chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; patient was scheduled to receive GARDASIL 9 but was accidentally administered a dose of PNEUMOVAX 23 instead; This spontaneous report was received from a registered nurse concerning a patient of unknown age (reported as "under the age of 50 years") and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.    On 17-FEB-2022, the patient was inadvertently administered a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot #U003306, expiration date 15-OCT-2022, for prophylaxis instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Wrong product administered) (Route of administration, and injection anatomical location were not provided). No additional adverse events were reported (No adverse event).
Information has been received through a Merck Pregnancy registry from an office manager concerning a female (age not reported) who on an unspecified date was vaccinated with a second dose of Gardasil. It was reported that the patient had a miscarriage after being vaccinated with a second dose of Gardasil. Upon internal review, the patient's miscarriage was considered an other important medical event. Additional information has been requested.
Called to report a temperature excursion, reported that MMR-II was administered after a temperature excursion; This spontaneous report has been received from a health care professional concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 26-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Lot # S031482, expiration date 07-OCT-2021 for prophylaxis (dosage regimen was not reported) which experienced a temperature excursion.       The temperature was reported to had been below 36°Fahrenheit (F)/2°Celsius (C) ( 0.9°C to 1.9°C) for 10 hours, and above 47°F/9°C (9.1°C) for 30 minutes.    The total time frame was reported as 10 hours and 30 minutes.  There was no digital data logger involved and no previous temperature excursion was reported. ; Sender's Comments:  US-009507513-2010USA010872:
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and the inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is two of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956571A, A0956572A and A0956573A for details regarding the additional cases.
No additional AE reported; temp excursion 47.9 degrees; This spontaneous report was received from a certified medical assistant and refers to a 6-month-old male patient.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-DEC-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and exact dose were not provided).  The vaccine underwent temperature excursion of 47.9 degrees Fahrenheit for 47 min (incorrect product storage) in clinical Practice on 01-DEC-2022. Data Logger was involved. No additional adverse event (AE) was reported. There was no product quality complaint (PQC).
This spontaneous report was received from a nurse practitioner regarding a 1 year old patient of unknown gender. There was no information on patient's medical history and drug reactions or allergies. On 09-JUL-2014, the patient was vaccinated with M-M-R II first dose (dose .5ml (millilitre). The concomitant medications was unknown. The patient had received an expired dose of M-M-R II and no adverse effects was reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous case was reported by an other and describes the occurrence of MUSCULAR WEAKNESS (Muscle Weakness in legs) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle Weakness in legs). At the time of the report, MUSCULAR WEAKNESS (Muscle Weakness in legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was given.
Site: Pain at Injection Site-Severe, Systemic: Weakness-Severe, Additional Details: Patient called pharmacy on 8/18/22 to reports adverse effects post vaccination. Patient reports limited arm mobility (only able to lift arm half way up, very painful to move) and arm pain. Reports this started after receiving Bexsero vaccine at pharmacy on 8/3/22. She reports seeing her primary care provider for this issue. She reports being referred to physical therapy to help with issue. Reports seeing phyiscal therapist on 8/15/22. See attached for additional details.
7 days after the shot the arm I got my vaccine in started itching very badly and becoming swollen around the injection site early on in the morning.  By 8:00p.m. my entire upper arm (the one which got the shot) was extremely red all the way down to my elbow, into my armpit and up to my shoulder.  It was very swollen as well.  This lasted for about 4 to 5 days and the swelling subsided but it remains itchy and the flesh on my arm looks bumpy and marbled in color.  It seems to be getting better as the days pass.  A relative who is an ER doctor recommend I NOT receive the second vaccine.
57-year-old female with known history of end-stage renal disease, presently on dialysis. Patient recently discharged from the hospital, returned with shortness of breath and fever. Patient evaluated in the emergency room, and found to be COVID-19 positive. Chest x-ray was consistent with COVID-19 associated pneumonia. The patient required oxygen, was admitted to the hospital. She was started on Decadron, anticoagulation therapy and administered 5 days of remdesivir. The patient became nontoxic, afebrile and reverted to her usual oxygen requirement. Dialysis provided throughout. Subsequently, the patient wished to return for physical and occupational therapy. Discharge planner was consulted after many days of attempting to obtain placement for the patient. The patient stated she wished to be discharged home. She was subsequently discharged from the hospital. All medications and instructions were provided.  She was also provided with an additional prescription for percutaneous biopsy of renal mass with the plan being if this shows cancer, she will undergo cryoablation of the mass.
nauseous that night (thurs) and off / on following day (fri), slightly nauseous on sat, rash at injection site since thurs. low grade fever in afternoon on Friday. Sore arm late Saturday. Chills on thurs night and Friday afternoon
Patient fully vaccinated with Pfizer vaccine. Tested positive for COVID 19 on 9/17/2021. Brought to ED at Medical Center on 9/18/2021 with shortness of breath and expired while in the ED.
