chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; cardiac event; herpes zoster/ rash; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash, herpes zoster, postherpetic neuralgia and a cardiac event. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia and a cardiac event was considered as not recovered. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events herpes zoster, postherpetic neuralgia and a cardiac event to be disability.
Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itching all over arms, back hands, scalp. BP 138/62, gave one diphenhydramine 25mg po. At 2:15-- same symptoms, no worsening. At 2:30pm, per pt less itchy; NO n/v; NO thickening feel of tongue/throat; pt will take Allegra at 6pm; will notify Dr/ER if any worsening of symptoms
Soreness at injection site beginning 0230 hrs following an injection at 1400 hrs the day previously.  Self-administered 1000 mg Acetaminophen PO. Just in second day now. Soreness less. Taking 500 mg Acetaminophen PO Q8hours
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 22-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012973: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012614: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980:
Information has been received from a Doctor of pharmacy concerning a female baby (1-2) days old who on approximately on 05-JUL-2009 was vaccinated with MERUVAX II (lot # not reported) instead HEPATITIS B (manufacturer unknown). Reported as human error. On an unspecified date she received HEPATITIS B (manufacturer unknown) (lot # not reported). No adverse effects were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of two reports from the same source.
fatigue, join aches, sore throat, nausea starting  24 hours after injection, subsiding 24 hours later
Patient reported weakness in both legs and that her "legs gave out". She required a wheelchair as she couldn't walk and could barely stand. This began approximately 26 hours after the dose of the vaccine. She does not report any other symptoms at this time.
With the 1st dose, I had headaches but did not seek treatment (Lot 039K20A IMLA). I went ahead and proceeded to get the 2nd dose. That evening, I had a low grade fever and headaches. I took Tylenol during the day for the headaches. I felt tired but the headaches never went away. I have a first aid team at work and they took my blood pressure and it was 180/95. I also checked my blood pressure at home and it was 150/90. I went back to the first aid team and my BP was still high. I went to the doctor and was prescribed amlodipine. It did lower my BP but I had heart palpitations. I did not feel good on that medication. They changed the amlodipine to losartan. After about a month, my BP has decreased to normal levels and I have been able to wean off losartan to 25mg and my BP numbers have been good so far.
Erythema multiforme rash began 07/01/01 Fever 102.5 on 07/04/01
Case number PHEH2014US011536, is an initial spontaneous report received from a medical assistant on 06 Jun 2014. This report refers to a 11 year old female patient. Past medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13017), without being reconstituted with Men A lyophilized conjugate vaccine component on 29 MAY 2014. No adverse event was reported following this administration error.
Pt started to becomes lethargic and was placed on cot. Pt was laying down and started to have seizures. She would become alert and more responsive between seizures. She was laying down to keep her safe and prevent a head injury. 911 was called and arrived. She did not want to be touched, not even for vital signs, she only talked  by emergancy services.
4-14-09 Mother brought pt to office w/ c/o redness + swelling in the  14cm x 8.5cm left leg at the injection site of DTaP.  He was given BENADRYL in office (6.25mg)
A short time after the injection a tingley, prickley feeling went down both arms and legs to my hands and feet.  I felt normal otherwise. The intensity varies but is always there. My doctor could find no serious problem and suggested a possible B12 connection and ordered a blood test.  The test showed my B12 went from around 200 to over 1000.
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Bivalent as their first dose).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
A lot more side effects than after second dose/Side effects are lasting longer than after the second dose; Aches; I think I need to go vomit; Chills; Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches), VOMITING (I think I need to go vomit), CHILLS (Chills) and ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches), VOMITING (I think I need to go vomit), CHILLS (Chills) and ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose) had resolved. At the time of the report, VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches) and CHILLS (Chills) outcome was unknown and VOMITING (I think I need to go vomit) had not resolved.            No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-363088, MOD-2021-363309 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Reporter details updated, Patient demographic updated, patient route of administration updated and Event updated.
