chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 4 year old male patient with no pertinent medical history who on 03-OCT-2007 was vaccinated with a dose of VARIVAX (lot# 658191/0853U). Concomitant vaccinations on the same day included a dose of TRIPEDIA and a dose of HAVRIX. On 12-NOV-2009 the patient developed "mild breakthrough" chicken pox. There were about 15-16 lesions. The patient was evaluated in an emergency room, but was not admitted to the hospital. There were no laboratory diagnostic studies performed. On an unspecified date, the patient recovered. No further information is available.
A Hepatits B vaccine was ordered for this pt. however, the nurse inadvertently administered an influenza vaccine to the pt.  There was NO negative side effects reported.  This error was reported to poison control as well as the Immunization Branch who advised us to complete this form.  The mother has been made aware and reports no negative reactions.  Pt is doing well.
mom reported pt became pale, eyes rolled back & started to shake; was very stiff & difficult to get pts head forward when observed; pt was slumped over in chair upper body was twitching, very pale, perspiring heavily;
Pt recvd vax & exp rash all over body; pt went ot ER on 4DEC92 where was treated w/Epi & DPH;
Immunizations received on 04/06/2002. The pt seemed fussy that evening. On 04/07/2002, mom gave him a bath and noticed significant swelling in right leg, primarily in the thigh. Swelling extended down to foot, redness around the injection sites. No fever, itching or loss of circulation. Seen in ER and had Motrin at home.
Adacel was administered to a patient in the back of the arm in the subcutaneous area/NO AE; Adacel was administered to a patient in the back of the arm in the subcutaneous area/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who was administered with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) via subcutaneous route in the back of the arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine administered at inappropriate site and inappropriate route of vaccination.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested.  List of documents held by sender: none.
Pain in (L) shoulder radiating to the elbow and to the fingers. Pain dull 2/10 to 5/10- started immediately after receiving vaccine- as she was leaving the office. Vaccine given 9/3/08
Opened Moderna Bivalent Booster at 9:10 am on 12/19/22. Old drawn up ones were not throw away and one expired one was used accidentally today at 12/20/22 at 10:00 am. Patient has not had any bad reactions.
Ipol was administered to a patient after the expiration date with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient to whom IPV (VERO) [IPOL] was administered to a patient after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 28-Jul-2022, the patient received a 0.5ml once dose of suspect IPV (VERO) (strength, formulation was unknown, lot T1D48214 and expiry date: 25-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 28-Jul-2022 the patient developed a non-serious ipol was administered to a patient after the expiration date with no reported adverse event (expired product administered)(Latency: same day) following the administration of IPV (VERO).First time product used : No Still using product : Yes  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Severe Dizziness and Nausea lasting 8 hours.  Unable to sit or stand.  After 8 hours the symptom has lessened considerably.   Expected sore arm is not worrisome.
caught covid 2 months after booster, symptoms: fever, chills, cough, shortness of breath, fatigue, body aches, headache, sore throat, congestion, runny nose, hydrophobia. Only fatigue was severe enough to be troublesome for more than 2 days.
The pt was given her 5th DTAP. She was very afraid and crying uncontrollable. She was sitting on her grandmother's lap as she held her while the shot was administered. Immediately after, the pt threw herself back and seemed to faint. She was out for not more than 3 seconds. When she came to, she was nauseous but alert.
17 hours after 2nd vaccine administration developed fever(101.0), severe muscle pain(mostly legs and back), Chills, Insomnia, Nausea, Headache, arm pain (injection site). After 48 hours nausea, headache, vertigo(dizziness) lack of apatite, fatigue. Injection site itchiness, continues 72 hours after vaccination.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 3 of ROTATEQ oral (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ oral (case IDs 1210USA002302, 1210USA006259, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored M-M-R II (case ID 1210USA006263), all on the same day. Additional information has been requested.
The following morning at 5:00 AM, patient was drinking his bottle when I noticed a large lump on the top of his head right over his soft spot. I called the triage nurse who did not immediately answer the phone. I left a message, but then decided to take patient to the emergency room. The nurse called back while we were waiting at the ER and said to immediately take patient to the ER. The ER physician stated he has a "bulging fontanelle" but appeared alert, responsive, and in no distress. He recommended a visit to patient's pediatrician. We then went to his pediatrician's office where they also confirmed him to have a "bulging fontanelle." They ordered a head ultrasound scan of his brain. The findings indicated, a build-up of cerebral spinal fluid over the fontanelle. They classified it as idiopathic. The radiologist recommended a possible MRI for further analysis. The pediatrician scheduled a follow up appointment on 10/26/2017.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Step mother reports child had a seizure while attending the Parade. He bent over to get candy that was thrown and had a seizure which the entire event lasted about 3 minutes. She has contacted his specialist and his medication has been increased.
