chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flulaval administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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 reported as follows: The reporter reported that flulaval underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter
Slight dizziness for about 15 minutes. Not so severe as to prevent standing/walking, but noticable.
Same day post vax, the pt experienced fever of 104, nausea, vomiting, and a 4-6 inch induration at the vaccine injection site. There was also redness, swelling, and tenderness at the injection site.
Per ED and parent report the timeline for symptom onset varies.  ED records state that rash appeared 1-2 hours prior to admission at 0530 on 1/25/13.  The fever appeared 3 to 5 hours prior to ED admission.  Oral Tylenol and IM Benadryl given at 0615 on 1/25/13.  Baby released to home from ED at 0642.
Demonstrates swollen axillary lymph nodes and a stiff trapezius with soreness.
This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 79-year-old male patient who received Shingrix for prophylaxis. On 16th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2018, less than a day after receiving Shingrix, the patient experienced limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping. The patient was treated with Advil. On 17th October 2018, the outcome of the fever and feeling hot were recovered/resolved. On an unknown date, the outcome of the limbs stiffness, general body pain and chills were recovering/resolving and the outcome of the injection site pain and difficulty sleeping were recovered/resolved. It was unknown if the reporter considered the limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: This case was reported by patient's wife. On 16th October 2018 at approximately 5:30 PM, the patient received Shingrix on the right arm. The patient experienced body and leg stiffness and his body was hurting. The patient could not sleep and the next day he was complaining about that. The patient had pain in his arm at the injection site for a few days and then the pain was resolved. The patient also felt feverish for one day. The patient took Advil every six hours or so and the Advil was helping his symptoms. The patient denied permission to contact their physician.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. No data about patient's demographics or medical history provided. On an unspecified date in August 2008 the patient was given the first dose of GARDASIL; dose, route and lot # not reported. The second dose was administered on an unknown date in December 2008, route and lot # not reported. On 26-MAR-2014 the patient was in the office to have the third dose of GARDASIL administered; dose, route and lot # not reported. There were no adverse effects to report. Additional information is not expected.
Every severe allergic reaction, with except for the hives. Breathing, heart rate, dizziness, fever, even  the left kidney - sever pain. No medical coverage for hospital visits.
On 10/23/13 Pt developed rash on entire body. No fever and no other symptoms. No changes to current meds or food. Has not had adverse reaction in past with flu vaccine but didn't know what else could have caused rash. Will follow up with MD soon and take antihistamine. 11/19/13 attempted to f/u x2. Able to reach client today. Reports he was able to get into MD who gave an IM steroid injection, a week prescription for a steroid and antihistamine. Client reports after these treatments rash went away and has not returned.
Vaccine was administered on 1/19/23. Patient developed blister like rash approximately on 2/9/23, seen in doctors office on 2/13/23,  rash was swabbed, and came back positive for Varicella.
Started with chest pain, a couple of days after the shot. Fainted on 3/13/21, transported by EMS to emergency room. CT scan was done, Dr. said she has blood clots in her lungs. Was given a prescription for Eliquis 5 mg twice daily.
Same day of vaccination (1st dose) Patient reported 1)burning sensation in penis, 2)loss of use of arms for period of time, followed by severe pain in arms.  Continued numbness in arms.  Patient scheduled follow-up appt with his HCP for 5/24.
Approx 6-7  hrs post injection, chills, body aches, stuffy nose, sneezing began, subsided in 30 hrs.  S/Sx identical to sinus infection sec to pt's seasonal allergies.
MA inadvertently gave pt injection of adult flu dose with immunizations listed below. No tx necessary d/t no adverse event noted. Pt's mother notified of error & instructed to monitor & bring back into office.
Right leg red and swollen. Instructed to give Tylenol and use warm compresses to area.
Bones hurt very much (where you want to cry), especially my neck; Shortness of breath; Bones hurt very much (where you want to cry), especially my neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck). At the time of the report, NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Pharmacist discovered vaccine product (Pfizer) had extra doses /solution then what he has normally come accustomed to into later part of working shift when recording/drawing  a 6th and final dose to be administered of Pfizer vaccine. Pharmacist believes there were 1-2 more doses at least left worth remaining to able to be given from product.  Pharmacist also discovered extra recording "tally" mark on vial on how pharmacy records vials per company standing operating procedure for Moderna opened product. Video footage has not been studied nor possibly will not be able to reviewed or confirm but am taking precautions in case vaccine product did not have "extra" doses and patient was inadvertently  given wrong vaccine (Moderna) as booster and or overly diluted product.
shingles; development of rash.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient presented with shingles and had subsequent office visit on 8th November 2021. No other intel or adverse event reported to office outside of development of rash. Consent to follow up was granted.
Patient has received pfizer vaccine on 2/26/21, 3/26/21, and 10/1/21. Covid 19 Positive 4/29/22 , vaccinated, clinically asymptomatic. Came to ER on 5/2/22 and admitted for a fib. Asymptomatic for COVID19 so no treatment. Discharged on 5/11/22
Fever about 12 hrs after vaccine given (T 103 degrees F) refused to walk at home. Swelling at area of injection, no redness or bruise.
