chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Bell's Palsy. Symptoms began with some loss of taste on the evening of 07/12/2021. On the morning of 07/13/2021, I was still experiencing the loss of taste but also had pain along the jaw near the bottom of my right ear. I went in to get a COVID-19 test at a testing site on the morning of 07/14/2021. By the time that I was arriving back at my home, I was experiencing right-sided facial drooping and some numbness. I called my primary care provider who advised me to go to my local Emergency Room. The emergency room diagnosed me with a classic case of Bell's Palsy on the right side of my face.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccine underdose in a 51-year-old male patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric. On 16th April 2014, the patient received the 1st dose of ENGERIX B pediatric. On 16th May 2014, the patient received the 2nd dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the vaccine underdose, inappropriate age at vaccine administration and wrong vaccine administered to be related to ENGERIX B pediatric. Additional information received: Per HCP, adult patient received pediatric doses of ENGERIX B for dose #1 given 4/16/14 and Dose #2 given 5/16/14. HCP could not provide lot numbers or expiration for doses of ENGERIX B that were given.
Patient fainted after flu shot. Was seated at the time, so did not fall off or hurt herself. Regained consciousness quickly. Drank some water but vomited after a few minutes. Mother stated patient has fainted post HPV vaccine in the past, possibly due to nerves and dehydration. She had verified before administration of flu shot that daughter has been fine with flu shots previous years. Patient is very prone to feeling anxious with immunizations.
Twelve hours after the vaccination I had typical side effects including fever feeling, body/joint aches, pain at the injection site, extreme fatigue, and nausea.  While those side effects resolved I had fatigue, brain fog, intermittent joint pain, and sleep disruptions for about 6 weeks after my second vaccination. The vaccine taxed my adrenals and as a result I've had to increase the dose of hydrocortisone I take on a daily basis. I find that my adrenals are less resilient, and when I moved I experienced increased fatigue for a longer period fo time than I normally would.
3 inmates that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; 3 inmates that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; This is a spontaneous report from a contactable pharmacist via medical information team. A 36-years-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: en5318), via an unspecified route of administration on unspecified date as 1st dose, single dose and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: el8982), via an unspecified route of administration on unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter had 3 inmates that were fully vaccinated with the Pfizer COVID19 vaccine and had contracted COVID. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the inmates. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: contracted COVID. The outcome of the events was reported as unknown.; Sender's Comments: Based on the information currently available the lack of efficacy of a vaccine BNT162B2 cannot be excluded. The case will be reassessed if any new information is available.,Linked Report(s) : US-PFIZER INC-2021665561 same reporter/drug/event, different patient;US-PFIZER INC-2021669261 same reporter/drug/event, different patient
pt recvd vax;PC from mom 5jan95,states pt had high fever due to possible immun;motrin given q 4 hrs x 48 hrs;next day took pt to clinic w/ generalized rash all over body;dph prescribed;by next day,fever & rash had subsided;on 11jan pt fine
Noticeable numbness on left side (same side as injection) - arm and leg; moderate chest pain that lasted about 3 seconds; slight dizziness; fingers slightly numb; no pain the next day but was fatigued after walking or climbing stairs; some numbness that subsided after a couple of days; injection site was sore for about two weeks; no treatment
10 min after Tdap vaccine, pt told her friend she felt like she was going to faint so he helped her sit down. I asked how she was doing, she drank some water, then threw up. We called 9-1-1. EMT gave ZOFRAN. BP 80/50, HR 50. Took her to ER diagnosed w/ syncope.
