chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received second dose beyond 36 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose). On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medication reported.   Action taken with mRNA-1273 in response to event was not applicable.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # M024677 and expiry date: 18-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature of -13.2 degrees centigrade for 10 hours 2330 minutes. Previous temperature excursions included 7.3 degrees centigrade for 10 hours 30 minutes and 23.7 degrees for 2 hours. the call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA004233:
After receiving the Johnson & Johnson vaccine at noon on April 9, at around 11:30 that evening, symptoms of muscle pain and fever began to appear throughout the body. When lying down in the middle of the night, I experienced severe shortness of breath. The above situations lasted for 2 days. It began to ease on April 13, and there are still fever symptoms now.
Acute gastritis that began 7 hours following injection. Confirmed by hospital. Manifested as epigastric pain, headache, nausea, difficulty sleeping Ongoing as of 48 hours after the shot
Sleeping a lot; Feeling tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued). At the time of the report, HYPERSOMNIA (Sleeping a lot) and FATIGUE (Feeling tired/fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
About a month after getting the vaccine shot I noticed I was thirsty all the time, had to urinate often, started to lose weight even though I was eating more than normal, felt irritable and started to have blurry vision (over night my short and long range vision deteriorated, long range has since come back but short range still bad).  Saw a doctor a couple weeks later and was diagnosed with Type 1 Diabetes.  Been taking insulin shots every day since...
Patient received the 1st dose of the Pfizer COVID vaccine  and was being observed for the 30 minute observation due to history of :severe allergic reaction (anaphylaxis) as a child, with unknown etiology. About 20 minutes into the observation period patient began complaining of tightness in her chest and heaviness in her shoulders.  respiratory rate = 20 and unlabored; breathing spontaneously with O2 saturation 100% on room air; BP 116/69, Pulse 103 Mentation: Alert Skin: Cool   at onset of symptoms, per EMS recommendation, the patient was placed on oxygen 2 liters via nasal canulaO2 saturations remained at 100 %. Patient noted slight improvement of her symptoms after about 15 minutes with oxygen continuing at 2 liters/Nasal cannula. Continued to observe patient for another 10 minutes, after which time the patient began to complain of a scratchy feeling in her throat, swelling around her mouth, itching and flushing of her face. At 19:05, EMS administered  0.3 mg intramuscular, Epinephrine via auto-injector into patient's right thigh.  After 5-6 minutes post-Epi administration, the patient reported having relief of symptoms. Vital signs obtained (BP 108/69, pulse 108) and oxygen saturation stable at 100% on room air. Patient was advised, she would need further evaluation in the Emergency Department after receiving the dose of Epinephrine via auto-injector. Patient was advised to be transported via ambulance. Patient declined transport via ambulance. Patient called a friend to give her a ride to the Emergency Department. EMS personnel called report to the ED. Patient was alert, oriented x3 throughout the adverse event and stable upon leaving the clinic at 40 minutes after Epi had been administered. Vaccine providers were notified of the adverse symptoms post vaccine. Patient will follow-up with her primary provider and allergy provider to determine if second dose will be a possibility to receive.
the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.
Tdap was given instead of Dtap. No adverse reaction observed or reported by parent.  Spoke to someone for further guidance, Parent notified. Since this was the 4th dose in vaccine series, and CDC guidance vaccine does count and will not need repeated. No further action needed
Patient initially reported lightheadedness after vaccine was administered. She was then instructed to put her head between her knees which she did. Shortly after she reported intense pain in her arm muscle which radiated down her arm and also tingling. After 20 min. the tingling subsided, but the pain remained.
loose bowels/diarrhea; bloated and gassy; bloated and gassy; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 11:30 (Lot number: EN6207) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "myastenia gravis" (ongoing); "hypothyroid" (unspecified if ongoing); "allergic to aged or fermented things" (unspecified if ongoing); "candida allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL (ongoing); PYRIDOSTIGMINE taken for myasthenia gravis (ongoing); GAMUNEX C (ongoing). Vaccination history included: Polio vaccine, for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovered" (16Mar2021), described as "sore arm"; DIARRHOEA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "loose bowels/diarrhea"; ABDOMINAL DISTENSION (non-serious), FLATULENCE (non-serious) all with onset 17Mar2021, outcome "not recovered" and all described as "bloated and gassy". Additional information: The patient cannot consume alcohol, alcohol related things or even vanilla extract. She can't eat any mushrooms or spores, soft cheeses, there's a whole list of things she can't eat.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative and refers to an uncpecified number of patients below age of 50 years old. Patients' concurrent conditions, medical history, known allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for unknown indication. No adverse effects were reported. Additional information is not expected as there was no consent for further contact.