About 4 hours after the vaccination I developed significant soreness in my arm, my shoulder was warm to the touch, and I developed a fever and a headache. This lasted for 36 hours, but symptoms were substantially relieved with TYLENOL.
Calves hurt; Tremendous pain; Diarrhea; All the muscles in his body hurt; Chills; Lowgrade fever; Puking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Calves), PAIN, DIARRHOEA, MYALGIA, and CHILLS in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08 (or a 9)1D21A (or a 9) and 024C21N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included PRAVASTATIN for Blood cholesterol abnormal, LISINOPRIL for Blood pressure abnormal, TEMAZEPAM for an unknown indication.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Calves), PAIN, DIARRHOEA, MYALGIA, CHILLS, PYREXIA, and VOMITING. At the time of the report, PAIN IN EXTREMITY (Calves), PAIN, DIARRHOEA, MYALGIA, CHILLS, PYREXIA, and VOMITING had not resolved.            Concomitant medication included pain medication. No treatment medication was provided.   This case was linked to MOD-2021-294487 (Patient Link).
Post vax, area on left leg the size of the "end of pinky" that looks like a cigarette burn, denies symptoms of infection. Child had multiple mosquito bites on lower extremities.
Information has been received from a pharmacy referring to unspecified number of patients of unknown age and gender. The patients' medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored ROTATEQ (dose and frequency were not reported, data logger was involved), lot # L035510 with expiration date 13-MAY-2017, orally. The ROTATEQ was improperly stored at 9 centigrade for 30 hours and then was back in range. No adverse effects reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
12 yr Female attendee; tall slender build without breakfast felt faint, pale 7 minutes after injection;  went prone for 15 to 20 minutes, self resolved and went home with father
fever 105 occurred in afternoon of day vax given & persisted for 2 days; adm to hosp for observation;
PSORIASIS FLARE UP/ PSORIASIS CAME BACK EVERYWHERE; DRUG EFFECT INCOMPLETE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis, and psoriatic arthritis. On an unspecified date, the patient experienced psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. This report was non-serious.
Pain started four days after shot in arm. It worsened over days to dull aching in the upper arm, then into upper back, scapula, down arm and into rib cage. It is Charley horse cramping and has become so severe that I cannot sleep on that side, lift my arm above shoulder level or lift heavier objects, like milk jugs. I have never had issues with flu shots before, but this has become extreme.
Red, rashy bumps from injection site to chest and back. Patient was to try BENADRYL and topical steroid unknown results.
Visit at ~10am for vaccination, note from ED about visit at 12pm same day 8/8/2019. Reported myalgias, paresthesias around mouth, physician diagnosed panic attack. Discharged 3pm from ED.
10/25/06 and 10/26/06 swelling and pain in left deltoid at injection site of Tdap, called health department on 10/27/06 complaining of redness, swelling and difficulty in raising arm. Advised to come by health department for nurse to look at arm. Advised as of wet compresses alternating cool and warm to reduce swelling and redness. Client called on 10/31/06 and came by for nurse to look at left deltoid arm. There is edema of arm 3-4" from site of injection. Area is tight and warm to touch. client complain of itching and still some tenderness. Advised warm moist compresses to area. Instructed to take ASA (no allergy) to reduce inflammation. She is to see doctor on 11/01/2006. Instructed to keep appointment.
Butterfly rash on face/  and neck/continual rash; Burning / still get unexplained / burning on right eye sporadically; Raw Swollen eyes / still get unexplained swelling / on right eye sporadically; Raw Swollen lids / and under eyes; Welt developed under right eye / welt allergy under my right eye; Sensitivity to any facial product; Redness; discoloration under eyes; Resembled lupus; Date of vaccine. June 19, 2019; Rash; Was miserable for over 1 1/2 years; This case was reported by a consumer and described the occurrence of butterfly rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration, rash lupus-like and incomplete course of vaccination. On an unknown date, the outcome of the butterfly rash, burning sensation, eye swelling, swelling of eyelid, sensitive skin, skin discoloration and rash lupus-like were recovered/resolved and the outcome of the welts, erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration and rash lupus-like to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient experienced butterfly rash on face and neck. The rash resembled lupus, burning.  The patient also experienced raw Swollen eyes and lids continual rash redness discoloration under eyes still sensitivity to any facial product for few months. The patient had welt developed under right eye. The patient was attended by dermatologist and ophthalmologist for extended period of time. Some side effects lasted over 1 year. The patient would not take the second dose because of this reaction, which led to incomplete course of vaccination.  Up until now, the patient did not see where to report adverse effects to but the patient was reporting now for your data. The reporter did not consent to follow up.
