chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one of the medical assistants gave the Ipol and dtap portion of the pentacel vaccine without giving the hib portion with no reported adverse event; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-month-old male patient whom  "one of the medical assistants gave the IPOL and DTAP portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine without giving the HIB portion" (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 31-Aug-2021, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6899AA, expiry date 05-Feb-2022 via intramuscular route in the left thigh for prophylactic vaccination.  It was reported, "Caller stated that a 2-month-old patient was given the Ipol and dtap portion of product and not the Acthib. Caller wanted to know if the ActHIB can be given separately. She also wanted to know if there was any concerns of not given the product with acthib."  It was a case of actual medication error due to inappropriate reconstitution technique (same day).  At the time of report, no adverse event was reported.  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 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.
Child would fall sleep and it was hard to wake him up.  When awoke, he would scream and fall asleep again.  "Bumps on mid torso section (back, chest, genital area, underarms), ear infection, respiratory infection.  Next day had throat infection, diarrhea.  Throat still hoarse.
At 4 hrs post - severe pain at injection site, unable to lift arm At 10 hrs post - fever 102, rigors, chills, body aches, ending ~24 hrs post vaccine at 24 + hrs post, low grade temp 100 and muscle aches, chills, more tolerable
About 20 - 24 hours after vaccine administration, 4:30 pm on 10/9/2021, I experienced a couple of heart palpitations and my heart rate became elevated. My resting heart rate went to 105 bpm and my normal resting heart rate is 75 -78 bpm. The elevated heart rate lasted a few hours. Palpitations only happened a couple of times. The next day, 10/10/2021 my resting heart rate was back to normal.
I started feeling abdominal pain/bloating on August 1 around 10am. On August 2 it turned into a more acute pain in my lower right abdomen, so I went to the urgent care. They performed a number of tests and determined it was a 4cm right ovarian cyst. After another day or two the pain went away on it's own. I haven't gotten another scan to confirm that the cyst is gone, but the pain is gone. Here's the Narrative from the note:  Patient reports here with abdominal pain as above, exam with right lower quadrant tenderness concern for differential including ileitis, appendicitis ovarian adnexal pathology. Also reported episode of atypical chest pain here EKG and troponin reassuring. Abdominal CT with no signs of obvious colitis ileitis or appendicitis, adnexal cyst appreciated in follow-up on showing 4.0 right centimeter ovarian cyst with avascular septation but no torsion. Patient was here nontoxic-appearing, doubt acute appendicitis or torsion detorsion given history. We discussed close monitoring, strict return precaution and follow-up with primary care provider and OB/GYN for cyst evaluation and if symptoms return or occur or worsen she is instructed to present to the emergency department for follow-up and GYN evaluation as needed
Sharp pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain in chest) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sharp pain in chest). At the time of the report, CHEST PAIN (Sharp pain in chest) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided. Laboratory details: EKG, chest X ray diagnosis were unclear CT scan, respiratory testing ,echocardiogram, blood work and CT angiogram with and without contrast results were not provided   This case was linked to MOD-2021-114557 (Patient Link).
8/12/2021 RAN A FEVER THE DAY AFTER. Chills, headache, back pain, stomachache 8/15/2021 C/O HEADACHE AND EAR PAIN 8/16/2021 C/O HEADACHE, EAR PAIN, AND ABDOMINAL PAIN 8/17/2021 TOOK TO PEDIATRICIAN BILATERAL EAR INFECTION AND SINUS INFECTION - ANTIBIOTICS STARTED FOR 10DAYS- COUGH STARTED THAT EVENING
Myalgia of the left quadriceps and left gluteal muscle starting 3 days after vaccination. This has eased with ibuprofen 200mg daily - BID over the course of 3 additional days to only distal 1/3 left quadriceps and patellar tendon and superior gluteal muscle tenderness. Based on rate of progression would anticipate full improvement by 7-14 days from symptom onset.
Swollen lymph nodes under arm where shot was injected. Sudden swelling, whelps around injection site.  Swollen area was  warm/ fevered to the touch
Anxiety, Depression < Panic Attacks(Never had before) 11-7 -21 (12:30am) woke up from a sleep and could not catch my breath, body chills, numb arms, feeling of doom, and chest pain 11-21-21 (10:30p) could not catch my breath, body chills, numb arms, feeling of doom, chest pain, and negative thoughts
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse.  The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma  chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing.  I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
Pt was seen 3 days p/vax @ ER w/t103.8 x 3 days & cried x 3 days; no tx given APAP would bring temp down for just a short time;
Constant headache  Body on fire Fatigue Nausea Dizziness  Pain and muscle ache Anxiety High blood pressure
Information has been received from a registered nurse on 12-JAN-2015 referring to a 14 year old female patient with BACTRIM allergy. The patient's pertinent medical history included left chalazion eye surgery on an unspecified date in 2013 and had right eyelid chalazion on 15-MAY-2013. The patient was vaccinated with her first dose and second dose of GARDASIL (first dose: lot#K006124, expire date: 02-FEB-2017; second dose: lot # K009482, expire date: 06-MAR-2017) 0.5 ml, intramuscular on 10-NOV-2014 and on 12-JAN-2015, respectively. There was no concomitant medication. "Within the first five to ten minutes" of receiving her second dose of GARDASIL, the patient developed lightheadedness and her vision felt "shaky". She felt like her eyes were "unable to stay focused". The patient had been in the office for "about two hours now" "resting" and her lightheadedness had gotten better and her vision had gotten a "tiny bit" better. No treatment was given for the events. No lab diagnostics studies were performed. The patient took vital signs test at 3:30pm (12-JAN-2015): pulse 61, temperature 98F, and blood pressure while siting was 118/62. A second set of patient's vital signs were taken at 5:20pm: pulse 68, temperature 98.4F, blood pressure while sitting was 120/60, and blood pressure while standing was 120/68. Additional information has been requested.
