chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEAT PATCH; SWELLING AT INJECTION SITE; ITCHINESS AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced soreness at injection site. On 18-MAR-2021, the subject experienced itchiness at injection site. On 18-MAR-2021, the subject experienced redness at injection site. On 19-MAR-2021, the subject experienced swelling at injection site. On 20-MAR-2021, the subject experienced heat patch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, redness at injection site, swelling at injection site, and heat patch, and the outcome of itchiness at injection site was not reported. This report was non-serious.
Started having myoclonic jerk within few months after shots. Reported to physician who said may be stress. Jerks continued then grand mal seizures started. Continue to have myoclonic jerks and grand mal seizures. Have had other hospitalizations due to seizure complications.
No adverse event occurred. The baby's mother is a medial assistant & accidentally gave her own baby ZOSTAVAX instead of VARIVAX.
RASH TO FACE, BACK, STOMACH, BILATERAL UPPER EXTREMETIES AND UPPER PART OP  LOWER EXTREMETIES
Patient was given child dose by mistake.  Patient turned 12 in October.  The parents were informed that they should get another dose (12+) in 3 weeks, however parents opted not to have child return for another dose.  This was the second dose for this child.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004690: US-009507513-2207USA001345: US-009507513-2207USA004695: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004697: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Pt admitted to facility on 5/18 with shortness of breath, chest tightness and was found to have bilateral pulmonary embolism and mild patchy scattered groundglass opacities . Pt reportedly received 1st dose of Moderna COVID vaccine '2 weeks ago' (not vaccinated at this facility). Pt reportedly tested positive for COVID 1 week later (also not at this facility) and was also COVID positive on presentation here on 5/18. Admitted to ICU and currently being treated with Remdesivir, dexamethasone and enoxaparin for anticoagulation. Pt reportedly does have history of DVT/PE in past in 2012.
p/vax pt devel T101-103; extreme irritability which lasted 48 hr before resolving completely
Pt stated to pharmacist that she noticed "nerve sensitivity" in left arm within hours of receiving shot.  She described the sensitivity like mild electric shocks.  She stated that on the day after the shot (shot given on 6-5-19 in afternoon) that she felt the same nerve sensitivity all over.  Twenty-four hours after the shot, she was still having these sensations.
Temperature high of 102 deg controlled by ibuprofen i tab 500 mg every four hrs One night two Motrin due to body aches. Temperature as of Jan 27, 2023 controlled with one Motrin every 4 hrs. Still body aches esp. right hip. Rx'd Paxlovid, but decided not to take due to 'rebound'.
Shortness of breath, tightness in chest, rapid heartbeat, throat closing in, Right arm of injection site extremely swollen and red.
red face w/blotchy rash on face;hot & cold spells x 2 days;
No Adverse Event; Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    No concomitant medications were reported. This case was about one of the 5 Adult patients who received 0.5ml of Monovalent Moderna COVID-19 vaccine 6M-5Y, instead of the Bivalent Booster. Reporter complained that the vial caps and labels looked too similar and requesting that Moderna do something about the vial similarities. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Follow-up received included quality complaint numbers.
Initial report was received on 27/Jul/2006 from a health care professional. A female patient with no concurrent illness had received an intramuscular dose of Adacel, lot number C2457AA, in the deltoid. Three days post-immunization, the patient experienced injection site, and soreness in the armpit area and neck.  Per the reporter, the patient did not seek medical attention, and no relevant diagnostic test/laboratory data were performed.  It was reported that the patient had previously received a Tetanus Diphtheria vaccination over two years ago, but less than five years ago.  No adverse events were reported with that vaccination.  The recovery status of the patient was reported as recovered.  The reporter for this case is the same for case number reported and case number reported through case number reported.
pt recv vax 13JUN96 & on 15JUN96 pt exp a rash @ inj site;the rash was described as one big blotch the size of a hand;
Patient injected with flucelvax flu shot shortly after 1pm, and called back after about an hour saying they just noticed a rash on their leg running along their calf, on their left side (same side as injection was administered) Patient instructed to take oral Benadryl, and recheck it after a couple hours. Instructed patient for warnings of more severe allergic symptoms, with directions to call 911 if they experienced and difficulty breathing. If rash did not diminish or grew in size to call back for further care instructions.
