chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; inappropriate schedule of vaccine administered; Information has been received from a lawyer referring to a 58 years old female patient. Information about concurrent condition, history condition and concomitant medication was not reported. In November 2010 (conflict information, also reported as 01-FEB-2012), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles in or about February 2011, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): shingles. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s defective design, the patient suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles to be disability.
product storage error temperature too low, with no reported adverse event; product was administered to patient post excursion, with no reported adverse event; Initial information was received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA057733.  This case involves Child and unknown gender patient who experienced product storage error temperature too low, with no reported adverse event and product was administered to patient post excursion, with no reported adverse event after receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  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 unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot UT7683NA, Expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of product storage error temperature too low, with no reported adverse event (product storage error) and product was administered to patient post excursion, with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable  At time of reporting, the outcome was Unknown for the event product storage error temperature too low, with no reported adverse event and was Unknown for the event product was administered to patient post excursion, with no reported adverse 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 guidelines. 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.; Sender's Comments:  US-SA-2023SA069591:01495415 US-SA-2023SA069475: US-SA-2023SA069466:01495415
Approximately 19cm x 8cm red area on the left upper back of the arm, warm to touch. Treated with Benadryl and Steroid.
Patient fainted less than five minutes after receiving the vaccine, and was unconscious for less than 60 seconds before waking up and sitting up. Complained of ankle pain and that she was feeling hot. Paramedics were called to assess vital signs. Patient walked out of the store after finishing with paramedics.
Patient's mother stated to physician that patient needed their first dose Covid vaccine, so Covid Vaccine First Dose appointment created per protocol. Patient mother signed all required paperwork. Prior to vaccine administration, RN gave the opportunity for questions or concerns. After vaccine was administered to the patient, patient's mother asked if they could receive a new card with all administrations present. At this time RN pulled up the Immunization registry and discovered that patient had already received 3 doses of Pfizer vaccine with the most recent being on 2/4/22.  Patient held for observation with no adverse reactions or physiological distress observed prior to patient leaving clinic. Parent was counseled on signs and symptoms of myocarditis.
This spontaneous report was received from a female registered nurse reporting on herself who on an unknown date, was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that at an unspecified time in the past, she experienced sore muscle at her left deltoid. She believed that vaccine was administered intramuscularly (also reported as subcutaneously). No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for the patient developed a sore muscle on her left deltoid was unknown for ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from licensed register nurse, concerning a 14 year old male patient. Patient's pertinent medical history, drug reactions/allergies were not provided. On 02-JUN-2014, the patient was vaccinated with a first dose of GARDASIL, right deltoid, lot # J009788 and expiration date on 17-MAR-2016; which was improperly stored. No adverse reaction reported. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 7/26/2022 Discharge Date: Jul 29, 2022  PRESENTING PROBLEM: Left-sided sensory deficit present [R44.9] Acute ischemic stroke (HCC) [I63.9] Stroke-like symptoms [R29.90]   HOSPITAL COURSE: Patient is a 64 year old male (speaks Spanish only) with a PMH significant for HTN, HLD, prior R MCA stroke (2014) without residual deficits, left PCA stroke found on MRI 1/2021, severe stenosis of left vertebral artery on ASA & Plavix (Non-compliant), CAD, OSA, Diabetes type 2, and glaucoma that presented 7/26 with slurred speech, acute onset dizziness and lightheadedness, left facial droop concerning for acute ishcemic stroke. Initial NIHSS 8. CTH negative for acute pathology demonstrates prior strokes, CTA head/neck revealed unchanged chronic occlusion of left A2 and left P2, occlusion of V3/V4, severe stenosis of left vertebral artery with possible dissection, CT perfusion with 64 ml hypoperfusion in A2/P2 segments. TNK was administered at 1801, he was not a mechanical thrombectomy candidate as there was no noted proximal occlusion. Neurosurgery was consulted for possible CT angiogram but patient is not deemed a candidate for intervention given occlusion is chronic. MRI brain 7/27 showed a 7mm focus of restricted diffusion in the pons just to the left of midline. TTE w/ EF 48%, mild global hypokinesis, LA mildly dilated, no shunting. Initial blood glucose was 426, HbA1c of 11.3, LDL 63. Etiology secondary to intracranial atherosclerosis. Patient was started on Lipitor 80 mg daily and DAPT with ASA 81 mg daily and Plavix 75 mg daily for 90 days, followed by monotherapy of ASA 81 mg daily. Pt mildly hypertensive despite home Losartan 100 mg daily and Norvasc 10mg daily so Coreg 6.25 mg BID was added with improvement in blood pressure. Patient was evaluated by endocrinology who resumed home diabetic agents upon discharge with plans to follow up with DGMS outpatient. Pt was re-evaluated by PT/OT day of discharge who recommended disposition of home with outpatient PT/OT. He tested positive for covid during admission but remained asymptomatic. Discussed at length with patient and his wife (using hospital translation services) importance of medication and follow up compliance. Pt was also provided educational materials regarding recent hospitalization, medications, and covid. Pt verbalized understanding. Patient discharged in stable condition to home with plans for follow up with stroke clinic, neurosurgery team, and DGMS outpatient.
My wife received both Pfizer shots Feb 5, and 27, 2021.  About May 1, she still got Covid
Patient experienced "flushing" after receiving her Dose 2.  Symptoms resolved within 15 minutes.
immediate post-12mo vaccine rash (scattered papules starting on face descending down) and acute cerebellar ataxia 1 wk later.
p/vax pt MD noted a red rash w/confluence in head/scalp; macules/papules; believed to be minor measles inj from vax
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a female who was pregnant and vaccinated with the third dose of GARDASIL, IM, 0.5ml.  Subsequently the patient had a miscarriage.  This occurred some time ago and the reporter does not have patient information at this time.  The patient sought unspecified medical attention.  Upon internal review, miscarriage was determined to be an other important medical event.  Additional information has been requested.
At 6:30 pm while sitting still, heart rate became rapid, thread then would have a long pause & return to normal. Chest pressure left of sternum at time. This happened intermittently until now. Sx have decreased. 2009-2010 Influenza season when (H1N1) swine flu vaccine first available. Received vaccine in fall & 2 wks later received swine flu vaccine. Within a few days I experienced slight irreg. heart rate which increased in severity as each day went on. Other sx were chest pressure, SOB, unable to take deep breath without pain or lay down flat. When at its worst, I was seen at a clinic with chest x-ray, bloodwork, EKG, ultrasound, etc. Dx was pericarditis. Tx was high doses Ibuprofen & HCTZ x 2 + wks. Dx was approx 2 wks after 2nd inj. I was told it wasn't from flu vaccine since it wasn't the live virus, but it was probably caused from "a virus". 2010-2011 vaccine yr. I didn't have the injection. Three months after the the onset of sx w/ Dx of Prolonged QT Interval & Pericarditis, EKG's and blood work was normal. No sx since until this flu vaccine 2011/2012. Sx started 5 hrs after injection and feel similar to the time it started 2009/2010. I took the Ibuprofen as directed before and a few days of HCTZ. Sx are almost gone, however at times the chest pressure, discomfort is there at the same spot. Occasional irreg heart beat remains.
Fever; chills; body ache; headache; swollen lymph node in under arm of left arm (injection arm); injection site soreness/left arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 12:45 (Lot number: FF2589) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "known allergies: Sea food" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "body ache"; HEADACHE (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "swollen lymph node in under arm of left arm (injection arm)"; VACCINATION SITE PAIN (non-serious) with onset 13Nov2021 11:00, outcome "recovering", described as "injection site soreness/left arm pain". Therapeutic measures were taken as a result of pyrexia, chills, pain, headache, lymphadenopathy, vaccination site pain.  Additional information: Other medications in two weeks: Metformin, Multivitamin.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching). On 04-Mar-2021, URTICARIA (Woke up with random hives/very mild hives) and PRURITUS (Itching) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. On 04-Mar-2021, the patient woke up with random hives and itching but it was mild and unexpected. On 25-May-2021, the patient reported that the patient had very mild hives and itching that only lasted a couple of hours. Reportedly, the patient had received their second dose. No Concomitant product use was reported. The patient took antihistamine and felt relief. This case was linked to MOD-2021-169947. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up was received on received on 25-May-2021.Updated outcome of the events. Added treatment medication and updated the action taken.
"covid arm" .   It started as red area that grew to about 3-4 inches across as a circle.  Became visibly swollen and raised.  Was very hot to touch and after a few days became itchy and the texture of the skin changed.  After about a week the skin was no longer hot, the redness was intermittent and a rash with itching in that spot would appear randomly each day.  It looked the same as if you search "covid arm" and compare the photos.   Day 13 after injection I still experience itching and irritation on that arm in that same 3-4 inch area.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
FELT VERY DIZZY; ARM WAS IN SO MUCH PAIN; FELT NAUSEOUS ALL DAY; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported.  On an unspecified date, the subject experienced felt very dizzy, arm was in so much pain, felt nauseous all day, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was in so much pain, felt very dizzy, felt nauseous all day and mild fever was not reported. This report was non-serious.
76 year old female received the 2nd dose of the Moderna COVID-19 vaccine at Church on 05/14/2021 @ 09:15. Same day 05/14/2021 pt started experiencing errythema and site of injection was warm to touch. On 05/20/2021 pt started experiencing pruritus at the site of injection. On 05/21/2021 pt noticed a pimple at the site of injection and discoloration of the injection site from red into a more blue color. Pt placed peroxide and neosporin on injection site on 05/22/2021. Pt denies any allergies. Pt takes Levothyroxine and multivitamins. Pt is diagnosed with hypothyroidism. Pt was advised to make an appointment with doctor to have the injection site physically examined.
I received the vaccine at 0830. My arm felt sore during the day. In the evening (around 1700), I began to feel muscle aches and pain in my joints (wrists, knees, ankles). I also felt fatigue and brain fog. My injection site (L upper arm) was sore, felt hot to touch and was about 5/10 pain-wise.  I took Tylenol 1,000mg PO and rested for the next 24 hours. The muscle aches and joint pain resolved after 24 hours. However, up to 48 hours after receiving the vaccine, I felt extreme fatigue and could not resume my regular level of activity. After 48 hours, I returned to regular activities.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Fever after received 3 vaccinations from 5/3/12. Fever 101-102 F.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
This is a spontaneous report from a physician referring to a female who, in August, 1999, received the 1st dose of Lymerix and for several hours after the 1st dose, the pt experienced injection site pain. The most recent information, received on 8/19/1999, reports the condition of the pt is unknown.
PATIENT GIVEN HPV, MCV AND TDAP VACCINES. AFTER THE TDAP VACCINE SHE FAINTED, PROVIDER NOTIFIED. PT RESPONDED WITH AMNONIA INHALANT, 911 AND AMBULANCE CALLED. TAKEN TO ER VIA AMBULANCE.
pt recv vax 19JUL78 & again 29AUG90 & 10JUL95 lab testing showed a mumps titer of 2.66, rubella titer 32.8 & measles titer 0.71;pt recv vax 25AUG95 & 14OCT95 rubeola IgG ELISA test showed measles titer 1.56;MD felt lab error was responsible
Pharmacist did not add the diluent to the vaccine and drew up 0.5 ml and administered to patient. I found out the mistake 06/22/2021 and called the patient in question and they claimed to not experience any adverse events since receiving the vaccine.
chemotherapy; This spontaneous report has been received from a male patient (consumer) of unknown age referring to himself. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.        After vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient in life had had "chemotherapy" and wanted to know if it was safe to be revaccinated on the advice of his doctor. He declined to participate in the adverse event report and declined to provide full demographics. The outcome of the event was not reported.        The causality between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
shortly p/vax administration pt devel eyelid edema, watery & scratchy eyes; this was followed by throat feeling closed & then SOB;
Contracted covid - positive test 05/02/2022 (May ,2 2022)
Pt received Menactra with TDAP on 4/28/06. On 4/29/06 was sick with fever of 103 with hives. On 4/30/06, saw pt in office and fever was 100 and resolving.
Swelling, itching, redness in a circle, but below the injection site. - Swelling started on Saturday 3/20, redness started 3/24 and headache, nausea, fatigue, brain fog, body aches started during the night of 3/22