chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild flu-like symptoms; Lot of tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Mild flu-like symptoms) and tiredness (Verbatim: Lot of tiredness). The outcome of the influenza-like symptoms and tiredness were resolved.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that, glad to say he/she got the vaccine. the first, no big deal. The second one gave her/ him mild flu-like symptoms and a lot of tiredness for a few days but he/she will prefer that over shingles. The follow-up could not be possible as no contact details were available.
Patient received the vaccine. Immunizing tech stated: the patient seemed fine at the time of the shot. After administration of the shot the patient began to bleed out of injection site (like normal). The immunizing tech swabbed the area with cotton and placed a Band-Aid on the patient then stepped back into the pharmacy to grab another band aid while the patient remained at the immunization chair. The tech applied another band aid and told the patient to wait 15 minutes after the immunization and directed him to a waiting chair. The tech came back into the pharmacy and was cleaning the immunization basket when the patient's wife yelled for help. At this point I went out to the patient. Another tech called 911, another grabbed a nearby EpiPen. The immunizing tech grabbed the e-kit while I was out with the patient while he was unresponsive. Patient was unresponsive and slouched in chair. His wife and I supported the neck of the patient and laid him on the floor. I checked pulse and breathing to which both were present. Patient was still unresponsive and making strange movements. Pulse and breathing remained present and then the patient became responsive relatively quickly. At this point patient responsive and answering questions and moving fine. He asked if he had passed out then stated, he had a phobia of needles and said he felt nauseated. (wife previously stated he had a fear of injections). Soon after the ambulance showed up and I told the paramedics the above story. After a few more minutes I checked in with the paramedics and they said the patient was doing fine. Lastly, he was taken out of store with paramedics.
Red papules with erythematous base on chin and upper chest that progrssed to trunk, abdomen and hands by 10/25/2012 with fevers to 38.4 celsius on 10/28/12.
Chest pain, left rib pain, ear, jaw, arm all left side, nauseas,  low oxygen. 2/28/22 ER
Patient developed marble size lump on the right side of the neck four days after receiving the first dose of Moderna vaccine. Patient saw a surgeon (unable to remember name of MD) and the surgeon removed the lump after two weeks. Sent off for evaluation and with no abdnormalities.
Started as a band of rash across abdomin, then spread to both arms and back of neck .Extremely itchy. Went to an urgent care who gave her prednisone and Benadryl.
Mild Flu-like symptoms for 1 day: body aches and weak: slept several hours in afternoon - unusual for me.
"Covid-Arm": red, hot, itchy, achy rash below the injection site. Showed up on Day 2. Icing it and taking benedryl hoping it'll get better.  (First shot; covid arm showed on Day 8 and disappeared on Day 15).  Severe muscle ache/joint pain: took ibuprofen. Symptom disappeared after 24 hours.
Information has been received from a physician concerning a 16 month old female with no known allergies or pertinent medical history who on 21-APR-2008 was vaccinated with a single dose of VARIVAX (Merck) (lot # 659432/1918U).  There was no concomitant medication.  The physician reported that on 09-MAY-2008 the patient developed a rash at the injection site and soon after developed chickenpox.  Viral count was performed (result was not provided).  The patient's rash at the injection site and chickenpox persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
1 of 2 children vaxed from the same lot who exp a fever;pt recvd vax 1FEB95 & devel fever of 105R x 3 days following vax;pt recovered
-Fever, vomiting x 1, semisolid stools x 2 in first 24 hrs. -Mouth sores on day 2 -> decreased eating, -seen in office day 5 -> aphthous ulcers tongue x 2 posterior pharynx x1, gum x1, well hydrated; No acute distress.
Initial unsolicited report received from Healthcare professional (nurse) in on 16 October 2014. A female patient (age was no reported), whose medical history and concomitant medications were not reported, had received a subcutaneous dose of FLUZONE QIV (Batch number, expiry date and dose number was not reported) on an unspecified date. The patient had received dose subcutaneous instead of intramuscularly i.e. wrong route of administration and the patient had experienced painful arm and swollen arm after vaccination on an unspecified date. Lab investigation and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a nurse on 06 April 2015. No new information was provided. List of Documents held by sender: None.
I developed a very bad case of Shingles. I was perfectly healthy & active  at the time of the vaccine . This is 4.5 weeks after developing shingles... the rash & pain are still so severe. I sought treatment within 15 hours of developing the rash & received antivirals.
Pain at injection site; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Severe diarrhea for three days; Nausea; Fatigue; Heart was slightly elevated; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 27Mar2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal and obesity (BMI 49). The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, at 14:30, the patient experienced severe diarrhea, nausea, fatigue and heart was slightly elevated. The patient reported that she had severe diarrhea for three days following vaccination date along with other side effects like nausea, fatigue and her heart was slightly elevated than normal rates. She stated that, she was reporting this in hope of bringing awareness for others without gall bladders and high BMI. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe diarrhea, nausea, fatigue and heart was slightly elevated was recovered/resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Reports feeling bump at injection site 1-2 days post vaccination. No pain, no redness. Seen by this RN on 05/16/2015 who told patient to see her PCP. Patient declined.This RN palpated a distinct firmness in left upper arm. About 3cm across with irregular margins. Was not superfiscial- was about 2-4 cm from surface of arm.  No fever, no other sxs. Full ROM in arm. The area appeared to be accurate placement of IM vaccine.
