hr p/vax pt devel achiness & an inj site rxn characterized by redness & warmth;3wk post vax pt devel axillary lymphadenopathy & a boil under the arm;pt expressed pus & a core from the boil;site reportedly healing @ the date of rpt;
Approximately 2 1/2 hours after receiving IPV, MMR and DTaP patient developed a rash on her forehead.  While in the ED rash was also noted on her legs.  Treated with Atavax.
Really tired on Monday the 22nd and I felt fatigued. I began to get nauseated and then I began to vomit. I vomited 5-6 times even though I had not eaten anything. I also had diarrhea. I had chills. Some point during the night I spiked a fever, I woke up and drenched. Yesterday  the 23rd I  had a fever, my stomach still does not feel settled. I have not ate much since Sunday but have been trying to stay hydrated with lots of water.  I also developed a cough yesterday. Tuesday night my temperature 100.6 and I think it got higher because I woke up once again drenched in sweat. This morning my temperature was 99.  I am achy today with muscle and joint pain,  my stomach feels better but I still leery of  eating. I did eat some Ginger ale and eat some saltine crackers.  I also feel horse.  I called my doctor yesterday and still have not heard back. I will call again today.  It feels like I feel better in the morning but as the day goes on I get worse and start feeling worse. I have been resting a lot in bed.
Hives, rash, itching, swelling. Administerd 25mg IM Benadryl, 125 mg IM Solu-Medrol, 4mg PO Zofran.
Currently have one alive baby who is age 1. Second pregnancy was active during time of first dose of  COVID vaccine,  all tests were normal before hand as well as a healthy blood panel. I was a little over 5 weeks pregnant. A few days later a spontaneous miscarriage was occurring where massive tissue was expelled.
Patient had mild, red, warm to touch rash developed couple days after the shot. They complain their arm hurts, but pain has gone down.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 3:Pfizer / Dose Number: 2:Moderna / Dose Number: 1: Jansen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 16:00 as dose 3 (booster), single (Lot number: Fp7139) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Oct2021 at 16:00 as dose 2 (booster), single (Lot number: 066F21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Mar2021 at 13:00 as dose 1, single (Lot number: 1805020), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2022, stop date: 29Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Aug2022 at 16:00, outcome "unknown", described as "Dose Number: 3:Pfizer / Dose Number: 2:Moderna / Dose Number: 1: Jansen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative for Covid for 3 days; Positive, notes: Positive test and return of symptoms on day 5; Negative, notes: tested negative for covid via Home Binax Now test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the 2 days after completion of Paxlovid, tested negative for covid via Home Binax Now test. Continued to test negative for Covid for 3 days. Positive test and return of symptoms on day 5 following completing Paxlovid. Symptoms include headache, chills, congestion, Symptoms include headache, chills, congestion, tightness in chest, cough.  No follow-up attempts are possible. No further information is expected.
This report describes the occurrence of autism in a male child of unspecified age who was vaccinated with hep B vaccine for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medial history, concurrent conditions, and concurrent medications were not reported. The subject reportedly received an unspecified number of injections of Engerix B "in or about 1997." "In or about 1997 and 1998," the subject also reportedly received injections of Tripedia. "In or about 1997," he reportedly received injections of HibTiter. The subject's attorney alleged that "As a result of the mercury in the thimerosal-containing vaccinations received during these developmental years, the subject now suffers and in the future will continue to suffer, from the toxic neurological effects of his mercury poisoning, including but not limited to autism." The autism and mercury poisoning in this report are considered to be medically serious (OMIC).
No signs of reaction at time of shot, but about 2 hours later fell in local Hospital parking lot, broke glasses, hit head on left side, and skinned knee.