Second dose: it is red at quite an area of her arm; lymph nodes under that arm started getting sore; This is a spontaneous report from a contactable consumer reported that.A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6204) as DOSE 2, SINGLE for covid-19 immunizations(Age at vaccination 76 years). The patient past Medical history included, Overweight from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing. The Historical Vaccine include Pfizer-BioNTech Covid-19 Vaccine (1st dose) for covid-19 immunizations on 17Feb2021 and experienced the event Nausea. It was reported that after the second dose of vaccine the patient started having redness that wasn't just at the injection site, it is red at quite an area of her arm on 10Mar2021. This was a week ago today that she got the shot, and the redness seems to be spreading and what she is wondering is if they would ever need a booster would it be recommended that she has the booster. she was also noticing the lymph nodes under that arm started getting sore but that has subsided on an unspecified date in 2021, she will kind of have a tinge of that feeling there but that has gone away. The redness is ongoing and seems to have persisted and today it kind of rolled around to the inside of the arm. She clarifies the lymph node soreness is the same arm as the injection was given, the left arm. The patient underwent lab tests and procedures which included blood cholesterol: which results in high and Glycosylated hemoglobin: 6.3-6.5 on Unspecified date. The event outcome was not recovered for Second dose: it is red at quite an area of her arm and Unknown for Lymph node pain.  Primary Care: She does not have the contact information with her. She has been in contact with the office, but they seem to think she is having what people would normally have but now the redness   Reporter details: She was in nursing and then she worked as a pharmacy technician. She clarifies she worked as an RN, she was an ADN she did not have a bachelor's degree. She declines to provide email. They do not have a computer which stinks because she has been on the line for an hour which is okay because she can appreciate the time. She went down the risks of vaccine and she is finding pretty much everything is checked off that came with the vaccine. No further information provided.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303313 similar report from same reporter
Pt received wrong Pfizer Covid 19 vaccine as a booster dose; she should of received Pfizer Bivalent. No adverse effects at this time.
1635 Generalized itching right shoulder increased back + legs, welts noted above RD site + upper back - Benadryl 12.5 mg 15ml  PO Given @ 1640. No S/SX anaphylaxis.  Recovery 20 minutes.
Woke up with pechial rash on face and neck, spread from face and neck to shoulders and chest. Onset of fever during day and doctor sent child to Hosp. and was admitted for 72 hours. She was given antibiotics and symptoms cleared up.
Information has been received from the medical assistant concerning a 4 year old male with no pertinent medical history and no reactions/allergies, who on 05-JUN-2004 and 10-AUG-2007 was vaccinated with first (a 0.5 mL SC) and ( IM in the right thigh) second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number: 645146/0060N and lot number: 654686/1003F, respectively). There was no concomitant medication. On 13-AUG-2007 in the AM the patient developed parotiditis (parotid gland swelling and pain) on the left side. The patient is being treated with acetaminophen as needed for discomfort. No further information is available. There was no illness at the time of vaccination. There was no lab diagnostics studies performed (physical exam). There was no adverse event following vaccinations. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. Follow-up information indicated that the outcome was reported as recovered about 4-5 days after treatment started.
Pt began experiencing dizziness within 24 hours, post vax. Pt had flu-like symptoms to include productive cough of green sputum and nasal drainage and severe weakness. Over the next 4 days, he began to develop flu-like symptoms including fever, diaphoresis, a pounding headache in the back of his head, a ringing in the right ear and generalized weakness and tinnitus. He does experience occasional blurred vision and has had a decrease in appetite. Following the removal of the cerumen impaction of the right ear, the pt began to feel some relief of his dizziness and complete relief of his headache. He does continue to experience a productive cough and nasal drainage. He was advised that these symptoms would resolve as his bronchitis resolves. He continues to take the Zithromax and Duratuss. He was also advised that if these symptoms do not resolve, to contact the VHC for further evaluation. The pt has completed his required immunizations against polio. There is not a strong enough association between his symptoms and IPV to prohibit him from receiving future vaccinations. It is safe for him to receive other immunizations such as influenza and TD. VHC will contact him in a few days to follow-up on his symptoms. Add 3 more days of Duratuss (total 6 tablets) for cough; begin nasal saline spray (2 sprays each nostril QID to help with nasal drainage) and begin Afrin nasal spray (2 sprays each nostril TID to help with nasal drainage). On 9/19/01, repeat tilt test was positive, therefore 1 liter of NS was given IV. Continue to hydrate orally.