Janssen COVID-19 Vaccine EUA  Tinnitus in my left ear started about 4 hours after the shot. I have never had this condition before.  Four days later and it?s still there.  The ringing is constant and somewhat loud.  I pray it goes away.  Nothing but this shot could have caused this.    I will go see a doctor if it persists.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6202), on 24Mar2021 as dose 2, single (Lot number: ER8727) and on 10Sep2021 as dose 3 (booster), single (Lot number: KW0177) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "cardiac vasospasm" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "PF due to SSc" (unspecified if ongoing), notes: PF due to SSc; "PF due to SSc" (unspecified if ongoing), notes: PF due to SSc. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; LEVOTHYROXINE; WELLBUTRIN; CELLCEPT [MYCOPHENOLATE MOFETIL]; FLUOXETINE; ATORVASTATIN, stop date: 12May2022; AMLODIPINE, stop date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Known allergies was none.
Patient received her COVID-19 Booster vaccination and ten (10) minutes into her post vaccination monitoring period stated that her heart was beating too fast. Additional monitoring time was added to her wait.   Vital sign monitoring of her heart rate, breathing and blood pressure every 15 minutes. After 40 minutes of waiting, patient stated after inquiry that she still felt weird." Emergency Medical Service was summoned and arrived and did the applicable assessment to include and EKG that they said was in normal sinus rhythm. She was offered a trip to the hospital for further evaluation which she declined.  The patient was given precautionary instructions of when to seek emergency medical attention which she was able to re-verbalize and was released from the post vaccination area - accompanied by a managerial staff member to leave the area.
Once I inserted the needle for IM injection for the flu shot, the patient complained about the pain. I asked her if she was OK. She said yes. So I continued. After I finished the injection, she complained that her whole left arm from shoulder to the tip of her fingers were numbed. She suspected that I hit her nerve. A few minutes later, she complained that her right temple hurt and just did not feel right. I offered to call 911 for her but she declined and left. She threatened to file a lawsuit if it caused permanent damage. I contacted Incident Reporting Hotline and received a claim# should I decide to file a lawsuit.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered VARIVAX (lot#, expiration date, dose, route and indication not reported) that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I've had slight side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I've had slight side effects) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I've had slight side effects). At the time of the report, IMMUNISATION REACTION (I've had slight side effects) had resolved.            Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications were not reported. Unknown whether patient seek medical care for AE and experienced a similar event in the past. The symptoms were improved. No treatment information was provided by the reporter.
Caller has ringing of the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Caller has ringing of the ears".  Additional information: She has ringing of the ears and got her 1st dose of the Covid vaccine and wants to report it. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inj. given at 11:30 AM, call received at 12:58. Patient states "I am having a reaction to the flu shot. I have been dizzy, nauseous, and having hot/cold flashes. Denies SOB, rash, or fever. Instructed to call 911 if symptoms worsen or with any change in breathing. (2:37) Patient denies nausea or dizziness. Still complains of hot/cold flashes continuing to follow.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 received on 12-FEB-2021 and Dose-2 received on 02-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Relevant concomitant medications were not reported. On 12-Feb-2021, he received first dose COVID-19 Vaccine manufactured by Moderna and on 02-Mar-2021, he received second dose COVID-19 Vaccine manufactured by Moderna. Treatment information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to MOD-2021-623319 (Patient Link).