Vaccination site was warm; Lack of appetite; Vaccination site was swollen knot; Vaccination site erythema; Vaccination site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site was warm), DECREASED APPETITE (Lack of appetite), VACCINATION SITE SWELLING (Vaccination site was swollen knot), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and MYALGIA (Vaccination site was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Previously administered products included for an unreported indication: Steroid shot (Steroid shot) on 25-Jan-2021.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site was warm), DECREASED APPETITE (Lack of appetite), VACCINATION SITE SWELLING (Vaccination site was swollen knot), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and MYALGIA (Vaccination site was sore). On 07-Feb-2021, DECREASED APPETITE (Lack of appetite) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Vaccination site was warm), VACCINATION SITE SWELLING (Vaccination site was swollen knot), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and MYALGIA (Vaccination site was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Dec 12 shot given, Dec 21 thin red line extending medially, Dec 22 erythema expanded to cellulitis, TX with Bactrim DS x 10 days and Rifampin 600ml daily x 10 days.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included SPEECH AND LANGUAGE DISORDER. FLUMIST started on 10-Sep-2012. The patient experienced RASH ON HEAD AND EXTREMITIES which started on 15-Sep-2012. At the time of reporting, the event of RASH ON HEAD AND EXTREMITIES was ongoing. The report was considered to be non-serious.
Patient is a 73 y.o. male patient of Physician No with history of COPD presented to a local Hospital with generalized weakness.   Covid-19 Virus Infection, POA, currently improving Date of onset of symptoms: 3/23/2023 Symptoms present on admission: weakness, confusion, SOB Date of covid positive test: 3/23/2023 Vaccination status: vaccinated Imaging: CXR with left upper lobe infiltrate Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: ID Anticipated special isolation end date: 4/3/2023   Diarrhea, POA improving Likely due to COVID Patient reports it is improving. IV hydration and monitor.   Possible community-acquired pneumonia X-ray of the chest showed possible left upper lobe infiltrates Ceftriaxone and azithromycin then discontinued as per ID recommendations. Strep and Legionella antigens   Hypokalemia: Electrolyte replacement protocols   Elevated Troponin: NSTEMI type II due to demand ischemia Elevated pro-BNP: Likely due to COVID Troponin 70; follow-up level 80.  The patient does not have chest pain.  No need for further testing. pBNP 3886 Follow-up with cardiology as an outpatient.   Abnormal UA: Rhabdomyolysis UA positive for large amount of blood, but only 4 RBCs/hpf CPK 5787.  Continue IV fluids. Follow-up urinalysis as an outpatient to confirm clearance of hematuria.   COPD: Not in acute exacerbation Spiriva and Symbicort Albuterol PRN
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involed. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009261: US-009507513-1811USA009142.
Swollen lymph nodes in collarbone region on same side as injection .  All over headache.
pt recv vax & exp inj site swelling (10" diameter), tachycardia, resp distress, fever of 103F, chills & shoulder pain for 7 days;pt also exp gen malaise;
Reported dizziness, burning at injection site  5 mins after injection.  VS stable, laid down for 10 mins.  Dizziness subsided.
nausea;inj site blistered;t103-was given epi @ urgent care ctr;
hearing loss approx 1 mo p/shot began noticing hearing got worse; now wearing dual hearing aides;
Deep vein thrombosis  was the diagnostic from the after effects of the second vaccination. Blood cot caused leg swelling and pain  They did a cat scan & MRI   Treatment was being given Eliquis (4 pills a day for 7 days) (2 pills after) It is a blood thinner and must follow up with my doctor.
no adverse effect; less than 1 full dose of proquad was administered to 4 year old child(patient); less than 1 full dose of proquad was administered to 4 year old child(patient) via IM; This spontaneous report was received from a nurse coordinator referring to a 4-year-old patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were unknown. On 31-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (dose number, anatomical location, therapy type, lot number and expiration date unknown) that was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (lot number and expiration date unknown) intramuscularly for prophylaxis, which was administered with less than 1 full dose (product administered at inappropriate site and incorrect dose administered). It was also reported that, the "patient pulled arm away and needle of vaccine went out of the patient's arm". No adverse effect was reported. No product quality complaints (PQC) were involved.