Hives, started out looked like small bites on feet then swelled up, then a couple hives broke out on face by hair line, gave Benadryl and hives were away within a 2hour period.
Brain fog, brain fatigue, severe fatigue, pain, memory issues, sleep issues, concentration issues, energy crash after mental or physical energy exaggeration, some depression.
2 month age vaccines Rotavirus, PREVNAR, Hep B, PENTACEL given to pt @ age 26 days old.  Incorrect vaccines administered.
No immediate reactions, other than a sore, swollen arm, which was to be expected. However, since less than a week after the second injection, I have suffered badly from sciatica, which has never happened before and I've had no injury or incident! The sciatic pain is still a huge issue for me; I'm in pain pretty much constantly from it! I've not been able to understand what is going on, but now I'm reading that the Moderna vaccine is causing this awful side effect in numerous people, of which I am one. I thought I did the responsible thing by getting the vaccine; now I'm not so sure, as I am in constant pain!
maladministration of a Havrix vaccine, in which an adolescent was given an adult dose; maladministration of a Havrix vaccine, in which an adolescent was given an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a adolescent patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult use of a child product. On an unknown date, the outcome of the overdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-NOV-2022 Reporters comment: The pharmacist reported that patient received a maladministration of a Havrix vaccine, in which an adolescent was given an adult dose. During the recollection of the event the reporter mentioned that no information could be relayed as they did not have any on hand. The reporter consent to follow-up. Additional Supportive information: The adolescent patient was given an adult dose, which led to overdose and adult use of child product
Chills and fever for 2 days after shot.  Swelling in arm where shot  was for a couple days.  Moderna Covid-19 vaccine EUA
Severe, Crushing/ Headaches much like Migraines that have been reported to be sensitive to light and sound. Constant neck and back pain, Numbness to face, hands and fingers. Severe fatigue that has kept her in beds days at a time, loss of appetite, has lost over 10-15lbs in weight in last 6-8 months.   Have been told may be sinus/allergies, have been prescribed antibiotics, taken over the counter allergies meds with no relief. Has gone through several bottles of over the counter ibuprofen and tylenol with limited relief. Recently dehydrated due to constant nausea and loss of appetite, was seen in ER for IV fluids. Very weak, not able to function at work due to the headaches and fatigue. Now trying migraine meds that only give limited relief.
Dizziness, Headache, NauseaVomiting, right arm pain at injection site. Narrative:
fever, T104; vomiting; red rash; hosp on 7/11/99; released 7/12/99;
Developed: Acites / Nueropathy / enlarged liver / swollen legs, feet, and abdomen / multiple emergency room visits due to pain and swelling / multiple ultrasounds, blood labs, ct scans, x-rays / unable to walk or drive due to Nueropathy
Patient received injection, told to remain in store for observation for 15 minutes. several minutes later patient briefly collapsed and fainted for a few moments. no recollection of fainting. but alert and oriented upon waking up. Patient later claimed he had fainting spells when drawing blood, never from vaccine. woke up pale and very sweaty.
Chana walked outside after receiving DT booster and passed out. Brought back site office had a generalized seizure called ambulance to ER via Hatzalo ambulance. The follow up received on 2/8/03 states fainting spell/approx 5 minutes after injection.
Pt contacted pharmacy stating his (L) cheek is sore. Started a few days after soreness on (L) arm subsided.
Muscle aches, fatigue, chills, and swelling at the site of injection. I had everything above and more after  my second dose with the exception of the swelling at injection site.