Patient came in for first dose of Moderna stating she needed at least her first dose of the COVID vaccine to go into the hospital for surgery. Pharmacy staff confirmed patient wanted a first dose and not a booster shot. Pharmacy staff scheduled her first dose of Moderna as a walk in appointment and adminstered 0.5mL of the Moderna vaccine. Patient had no reaction to vaccination. Next day pharmacy was auditted stating the patient had previously received two doses of the Pfizer vaccine.
can't stop sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (can't stop sweating) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (can't stop sweating). At the time of the report, HYPERHIDROSIS (can't stop sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No concomitant medications were reported. for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) ,the reporter did not find any causality assessment.
eye and mouth twitching 1 hr to 1 hr and a half after administration , is seeing a doctor - needs head scan
High fever (101.9 by thermometer) and Swollen painful lymph node approximately an hour after the vaccine.  Now the lymph node is larger and my arm is swollen?pain radiates from my left armpit down-past my elbow and towards my chest muscle.
1st trimester estimated due date May 10, 2022.  2nd pregnancy  6:00 pm day 1 of second dose had a fever of 102 till the following afternoon on the second day around noon while taking Tylenol as well as nausea and lightheadedness during that same time. By 6:00 pm the following day no longer had a fever but was experienced chest pains almost called emergency services but did not feel it was life threatening at that time. Ended up falling asleep and woke up on day 3 feeling much better
itchy red area about 1 week after, at site of injection - resolved with Hydrocortisone cream. Not super alarming but super annoying. Went away within 24 hours
Severe vomiting starting about eight hours after vaccination, occurring about every half hour for about five hours.   Also diarrhea and body aches.  Rigors (uncontrollable trembling chills) and fever of 100.8.  Fever was gone by noon the next day but body aches and fatigue remained. Since severe vomiting is not reported as a side effect of RSV vaccine I decided to report to make this adverse event of this vaccine known.
suspected vaccination failure; breakthrough cases; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in an unspecified number of patient's 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 and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that she had seen a couple of breakthrough cases in patients who had received both doses of Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter denied consent to follow-up. This case has been linked to US2022AMR016206, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016206:Same reporter
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently the patient experienced "had alot of anxiety and passed out."  At the time of the report, the patient's outcome was unknown.  Additional information is not expected.
Contracted symptomatic COVID-19. Positive test result on 06/20/2021. Symptoms included shortness of breath, fatigue, fever, headache, body aches, diarrhea, loss of smell. Majority of symptoms lasted 1 week. Shortness of breath, headache, and loss of smell lasted 3-4 weeks.
2-23-19 am significant nausea, exhaustion. 2-23-19 pm headache. 2-24-19 - cont. nausea and exhaustion. 2-25-19 less nausea and exhaustion. From 23-26 - arm continued to turn red and spread - pharmacist 2/25/19 prescribed BENADRYL - took week. 23/24 less red.
Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) Strange/adverse sense of taste (3 days) EXTREME lethargy /sleepiness (10 days) Aggravation of arthritis in left knee (could not walk normally for 8 day, but the condition still persists and now includes swelling) Loss of use of left arm - no range of motion, pain, etc. (ONGOING) Numbness of left leg in various stages (ONGOING) Complete numbness of left leg with sudden loss of use of left leg, resulting in a fall (March 27, 2021) Shoulder swelling in muscle at the front of left shoulder, resulting in pain with use of arm (ONGOING).
Nov. 2 - Friday - By next morning heart was erratic, pounding, extremely rapid.  Nov. 3 - Saturday - even worse - Sunday - somewhat better.  Monday - called health department.  Saw doctor at 12:00.  Heart monitor for 24 hours.  1 week before results, some improvement.  Nov 12 thru Nov. 16, cardiologist, more improvement.  Today, Nov. 25, still had some erratic throughout day.  Called health department.
At injection site there was immediate swelling, redness and skin/muscle was hot to touch.  Patient experienced a fairly intense headache, her entire arm was quite painful and she was not feeling well ingeneral.  This lasted for several days.  PLEASE NOTE:  HEP A IMMUNIZATION WAS ADMINISTERED ON THE SAME DATE AT A DIFFERENT LOCATION (PUBLIC HEALTH CLINIC).
pt recv vax 25FEB97 & 22MAY97 pt exp a breakthrough case of chicken pox;pt recovered ;