chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; Patient received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #U026217, expiration date: 02-NOV-2023) administered for prophylaxis (strength, and route of administration were not provided).  The administered doses experienced a temperature excursion of 34.3 Fahrenheit (°F) during a time frame of 55 minutes. No previous temperature excursions were reported.   No additional adverse events were reported.
Eye, cheeks & lips swelling approx 10PM; visited local ER-PE;
sore arm; stomach ache; headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adolescent male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes:  prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacture), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Oct2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "recovering", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Oct2023, outcome "recovering", described as "stomach ache". Therapeutic measures were not taken as a result of pain in extremity, abdominal pain upper, headache.  Additional information: The patient was not COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SKIN REDNESS ON THE EARS ,LEFT KNEE AND RIGHT HAND; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced skin redness on the ears, left knee and right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin redness on the ears ,left knee and right hand. This report was non-serious.
Did not have any adverse event; Administered Proquad via intramuscular route not subcutaneously; This spontaneous report was received from a pharmacist referred to her daughter of unknown age. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 01-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter, intramuscularly as prophylaxis. (lot number, rHa, expiration date and anatomical location were not provided).  On 01-MAR-2022, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) via intramuscular route instead of subcutaneous route (Incorrect route of product administration). The reporter confirmed that her daughter did not have any adverse event associated with the vaccination. Caller declined consent to contact the health care professional (HCP). No additional information provided.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month 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 reported as follows: The patient experienced sore arm and it was so insignificant that the patient could not remember how long it took to resolve. The contact details of the physician was provided. For tolerance to next dose, refer case US2018GSK159188.
I had my vaccination on 09/16/2022. On 09/28/2022 I woke up with a very sore throat and sore tongue. I did an at home COVID-19 test and it was Negative. My spouse and grandchild had positive COVID-19 cases. I tested COVID-19 Positive on 09/30/2022 and I was prescribed Plaxovid per my request. My throat is still sore and a funny taste in my mouth as of 10/03/2022. I have a lot of hoarseness to my voice and phlegm in throat with a low grade fever of 100.
From initial information received on 8/17/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 15 year old female patient received a dose of TD ADS ADULT, lot number U1015AA, administered on 7/8/04. The route and site of administration were not reported. Three days later, on 7/11/04, the patient experienced fatigue, bruising and bleeding of her gums when brushing her teeth. On 7/20/04, her platelet count was at 80 and she was diagnosed with thrombocytopenia. As of 8/4/04, her platelet count had increased to 148. Reportedly, the patient recovered from these events.
Patient received second covid vaccine dose early, at 16 days, instead of 28 days.  Patient came because she was told by command to get her vaccine. No side affects. tolerated vaccine without incident.
muscle spasms; muscle pain; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle spasms), VACCINATION SITE PAIN (sore left arm) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     The patient's past medical history included Ear drum perforation. Concomitant products included TIMOLOL MALEATE and TESTOSTERONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle pain). At the time of the report, MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle pain) had resolved and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            The patient reported muscle spasms and muscle pain which started 2 weeks after the booster dose. Patient had a perforation in his left ear drum at the time that he received the Moderna Covid-19 vaccine.  Treatment drug was not reported.   This case was linked to MOD-2022-664794 (Patient Link).
Fever; bed sweating; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious  media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who experienced fever (pyrexia) and bed sweating (Hyperhidrosis), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported that got it for 24 hours after the shot and had fever (pyrexia) and bed sweating (Hyperhidrosis).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown.  There will be no information available on the batch number for this case.
VACCINE ADMINISTERED AFTER THE MANUFACTURER'S RECOMMENDED EXPIRATION DATE; This spontaneous report received from a patient 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 was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the patient experienced vaccine administered after the manufacturer's recommended expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the manufacturer's recommended expiration date was not reported. This report was non-serious.
Patient was inadvertently given a third dose of BEXSERO. Unnecessary repeat dose.
Injection site arm was sore after the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination). At the time of the report, VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.    Patient do not remember which arm she received first and second Moderna vaccinations. The patient injection site arm was sore after the second vaccination did not remember which arm.   This case was linked to MOD-2021-355043 (Patient Link).
On 4/26 around 4pm 2 Moderna vaccine doses were drawn up for immediate administration to patients with the evening appointments that day.  By 7pm the last 2 appointments did not show up. The pharmacist placed the 2 syringes in the fridge to report as waste the next day in inventory counts. This pharmacist did not work the next morning. On 4/28, the pharmacist working the afternoon shift thought the 2 drawn up syringes were from that morning and administered one to patient. Moderna manufacturer was contacted on 4/29 to advise on next steps and if re-vaccination was required. They advised that the reason for the 12 hour window after puncture of the vial is because it does not contain preservative and to avoid potential infection it should be disposed of after 12 hours, however the vaccine is viable for 30 days in the fridge at manufacturer?s temperature. The vaccine was within the 30-day window and remained in the fridge the entire time. The patient was called two times after their vaccination to check in for any adverse event or signs of infection. The patient reported only a sore arm for a few days, no signs of infection or other adverse reaction. The 1st dose was not re-administered. Pt was administered the 2nd vaccine on 5/26, 28 days later. The pharmacy updated their procedures for immediate vaccine disposal before leaving for the evening and other procedures such as clear labels and individual draws to avoid this same error. All staff were retrained.
