chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated MMR II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Began with low grade fever then headache then chills and muscle aches. Now temperature is 100.3.
The patient developed a "worse than normal skin reaction" all over her body. The reporter noted that at the time of the vent, she attributed these symptoms to the winter weather and dry skin. The consumer reported two similar occurrences following immunizations with a flu vaccine. See Case ID HQ9120305DEC2001 and HQ8356213NOV2001. No additional information was available as of the date of this report. Follow-up info received on 02/19/2002 from consumer contained name and address of treating physician. The reporter states she has received the flu shot for over 8 years. Over the last 8 years, she has developed increasingly "worsened" rashes, each winter, spreading to more areas of her body, mostly her hands, arms and legs. She has also developed "uncontrollable" itching on the back, face and gums. The consumer stated that her legs and arms would bleed from the "itching rashes." In the last few years she has developed "borderline" asthma. The consumer also noted htat she chose not to receive the flu shot this year and so far has not experienced any of these symptoms. Her dermatologist, determined a positive skin test to thimerosol. FOLLOW-UP information received 04/02/02. The skin test  was noted to be "patch test" and was performed  12/18/98.
This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a adult female patient who received ROTARIX (lyophilized formulation) (batch number 94F25, expiry date 16th July 2018). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the laceration of finger to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: This case was associated with the product complaint. The age at vaccination was not reported. The caller reported that the nurse cut her finger on a cracked vial of ROTARIX powder. The nurse was fine at the time of reporting and a Band-Aid was applied on the finger.
Received flu shot from Pharmacy in left arm. Arm immediately started hurting. Cannot move arm without pain.  Cannot sleep at night because arm throbs.  Went to my personal physician on Dec. 1, 2014.  Had ultrasound done to check for blood clots.  No clots.  He said muscle in arm is inflamed.  There has been a knot in muscle since I received shot.  Have been using heating pad but is not any better.  Loss of range of motion in arm.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Between the date of 02-MAR-2015 to August 2015, the patients were vaccinated with doses of improperly stored ROTATEQ (lot# K016311 with expired date 26-MAY-2016, oral, dose was unknown). No concomitant medication was provided. No adverse effect was reported. This is one of two reports received from the same reporter (1509USA004806). Additional information has been requested.
Red circular rash at injection site.  Warm and a bit swollen.  Appeared 8 days after injection.
I had the Janssen vaccine at 2pm. on Friday afternoon. By 8:00 I was doubled over with stomach pain.  All weekend had pain, diarrhea and vomiting horribly.  By Monday March 8th I doubled over in stomach pain so bad I had to call an ambulance.  Was admitted to hospital on Monday with Accute Pancreatitus.  Was in the hospital until Friday March 12th.  I am a TOTALLY HEALTHY person that is NEVER sick,  very healthy,  and I workout daily.   I have no gallbladder, I NEVER drink ANYTHING,  there was NO reason I should have been there except for the vaccine  reaction.  After having a Cat scan, MRI, Altrasound , and an Endoscopy,  the my specialist concluded it was the vacinne.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration date 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Report side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effect) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report side effect). At the time of the report, VACCINATION COMPLICATION (Report side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient called because after receiving the first vaccine side effects, that where not mentioned as normal when giving the vaccine, were developed. Wanted to know if there was any chance of receiving only one dose instead of two doses.  no concomitant medications are provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel. Concomitant medication(s) included: WELLBUTRIN, start date: Mar2022; LEXAPRO, start date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 07Dec2022, Treatment stop date: 09Dec2022, Indication: Treatment of COVID-19.
Pt began experiencing symptoms in waves of profound lethargy, diaphoresis, headache on the night day 2 s/p second vaccine. Afebrile.States he also gets allergic rhinitis this time of year with similar symptoms.   COVID test here negative.  Unsure if vaccine reaction, alllergies or combination of both.
red rash on her chest and arms; had a tightness and lump in her throat; had a tightness and lump in her throat; cheeks were flushed; This is a spontaneous report from a contactable nurse and contactable physician. This nurse reported similar events for 3 patients. This is the 3rd of 3 reports.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red rash on chest and arms, tightness and lump in throat and cheeks were flushed. The patient outcome of the  events was unknown.    The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516277 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.