This spontaneous report as received from a physician refers to an 11-year-old male patient. The patient had no drug reactions/allergies. On 23-JUN-2014, the patient was vaccinated with GARDASIL (lot # J009788, expiration date 17-MAR-2016), 0.5 ml, intramuscular. Concomitant therapies included VYVANSE. On 30-JUN-2014 (2 days ago), the patient developed lymph node swelling under his arm (left axilla) after receiving GARDASIL dose on 23-JUN-2014. Patient came in to the office on 02-JUL-2014 for swelling under the armpit and pain around injection site. Physician reported that swollen area was not infected but it was hardened and tender. No treatment was given for adverse events and no lab diagnosis studies were performed. The outcomes of the events were reported as not recovered. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On 08-SEP-2014 the patients were vaccinated with improperly stored PROQUAD (lot #, expiration date, dose and route unspecified). No adverse symptoms reported. The temperature excursion was found to be supported by in-house stability data. This is one of several reports received from same source. Additional information has been requested.
RIGHT THROBBING UPPER ARM PAIN, COVID INFECTION, PEA SIZE KNOT AT INJECTION SITE Narrative: COVID infection after completion of COVID vaccine series 01/14 COVID vaccine dose #1 02/04 COVID/ vaccine dose #2 02/16 pt c/o right upper arm pain, throbbing in some area 02/18 seen in ED for arm pain, rx'd lidocaine/prilocaine and diclofenac gel 03/17 c/o 1 day of runny nose, back body aches, son tested positive for covid 03/18 c/o congestion, sneezing 03/21 pt is improving 03/23 ot c/o fatigue, congestion, myalgia 03/25 slightly dry cough continues, congestion improved 04/06 reports lingering cough, but otherwise better 04/09 CXR normal
Swelling of right deltoid with erythema and tenderness, including fever to 102.8.
Lymph nodes under left arm were painful and inflamed when I woke up the morning after I received the shot.  The lymph nodes by my collar bone were painful and inflamed when I woke up the second morning after the shot.  I went to my PCP on Monday, October 8, 2012.  he gave me a course of antibiotics (Augmentin) and I was told to return to see him on October 15.  I did so and the swelling had gone down but was not completely gone.  To this day the glands are still a little swollen and painful.
Patient reported an episode of lightheadedness, and loss of balance resulting in a fall with injuries.  He required a trip to the ED for stiches and follow-up examination.
Initial misuse report received from a healthcare professional on 14 January 2013. A patient (No information was provided regarding the patient) had received two doses of MENACTRA within a week due to parent error. No adverse event was reported. List of documents held by sender: none.
FIRST SIGN PEEING BLOOD AFTER VACCINE  ACUTE KIDNYE FAILURE DIAGNOSED WITH IGA AND CHRONIC EXZEMA SO BAD COULD BARELY WALK
had urinary incontinence; couldn't move from waist down; paralyzed for 10 hours; This case was reported by a consumer via other manufacturer and described the occurrence of paralysis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leg discomfort (Right leg not fully functioning all the time), constipation (had constipation), tuberculosis (had TB positive), cane user (had cane use) and multiple sclerosis (had MS(Multiple sclerosis)). Concurrent medical conditions included urinary tract infection. Concomitant products included ocrelizumab (Ocrevus), colecalciferol (Vitamin D3), Bone Strength, lactobacillus acidophilus (Acidophilus), magnesium + malic acid (Magnesium Malate) and dronabinol (Medical Marijuana).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), urinary incontinence and movement disorder. On an unknown date, the outcome of the paralysis, urinary incontinence and movement disorder were recovered/resolved.   It was unknown if the reporter considered the paralysis, urinary incontinence and movement disorder to be related to Shingrix.  Additional details were provided as foolows: The age at vaccination was not reported. The reporter stated that, after vaccination with Shingrix, in 2019 the patient experienced paralyzed for 10 hours, could not move from waist down, and also had urinary incontinence. The patient received Hyland's cough, Craneberry, Dulcolax and  Dramamine as a concomitant medication. The reporter stated that, patient recovered from paralysis, could not move from waist down and urinary incontinence.
Only had soreness which is normally the same reaction she gets with the flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 01Feb2021 (Lot number: NM5318) as dose 1, single and administration date 22Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism; "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Allergy" (unspecified if ongoing), notes: Additional Information for Other Conditions: gets hives; "COPD" (unspecified if ongoing); "Extreme arthritis/ severe arthritis in her neck" (unspecified if ongoing), notes: she has severe arthritis in her neck which started before she got any of the, doses of the vaccine; "Hives" (unspecified if ongoing), notes: Additional Information for Other Conditions: gets hives. The patient's concomitant medications were not reported. Vaccination history included: Typhoid vaccine (she had problems after having the Typhoid vaccine). The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "Only had soreness which is normally the same reaction she gets with the flu shot". Additional Information: The patient had the first 2 shots in Feb2021, and since she was in an area of withheld where Covid was more aggressive she wanted to get the booster, so she got it on Monday at around 1pm. States that she didn't have much of a reaction to the 1st 2 shots; she only had soreness which was normally the same reaction she gets with the flu shot.   No follow-up attempts are possible. No further information is expected.
Patient fainted after vaccine. Patient quickly arose after fainting and was and monitored for 30 minutes with no other adverse reactions.
Body aches, headache, continued pain at injection site speeding up arm and shoulder, fatigue