chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative regarding a 15 to 16 year old male patient. The patient's pertinent medical history and drug reactions of allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 INJ 1 dose (also reported as first shot) (dose number and lot number unknown) intramuscularly. Concomitant therapies included TRUMENBA, DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) (TDAP) MCV4. On an unknown date, the patient was feeling woozy, like he was about to faint but did not faint. The patient sought medical attention- the doctor let patient sit and wait until the feeling subsided. No treatment was given for the event. The outcome of the event was considered as recovering/resolving. Causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved. Additional information has been requested.
Pt. arm at the injection site was swollen, red, hot and painful. It was swollen for 1 week - the upper arm also spasmed at the injection site.
After first dose on 8.4.21 (Lot EW0172) within 24 hours had tingling sensation in hands and feet and itching palms and soles of feet. Around mid-January 2022, joint swelling noted in hands and feet. Now suffering from dorsalgia, fatigue, myalgia, paresthesia of skin, inflammatory polyarthropathy
None  MMRV is indicated 4-12 yrs. patient is 16y.o.
COULD NOT SLEEP; ITCHY RASH ON HIS ARMS AND LEGS WHICH WAS SPREADING UP; BODY ACHES; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included eosinophilic esophagitis. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced could not sleep. On 11-APR-2021, the subject experienced itchy rash on his arms and legs which was spreading up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash on his arms and legs which was spreading up, and the outcome of body aches and could not sleep was not reported. This report was non-serious.
Received ZOSTAVAX vaccine on Tuesday 1/6/15 at 6:11 pm. Went to ER Thursday 1/8/15 with large lump on arm at injection site. Was told he had slow anaphylactic reaction and was kept overnight for monitoring.
5.5cm x 4.5cm rt deltoid region (area of DTAP) erythema, indurated, tender, non fluc warm lesion;1st noticed by mom p/vax; dx cellulitis vs early abscess (sterile vs bact);tx med;
After the 1st shot I broke out in rashes chest up, I had a 3" Large lump on my arm and very small lump still there. A couple days later I was getting pain shoot my right side of head above right eyebrow. Like bubble pain or small shooting pain. A few weeks later I noticed a little dizziness but didn't think a lot about it. I didn't take the second shot until about 4 months later and within a few days I started to get pain then running up the left side of head above eyebrow. A week or so later I was experiencing dizziness and head fog. I get extreme head pressure pain kind of like a headache but not a headache. Hard to explain. I caught Covid from work for the 2nd time and after my 14 day quartine from 11/29/22 to 12/10/22 I ended up in the hospital with stroke like symptoms or TIA and then they found leisons in same spot in my head on both left and right side where my pain is. Then I had an eye exam at the clinic, and he did an eye scan that shows some constriction in same spots as leisons. The neurologist didn't even want to see the report he said he is not an eye Doctor. I am still in extreme pain.
1 month old given Hep A vaccine instead of Hep B. No immediate adverse reaction. No treatment given.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 57-year-old male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult, ENGERIX B adult and ENGERIX B adult (batch number 9L2LK, expiry date 21st October 2017). In January 2014, the patient received the 1st dose of ENGERIX B adult. In February 2014, the patient received the 2nd dose of ENGERIX B adult. In June 2014, the patient received the 3rd dose of ENGERIX B adult. In October 2015, the patient received the 4th dose of ENGERIX B adult 1 ml. In June 2014, not applicable after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. In October 2015, the patient experienced drug dose administration interval too long. In January 2016, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: In June 2014, the patient received 3rd dose of ENGERIX B adult, which led to lengthening of the vaccination schedule. In October 2015, the patient received 4th dose of ENGERIX B adult, which led to lengthening of the vaccination schedule. In January 2016, 3 months after receiving the 4th dose of ENGERIX B adult, the patient underwent laboratory test, which revealed 3 mIU/ml (less than 10 mIU/ml) i.e. no antibodies against hepatitis B antigen leading the patient to be a therapy non-responder. It was reported that, the laboratory test for testing the efficacy of the vaccine technically should have been performed 1 to 2 months after 4th dose. The reporter's call was escalated to Medical Information System. This case was identified as duplicate of US2016012046. Case US2016012046 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient.
