chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Polymyalgia; inflammation of the muscles throughout the body/ all systems in the body, Her arm, leg, torso, everything; this is so dramatic and so painful; an autoimmune attack on her body; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 28Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Guillain-Barre; when she was 19 years old, she was paralyzed; she has never been able take a flu vaccine until about two years ago she had her first one and a year ago she had her second one; and compromised immune status. The patient's concomitant medications were not reported. The patient did not have any vaccine prior vaccination within 4 weeks. On 20May2021, the patient experienced polymyalgia, and inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything; on an unspecified date 2021, this is so dramatic and so painful, and an autoimmune attack on her body. The patient underwent lab tests and procedures which included blood test: unremarkable on 28May2021, and blood test: sedimentation rate went down on 04Jun2021. The outcome of the events polymyalgia, inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything was not recovered; this is so dramatic and so painful, and an autoimmune attack on her body was unknown.  VACCINE SUPPLEMENTAL FORM: Details coded in narrative.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Patient is 9 years old but received 0.5ml does of the 12+ vaccine instead of the 0.25ml dose for 6mo-11yrs
Mom stated both legs (thigh area) became slightly swollen, no redness or fever. Mom treated with warm compresses and swelling subsided.
Client called health department 11/25/03 to state he ahd developed "20" red hives on right hip during the late afternoon of 11/24/03.  Stated he had flu shot in am of 11/24/03.  Stated he did not call or go to private MD.  No other symptoms of fever reported.  States he applied "cortisone cream" to relieve his itching area of right hip.
Pt received 3 doses of vaccine in 3 visits to Facility Pt had been discharged and family member told to bring pt back to complete series. Facility unable to find pt's record. Family unable to locate vaccine card. Discovered pt had 3rd dose when returned to pharmacy to enter administration information.
they have administered ACTHIB that has expired on 11Sep2023 to a patient today with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 years old male patient who was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination.  On 20-Sep-2023, the patient received 0.5 ml (Dose 4) of suspect Haemophilus Type B (Hib) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB) (Expiry date: 11-Sep-2023) via unknown route in unknown administration site for Immunization.  On 20-Sep-2023 the patient was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, Physician asks if there is a grace period for expired ACTHIB, and if there are dosing recommendations for re-vaccination after they have administered ACTHIB that has expired on 11Sep2023 to a patient today 20Sep2023. This situation is reported as a medication error due to a patient was administered with expired ACTHIB.   Action taken: not applicable.  Outcome: Recovered / Resolved on an unknown date for the event   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.
Redness; Firmness; Elevated skin; felt itch like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE PRURITUS (felt itch like bug bite), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN, METOPROLOL, CELECOXIB (CELEXA [CELECOXIB]), CALCIUM and VITAMIN D NOS for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (felt itch like bug bite). On 06-Feb-2021, the patient experienced ERYTHEMA (Redness), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin). The patient was treated with CETIRIZINE at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), VACCINATION SITE PRURITUS (felt itch like bug bite), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included Ice.
Arm soreness, unable to sleep, patient is hypoglycemic - felt like having an episode, dizziness, patient loss consciousness for about 2 min, spouse called 911, patient had food then milk and ham, patient was pale, sweating, hands cramping, dizzy, shaking. Paramedics checked BP 118/76, sugar levels back up and oxygenation normal. Patient refused offer for transport to ER. Doctor visit in the AM ? EKG test: normal. Doctor requested for F/U prior to receiving 2nd COVID19 vaccination. Doctor unable to determine cause of low blood pressure that caused patient to faint. Previous TB test 20 years of age, 1988, caused fainting spell- blood pressure dropped and sugar levels for patient in the past. Patient today 1/14/21 is feeling foggy, dizzy, and fatigue blood pressure is still low, arm still sore.
Within 3 weeks of injections of both Covid 19 (Moderna) and an annual flu shot (type unknown), I experience severe sharp pain in my right foot and increased dull pain in both knees (right fully replaced and left severe arthritic.  Upon visiting primary care in early January for a routine annual visit I complained about my foot pain and a new occurring ongoing pain and numbing in both hands.  I was referred initially to a podiatrist at the end of January, and by then the right foot pain had disappeared completely both both hands were worsening.  I was referred to physical therapy and from there a hand specialist.  I saw the hand specialist for two or three sessions but by then the issue was rapidly disappearing.  By the beginning of April the foot and hand issues were completely gone, although the soft tissue in my replaced knee continued to create pain and a burning sensation.  The left knee gets periodic steroid shots were its condition.  I visited my orthopedic surgeon regarding the right knee and underwent a series of X-Ray and MRI exams which revealed nothing more than cases of slight to severe arthritis in my hands, back and left knee.  By the end of April I was feeling near normal again.  I received my second Moderna booster on April 28, 2022.  Within two weeks I experienced severe back pains in my left side moving to my spine and eventually settling in my right sciatic to a virtual crippling level.  See records for further information.  I currently am receiving pain management treatment at the clinic.
I had a headache on the 24th, blood in his stools 11/27/2021, dizziness, vomiting, fatigue, sore arms.
COVID-19 Treatment; COVID-19 Treatment; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.  This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events drug ineffective, covid 19 and the suspect drug cannot be excluded.