Pt developed left flank pain the day after receiving the vaccination. Workup for kidney stone was negative. Was seen by PCP on 1-11-21 and was given diagnosis of probable shingles due to type and nature of pain. No rash is present. Also lymphadenopathy of left axillary lymph nodes. Was prescribed medication for pain only.
Formation of Rash bilateral upper and lower extremities. Red itchy, present for 4 days and getting worse.  My son who does not live with me also had similar reaction of red raised itchy bumps all over upper extremities after a few weeks after receiving the Janssen Vacine.
Severe swelling and redness of left whole thigh which she received FLUZONE vaccine (she also had the same reaction last year with Flu vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Full body cramping.    Stomach feel like it?s in knots.  Headache.  Nausea.   Vomiting.   Stumbling.  Dizziness.   Sinuses and mouth scratchy.   Congestion.   Severe fatigue and lethargic.   Loss of appetite, taste and smell.
Patient reported 6/21/06 developing fever of 101F orally, malaise and redness on left arm distal from injection site with hardness and feeling hot. treatment included warm compress, tylenol or aspirin and follow-up the following day to assess.
approx 24-48hr p/vax pt had inconsolable screaming for about 5hr;subsequently seem nl;
Chest tightness and throat tightness 1 hour following vaccination along with itching and rash at injections site. Zyrtec was taken along  with  use of Albuterol inhaler.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 13-FEB-2017 at 14:54, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Cold feeling to throat and mouth 30 minutes after administration lasting 15 minutes. Followed by: Tongue swelling Lip swelling with hives Itchy throat and lips lasted approximately 4 hours.
First chest pain followed by vomiting.  Then 15 minutes later on the ride home, bright red skin, swollen eyes, swollen ears, itchy rash from head to toe, watery nose and eyes.
This spontaneous report as received from a office manager refers to a 68 year old female patient. The patient's medical history was not reported. She was allergic to lidocaine. On 14-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). Concomitant therapies included SYMBICORT and other unspecified blood pressure medications. On 15-NOV-2016, the patient developed a red rash at the injection site that spread from the armpit to the elbow. There were no lab tests performed and no treatment was given for the event. She sought medical attention. The outcome of the event was reported as not recovered/not resolved. The causal relationship between PNEUMOVAX 23 and the event was not reported. There was no product quality complaint involved. Additional information is not expected as there is no consent to contact the physician.
Arm started aching a couple hours after receiving the influenza vaccine.  Ibuprofen was taken.  Arm has since been aching with movement.  Feels bruised to the touch. If lying on it at night, pain will wake her up from sleep.  No pain while arm is at rest.
no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) subcutaneous injection, lot #U030591, expiration date: 29-MAR-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.  This is one of the 14 reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008492:
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning an 18-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
she got sick which lasted a day and a half and now 8 days later, she got sick again; She has a fever; feels hot and cold; severe headaches; has thrown up 5 times; bad taste in her mouth; feels dizzy; This is a spontaneous report from a contactable consumer (patient).  This 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) administered on unknown date at single dose for COVID-19 immunisation. She got her second vaccine and a couple of days after it, she got sick which lasted a day and a half and now 8 days later, she got sick again.  She had a fever, feels hot and cold, severe headaches, had thrown up 5 times and had a bad taste in her mouth and felt dizzy. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
lips swelled up; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 25Jan2021 (Lot Number: EL9262, Expiration date unknown) as dose 1, single for COVID-19 immunization (reported as 'Scared of getting COVID 19'). Medical history included knee pain and was prescribed an anti-inflammatory and pre-existing allergy to anti-inflammatories both on unknown dates. The patient also had a family history of heart disease. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for the prevention of heart attack, start and stop date were not reported.  The patient previously took Mobic on an unknown date (reported as about 12 years) and experienced an allergic reaction, Ecotrin (low strength) on 2011 (started 10 years ago) but was stopped due to an allergic reaction, Aleve and Advil for which the patient had allergies to both medications on unknown dates. The patient also previously received a flu vaccine in 2017 for immunization and experienced his arm hurt. The patient reported that after the first shot, maybe a couple of days of the week later, on an unknow date in 2021, his lips swelled up and he was beginning to have an allergic reaction like with his anti-inflammatories. The patient didn't give it a second thought. He thought it could be a shampoo or something. All he did was take a Benadryl and it was gone. Everything's gone. It all went away, it went away the next day. He spoke with an allergist. The events recovered on an unknown date in 2021.
8/6/02 bad stomach cramps, fever, dehydrated, temp 103.2. Admitted to hospital 8/12/02. Diagnosis not yet available.
Received CERVARIX immunization #1 on 6-12-12. Later in day broke out in hives over entire body. BENADRYL given by parent.