This spontaneous report was received from the registered nurse regarding a 7 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 29-OCT-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Guillain-Barré Syndrome, IVIG treatment, numbness, tingly, sharp needle feeling, could not walk.
pt recvd vax & noticed swelling @ lt arm inject site; mom states was 2-3 times larger than should be; denies any redness; states vomited x 1 was put on ATB x 10 days;
This case was reported by a consumer and described the occurrence of epilepsy in her 4 month old son was received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. A physician or other health care professional has not verified this report. On 6/23/04, the patient received a dose of Pediarix 9dose number not specified). Approximately three hours after the administration of Pediarix, on 6/23/04, the patient experienced a seizure. The patient was hospitalized for five days and was treated with an unspecified anticonvulsant. The reporter stated that the patient, has developed new onset epilepsy and has 10 to 20 seizures a day. The event was ongoing at the time of initial reporting.
Case number PHEH2013US005298 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with the follow-up received on 25 MAR 2013. This report refers to a 16-year-old male patient. He was vaccinated with MENVEO (batch number: M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 24 JAN 2013. This vaccine had undergone temperature excursion. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that MENVEO had a temperature excursion. The patient did not experience any adverse events as a result of the temperature excursion. IT was reported that the patient will be revaccinated.   Follow up information received on 25 MAR 2013. Confirmed that the patient did not experience any adverse event and will be revaccinated.
Shortness of breath; Tongue swelling; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO178), via an unspecified route of administration, administered in left arm on 01Jun2021 10:30 (at the age of 49 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, crohn's disease (reported as "Conhns") and Psoriasis. The patient is not pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); fluticasone propionate, salmeterol xinafoate (ADVAIR); inositol; azelastine hydrochloride (ASTELIN); mometasone furoate (NASONEX) and salbutamol (ALBUTEROL). The patient did not take any other vaccine in four weeks. The patient has not had COVID prior to vaccination. The patient experienced shortness of breath, tongue swelling and abdominal pain on 01Jun2021 15:00. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included Benadryl, Epipen and prednisone. The patient was not tested for COVID post vaccination. The outcome of the events was unknown. The reporter assessed the events as non-serious.   No follow-up attempts are possible. No further information is expected.
Within 2 - 3 minutes of receiving the vaccine in my left deltoid muscle, the upper half of my left middle finger felt numb, had tingling and felt very cold. There was significant color change: it turned white and my pulse oxygen level could not be measured in that finger. It took approximately 25-30 minutes to go back to normal. I?ve never had any type of reaction to a vaccine or injectable medication in the past.   No  treatment was necessary and no additional symptoms  have been noted this evening / 6 hours later.
Mother reports that after she immunized her son with TDAP (Boostrix) he c/o burning sensation in IM arm. At 1230am he woke up c/o burning & itching all over his body. She took him to the ER. ER Dr. didn't think it was from the IM but something he came in contact with while mowing the evening before. At the Er he was treated with IV solumedrol & benedryl, observed for 30 min & released home. There was still some rash & itching when he was relesed from ER. On 4-11-06 he stayed home from school. There was still rash & itching present on his body. It progressively got worse again. Mother then took him to the doctor. The doctor felt that IM caused hives & itching VIS shown to doctor. Prednisone & Zyrtec RX to Pt.
Since the 31st I have had Ringing in my ears (Constant)  Severe Headache (Constant)  Fingers go numb (On Occasion), left arm, goes numb (On Occasion) Severe Breathing problems (cant even walk up the stairs) (Constant)  The top of my head is numb (Constantly), hard to see out of my left eye.  Dry Heaves all night (Constant), Heavy Sleep patterns (13 to 20 hours a day) continued Nauseating to the point of throwing up at night cant keep food in my system because I feel like throwing up.  It hurts to look at Lights.