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Vaccination right deltoid on 2/4/2021. Reports awakened on 2/13/2021 and right arm was tingling and was unable to lift. Seen in office 2/17/2021 and had improved some, can raise arm but unable to grasp pen, significantly weaker than left hand. Reports right hand dominant and unable to type or write at work. Reports some nausea and diarrhea initially following vaccine given on 2/4 that resolved a few days later/
(L) arm with redness, swelling, decreased possible future "abcess formation" as noted per child's PCP. Symptoms began 5/27/11, being treated with KENALOG & BENADRYL & is improving.
right arm soreness; left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness) and PAIN IN EXTREMITY (right arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness). On 18-May-2021, the patient experienced PAIN IN EXTREMITY (right arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, PAIN IN EXTREMITY (left arm soreness) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (right arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-142107 (Patient Link).
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 number of patients were vaccinated with RECOMBIVAX HB (dose, route, product lot and expiry date was not provided) 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.
06/24 Pain in right side was worsening and numbness would not go away.(Intermittent currently) Went to urgent care to find out more and there they did an X-ray(All Normal), 08/09 Lower Back pain issue occured and sought care at urgent care again. Had a MRI for lower lumbar mild multi level degenerative L3-5s1. Was referred to physical therapy for a month, and after about a month and a half I had mostly recovered and was advised to stretch as taught and if got worse come back.  12/27 I went to urgent care because lower back could not stabilize with stretches. I must have made a wrong move when I got into my care and felt shooting pain down my right leg. They had a long wait time and couldn't take me, went home and rested. After a couple of days it finally released and I was able to walk again. Currently being very cautious but was able to do things without pain.
CONTINUOUS FIZZING IN HEAD  24/7         1  TYNELOL DAILY
Indication: Treatment of COVID-19; Indication: Treatment of 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 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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's relevant medical history included: "known allergies: yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid arm (swelling, redness, itchiness, 10 days after first shot)
2 DVTs; PE; This is a spontaneous report from a contactable nurse (patient). A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Er2613), on 29Mar2021 (at the age of 36-years-old) at dose 2, single for COVID-19 immunisation. Medical history included COVID prior vaccination; diabetes mellitus (DM); hypertension (HTN); high cholesterol; known allergies to bananas and latex. Concomitant medications included losartan; metformin; amlodipine besilate (NORVASC); sitagliptin phosphate (JANUVIA); canagliflozin hemihydrate, metformin hydrochloride (INVOKANA DUO); all reported as other medications in two weeks. The patient received the first dose of BNT162b2 (lot number: EN6199) on 06Mar2021 (at the age of 36-years-old) for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced 2 deep vein thrombosis (DVTs) and a pulmonary embolism (PE) on 27Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. Treatment was administered for the events and included prolonged blood thinner treatment. No COVID tested post vaccination. The patient was recovering from the events.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Deep vein thrombosis and Pulmonary embolism and the suspect drug BNT162b2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt came into the office and received his KINRIX IM in his Rt. leg and received his PROQUAD, subq in his Rt. leg also. On the side of his right leg is where it was really red, swollen and had blisters. The site where his PROQUAD was given.
had the first dose on 22Mar2021 and tested positive with Covid-19; had the first dose on 22Mar2021 and tested positive with Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose and tested positive with Covid-19 in Mar2021. His second dose was due on 12Apr2021 and he would like to know if he still needs to take the second dose. Outcome of event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Case number PHEH2014US022377 is an initial spontaneous report received from a pharmacist on 04 Nov 2014. This report refers to a 81 year old male patient. His past medical history and concomitant medications were not reported. On 15 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly. He consulted a physician nine days after the vaccination. On 02 Nov 2014, he had fatigue and after 02 Nov 2014, he developed swollen red and itchy eyes. The patient completely recovered from the events. The seriousness and causality of the events was not reported.
Within 24 hours of vax, the pt developed a fever of 104 (rectally) and fussiness. The child was seen the following day with a fever of 101.3 (axillary). Child was fussy, had urticaria on lower extremities. The child recovered.
Menstrual Cycle lasting 2 weeks every month. Massive blood clots every month. Bleeding thru tampons in less than an hour.
15 month old patient that inadvertently received Quadracel / no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 15 months old female patient who experienced 15 months old patient that inadvertently received 0.5 ml vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AB via intramuscular route in the left thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and (Varicella vaccine).  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that 15 month old patient that inadvertently received Quadracel.  At the time of reporting no adverse reaction 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 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.  List of documents held by sender: none.
Patient given PCV 20 too soon first dose 08/03/2022 and  2nd dose 07/18/2023.
9/30 Shoulder to elbow swelled up, felt warm, some pain. patient self treated with advil. Swelling went down, stopped Advil, swelling returned, patient was to restart Advil and Benadryl on 10/2 when called to report adverse event.
Pain in arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR025409).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR025409   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced a sore arm for 4 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR025409:Same reporter
Patient received Fluarix vaccination - this is not approved for those under age 18. No adverse reactions reported by Mom.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M026306 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Pt was given Tdap vaccine in L delt and HPV GARDASIL vaccine in R delt at appx 8:30 AM by RN. Appx 8:45 AM pt's mom went to Hospital Assistant and stated that her daughter's R arm is "itching and breaking out". Pt was brought back to nurse's office. Pt had red raised rash R arm from forearm to delt area. Pt given 75 mg BENADRYL IM R hip. After waiting in office for 20 mins, rash is noticeably smaller and resolving. Mom told to take pt to ER if any problems occur again. 2:15 PM -- PC to pt's mom. Mom states that pt is doing much better. Has occasional itching still, but no rash. Advised mom to give pt OTC BENADRYL. Mom voiced understanding.
immediate reaction dizzy, flushed, nausea, headache (sharp) photophobia Resolved after 10 minutes