Headache, Myalgia, sinus/head pressure, arm soreness at injection site Narrative: N/a
Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the time I came back home I went to bed with all my cloths on and 2 more blankets I had a fever of 103 and was very hot to touch the shakes would not go away. The next day I started feeling a little better still cold and had a very sore throat and runny nose body ached bad very bad friday I feel better but feel like I was hit by a truck
on 4/10/21 headache, feet felt numb, continued to get worse until almost total paralysis of body.  He is still currently in hospital getting treatments. ,
EXTREME NAUSEA; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastroparesis, non smoker, non alcohol user, and sulfa allergy, and patient had no known drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the patient experienced nausea and have had extreme nausea every day. Patients doctor (Gastroenterologist) was aware of the adverse effect. Patient was currently taking ondansetron for nausea but it was not working. Patients husband described her as deathly sick.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case was assessed as non serious.
AFTER PATIENT RECEIVED THE VACCINE, HE DID NOT SIT DOWN FOR THE 20 MINUTES AS HE WAS TOLD. PHARMACIST WAS TOLD THAT HE FELL AS HE WAS WALKING AROUND IN THE STORE.  THE FAMILY MEMBERS SAID HE FELT LIGHT HEADED AND FELL BACKWARDS. WHEN PHARMACIST ARRIVED AT THE SEEN, THE PATIENT WAS FOUND SITTING DOWN ON THE FLOOR WITH HIS LEG STRETCHED IN FRONT OF HIM. HE WAS PALE BUT COMPLETELY COHERENT AND ANSWERED ALL PHARMACIST QUESTIONS.  HE HAD NO BREATHING OR VISION PROBLEMS , HE KNEW WHERE HE WAS, DATE AND TIME, AND IF HE HAD NO NAUSEA OR HEADACHE. THE PARAMEDICS WERE CALLED REGARDLESS WHO TOOK OVER EXAMINING THE PATIENT AND TOOK HIM OUT OF THE STORE. PHARMACIST FOLLOWED UP WITH THE PATIENT TODAY9/2/21. THE PATIENT REPORTED THAT THE PARAMEDICS DID NOT TAKE HIM AFTER EXAMINATION AS HE WAS FINE. HE WENT HOME AND HE REPORTED NO OTHER ISSUE.
Headache, diarrhea, hot/chills, severe muscle spasms lasting 10 hours, nauseated, weak, fatigue.
I felt a hard nodule in my left clavicle on Saturday 14 Nov 2020 and when I looked in the mirror there was a pillowy lump above the area.   I went to a Clinic where the Dr. told me that the pillowy lump may be normal.  It is not.  Initially, she also claimed she could not feel the nodule until I insisted.  They did an X-ray there and said there was some deterioration of the left clavicle.     On Monday, 16 Nov 2020 I saw a Dr. filling in for my regular PCP.  She ordered an ultrasound and the results are:   Ultrasound soft tissue head and neck  CLINICAL INDICATION: Left supraclavicular lump.  Real-time ultrasound evaluation of the left side of the neck was performed in the supraclavicular region in the region of the palpable lump indicated by the patient.  In this region, there is a lymph node measuring 0.9 x 0.5 x 0.9 cm. The cortex of this lymph node is hypoechoic and thickened diffusely and demonstrates mild hyperemia. This most likely represents a reactive lymph node.  IMPRESSION:  The patient's palpable lump most likely represents a reactive lymph node.   I asked the Dr. if this could be an adverse event and she said maybe.  She did not ask for or take any information to report this.   I noticed today on the website for this specific flu vaccine that Lymphadenopathy is a post marketing experience so I thought my symptoms should be reported.  Although I have not completely recovered, the hard node is mostly gone.  The pillowy lump above the node area comes and go.  I feel like I have a mild flu.
Initial information regarding unsolicited case received from nurse on 07-Nov-2013: This case involves four patients (demographic detail unknown). The patient's past medical history and concomitant medications were unknown. On an unknown date in November 2013, the patients received FLUZONE ID (Lot# UT4725AA and expiration date unknown) through intradermal route. The patient reported inflamed reddened area at the injection site, and fever. The outcomes of the events were recovered. No further relevant information provided. List of documents held by sender: none.