Received Shingles vaccine in right arm on 8/16/14. Client woke up in the AM with HA, fatigue, weakness, nausea and right arm swelling and redness. Symptoms continued throughout the day followed by two episodes of vomiting; 8/17/14 pm and 8/18/14 am. Missed work 8/18/14. Symptoms resolved 8/18/14 expect right arm stayed swollen and red through 8/13/14. Client attended a public vaccine clinic for shingles vaccine. Large crowd attend and the wait line was  approximately one hour.
severe headache, nausea, sweating,  eventually no feeling on left side of face,mouth,  arm, leg, and foot
NUMBING IN THE FACE; DIZZINESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included ulcerative colitis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 19-MAY-2021, the subject experienced numbing in the face. On 19-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, headache, and fever, and had not recovered from dizziness, and numbing in the face. This report was non-serious.
Patient received vaccine, was waiting his 15 minutes, got up and got pharmacy staff attention saying he was not feeling well. Pharmacist went our to waiting area, and patient lost consciousness momentarily. Patient was able to regain a seat in a chair, but then blanked out and was not responsive to his name. He was breathing and had a pulse, but eyes were open in a blank stare and he did not respond to verbal or to gentle shaking. After a few minutes he came out of it and said he was feeling better. A few minutes later, the episode happened again. Emergency responders was called and the pharmacist continued to monitor him until paramedics arrived. The episode happened again while paramedics were attending to him and he was taken to the hospital. Patient did return about 6 hours later looking much better and thanked the staff who helped him.
I experienced sore muscles about 6 hours after my vaccines.  At 2am I experienced fever, chills, nausea and diarrhea.
p/vax pt exp myalgia; dull h/a; T102 N/V; resolved
I was GREAT from the vaccine time of noon Tuesday until 9 am. Wednesday a.m.  I started feeling a wall of tiredness followed soon after by chills and back ache. I took tylenol and was able to work until noon. I rested most of the day but the chills increased tremendously, as did the back ache. It was bad - so bad I was prepared to go to hospital if needed. I decided to go to bed instead. I awoke at 5 a.m. Thursday - once again feeling GREAT. Although a rash (looking like a sort of scalding) appeared on both breasts and near my pelvis. It is still there. I read online these rashes can last up to 7 days.
Hives to chest, back, upper and lower extremities, extreme closed pruritic vesicles, redness and hardness at injection site initially for two days. Continue with site tenderness and warmth and upper back hives with pruritic small vesicles presently, fatigue, and chills alternating with sweating.
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The medical assistant reported that they inadvertently administered expired FLUMIST to a patient on 27-Nov-2013. The outcome of the event of administration of expired dose/we inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious.
Tinnitus 11pm , post-menopausal bleeding with abdominal cramping at 1130pm, Swollen painful lymph nodes on left side of neck
Enlarged and painful lymph nodes under arm / in left arm pit for approximately 5 days following the vaccine. Significant enough that it was uncomfortable for arm to hang at side when standing and would awaken me from sleep if arms was not held out from side.
Pt recv vax on 3/31/98; 6 hrs later pt exp fever (101.8F) and inconsolable crying.  Pt seen by Dr; tx=Tylenol&tepid bath.
FEVER 101.0 HIGHEST, TAKEN BY PARENTS, ORALY. FEVER INCREASES AT NIGHT. SLIGHT COUGH.
By the time she got to monitoring area in our drive through vaccine clinic she was complaining of chest tightness, rash, dizziness, and clammy. BP 140/80, HR 143, SPO2 100%. She was given Epi pen injection to right thigh and Benadryl 50mg IM at 15:55. At 16:01 she was given Albuterol MDI along with another Epi pen. 1610 BP 120/74 HR 109. EMS arrived shortly after this.  She has a past history of anyphalaxis to nuts and peanuts. She was transported via EMS to hospital in stable condition for ongoing monitoring and treatment.
