chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 year old daughter with a history of seizures and heart arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On 27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA. Subsequently, the patient began to have seizures, developed a rash on her arm, and was complaining about headaches. On 22-JUN-2007 the patient experienced a heart arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on life support and died on 29-JUN-2007. The patient's mother reported that the patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT syndrome. The test came back normal. It was reported that at that time the patient was in and out of the emergency room due to having seizures periodically. The patient had been seeing a neurologist and had not had any seizures for about two years until she received the second dose of Gardasil. The patient's mother reported after her daughter's death and burial she had received copies of her daughter's medical records. Throughout the reports it showed that for the past five years the patient had prolonged QT syndrome, and proguda syndrome "which causes seizures and heart arrythmias." The patient's cause of death was prolonged QT syndrome, brain death, and proguda syndrome. No product quality complaint was involved. The seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death, and proguda syndrome were considered to be other important medical events. Additional information is not available.
Immediately dizzy. Sat for 15 minutes. Still dizzy but drive home. Lay down woke up two hours later still dizzy. The dizziness has subsided somewhat but I veer to my right side when I walk. It has yet to go away
Morning of 12/28/10 neck & body very stiff. Patient still had neck stiffness after consulting MD & follow up on 1/6/11.
Hospitalization for altered mental status post-seizure and also tested positive for COVID on dates  6/29/2022-78/2022.  Treated with dexamethasone,  Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient reports he thinks we hit a nerve. Affected arm went limp. Now aches from shoulder to elbow. Has lost strength in that arm. Reported all of the above to local health dept. 01/12/10.
Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old female patient who received PENTACEL without the ACTHIB portion. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. Concomitant medications included MMR VACCINE for Immunisation; and VARICELLA VACCINE for Immunisation. On 24-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5572AB via unknown route in the left thigh. It was a case of actual medication error due to inappropriate reconstitution technique. HCP diluted the DTAP-IPV with a "sterile diluent and administered it to the patient. It was unknown if adverse event occurred. 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 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.
Side effects; Barely could get out of bed, trouble straightening up, homebound for 4-5 days; Left leg pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (Side effects), PAIN IN EXTREMITY (Left leg pain) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days) 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 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 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain). On an unknown date, the patient experienced ADVERSE REACTION (Side effects) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days). At the time of the report, ADVERSE REACTION (Side effects), PAIN IN EXTREMITY (Left leg pain) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days) outcome was unknown.            No concomitant medication was provided. No treatment information provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was considered to be not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 30 April 2021. Patient demographics and new events ( pain in extremity and mobility decreased ) were added.
Patient received a Moderna vaccine on 08/03/2021 and upon entry into the system; it was discovered that he'd previously received another branded vaccine: Pfizer on 04/30/2021
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 26-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000652: US-009507513-2109USA000653: US-009507513-2109USA000654: US-009507513-2109USA000655: US-009507513-2109USA000656: US-009507513-2109USA000651: US-009507513-2109USA000649: US-009507513-2109USA000648: US-009507513-2109USA000647: US-009507513-2109USA000650:
Information has been received from a licensed practical nurse, concerning a 20 year old female patient, who on 03-JAN-2007 was vaccinated with the first dose, 0.5 ml, IM, of Gardasil (Lot # 654389/0961F). There was no concomitant medication. On approximately 23-FEB-2007, the patient developed "hives that started approximately 1 week before her appointment for the second dose (02-MAR-2007). The nurse added that the patient's "primary physician gave her an analgesic" (name unknown). The nurse stated that the patient"still had the hives when she came to the office" for her appointment and reported "the hives were mostly on both arms." The patient "received the second dose" of Gardasil on 02-MAR-2007. Additional information has been requested.
Pt received vaccine at 14:00 and by 18:00 that night pruritis on lower body trunk. By 20:30, noticed papular injected lesions involving trunk. Pt seen in ED and started on Benadryl.
1/7/2022 began extreme itchiness, hives, redness and raised welts appearing where scratched, all over upper body (from head to groin). Reflux began 1/9/2022, resolved with Zantac. Itchiness and rash continue currently, but respond to antihistamines (Zyrtec most effective, hydroxyzine moderately effective, benadryl least effective).
Syncope and collapse 3 times; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021 (Batch/Lot Number: EN6199) as single dose for covid-19 immunization. Medical history included allergy to penicillin. Concomitant medication included amlodipine accept in two weeks. There was no other vaccine in four weeks. The patient experienced syncope and collapse 3 times on 06Mar2021, resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for syncope and collapse 3 times for 3 days. The patient has not covid prior vaccination, tested covid post vaccination. covid test type post vaccination was Nasal Swab, covid test date on 31Mar2021 with negative result. Therapeutic measures included potassium replenishment, rest and monitor were taken as a result of syncope and collapse 3 times. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Reason for Visit   Cough  Generalized Body Aches  Headache   Diagnoses   RSV bronchitis  Nausea  Cough  Sorethroat  Periodic headache syndrome, not intractable  Generalized body aches
"Electric shot" feeling in body 30 minutes after injection; Light headedness; Trouble breathing; Eyes blood shot; Heavinees in head 30 minutes after injection/Heaviness in body 30 minutes after injection; Urination was achy; Swelling  in vulva; swelling in vulva; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DYSPNOEA (Trouble breathing), OCULAR HYPERAEMIA (Eyes blood shot), DISCOMFORT (Heavinees in head 30 minutes after injection/Heaviness in body 30 minutes after injection) and DYSURIA (Urination was achy) 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.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Light headedness), DYSPNOEA (Trouble breathing), OCULAR HYPERAEMIA (Eyes blood shot), DISCOMFORT (Heavinees in head 30 minutes after injection/Heaviness in body 30 minutes after injection), DYSURIA (Urination was achy), VULVOVAGINAL PAIN (Swelling  in vulva) and VULVOVAGINAL SWELLING (swelling in vulva). On an unknown date, the patient experienced ELECTRIC SHOCK ("Electric shot" feeling in body 30 minutes after injection). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headedness), DYSPNOEA (Trouble breathing), OCULAR HYPERAEMIA (Eyes blood shot), DISCOMFORT (Heavinees in head 30 minutes after injection/Heaviness in body 30 minutes after injection), DYSURIA (Urination was achy), VULVOVAGINAL PAIN (Swelling  in vulva), VULVOVAGINAL SWELLING (swelling in vulva) and ELECTRIC SHOCK ("Electric shot" feeling in body 30 minutes after injection) outcome was unknown.            No concomitants were reported.
Awoke the next morning with upper arm muscle pain bilaterally. The left arm was NOT worse than the right. Pain spread across the neck and shoulders over the following two weeks, with increase in intensity. No treatment given, physical therapy referral made. As of today pain persists in arms and hands, worse in the morning.
Confusion, trouble concentrating/gathering thoughts. Twitching/tingling sensation on face (on the right side, same side as where the shot was administered). Chills, body aches.
that afternoon p/vax pt started shaking (inc body only);eyes rolled back into head-pt became lifeless but body was shaking;very drowsy;slept for 2 1/2 hr p/episode;
12/11/2021-About 06:00PM that evening her face starting swelling up and she started felling faint. Husband and I are both doctors and we looked at her and her face was swollen, her pulse was very faint. we gave her 10mg Claritin and 40mg prednisone, She started having a hard time breathing and we gave her nebulizer treatment for 10 minutes, face started going down but she started felling very dizzy, check blood pressure and it was 80/40 and she looked very dehydrated and we started pushing fluids, water, soda and lemonade for about 2 hours. Afterwards, she started having severe chills, shaking really bad. She had a hard time walking. She started having fever about 06:20PM. We then gave her Motrin and Tylenol. Finally after pushing fluids, we were checking her vitals and by 09:15PM, she stopped shaking and she stated that she was feeling better. The next morning, her face was still swollen a little, gave her another nebulizer treatment and gave her prednisone and Claritin but was very weak. She is feeling better right now but still complains of being tired.
