chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 08-Jun-2018. This case involves a four-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event 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 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. List of documents held by sender: none.
Shakes(chills)/ Tachycardia/altered mental status/sent to the hospital for evaluation
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # J005848, strength and dose unknown) that had expired on 17-AUG-2014, subcutaneous. Other suspect therapies included PNEUMOVAX23 (strength, dose, route and lot# unknown) started on 16-SEP-2014. The ZOSTAVAX had also been improperly stored. No adverse effects reported. Additional information has been requested.
developed shingles.  had no known reporting of chicken pox prior.  had received chicken pox vaccine and booster.  Examinations described below. Developed bleb on eye, swollen eye and scabs on upper right quandrant of face.  Still visible after 6 weeks. 7/29/08-records received-presented to PCP with vesicular eruption right eyelid. 11/21/07-eye swollen but less pain, treated with acyclovir. 12/28/07-ongoing cough history of asthma. wheeze and rales. No mention of previous C/O related to eyelid swelling.
Tired; horrible stomach pain; Bloating; Gas; awake all night with stomach pain; Chills; keep getting headache off and on; terrible pain; just felt extremely horrible; I am sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Tired, horrible stomach pain, Bloating, Gas, awake all night with stomach pain, Chills, keep getting headache off and on, terrible pain, just felt extremely horrible, and I am sick. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Excessively tired; Severe body aches; Nausea; Diarrhea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included allergy to persimmon fruit, Guillian-Barre Syndrome, and the patient was hospitalized in 2007 for a rare variant called Miller-Fisher syndrome which the neurologist believed was caused by a virus and laryngitis that the patient had. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 11Mar2021 at 05:00, the morning after the vaccine the patient was excessively tired had severe body aches, nausea, diarrhea, and headache. It was so bad that the patient could not eat and went to bed for the day. The patient had questioned that whether she should forego getting the second shot. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excessively tired, severe body aches, nausea, diarrhea, and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Acute Myocardial Infarction 48 hours after vaccine with cardiology and electrophysiology evaluations cleared patient within 2 months prior.  Medically he was doing well - sudden death is unexplained other than a surprise coronary thrombosis induced by the COVID vaccine in a patient with known CAD.
Soon after the 2nd dosage of the vaccine I began to get cramping and arthritic symptoms in both my hands.  It lasted for about 90-120 days and then subsided.  However, after the booster shot (3rd dose), the symptoms returned and have not subsided, but instead have worsened.  It is hard to write, use tools or participate in daily life without pain in all my fingers and both thumbs.  My hand strength has weakened significantly and continues to get worse.
Headache, sore arm, pain in neck, stomach pain, dehydration, sharp pain in the front of the head, tension in neck area, chills. Symptoms come and go.
Patient presented to the ED with complaints of a recent syncopal events while he was using the restroom. He had COVID infection in January and states that ever since being sick, he feels he continues to get worse, complaining of increasing weakness in his legs. He was subsequently admitted for further workup. He was discharged 3 days later in stable condition.
Sudden onset of Meniere's Disease after severe like flu symptoms after each vaccine. ER had my WBC at 17.1 and said symptoms from vaccine/my body fighting hard.
This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-AUG-2016, the patient was vaccinated with ZOSTAVAX (lot # L046893, expiry date: 23-FEB-2017), administered per subcutaneous route. Concomitant therapies were not informed. It was reported that the patient did not receive the full dose of ZOSTAVAX due to leakage around the needle. No adverse effects reported. Follow up information has been received from a pharmacist on 18-OCT-2016. It was informed that the report was concerning a 67 years old male patient. Regarding the vaccination, it was stated that the patient was vaccinated in the right deltoid and that the vaccine was purchased with private funds. Finally, it was reported that the syringe leaked minimally and that the vaccine was injected. Additional information is not expected as the follow up information required was received.
Joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received Shingrix. On 28th February 2020, less than a day after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix vaccine on left deltoid and experienced joint pain. The reporter consented to follow up
Patient states that his left shoulder has been hurting since he received his flu shot on 9/28/16. He pointed to the top of the shoulder and towards back of arm.
Flu like symptoms.  Swollen left armpit. I have not seen a Dr. for this.
