chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse initially calling in for a temperature excursion evaluation. VARIVAX administered post temperature excursion.; This spontaneous report was received from a licensed practice nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, drug reactions/allergies, medical history and historical drugs was not provided.  On 31-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live VARIVAX , 0.5 milliliter lot # S032355 and expiration date 14-OCT-2021 (route of administration not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -9 to -8 degree Celsius (°C) (-2.8°C) for 5 hours and 2 minutes on unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.; Sender's Comments:  US-009507513-2009USA001227: US-009507513-2009USA001249:
pt recv vax 18MAY96 & 28JUN96 pt exp two, short, gen sz;pt was hosp for diagnostic workup, which was negative @ the time of this report;no further sz activity has been detected;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L046900, expiration date: 23-FEB-2016, exact dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Initial report received from a health care professional on 07 Oct 2010: This patient was vaccinated with FLUVIRIN 2010/2011 (batch number: 111625A01) on an unspecified date. At the time of vaccination, the patient was pregnant. No adverse events were reported. Follow up report health care professional on 19 Oct 2010: The patient had history of one previous healthy birth. The patient received FLUVIRIN 0.5 ml intramuscularly on 06 Oct 2010. The estimated date of delivery was reported as Jun 2011. No prenatal tests were performed. The patient had spontaneous abortion in first trimester after 5 days of vaccination. The case was reported as non serious. No other information was reported.
I began breaking out in hives all over my body, and they would disappear and reappear elsewhere. I went to my primary care provider in December and was told I had chronic urticaria and to take one Zyrtec a day. My symptoms persisted for through the end of February, so I went to the allergist who gave me the same diagnosis and upped my does of Zyrtec and gave me Pepcid. My symptoms are managed with these medications, however, if I forget to take them I do break out in hives.
Besides flu-like symptoms (muscle and joint pain throughout my entire body), I developed a very large swelling of lymph gland in my right armpit (shot was in the right shoulder). Swelling extended to below right clavicle. This swelling was discovered about 24 hours after the shot. Swelling is still present but is shrinking. Still tender to the touch.
Vaccine Administered at Inappropriate Site; Injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 42PT4, expiry date 5th October 2019) for prophylaxis.   On an unknown date, the patient received Boostrix (intradermal). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 66 years or 67 years. The health care professional reported that a Boostrix dose was inadvertently administered via the intradermal route, which led to the intramuscular formulation administered by other route. The intended vaccination was a tuberculosis skin test however Boostrix was mistakenly used instead.   Follow up information was received from nurse on 26th April 2019: The patient's demographics were updated. On 4th April 2019, the patient received 0.5ml of Boostrix intradermally. The patient notified that as per GSK and CDC, Boostrix given intradermally could not be determined to be effective and would have to be administered intramuscularly at a later date. After receiving intradermal Boostrix the patient denied discomfort, but was advised that the injection site area could become reddened or puffy. On 5th April 2019, the reporting manager called the patient for follow up via an interpreter registered nurse. The patient had no swelling, pain, no fever. Less than a day after receiving Boostrix, the patient's injection site was slightly reddened in arm area of size of a quarter. The patient's family advised to call back if any worsening of area, fever, other discomfort. On 10th April 2019, the patient's daughter called the clinic and stated that the patient's site was normal with no further complaints or concerns. The intended vaccination was a Tdap vaccines however Boostrix was mistakenly administered intradermally instead of intramuscularly. It was unknown if the reporter considered the injection site erythema to be related to Boostrix. This case was medication error with adverse event. The VAERS details were updated.
Right afterward, sore & warm arm. Pt. said this has never gone away. Waited 5 months to report event.
2nd dose of Pfizer COVID-19 vaccine administer 14 days after 1st dose not 21 days.
COVID 19; COVID 19; off label use; Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastric bypass" (unspecified if ongoing); "hernia repair" (unspecified if ongoing); "gallbladder removed" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; FAMOTIDINE; CALCIUM; and Multivitamin, all received in 2 weeks of the vaccination. Past drug history included: Rocephin, reaction(s): "known allergies: Rocephin". The following information was reported: IMMUNISATION (medically significant) with onset 22Apr2022, outcome "unknown", described as "BOOSTER"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 1 Moderna; Dose Number: 3 Moderna; Dose Number: 4 Pfizer / BioNTech"; OFF LABEL USE (medically significant) with onset 22Apr2022, outcome "unknown"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (26Aug2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events and the suspect drug cannot be excluded.
Information has been received from a registered nurse concerning a female patient with no allergies who on an unknown date, was vaccinated IM into the hip area with a second dose of Gardasil. It was reported that the vaccine was painful. It was reported that the patient was not experiencing any other known symptoms. No medical attention was sought. At the time of this report, the patient's outcome was unknown. The patient is due for her third dose on 20-AUG-2007. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007.
Patient received 3 doses of Pfizer Dose 1: 03/22/21 Lot EN6199 Dose 2: 04/12/2021 Lot EW0162
received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves Infant and unknown gender patient who had received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] (HAEMOPHILUS TYPE B (HIB) VACCINE).  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination.  On an unknown date the patient received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency- same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "Thirty children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window. On outbound call with physician, he provided that the 30 children were within 2, 4, and 6 months of age".  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shots given 9-4-15 mom states child started running high fever 103, with rash to trunk of body, arms, and legs, itching, and red throat on 9-21-15. Inst. to go to doctor. Child had red swollen tonsils with pus on visual exam. Mom brought child to doctor. Doctor said Fifth disease and started on antibiotics.
