chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose on 2019, Only first was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (first dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 28-JUN-2022 Reporter's Comment: The patient was late for the second dose of Engerix-B. No adverse event was reported. No patient's identifiers were provided. No lot number and expiration date was provided. No vaccination date was provided. The Vaccine Administration Facility was the same as Primary Reporter. The VAERS details for first dose was reported. The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
- 64yoF presents with a cc of dizziness that started one week after getting her covid vaccine - symptoms started 2 weeks ago, comes and goes; can occur at rest but especially occurs with movement - describes it as room spinning, feels like she is drunk; she has never had this before - at onset of symptoms, she had R ear pain and worsening sinus congestion; she was placed on augmentin and pseudophed by her pcp; her sinus congestion has since resolved but dizziness has not - has had gait instability; feels like her balance is off - reports very faint headache, barely there; has a hx of migraines, this is much less and doesn't happen every day, comes and goes; her migraines when she gets them her R eye hurts, she has had this recently - has been taking meclizine which help somewhat - denies changes in her vision; denies numbness or weakness, changes in speech, trouble swallowing - denies chest pain - had first dose of moderna on 5/18
rt anterior thigh 4", circular, red, warm to touch, itching, dimple area @ site of inj, blue darkened are @ site of inj;no fever;no temp for past 48hr;not tender to touch;no voiced complaints noted yesterday but inc in size today;given DPH
430AM 9MAR96 t105.2 oral mode on thermoscan thermometer;no other sx;temp temp 101.2 po p/tempra;9MAR noon temp 101.3 ax;
High Blood Pressure. Anxiety. Depression. Hypothyroid condition. Fatigue. Easy to catch colds. Arthritis. Coronary artery disease. Was administered 6 Anthrax shots over scheduled time period from 1998 through 1999. Bioport manufactured. Including contaminated lots. Prior to these vaccinations I had no significant illnesses or problems.
Patient came into the store on 10/12/10, and reported minor soreness and redness. Patient came in on 10/13/19 at approximately 12:00Noon presenting with a red swollen right bicep muscle. Patient said there was no pain, soreness, or itching.
fever of 100.7F, body aches, HA, sore throat, fatigue, dizziness, sore arm
I have not had a period for over a year due to my birth control. 2 days after the vaccine I started a heavy period.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles on or about 21-DEC-2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
p/vax pt 8x10 cm size reddened ; raised swollen area to rt anterior thigh noted; inc edema to thigh; tx: ice pack;
Pt was given a flu shot during a school flu event and at that time, it was not known that the child received a flu shot on 10/27/2022.
Saturday 9/25/21- around 6pm I started feeling tingling on my left hand Sunday 9/26/21- woke up with tingling on my left hand, pain on my left arm, shortness of breath at night. Monday 9/27/21- tingling on my left hand, shortness of breath, chest pressure, lightheaded, Hives on my face and neck. Called my doctor whom advised to go to the hospital if symptoms persist. Tuesday 9/28/21- Went to the ER for shortness of breath, lightheaded, and tingling on both hands at this point. Got sent home , to drink lots of fluids and rest. Wednesday 9/29/21- tingling and cramps on both my hands, shortness of breath Thursday 9/30/21- tingling and cramps on my hands, shortness of breath Friday 10-1-21 - went to my doctor's office with shortness of breath & pressure on chest. Tingling on my hands stopped. Saturday 10-2-21 - shortness of breath and pressure on chest Sunday 10-3-21 still experiencing shortness of breath and small chest pressure.
