chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given ACTHIB and PENTACEL on the same day extra dose adminstered with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA294411 for same patient.  This case involves a 14 months old female patient who experienced patient was given ACT-HIB and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] on the same day extra dose adminstered 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), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 19-Jul-2022, the patient received a 0.5ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection  (lot UJ660AA;strength and expiry date not provided) via intramuscular route in the left thigh for prophylactic vaccination.  On 19-Jul-2022 on same day it was reported patient was given acthib and pentacel on the same day extra dose adminstered with no reported adverse event (extra dose administered). Reporter asked if there were any concerns about the patient receiving two doses of HIB in the same day.  Action taken : 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 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.
Severe blisters on the tongue; unable to swallow and talk; unable to swallow and talk; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el9266) via intramuscular route of administration, administered in Arm Left on 12Feb2021 (at the age of 37 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included known allergies. There were no concomitant medications patient received within two weeks of COVID vaccine. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: en9266) via intramuscular route of administration, administered in Arm Left on 22Jan2021 (at the age of 37 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced severe blisters on the tongue, unable to swallow and talk on 15Feb2021. No treatment were given for the events. Outcome of all the events were not resolved.  Follow-up attempts completed. No further information expected.
COVID Breakthrough case Symptoms began: 10/05/2021 Lab confirmed:10/13/2021
I had a rocking sensation that starts within about two hours after I get out of bed and continue throughout the day. It isn't stopping during the day once it starts occurring except if I'm driving. It doesn't seem to be related to any of the medications I take. If I don't take any of my medications for those two hours in the morning, I still get the same sensations. It's not a true vertigo. It's a rocking sensation that would be best to describe as getting off a boat and continuing to feel the boat rocking when on land. I went to my eye doctor to get re-examined, and everything was fine there. (I had just recently received new glasses). I went to a cardiologist, and they did a nuclear stress test. The results were normal findings for someone my age. I went to ENT doctor last week and he's ordered an MRI since I have a strong family history of strokes. I was worried about an occlusion. I have a personal history of breast cancer, I'm 9 years out right now. I have a strong family history of Parkinson's. I am still having these symptoms every day every two hours after I get into bed. When I'm driving, I don't have the symptoms because there is motion. No treatment yet.  Flu shot - I got my very first one ever on October 14, 2021 - I got the non-egg one at the same pharmacy as this COVID-19 vaccine. Received it in the right deltoid.
Fast heart beat, chest discomfort, dizziness, dry mouth, headache and neck ache and feeling of fainting. I went to the Emergency room on 12/28/17 and was admitted for 3 days.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, the vaccine was moved to fridge date was 06-OCT-2021.  Vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 8-degree Celsius, total duration of the excursion refrigerated temperature for maximum of 4 hours.  No treatment details were provided.   This case was linked to MOD-2022-496015 (Patient Link).
Migrating rash, starting above my eye then into the eye lid,  then moves around my face, then onto my torso
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 23 year old female patient with polycystic ovary syndrome, who had not her period in years (dates unspecified) and she was not sexually active. On 07-MAR-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number and expiration date not provided) injection (route, strength and dose not provided) and with the first dose of GARDASIL (route, strength, and dose not provided) (lot number and expiration date not provided). The patient sought unspecified medical attention. The reporter stated that the patient was pregnant. The Last Menstrual Period and Estimated Delivery Date were not known. No adverse effects was reported at that time. Additional information has been requested.
Pain in the site of injection (mild, 15 minutes after vaccine) Vasovagal syncope (12 hours after vaccine)
Pt developed redness with swelling at site. Next day developed increasing erythema and pain extending distally to elbow. Treated with antibiotics.
Described a feeling of ?heaviness in face?. Stated felt ?high?. Medics assessed and took vitals. Pt AMA?d from care/assessment.
rash on her back and stomach; body aches; headache; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 14th August 2019, the patient experienced general body pain and headache. On 15th August 2019, the patient experienced rash. On 15th August 2019, the outcome of the general body pain and headache were recovered/resolved. On 16th August 2019, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain, headache and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient reported that her rash was on her back and stomach. The reporter consented to follow up.
High fever (above 102 deg), lethargic, swelling/redness at injection site, rash on torso and leg of injection site. no tx done
Sore in left arm for days Hives on neck, chest, arms, legs, and groin area
Patient received 2nd Booster of Moderna. After several minutes, pt's wife and himself approach pharmacy counter and states that the pt is unable to speak. FAST technique was done on pt. Pt was completed all tasks other than speech (which resolved completely after several minutes). Informed pt's wife to call MD ASAP and inform of the possible TIA and to inform us of outcome. MD diagnosis confirmed possible TIA.
