chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prevention of shingles and zoster-related conditions by a healthcare provider at medical center. Pt was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. Pt claimed damages as a result of: injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the events was unknown.
Wrong second dose given.  Client should have had a 2nd dose of pfizer.  Now adverse reaction.
Arm swelled, fatigue, nausea, pain in muscles, joint pain;then major pain in hips both sides, and started having tremors in both hands. The tremors joint pain and hip pain have not gone away. Have increased falls. I would consider this permanent damage.
Adverse Event: Atrial Fibrillation (Afib).  Treatment: Cardioversion procedure, cardiac monitor surgically implanted Outcome: continuous doctor visits to monitor the Afib
The patient stated that immediately after receiving her vaccination, she had blurred vision in her operative eye.  The patient had a history of retinal detachments in the past.  She had blurred vision ongoing for a few weeks after vaccination.
Only the liquid componenet of the PENTACEL vaccine was given to a patient with no reported adverse event;Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from another health care professional via non-healthcare professional/consumer via Medical Information (Reference number- 00821192).   This case involves a patient (unknown demographics) who received only the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Oct-2021, the patient received a only liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (latency on same day).  It was reported "the caller states that only the liquid component of the PENTACEL vaccine was given to a patient today. What do they do?"   At the time of report no adverse event was 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Both does one and two resulted in chills, fever, and extreme weakness.  The patient could not stand up.  He was also quite incoherent.  The first time resulted in a fall in the bathroom and subsequent hospitalization.  The second he stayed in bed and recovered after 24 hours.
arm hurt; headache; This is a spontaneous report from a non-contactable consumer. A male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm hurt and headache on an unspecified date. Reported as: Upon callback, caller's mother stated, "Your shot is wonderful. My whole generation got it; my brother in law, sister in law, everybody took it. They got a light headache and their arm hurt, but it was not bad. We loved it. My husband is fine. My husband feels stronger now than anything." The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Generalized tonic clonic seizure lasting 1-2 minutes, resolved spontaneously, followed by postictal state
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 01Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
have a low grade fever 5 days after receiving her 1st dose of the vaccine/Slight fever; arm soreness; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 16:30 (at the age of 61-years-old) at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced a low grade fever 5 days after receiving her 1st dose of the vaccine/slight fever on 15Apr2021 and arm soreness on 10Apr2021. Patient stated that she got the first Pfizer COVID-19 vaccine on 9Apr2021 at 16:30. She states she is still running a slight fever and wants to know is that normal. She states that she first noticed the fever on Saturday and it still comes and goes. She states she is taking Tylenol for it. She states her arm was sore Saturday 10Apr2021 but by Sunday 11Apr2021 she had to really press around to feel where the shot was given and it wasn't sore hardly at all. She states she is completely recovered from the arm soreness.  The patient was asking if it is normal for her to have a low grade fever 5 days after receiving her 1st dose of the vaccine. She mentioned that she has had on and off fevers ever since the day after she got vaccinated. She is also asking if this would affect her 2nd dose and should she still receive it. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines administered on same date of the Pfizer Suspect. The outcome of the event fever was not recovered, and the patient recovered from the event arm soreness on 11Apr2021.
Breathing tightened and wheezing; left eye swelled, a few hives, hands had burning sensation and tingling
Later that night after the vaccine I developed a little fatigue which lasted about 24hrs. On 1/4 I developed a broken blood vessel in my eye so I went to see my PCP and my BP was elevated at that time so I was prescribed Metoprolol.  On 1/20 I developed a runny nose and a little sore throat. Chills developed as well and the next day I developed a fever so I went to the local Urgent Care where 2 COVID test were performed and both were positive for COVID-19. I was given a shot of prednisone and a B12 shot, Zithromax. I still didn't feel well and was extremely fatigue, a stomach ache followed by diarrhea so I took the pills that were prescribed at the urgent care. The sore throat finally went away, but to date I am still dealing with the congestion, a little fatigue, and I still have a little SOB with exertion but it has lessened significantly.
Swelling left side of face and left eye. No airway compromise. No tongue swelling.
This spontaneous report was received from a pharmacist concerning to two unspecified patients of unknown age and gender. Patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 28-OCT-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU, lot # L044528, expiration date: 09-FEB-2017 (Dose and route of administration were not reported), which underwent a temperature excursion of 19 Fahrenheit degrees, for 12 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Client reported a ruptured blood vessel in her right eye following vaccine administration.  Client was evaluated by Fire Rescue.  Client was released to go home at 3:59pm.  Per Fire Rescue patient does not need further onsite eval.
No additional adverse effects reported; Incorrect product storage; This spontaneous non-valid report was received from a healthcare worker regarding an unspecified number of patients of unknown age or gender. The patients' pertinent medical history, concurrent condition, concomitant medications, drug reactions and allergies were not reported.   On unspecified dates since July 2020, the patients were vaccinated with an unspecified amount of improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R021372 was verified to be valid, expiration date reported as 25-MAY-2021), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R020948 was verified to be valid, expiration date reported as 04-MAY-2021), hepatitis a vaccine, inactivated (VAQTA) (lot # S005723 was verified to be valid, expiration date reported as 10-JUL-2020) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1676332 was determined to be not valid, expiration date reported as 04-MAY-2021); (vaccination regimen, route of administration, and anatomical location were not reported for all the vaccines) all administered as prophylaxis (product storage error).   The vaccine was stored in temperature above 47 degrees Fahrenheit (F) (71°F) for a time frame of 596 hours and 35 minutes. There was no previous temperature excursion. The call was due to a data-logger. No adverse effect reported.