Initial and follow up information has been received from a physician concerning a 56 year old male sales person with low back pain and no known allergies who on 05-SEP-2007 at 02:00 PM was vaccinated into the arm (not specified) with a first dose of Pneumovax 23 lot#658075/0962U (Previously reported as lot #658075/0962U). Concomitant therapy included "TALECRIS", exetimibe (+) simvastatin (MSD), pantoprazole sodium (PROTONIX) and tetanus toxoid. The physician reported that the patient called the office two weeks later to report that he was experiencing "fever, sweating and non productive cough". He reported that the patient also complained of injection site reactions which included pain, swelling and redness. In follow up it was reported that on 06-SEP-2007 at PM patient developed painful red swelling at injection site. This was in arm that received the Pneumovax 23. In addition he developed cough, congestion and fever. In follow up information it was also reported that on 18-SEP-2007 chest xray was done and it showed active disease. Patient was prescribed oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat the fever, sweating and non-productive cough. On 25-SEP-2007 patient recovered. The reporter felt that getting oral steroids, antibiotics and over the counter (OTC) acetaminophen (TYLENOL) to treat fever, sweating and non-productive cough was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with RECOMBIVAX HB [Lot# K010216, Expiry date: 17-SEP-2016, Lot# K006682, Expiry date: 17-DEC-2015, Lot# L030865, Expiry date: 07-JUN-2018] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from the patient's uncle and a physician (who is also a patient's cousin) referring to a 49-year-old male patient. The patient did not have pertinent medical history, concomitant medications or drug reactions/allergies. The reporter explained that the patient who is a dentist was performing a root canal on an anonymous patient with a history of Hepatitis B, was poked with a needle used on the patient with a history of Hepatitis B. On 14-APR-2017, the patient went to a clinic and was vaccinated with RECOMBIVAX HB one injection of 1 ml, intramuscular (lot number M046373 and expiration date: 12-NOV-18) as a hepatitis B booster. On 15-APR-2017, the patient began to developed unspecified muscle pain and on 16-APR-2017, the muscle pain worsened. The patient though he was getting a cold. On 17-APR-2017, the patient was not able to finish his work because he was achy and slow in the muscles. On 18-APR-2017, the patient went to a pharmacy for unspecified over the counter cold medicine. While the patient was in the pharmacy, he collapsed (loss of consciousness). He subsequently drove to an emergency room; there, he was diagnosed with the Guillain-Barre syndrome and admitted to a hospital. His condition was worsening. On an unknown date, an unspecified hepatitis B test was performed and it showed a borderline hepatitis B. The patient was placed on a five-day treatment with intravenous immunoglobulin and unspecified pain killers. The patient walked into the emergency room by himself and at the time of the report, he was not able to move. The five-day treatment was done, and they physicians would treat the patient with either an unspecified plasma procedure or another five days round of intravenous immunoglobulin therapy. The physician confirmed the diagnosis of Guillain-Barre syndrome and reported that the patient was paralyzed, although the location of the paralysis was not confirmed. At the time of the report, the patient was still hospitalized and no further information was provided. The outcome of the event Guillain-Barre syndrome was not recovered and unknown for loss of consciousness. The causal relationship between the events and the vaccine was not reported. Upon internal review, the events Guillain-Barre syndrome and loss of consciousness were considered to be medically significant. Additional information has been requested.
Generalized itching; Mild feeling of constriction in throat/roof of mouth; This is a spontaneous report from a contactable 53-year-old non-pregnant female Physician reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809), via an unspecified route of administration on 12Feb2020 13:45 at single dose in left arm for covid-19 immunization. The patient's other medical history included DM (Diabetes mellitus) and POTS (Postural orthostatic tachycardia syndrome) and known allergies included Sulfa and latex. Concomitant medications included carvediol, metformin, and melatonin. On 12Feb2020 at 14:00, the patient experienced generalized itching and mild feeling of constriction in throat/roof of mouth. The events were resulted at Doctor or other healthcare professional office/clinic visit. The patient took 100 mg Benadryl, repeat 50 mg q (every) 4 hr as a treatment for the events. The outcome of the events was Recovering.