Narrative:  Pt at vaccine clinic, received her COVID-19 vaccine (Moderna) and flu shot. While on observation, 15 minutes post vaccine administration, she became limp and minimally responsive. Pt brought to Urgent Care, noted with left sided facial droop. Pt report has numbness/left sided weakness. Pt state she gets (L)side hemiparesis (Todd's paralysis) when she gets migraines. Vital Signs * Temperature Pulse 81, Respirations 16, Blood Pressure 142/63, Pain scale recorded: 99, Pulse Oximetry 99 Room Air. Code blue called. Responded to Code Blue, pt noted with lips shivering, Code blue called. Responded to Code Blue, pt noted with lips shivering, responding minimally and slowly, but appropriate. Pt brought to room 2, Placed on cardiac and pulse ox monitor. FS 74, #20g IV access placed to (L) AC and secured. MD at bedside evaluating pt. Pt to be sent to non agency Hospital. 911 called and booked. MR arrived for transport. Outcome unknown. No further documentation in patients chart to date regarding this issue. Patient did return to facility on 9/30/21 for a physical therapy appt unrelated to this issue. There was no documentation or reference in the physical therapy note on 9/30/21 regarding the adverse event that occurred on 9/20/21.
pt recv vax;facial flush;BP inc,feeling faint&tingling all over;tx w/ meds;
Well the initial reaction I experienced was stiffness swelling a little pain but my pain, and stiffness with swelling increased I have dull pain Can't move the shoulder Nor the forearm but so high tingling and numbness through the fingers I would like to say due to this last vaccination it has caused me undo stress prior to this vaccination I had no experiences with the previous vaccinations in the past my reasons for me taking the flu shots I have bronchitis now I need to find other alternatives because Im/afraid this may happen again I have limited range of motion in my shoulder down my arm through my fingers I had long hair I had to have my hair cut rather short to maintain it I can't whipe myself with my left side nor bathe myself these are really trying times for me I stay in Chronic pain daily I've had physical therapy which help some my therapist told me it wasn't much more they could do for me. I've had several shoulder 'injections' that didn't work several different medicines from the doctor that didn't work I put over the counter pain cream on it that didn't work, pain killers still painful I elevate it still painful on the pillow Can't sleep at night can't lay on my arm which I'm used to doing Not any longer can't do much reaching due to it's limited motion Nor holding different objects my shoulder swells up a lot I had a MRI which shows inflammation in my rotator cuff my doctor says it's tendonitis I also had a ultrasound they were looking for blood clots which I didn't have thank God for that
Fever to 101.7. Extreme irritability-unconsolable for periods of up to 3 hrs the 2 days following immunization.
Sudden onset of left shoulder, upper arm pain and stiffness. Limited mobility. Weakness. Worsening daily and difficult to sleep or lift things.
Child was shaking all over & temp to 102; Taken to ER, treated & released that same evening.
Fever, chills, body aches and fatigue. Lightheadedness and fatigue continue
pregnant woman received Moderna COVID vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Spontaneous Abortion) on 20-Feb-2020 and Alcohol use (wine/alcohol occasionally). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-May-2020 and the estimated date of delivery was 06-Feb-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-eighth week of the pregnancy.  On 23-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 14-Sep-2018, patient had a previous pregnancy that ended in live, full-term birth. On 20-Feb-2020, patient had a previous pregnancy that ended in miscarriage.  Estimated date of conception was reported as 16-May-2020. The patient had established prenatal care. It was reported that there was no maternal history of subfertility, complications or acute illness during that pregnancy to date. The patient passed glucose tolerance test.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
PATIENT WAS GIVEN A SECOND SHINGRIX SHOT 2 WEEKS AFTER THE INITIAL DOSE RATHER THAN 2-6 MONTHS AFTER INITIAL DOSE
Within 3 hours employee developed fatigue and rhinitis.  Within 8 hours employee developed chills and felt feverish.  Within 24 hours noted lymphnode enlargement at axillary area and redness at the injection site.  Generally unable to function and stayed at home 48 hours.  The redness and swelling at the site increased to about 10-12 cm round, warm area ( at its height)  and redness at site persisted until day 6.
Extreme sore throat, fever up to 102.4°F, muscle aches, mild cough
Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left side.  Both times I was vaccinated in my left arm.  The first shot I experienced numbness to my left face,  neck,  ear and eventually my left arm and leg.  I had no trouble with movement,  the sensation felt dull. There was no associated pain. Numbness resolved completely after 2 days.   The second shot,  I again about 20 minutes following experienced numbness to my left face and ear. This time it resolved after a few hours.    Also,  two days following the first shot,  I experienced severe nerve pain in my low neck/ upper back radiating down my right arm.  As I do not remember injuring it,  I am unsure if this is related to the vaccine or not.  It has lessened in severity over time but is still present 3 weeks later.