Tightness in his fingers; First work up my hands were hurting; Knees were hurting; feeling a little sluggish now.; Feeling a little lightheaded; Joints in his legs are sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Mar2023 as dose number unknown (booster), single (Lot number: GL0447), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Mar2023, outcome "unknown", described as "Feeling a little lightheaded"; ARTHRALGIA (non-serious) with onset 13Mar2023, outcome "unknown", described as "Joints in his legs are sore"; ARTHRALGIA (non-serious) with onset 13Mar2023, outcome "unknown", described as "Knees were hurting"; SLUGGISHNESS (non-serious) with onset 13Mar2023, outcome "unknown", described as "feeling a little sluggish now."; PAIN IN EXTREMITY (non-serious) with onset 14Mar2023, outcome "unknown", described as "First work up my hands were hurting"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 14Mar2023, outcome "unknown", described as "Tightness in his fingers".  Additional information: A grandfather called for his 17-year-old male grandson and stated that he got the Pfizer Covid 19 booster but did not say when. Stated he went to school the other day and was feeling a little lightheaded but that has passed now. This morning he felt a little lightheaded but has resolved. The joints in his legs are sore and he also had some tightness in his fingers started around 5 this morning standard time. Grandson got on call and said when he first woke up this morning his hands were hurting. He stayed home from school today. Called to report his side effects. Stated that his joints in his legs and knees were hurting. The caller had to get his glasses and he is reading from the vaccine card, the record shot. Stated that it happened after the third booster. Patient Height is 5'9.5"-5'10". The caller stated outcome is unknown; subsided somewhere down the line on 13Mar2023, he came back this morning and called him and told him that he was feeling lightheaded, and his fingers were hurting. Also stated Is feeling a little sluggish now. Stated that the tightness in his fingers and his hands hurting were all the same things. Started today, 14Mar2023. Resolved today 14Mar2023. Recovered completely.
I had Pfizer for the first two, Moderna for the booster.   On day 2 I had a fever of 102.5. On day 3/4 i developed a rash/hives on my face and scalp. The lymph nodes in my face and neck particularly around my ears on the side where the rash was worse were swollen and painful.  The rash has not yet subsided
pt recv vax 17MAY95 & devel fever to 102; was seen in ER 320AM 18MAY95 & follow up w/ MD; mom stated had loose stools 3d; CBC 24,800 w/no shift to left;
Patient received a monovalent booster in error when should have received the bivalent moderna booster patient requested.
Chronic hives that began about two weeks after the booster and have not resolved 6+ months later
Information has been received from a physician and a certified medical assistant, for GARDASIL, a Pregnancy Registry Product, concerning her 17 year old niece with no pertinent medical history and no known allergies who on 14-NOV-2007 was vaccinated (injection) with a first dose of GARDASIL (lot# 659437/1266U), a second dose on 16-JAN-2008 (lot# 659439/1267U), and a third dose on 21-MAY-2008 (lot# 660389/1968U). Concomitant therapy included MENACTRA (lot# U2538AA) and influenza virus vaccine (unspecified) (lot# U2475KA). In June 2008 the mother found out she was pregnant. It was the mother's first pregnancy. The mother then had her baby in March 2009 and the baby was born with brain swelling. The baby then had surgery (name of hospital, address and phone number unspecified) to have the fluid around the brain drained and once the fluid was drained the physician noticed that the baby's brain was not fully developed in the frontal cortex. The certified medical assistant reported that the mother and baby were under care with the mother's Obstetrician/Gynecologist (OBGYN). The mother's last menstrual period (LMP) was reported as "around June 2008". The infant was diagnosed with hydranencephaly at birth (also reported by the physician as 2 months after birth). Unspecified medical attention sought. At the time of the report, the infant had not recovered. An obstetrician indicated that the mother with late prenatal care during pregnancy delivered a male infant (APGAR score 9) on 23-MAR-2009 at over 41 weeks. Concomitant therapy included prenatal vitamins. On 17-DEC-2008, an ultrasound was performed. The mother was pretested for mitral obstruction at 25 weeks. The baby experienced fetal distress during labor and delivered by low forceps. The obstetrician reported that the infant was normal and there were no complications or abnormalities. A registered nurse from the office of the mother's pediatrician reported that with each office visit, the physician was concerned about the baby's increasing head circumferences. The grandmother was reported as saying that "everyone in the family had a big head." On 18-JUN-2009, both an ultrasound and a computed axial tomography (CT) scan of the head were performed showing "vastly abnormal" results. The baby was then admitted to hospital, where shunts were placed (hospital name was reported). The baby was seen in the office on 20-JUL-2009, where it was noted that the baby was feeding well. Hydranencephaly was considered to be a congenital anomaly. Additional information has been requested. The mother's experience has been captured in WAES#0907USA04345. This information was previously reported in WAES#0907USA04345.
The patient was admitted with the diagnosis of respiratory failure due to COVID-19, as well as pneumonia.  She was started on cefepime, Flagyl, and vancomycin, as well as remdesivir and dexamethasone.  She required fairly low-flow oxygen to obtain adequate oxygen saturations.  The patient was discharged home on day of hospitalization four.
J&J vaccine 4/2021. Moderna booster 11/1/2021. 11/4/2021 began light menstruation in the middle of my cycle. I don?t spot between periods. I kept bleeding and bleeding. Gradually becoming heavier. On 11/24/2021 i began to bleed uncontrollably. Clots the size of my fist. Blood running down legs. Went to ER. Dr. removed excess blood from cervix. Given IV and progesterone. Hemoglobin at 8. Sent home and given tranexamic acid. Continued to bleed. Had Lilleta IUD put in to help control bleeding on 11/27/2021.Had to quit job before I even started because of the blood loss. Continued to bleed until 12/22/2021.
