chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot# L050788, expiry date 12-OCT-2017; lot# M020521, expiry date 17-NOV-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT REPORTED SHE BEGAN TO FEEL LIKE SHE WAS GOING TO VAGAL.  EMS CAME OVER TO CHECK HER OUT AND VITALS WERE NORMAL.  SHE SAID SHE NEEDED TO GO TO THE BATHROOM, WAS ESCORTED TO THE RESTROOM AND HAD A BOWL MOVEMENT AND RECOVERED FINE
Elevated temperature beginning on evening after immunization were given. Cough beginning on 08/08/2012.
Pt recvd 1st & 2nd hep B vax 21FEB90 & 14JUL90 & was not immune.Recvd 2 boosters 08OCT90 & 10JAN91 & was still not immune.
I received the first vaccine on Thursday afternoon 4/15. My upper arm/shoulder began hurting within a couple of hours, and by that evening I could barely lift it. This continued for 72 hours (Sunday evening), and then subsided. By Thurs. 4/22 it was hurting again, and still is (today is 4/27). I can barely lift my arm to get dressed.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL (Concentration, dose and route were not reported), lot # M005714, expiration date 03-OCT-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 16OCT97 & 1wk later pt exp a rash on neck & wrist; treated w/medrol;30OCT pt exp rash around body trunk;
I started having a warm left arm. It felt as if it was a sunburn to the touch. like a having a fever in arm. I reached out to my doctor and was told to watch it for two weeks.
Mom describes the pt began running a fever w/in 1 hr of immun, fever w/APAP 102.4; Pt cried unconsolably for hrs, until around MN, then slept so deeply that mom stated nearly unarrousable; Mom phoned Hosp & was told not to worry;
rash on neck , back, and chest , occurred right after vaccination by certified pharmacy tech.  Pt took 25 mg of benadryl and rash subsided within an 1.5 hr.
soreness at injection site; redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for another co worker. The age at vaccination was not reported. The nurse reported that patient received a Shingrix vaccination.  The patient experienced redness and soreness at injection site. The reporter consented to follow up. This case has been linked with the case US2020138148 and US2020138149, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138148:same reporter US-GLAXOSMITHKLINE-US2020138149:same reporter
Recieved vaccine to L deltoid, and LOC for 15 seconds and seized for 10 seconds, refused EMS transport, and gave 16 oz of H2O afterwards.
Patient was given MMR11  ( live vaccine) on 3/20/23 in Pediatricin clinic. Patient Was given yellow fever vaccine ( live vaccine ) on 3/28/23.  Yellow fever was given too  early. Should have been given after 4/17/23. No adverse results evidenced.  May cause patient to not have the immunity he needs for Yellow Fever, for his life time.  May need a yellow fever booster when he is older. Mother has been informed.
Significant redness, swelling, pain in forearm at vaccination site Started ~36 hours after vaccination Possibly normal vaccine reaction, but is large area of redness, pt anxious, and do not have familiarity with this vaccine
Patient received the vaccine in the afternoon and within hours he was fevered with a high pitched cry. He got worse through the night where his back would arch upwards, his head would go back and his body would tremble for a mattter of seconds. This happened several times that night. He regressed almost immediately and became nonverbal and developed repetitive behaviors.  Nurse follow up on 07/27/04 states: "injection site reaction (red, swollen); autism; developmental delay
no AE; product experienced multiple temperature excursions and that some of the product might have been administered to patients; This spontaneous report was received from a medical assistant, referring to a 12 years old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1637648, expiration date 19-JUN-2022 for prophylaxis (strength, route and frequency were not reported). The reporter said the vaccine experienced multiple temperature excursions and that some of the product might have been administered to patients.  The temperature excursion was of -2.09 Centigrade degrees (°C) during 37 hours. A previous temperature excursion occurred of 12.9 °C for 2 hours.A digital data logger was involved. No other adverse events were reported. This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA011510: US-009507513-2101USA011511:
A non-serious spontaneous report of administration of FLUMIST to a 59 year old was received from a health professional concerning a 59-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Dec-2011, FLUMIST was inadvertently administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt. states that after receiving the 3rd Booster of Phizer 09/27/2021, started experiencing symptoms 09/28/2021 of fatigue, sore arm, fever (101.2), chills, lymph node swelling, and burning hives throughout the body. Allergist visit 10/22/2021 recommendation treating with Allegra. Still continuing to experience symptoms.
24 hrs post inject pt c/o aching in LA; 48 hrs later c/o tingling & burning on posterior area of arm, radiating downward; no redness or swelling noted by mom; PHN advised applying heat & giving APAP; tx measure effective;
15 year old administered adult dose of Hepatitis A vaccine instead of pediatric/adolescent dose. Voice message left for parent asking them to call back. Manufacturer contacted and awaiting information. No reported concerns currently.