Within 3 minutes of vaccine administration, hives head to toe. Sent via ambulance to ED. Pt. recovered after DECADRON given. No SOB.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: 006m20a), in left arm, on 30Mar2021 as dose 2, single (Lot number: 046a21a), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 076?z1a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "mesothelioma cancer" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 "; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Client was waiting in line for Covid shot, client fainted.  She caught herself on a tale with her father's assistance.  Event was not witnessed by any staff at POD site but client moved to cot after reporting what happened. Patient denied hitting head and it was confirmed b father.  BP 102/81, P 85,  oxygen 99%.  Vaccination given without further incident.
After 15min wait patient had glassy eyes and shaky left hand ,increased heart rate ND low glucose. After being observed 30 min more patient was alright to drive.  A follow up phone call was made patient was doing fine some pain at injection site.
Full body rash. Dr prescribed generic for Medrol 4mg dose pack, 21 tablets.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. Since 01-JUN-2015 the patients were vaccinated with an unspecified number of improperly stored (Merck) VARIVAX (lot # K015992, expiration date 23-SEP-2016) (dose and route unspecified) by an unspecified physician. No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K015970 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
-Low grade fever at 100.9.  -Excessive chills followed by feeling very very hot and excessive sweating. Kept going back and forth from chills to feeling hot/sweating throughout the night  from approximately 8pm till 8am.  - had almost ?Gumby legs?. Felt a mild loss of control of my legs and arms for about 10 hours. Was scared to hold my child in fear I would drop him. Also had w some numbness in hands and legs during this time period.
Patient calls, reports that on 6/15/20 she received a pneumonia vaccine. She reports that she reacted to this vaccine as follows:   Patient began experiencing severe left arm pain in the arm she received the pneumococcal 23 vaccine in, along with being unable to lift it.  Patient stated she began to ache all over her body and began to vomit.    The GI symptoms have subsided.  Her arm pain is much improved and she is able to lift it again.   She is home resting.
Initial report received from a non-health care professional (consumer) on 30 April 2014. A 42-years-old female patient, had received a first dose of FLUZONE vaccine (lot number: UH941AF) intramuscularly in the right arm on 13 December 2013. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not applicable. On 17 December 2013, 3 days after the vaccine right arm started to hurt and is still sore. At times she feels numbness and tingling in fingers. The arm is sore in the morning and when she sits up. Any movement or pressure hurts her right arm. It is getting worse every month. The patient went to the doctor a few times and they are now ordering an EMG. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of the event was not recovered from the adverse event. Documents held by sender: None. Follow-up information received from a non-health care professional (consumer) on 16 July 2014: EMG was normal; therefore there was no nerve damage from shot. MRI was ordered and showed tear of rotator cuff tendon. The patient was referred to orthopedic surgeon. Gabapentin was started for nerve pain.
Swelling of left thigh with redness x 2 days. Treatment; prednisolone 15mg/5 ml take 4 mL daily x 5 days. AUGMENTIN 200 mg twice a day x 10 days.
1/18/21Moderna injection on 1/18/21 1/21/21ER- right flank pain/kidney: Blood in urine?prescribed Naprosyn 1/27/21 Dr /for pain right kidney/ Blood in urine/ prescribed Ciproflaxin 500 mg/2 times daily for 7 days and Phenazophridine 200 mg tab every 8 hrs as needed 2/7/2021 clinic /red eyes and urine pain/ antibiotic eye drops
I received the shot a couple days before my period was to begin. My period last month and the one I am on now were late, and I have severe symptoms. I have a lot of fatigue, increased appetite, low stamina for workouts, and nausea. My internist ran my bloodwork and it looked good. We are trying to figure out what I can do to feel better.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information was received from a Licensed Practical Nurse. The nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at the reporting time. The nurse also stated she might fax information at a later time. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 17 years old adolescent. The patient was vaccinated with GARDASIL (J015378, expiration date 09-APR-2016) on 22-SEP-2014. Additional information has been requested.