Symptoms: Very sore arm that went away in a day. Light period that has continued over a week after the shot was given. Period is still present but getting lighter and lighter.
A four year old was administered an improperly stored MMRII Vaccine; No additional AE; This spontaneous report was received from a physician referring to a 4-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis.   The vaccine went through a temperature excursion above 9 degrees Celsius (°C), with an average of 8.81°C for 1 hour and 30 minutes, and a cumulative timeframe of 16 hours. The vaccine had 2 previous temperature excursions as follows: above 9°C, with an average of 8.69°C for 1 hour and 30 minutes, and 9°C with an average of 8.68°C for 13 hours. The call was due to a digital data logger.   The physician requested more stability studies regarding measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Patient's wife came to report to us her husband still had a stick neck and swollen hands several weeks after vaccination. They report going to their provider and reporting this and their provider started them on prednisone 10mg to be taken daily. they state this has helped them.
administered PENTACEL to a patient but only the liquid, not the powder component with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] to a patient but only the liquid, not the powder component 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 hepatitis B vaccine (Hepatitis B Vaccine); pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine); and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination (immunization).  On 23-Aug-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ844AB expiry date: 02-Mar-2024 via intramuscular route in the right thigh for immunization.  On 23-AUG-2023 the patient administered pentacel to a patient but only the liquid, not the powder component with no reported adverse event (incorrect dose administered) on the same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Reportedly, Medical assistant states that they administered PENTACEL to a patient yesterday but only the liquid, not the powder component. The patient is in the clinic today for their repeat dose. Caller wants to know if it will be ok. They also asked what would be the possible issues regarding extra dose of DTAP-IPV.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered pentacel to a patient but only the liquid, not the powder component with no reported 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 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.
Report describes vomiting in a 32 year old female who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were unspecified. On 12/07/2001, the vaccinee received her first injection of Havrix. One hour later, she began experiencing abdominal pain and cramping, nausea, vomiting, vertigo, and diarrhea. On 12/11/2001, the vaccinee was seen in the ER for these symptoms. In the ER, unspecified blood analyses were performed, which were negative. The vaccinee received unspecified fluids and Tigan. A stool sample analysis was performed to test for Clostridium difficle. The result of this analysis was unknown at this time. As of 12/20/2001, the outcomes of the events were unknown.
My first period since getting my second dose of the Pfizer COVID-19 vaccine was much heavier than usual. Normally during my period, I have one or two days of heavy bleeding, and one or two days of feeling more tired than usual. This time, I had two days of heavy bleeding. What was unusual was that the second day was extremely heavy, and I was extremely fatigued. I had to change my pads more frequently than usual, and saw multiple small blood clots in the toilet which is unusual for me. For about one and a half days I felt extremely fatigued and lightheaded, and for a short time nauseous, all of which is not normal for me. Also unusual was that I had a tight feeling in my calf muscles, similar to feeling swollen, but they looked normal. The fatigue was so bad that I had to call a sick day at work; something I never have to do because of my period. The fatigue lasted for several more days.
seizure; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown". It was reported that patient had a seizure right away after Trumenba.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event seizure with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No adverse effects; Nurse reports that one dose of PROQUAD (lot number R030800, expiration date 4/22/2020) was administered to the patient when the patient was 15-months-old. Nurse states the patient received an original dose of PROQUAD when he was 12-months old; This spontaneous report was received from a nurse practitioner and a registered nurse and refers to a 15-months-old patient of unknown gender. There was no information concerning the patient's pertinent medical history, concomitant medications, concurrent conditions or allergies provided. Approximatively in December 2018 (also reported as when the patient was 12-months old), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(dose, lot#, expiration date, therapy type and route of administration were not provided) for prophylaxis. On 18-MAR-2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type: rHA (lot # R030800, expiration date: 22-APR-2020, subcutaneously) for prophylaxis. There were no adverse effects reported.
extreme exhaustion/really really tired; This spontaneous case was reported by an other caregiver and describes the occurrence of FATIGUE (extreme exhaustion/really really tired) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme exhaustion/really really tired). At the time of the report, FATIGUE (extreme exhaustion/really really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Maculopapular rash trunk, extremities, face 12 days after the vaccine.