Headache began within 20miutes, Gradually increasing in pain over 2 hours. Dizzyness began around 2 hours. Pain in shoulder and neck became excruciating and 2 Extra Strength Tylenol were taken for pain at 9 PM to little effect. At 11 PM shivering began in back muscles, quickly ramped up to full body uncontrollable seizures which caused my back to bend backwards and made walking and arm use impossible and breathing difficult. This lasted for THREE HOURS. Finally subsided back to normal shivering. Fever of 100.3 was noted at 5AM on 6/04. ALL joints painful, eyes and mouth very dry, long bones in legs and arms hurt to touch. Headache very bad and shoulder of injection site and neck felt like broken glass. Joint pain and headache very bad all day. Fever stayed up until 5pm on  6/05,  and then subsided to 99.8. On 5AM of 6/05 fever and headache was gone but joint pain and residual stiffness and pain in spine and joints remain to this day.
At day 11 I started a rash on upper tights elbows and fingers of hand and feet very itchy red bumps
Patient received a FLUZONE HD instead of FLUARIX PFS Qud. Had low grade fever, malaise and head/body ache.
This spontaneous report was received from a physician via company representative and refers to a 17 year old male patient. The patient's concurrent conditions included Gardner's syndrome (familial polyposis). The patient's medical history included esophagitis issues and routine colonoscopies. The patient had no history of fainting with other shots. The patient had eaten on the day of vaccine administration. On an unknown date in approximately 2017 (reported as "recently"), the patient was vaccinated with his first dose of GARDASIL 9 intramuscularly (lot# and expiration date were not reported) for prevention of HPV. The patient was concomitantly vaccinated with MENVEO. Each vaccination was administered in the deltoid of a different arm. The patient's concomitant therapies included omeprazole. While in the waiting area following the administration of GARDASIL 9, the patient began to be lightheaded, he passed out, slumped over in his chair and was unresponsive. The patient began to have a seizure, was stiff, rigid, experienced fecal incontinence and deep nasal breathing. The patient recovered from the events in 30 minutes (in approximately 2017). The patient received a treatment for the events. He was "hydrated and given crackers" in the physician's office. The relatedness between the events and therapy with GARDASIL 9 was not reported. Upon internal review, the event of seizure was considered to be medically significant.
A non-serious spontaneous report of fever and headache involving a seven-year-old male subsequent to the administration of H1N1. The patient's medial history and concomitant medications were not reported. The patient received H1N1 on 09-Oct-2009. On 16-Oct-2009, the patient presented to the doctor's office with a fever of 103 and headache. The outcome of the event was not reported.
Dysautonomia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: FC3180) at the age of 20 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot Number: ewo181), for COVID-19 immunisation. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset 2021, 2 weeks after the suspect product(s) administration, outcome "not recovered", described as "Dysautonomia". The event "dysautonomia" required emergency room visit. Therapeutic measures were not taken as a result of autonomic nervous system imbalance. Clinical course: Dysautonomia after 2 weeks of receiving 2nd dose. Almost 2 years later and no improvement. Patient had no COVID prior to the vaccination.    No follow-up attempts are possible. No further information is expected..
Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Pain and soreness in the shoulder that received the vaccine starting the next day, and pain continuing for 12 days. Patient was seen by primary MD who said it was likely an injury to ligament in shoulder. Patient received cortisone injection from MD office today, 11-06-18.
I seemed okay after my first shot. One week after the second Pfizer shot I noticed several eye floaters in my right eye. I went to my eye doctor who did diagnose the condition as eye floaters. It has been almost three months, and no improvement. The floaters impair my vision; it seems as if I am looking through fog in my right eye.