I have begun to have an increase in gout attacks and an increase in my blood pressure all after my COVID-19 vaccine shots. My doctor has prescribed daily medications for both gout and my high blood pressure.
On 4/5/2000, mother called, stating child started dragging right leg about one month ago. Right foot turns inward and child ambulates like one leg is longer than the other leg.
Approximately 12 hours after receiving the second Moderna shot, I was awakened by violent convulsions that rolled through my torso and then though my entire body. The convulsions lasted for approximately 15 minutes. My wife called emergency number and an ambulance took me to the hospital, where I spent the night in the emergency room.
High fever the night of the shot, shaking and chills. Puked a few times that same night. Felt very sick, like a very bad flu. Next day had a low grade fever all day and evening, extreme lethargy, and muscle aches all over my body, especially my back. That night, 2nd after shot, I had profuse sweating in bed while trying to sleep. Had to wake up several times to change clothes and bed sheets as they were soaked in sweat. Feeling better today, still a little lethargic but no fever or sweats. It?s been a rough couple days.
None stated. Information from 60 day follow-up report states: pt had brucellosis from eating unpasteurized cheese was not due to vaccine.  Discharge summary states constipation, abdominal pain. hepatosplenomegaly, fever, dehydration, bacterial infection, rash. msv Medical records states hepatitis, pleural effussion. msv
temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unknown date the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) orally, for prophylaxis. It was reported that this was the second dose of the vaccine administered to the patient. The vaccine was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. No additional adverse event was reported.  This is one of the multiple case reported from the same source.; Sender's Comments:  US-009507513-2104USA002045: US-009507513-2104USA002042: US-009507513-2104USA002044: US-009507513-2104USA001947: US-009507513-2104USA002041:
received Tenivac instead of Adacel/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional   This case involves a 11 years old female patient who experienced received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] Prefilled Syringe for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 04-Dec-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA via intramuscular route in the left deltoid.  It was of actual medication error due to Wrong vaccine administered.  At the time of reporting, no adverse event was noted.  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.  The patient outcome is reported as Not Applicable for received tenivac instead of adacel/no ae.
oRestlessness, hyperactivity or inability to concentrate (this could be normal; just seemed to get a tad more extensive as gotten older); oSleep disturbances that change wake/sleep pattern; has had different sleep patterns. Would sleep only 6 hrs sometimes or sleep 12 hrs other times.
The patient was administered an expired MMRV ProQuad on January 17, 2022 at 04:10 pm. MMRV ProQuad was expired on January 09, 2022. No adverse reaction nor symptoms were reported after 15 minutes of monitoring.
Information has been received from an NP concerning a 17 year old male who was vaccinated with Hep-A virus vaccine inactivated. In 2000, the pt experienced elevated bilirubin levels. Lab evaluation also revealed AST and ALT normal. It was noted LFT's would be checked in 1 month. Medical attention was sought. No further information is available.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLUALVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. The reporter did not have date of birth. This case has been linked with case US2018180227 and US2018180228, reported by the same reporter.
Shot given just before 12pm on the 19th of September. Woke up the morning of 21st and noticed rashes on back of right thigh, as well as back and chest. She seemed to be acting totally normal and I read that sometimes vaccines can cause eczema to flare so I thought that was the case and since she acted fine I let her go to school. Complained of her butt itching when I dropped her off to school at 12:45 on the 21st. Was called to pick her up from school around 2pm because the rashes/hives were spreading. Upon getting there and seeing her she had rashes/hives on her arms now and a little on her face. Took her home and she went to my wife?s work later that day around 5pm and at that time the rashes/hives on her face had gotten worse. Doctor prescribed Zyrtec to control the issue. Symptoms cleared very quickly. Was told to continue Zyrtec for 4 days. The rashes/hives did come back the next day and cleared after another dose of Zyrtec. Same thing again the next day but less severe. As of today (5th day - no Zyrtec) it seems to be done with.
