chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got 2 shots, developed shingles / Suspected vaccination failure; Two Shingles outbreaks; received second dose almost 1 year after the first dose because the pharmacy had ran out; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got 2 shots, developed shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Two Shingles outbreaks) and drug dose administration interval too long (Verbatim: received second dose almost 1 year after the first dose because the pharmacy had ran out). The outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2023 The reporter was the patient. The patient received her first dose of Shingrix in 2020 and the second dose in 2021. The patient developed shingles around Christmas time 2021. She developed shingles again 15th February 2023. The patient received the vaccines at 2 different pharmacies. The patient did not have the exact dates of the vaccine nor she had the specific contact information for the pharmacies at the time of the call. The reporter/patient gave consent to follow up with her and healthcare professional (pharmacies). The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Breakthrough case admission after three doses  Moderna 2/8/21 Lot# 013M20A Moderna 3/8/21 Lot# 03021A Moderna 9/24/21 Lot# 006C21A
Body aches, nausea & chest (lung) discomfort lasting from approximately 4:00am until 12:00pm
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced an unknown reaction. It was reported that "this reaction occurred sometime in the past few months". The patient would not receive any other doses. The patient recovered from the unknown reaction. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the physician who reported that the vaccine was advised/provided by the patient's gynecologist. Details were completely unknown. The reporting physician did not administer the vaccine or treated patient. The physician only heard about it. The physician did not even know if the patient's symptoms were from vaccine. The patient was not under the reporting physician's medical care. Follow up information has been received from the physician who reported that this was not his patient. The physician did not administered GARDASIL. The physician did not have details about this event. No further information is available.
Medical assistant forgot to mix the Hib part to the DTaP/IPV component so patient only received the DTaP and IPV and not the Hib part.
tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Injection Location: Pain-discomfort. General symptoms: headache, joint pains, dizziness.  Narrative:
Tongue feels numb.  Breathing without difficulties.    b/p 150/60  continued to monitor.  Refused any further treatment.  b/p140/80
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/14/21 2nd dose02/05/21 Diagnosed covid positive:09/07/21 Symptom onset:09/04/21 Exposure:Home Symptoms:fever, cough, fatigue, muscle aches, sore throat,chills, runny nose HA.
8 hours after vaccines administered, baby had 3 episodes within 1 hour of arching his back & eyes rolling up. Cleared at ER room.
This spontaneous case reported by a patient, describes the occurrence of malaise (feeling very ill), pyrexia (fever), myalgia (body ache/achy), insomnia (could not sleep) and dizziness in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 017C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 4, 2021, patient experienced insomnia (could not sleep). On May 5, 2021, patient experienced malaise (feeling very ill), pyrexia (fever), myalgia (body ache/achy), dizziness, diarrhea and asthenia (still very weak). On an unknown date, patient had pain in extremity (left arm was very sore). At the time of the report, malaise (feeling very ill), pyrexia (fever), myalgia (body ache/achy), insomnia (could not sleep), dizziness, diarrhea, asthenia (still very weak) and pain in extremity (left arm was very sore) outcome:  unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient does not want to take her second dose. No concomitant medication or treatment information provided.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown dates the patient experienced herpes zoster (6 times). The outcome of herpes zoster is unknown.
Pt received Fluarix vaccination in left deltoid, one day later presented with 2 lesions his arm (c) diagnosed as erythema multiforme - appeared one day after vaccination.
Tachycardia 120s-130s that lasted ~8-10 hours Other symptoms included fever, chills, body aches, headache, malaise, cough, chest irritation, pain at injection site, pain with movement of the affected arm.  I received an influenza vaccine on 12/17/20 but do not know the manufacturer or any other details. If needed, please reach out to my PCP:
Large area of swelling, redness & itching.  Some difficulty breathing, temp 102 degrees.  Given Benadryl & Keflex by DO.
Patient got FLUZONE HD & PNEUMOVAX in same arm. Next day felt a little "off". Little clammy & tired, arm a little red. Next day arm very red & warm but not at injection site was down by elbow. Also tender where red.
Patient to bed C301 from triage and being evaluated for possible allergic reaction to after 2nd dose of pfizer vaccine. Patient states she is having itching throat at this time and had same issue last time but 14 hours after injection. Patient states she did take zyrtec 1 hour prior to receiving vaccine today. Patient is noted to be speaking in clear sentences, no swelling or drooling noted and no coughing.Patient was given Benadryl. After treatment Benadryl symptoms resolved.
