chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination failure; Shingles; swelling in groin area; difficulty walking; itching; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and 183 days after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, groin swelling, walking difficulty and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, groin swelling, walking difficulty and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix. It was unknown if the reporter considered the groin swelling and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed a widespread case of shingles. The shingles was itchy and the patient developed swelling in the groin area had difficulty walking as a result. The reporter consented for follow up.
Information has been received from a registered nurse concerning a 6 month old female who was vaccinated with a first and second dose of Rotateq on 15-JAN-2007 and 27-APR-2007, respectively. On 11-MAY-2007 the patient was vaccinated with third 2 ml oral dose of Rotateq (Lot# 656391/0238U). No product quality complaint was involved. No other information was provided. Additional information has been requested.
The patient is a 79 y male with H.o CAD s/p CABG and stents with last DES placed in Jan 2021, Essential HTN, dyslipidemia, Atrial fibrillation, H.o AV block s/p PPM, BPH with H.o recent transrectal prostate biopsy done on 2/1/22,   admitted to the hospital for 0 days with the chief complaint of bleeding per rectum. During this admission, he also tested positive for COVID 19 infection on routine testing. He is asymptomatic and also had all 3 doses of COVID 19 vaccination. He is on contact and droplet isolation precautions   He states that his rectal bleeding had started on the day of admission. He states that he started taking his Plavix from last Friday, Eliquis since Saturday. He underwent Biopsy on the Tuesday of that week.  Denies abdominal pain. No prior history of GI bleed in the past. No lightheadedness. No shortness of breath. His hemoglobin at the time of admission was 12. Complained of bright red colored bleeding per rectum. Repeat Hg the following day of admission was 10. Cardiology - (Privacy) and Dr. (Privacy) - colorectal surgeon were consulted. Recommended to continue to hold off Plavix and Eliquis as long as deemed safe to be held per Cardiology. Aspirin to be continued per cardiology. Underwent rectal examination under anesthesia in OR on 2/9/22 - which showed bleeding from the biopsy site from the previous transrectal US biopsy site in the right posterior quadrant. Old rectal clots were evacuated. No complications at the time of post procedure.   Later in the night he became hypotensive with BP in 70's/30's, unstable V.tach. Monomorphic ventricular tachycardia per code note. Code blue was called. Vtach with HR in 180's-190's. He was intubated to protect his airway. Received Magnesium, amiodarone during the ICU and was then transferred to ICU. Patient never lost a pulse during the code per code documentation. He was cardioverted at 200 joules, was started on dopamine drip and amiodarone drip initially. However, because of hypotension - amiodarone drip was stopped.  He was transferred to SICU   He was SICU he was placed on multiple pressors - Norepinephrine, dopamine, vasopressin, Neo synephrine and epinephrine. No active Upper or Lower GI bleed was suspected at that time and there was no drop in hemoglobin noted. Emergent bedside Echo was done by cardiology and it was negative for PE or right ventricular strain.  Later family was approached to discuss goals of care including comfort measures to which eventually family agreed to with draw life support. He was extubated at 0219 on 2/10/22 and was pronounced dead at 0222.        Cause of death: Cardiorespiratory arrest secondary to unstable/refractory V.tach Cardiogenic shock Unstable/refractory ventricular tachycardia
Severe pain in left hip. Trouble walking. Diagnosed with hip impingement and need physical therapy. Never had this before and no other injuries.
Large rash area of injection site 5 inches in diameter.  Red, raised bumpy. Painful, itchy and hot to touch. In 24 hours doubled in size. Pain down arm. Redness, swelling went away 1 week later. A day later  numbness, tingling pain left side of face up into head and ear. Extremely painful to touch. Left side of throat, teeth upper and lower. 3 days later left leg be an bothering. Felt better 5 days later. Left side of face still uncomfortable, left eyelid feels heavy still.
No adverse event; child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Seizures and Stroke (neonatal strokes). Concurrent medical conditions included Developmental delay.    On 12-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (child that received an incorrect dose/dark pink cap of 0.25 ml but instead received the dark pink cap 0.2 ml).    No concomitant medication was reported.  No treatment information was reported.
Received Yellow Fever vaccine 2/27/09.  According to patient, started having itchy grouped rash on right arm area and continues to spread to other areas.  Rash first started 3/6/09 (8 days after vaccination in left arm).  Denies any new laundry and skin products.  Grouped tiny cream/brown papules with satellite papules all over arms, trunk, legs.  Arrangements made for patient to see dermatologist 3/17/09.
Information has been received from a physician concerning a 4-month-old birth twin who on 09-FEB-2007, 30-MAR-2007 and 06-APR-2007 was vaccinated with the first, second and third doses respectively, of rotavirus vaccine. It is unknown if medical attention was sought. No symptoms were noted. This is one of several reports received from the same source. Additional information has been requested.
Six days after having our first COVID-19 vaccine my husband and I started experiencing fever, aches, and lethargy.  We notified our primary care facility.  We were sent to get a test for COVID-19.  We both tested positive.  We need to know how this affects our second vaccine which is scheduled for January 27th.  Please advise us.
Anthrax #1 on Aug 3 - no reaction; Smallpox on Aug 13 - no reaction; Anthrax #2 on Aug 17. ER visit on 8/21/04. developed rash starting at the injection site - 10 cm of erythema with difuse urticaral rash on trunk, arms, legs and lips.  treating with Atarax and Doxepin.