He received his second seasonal flu vaccine and first H1N1 vaccine on Saturday.  Sunday afternoon he became cranky and was acting tired.  He started coughing that night and was up and down all night.  His temp reached 101.3 during the early morning hours.  He was very tired that day, continued to cough.  Runny nose started Monday afternoon.  We gave him Motrin starting Monday morning.  Tuesday he woke up with temp of 101.8 and he continued with chest cough and runny nose.  This morning he woke up with temp of 99.8.  We did not give him Motrin during the nights, only during the day.  He still has runny nose and cough today.  He is sleeping through the night again.  He did not react this way after his first seasonal flu vaccine. I did not report this to his doctor so you do not have my permission to contact his doctor.
Tues: sore arm, sore glands in neck, hurt to turn.    Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
At approximately 2am, I started itching  on both upper leg areas. I noticed both sides with red rash/welps. Then about 30 minutes later my inner arms were also irratated with same symptoms. I then took 1 Benadryl tablet at 215am and went back to bed.  I awoke at or about 8am. I noticed the rash/welps on both upper legs were now starting to disappear. However, now the rash/welps has moved to my upper chest. Also, the rash/welps are no longer on my inner arms. It is 10:18am and appears the rash/welps are now going away.  I had the Johnson & Johnson Vaccine
1120 PT C/O  numb lips throa tight. Benadryl 25mg po given. BO 120/80 P65 R 18 SAO2979 1135 BP110/80 P66   R18Sao states lips feel better but a little hard to swallow  1155 pt asymptomatic BP110/80 P62 R18 released in stable condition. Friend is driving her home
Mom reported that within x 2 hrs (1:30 pm) post vaccination, patient became extremely irritable, drawing up his legs, gagging and vomiting intermittently along with inconsolable crying. At 4:15 she took him to the M.D. for reevaluation - at which point he had stopped crying. As of 10-8-14 0845 he  had slept the night, but she verbalized he continues to intermittently vomit. No bloody stools noted. 10-8-14 1830 mom reports patient still intermittently vomiting, but no further crying episodes.
Felt flush and had a strange feeling. Took Tylenol at 11:00 am. Felt some better but still felt strange. At 06:00pm felt rapid heart rate and dizziness. At 11:00 pm rapid heart rate was gone but still felt dizziness and nausea. On 10/16/15 06:30 am feeling dizziness and muscle fatigue with muscle aches, and just an overall strang feeling in my face and head. I went to employee health and informed them of the symptoms. I took 25mg diphenhydramin P.O. at 10:15 10/16/15 feeling some what better but still have a weird hard to describe feeling.
Extreme itching in hands, arms, legs, scalp,  neck etc. Eczema- scabbing, bleeding, dry skin. Sensitivity to wheat.
Initial unsolicited report received from nurse on 28-Nov-2017. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml prefilled dose of FLUZONE QIV (Batch number: U589DA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced large red rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Day of vaccination head ache and sore arm, next you had slight fever99. degree fever an it went a way in an hour after self medication Tylenol for both head ache and the fever. Next day, heart  palpitations  began and head aches returned  continue for 4 weeks. Had a  doctor for pre for pre-existing visit, called to have EKG exam included 04/13/2021 on 04/14/2021 exam and EKG included and came out normal. Referral to Cardiologist, 04/30/2021 re-evaluated, the prior exam and confirmed that having the PVC, portal exam purchase and used so provider could have additional information.  4/15/2021 heart palpitation returned , 04/16/2021 ,another EKG done and was record that she was having PVC. Referral to Cardiologist, 04/30/2021 re-evaluated, the prior exam and confirmed that having the PVC, portal exam purchase and used so provider could have additional information.
Received 3rd dose of Prevnar on 5/16/03. Mother called on 5/23/03 to report child had mild red rash starting 5/18/03. Rash became worse on 5/21/03. Red blotchy slightly raised rash on trunk, arms and legs. Mother took child to MD on 5/21/03 and MD thought rash due to Prevnar. Child had slight fever 100 degrees on 5/20/03.