Received a dose of Bexsero that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABXV3588, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 22-AUG-2022 Reporter's comments: This case was reported by a nurse. The reporter stated that a patient received a dose of Bexsero that had expired. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consented to follow up. Additional Supportive Information: The reporter stated that a patient received an expired dose of Bexsero which led to expired vaccine used.
noticeable, persistent dull ache about 1-2 inches distal of the injection site. Pain is still present and worsens slightly when moving arm in certain motions (mostly raised above shoulder level)
This case was reported by a nurse via call center representative and described the occurrence of vaccine underdose in a 91-year-old female patient HAVRIX 720 (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received HAVRIX 720. On an unknown date, an unknown time after receiving HAVRIX 720, the patient experience vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information: A pediatric dose was inadvertently given to an adult patient. Was unable to collect addition information. Contact phone number provided by reporter not working.
pain on the right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the right leg) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, POTASSIUM, COLECALCIFEROL (VITAMIN D 3) and CHLORTHALIDONE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the right leg). At the time of the report, PAIN IN EXTREMITY (pain on the right leg) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol and ibuprofen.
Splotchy itchy rash at injection site since day 1 after shot, cleared up, then came back on day 7
After about 12 hours (around 11PM), I started feeling sick. By midnight I felt flu-like symptoms like lethargy, body aches, and a headache. I also had a dull pain at the injection site. I still had sense of smell and taste and a normal appetite. I slept on and off through the night, and felt worse in the morning. I took 1000 mg's of generic acetaminophen around 11AM and felt much better after about 45 minutes. My symptoms started coming back after about 5 hours, so I took another 1000 mg's of generic acetaminophen at 4PM and felt relief after 45 minutes. I fell asleep for a couple hours around 5PM and when I woke up at 7PM I felt noticeably better. I took 500 mg's of generic acetaminophen before bed at 10PM and slept through the night. When I woke up the next day (today), my body aches and headache had mostly receded but I still felt tender pain at the injection site. It's now 11PM and I'd say I feel 80% better. I just took 500 mg's of generic acetaminophen about 45 minutes ago and I feel almost 100% normal. I expect to feel 100% normal in the morning without taking any additional acetaminophen based on my current rate of recovery.
Shortly after my first shot, I began developing lesions and irritated spots in my mouth.  At first, my dentist thought this was just from eating something too hot or brushing too hard.  The irritations got worse (blisters, swelling, and erythema along the gumline) over time and by October, they thought I had periodontal disease.  Treatment for that yielded no improvement and in December, I was referred to an oral pathologist.  In January, I was finally diagnosed with oral lichen planus, an autoimmune condition affecting the tissues of my mouth.  I have been on a Dexamethasone mouth rinse for a little over a month with dramatic improvement.  Since the symptoms appeared shortly after my first shot but took awhile to diagnose, I thought it was relevent to report this as a possible adverse event from having the vaccine.
Patient appeared warm and RN asked her to consider taking her jacket off.  Patient suddenly fell forward and appeared unresponsive; two nurses eased pt down to the floor.  Within a few seconds, pt  began having tonic clonic seizure and promptly turned onto her right side.  EMS,  came to pt's side.  First seizure lasting 56 seconds; IV access to right AC secured.  2 min postictal/rest followed by 15 second seizure and 5 mg Versed infused to right AC access. Roughly a 60 second postictal/rest followed by 15 second seizure; more paramedics at site at this point.  During this time, very little oral secretions, lungs clear, pulse 102; unable to obtain BP.  10 sec seizure began with postictal/rest.  Pt remained on right side approx 2 minutes followed by an  8 second seizure.  Paramedic directed another 2.5 mg versed.  Within approx 60 seconds pt had sixth seizure lasting 31 seconds.  Pt placed on stretcher and transferred to care of EMS.
Two days later patient had red area 71/2cm by 71/2cm area, warm to the touch. Provider sent prescription Loratadine 5mg children's chewable tablets, and children's Benadryl cream. Gave child dose of 2.5mL of children's benadryl in office and ice pack. Patient no fever or report any other symptoms.
Arm very warm & swollen. Fever, cough. Pneumonia (hospitalized).
On Friday 10/15/20201 I felt slight twitching on my right cheek. On Saturday 10/16/2021 my tongue started to feel numb. That night while sleeping I felt sharp pains behind my right ear. On Sunday 10/17/2021 I noticed blurry vision in my right eye which gradually progressed to drooping right eyebrow and difficulty closing right eye. The right side of my lips/mouth which caused difficulty drinking, eating, and pronouncing words. I check into the ER for fear of stoke and was diagnosed with Bell's Palsy. Bell's Palsy is a rare condition, and I am an otherwise perfectly healthy 38-year-old male.
Granulomatosis Polyangiitis- GPA; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) (seriousness criterion medically significant). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient was recently diagnosed with limited Granulomatosis Polyangiitis- GPA. He had a schedule for his first Rituxin infusion treatment on 10/3. He had received all the Moderna COVID boosters to date and would like to receive the newest Moderna booster. He was due of 19 days currently from Rituxin treatment. No prior immunosuppressive treatments were taken by him. Treatment information was not reported.  Company comment: This spontaneous case concerns a 70-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of Granulomatosis with Polyangiitis. The event occurred on an unknown date after a dose of mRNA-1273. As reported, patient was recently diagnosed with limited Granulomatosis Polyangiitis- GPA. and he had received all the Moderna COVID boosters to date and would like to receive the newest Moderna booster. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2023: Live follow-up received and had no new significant information. Reference number added.