The early morning on 9-2-2021 I was feeling chills, muscle pain, upset stomach
Headache, Myalgia, Fever, c/o injection site itching and warmth,fatigue Narrative:
Six hours after getting the second dose of the vaccine I started to have a headache. The next day I had fever and chills. The fever was 103. I had those symptoms for three days and I was extremely fatigued. The fatigue lingered for about three months total. I got headaches and flu-like symptoms one week after the initial symptoms. I had little appetite and a low-grade fever and it lasted about four days. I kept having those recurring rotation of symptoms for a few days for about 10 weeks. After the third dose I had similar symptoms for 3 days which reoccurred 10 days after which lasted for 2 days. I still get headaches intermittently. It has only been seven weeks and now I am just getting a headache. Each time I get the symptoms I get tested for COVID-19 and all tests have been negative.
Initial report was received on 02 March 2012 from a health care professional. A 43 year-old male patient with no known allergies and no medical conditions had received on an unknown date in October 2011 an intramuscular left deltoid injection of FLUZONE (sanofi pasteur lot number was not reported) and two days later, developed winged scapula on the right side. Damage to the long "thoracic" (thoracic) nerve was confirmed. According to the reporter, the patient was thought to have had Lyme disease and was being treated however the patient does not. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received from a health care professional on 06 March 2012. The patient has had right arm weakness (without pain) since October that was most noticeable when the patient tried to raise his arm over his head. At that time, the patient's work-up included a serology panel for Lyme disease with results IgM [+], IgG [-]. Consequently, the patient began antibiotic therapy for Lyme disease. The patient has since been seen by four other infectious disease (ID) physicians who have repeated the Lyme serology panel and gotten the same results, leading them to think that the initial positive IgM represents a false-negative result (coupled with the patient no reporting any obvious risk factors for Lyme disease and his review of systems (ROS) being negative except for the right arm weakness). Despite this, the original ID physician has had the patient on at least 4 months of antibiotics therapy since October. The patient had also been evaluated by an orthopedic surgeon; nerve conduction studies confirmed damage to the right long thoracic nerve. An evaluation by a neurologist was unrevealing. A computed tomography (CT) scan with contrast was planned to rule out a compression injury to the nerve. The patient's outcome was not recovered. Documents held by sender: none.
10 year old was administered Kinrix vaccines; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The registered nurse reported that a 10 year old patient was administered Kinrix vaccines.  At the time of call, the nurse did not had the patient details, date of administration, or the information of what vaccines were given.  The reporter did not had the lot number/expiration date information of the doses. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The registered nurse reported that a 10 year old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136451:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
pt presented red itchy rash from face down to legs, pt took 50 mg of benadryl prior to coming to clinic. pt was given in clinic 125 mg solu-medrol and 20 mg of pepcid, symptoms resolved pt sent home
Started feeling bad same day after second dose.  Thought it was typical reported symptoms associated with second dose.  Tuesday checked and had fever.  Thursday went urgent care for Covid test that was negative.  Followed up with primary care and after many test was diagnosed with staph/strep blood infection and hospitalized for IV antibiotics.  Had another 6 weeks of at home IV antibiotics.  Have been on oral antibiotics since.  Infection left a vegetation.  Recently 8/29 went back to urgent care with shortness of breath.  Was told fluid in lungs - pneumonia.  Went to ER next day as it worsened.  In hospital for testing and diagnosed with congestive heart failure.  Mitral valve repair/replacement surgery scheduled 9/28.
Mom noticed on 03/05/2006, small tiny bumps on extremities where vaccines were given.  No treatment needed.
Lost control of right leg; Left thumb and index finger became red; Left thumb and index finger became scaly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONTROL OF LEGS (Lost control of right leg) and ERYTHEMA (Left thumb and index finger became red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain operation NOS (She has had operation on her left brain at the clinic in the past).   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (Lost control of right leg) (seriousness criteria hospitalization and medically significant) and ERYTHEMA (Left thumb and index finger became red) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced SKIN EXFOLIATION (Left thumb and index finger became scaly). The patient was hospitalized on 10-Mar-2021 due to ERYTHEMA and LOSS OF CONTROL OF LEGS. At the time of the report, LOSS OF CONTROL OF LEGS (Lost control of right leg), ERYTHEMA (Left thumb and index finger became red) and SKIN EXFOLIATION (Left thumb and index finger became scaly) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was unknown.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.