chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. In 2015, the patient was treated by a physician at a clinic for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Rash essentially on all parts of the body except chest and back. Redness of areas as well as red bumps, has rash over on both sides of hands, feet, legs, face, neck, etc.
Presented to the ED for fever.Positive for COVID19 on testing, COVID-19 virus infectionhypoxic on room air,  placed on supplemental O2, Decadron,
HIGH TEMPERATURE (2 DEGREES HIGHER THAN PATIENT NORMAL). IT WAS 100.6 DEGREES FOR 2 DAYS  ATARTING DAY AFTER VACCINE ADMINISTRATION.  ALSO HAD SORE LYMPH NODES UNDER  ARMS.
This spontaneous report as received from a nurse to a 12 month old patient of unknown gender. The patient's pertinent medical history and concomitant medications were not reported. On 01-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiry date, dose and route of administration not reported) and then was administered a dose of PROQUAD (Merck) (lot#, expiry date, dose and route of administration not reported) instead of a dose of M-M-R II as prescribed. No adverse events were reported. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with an injection of ZOSTAVAX. Subsequently the patient experienced redness around the injections site. No other information was available. Additional information has been requested.
Woke up  15 hours after receiving 2nd covid shot with aches, chills and raging headache. Lasted about 12 hours  along with tiredness -  3rd day noticed rash and extreme itching around injection site and very painful.
sick for 3 days; got my flu shot and it made me real sick for 3 days ,no more shots for me.; Initial information received on 26-Jan-2022 with live follow up 26-Jan-2022(processed together) regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported sick for 3 days and got my flu shot and it made me real sick for 3 days ,no more shots for me. while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "sick for 3 days" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "got my flu shot and it made me real sick for 3 days ,no more shots for me" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my flu shot and got very Ill for 3 days could not get outta bed. Never again".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick for 3 days, got my flu shot and it made me real sick for 3 days ,no more shots for me).  At time of reporting, the outcome was Unknown for the event sick for 3 days and was Unknown for the event got my flu shot and it made me real sick for 3 days ,no more shots for me.  Additional information was received on 28-Jan-2022 from consumer/non-Health care professional : event( malaise) added and narrative amended accordingly.
This spontaneous report was received from a medical assistant (healthcare worker) regarding an unspecified number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On unspecified dates, an unspecified patients were vaccinated with VAQTA (dose, route, product lot and expiry date was not reported) that might had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Bell's Palsy; Tingling in both arms and hands; Did not receive second dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a female patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she (the pharmacist) was involved in administering the Pfizer COVID-19 vaccines at her work and due to the increase in concerns about Guillain-Barre syndrome developing, prompted her to call Pfizer because she remembered one patient who was diagnosed with Guillain-Barre syndrome after receiving the second dose and she remembered two patients who experienced Bell's Palsy after receiving their first doses of the Pfizer COVID-19 vaccines and they were not given the second doses due to those adverse events. On an unspecified date, caller stated that the patient had bell's palsy, Later in the call that the patient also experienced tingling in both arms hands that lasted for at least 6 weeks. The caller stated that she was at home and did not have the reports or details of the patients on hand. She stated that she did report those events through the VAERS reporting system as per their protocol. These doses were given to outpatient. The caller stated that she did not call and report these adverse events to Pfizer at that time because she did not want to double report and she would like to know of VAERS, shared these AE reports with Pfizer. Outcome of the events was reported as unknown.            Information about lot/batch number can be requested.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between reported event Bell's palsy and suspect product BNT162B2 cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021895192 same reporter/drug/event, different patient
on two occasions after receiving the Moderna  covid vaccine  two days later I broke out with herpes sores across my lips and below
Redden/swelling to touch, RA, area approx 3" x 2" where the Flu vac. was given. Raised area approx 1 1/4" where the Tdap was given.
Rash; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (Rash) in a 23-year-old female patient 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) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt reported initial iching at site of injection that spread to other arm & then broke out in hives on arms, chest & back. Also reports tingling of face & tongue. Pt took 50mg BENADRYL and saw medical provider, given Epinephrine and SOLU-MEDROL in route to hospital. Vaccine given approximately 12:40. Received call from hospital about 2pm.
herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On 22-AUG-2016, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) as routine health maintenance and for the prevention of shingles (herpes zoster) (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff suffered herpes zoster with a red vesicular rash on the left breast and radiating to the dorsal thorax. As a direct and proximate result of defective zoster vaccine live(ZOSTAVAX), Plaintiffs symptoms have resulted in physical limitations not present prior to product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not recovered.    The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
A report was received from a health care professional on 11/17/03 concerning a group of approximately 18 vaccinees who inadvertently received Fluvirin SC between 11/4/03 and 11/5/03. Between 11/4/03 and 11/5/03, approximately 18 vaccinees were administered Fluvirin SC. All vaccinees were in good health at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Myalgia, Fever, chills Narrative: Employee called after the event to report she was positive for COVID on 12/6/2020, side effects of vaccine were sore arm, chills and fever to 101. She took Tylenol and motrin at home, Symptoms self resolved at approx 48 hrs; no care needed from provider
Enough tiredness to recognize as such on second day.  tiredness gone by about 8 p.m. second day
I received my menstruation 9 days before it was planned. It is heavy and I also have slight nausea. It was unexpected and I would like to know if the vaccine correlates to the early menstruation.  I am not on any birth control.
On 02/26/2021, 10 days after given the vaccine I was admitted to the hospital with a blood clot in my left leg and in both lungs. I was given Heparin, admitted, started on Xarelto,  released on 02/28/2021. I will be on blood thinners for a at least 90 days.