25min after. Rapid heart rate, drop in blood pressure ER visit 1 Day  1-3headache, neck ache Day 4 heart palpitations/dizziness ER visit 2 Day 5 Heart palpitations/dizziness ER visit 3 Day  6 mild heart palpitations, bone aches in left ankle  Day 7 general weakness, aching joints, tired all week, ankle still  aches
patient inadvertently received an extra (third) dose of FLUZONE with no reported adverse event; Initial information  received on 22-Mar-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an 18 months old female patient who inadvertently received an extra (third) dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past vaccination(s) included Fluzone Quadrivalent on 30-NOV-2021 and 03-FEB-2022. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine RHBSAG (yeast) (Recombivax) for Prophylactic vaccination.  On 22-Mar-2022, the patient received a dose of suspect Influenza quadrival A-B vaccine (with an unknown formulation and strength) (lot number: UT7376NA and expiry date: 30-Jun-2022) at a dosage of 0.5 mL via intramuscular route in the left arm for prophylactic immunization.  On 22-MAR-2022 (latency: same day) the patient inadvertently received an extra (third) dose of Influenza quadrival A-B vaccine with no reported adverse event (extra dose administered).   Action taken was not applicable.  Outcome: Unknown    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.
the dose administered past the expiry date was their first dose, administered on 20Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and GERD.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (the dose administered past the expiry date was their first dose, administered on 20Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Significant follow up (Other medical information updated)
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#136230) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 112 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
9-12-08 LOCAL REACTION (ERYTHEMA AND MILD SWELLING AT INJECTION SITE.TX.ADVISED COLD COMPRESS AND ADVIL OR TYLENOL. 9-13-08 TO 9-23-08 CONTINUES TO C/O INTERMITTENT PAIN IN L ARM.- TREATMENT COURSE - WARM COMPRESS, ALEVE, NAPROSYN,VICODIN.RECOMMEND P.T. 9-19-08 PATIENT REPORTS VISIT WITH CHIROPRACTOR. X-RAY DONE AND SHOWED ARTHRITIS IN NECK AND VERTEBRAE. 12-04-08 PT. REPORTS IS STILL HAVING NUMBNESS IN ARM, NECK,AND BACK WITH PINS AND NEEDLES SENSATION. HAS APPT. WITH NEURO FOR NERVE CONDUCTION STUDY.
Dx Brachial Neuropathy. Vaccine given 1/5/06. Pain at injection site eventually traveling down arm. Diffuse myalgia, vomiting 10 days later. Seen 1/27/06 with very tender shoulder. 2/16/06 and 2/17 visits showed 3/5 weakness, loss of sensation left arm. Given  Lyrica Mesic Ultracet. Information received from the annual follow up indicates patient has not recovered. Has continued LUE neuropathy with significant disablity. Difficulty working as hairdresser. Patient does not have insurance. Wants to know is there compensation available for her at least to cover medical costs? Lost contact with patient. Moved to California.
PT contacted flight surgeon via phone & instigated to flu with HS, in the morning. Tx with Benadryl as Erythematous Tixinum, and later updated Dx to vaccinium as per MD.
Red, bumpy rash on left arm from shoulder to midway down the upper arm; itchy
Nausea, vomiting, dizziness, feeling faint, hypotension, hypoglycemia
At 4:35 p.m. while in observation area, patient c/o feeling, dizzy. VS obtained: B/P 157/99 P 95 100%RA, feet elevated. Patient stated she hadn't eaten since noon, patient given water and crackers. VS obtained again at 4:40 p.m. B/P 158/107 P 93 100%RA. Daughter with patient and states b/p runs high at times. Patient stated she is feeling better. At 4:45 p.m., VS retaken B/P 145/97 P 79 100%RA. Patient stated she is feeling dizzy again. RRT called at 4:45 p.m. RRT arrived at 4:50 p.m. MD given verbal report and patient and daughter agreeable to go to ER for evaluation. Patient remained alert and verbal
swelling on knee; hard to walk; tired; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (achiness), FATIGUE (tired), JOINT SWELLING (swelling on knee) and GAIT DISTURBANCE (hard to walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache) and PAIN (achiness). On 08-Feb-2021, the patient experienced FATIGUE (tired). On 10-Feb-2021, the patient experienced JOINT SWELLING (swelling on knee) and GAIT DISTURBANCE (hard to walk). At the time of the report, HEADACHE (headache), PAIN (achiness), FATIGUE (tired), JOINT SWELLING (swelling on knee) and GAIT DISTURBANCE (hard to walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.