DEATH; This spontaneous report received from a consumer via a company representative concerned an adult male. Additional live follow up was received on 14-JUN-2021.  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) one total dose, start therapy date were not reported 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 an unspecified date, the patient was died. The cause of death was not reported. It was unknown whether the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210629311- covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Lymph node in left arm pit swollen and sore; Lymph node in left arm pit swollen and sore; A quarter size rash on neck started approximately 24 hours post vaccine. Rash spread within 48 hours to cover neck from collar bone up and onto face; Rash on face covers both sides of jaw and part of right eye lid; Rash is red, swollen, tight and feels like sunburn, but does not itch; Dose number 3; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 at 18:00 (Lot number: FJ8757) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Hay fever" (unspecified if ongoing), notes: Known allergies: seasonal hayfever. There were no concomitant medications. Past drug history included: Aspirin, reaction: "Drug allergy", notes: Known allergies: aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0150; Administration time: 11:00; Anatomical location: left arm), administration date: 03Apr2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0161; Administration time: 11:00; Anatomical location: left arm), administration date: 24Apr2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 18:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious) with onset 18Dec2021 at 18:00, outcome "not recovered", described as "Lymph node in left arm pit swollen and sore"; LYMPH NODE PAIN (non-serious) with onset 18Dec2021 at 18:00, outcome "not recovered", described as "Lymph node in left arm pit swollen and sore"; RASH (non-serious) with onset 18Dec2021 at 18:00, outcome "not recovered", described as "A quarter size rash on neck started approximately 24 hours post vaccine. Rash spread within 48 hours to cover neck from collar bone up and onto face"; EYELID RASH (non-serious) with onset 18Dec2021 at 18:00, outcome "not recovered", described as "Rash on face covers both sides of jaw and part of right eye lid"; RASH ERYTHEMATOUS (non-serious) with onset 18Dec2021 at 18:00, outcome "not recovered", described as "Rash is red, swollen, tight and feels like sunburn, but does not itch". It was unknown whether any therapeutic measures were taken as a result of the reported events.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Angioedema.  Pt with facial swelling and rash.  Swelling was mainly to lower part of face, including lips.  Also reports numbness of face and numbness to a section of her R hand.
From telephone correspondence received at manufacturer on 12/11/02, it was reported that a 5 year old child received Tripedia (Lot # U0581AA) given in the left deltoid in August of 2002. One to two days after vaccination, the pt developed swelling 3x size of arm. The area was red, warm and painful.  It was diagnosed by the physician as Cellulitis. No lab/diagnostic tests were needed, as it  was very obvious.  The pt was not taking any other medications at time of vaccination, did not receive any other vaccinations within a 4 week time period and did not have any illnesses or pre-existing diagnoses at time of vaccination.  The pt reportedly recovered from this event.  The case is closed.  See cases U2002-00494, U2002-01159, U2002-01161 & U2002-01162 with same reporter.
Presented to hospital 2/16/22 for weakness O2 sat 88% on room air, chest x-ray no infiltrates.   pt admitted to floor started on IVF which corrected AKI , ALSO managed for COVID with dexa and remdisivir with O2 supply currently on RA with O2 sat >94%  trop was 135 down to 109>102 no chest pain seen by cardiologist and no further intervension likley 2/2 aki and infection  pt 94 y/o ives alone and has difficult hearing will dc to SNF.  discharged 2/17/22.  Previously vaccinated Janssen 3/15/21
still sore; fever; nausea; achy all over; joint pain; Really bad reaction; felt horrible/She felt bad; Migraine 10/10; hot/still warm; hard/ It was initially hard as a rock; Her arm became red/ It is still red/still has a 4x5 inch mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm) and VACCINATION SITE INDURATION (hard/ It was initially hard as a rock) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First shot, LOT- Ej1685, Intramuscular.) on 21-Dec-2020, Pfizer Vaccine (Second shot and LOT- EL1283) on 07-Jan-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine and Pfizer Vaccine.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain). On 30-Dec-2021, the patient experienced VACCINATION SITE PAIN (still sore). On 29-Dec-2021, VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark) and VACCINATION SITE PAIN (still sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) She got a COVID test and it was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's weight was reported as  175 and units were not reported. No concomitant information was reported. Patient Tried to put heat and lots of steroid cream for events. Patient had stated that she still has a 4x5 inch mark in the left deltoid and initially it was hard as rock.
09/20/22 presents to ED for "pain and swelling of left upper extremity" "cat bite". PMHx of "Afib, HTN, PUD, GERD"