Since this shot I have constant ringing in my ears. My left arm where I had the second shot often times gives throbbing pain all the way down my arm and fingers especially at night that is usually the side I sleep on and I have been unable to to to this pain.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. In July 2013 the patients were vaccinated once with doses of GARDASIL (lot number and expiration date at the time of report not available) 0.5 ml injection, intramuscularly which were exposed (date unspecified) to 25 Fahrenheit for cumulative total of 205 hours. No patient data was available at the time of report. No adverse effects reported.
patient fainted about 2-3 minutes after receiving the vaccine, for a few seconds.  Patient's blood pressure taken after fainting was 86/62.  Paramedic was called but by the time they got to the pharmacy patient's vitals were stable and she was not taken to the hospital.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 4 year old patient. On an unspecified date, the patient was vaccinated with the 1st dose of VARIVAX (strength, dose and lot# not reported). On 02-MAY-2014 the patient was vaccinated with the 2nd dose of VARIVAX (lot # J009166, expiration date: 24-JUL-2015, strength and dose not reported) which was improperly stored at -11 Celsius degree for an unspecified number of hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
51 year old male with no significant PMH who presents with RLQ abdominal pain for the past week. He reports that pain began last Tuesday but that he thought it was due to a Covid infection which he had at the time. When his Covid symptoms of malaise and lethargy subsided, his RLQ pain persisted which is why he presented for evaluation. Pain is described as sharp, moderate-severe, worsening, non-radiating, and not exacerbated or alleviated by any known factors.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 002B21A and 016C21A) for COVID-19 vaccination.  No Medical History information was reported.On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch) and VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch). On 25-Nov-2021, the patient experienced VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), PARAESTHESIA (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE WARMTH (tingling from the vaccine injection site to the tips of fingers which is hot to touch), VACCINATION SITE SWELLING (the arm that she got the booster shot of vaccine in is still swollen) and VACCINATION SITE ERYTHEMA (vaccination site is red and a huge redness all around the area) had not resolved. No concomitant medications were reported.No Treatment medications were reported.
Chest pain developed 3.5 weeks after vaccination and EKG shows pericarditis
11/21/18 pain, swelling, redness, hard, warm to touch started in Rt. arm - where PREVNAR was given. 11/23/18 symptoms improving - taking ibuprofen and using ice packs.
Received second vaccine on 4/30/21. Twelve hours later he developed fever, body aches, and a sluggish feeling. Symptoms lasted 3 days.
Patient received FLUARIX (Lot # 25N22) on 4 Nov 2015. Began to experience lower extremity weakness/tingling and low back pain on 07 Nov 2015. Reported to ED and admitted to hospital for treatment of Guillain-Barre Syndrome. Pt. is still under treatment.
Approximately 24 hours after administration, developed sudden onset of severe headache, nausea, severe abdominal cramps, followed by generalized body aches, pallor, 'brain fog', and approximately 4 hours later had stabbing chest pain on inspiration. Majority of symptoms passed within 8 hours. Brain fog, headache and fatigue lingered through 12/30/20.
pt rec'd vaccine, sat in waiting area for 5 minutes, reported feeling lightheaded, then collapsed onto floor, appeared to be having a small seizure for less then 60 seconds, then immediately sat up on the floor and asked rph what happened, he did not remember; 911 was called and pt was taken away in ambulance
Day 1:  Fever, chills, headache, sore arm and lethargy.  Day 2:  Severe ear and throat on one side, headache.  Pain lasted 5 days.
Vertigo, dizziness, lightheaded.  Start 10 days after 2nd shot and still continues today.   It happens when I lay down, when I stit up in the morning and can happen anytime during the day. I feel like I am in a fog all day!!!