Fever (102 degrees) for 30 hours; Pain near injection area; Several headache for 24 hours
Pt inadvertently received insufficient dose of MODERNA vaccine; no signs or symptoms of adverse reaction per dad
Client received a dose of Kinrix rather than DTaP and the client had already received a dose of IPV today.  Client had a bone marrow transplant in July of 2020, this is the first of his recommended replacement vaccination series.
This spontaneous report as received from a registered nurse refers to a multiple unspecified group of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, frequency, lot #: not specified) that was improperly stored. Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received flu vaccine 10/7/03. Reports developed itchy rash 3 days later. Did not report or seek medical attention due to child in hospital. Reports was told 10/30/03 by child's doctor to take Benadryl and use OTC cortisone cream. Presents to clinic today with red macular rash and multiple areas or ? on all limbs. Has not yet used meds.
Constant Visual Snow, Light flashes in eyes, Ear ringing, muscle pain, Tingling (needle pricks) all over
Pharmacist gave me the shingles vaccine in my left arm. However he did not give it in my deltoid. He gave it on the back of my arm about 2" above my elbow - perhaps in a tendon? I have a large painful lump which is hot to touch. I'm also worried that if he didn't hit a large muscle, the $250 shot I paid for may not be effective. Additionally, he never gave me a VIS. He told me AFTER the shot that it was a live virus and could give me flu-like symptoms.
3/20/08 - Mother brought child to Health Dept. today. 12 month old received Varicella in right thigh on 3/10/08. Mother noticed redness/blistering/swelling at site on 3/17/08. Irregular shaped erythema 25mm x 45mm with 6 small blisters on right thigh. Mother denies child had any fever. States child keeps trying to scratch site. Light gauze dry covering.
sicker than a dog; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.   This case involves a patient (demographics unknown) who was sicker than a dog (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sicker than a dog (illness) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.   No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
Child complained of being itchy over the injection site 5 min after the injection was given. The site was examined and she was noted to have a macular lacy erythemeties patch that enlarged to 5cm. Mild but noted. Cool compress placed and  erythema diminished. no hives on today
information has been received from a consumer concerning her elderly mother with celiac disease who on Aug 27 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number not available). Subsequently, the patient has been experiencing more heart burn and stomach distress. The patient has seen her physician. the outcome was not reported. No further information is available.
had just ended her period and as soon as she got up the next morning she was bleeding heavily/ bled for about 3-4 weeks straight; bleeding heavily; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm right on 22Jun2021 (Batch/Lot Number: EW0186) as dose 1, single for COVID-19 immunisation. Medical history included headaches. Family medical history relevant to events was none. No other vaccines given the same days as the COVID vaccine and no problems with vaccines in the past. She has never even had the flu shot before. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Concomitant medication(s) included ibuprofen taken for headache, start and stop date were not reported. Got the first dose on 22Jun2021 and the second dose on 13Jul2021 15:00 (Batch/Lot Number: EW0198) administered in arm left. Three days before the first COVID shot, she had just ended her period and as soon as she got up the next morning (on 23Jun2021), she was bleeding heavily. Stated that technically she bled for about 3-4 weeks straight (reported as from Jun2021 to Jul2021). Heavy bleeding for 3-4 weeks until she got the second dose. She just got the second dose on 13Jul2021 and she has just stopped bleeding. Was told she should let Pfizer know about this since it was not normal to be bleeding like that. Her period ended Saturday (19Jun2021) before her first dose and then she woke up the morning after that dose to the heavy bleeding. At time of report, she has stopped bleeding. Stated she was not in any pain or hurting anywhere and just had to deal with it. Didn't go to doctor or emergency room because she just got done paying those past bills off and didn't want to be in anymore debt. Outcome of event bleeding heavily was recovered on 14Jul2021, while other event was recovered on Jul2021.
Left arm swollen from shoulder to elbow with redness larger than half dollar size. complains of tenderness @ site.
About 10 hrs after receiving the vaccine I felt severe  cold chills and body aches for about 10 hrs. Then, all the sudden I felt a hot flash and my body aches almost instantly disappeared.
Next day from application, I started to feel cold. I am the kind of person who always complained because the heat, but it has changed. At the vaccine time,  the weather was 22ºC, and nowadays, the weather is 26ºC. Two months ago I wore just a t-shirt, but today, when the temperature is 25ºC, I want to wear a coat. I started to feel cold, more than my normal, since day after the vaccine. I didn´t take any treatment after that.
ABOUT FORTY HOURS AFTER THE SHOT SHE DEVELOPED A FEVER THAT LAST ABOUT THREE HOURS<  SHE THEN DEVELOPED A SPOTTY RASH THAT STARTED ON HER FACE>SHE STILL HAS THE RASH ALL OVER HER FACE AND BODY> NOW FIVE DAYS AFTER THE SHOT SHE DEVELOPED A TERRIBLE HEADACHE>SHE HAS NEVER EVER COMPLAINED OF A HEADACHE BEFORE>MOTRIN HELPED WITH THE FEVER AND HEADACHE>BENADRYL DID NOT RESOLVE THE RASH
Patient was scheduled for pfizer but ran out and was offered moderna. Patient was  17 years old and administrator thought moderna was approved for younger than 18 and didnt look at age.
Initial report received on 18 October 2012 and follow up report received on 25 October 2012 from an Investigator participating in a study. A 74-year-old female subject experienced double vision on 11 October 2012 i.e. 01 day after receiving the first dose of study vaccine (FLUZONE High Dose or FLUZONE) on 10 October 2012. The subject had medical history of hypertension and neuralgia of the face since 1950. It was reported that the subject experienced double vision and photophobia on 11 October 2012, approximately 25 hours after receiving study vaccine. She was unable to drive. The subject visited an ophthalmologist on 11 October 2012 who observed no findings. The laboratory investigation included magnetic resonance imaging of brain on 15 October 2012 which showed no acute intracranial abnormality. Corrective treatments were not reported. The seriousness criterion was reported as other important medical event specified as double vision. The event of double vision along with associated symptoms of double vision and photophobia was ongoing at the time of this report. According to the investigator, the event of double vision was related to the study vaccine but not related to the trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by the sender: None. Medical Assessment: This case of "double vision" experienced by a 74 year old subject 25 hours post vaccination, was assessed as related by the investigator due to the close temporal association with study vaccine administration. No obvious alternative explanation is evident from the information reported by the investigator. The sponsor considers that biologic mechanisms linking the vaccine effects with the occurrence of the event are unlikely. In addition, further details on the pre-existing medical history of facial neuralgia and hypertension may be informative in the assessment of alternative etiologies, including underlying conditions as well as therapies; for instance, it is described in the medical literature that some therapies used for the treatment of facial neuralgia can be associated with double vision. The sponsor assesses this event as unrelated to study vaccine. Cumulative Assessment: This is the first case of diplopia as the main manifestation reported from any clinical study of FLUZONE and/or FLUZONE High-Dose vaccine conducted by the sponsor. There were four cases of diplopia event reported as co-manifestations of other diseases (stroke, cerebrovascular accident, transient ischaemic attack and sinusitis) in the clinical studies of FLUZONE and/or FLUZONE High-Dose vaccine conducted by the sponsor. However, from almost 2 decades of post marketing experience with standard FLUZONE seasonal vaccine (from 1993 to 2012) a total of eleven (8 serious) medically confirmed cases of diplopia were received. In all serious cases, diplopia was reported as co-manifestations of other serious disease (ie: encephalitis, meningococcal infection, brain stem haemorrhage) and an alternate etiology was available for each case.
patient reports shaking and feeling like she can't breath (more like panic attack not anaphylaxis)
Unsure if directly caused by vaccine, but wanted to report it just in case:  Left arm pain, numbness, tingling and  weaknesses started on Monday March 1, Rash on left hand and upper body began on Wed March 5, diagnosed with Shingles on Thursday March 6.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient has agreed to repeat this vaccine dose and has scheduled to return on 22 April 2021.
presented an allergic reaction looking rash all around vaccine area, used cold compress to alleviate itchiness discomfort.
Pt wanted to receive the Prevnar 20 vaccine but received a Fluad vaccine.  She had already received Fluarix in August so did not need an influenza shot this season.  Pt did not report any side effects and still received the Prevnar 20 vaccine.
Dark mark and lines appeared in right eye.  Pharmacist said to go to Emergency Room or Critical Care Clinic.  Doctor was called immediately and they also said go to ER.
Initially, on 26MAR92 mild h/a & insomnia lasted two nights; 28MAR & 29MAR92 devel flu sx, sore throat, fever, malaise;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unkonwn date improperly stored doses of RECOMBIVAX HB (route, strength, dosage, lot number and expiration date were not reported), were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Patient came into our pharmacy for the 3rd dose booster on 1/10/22. The patient had a card for an adult dose of pfizer on 5/16/21 and 6/6/21 from the same pharmacy.  The card from the previous pharmacy had the incorrect DOB  and a missing lot number for the first shot. This was suspicious since I verified with the father that his correct DOB is in fact  meaning he was actually 11 when he got the first two adult doses.  Either the family purposely lied to the previous pharmacy and knowingly vaccinated their child with the wrong vaccine using an incorrect DOB or the pharmacy was aware of the pt's actual age and purposely left out the correct DOB and adult lot number to throw off a paper trail. Either way, I am reporting this incident as I am afraid that other parents or pharmacies could purposely be giving the wrong vaccine to patients.