Vaccine administered as an off label indication to a 16 year old patient. the vaccine administered is only approved for use in patients 18 years of age and older.
top and  botom lips numb. Fet like lidocaine cream applied to them.  As soon as I sat down to work at 0530, I noticed it.  Itchy on top right forehead. started at 0530. 1300, numbness almost gone in lips. Right forehead feels like a scratchy needle cutting my skin. No apparent rash on forehead.
Mom states took pt to ER 8 days post vax; fever was 106; Test run & MD said probably rxn to MMR;
Pain in deltoid area starting approx 4 days later gradually extending down to elbow and also involving (L) shoulder. Very limited mobility in (L) arm for 6 weeks. Still have some pain in arm. There was never any redness or edema, only pain.
Significant swelling of left arm with accompanying severe left shoulder pain developed within 1hr. of vaccine administration. No erythema, increased warmth, or arthalgias. Low grade fever 98%. on 11/25/2008.
vial stored post puncture vial was stored under refrigerator; Moderna doses administered past 12 hour BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour BUD) and PRODUCT STORAGE ERROR (vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Vial was first punctured on 21APR2022 at 10:20 AM and stored in Refrigerator.  Patient did not experienced any adverse event to the expired dose administered.  No treatment medication was reported by the reporter.
the adverse event its a error on administration. Patient comes to the clinic for her 3th dose (1rst  booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered), the administered vaccine doesn't present any previous temperature excursion or any related problems. We are waiting responses of the immunization system of virginia to see how proceed with the patient, if we need to revaccinate the patient(s) or what else we can do.
Continuous sneezing for 12 hours, congestion for 2 days; similar to allergy attack
11:45am, 3/13/12. Called to exam room 1 secondary to patient having an unresponsive episode after the vaccine was given. After the two shots (Hib and PREVNAR) given, patient held breath for prolonged period of time with bluish discoloration noted especially around the mouth and bridge of nose. Patient became unconscious and unresponsive. Episode lasted approximately 5 minutes. Noted to reawaken to drowsiness and some fussiness afterwards. No fever noted. No shaking noted--still and limp. Patient breastfed intermittently. Patient noted to have normal respirations, normal pulse ox of 97% on room air, and normal heart rate in 80's. Normal coloration returned. Patient assessed as having a breathholding spell with seizure. Mother given information and reassurance about breathholding spells. Mother concerned about possible future seizures, brain damage. Reassurance provided. Mother given Dr's phone number for an appointment.
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The reporter stated that the patient blew her nose after receiving Flu vaccine which started on 14-Sep-2013 and it irritated her nose. The outcome of the event of irritated her nose and blew nose after receiving flu vaccine is unknown. The event of blew nose after receiving flu vaccine was assessed as non-serious by the reporter. The event of irritated her nose has been identified by the company physician from the source documents and added as a non-serious Adverse Event. Corrected Report on 28-Sep-2013: New event was added (Irritated her nose).
pt recv vax & approx 4hr later pt exp severe inj site soreness, malaise, fatigue, low grade fever, lymph node involvement & whole upper arm was painful;
Itchy throat, tongue, Numb Lips, Flush, Redness and hives
Nausea, dizzy, diarrhea, flank pain, nasal congestion, and wheezing.
faint; dizzy; Injured her face and chin/wound up doing a face plant on the side walk; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) 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 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), DIZZINESS (dizzy) and FACE INJURY (Injured her face and chin/wound up doing a face plant on the side walk). At the time of the report, SYNCOPE (faint), DIZZINESS (dizzy) and FACE INJURY (Injured her face and chin/wound up doing a face plant on the side walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  The reactions occurred 45-60 minutes after receiving the shot.  No treatment information was provided by the reporter.  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested.
start with covid vaccine on one arm and gave flu shot on the other arm. Then I saw patient lost consciousness on the chair. It came normal after few seconds.  Last time he had this issue was when he was little with blood draws. Patent went home without any issue.
Information has been received from a pharmacist concerning a 14 year old hospitalized male who is status post splenectomy who in October 2004, was vaccinated with a first dose of pneumcococcal 23v polysaccharide vaccine. It was reported that the stability of the product was questionable and had reached freezing temperatures. Within one months time, the patient was revaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed edema in the distal part of his arm. The patient was given IV antibiotics in hospital and was discharged home after four days on IV antibiotics. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Mild Fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Mild Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: One dose of undiluted vaccine, 0.2ml, was administered 3 times to 3 different patients. It was reported that an event in which the vaccine was administered undiluted and was looking for recommendations and guidelines in that situation.  Follow-up attempts are completed. No further information is expected.