Moderna Dose 1 4/5/21 (006B21A); Moderna Dose 2 5/3/21 (036B21A); COVID Positive 1/3/22; 1/3/22: A 73-year-old male with past medical of type 2 DM with neuropathy, hypertension and Parkinson's disease comes to ED following an episode of fall.  Complains of falling on the floor this morning, on was lying on the floor for a few hours.  Denies pain in the hip are back.  Has cough, mostly nonproductive.  Denies chest pain or shortness of breath or fever or chills.  Patient is vaccinated against COVID-19, has not had booster.  Denies sick contacts. In the ED he was febrile, vital signs stable and pulse ox 92% on room air.  CT angio chest showed multifocal pneumonia, D-dimer was elevated.  Acute PE ruled out. 1/11/22: Patient is admitted to the hospital, started on IV hydration and pulse ox is monitored.  Patient had hypoxia, was started on IV remdesivir and IV dexamethasone.  Has his oxygen requirements were trending up with the elevated CRP and elevated D-dimer, pulmonology consult was requested and the patient was started on Baricitinib.  He was also started on therapeutic anticoagulation with Lovenox 1 milligram/kg subcu q.12 hours as his D-dimer was greater than 4.0.  CT angio chest is negative for PE.  As the patient's medical condition gradually improved, oxygen has been weaned down.  Inflammatory markers were monitored, CRP and D-dimer trended down towards normal.  Lovenox is changed to 40 mg subcutaneous q.12 hours.  Patient did have mild troponin elevation without chest pain or EKG changes which is most likely secondary to tachycardia.  He is started on aspirin and the metoprolol.  His cultures have been negative.  Patient is also diuresed with the low-dose Lasix 20 mg p.o. daily.  Patient has been medically stable. Oxygen walk test is done, patient qualifies for home O2 2 L oxygen at rest and 4 L oxygen with exertion.  Findings are discussed with the patient, he is agreeable to have home oxygen.  Care coordination has assisted in delivering oxygen cylinders at home, both stationary and portable as patient is mobile.  Patient does have myotonic dystrophy, does not ambulate much around, uses walker and braces for ambulation.  Pulmonology has cleared him for discharge with the above oxygen settings and recommended follow-up with Dr. in 1 week via tele health.  PT, OT evaluation is done, patient is discharged home with visiting nurse services.  Discharge plan is discussed with the patient.
Child developed severe thrombocytopenia (ITP) (platelet count 1,000) with petechiae and ecchymosis - diagnosed 4/1/15 21 days after MMR-V admin. (Given on 3/10/15) - admitted.
adm to hosp w/lethargy, inc temp, diarrhea, anorexia;also hypokalemic, orthostatic hypotension;adm for rehydration, given Kcl, IV's, APAP final dx'd was krohn's disease surgery required 29NOV95 pt still hospitalized
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II, intramuscularly (strength, dose, anatomical location, lot number and expiration date were unknown) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sore arm at injection sight; Joint pain in legs; Bone pain in legs; Chilled; Tired; This is a spontaneous report received from a non-contactable consumer, the patient. A 32-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 18Mar2021 at 11:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included methylphenidate (RITALIN), desogestrel, ethinyl estradiol (ISIBLOOM) and multivitamin (MANUFACTURER UNKNOWN), for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm at injection sight (vaccination site pain), joint pain in legs, bone pain in legs, chilled and tired on 18Mar2021. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of event sore arm at injection sight, joint pain in legs, bone pain in legs, chilled and tired were not recovered.   No follow-up attempts are possible. No further information is expected
Patient said that on Tues/Wed (9/15, 9/16) he developed swelling of his top lip and right face.  He took some antibiotics which seemed to help.  By that Thurs/Fri (9/17, 9/18), the swelling had gone down.
Cold; Shivering; Fatigue; This is a spontaneous report from a non-contactable other health professional (patient). A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 19:00 at left arm, at single dose for covid-19 immunization.  Medical history included autoimmune disorder, spinal stenosis, pre-Diabetic. Known allergies was yes. The patient's concomitant medications were not reported. No other medications in two weeks. The patient experienced shivering 8 hrs later at 20Jan2021 03:00 and fatigue immediately after 1 hr of vaccine at 19Jan2021 20:00 and 3 days later cold and fatigue on 22Jan2021. No treatment was received for all events. The outcome o the events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected.