chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included egg allergy. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, swelling arm and fever. On an unknown date, the outcome of the pain and swelling arm were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the pain, swelling arm and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the certified management accountant (CMA). The healthcare professional (HCP) was reporting on behalf of the physician. The patient was a relative of the physician and did not receive SHINGRIX within their facility. The patient had a history of egg allergies but no other medical history noted. The patient developed severe reactions after receiving a dose of SHINGRIX. The patient reportedly had a fever of 104 degree F, achiness, severe arm swelling and pretty much every symptom listed by the company. The fever lasted for several days. The HCP did not want to be contacted further regarding the reported adverse events.
fluzone high-dose qiv. administration of 2 doses instead of 1 with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] administration of 2 doses instead of 1 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2023, the patient received 2 doses instead of 1 at dose 0.7 ml (Frequency = Twice) suspect Influenza Quadrival A-B High Dose HV Vaccine (lot: UC8072AA, Expiry date: 30-Jun-2024) with unknown formulation, strength via unknown route in unknown administration site for Immunization with no reported adverse event (overdose).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-790) was received from a consumer on 02-Apr-2019. It describes an elderly male consumer who "took an unrefrigerated dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003242 and expiry date: Nov 2019) for typhoid prophylaxis.   Case report: The consumer did not refrigerate Vivotif for 18 hours and took the first dose on 30-Mar-2019. The exposure time and temperature of the vaccine was acceptable for this lot number. However, he took the second dose on 01-Apr-2019, which was not an effective dose.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Dizziness/ Lightheadedness; equilibrium; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, 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 experienced DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium). At the time of the report, DIZZINESS (Dizziness/ Lightheadedness) and BALANCE DISORDER (equilibrium) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Packaging of vaccine conceals the powder in the package insert. It appeared to me and my nurse that the dilutent was the entire vaccine. The pt was given only the dilutent. The error was discovered later that day and the pt is being rescheduled for reinjection with reconstituted vaccine.
BREAKTHROUGH COVID: FULLY VACCINATED WITH JANSSEN BOOSTER. 97 YO FEMALE WITH COVID-19 infection, COPD exacerbation , Acute on chronic hypoxic respiratory failure. Coronavirus disease 2019 pneumonia in this patient. PT On Rocephin and Zithromax procalcitonin level slightly abnormal, discontinue antibiotics at discharge.  Continue dexamethasone. Pt is here for weakness, her family is at bedside and provides most of the history.   Pt admitted with Pulmonary fibrosis, ELEVATED TROPONIN, CKD. Severe Pulmonary HTN on Echo ,Hyperglycemia. She was treated with antibiotics, steroids, albuterol. She has been on oxygen for several years now.  She has decreased exercise tolerance.  She had echo on 02/15/2022 with normal ejection fraction, there is pulmonary artery pressure was approximately 77 mmHg, mild-to-moderate MR.  Moderate to severe TR.  She was not able to perform lung function test in the office, invasive testing was deferred secondary to risk vs benefits. CXR here with bilateral airspace/interstitial opacity which may represent pneumonitis, pulmonary vascular congestion and/or chronic changes.
About 13 hours after the shot, patient had the following symptoms: Shaking,  Could not get warm enough Chills Body aches
Rash appeared 24 hours after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0182) via an unspecified route of administration in the left arm on 14May2021 at 18:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not take any other medications within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, rash appeared 24 hours after injection. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with Benadryl. The clinical outcome of the event rash appeared 24 hours after injection was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Extreme pain in lower left leg. I have blood pressure cuff at home. BP when extreme pain hit was 188/91. I took my BP the afternoon before injection it was 129/73. My BP has been high ever since. Top numbers in upper 130 to 160s bottom number in 90s. I write down all BP readings. My lower left leg has swelling and veins sticking out of side. I have been photographing daily. It has not changed. My veins did not stick out of my leg and I didn?t have pain prior to injection. I also was on no pain killers prior to injection. Today, I woke up with migraine. I have migraines prior to hysterectomy in April 2021. I have not had one from April 2021 to today.
HPV was administered at 5:30pm.  Patient did consume some Wavy Potato Chips and French Onion dip approximately 1 hour later.  Around 8pm patient complained of a rash.  Mother gave Benadryl before bed and rash largely disappeared- woke up the next morning with  hives on arms, legs and face and vaccine site was red, warm and swollen.  Denies any difficulty breathing. Advised parent to monitor next few days, benadryl prn and to report what happens next few days to help figure what was going on.  Also to avoid the chips and dip until known cause.  Parent was told to come in if symptoms continue or to ER for difficulty breathing or swallowing.
full body measle type rash; full body measle type rash which has now changed to new fluid filled sores that expand to almost half inch then bursts.; smaller chicken pox type sores. This continues as of today. Yesterday a large one appeared under my tongue toward the back of my mouth.; This is a spontaneous report from a contactable consumer (patient) and other health professional. A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8730; Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 04Apr2021 at 12:00 am (at the age of 73-years) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior COVID vaccine. Post vaccination, the patient was not diagnosed with COVID-19. No known allergies were reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EP7534; Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 am (at the age of 73-years) as dose 1, single for COVID-19 immunization and experienced measle type rash at neck area. The patient experienced full body measle type rash, full body measle type rash which has now changed to new fluid filled sores that expand to almost half inch then burst and smaller chicken pox type sores this continues as of today, yesterday a large one appeared under patient's tongue toward the back of her mouth on 17May2021. Second event following 2nd vaccine: On 17May2021 12:00 am, 14 days following vaccine full body measle type rash which had now changed to new fluid filled sores that expanded to almost half inch then bursts. Also, smaller chicken pox type sores. This continued as of that day. Yesterday a large one appeared under her tongue toward the back of her mouth. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with the steroids. The clinical outcome of all the events was not recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
pt recv vax 31AUg94 & pt devel inguinal regional adenopathy that was 15x10mm; 9SEP94 the size had inc to 20 x 17.5mm; 24NOV94 area had dec to pea size;
Patient given vaccine at 3:46 p.m., while in observation area patient stated his throat felt tight, patient states this happened with his previous two doses of covid vaccine. RRT called immediately at 4:13 p.m. B/P 128/80 P 72 RR 18  O2 sats 98%RA. Patient denies feeling shortness of breath.  RRT arrived at 4:15 p.m. and patient left with RRT team to go to ER at 4:16 p.m.
3 1/4 hrs p/vax pt t103 then elevated to 105; no irritability-no other sx; 6 hrs p/shot no redness or swelling @ site; entire exam neg; no treatmnet or viral or UTI
Pt feels fine - when I called to his home - per family member that speak a little English.
1-2 mins p/vax pt went into deep sleep stage x 2 hrs; pt cried p/shot was fuzzy & then was sleeping; no neurologic changes; no change in tone; no pathological reflexes or signs of sz; observed in hosp x 20 hrs; no changes;
Moderna COVID-19 Vaccine EUA: patient presented to emergency room with shortness of breath and COVID-19 infection. Diagnosed with pneumonia and acute hypoxemic respiratory failure and pulmonary embolism. Received oxygen, steroids, remdesivir, and anticoagulation. Discharged to home medically stable.
Pt recv vax on 12/16/98; 20 min post vax pt exp hives on rt arm, hands & face; swollen lips; itchy all over; tx= Benadryl
Reconstitution of Hiberix with other Liquid Diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-month-old male patient who received Hib (Hiberix) (batch number 4SM94, expiry date 18-APR-2024) for prophylaxis.   On 27-APR-2023, the patient received Hiberix. On 27-APR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution of Hiberix with other Liquid Diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter stated that one of her colleagues, a Medical Assistant, reconstituted Hiberix with the other diluent that came with MMR vaccine from Merck Company and administered to a kid which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient had no side effects. The reporter consented to follow up.
little itchy rash where she had the vaccine; little itchy rash where she had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine). At the time of the report, VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medication has been reported.
HCP states there were about 100 patients administered moderna vaccine which was intended to be stored in refrigerator and exposed to temperature of 8.5 degrees Celsius for 15 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states there were about 100 patients administered moderna vaccine which was intended to be stored in refrigerator and exposed to temperature of 8.5 degrees Celsius for 15 minutes) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states there were about 100 patients administered moderna vaccine which was intended to be stored in refrigerator and exposed to temperature of 8.5 degrees Celsius for 15 minutes). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states there were about 100 patients administered moderna vaccine which was intended to be stored in refrigerator and exposed to temperature of 8.5 degrees Celsius for 15 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
NO ADVERSE EVENTS REPORTED. PARENT GAVE INCORRECT DATE OF BIRTH, RESULTING IN WRONG VACCINE GIVEN FOR AGE (GRAY CAP FOR AGES 12+ WAS ADMINISTERED INSTEAD OF ORANGE CAP FOR AGES 5-11)
Patient received undiluted Pfizer 6mo-4yr yellow cap, gave 0.3mL on LD w/o complications patient waited in clinic for 15 minutes for observation. Once documenting realized error was made consulted with Dr. and CTs per Dr. no need to re-vaccinate and no additional precautions, pt left before letting her know will follow up on Monday.
Patient received vaccine at 2:15 PM, and around 9:00 AM, she noticed chest pain, lymph node swelling, generalized aches, headache (front and back of head), fever, vomiting, chills. Side effects were severe. Patient stated she had covid-19 infection during November 28, 2020. Patient received first Moderna dose on 3/3/2021
after recv vax 11/96 pt was exposed to chickenpox on 3/98 devel lesions. next day more than 30 appeared over body, pt was febrile.
Post vax the patient experienced "incidence of rash or lesion and transmission". Additional information has been requested.
- Enlarged lymph node, approximately the size of a golf ball  in axilla of injection site arm.   - Small, round red rash over both arms
baby cried for 2 hrs 15 min.-screaming, mother contacted Peds MD who ordered DT for next immunization.
received a dose of PROQUAD; received a dose of PROQUAD; the PROQUAD was in the bin in the freezer where the MMRII was supposed to be stocked; received a pediatric dose of RECOMBIVAX HB; did not experience any other adverse events; This spontaneous report was received from a nurse referring to a 49 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 15-MAR-2021, the patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) but received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) (lot # was reported as t027115, but upon internal validation, it was changed to the valid lot# T027115, expiration dates was 07-FEB-2022; route was not reported) for prophylaxis (wrong product administered and product administered to patient of inappropriate age). The reporter said the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was in the bin in the freezer where the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was supposed to be stocked and she grabbed the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) without checking the label and administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) to the patient (product storage error). On the same day, the patient received a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for (0.5ml/1st dose, lot# was reported as r031056, but upon internal validation, it was changed to the valid lot# R031056, expiration dates was 04-JUN-2021; route was not reported) prophylaxis (incorrect dose administered). The patient did not experience any other adverse events. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R031056; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire.  She was flushed and itching.  When she scratched her skin it would turn into a hive.  Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow.  She became nauseous and winded.  She went to the ER.  Her entire back was red and inflamed.  They administered Benadryl.  Pt was released and to FU w/ PCP.  That night she had some chills and fatigue.  When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours .  She had a virtual appt w/ doctor and was referred to see her PCP.  She made an appt  w/ PCP.  Her Dr. wrote her a RX for prednisone.  Told her to take Benadryl  as well and to stay off work for a couple of days.
delayed, cutaneous hypersensitivity reaction Narrative:  24 hours post vaccination rash occurred about the size of baseball. 96 hours post vaccination rash decreased to about  manadrin.   Other Relevant History:
Information has been received from a  Nurse Practitioner (N.P.) concerning a 68 year old patient who on 03-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663779/1791X). On 13-APR-2009 the patient experienced redness, tenderness and swelling where the vaccine was given. Additional information has been requested.
Patient was inadvertently given dose of Pfizer that  did not have diluent added, she received 0.3 ml full dose of vaccine
Had vaccine on Tuesday. Wednesday around 11 am, deltoid area had a small palm size pink area, no warmth, no edema noted. Thursday around 11 am, larger area to deltoid was noted to be red in color, slight edema noted and slightly warmer that rest of arm. Friday 7am area is much larger, spreads from shoulder to almost elbow, very red in color, swollen and hot to touch. Treatment to include: BENADRYL 25mg tid prn, ibuprofen 400mg tid prn and ice to area 20min on and 20 min off.
This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ, oral. No co-suspect and concomitant therapies were reported. The nurse reported that an unkown number of patients received improperly stored ROTATEQ on unknown dates. No adverse symptoms reported. The temperature excursion for ROTATEQ was found to be a supported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
I developed hives, itching, burning rash. It will not go away. Saw family doctor, referred to dermatologist.  Found to be from covid booster
Pt reports after receiving shot applied alcohol after getting home noticed after she would apply alcohol arm was getting sore, felt warm and started to swell. Dr presentation to clinic Lt arm at injection site red, edematous. Pt also reports back on neck sore and stiff with HA's started post being immunized also c/o nausea. Pt instructed if symptoms change or worsen to RTC.
I felt a little sniffly on that Friday at night. By the next morning it was sniffles, body ache, tired and runny nose. I completed a PCR with a doctor who came to my room on June 12th and it was positive. We spoke to the doctor on Tuesday 06-14-2022 and she prescribed Paxlovid. I still am slightly more tired than usual but everything else is gone entirely. I think I have completely recovered from this event.
Fever (100 - 101 F), severe headache, body aches, fatigue, nausea -- 3 days
8 days after injection the injection site became very itchy. 9 days later I have a large red circle around the injection site and swelling.