crying constantly p/shot for 5 hrs then had a spell of palor, eyes twitching & hands trembling; admitted to hosp - WBC 23,000 neg blood, CSF, urine clutures; nl EEG:
28sep89 pt vax hepta B. 4hrs later pt ex lightheadedness and dizziness. recv 2nd and 3rd vax w/o adverse reaction
received a Moderna as 2nd dose  after having received a Pfizer as the first dose 3 weeks prior.  Patient c/o fatigue and "under the weather on 5/26 (day follwing vaccine administration) on 5/27 patient states she is feeling well
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) by subcutaneous injection in June 2008. No other co-suspects were reported. No concomitant medications were reported. In June 2008 (also reported as the patient later had an outbreak in July 2012) the patient experienced broke out with herpes zoster on the face. The rash did clear up but the pain still exist. The patient was given prescription included VALTREX, prednisone, NEURONTIN, ATIVAN, LIDODERM, acetaminophen, VICODIN, erythromycin. The outcome was unknown at the time of report. The patient had sought unspecified medical attention. Additional information has been requested.
Pt called and claimed he received his shot on 10/19 and started getting headaches, muscle aches in his back, neck and arms on 10/22. He states hes been taking ibuprofen but the muscle aches continue to move around.
Had increased spitting up after vaccines. The day after vaccines mother noted that child had larger than normal anterior fontanelle. Parents took child to urgent care facility which sent child to ER for further management. Child had CT of head, LP, and septic work up. All is negative. Admitted and given vancomycin and ROCEPHIN. Discharged 07/31/2016.
Pt became syncopal, shaky, and had splotchy rash. She also had a metallic taste just after the vaccine was administered. Patient received Benadryl 50mg IM and Decadron 10mg IM in the urgent care setting, was observed and sent home in stable condition.
I felt tired/exhausted all day; didn't really felt hungry; I felt a little noxious; This is a spontaneous report received from a contactable healthcare professional.  A female patient received bnt162b2 (BNT162B2) (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: FATIGUE (non-serious), outcome "unknown", described as "I felt tired/exhausted all day"; DECREASED APPETITE (non-serious), outcome "unknown", described as "didn't really felt hungry"; NAUSEA (non-serious), outcome "unknown", described as "I felt a little noxious".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash observed distal of injection partially encompassing upper arm on anterior plane, hot to touch.  Tingling and neuropathy distal of injection site extending completely through extremity.
Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of GARDASIL (lot # K023432, expired date, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
A few hours post vax the pt developed an itchy and red raised rash with a few vesicular areas. Follow up information indicated the patient began itching 30 minutes to 1 hour post vaccination. A physician was contacted and ordered Benadryl. The injection site was red and swollen. Subsequently, the patient recovered.
L leg (distal to site of pediarix and HIB) was swollen and red and patient had non-stop crying after leaving office.  Infant returned to office around 4pm and was noted to have edema and redness of L leg and leg at times was purple in color.  Infant was crying intensely and very difficult to console.  She was treated with a dose of Benadryl and observed in the office for >1 hour.  Her swelling improved and erythema and purple discoloration resolved.  She continued to be very fussy but would console if mom held her upright and bounced.  Infant otherwise had a normal exam.  She returned home and follow up with the mother by phone the following day noted that she was very fussy and difficult to console the entire evening until falling asleep.  The next morning she awoke and was back to baseline without leg swelling or fussiness.
Patient called and reports she has a purple knot in injection site and cannot move her arm more than 3 inches away from body. She also reports pain. She reports no other symptoms at this time.
PT GOT SHOT AFTER 5 TO 10 MIN WENT HOME, ATE, THEN GOT NAUSEA, VOMITED, HEADACHE, CHILLS.  WENT TO CLASS NEXT DAY. FELT NO BETTER. WENT TO STUDENT HEALTH HAD 104 FEVER. THEY SENT HIM TO HOSPITAL.
Started noticing a "heat sensation" in distal right leg about 9-10 days after vaccination. Sensation would last anywhere between 3 seconds to 30 seconds, and occur from 5 x per hr to 15 x per hr. Two weeks after vaccination, intermittent numbness in toes and fingers of bilateral extremities appeared.
He got his vaccine, the only thing that really hurt was that it felt like somebody shot him in the arm which lasted for a week.  Then on Sunday he has had what he thought was a heat rash, and went and did laundry and when they dropped him off he has realized that he has a rash that has multiple little spots on his arms and legs, and they fester like a heat rash, and feels like somebody is pinching his skin with  plyers.  On his chest/torso he has the rash that is sensitive to the point that it bothers something rubbing against it.  When they fester up he squeezes them to get rid of the pain and it's painful.  He also has a dry skin rash on his right butt cheek, which also started when this started as well.   He has not taken anything for this reaction.  He called the pharmacist and they told him to call us and report it.   The area of the shot looks like a state map shape rash area on his shoulder.
Delayed menstrual Cycle by 12 days; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (lot number: EW0158), via an unspecified route of administration in left arm, on 13Apr2021 10:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. No other medical history. No other vaccines were received within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient's medical history was none. Concomitant medications were not reported. The patient experienced delayed menstrual Cycle by 12 days on 13Apr2021. No treatment was received. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected
Information has been received from a registered nurse concerning an 8 year old female who on 06-NOV-1998 was vaccinated SC in the right arm with a first dose of Varivax (Oka/Merck) (lot# 628147/1262H). Concomitant vaccinations included Dtap and poliovirus vaccine live oral. On 28-JUN-2006 the patient developed varicella disease with moderate to many papules. The patient had an office visit for confirmation on 30-JUN-2006. Subsequently, the patient recovered. Additional information is not expected.