Covid symptoms started 7/28/2022, first positive test 8/1/2022. My first positive test was 3 days after my husband's first test. He is still positive on 8/4, so I will test again on 8/7. Only current symptoms are residual cough and mild fatigue.
Pt recvd vax on 17JUL90 & on 03AUG90 devel T-102,submandibular adenitis,arthralgia,myalgia,h/a w/ neck pain & stiffness.Tx w/ ketoprofen.Lab eval revealed no measle titer.
Patient reported pain and extreme swelling at site of injection. The area was also very red and hard. Symptom also included fever. Patient reported to the ER. He was prescribed Levocetirizine.
Vaccines were given on (R) deltoid area. Pt. started with a rash that a day after and started to spread down her arm, very hard to the touch, painful, no itching.
Flush race on face and swelling of face. Given Benadryl 1cc per Dr.
This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), lot # M035691 with expiration date: 07-NOV-2017, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # reported as N015632 with expiration date: 18-FEB-2019. On an unknown date the patient experienced incorrect product storage and no adverse event. 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 ZOSTAVAX. Additional information has been requested.; Sender's Comments: US-009507513-1707USA001501:
Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored GARDASIL (dose, dose #, lot #, route and application site were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Felt achy at work day after vaccine; took Advil.  Later that day felt worse, went to bed and 2 hours later woke up in a pool of sweat.  Repeated every 2.5 hours throughout the night.  Total 10.5 hours.  Lost 2 pounds.  Diarrhea on night 2.    Janssen COVID-19 Vaccine EUA
While waiting in office following vaccines, he developed a cough, watery eyes and a red blotchy rash to his chest with some swelling of the left hand.  His exam was otherwise normal, with no difficulty swallowing and no wheezing.  O2 was 100%.  He was given 25 mg of Benadryl and calmed down, but kept with cough and tiredness.
2 days after second COVID shot patient developed significant outbreak of Shingles on the same arm, involving dermatomes C6 and C7.  She had not previously received the Zoster vaccine.  She did have chicken pox as a child.
Fever for 24 hours 101.5.  Nausea, extreme night sweats for 3 nights
I believe the vaccine triggered shingles  as rash appeared 5 1/2 days after vaccination. Rash on left hip and toward back. It is itchy, painful shooting pain.  Dr diagnosed as probably shingles.  It?s been over a week later and still have same symptoms . Being treated with antiviral med but no noticeable difference yet.
Felt really sick; Coughed; Wheezed; Lungs were really tight; Rashes on the entire left arm; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Felt really sick), COUGH (Coughed), WHEEZING (Wheezed), CHEST DISCOMFORT (Lungs were really tight) and RASH (Rashes on the entire left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (rested at home for 1 to 2 weeks.) from December 2020 to January 2021. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, NAPROXEN for Fibromyalgia.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ILLNESS (Felt really sick) and RASH (Rashes on the entire left arm). 22-Oct-2021, the patient experienced COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and DEXAMETHASONE at a dose of 1 mg twice a day. On 29-Oct-2021, ILLNESS (Felt really sick) had resolved. At the time of the report, COUGH (Coughed), WHEEZING (Wheezed) and CHEST DISCOMFORT (Lungs were really tight) had resolved and RASH (Rashes on the entire left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included topical Anti-rash Cream and Albuterol/budesonide nebulizer twice a day.  Patient stated it has been 2 weeks since she had seen the doctor and still had to use regular nebulizer twice daily. Symptoms including lethargy and body aches .Took Tylenol for the body ache.
within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VERTIGO (that was the worst).  Re the Vertigo, I didn't fall but experienced it whenever moving.  I was bumping into walls and was dizzy whenever I moved position (e.g. sitting to standing & vice versus).  These symptoms lasted 5-7 days after they began (both shots).
LUE swelling on evening of vaccines. Went to ER on 10/22/08. IV abx d/c'd home on Th 10/23/2008.  3/23/09 Received hospital medical records for 10/22-10/23/2008. FINAL DX: hypovolemic hyponatremia; symptomatic orthostasis; left arm vaccine site reaction; SIADH; DM; HTN; Parkinsonism. Records reveal patient experienced syncope, fatigue, UOP decreased, left arm swelling, warmth, redness & pain from Td & pneumo injection sites to midforearm x 1 day.  Improved w/IVF & antibiotics.  D/C to home on continued oral antibiotics w/PCP f/u of labs.
Temp 102.6, head to toe body rash, syncope episode, facial edema, nausea, vomiting