chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Infanrix on June 9th, 2021/ dose expired on May 21st, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number unknown, expiry date 21st May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 age at vaccination was not reported. The patient received dose of Infanrix that was already got expired on 21st May 2021, which led to expired vaccine used. The health care professional had no information available about the patient and she offered to provide more information during the follow-up. The reporter consented to follow up.
DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.
pt recv vax;15may96 pt exp chicken pox w/ about 45 fluid filled lesions, according to pt's mother; pt noted to be moody and itchy; was not seen by MD;
Received ZOSTAVAX vaccine on February 17th, 2014 and started feeling viral illness next day. Broke out in a shingles looking rash with blisters and redness on the back of arm where injection was given. The patch is approximately 3 inches by 5 inches. Dr initiated treatment with valacyclovir 500 mg TID x 7 d.
Mild shivers; Mild Body Aches; Tired; Chills; Foggy; Thirst; Mild Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Thirst), PYREXIA (Mild Fever), CHILLS (Mild shivers) and PAIN (Mild Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Mild Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, PYREXIA (Mild Fever) had resolved. On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Thirst), CHILLS (Mild shivers), PAIN (Mild Body Aches), FATIGUE (Tired) and CHILLS (Chills) had resolved.            Concomitant medications were not provided by the reporter.
Patient c/o dizziness, no SOB, no LOC, alert & verbal, no n/v, no pain/discomfort. Patient assisted to gurney in supine position with HOB elevated. Pt given water/ vital signs monitored BP 106/91 pulse-81, RR - 17, ~2 sat - 98%, RA  2:50pm - patient verbalized relief from dizziness, no SOB, no headache, no n/v, alert & verbal, lip color returned back to normal, no LOC. Vital signs BP 108/77, pulse - 91, RR - 17, 02 Sat 98% RA
Swelling of lymph nodes near clavical/neck on injection side (Left side): Second day after injection lasting 4+ days now, headache lasting 4+days now, extreme fatigue. lasting 4+ days now.
REDNESS, TENDERNESS, HARDNESS ABOUT A QUARTER SIZE IN DIAMETER.
No reaction noted-child died 24 hours after vaccines given.  Autopsy neg-states SIDS
Pt recvd vax & 1/2 hr p/vax exp h/a & lt arm sore & tingly;
Headache, tingling of lips, chills,joint pain, muscle pain, fatigue sore and swollen site
Shoulder injury on the left side due to vaccine administration, due to injection of influenza vaccine into the subacromial bursa. [Vaccine over penetration].
Rash on her arm at the injection site; Injection site / rash has little bumps; Injection site / rash / is itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th August 2021, 2 days after receiving Shingrix, the patient experienced injection site rash, papular rash and injection site itching. On an unknown date, the outcome of the injection site rash, papular rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, papular rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm and 2 days after the vaccination the patient experienced rash on her arm at the injection site. The reporter stated that the rash had little bumps and it was itchy. The reporter mentioned that the symptoms were not resolved. The reporter did not consent to follow up. The did not give permission to contact HCP (Health care professional).
Swelling in tongue; Nausea; Throat scratchy; This spontaneous report was received from a consumer of 60-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of swelling in tongue, nausea and feel like throat scratchy.  The patient's medical history was not provided. No Concomitant medications were reported.  On 23 Dec 2020 at 10:30, the patient received their first of two planned doses of mRNA-1273 (Lot# not reported) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient experienced swelling in tongue, nausea and feel like throat scratchy. No treatment was administered.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, swelling in tongue, nausea and feel like throat scratchy was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of swollen tongue, oropharyngeal discomfort and non-serious expected event of nausea. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.
patient in third trimester of pregnancy received Fluarix; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 53Y2G, expiry date 30th June 2023) for prophylaxis.   On 20th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse practitioner reported that the patient who was in her third trimester of pregnancy, received Fluarix on the day of reporting (season and formulation not reported). The reporter (also a GlaxoSmithKline employee) reported that suspect product was reported as Fluarix only with lot number and expiration date (season was not reported).  No general option for Fluarix was available, hence product was selected with one or the available options in the system. The reporter consented to follow-up. Additional supportive information: The patient received Fluarix during pregnancy, which led to vaccine exposure during pregnancy.
Headache; Fever; chills; Body ache; Nausea; Swollen  armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:30, (At the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, atrial tachycardia, thyroid disease and Hashimotos disease. Concomitant medications taken within 2 weeks prior to vaccination include Levothyroxine (MANUFRATURER UNKNOWN) and Diltiazem hydrochloride (CARTIA) both for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. The patient was allergic to codeine and demerol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, the patient experienced headache, fever, chills, body aches, nausea and swollen left armpit. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not take any medication for headache, nausea, chills, fever, swollen arm, general body pain. The clinical outcome of the events headache, nausea, chills, fever, swollen arm, general body pain was recovering at the time of this report.   No follow-up attempts possible. No further information expected.
Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.
Within minutes of injection dizziness, increased heartrate, increased blood pressure, flushed color, feeling of weakness in limbs, and shakey hands and feet. This was treated by reclining with feet up, sitting in a dark room, and drinking cold water while monitoring symptoms. Symptoms resolved within minutes.  About an hour after injection lethargy, feeling chilled, in particular hands were very cold, mental fog, and slurred speech. This resolved without intervention within a couple of hours.