Client received Tdap vaccine in her right thigh at hospital; came for WIC appt and c/o pain in right leg; right leg red, swollen, and warm to touch; client referred to Dr. (to see him after leaving health dept).
left shoulder, left neck pain. Started ~48 hours after vaccine Continued for >14 days Presented to ED day 18 after vaccine treated with NSAIDs and referred to PMD for physical therapy
During evening of second day I started to itch all over. I have no raised hives just itchy skin Everywhere. I feel like I am wearing a wool sweater body suit. As of today I am still itching
PT was administered High Dose Fluad and Pneumovax 23 vaccine at his annual visit appointment on 10/21/2019. The next day, he stated that his legs gave out on him as he was trying to get into his vehicle. He also states that his legs are sore and feels fatigued. He fell a second time, this time he fell out of his bed. He does not recall how he fell but only remembers waking up on the floor out of his bed. He had to call the EMT to help get him up of the floor.   I called the patient to check in on him, he says he is feeling well. He also says that he is a little sore but he thinks this may be related to him falling. I spoke with his PCP regarding these issues and he finds it best that the patient come back into the office to be evaluated.
high blood pressure; anxiousness; heat in her neck and face; dizziness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure), ANXIETY (anxiousness), FEELING HOT (heat in her neck and face), DIZZINESS (dizziness) and PYREXIA (fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills). On 05-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure), ANXIETY (anxiousness) and FEELING HOT (heat in her neck and face). On 02-Mar-2021, DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure), ANXIETY (anxiousness) and FEELING HOT (heat in her neck and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she was already on high blood pressure medications but her blood pressure does not seem controlled despite started a new medication Norvasc (amlodipine besylate) as treatment.
covid test result was positive; covid test result was positive; First dose on 08Apr2021 and second dose on 16Apr2021; This is a spontaneous report from a contactable consumer (patient). A 30 years old non -pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6207) on 16Apr2021 (at the age of 29 years old) as dose 2, single and on 08Apr2021 (Lot Number: EW0151, at the age of 29 years old) as dose 1, single, both administered in right arm via an intramuscular route of administration for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine was given in four weeks. No other medications were in two weeks. It was reported that the patient did not have covid prior to vaccination. The patient was tested for covid post vaccination. There were no known allergies. The patient was not pregnant at time of vaccination. On 18Aug2021, the patient experienced covid test result was positive. The patient received first dose on 08Apr2021 and second dose on 16Apr2021. The patient underwent lab tests and procedures which included nasal swab Antigen Test was positive on 18Aug2021 and nasal Swab PCR test was pending for results on 18Aug2021. The outcome of the event was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Site of injection: swelling, red, sore. Movement painful for two days. That night through 35 hours, systemic reaction: full body shivers, painful muscle inflammation in legs, arms, hands, neck, headache, feeling sick, low appetite, exhaustion, slept most of the day, alternate between ibuprofen and acetaminophen.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 26-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, sore arm expected and resolved in 24 hours. Unexpected bright red gums, bleeding between teeth 48 hours after. Will notify if doesn't resolve on its own.
Headache, fever, fatigue, 4/8/21, 8:00 p.m. - 4/9/21, 12 p.m.
I gave a patient a 1st dose Pfizer vaccine. Within few minutes, she felt her throat mildly tighten and felt hot, she could still breath and was conscious. I ask if she wanted me to use an Epipen on her. She wanted to wait to see if it would gradually get better. In 5 minutes, she said it did not worsen. I gave her a cold pack and ask her to wait another 15 minutes. During her wait time, she said she felt better and was able to proceed as usual.
Headaches; Severe body aches; Increased temperature; Fatigue; Joint Pain; Loss of appetite; brain was foggy almost felt like she had drank too much; very sore arm/pain at injection site; pain coming from injection site across shoulders and down her back; pain coming from injection site across shoulders and down her back; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 04Mar2021 at 13:30 (Lot Number: EN6199) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date. The patient had no known allergies. The patient did not have COVID prior to vaccination. Concomitant medications included ibuprofen (ADVIL); fexofenadine hydrochloride (ALLEGRA); escitalopram oxalate (LEXAPRO); paracetamol (TYLENOL); vitamin d (manufacturer unknown) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in four weeks. The patient previously received the BNT162B2 (lot number: EN6201) on 11Feb2021 at 13:30 in the left arm as dose, 1 single for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 04Mar2021 at 16:30, the patient experienced headaches, severe body aches, increased temperature, fatigue, joint pain, loss of appetite, brain was foggy almost felt like she had drank too much, very sore arm/pain at injection site and pain coming from injection site across shoulders and down her back. The patient received unspecified OTC remedies, rest, fluids, Advil and Tylenol as treatment for the events. The events recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.