4/2 started with a sore arm, redness and warmth and swelling the size of a soft ball. Symptoms are getting better.  She continues to use motrin and cool compresses.
Within 5 mins after MMR and Prevnar given developed facial erythema, sleepy acting progressed to mild edema of lips and cheeks and redness of upper chest.
Patient states she just noticed today, 2/2/21, that there is a red mark on her arm, 2 inches long, 1 inch wide, where she received the vaccine.  No other symptoms.
arm is warm and feels hot; arm soreness; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is warm and feels hot), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (redness around the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery. Concurrent medical conditions included Arthritis, Vision loss and Sulfonamide allergy. Concomitant products included NAPROXEN (NAPROSYN E) for Arthritis.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm is warm and feels hot), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (arm is warm and feels hot), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Immediately after getting the vaccine, AP reported a feeling of tingling of her tongue. She denied any feeling of swelling. Spoke to her on 1/15/21, AP reports that the feeling only lasted for the 30 minute observation time that we kept her post-vaccination.
Relieve of nerve pains in hands and feet/happened agains on my 2nd shot and again was short lived/ still suffer from the constand nerve pain like shards of glass; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of therapeutic response unexpected (received 1st dose in 2019 or 2020 and after receiving Shingles vaccine, almost instantly relieved of nerve pains in hands and feet and nerve damage and associated pain dramatically improved, refer case US2022156236). Concurrent medical conditions included nerve damage and nerve pain.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022156236   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Prior to receiving vaccine, the patient suffered from severe nerve damage and pain from a cervical injury a couple years after the accident.  The patient received the Shingles vaccine in either 2019 or 2020 and it changed his life. Although it was short lived for about a week. The patient thought it was a new him, this happened again with the 2nd shot and again was short lived. The physician could not able to explain why this occurred.  The patient still suffer from the constant nerve pain like shards of glass throughout his body daily.  The patient prayed that he never get shingles but he did not thought it could get worse. No additional details were provided by the reporter. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022156236:Same reporter
Pregnant at the time of first dose; Interval between doses > 42 days; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days) in a 42-year-old female patient (gravida 1, para 1) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.
pain Narrative:  He notes having developed the following after the first vaccination: *Right arm deltoid pain: started off as mild ~3 hours after the vaccination. Became progressive to the point where he felt that he was unable to lift his arm to get dressed or comb his hair. He tried to apply warm compress and take OTC acetaminophone, but did not obtain relief. On 2/24, he went to the ER (see note for full details). He was prescribed vicodin 5/325 to take 1-2 tabs q6H prn pain #10 tabs and prednisone 4mg x5 days. He states obtaining relief from these rx and resolution of the pain. *Scattered rash over b/l medial calves L>R: started the day after the vaccination and continues to be mildly persistent. Described as "a little bit" itchy, red small papules. No pustules, erythema, induration, warmth to touch, sloughing. No therapies were tried or applied, although the prednisone rx'ed for his arm pain did a/w the papules, Faint scattered papules, mostly over left medial calf were visualized (some over right as well). He denies new detergent, soaps, OTC or other rx, and plant exposure.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Treatment: COVID 19 Treatment, treatment start date on 24May2022, indication was treatment of COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODYACHES, UNABLE TO MOVE, DISORIENTATED, CHILLS, REDNESS,  SWELLING AT THE SITE OF INJECTION AND HOT TO THE TOUCH.
red swollen lower lip, slight hoarseness and sensation of burning in mouth.  Later approx 1:00 pm noted to have redness and swelling 3 inches below injection site.
Patient (the reporter in this form) developed Shingles. Covid-19 vaccine second dose was administered on Wed. 4/28. First hint of symptoms with redness on left thigh started on 4/30 and spotty rash started to appear on 5/1, continuing to grow on 5/2-5/5, and showed blisters. Rash spread on the left thigh and buttocks. Back pain on the left, in the torso.  The blisters and back pain increased over time from 5/1-5/5.
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general  flu like feeling
This spontaneous report as received from a other health professional refers to an approximately 16 year old patient. On 11-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse event were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Office visit 12/01/2022 - Left side of face, neck and ear swollen and painful x1 day. Recommended being seen at ER. Was seen at ED  for left facial swelling. Dx'd with parotitis. Treated with IV abx, as well as well as amox.  Symptoms have resolved. Back to normal self. Follow up office visit on 12/08/2022
contracted COVID in September 2021; contracted COVID in September 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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) with onset Sep2021, outcome "unknown", COVID-19 (medically significant) with onset Sep2021, outcome "recovering" and all described as "contracted COVID in September 2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) contracted covid. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sore arm Fever  Cough  Headache  Body ache  Weakness  Runny nose
Patient's right deltoid was swollen and warm to touch extended to just above the elbow.  Child c/o soreness to touch, denied inability to move extremity. Instructed mother to administer tylenol and place cold compress on arm.
This spontaneous report was received from a pharmacist refers to a 68-year-old female patient. The patient did not have any pertinent medical history and any known drug reactions or allergies. On 09-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L021367 expiration date 05-NOV-2016) (dose and anatomical location were not reported) for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified). On the same day, the patient experienced soreness and induration at the injection site. The outcome of the events was reported as recovering (symptoms have improved, but are still present). Causality assessment was not reported.
Mom states child complained of HA X2-3 days. She gave tylenol 160 mg chewable tablets on days he complained. No other symptoms or an other adverse events. Child received dose one on 11/17/21 and dose two on 12/1/21, dose two was due on 12/8/21.