chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got KINRIX instead of PEDIARIX; Kinrix to a 4 month old patient; Drug dispensing error; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and drug dispensing error. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant at clinic who called in to advise that, a staff member administered the incorrect vaccine to a 4 month old patient instead of pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration and drug dispensing error. The reporter wanted to know how they could proceed after this administration. The reporter consented to follow up.
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 66-years-old, via an unspecified route of administration in left arm on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included high blood cholesterol and triglycerides. The patient was allergic to medications, food, or other products (unspecified). She was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. She received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a hospital. On 09Mar2021 at 15:00, the patient presented with Bell's palsy which required a doctor or other healthcare professional office/clinic visit and was treated with BETAMETASONA 5.0 mg. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Patient received pnuemonia 20 vaccine instead of the ordered Shingrix vaccine.
This spontaneous report was received from a licensed nurse practicioner concerning a 61 year old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. The reporter state that the ZOSTAVAX (Lot#: M041669) was received on 08-MAR-2017, and was stored in the refrigerator instead of the freezer and the vaccine was inactive. On 20-MAR-2017 at 10:38 am,  the patient was vaccinated with a improperly stored dose ZOSTAVAX lot # M041669, intramuscularly in the left arm for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003760:
Patient presented with swollen, red, hot to touch, injection site. MD prescribed cipro and Medrol dosepack. Patient's injection site is still swollen and it itches.
Mother of patient called on 10/09/18 and reported that on 10/06/18 child's left upper arm became very red, warm and swollen and she had a temperature of 100. Mother informed that she gave the child TYLENOL, BENADRYL and a cool compress was placed at the site. It was reported that on 10/08/18 the patient's upper arm became less warm and red and had a bluish tint ("almost like a bruise"). The Mother said on 10/09/18 that the area looked much better and there were no more side effects. Mother further stated that the patient had had the influenza vaccine for the past 3 years and she has never had any kind of side effect or reaction.
Anaphylactic shock; severe allergic reaction/felt tonge swell; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder, High cholesterol, MS, Shellfish allergy (anaphylactic shock), Iodine allergy (anaphylactic shock) and Allergy NOS (allergy to "many things"). Concomitant products included ATORVASTATIN for High cholesterol, GLATIRAMER ACETATE (GLATOPA) for Multiple sclerosis, VANEX for Sleep disorder, DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), BACLOFEN, VITAMIN D3 and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 2:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) (seriousness criteria hospitalization and life threatening). On 01-Apr-2021 at 4:05 PM, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 01-Apr-2021 to 02-Apr-2021 due to ANAPHYLACTIC SHOCK and HYPERSENSITIVITY. On 01-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) had resolved.            Symptoms of anaphylactic shock included couldn't breath, throat closed, and face was all red and puffy.   Treatment for the events included epinephrine, intravenous steroids and diphenhydramine hydrochloride, and "other stuff" at hospital.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded.  Patient's underlying multiple allergies may have been contributory.   This case was linked to MOD-2021-066604 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded.  Patient's underlying multiple allergies may have been contributory.
SUBJECT WAS FOUND DECEASED ON 22 FEB 2021 AT AROUND 11:30 PM
Tenderness of the underarm (Same side as injection). Sneezing. Low Grade Fever.
Stomach virus, lasting from 4/17/2022 to 4/21/2022. Symptoms included fever, nausea, and diarrhea
Suspected clinical vaccination failure; TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients. 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, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, seven patient's ware tested positive for covid-19 (suspected clinical vaccination failure) after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210531848-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Made patient hyper; reaction to first infusion for anaemia; Anaemia; A puffy face; Hair thinning; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia), SWELLING FACE (A puffy face) and ALOPECIA (Hair thinning) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia), SWELLING FACE (A puffy face) and ALOPECIA (Hair thinning). At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Made patient hyper), INFUSION RELATED HYPERSENSITIVITY REACTION (reaction to first infusion for anaemia), ANAEMIA (Anaemia) and SWELLING FACE (A puffy face) outcome was unknown and ALOPECIA (Hair thinning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Made patient hyper, reaction to first infusion for anaemia, Anaemia, A puffy face was unknown and Hair thinning was not provided. No treatment details were provided
Had a fever, chills and body aches the 1st 24 hrs. Saw primary to swab nose for flu. It was neg. 1 wk exactly later left arm not able to raise, or lift out to side.
