chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with RECOMBIVAX HB (reported as Hep B) lot # M011838 and expiration date 09-AUG-2018 (dose, route and frequency were not reported) and PEDVAXHIB (reported as Hib) lot# reported as UI645AA with expiration date 21-JUL-2017 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
A pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an area of redness that surrounded her leg wound. She also developed an injection site reaction characterized by swelling and tenderness. The reporter considered these events to represent an allergic reaction to Tetanus Toxoid Adsorbed, Ultrafined.
diarrhea for may days p/vax no tx;rash started on eyebrows & bridge of nose, spread to temples & back of head;tx w/HC ointment-no improvement;no weight gain p/2wk;put on propulsid;very slow weight gain;
This is a spontaneous report from a contactable physician assistant communicated to a sales representative report similar events for four patients. This is the 4th of four reports. A patient of unspecified age ethnicity and gender received TRUMENBA, intramuscular at 0.5 ml, single on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills/rigors, high fever and muscle achiness all over that required hospitalization. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Within 24 hours of injection, developed a fever, headache, right arm swelling, nausea, vomiting and fatigue. Prescribed Tylenol.
Booster given too soon, given only 1 month after 2nd dose of initial series
Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who in spring of 2007, was vaccinated with a first dose of GARDASIL (lot number ,injection site and route not reported). About two weeks after the vaccination, the patient developed intermittent fevers. The physician also reported that the patient completed the series of GARDASIL (the vaccine was given on a 0, 2, 6 month schedule) without any pattern of injection-related fever or associated symptoms. The patient has had three episodes of unexplained fever as high as 103-104 degrees F with no other localizing signs since her first dose. These episodes lasted up to several weeks and then resolved spontaneously. Medical work-up was negative except for a markedly elevated C-reactive protein. At the time of this report, the patient's event persisted. Additional information has been requested.
Information has been received from a Registered Pharmacist concerning a 69 year old female with no reactions/allergies who on 06-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously (lot 659760/0159X). On 06-MAY-2008, since the patient was given zoster vaccine live the patient experienced full body itching. No rash or injection site reaction was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a registered pharmacist concerning a 69 year old female patient with allergies to penicillin, CALAN and VICODIN all of which caused a rash and no environmental allergies and no illness at the time of vaccination who on the morning of 06-MAY-2008 was vaccinated subcutaneously in the left arm with a 0.65 mL first dose of ZOSTAVAX (Merck) ( Lot 659760/0159X). On 07-MAY-2008 at 14:00, the patient complained of full body itching including eyes and throat. She stated that the itching was coming from inside and her skin felt like it was burning. The patient had no fever or reaction at the injection site or rash. The patient was treated with BENADRYL for 48 hours. No diagnostic laboratory tests were performed. There was one healing lesion seen in exam on the patient's back which was located on the right L1 nerve distribution. No product quality complaint was involved. At the time of this report the patient had recovered. Additional information is not expected.
I have severe Hives, swelling and itching across my entire body. My legs, arms, back, chest, belly, butt, feet, face. I also have swelling of my face around the eyes and cheeks, swelling on my hands and wrists. I reached 103 degree temperature then it broke and became normal this was in association with the Hives.
Case number PHEH2014US005805 is an initial spontaneous report received from the nurse on 20 Mar 2014 with a follow up information received from a nurse on 29 Apr 2014. This report refers to a 15 years old male patient. He received only 0.5 ml Men CYW-135 liquid component of MENVEO (batch number: M11076) intramuscularly in the left deltoid without reconstitution with Men A lyophilized component on 20 Mar 2014. No adverse event reported following this medication error. It was reported that he went back next week and received the full dose. Follow up information received from a nurse on 29 Apr 2014: Patient demographics (initials, date of birth, age), batch number, dose and site of vaccination and revaccination details updated.
Information has been received from a physician concerning a 73 year old female who in 2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). The physician reported patient who had been given ZOSTAVAX (Merck) in 2007 was presently hospitalized in an unspecified hospital with shingles and encephalitis. Patient was still hospitalized. The date of hospitalization was unspecified. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 4th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: After receiving the vaccine, the patient experienced headaches on and off. The headaches had not resolved till the date of reporting. Additional information was not provided.
Fever/chills, vomiting, nauseous, severe clogged nose, headache, (all started within 4-6 hours after vaccine) Hives/rash all over body appeared at day 5, while all other symptoms were still active. Duration: Fever- 6 days, vomiting-6 days, hives 4 days, mucus membranes on going at day 12.