SUFFERING THE SIDE EFFECTS OF THE VACCINE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced suffering the side effects of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering the side effects of the vaccine was not reported. This report was non-serious.
Non-itching rash beginning on side, spreading over trunk of patient. Onset the day after receiving Prevnar vaccine. Pt seen by MD and prescribed Medrol dosepak. After 4 days of treatment pt reports the rash is slowly clearing and she is not having any other adverse effects.
Felt weak within 2 hrs of taking vaccine. Had a headache, sore arm at site of injection, red, itching eye lids for five days.
Information has been received from a nurse concerning a patient who was vaccinated with ROTATEQ.  On 22-APR-2009 the patient was diagnosed with rotavirus.  The patient was not hospitalized.  At the time of reporting, the outcome was unknown.  It is unknown if the patient sought medical attention.  This is one of several reports from the same source.  Follow up information was received from a physician concerning the 12 month old patient who on 10-JUN-2008, 11-AUG-2008 and 09-OCT-2008 was vaccinated with the first, second and third dose of ROTATEQ (lot # 660286/183OU, 660289/1888U and 660548/0501X) respectively.  Additional information has been requested.
Alopecia; Painful arm; Chills; FEVER; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache). At the time of the report, ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported. No treatment for the events was provided.
Everything is salty, all the food I eat even the water I drink. Salty after taste. All the time even now.
2-3 days p/vax noticed pain in base of neck & in both forearm & hands & in calves;using aspirin cream;tingling hot (feels internally but not hot to touch;site tenderness swelling;
Received vaccine, followed by redness, inflammation, heat to site, starting two days later.  Seen in ED diagnosed with cellulitis, given prescription antibiotics.
Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events.  Information for lot/batch number has been requested.
Chills; Body aches; Low grade fever; Headache; This is a spontaneous report from a contactable nurse (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), via an unspecified route of administration in right arm, on 06Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It has already been a week since he had the first dose of COVID-19 vaccine and he is still experiencing or having symptoms such as chills, body aches, low grade fever, and headache from 06Jan2021. The patient had been taking paracetamol (TYLENOL) for the symptoms, but they still reappear after the medication has worn off. Symptoms will go away with the paracetamol but come back when it wears off. The patient did not feel this is serious, just a little concerning. The patient wanted to know if this is a normal response. The patient had not recovered from the events.
7/25 at 315A per mom child was sleeping on back. Mom with hand on child, mom felt child miss a breath, picked him up, states he felt stiff instead of floppy, gently shook him, awake, mom called 911 child awake, normal when ambulance arrived.  Taken to ER - normal on arrival.
SUDDEN ONSET GRAND MAL SEIZURES; SUICIDAL THOUGHTS AND IDEATIONS; COULD NOT SLEEP; COULD NOT EAT; NOT ABLE TO LIVE LIFE ANYMORE; This spontaneous report received from a consumer concerned a 35 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient could not sleep, could not eat; also experienced suicidal thoughts and ideations, and not able to live life anymore. On 29-APR-2021, the patient experienced sudden onset grand mal seizures. She had been having countless doctor visits. On an unspecified date, she was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210726025- covid-19 vaccine ad26.cov2.s- sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore.. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Following consultation with the patient?s pediatrician, the patient?s mother requested that he be given a second dose of Moderna. Medical Director, consulted with another Medical Director. Given that the mother discussed this with her son?s pediatrician and made a shared, informed decision, Dr. approved administration of the Moderna vaccine.
Patient recently diagnosed with COVID19 on 12/30 despite being double vaccinated.   On 1/27 Patient came into ER with complain of chest pain.  EKG and Troponin were normal.  While in ER patient began complaining of severe headache and began having seizures.  Patient was intubated.  Stat HCT was unremarkable. Transferred to Neuro Critical Care Unit.  Extubated 1/28 and Transferred out of unit on 1/29.  Planning to follow up with GI consult as cause of chest pain??  Also MRI ordered but do not have results back at this time.
Pfizer vaccine was administered outside - reported by patient- NO LOT NUMBER WERE SUPPLIED; I95.9 HYPOTENSION 9/8/2022 CHF EXACERBATION, UNSPECIFIED; J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022; CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 10/19/2022 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 12/2/2022 CHF EXACERBATION, UNSPECIFIED I95.9 HYPOTENSION 9/8/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 10/19/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R57.0 CARDIOGENIC SHOCK 12/2/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE
approx 1hr p/vax pt became limp, difficult to arouse w/cold skin;pt became weak, pale, clammy & responsive only to vigorous stimuli;t101;? dec tone;pt lethargic & sleepy;
large hematoma at the injection site 1-2 days after receiving VAXELIS and VAXENEUVANCE at his 6 month visit; This non-serious spontaneous safety report with local event number 02395610, and interaction number 02395604, was received by a partner on 25-MAY-2023 and forwarded to agency on 26-MAY-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Injection site haematoma".   Further information is expected.
Bell's palsy due to flu shot, onset 2 days after administration, diagnosed. Required plastic surgery. Medical record states keratosis. msv