Child received a 15mcg dose instead of a 10mcg dose. Mother reports no side effects following vaccination.
Right arm was swollen where she got the shot; Sore where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot). At the time of the report, VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment details was not provided
Vaccine administered 8 days early . Error was discovered during checkout process. Pharmacist spoke to vaccinator and vaccinator support staff regarding issue and retrained to check first dose dates and vaccine card for return date.  Pharmacist had nurse educate patient on where to report any adverse events.
Continuous severe vomiting every half hour from 7:30 PM until 3 am. Chills, fever, unable to sit or stand due to weakness and doing so provoked more vomit. Diarrhea. Was home alone with no help. Did not know this would happen otherwise I would not have gotten this vaccine. I wanted to call 911 but I have no health insurance and was scared of getting another big bill.
This spontaneous report was received from a female health care professional (also reported as "administrator") of unknown age reporting on herself. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-MAY-2018, the physician accidentally touched a leaking ROTATEQ (lot number N021026, expiration date 24-FEB-2019, dosing tube.  No adverse effect reported. Product quality complaint filed. The action taken with ROTATEQ, the outcome of the event product quality complaint and the causal relationship between the event and therapy with ROTATEQ were not reported.
Erythema and swelling at vaccine site. Eyelid and mouth swelling x several days and wheezing with shortness of breath.
Following day after injection, arm had typical soreness but then about half an inch below injection site started to get red and by 48 hours had 4 x 3 inch red, swollen, painful area. By day 4/5 it started to become itchy.  I have been on Zyrtec 10 mg daily as I normally take this and it did nothing for the itching or reaction as far as I can tell. I had this happen on Dose #2 and 3 in the left arm so tried the right arm to see if it would help. I didn't develop the huge welt like reaction a week later like those doses but it did start on the 2nd day instead.
Moderna COVID-19 Vaccine EUA  aches all over, chills during the night that 1st night,  2nd day - achy all over - no chills, taking Alkaseltzer + for aches 3rd day - still occasional aches & still taking effervescent aspirin for it
Severely heavy periods lasting 10 days. Small clots are also seen. Severe menstrual pain.
Got "booster" dose / 3rd dose of Pfizer Covid-19 vaccine on 10/28/2021.  In less than 24 hrs he developed fever up to 103F, diaphoresis, fatigue and malaise.  He was seen in the emergency room in into atrial fibrillation with RVR while there.  Troponin series positive, consistent with NSTEMI.
Had injection on Sunday.  Woke on Monday with 104.5 temp, swollen joints and general body aches.  Temp broke about 6:00 pm but returned on both Tuesday and Wednesday.  On Tuesday my husband found out that a coworker was positive for Covid.  Wednesday morning both my husband and I also tested positive for covid.  Overnight Wednesday, the fever resolved itself.
Child received vaccine on 7-23-13 around 8:30 am. Later that evening he stated it was hot outside but he was cold as he went to bed. He got up early 7-24-13 went to check fishing lines on river and had emesis x1. When he got home temp was 100.9. He has been resting and sleeping since this morning.
Pt c/o H/A, dizziness, pain/numbness of L arm after receiving vaccine. Placed in supine position. Pupils non-reactive. Ammonic by inhalation given and followed by Sprite and crackers. Hand grips + bilat. Mom p/u child and reports gallbladder problems and throat infection. Student went home with mom after reviewing of s/s that would require MD f/u.
She had a hemorrhagic stroke March 8th at 7pm, she was non responsive almost the next 4 weeks . We git some hand responses only. Last week she was in horrible pain, we put her on hospice so they would get rid of her pain?and we let her go. I didn?t consider the vaccine at first, but after reading about it causing hemorrhagic strokes and only 10 days after her 2nd Covid 19 vaccine, I?m convinced, she died because of the vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 10:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.94 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 22-Oct-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 10:00 AM and on 27-Oct-2021 with temperatures 29 and 32 degrees Fahrenheit from 09:00 AM to 10:00 AM. On 29-Sep-2021, 2 vials were moved to the fridge and on 05-Oct-2021, 4 vials were moved to the fridge. Beyond use date for the 2 vials which moved to the fridge on 29-Sep-2021 was 29-Oct-2021 and for the 4 vials which moved to the fridge on 05-Oct-2021, it was 04-Nov-2021. All the 6 vials were moved to the clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Headache, SkinRash, reported fatigue and nausea H/A on 1/10/21. Reports rash, itching and fatigue began on 1/14/21 Nausea began on 1/15/21
Facial paralysis: treated with Prednisone 30mg & Acyclovir 800mg.
Had a 22 day long period beginning July 4th. I have never experienced a period longer than 6 days before this.   Have felt chronically fatigued since July 4th as well.
No additional adverse effect reported.; 2 patients received improperly stored PROQUAD since unspecified date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, current conditions, concomitant medication and drug reactions or allergies were not reported.     On 01-JUN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number S031884, which has been verified to be valid, expiration date reported and validated as 07-APR-2021 (strength, dose, vaccination scheme, anatomical location and route of admnistration were not reported), as prophylaxis (product storage error); which was reconstitued with a properly stored sterile diluent. It was stated that the vaccine was exposed to a temperature of 37 degrees Fahrenheit (F) for a timeframe of 70 hours. There was no previous excursion. Digital data logger was involved. No additional adverse effect reported.; Sender's Comments:  US-009507513-2006USA000690: