chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 1/24/2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 10/17/2003. On 10/17/2004 the vaccinee, who was less than 4 years of age inadvertently received Fluvirin. The vaccinee did not experience any untoward effects after receiving the Fluvirin. There was insufficient information to determine the reporter's causality assessment. Update 11/27/2003: Follow up information was received from a health care professional on 11/27/2003 indicating that no sequelae was noted following vaccination. No follow up pending.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 04-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of ZOSTAVAX (route was not reported, lot# K006438, expiry date: 05-AUG-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
onset 28MAy96 pruritic dermatitis face & neck w/erythema papular w/occipital lymph nodes
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021.and administered on 16 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021.and administered on 16 Feb 2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022 at 4:04 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Feb-2022 at 4:04 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021.and administered on 16 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021.and administered on 16 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The patient had a census ethnicity . The patient had received the vaccine dose number as booster. It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No Treatment medication reported.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report was received from a medical assistant (healthcare professional) regarding unknown number of patients. Age and gender of the patients were not provided. No medical history and concurrent conditions were reported. On an unknown date the patients was vaccinated with incorrectly stored (incorrectly stored product) PNEUMOVAX23. Concomitant medication were not reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was reported. This is one of the report from the same reporter. Additional information has been requested.
1 of 4 pt exp inj site rxn on same day as vax;rxn had appearance of acute cellulitis hot red, swollen 6x4 area p/vax; sx resolved w/in 1wk;
10-6-11 Patient received FLUZONE 0.5 ml IM in LD. Early pm pain began in (L) hand (later pain level 7). 10-7-11 Next day noted swelling in (L) hand and was unable to close fist due to swelling. Seen in clinic. Sent to ED - X-ray (L) hand. Normal 3 views (L) hand. Was told in ED prob. tendonitis. States 10-11-11 (L) hand still has pain level about 2-3.
Patient was 17 (1 week away from 18) at time of vaccination. No adverse reaction
101 fever with acetaminophen and Ibuprofen, Chills, nausea, Myalgias, insomnia
I did receive the newest Covid Booster, #5 for me,  about a week prior to getting the Shingrix vaccine.  I had no side effects from the Covid Booster at all.  After receiving the Shingrix, My temperature started to rise within a few hours.   After two days, my temp went up to 99.8.  Today is day 4 and my temp is down to 98.4 which is still up form my usual 97.2.  The most important thing that I want to report is that on day 3,  I started having very severe dizziness and nausea.  I have had probably every vaccine including the Hep B due to being in the dental field and I have never had anything throw me totally out of commission.  I could not move my head without experiencing vertigo.  I also had muscle aches and pains as well as fatigue and a constant headache, but those symptoms do not alarm me.  Although I am not supposed to take NSAIDS, I have been taking Aleve since I read that the Shingrix can cause inflammation in the sensory system.  I am seeing my neurologist on Monday and I will be discussing this with him since I have never had vertigo until now.  I am thinking that the risks of taking the second Shingrix do not support the second dose.
Patient reported no allergies. Approximately 5 minutes after receiving vaccine she reported redness and itching around the injecetion site. She reported no problem with swallowing or breathing. She reported mild itching at the site.
Injection 2.12.19 to right posterior arm; Began to sweat around 10 am; Swelling, redness, hot to touch with induration to right posterior arm around 1400. Swelling continued with fever 100.1 on 2. 13.19. Fatigue, increased swelling to arm to 6 x 9 inches in a somewhat oval shape; 2.14.19 notifed MD suggested warm compresses; 2.15.19 continued fatigue, swelling, warmth, no larger at this time in size.
First dose given 3/25/2021 was Pfizer EN6207. Inadvertently gave Moderna vaccine when doing a clinic. No reaction noted at this time.
STOMACH PAIN; CRAMPING; 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. The patient's pre-existing medical conditions included: Patient had done every test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 2021 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, the patient experienced stomach pain, and cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain and cramping was not reported. This report was non-serious.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 10 years old patient who was vaccinated with a 0.5 ml dose of Diphtheria and Tetanus Toxoids, Pediatric (DT) (Diphtheria Tetanus Toxoids Adsorbed) (batch number, expiry date, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by sender: none   .
she is bleeding into the eye and that to her is just, it keeps getting worse; thrombo; elevated potassium; had bruising in the other leg; doctor did PTT, confirmed as PTT, and it was elevated; This is a spontaneous report from a contactable consumer (patient).   An 81-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on an unknown date in Feb2021 (at the age of 81 years old) as a single dose for COVID 19 immunisation. Medical history was not reported. The patient received the medications within 2 weeks of vaccination was Asperin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 experienced adverse events such as large bruising on one leg, after the next dose, bruising on the other leg. She has bruising on both lower limbs, a bleeding disorder. She bled from her eye at the ophthalmologists office. On an unspecified date patient second one, then had bruising in the other leg. She went to the hematologist, and to the doctor. The doctor did PTT, confirmed as PTT, and it was elevated. Reported added that patient also had an elevated potassium. She states this was like what you would get if patient were taking warfarin. it was very concerning now, not only does she have bruising in the leg, but she was bleeding into the eye and that to her was just, it keeps getting worse. She has nothing else to add to that report except that her mom has an elevated PTT, TPTT and states she does not know, it was thrombo. At 81, her mom walks around an hour a day, does aerobics. She was not seeing a hematologist and she was concerned. If she cut herself, she would bleed out. The fact she was bleeding into the eyeball, she has to google the acronym but it was basically clotting issues it was resulting in. No additional details provided; Reporter did not know the name of the elevated test.  Information about lot/batch number has been requested.
Patient fainted after the injection for a moment but regained consciousness soon after. Patient was put on the floor with legs on a chair for 10 to 15 minutes.
Small pox given, 12 days later 16 lesions developed over on (L) & (R) shoulder, (R) side, (L) & (R) forearm 24-36 hours. No itching at site. No fever.
head ache, moderate lower G.I.cramps, Watery stools x 3, hot flashes and flushing after eating x4
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  Treatment information was not provided.
Information has been received from a medical assistant concerning a 29 year old female patient with unknown relevant history, unknown preexisting medical conditions and unknown past drug history who on 09-DEC-2008, was vaccinated with a dose of  ENGERIX-B. On 06-JAN-2009, the patient was vaccinated with a dose of Hep B (lot number, expiration date, dose and site of administration not reported). On unspecified date, the patient had a negative hepatitis B titer. As of 25-JUL-2011, the patient's hepatitis B titer continued to be negative. It was unknown if the patient would be receive any further doses of ENGERIX-B or Hep B. At the time of the report, the patient had not recovered. Additional information has been requested.
Large area of erythema at deltoid area, no fever, non-tender, no cellulitis.
Skin hypersensitivity still occurring on 5/17 when received vaccine on 5/15
Moderna COVID-19 Vaccine EUA On day 9 after receiving first dose of vaccine, redness, swelling, and itching -- aka "COVID arm" -- began near the injection site in left deltoid.  On day 10 single small hive appeared on right deltoid.  As of this report date (day 11) no other side effects have manifested other than soreness at the injection site and mild fatigue the day after receiving the first dose of vaccine.  The COVID arm side effect seems to be resolving.
8-31-17 (315pm) administered FLUZONE by Pharmacy. 9-1-17 adverse effect low grade fever, chills, headache, slight respiratory distress. Slight confusion. Symptoms ceased 9-5-17. First time I received this new vaccine over 65 yr old.
PATIENT WAS OBSERVED PALE AND DIZZY.  BP - 100/60 WAS TAKEN TO THE ER IN A WHEEL CHAIR.
high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85; April 2021 for oral surgery; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85) and ORAL SURGERY (April 2021 for oral surgery) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient started allergy shots after receiving the vaccine for environmental allergies), Drug allergy (Allergy to codeine), Drug allergy (Allergy to fentanyl - itching,welts) and Blood pressure high (Started more than 10 years ago and recent change in status was worsening.). Concomitant products included LISINOPRIL for Hypertension, ZOLPIDEM for Sleep disorder, PLECANATIDE (TRULANCE) for Stomach discomfort, SIMVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Apr-2021, the patient experienced HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85). In April 2021, the patient experienced ORAL SURGERY (April 2021 for oral surgery). At the time of the report, HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85) had not resolved and ORAL SURGERY (April 2021 for oral surgery) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication reported for dose 2.  TRULANCE was given in June or July 2021   This case was linked to MOD-2022-531903, MOD-2022-531876 (Patient Link).
Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; This is a spontaneous report received from a contactable consumer or other non hcp. A 48-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration in Arm Right on 25Aug2021 at 16:30 (age at vaccination 48years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks prior to the COVID vaccine reported as none. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history included congenital cystic kidney disease from an unknown date and unknown if ongoing Polycystic Kidney Disease, drug hypersensitivity from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing Very mild nut allergy. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced within three (3) hrs of receiving 1st dose of Pfizer vaccine i had an extensive rash and hives from my knees down on both legs that was itching and painful on 25Aug2021 at 19:30. Clinical course was reported as Within three (3) hrs of receiving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful. This lasted two (2) weeks then started to recede for a week. Rash came back with a vengeance on the evening of 9/14/2021 from midthigh down, as well as on my neck, ears and face. Initiated a walk-in clinic visit for treatment on 9/16/2021. The patient received treatment with Prednisone & hydroxyzine for the adverse events. The clinical outcome of the events was recovering. Therapeutic measures were taken as a result of within three (3) hrs of receiving 1st dose of Pfizer vaccine i had an extensive rash and hives from my knees down on both legs that was itching and painful.  No follow-up attempts are needed. No further information is expected.
reports about 15-30 minutes after receiving the moderna covid-19 vaccine, she noticed some shortness of breath.  She reports this continued for about 4 days post-vaccination.  She is already prescribed an inhaler and utilized it, but notes, usually with her asthma she feels relief after utilizing her inhaler. states that she did not notice relief from this dyspnea with her inhaler for the 4 days.
Administered flu shot to patient.  Asked her to wait in waiting area afterwards to make sure no adverse effect(s).  Patient informed me that she felt dizzy, cloudy, lightheaded, hot, sweaty and felt like she was going to pass-out.  Recommended that she sit down with her head between her knees.  Provided her with water.  Patient stated no improvement in symptoms after 3 -4 minutes.  Called 9-1-1 to have her checked out.  She left on her own about 20 minutes after medics arrived.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. A year after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
CAN'T BEND FINGERS; ARM WAS SWOLLEN/ ISSUES WITH ARM; ALL DO IS SLEEP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: ebv infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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, the patient experienced can't bend fingers, arm was swollen/ issues with arm, and all do is sleep. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't bend fingers, arm was swollen/ issues with arm and all do is sleep was not reported. This report was non-serious.
Ridge under the injection site; Rashes under the injection site; Muscle bulge a little; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (received 1st dose on an unknown date refer case US2022AMR181742).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site induration, injection site rash and muscle swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site induration, injection site rash and muscle swelling were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site rash and muscle swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR181742   Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The reporter stated that the patient had side effects with both shorts of Shingrix. The reporter stated that the patient had muscle bulge a little, creating a ridge under the injection site which lasted for 3 to 4 days The patient developed two small rashes about a half inch under the injection site. One the size of a half dollar or a little larger. The other one is smaller the size of a quarter which lasted for 1 to 2 days.; Sender's Comments:  US-GSK-US2022AMR181742:Same reporter