Pain in arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. A year before the time of reporting, the patient received a dose of Shingrix. Within a few hours after being administered the Shingrix, she experienced a sore arm for about 5 or 6 days. The patient when touched her arm around the injection site she would feel the soreness even more. The patient declined to provide physician demographics. No additional adverse event information was given. This case has been linked to US2019AMR222431, reported by the same reporter.
I woke up with stomach cramping at 4am. I went to the bathroom and had severe diarrhea and then vomited.
After the first dose of the vaccine, I began to develop painful, itchy, hot swellings on the arm of the injection site (left arm) and left side of chest. The swelling were the size of a quarter to a half dollar, and would appear for a few days, then disappear.  I would develop a new Swelling every few days (sometimes every other day, sometimes every 5 to 6 days) but due to Covid my primary care physician was only providing tela-health appointments. I received the 2nd dose of the Pfizer Vaccine on 01/30/2021. That is when these swellings began to appear more rapidly and appeared larger and more inflamed. One of these swelling got infected, which resulted in an urgent care appointment and then later that evening an Emergency Room visit. Doctors were unable to identify the source or the conditioned and referred me to a dermatologist, while prescribing me antibiotics, topical steroids, and oral steroids.   I began to see a dermatologist, who determined that the swellings were a most likely a histological response but prescribed me more antibiotics just in case it was bacterial. Then arranged for me to come every other week to check in. She additionally told me to continue to treat with topical steroids, Zyrtec and alieve. The traveling hives continued to appear in a more rapid procession post second vaccine. Despite treatment, I acquiring two to three new spots a day in various parts of my body including my stomach, back, legs, and face.    Finally at the end of February 2021 the swellings seemed to subside and appear less frequently, by March the stopped appearing.
I received the seasonal influenza vaccine from my employer while at work on the early morning of November 20, 2019. Later that night I developed moderate abdominal pain, decreased appetite, and bloating that persisted for several days.  On November 23, 2019 I went to urgent care, had labs drawn, and was sent home. On the morning of November 24 I received a call from the urgent care center regarding my lab-work, instructing me to go to the emergency department because my labs revealed pancreatitis. I went to the emergency department as instructed and was diagnosed with acute pancreatitis. Since November of 2019 I have had ongoing issues with abdominal pain and flare-ups of pancreatitis.
Child got up after receiving the vaccines. Walked out the door with his Dad, then fell down but was caught by the Dad. The child stated that his "vision went black and he felt some weakness but did not hit his head" on the floor. He reported he was aware and conscious the whole time. 2 RNs laid him down in a supine position and placed a rotating fan on beside him. He answered questions coherently. A pouch of juice was given to him and he drank it without difficulty. Verbalized he felt better after 15 minutes, got up, and walked out of the clinic office with a steady gait, accompanied by his parents and siblings.
Sudden Sensorineural hearing loss, occurred rapidly resulting in profound hearing loss.  The hearing loss occurred on a Sunday morning.   Significant tinnitus in the affected right ear.   The first time I saw the Dr, was on Monday morning, May 17th.  Dr administered oral (prednisone) and injected steroids (Dexamethasone 24mg/ml).  Completed oral steroid taper and have to date received eight steroid injections.  Also on treatment 26 of 30 hyperbaric oxygen therapy.  Minimal improvement in hearing as of todays date.  Still unable to hear normal sounds or speaking voices and currently not sufficient hearing for a hearing aid.  Checked "disability" box below as if hearing doesn't improve it may be a long term disability.
No additional adverse events reported; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; This spontaneous report was received from a physician referring to a 29 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 22-MAR-2021, the patient was vaccinated with pediatric hepatitis a vaccine, inactivated(VAQTA) (0.5 milliliters, one time dose, lot # T013204, expiration date 03-DEC-2021; strength and route were not reported) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No additional adverse events or product quality complaints were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
p/vax pt arm was red & had a knot in it;pt taken to ER w/hard, red, fist size knot in rt arm, fever;was placed on cephalexin for cellulitis;
At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor.