This spontaneous report as received from a nurse refers to an unspecified patient. On an unknown date, the patient was vaccinated with M-M-R II lot number N009172, expiration date 20-MAR-2019, therapy type rHA; lot number reported as N029919 with expiration date 13-JUN-2018 for prophylaxis or ROTATEQ lot number N005619, expiration date 29-OCT-2018 that were improperly stored. The vaccines underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. Lot number N029919 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Follow-up information was received from a nurse on 07-FEB-2018. On unknown dates, multiple additional unspecified patients were administered improperly stored doses of M-M-R II (lot N029919, expiration date: 13-JUN-2018; lot N009172, expiration date: 20-MAR-2019) or ROTATEQ (lot N005619, expiration date: 29-OCT-2018). The vaccine was reconstituted with sterile diluent (MRK INJ) (lot# N026286, expiration date: 06-FEB-2020). The vaccines underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 2 hours and 8 minutes. Previous temperature excursion included 47 to 77 degrees Fahrenheit for 1 hour and 10 minutes. No adverse effect reported. There was no product quality complaint involved.
Redness, itching and spreading of local reaction to immunization. Given prednisone and betamethasone.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient completed the series of M-M-R II (route and lot # not reported). The nurse reported that on an unknown date, titers for measles were drawn to the patient and showed no evidence of immunity to measles (measles antibody negative). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report has been received from a Medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M042498, expiration date 17-APR-2018; and lot # M044018, expiration date 05-JAN-2018 (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature of 8.6 Fahrenheit (F) for a total time frame of 20 minutes. The sterile diluent used to reconstitute vaccines was properly stored.There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Approximately 3 days after vaccination noticed swelling at site, armpit discomfort, and erythema. Symptoms and size increased. Sight necrosed and ulcerated approximately 5 days after vaccination.  Noticed purple scab this morning. Now adenopathy with pain. 9cm red induration, 1x1.3cm lesion with 0.5cm ulceration.  No treatment at this time.
muscle cramps; chills; neck sore; mostly fatigue; This is a spontaneous report from a contactable consumer or other non-Health Care Professional and report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient's concomitant medications were not reported. On Feb2021 the patient experienced muscle cramps, chills, neck sore, mostly fatigue. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Developed heaviness and leg pain both legs 3 wks post MMR vaccination. Lasted 3 days then gone. 2 days later pain, burning, tingling of both hands up to elbows, lasted 1 week and then gone.
Fine maculopapular rash no vesicles. No keplide pots. "Resembles measles".
after shopping and going to the gym 04Jun sx fatigue; HA myalgias; mild congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, single, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False), administration date: 17Feb2021, when the patient was 37-year-old, for covid-19 immunization; BNT162b2 (Dose 1, single, prev dose brand unknown: False,, prev dose lot number: EL3247,, prev dose lot unknown: False,, ), administration date: 27Jan2021, when the patient was 37-year-old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Jun2022, outcome "unknown", described as "HA myalgias"; FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown", described as "after shopping and going to the gym 04Jun sx fatigue"; NASAL CONGESTION (non-serious) with onset 04Jun2022, outcome "unknown", described as "mild congestion". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, myalgia, nasal congestion.  Additional information: If was unknown if patient received other vaccine in four weeks. If was unknown if patient had covid prior vaccination. Patient tested for covid post vaccination.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained. No further information is expected.
Put pt to bed about 7:30pm, woke with seizure at 10:00pm, temp 102.5 then called 911. Temp 104.5 upon arrival at facility. Labs done, ROCEPHIN given.
Vaccination failure; COVID-19 infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 1, single (Lot number: FK5618), in right arm and on 08Dec2021 as dose 2, single (Lot number: FK5618) at the age of 11 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14Aug2022, outcome "recovering", described as "COVID-19 infection"; VACCINATION FAILURE (medically significant) with onset 14Aug2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.
This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patient's were vaccinated with M-M-R II. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored  M-M-R II was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
2/18/2021- Patient called and states "my covid vaccine was given 1-1.5 inches below my deltoid muscle". Pt denies any side effects at this time. Pt concerned how effective this vaccine is.  2/19/2021- Patient called and states "arm is swollen and red to the right of injection site". Denies other symptoms. Pt states "it looks like a large knot to the right of the injection site".
On 10/16 patient noticed itching in response to vaccination given that day. By 10/17, the reaction was redness below the injection site, muscle pain from injection site to elbow, warm to touch; inability to hold arm down by side.
Tachycardia Hypertension (198/120) - no he of hypertension  Lightheadedness
Extreme sudden high blood pressure (199/99) and sharp throbbing, stabbing pain in left arm between armpit and shoulder.