Redness/swelling/whole arm was swelled/hot to touch/very painful elbow hives like bruises.
Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his second dose. Another 15 minutes later as he has a seizure and then was still very delirious. Ambulance was called but patient refused to go to the hospital.
Received 2nd dose Wednesday,3/3/21 6:00pm Tues. 3/9/22 late afternoon? fever 101.4 Wednesday 3/10/21? 1:25 or so... while sitting in recliner, starting seeing very bright light? couldn?t see anything but bright light.... within seconds starting convulsing/ seizure- for about 30 -60 seconds- was unaware of what was happening- eyes open but not focused... arms, legs and whole body convulsing? after it stopped within a minute or two? started vomiting uncontrollably? was able to hear me at this point? 911 was called at 1:35.... Taken to Hospital  Admitted?
Pt noticed burning left arm following vaccination with pneumonia. This increased by the next day to burning in chest and neck to left ear. She was advised to contact MD and subsequently went to ER Tx'd with Epinephrine, steroids x1 week. Noted difficulty breathing when weaned off, steroids restarted and continued Tx until 11/6/03.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB, 56 mcg/0.5 ml, lot # J013394, expiration date 25-AUG-2016; lot # L004754, expiration date 10-NOV-2016. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received fr om the same reporter. Additional information has been requested.
One week after the injection, I developed an itchy red rash just below the injection site.  The rash was about 2" in diameter and lasted about a week.  There was no swelling or soreness and the itchiness was mild.  The rash went away on its own.  No treatment was needed.
I developed a golf ball sized lump under my left arm pit the night after I received the vaccine which was tender and pain if I pressed on it. I developed headaches as well. I visited my doctor on 8/11. No treatment or test were provided but I was told to ice the lump. The lump is still there though smaller, the size of a quarter.
Returned to clinic 12/22. Left arm at deltoid swollen, red, hot to touch. Benadryl et Motrin ordered. Prognosis very good. Seen by NP.
felt bad; side effects were worse after the second dose; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.         No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received  updated event outcome to "Recovered" for all events.
Redness and swelling, itching at site where MMR was given LA. Initially ice used. Seen at medical center on 3/27/07. Redness continues size 30mm x 40mm erythema. No induration., No more pain. Applied hydrocortisone cream without improvement.
Patient called on 08/23/21 after receiving vaccine on 08/18/21 stating that he had the normal sore arm and muscle aches and fatigue, but also stated that he has had nausea and vomiting and has not been able to keep any food down since the day after the vaccine. Recommended that patient should go to urgent care or set up an appointment with PCP.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 71 years old female patient who was vaccinated with a 0.5 ml dose of ADACEL (expiration date 12-SEP-2019 and batch number C5519BAQ) via intramuscular route in the left deltoid on 12-Sep-2018. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient developed a non-serious sore and feels like punched in the arm following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to inappropriate age at vaccine administration. The patient was given recommendations by the pharmacy to ice it and the HCP wants to do an x-ray. No other information about a corrective treatment reported for sore and punched in the arm. The event outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Became itchty, red and hives on face, eyes, chest, and back within 15-20 minjutes.
27 patients were scheduled for the day and provider did not have a nurse or medical assistant, to help with any tasks or check-in. several patients were siblings needing different vials of Pfizer, which required different dilution amounts. Small (1ml) syringes were on the counter, and provider accidentally drew up the wrong dilution amount and diluted the vials with 0.22 mL of NS instead of 2.2 mL. the does given was still 0.2mL  Patient had no side effects
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color,  not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none.  She then had copious amounts of thin nasal drainage to her left sinus/nostril.  Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine.  Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning.  She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
1. Syncope shortly after with head injury (contusion) had CT scan in ER next day which was ok. 2. Fever next day (101.2)
4 days p/vax pruritic papular rash lt wrist;5 days p/vax macupapular rash over lt deltoid site of 8 target lesions w/fixed urticarial rash on lt thigh papules;rx DPH;
Patient developed a high fever, high pitched scream, explosive diarrhea, which persisted for a few days following vaccinations. Within a week, Patient lost all speech, lost eye contact, began banging head, began flapping hands, began tip toe walking, began having horrible meltdowns that never occurred prior to her last set of vaccinations.
3 DAYS AFTER VACCINE ADMINISTRATION PT STARTED HAVING BAD TASTE IN THE MOUTH AND SMELL IN THE NOSE WHICH IS TRIGGERED BY THE TASTE AND SMELL OF FOOD. PT IS STILL HAVING THOSE UNTOWARD VACCINE REACTION UP TO THIS TIME
At approximately 03:00 pm, patient had dizziness and fainting and it was notified to pharmacy staff by the patient?s brother.  Patient lost consciousness for less than a minute but awakened and was responsive and conscious and name and indicate that she was at the pharmacy for a covid 19 vaccine.  Vitals were taken at 3:09 pm and at 3:19 pm.  At approximately 3:25 pm she was able to leave the pharmacy on her own strength with her sister and brother.