Case PHEH2016US023362 is an initial spontaneous report received from a nurse on 13 Sep 2016. This case refers to 55 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one  single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
IMMEDIATELY AFTER RECEIVING PREVNAR VACCINE, RT BECAME VERY RED AND SWOLLEN. AREA DID BLEED AND SOME BRUISING NOTED. 7X7 CM AREA OF REDNESS OVER RIGHT THIGH.  ICE PACK WAS APPLIED IN OFFICE
Systemic: Dizziness / Lightheadness-Medium, Additional Details: DAD STATED PT DID NOT FAINT WAS JUST DIZZY
Needle tip broke off (bevel area) and was discovered when trying to penetrate skin. Needle was blunted and left tiny circular mark on arm - piece of bevel seen in MMR vial and in stopper. New dose drawn up and given - prev. dose wasted.
shoulder pain is expected with the injection and he has had the previous 2 shots and that is to be expected; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain is expected with the injection and he has had the previous 2 shots and that is to be expected". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT PRESENTED WITH A 4 INCH DIAMETER  CIRCULAR RAISED WARMRASH ENCIRCULATING THE INJECTION SITE,  SHE SAYS ITS BEEN GROWING LARGER THE PAST TWO DAYS WE RECOMENDED THAT SHE HAVE IT SEEN BY A DOCTOR
Hard, red swelling at injection site 9 days following injection with intense itchiness. Sore and hot to touch.
felt awful; like I had the flu; migraine/head blew up; sneezing all day; runny nose; Arm really hurt/like my husband punched me in the arm; Shoulder hurt/joints hurt/knees hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt awful), INFLUENZA LIKE ILLNESS (like I had the flu), MIGRAINE (migraine/head blew up), SNEEZING (sneezing all day) and RHINORRHOEA (runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm really hurt/like my husband punched me in the arm) and ARTHRALGIA (Shoulder hurt/joints hurt/knees hurt). On 07-Aug-2021, the patient experienced FEELING ABNORMAL (felt awful), INFLUENZA LIKE ILLNESS (like I had the flu), MIGRAINE (migraine/head blew up), SNEEZING (sneezing all day) and RHINORRHOEA (runny nose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt awful), INFLUENZA LIKE ILLNESS (like I had the flu), MIGRAINE (migraine/head blew up), SNEEZING (sneezing all day), RHINORRHOEA (runny nose), PAIN IN EXTREMITY (Arm really hurt/like my husband punched me in the arm) and ARTHRALGIA (Shoulder hurt/joints hurt/knees hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M035695 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown.  The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This was one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002271: US-009507513-1708USA002306:
hot red area around site of injection approx 10-15cms across; tx w/ATB for cellulitis;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reproter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 9 weeks old infant patient of unknown gender. On 18-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Pt with redness and hot (RD) per father started today. 5 inches x 5 inches instructed to place cool compresses on arm and give TYLENOL if pain. If not better to come back no fever.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.86.  No concomitant medications were reported.  Batch number 019B21A administered on 30 Mar 2021 underwent temperature excursion with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22 Apr 2021. Product moved to clinic on 30 Mar 2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Headache, red, warm to touch, pain at site of vaccine Motrin given for discomfort. Pt complains of itching at site with diffuse rash noticed.
Mom reports pt had t104 1 day post vax; Pt taken to MD & told to continue APAP & watch; MD felt rxn was from DTP;
This spontaneous report was received from a physician via an other company representative and refers to a female non-pregnant patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (anatomical location, dose number, lot number and expiration date were not reported). On an unknown date, right after ZOSTAVAX injection (also reported as immediately), the patient broke out in a rash from her chest to her neck and experienced extreme swelling at the injection site. The patient did not seek medical attention as the event occurred at the physician's office. It was not reported if any treatment was given for the event and if any lab diagnostic studies were performed. Product quality complaint was not involved. Company representative reported that the physician declined Varicella zoster virus (VZV) analysis. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Itching sore arm; Itching sore arm; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (12Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 05Feb2021 (Lot Number: F2L8982, Expiration date: Not reported) as dose 1, single (at the age of 77-years-old) and on 06Mar2021 (Lot Number: EP6955, Expiration date: Not reported) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included allergy shots for allergy in the left arm. The patient experienced itching sore arm on 05Feb2021. No treatment was received by the patient for these events. The patient also had the same events on 06Mar2021 after the second vaccination. These events were considered as non-serious and the outcome of events was recovered in Feb2021 since reported as 2 plus days.   No follow-up attempts are possible. No further information is expected.
This registered nurse reports that a 50 year old female patient received a pneumococcal vaccine 0.5cc in her right arm on 29Sep2009 for an unknown reason. Her relevant medical history, relevant concomitant medications and relevant past drug history are unknown. On 29Sep2009, swelling began at the injection site about one hour after receiving the vaccine which increased overnight. On 30Sep2009, the patient called the triage RN at Westside Health Center to say she had severe pain, redness and swelling on the right arm where she had received the injection. The patient was already on Percocet which she was instructed to take for pain and start Benadryl. On 01Oct2009, she was seen in the clinic and was prescribed prednisone 40mg for five days. No further laboratory testing was performed. On an unknown date in 2009, the reaction resolved
Brain very sluggish; Could not sleep well last night; This case was reported by a consumer via other manufacturer and described the occurrence of sluggishness in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced sluggishness and poor sleep. On an unknown date, the outcome of the sluggishness and poor sleep were unknown.   It was unknown if the reporter considered the sluggishness and poor sleep to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The patient had reported that she had taken a shingles shot and got a reaction and could not sleep well the night before reporting and her brain was very sluggish. The reporter had consented to follow-up.
Pain started in upper arm, it now goes on my shoulder - took physical therapy for 3 mos. and still paying my 800.00 bill off, and pain is no better.
cold; very sick; body aches; chills; possible administered a 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches), CHILLS (chills) and INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 030A21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose). On an unknown date, the patient experienced NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose) had resolved. At the time of the report, NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      Reporter stated that she was taken Heartburn pill before vaccination Concomitant medications was not specified   This case was linked to MOD-2021-361787 (Patient Link).