Moderna vaccine was accidentally administered to one of their staff members (patient) outside of the 12 hour post-puncture guidelines; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was accidentally administered to one of their staff members (patient) outside of the 12 hour post-puncture guidelines) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was accidentally administered to one of their staff members (patient) outside of the 12 hour post-puncture guidelines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was accidentally administered to one of their staff members (patient) outside of the 12 hour post-puncture guidelines) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Date the vial was initially stored in the refrigerator: 23-Feb-2022. Date the vial was first punctured: 23-Feb-2022, 9:30 am. Post punctured vial was stored in refrigerator. The vial did not undergo any temperature excursions.
The patient experienced vomiting and fever within 12 hours of receiving the vaccine. The patient had a 7x7cm area of erythema and warmth and increased respiratory rate.
Severe migraines 1 week after both injections. Daily persistent headaches, neck and back pains starting the week after the first injection and continuing for approximately 1-2 months after the 2nd injection.
33 y.o. male with no significant past medical history except for obesity who has been working as a nurse in the emergency room department in our hospital and today he received COVID-19 vaccine and 30 minutes later patient started having increased saliva, cold hands and feet, left-sided pressure-like headache and some numbness in his legs at the same time he suddenly started talking only in first language and lost his ability to speak in second language.  He understand second language but replying first language stating that he is talking in second language.  On exam he was alert oriented confused by people not understanding his second language stating that his numbness and cold feeling in the hands and feet have improved.  Initially patient received 10 mg of Decadron for possible allergic reaction he had a head CT scan that was negative and his labs were remarkable only for hypokalemia.  Patient had no prior history of any neurological symptoms he was advised admission to the hospital for observation     Patient symptoms resolved next day,he is alert oriented able to communicate in second language he had a head MRI and head neck MRA that came back negative and had an EEG that showed no seizure activities.  Patient was seen in neurology consultation who felt that patient most likely had an episode of migraine headache.  Patient is going to be discharged home and to have a follow-up with his primary care physician next week
That evening (after receiving Tdap), felt 'blah'. By 5 am next morning, had fever, joint pains, & severe HA (pressure: had to lie down) & decreased appetite. Lasted 10 days. No adverse reaction at site of injection.
ON 3-25-21, PATIENT REPORTS HER INJECTION SITE IS STILL SORE WITH A "KNOT" IN THE MUSCLE WHICH IS DESCRIBED AS "ALMOST AS LARGE AS AN EGG".   THE SITE IS NOT RED AND PATIENT REPORTS NO FEVER.
Fever; Body aches; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 15:15 as dose 1, single (Lot number: HF9299) at the age of 55 years intramuscular, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering"; PYREXIA (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering", described as "Fever". Therapeutic measures were taken as a result of pyrexia, pain, chills. Additional information: The patient had no other vaccines in four weeks or other medications in two weeks. The events were treated with acetaminophen. The patient has not been tested for COVID post vaccination. He has no known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician, concerning a 2 years old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis, which was considered an inappropriate age at vaccine administration. No adverse effects were reported and it was stated that the patient was doing fine. No product quality complaint (PQC) was involved.
9:00am woke up with headache, light sensitivity, dehydrated, soreness at injection site, body aches 9:15am took ibuprofen (200mg) 12:30pm fatigue 2:00pm took ibuprofen (200mg) 3:00pm chills 4:00pm fever of 102 F 6:30pm took Tylenol (500mg) 8:00pm cold sweats 10:30pm fever reduced to 98 F 11:00pm headache, cold sweats, chills 11:30pm took tylenol (500mg)  next day (10/31) 9:15am body aches, swollen left arm pit, headache, cold sweats, fever is gone 10:00am took tylenol 500mg 2:00pm dryness of mouth 4:00pm swelling of armpit continues 9:40pm tylenol 500mg  next day (11/1/21) 6:30am body aches, sore left arm, 7:50am took pamprin (500 mg) 10:00am swollen left arm pit 6:00pm swelling stops 11:45pm took tylenol 500mg  Today 11/2/21 6:30am body aches stop 9:00am swollen left arm pit stops