Possible COVID rebound case.; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 at 14:00 as dose 1, single (Lot number: EN6203), in left arm, on 28Mar2021 at 15:00 as dose 2, single (Lot number: ER8730), in left arm, on 01Oct2021 at 17:00 as dose 3 (booster), single (Lot number: EW0202), in left arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 08:00, outcome "unknown", described as "Possible COVID rebound case.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical Information: Patient started to took paxlovid from 18Aug2022 for Covid-19Treatment.other medication in 2 weeks product :other medication in 2 weeks product was Pantoprazole with brand name camber started from 12Aug2022. No other medical history.Possible COVID was rebound on 28Aug2022 at 08:00 AM. Patient was not recovered. No treatment taken for this adverse event.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe reaction to the product which lasted daily for 5 weeks. The patient reported general body aches which lasted way too long. After speaking with his physician, he made the decision not to get the 2nd dose because of the side effect he experienced. He claimed that it was not worth it and his physician agreed. The patient refused to provide any details over the phone.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/20/21 2nd dose01/07/21 Diagnosed covid positive:09/02/21 Symptom onset:09/01/21 Exposure: Symptoms:fever, cough, fatigue,muscle aches,sore throat,chills,runny nose,headache
Severe brain fog; Difficulty concentrating; Impaired balance; Difficulty with word finding; Memory issues; Anxiety; Dizziness; Low energy; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0173) via an unspecified route of administration in the left arm on 14May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisations. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 14May2021, the patient experienced severe fatigue within 5 hours and lasted approx. 24 hours. Severe brain fog started within 48 hours (16May2021) and lasted approximately 6 weeks. Including dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy. The patient was still experiencing occasional symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of event severe fatigue was resolved on 15May2021 and severe brain fog was resolved on an unknown date in 2021. The clinical outcomes of dizziness, difficulty concentrating, impaired balance, difficulty with word finding, memory issues, anxiety and low energy were unknown at the time of this report.
Nausea set in immediately, shortly after fever and chills began. By dinner time that evening the intense migraine was overpowering, the chills/nausea/muscle pain was intense. The chills went away on the third day after the shot. Muscle pain, fatigue, soreness, discomfort with breathing, headache, abdominal pain/swelling are still prominent.
Shot was administered with a "Punch Gun" not a needle.  I had intense pain and aching in my arm and terrible aches in my muscles. For months after, I felt as if someone punched my arm; range of motion was restricted. Then tennis elbow on that arm developed. Now, 5 mths later my upper left arm hurts whenever I put on clothes.
Employee received covid19 vaccine without issue. At discharge became diaphoretic and tachycardia. Medical proceed out called and ED team arrived. On arrival vital signs patient was hypertensive, A&O x3, able to answer questions. ED offered to transport employee to ED for observation. Employee chose to stay at the Administration Clinic to be monitored. After 30", vital signs were within normal range, employee stated he felt fine, no tachycardia, no diaphoresis. Ambulated out of department with out issue.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator was unknown. The vial didn't undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant information received.
26AUG93 vomited x 1 7 h/a w/some relief by APAP; 27AUG93 devel rash on trunk/arms/buttocks, raised red spots spread to rest of body 28AUG; seemed to be getting better; 30AUG vomited;
3-15-21 headaches, running a 101.8 fever Monday night. Tuesday ran a fever of 100.5. 3-16-21 Legs hurting on Tuesday and body sore.  Wednesday feeling extremely tired but no fever.  I went back to work today Wednesday 3-17-21
still testing positive/ she had covid; still testing positive/ she had covid; still has problems with her voice; feels tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still testing positive/ she had covid"; DYSPHONIA (non-serious), outcome "unknown", described as "still has problems with her voice"; FATIGUE (non-serious), outcome "unknown", described as "feels tired".  Clinical course: Caller said that she had covid, she still has problems with her voice and feels tired, but her throat is no longer hurting. She is still testing positive, and she would like to know how long she needs to wait before she goes out. She also asked about the new Pfizer covid vaccine release date. Caller has problems with her voice and feels tired due to covid and has taken four shots of Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
(2/6/2021) Tachycardia, (2/8/2021) Eliquis. Still having issues to this day. (07/22/2021)
I started to get a really bad headache and severe Diarrhea. I did a home test on 12/13/2021. I then got a runny nose extreme fatigue and coughing. I was very weak and I had no energy. The GI problems subsided in 3 days. I lost my sense of taste and smell for two days. It was everything tasted the same and it was not a good taste. I felt like I was hot but I did not have a fever. My Oxygen levels were low when I went in for the Monoclonal antibodies. I got those on 12/15/2021 the day after my positive PCR test. I am still very fatigued some days after 3 weeks. I had caught it from a family member in my household. I have returned to work.
Left deltoid muscle became red, hot and a lump formed within 5 minutes of receiving flu vaccine IM injection.
DIED; This spontaneous report received from a consumer via social media through a company representative concerned 3 patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown ) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (two weeks after vaccination), the patients died from unknown cause of death. It was unspecified if an autopsy was performed. As reporter reported " "Same here but × 3"(In response to this comment: "I have a friend who was young, took the Johnson shot and died two weeks later"). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220128561.; Sender's Comments: V0. 20220127876-covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 6 year old patient of unknown gender. On 19-AUG-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Cheeks and lips swollen - Oral mucosa inflamed - began on 9-14, saw her dentist today who thinks is an allergic reaction to something.