Left arm red and swollen. Treat with ice, Benadryl and Keflex 250/5 Tps every 8 hours x 10 days
dizzness  fast heartbeat  weak shaky legs  itching  hard to breath  tiredness
About 5 minutes after administration of HPV #2 immunization patient reported severe nausea and then began retching and vomiting, complaining of SOB and feeling lightheaded, and skin clammy and sweaty. BP obtained while sitting 90/65, pulses 2+ and symmetric radial, rapid shallow breathing but no wheezing or rhonchi appreciated, patient appeared to be in distress and her words were slightly unclear/slurred and voice more faint than our earlier interaction. She denied itching, I did not visualize urticaria, she denied lip/tongue swelling, or trouble swallowing. Due to GI system involvement and mild hypotension I had concern for ananphylaxis and administered epi 0.3mg (1mg/mL). Within 2minutes patients symptoms resolved and she was able to sit calmly on the table, BP 120/70 and HR 95. EMS arrived shortly thereafter and transported patient to ED. I called ED and spoke to Dr. to give her verbal report. I asked Mom to call before discharge.
she felt very light headed; her top gum of the right hand side started getting very tingly; her top gum of the right hand side started burning; she could feel her gum swelling/really swollen; got red/her bottom right gum got red/the whole left side gum got red/super red/cherry red; Burning like they were on fire/burning for all night long; her pinkie (little finger), and ring finger went numb on her right side,her forearm went numb; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she felt very light headed), PARAESTHESIA ORAL (her top gum of the right hand side started getting very tingly), GINGIVAL PAIN (her top gum of the right hand side started burning), GINGIVAL SWELLING (she could feel her gum swelling/really swollen) and GINGIVAL DISCOLOURATION (got red/her bottom right gum got red/the whole left side gum got red/super red/cherry red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FAMOTIDINE, CETIRIZINE, TRIAMCINOLONE and SEMAGLUTIDE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HYPOAESTHESIA (her pinkie (little finger), and ring finger went numb on her right side,her forearm went numb). On 20-Feb-2021, the patient experienced DIZZINESS (she felt very light headed), PARAESTHESIA ORAL (her top gum of the right hand side started getting very tingly), GINGIVAL PAIN (her top gum of the right hand side started burning), GINGIVAL SWELLING (she could feel her gum swelling/really swollen), GINGIVAL DISCOLOURATION (got red/her bottom right gum got red/the whole left side gum got red/super red/cherry red) and GINGIVAL DISCOMFORT (Burning like they were on fire/burning for all night long). On 21-Feb-2021, DIZZINESS (she felt very light headed), PARAESTHESIA ORAL (her top gum of the right hand side started getting very tingly), GINGIVAL PAIN (her top gum of the right hand side started burning), GINGIVAL SWELLING (she could feel her gum swelling/really swollen), GINGIVAL DISCOLOURATION (got red/her bottom right gum got red/the whole left side gum got red/super red/cherry red), GINGIVAL DISCOMFORT (Burning like they were on fire/burning for all night long) and HYPOAESTHESIA (her pinkie (little finger), and ring finger went numb on her right side,her forearm went numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Erythema indurated area at injection site 4 cm x 3 cm - pain with palpation and with walking. Diffuse maculopapular erythema rash on abdomen, chest, back and spreading to arms.
pt states that a few days after he got the Covid 2nd dose his arm became sore around the injection site.  Pt says  it started throbbing and sore and has been this way for almost 2 weeks but is not getting any better.  He says the throbbing very painful.  will contact his PCP for medical advice.
12/16 It's hard to know because I have a fever but I work on the COVID unit and there has been an outbreak, chills, fatigue, and the thought of moving to take a shower I feel in pain
FELT LIKE PNEUMONIA; FELT LIKE DYING; COULD BARELY MOVE; EVERYTHING HURT; POUNDING, EXCRUCIATING HEADACHES; This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 11-APR-2021, the patient felt like dying, felt like pneumonia, could barely move, everything hurt and pounding, excruciating headaches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like dying, felt like pneumonia, could barely move, everything hurt and pounding, excruciating headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422051-covid-19 vaccine ad26.cov2.s - felt like pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
PATIENT REPORTS SHE HAD SURGERY IN OCTOBER TO RESOLVE MOBILITY ISSUES IN RIGHT ARM. SHE GOT A VACCINE ABOUT A MONTH LATER IN THAT ARM AND A RECENT DOCTOR VISIT SHOWED REDUCED MOBILITY IN THE RIGHT ARM AGAIN.