Flushed, swollen tongue, swollen throat - minor swelling, could breath and swallow. Took Benadryl 1 hour (25 mg) after injection.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 22-JUL-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15 OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Collarbone hurt after receiving the injection; I think i am allergic; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Collarbone hurt after receiving the injection) and ALLERGY TO VACCINE (I think i am allergic) 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 BONE PAIN (Collarbone hurt after receiving the injection) and ALLERGY TO VACCINE (I think i am allergic). At the time of the report, BONE PAIN (Collarbone hurt after receiving the injection) and ALLERGY TO VACCINE (I think i am allergic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
The pharmacist discovered that the Johnson and Johnson vaccine had been left out longer that the 2 hours allowed after puncture at room temperature.  The vaccine had been out for approximately 3 hours after puncture.  The manufacturer was contacted, and the pharmacist was told that the literature does not state that this is a reason for revaccination.  The patient has not reported any adverse effects.
near syncope occurred about 25min after administering injection, patient reports she became flushed, felt lightheaded and slid down the wall to the ground, evaluated at site. transferred to ED for further evaluation. Discharged home from ED in good condition.
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PEDVAXHIB lot# L014428 with expiration date: 12-MAR-2018 and lot# L042258 with expiration date: 18-AUG-2018 (dose, route of administration, injection site were not reported). Administered doses of PEDVAXHIB underwent temperature excursions at 52.5 Fahrenheit degrees, for 9 hours and 10 minutes. Digital data logger was involved. Unspecified number of doses of PEDVAXHIB were also previously exposed to a high temperature of 48.9 Fahrenheit degrees for 13 hours and 40 minutes. Cumulative time out of range was 22 hours and 50 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain and discomfort and stiffness; Pain and discomfort and stiffness; Pain and discomfort and stiffness; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER8736 and Expiry date was not reported) dose 2 via an unspecified route of administration in arm Left on 11May2021 (age at vaccination was 59-year-old) and dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included Irregular Blood Pressure and hot flashes from an unknown date and unknown if ongoing. Concomitant medications included prescribed hormones pills from doctor for hot flashes, start and stop date were not reported. Patient stated that facing side effect day after her vaccination, on 12May2021 patient experienced Pain, discomfort and stiffness. Treatment received for the events was Ibuprofen 800mg. Outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
18MAY96 evening t103.3; 19MAY96 red blotches on face, arms, back, feet; no itching;20MAY96 same also loss of appetite;21MAY96 rash starting to fade in evening;22MAY96 rash disappeared;
Patient seen in clinic 2/26/07. Stated has developed rash 5 weeks after Zostavax vaccine. Saw dermatologist who prescribed po prednisone and topical steroids. minimal macular rash remains and patient describes hives when he scratches.
excruciating pain in arm (couldn't move arm for 5 days) bad headache, chills/shivering, fever, all-over body ache, no apetite - lasting 4 days
Information has been received from a physician concerning a 17 year old female student (weight 134.8 pounds, height 65.5 inches) who on the afternoon of 02-FEB-2009 was vaccinated with the third dose of GARDASIL, intramuscularly in the arm. Concomitant suspect therapy included VAQTA. On 02-FEB-2009 the patient had a syncopal episode few minutes after receive the GARDASIL vaccine in the waiting room. The patient recovered immediately from syncope but had to lay for approximately 30 minutes. Syncopal episode was considered to be an other important medical event by the physician. Additional information is not expected.
Erythema multiforme - onset of rash on feet on 12/30; progreesed to cover entire body as afternoon progressed, pruritis. Prednisone taper prescribed.
Some tenderness with 3 papules noted at vaccine site. Examined by physician, diagnosis Varivax reaction.
One month after the vaccine 2nd dose,  I developed acute rectal bleeding and loss conscousness due to the blood loss. I went to the emergency room and given a unit of packed cells.  Then I  was  transferred to Hospital and was hospitalized 5 days there.  I continued to bleed once the hematocrit and hemoglobin stopped dropping, I was discharged.   Etiology unknown.
Cellulitis of right anterolateral thigh 7cm at injection site of Varicella, treated with Cephalexin 500mg BID for 10 days starting 18APR2019. The lot number is presumed to be R023737. It is the only opened box in our current stock. The other unopened boxes in stock are R024265 and R030609.
Fever 3pm- overnight  Fatigue/aches, etc Some nausea after eating miso soup  Next morning all good, fever and fatigue again around 3pm
Patient DOB 9/6/57 received her first Pfizer Covid vaccine, then became dizzy, "I feel like I am drunk" Patient laid down on an exam table, her husband brought her cookies and water, Patient stated that it had been several hours since she last eaten, left the clinic with her husband as an escort without incident
Bell's Palsy developed 17 DEC 08. 2/17/09-records received for DOs 12/22/08-Released form hospital after exhaustive investigation into sudden left facial palsy.
GAVE FLUCELVAX TO UNDER 18 (NOT FDA APPROVED FOR UNDER 18).
06/10/2022 I began coughing which lasted off and on. On 6/14/2022 I went to the clinic to get cough medicine. They tested me for COVID which came back positive. My cough is better, I just have a mild cough every once in a while.
Sore arm, headache, fever, fatigue and later hot red blotch on arm at injection site .