This study case was received on 25 February 2013 from the investigator in a trial. A 28-year-old male subject with no relevant past medical history, developed a transient elevated Troponin level and chest pressure 16 days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 05 March 2012. On 21 March 2012, sixteen days later, the subject developed transient elevated Troponin and chest pressure, considered mild in severity. On 16 March 2012, a Troponin I level was reported as 0.26 ng/mL (also reported as date of 02 April 2012); repeat Troponin level was reported as normal on 02 April 2012 with result < 0.10 ng/mL. An electrocardiogram on 02 April 2012 was reported as normal ECG (also reported as abnormal, inverted T waves; asymptomatic). The subject reported "chest pressure" when thinking about elevated Troponin; no other time. According to the investigator, chest pressure was likely anxiety and no further work-up was needed. Treatments were reported as none. The stop date of adverse events was reported as recovered/resolved on 02 April 2012. According to the investigator, the events of transient elevated Troponin and chest pressure were considered an other important medical event and possibly related to the trial product. This represents a case of potential myopericarditis per the investigator and has subsequently been referred to the  Adjudication Committee for assessment. Documents held by sender: Medical records.
fever to 103 x 4 hrs p/1st vax, screaming , unconsolable x 4 hrs started 6 hrs p/inject given;
Initial report received on 23 April 2007 from an investigator participating in the above-mentioned trial in the United States under the reference number FIM05. An 83-year-old male subject developed myasthenia gravis approximately one month after he had received a first, intramuscular, left deltoid dose of study vaccine FLUZONE (lot number not reported), on 14 October 2006. The subject had relevant past medical history of fatigue (2005) and ocular hypertension. Sometime in November 2006, approximately one month post-vaccination, the subject began having bilateral facial weakness, difficulty swallowing both liquids and solids, and difficulty articulating his words. He was diagnosed with myasthenia gravis. The subject had a radiographic swallowing study that was normal. An MRI of the brain on 30 November 2006 showed normal brain with mild atrophic changes commensurate with age, thickening of the transverse ligament compatible with inflammatory arthropathies, and no flattening of the cervical medullary junction. On 02 December 2006 and MRI of the cervical spine showed diffuse degenerative disc and vertebral disease changes at the cervical spine with mild central stenosis involving C3-4 through C6-7 levels. There was multilevel asymetric foraminal narrowing and abundant pannus formation about the dens. An Esophagram on 15 December 2006 was normal. On 20 December 2006 EMG and nerve conduction studies showed abnormalities that were not specific for nerve, neuromuscular junction, or muscle disease. Diagnostic laboratory data on 02 January 2007 showed creatine kinase level of 36 (normal range 24-26), and elevated acetylcholine receptor antibody levels of 8.4 (normal range 0.00-0.24). On 18 January 2007, the subject was evaluated by neurology and started on Mestinon. A CAT scan of the chest was ordered along with thyroid panel, serum B12, methylmalonics acid, and ANA (results not reported). The subject continues to progress "well" and is being followed by neurology. The subject did not recovered, but has continued in the study trial. According to the investigator, the event of myasthenia gravis is related to the study vaccine, but not to the concomitant medications. Document held by sender: Neurology doctor notes, EMG and nerve conduction study results. Unblinding information received on 31 August 2007. The subject received Fluzone.
Tingling and numbness on skin all over body and mild tongue swelling. Slow onset over a few hours and lessening after about six hours.