Woke up in the middle of the night and was paralyzed. She couldn't move her arms are legs.  It lasted for about 5 hours. But she was able to move it is still hard. Spoke with her dr.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy. On 16-SEP-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #J002869, expiry date 14-JUN-2013, subcutaneous). On 17-SEP-2013, the patient developed flat rash at the injection site and on the patients abdomen and left side and the patient stated that immediately after vaccination she noticed a tingling in her throat. There was no treatment rendered of the events. The outcome of the reported events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Patient described a severe rash that developed after receiving the vaccine and lasted for an extensive period of time ("About a month")
Spoke to pt, states she developed itching at injection site on Monday, 7/19/21, about 72 hours after the first Pfizer dose (administered 7/16/21). She also noticed a raised, reddened area on R wrist. The itching intensified throughout the day, she applied Benadryl cream which did alleviate the symptoms. Still has slight itching today at injection site. Denies any other symptoms.  Explained need for allergy/immunology consult prior to receiving second COVID-19 dose. Pt states she saw an allergist within the last month to identify a possible food allergy. She agreed to schedule the appointment; acknowledged she cannot receive the second dose at this time. She is also aware she will need clearance prior to receiving the second dose. Progress Notes Called patient for well being check. Pt states she felt fine until Sat evening when she experienced "poundig in my ears." She checked BP and pulse several times throughout the evening. BP was stable but pulse low, 36 - 46. Acknowledged she has low pulse and recently had stress test due to another recent event of bradycardia. Felt fine yesterday and this AM, pulse remains at 46. Advised her to contact PCP and cardiologist and she will today. She does have appointment for the second dose 8/6/21.  Progress Notes After patient received first COVId-19 dose, she recalled that "some years ago, I had a rash that my doctor thought was related to something I ate." She has never been tested and no further episodes. Advised her to remain in observation for 30 minutes. 20 minutes after the dose, patient noticed a red area on R wrist. No itching but area swollen. Returned to exam room, lungs clear, no SOB, wheezing, difficulty swallowing although patient cleared her throat a few times and then developed a red, raised area on R shoulder. No facial, lip nor tongue swelling.Denies any tingling nor itching. Speaking in complete sentences without pausing, no audible dyspnea, wheezing, hoarseness nor labored resp during the conversation. Dr. saw patient. Both reddened areas resolved and no longer clearing her throat. He advised Benadryl 50 mg. Pt reluctant, agreed to take 25 mg cap after she discussed further with Dr.  She remained in clinic another 20 minutes with no recurrence nor new onset of symptoms. Strongly encouraged her to contact her PCP regarding this episode. Assured her he will be able to review documentation via site as he is at Rush. Progress Notes Patient states that she is feeling better. Vitals taken and explained to pt that she should let her PCP know about the reaction she had and to call 911 if she develops any sign/symptoms of distress. Pt verbalized an understanding.  Progress Notes Pt noted red itchy area on right wrist. When her 30 min post vaccine time was up she noted itchy reddish spot by her elbow. Examined by RN and Dr. advised to take benadryl and monitor for another 20 minutes. Given 25 mg of benadryl per RN. Will monitor until 240pm
Left side body pain, hip, ankle, thigh involved teeth hurt, chest tight, felt throat closing.
Onset of chills, fatigue, and fever approximately 3 hours after administration of pneumovax and influenza shots.  Next AM took to the ED, was noted to have mild hypotension and fever (to 101).  Had loose stools in the ED.  No cutaneous or resp symptoms.  Admitted to the ICU for observation and BP controlled with fluids.  BPs remained low 23Oct, antibiotics started that evening.  BP issues resolved over the weekend.
patient had tingling on face starting on 6/3/21, on 6/4/21 broke out in rash, on 6/5/21 rash broke open to open sores\ 6/10/2021 diagnosed with shingles
Information was received on 13-OCT-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 21-MAY-2012 at outpatient clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-NOV-2014, the patient was treated at a health system for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Shaky; Fell out of bed; Weak; Got really sick after booster; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced ILLNESS (Got really sick after booster) (seriousness criterion hospitalization). On 10-Dec-2021, the patient experienced TREMOR (Shaky) (seriousness criterion hospitalization), FALL (Fell out of bed) (seriousness criterion hospitalization) and ASTHENIA (Weak) (seriousness criterion hospitalization). The patient was hospitalized from 10-Dec-2021 to 12-Dec-2021 due to ASTHENIA, FALL, ILLNESS and TREMOR. At the time of the report, TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood potassium: high (High) High. In December 2021, Blood pressure measurement: low (Low) Low BP.         At the hospital patient received IV Fluids.  Company comment:  This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-410982, MOD-2021-410964, MOD-2021-412276 (Patient Link).; Sender's Comments: This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Vaccine was placed in refrigerator on 04-Nov-2021. Vaccine did not undergo any temperature excursion. No adverse events were reported.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated PO with a dose of ROTATEQ (Lot# not reported) at 34 weeks instead of 32 weeks. There was no adverse event involved. No further information is available.