ARM FELT IRRITATED LIKE SUNBURN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced arm felt irritated like sunburn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt irritated like sunburn on MAY-2021. This report was non-serious.
Pt reports throbbing, arm pain, inflammation, fatique and trouble sleeping within 24 hours of injection.
Violent vomiting,  high fever,muscle pain, chills and fatigue started  late on 10/21/19 and gradually became worse until he was hospitalized less than 48 hours of receiving the vaccine.  His anc was 1600 then dropped to 170 then again to 5 on 10/24/19
Fever lasting 5 days. Highest emp 100.6 Headache Generalized body aches
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA, lots# M027879 and M036459, expiration date 24-JAN-2018 and 18-JAN-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013439: US-009507513-1612USA010790: US-009507513-1612USA013441: US-0095075131612USA013440:
Stiff hands.  Headache. Vomiting.  One month before.  Tylenol.  Lasted about two hours.   HEADACHE:    Started two hours after vaccination with HPV.  Recurrent HA this AM one month later.  Associated with vomiting.
An extra non paired diluent of Menveo was found; Someone may have gotten a powder vial wrongly reconstituted; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an extra non paired diluent of Menveo was found.The reporter was thinking someone might have gotten a powder vial reconstituted with a non approved diluent but the investigation was still in progress, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Arm soreness, Felling dizzy, nausea, congested,  fever102, H/A, chills. Vomiting, diarrhea, 5 LB weight gain. Hands swelling.   Lasted  a little over48hrs.
PT presented with cough and shortness of breath for over a week; Inpatient; PT is on Remdesvir, Aspirin, Medrol, vitamin C and D
2nd dose provided outside of recommended 2nd dose time frame. 1st dose Pfizer provided on 01/16/2021, client claimed to have contracted COVID-19 and is now asymptomatic, 2nd shot of the series provided as per CDC/Pfizer recommendation
I received Pfizer dose #1 on 4/1/21 and Pfizer dose #2 on 4/22/21.  On 5/28/21, pruritic blisters/red rash started on my left middle and left index fingers; over the next 10 days, very pruritic blisters/red rash have appeared on left buttock (in a line from left front hip bone along panty line down butt cheek ending at anus), bilateral front thighs, central pubic area, right buttock, right hip bone area, and along spine on right side; the rash is predominantly on my left butt cheek and although very itchy has not been painful.  I conducted telemedicine visit with my PCP today (6/7/21), who said rash was likely shingles (although she was not sure about the fingers rash), and she suggested I file a VAERS.  I have had no precipitating event/medication leading up to this rash other than the covid vaccinations.  I have treated itch with PRN topical Benadryl, PO Benadryl at HS, then switched to 25 mg hydroxyzine at HS, and added BID topical 0.1% triamcinolone.  I am a registered nurse, and have documented  this skin event in my calendar.
After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; After the first injection, I noticed that I can barely move my arm. Lots of pain and hard join movement.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not re-ported. On an unknown date, it was reported that after the first injection, he noticed that he can barely move his arm. Lots of pain and hard join movement. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab as Covid test type post vaccination: Nasal Swab  Covid test result: Negative on an unknown date.  The outcome of all events reported as an unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634370 similar report from same reporter
I lost the sense of taste; I am getting the same sensation on my tongue that I got when I tested positive with Covid; I am smelling a chemical smell; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date at a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 (tested positive with COVID), which the patient elaborated, "I could not taste a thing as I normally would so I went out to drink some coffee to taste the coffee and you know I am getting the same sensation on my tongue that I got when I tested positive with COVID but that's all. I have never experienced before until I became positive about 2 months ago and that was in the first of November and I, that has never happened before and now, then it came back while I was quarantined and now, you know I was eating earlier and I had the taste everything I ate and then just called all of a sudden I couldn't taste I was snacking on so." Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE). On an unspecified date, the patient lost the sense of taste; she was getting the same sensation on her tongue that she got when she tested positive with COVID. She was also smelling a chemical smell. No therapeutic measures was taken as a result of the event. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.