Patient alerted staff approximately 15 minutes after receiving H1N1 inactivated vaccine that "I just don't feel right." Complaints of feeling hot & cold all over, dizziness & a raw throat. Reports throat felt dry like cotton. Patient reports a history of anxiety, panic attacks & hypoglycemia. Stated that she also has hypertension & took medicine today. Reports ate candy & drank something before coming to clinic. Patient denied any shortness of breath with episode. When patient alerted staff at 4:30 pm her blood pressure was 180/106 & heart rate 80. Blood pressure retaken at 4:35pm was 159/98. On assessment skin was pink, warm & dry. Lung sounds auscultated per ARNP & no abnormal lung sounds heard. Patient's husband notified to come pick up patient. Phone call made to her primary care physician but obtained answering machine. Husband arrived at 4:45pm. Advised patient & husband to go to Dr. office after leaving clinic for evaluation of symptoms. Advised if office closed to go to emergency room. Patient remained alert & oriented during episode. Respirations were even & non-labored. On 11/4/09 at 8:00am I notified patient by phone to follow up on symptoms. Patient she reports she went to Dr. office after leaving clinic but was advised by them to go to emergency room. States she was given Benadryl, VICODIN & Prednisone. Had some itching on legs prior to taking meds in ER. States she noticed hives on arms, legs, back & chest while she was getting dressed to be discharged. Patient reports  that this morning she still has a raw throat & also has a headache. States "I feel like I have been run over by a truck." RN states unable to patient 11/05/09. Spoke with patient 11/06/09. Says hives were resolved by 11/04/09. Says has headache and itchy raw throat. Unsure if is getting cold. Has returned back to work. Was advised by ER physician to take 2 tablets of Benadryl every 4 hours. Says is not taking regularly now. Received seasonal flu vaccine at store,  where is employed in September.
About one week after receiving shingles vaccine, I got shingles in my eye & forehead & head. I've had to go to eye clinic regularly for over a year - still having pain & redness in left eye (5 mo. later).
Patient received a sup-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The CDC requested that a VAERS form be submitted for this patient.
At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm was hard and soar to wrist. couldn't make fist. joints throbbing. foot swollen and couldn't lift up arm. Feeling like getting flu. Most symptoms lasted 1 week- last reported 2/11/2021.
got my period a week earlier than it's suppose to come; because it's 11 days now and I am still bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2022 (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: MENSTRUATION IRREGULAR (non-serious) with onset 14Mar2022, outcome "not recovered", described as "got my period a week earlier than it's suppose to come"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Mar2022, outcome "not recovered", described as "because it's 11 days now and I am still bleeding". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional information: Patient always had her period tracker and was surprised to get her period 2 days after she got the shot. It was 11th day and patient was still bleeding. Patient was not on any medication, haven't change anything in her lifestyle except 12Mar when she took the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.    ~
24 hours after 1st dose small rash appeared on the underside of my right arm.  48 hours after 1st dose, rash spread to entire body including: left arm, hands, fingers, stomach, lower back, buttocks, legs and feet. Rash looks like hives, raised red bump, some look like pimples, and are very itchy
pt recv vax 16SEP98 & 2 days later devel rt arm (recv HIV in lt arm) warm, rash, soreness, sl fever 100, hives, welts later that week;hands & feet were puffy per mom;also rash on torso;
Patient reported that early next morning following the vaccine she woke up with severe arm pain around the injection site.  The pain then progressed down the arm and throughout the body over the next few days.  She then went to her physician for lab work after 10 days of discomfort because she was concerned that she had rheumatoid arthritis.  The lab testing did not show any abnormalities and it was thought to be either an immune response to the shot, a viral infection, or fibromyalgia.  The patient then called the pharmacy to report her experience.  The pharmacist suggested using either acetaminophen or ibuprofen to help with the aches. She did state that ibuprofen had helped her a little bit.
Initial report received from a patient on 08 November 2006.  A 64 year old, female patient experienced persistent sinus congestion, infection, phlegm and mucous that began on the same day, after she received Fluzone (lot number unknown, route of administration not reported) in the left deltoid on 07 October 2006.  At the time of the vaccination, she had a post nasal drip; she was on medications but they were unknown.  At the time of the report, the signs and symptoms were continuing.  Augmentin was prescribed, but it did not help.
Information has been received from a nurse practitioner concerning a 41 year old male with environmental allergies and no past medical history who in approximately 1993, "ten years ago," was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently the pt expereinced an anaphylactic reaction with SOB. The pt received one dose of epinephrine and the symptoms resolved. The pt indicated that he is unsure if he had ever previously received the vaccine. A recent titer was negative. No additional info was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Anaphylactic reaction and shortness of breath were considered to be immediately life-threatening. Additional info has been requested. Follow up on 12/19/03: "Follow up information received from a nurse practioner indicated that the pt's "pneumovax titers" were unprotected.  The pt did not visit the ER and recovered without sequela.  The pt was not revaccinated.  Anaphylatic reaction and shortness of breath were considered to be immediately life-threatening.  No further information is expected."
Anaphylactic reaction: SOB, swelling over face, extremities, hives, flushing. Treated with Epinephrine and Benadryl CO2. Transported to hospital for further treatment.  Nurse follow up on 06/28/04 states: "ADD: urticaria."