Syncope approximately 3 minutes after shot with resulting head injury.  Pt conscious on paramedic evaluation with hematoma on forehead.  Unable to walk without assistance.  Pt's mother chose to drive her for follow up at ED against recommendations of reporter.  Fire Department wheeled pt to personal vehicle.  Unknown dispositions/outcome.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 03-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
The very next morning had pain and heaviness, numbness, tingling and muscle twitches in both legs. It has been 5 weeks since the first does of Moderna  vaccine and both legs are still left with sporadic pain, muscles twitches, numbness and tingling.  I have reached out to my primary care doctor to evaluate my concerns and if I should proceed with next Moderna dose.
injection site was red; injection site was red and swollen; on 30-AUG-2022, a 12 month old child who was supposed to receive a VARIVAX vaccine, was accidentally given a; HCP states that this vaccine was given subcutaneously instead of IM.; This spontaneous report has been received from a physician referring to a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.      On 30-AUG-2022, the patient was supposed to receive a varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported), but accidentally was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine HBsAg (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) at a dose of 0.5 milliliters (mL), administered subcutaneously (lot number C5808AA had been verified to be a valid number; expiration date reported as 24-JAN-2024 and upon internal validation established as 14-JAN-2024) (vaccination scheme, frequency,  and anatomical site of injection were not reported) (wrong product administered and incorrect route of product administration).   On 31-AUG-2022, the mother of the child called the physician's office stating that the patient's injection site was red (vaccination site erythema) and swollen (vaccination site swelling). The outcome for both events was reported as recovered.  The causality relationship between diphtheria toxoid (+) hepatitis b virus vaccine HBsAg (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) and the events vaccination site erythema and vaccination site swelling was considered by the reporter as related; whereas, the causality assessment between the adverse events and varicella virus vaccine live (oka/merck) (VARIVAX) was considered to be not related.
Ears are ringing; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; His neck hurts and his spine and his chest; his back hurts and spine and neck; He is sick; He has no energy; all day long he was sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown, 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) with onset Aug2021, outcome "unknown", described as "Ears are ringing"; NECK PAIN (non-serious), CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset Aug2021, outcome "unknown" and all described as "His neck hurts and his spine and his chest; his back hurts and spine and neck"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "He is sick"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "He has no energy"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "all day long he was sleeping".  Additional information: Expiry Date of COVID 19 Vaccine was Unknown. Additional Context: Concern: Reporter stated, "My son just had the COVID shot not instant but day before and I guess all day long he was sleeping and now he just woke up he says his ears are ringing, his neck hurts and his spine and his chest." When paraphrased: Reporter stated, "Yes and his chest and he has easy disorders (Further clarification unknown) so you know we are checking out him because he was way underweight (Further clarification unknown hence not captured in tab) just like that, so I don't know if that has something to do with because he has no energy right now and he was hungry but hasn't eat because I guess he was sleeping all day but now I am trying to feed him but he does not, because his back hurts and spine and neck." Reporter was informed about role of Pfizer Drug Safety and asked for filling the safety report: Reporter stated, "No, he is sick."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gave vaccine intramuscular in left deltoid. Patient tolerated vaccine well no signs of symptoms at time of vaccine.
Pain at injection site for 2 days. Chills, headache, nausea, lethargy for 1 day following the injection. No symptoms on day 3.
Woke up middle of night (1-2am) 11-5-16 complete paralysis in hands and feet and increased weakness. Patient spent 1 week back at home getting multiple tests to diagnose problem, had multiple falls and was admitted after broken tailbone. Admitted on 11-11-16.
Left leg swollen (8.5 cm X 9 cm), red, warm to touch, Temp 99 -ear, fussiness, decrease in appetite
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, (reported as "before 12-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II, lot number K011188, expiration date 12-AUG-2016, and lot number L003858, expiration date 05-FEB-2017, (route, anatomical location and frequency were not reported), for prophylaxis. The temperature was 8.7 Celsius degrees, time frame 1.5 hours without previous temperature excursions. Digital data logger was involved. No adverse effects were reported and no product quality complain was involved. No other suspect or concomitant therapies were reported. This is on of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014046.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16 year old patient of unknown gender, allergic to nuts and rice / grass and who had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 05-FEB-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Arm turned red; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 (Wednesday) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) (Patient has no bleeding disorder but took a low dose aspirin before having the vaccine) taken for an unspecified indication, start and stop date were not reported. It was mentioned that, when vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. The patient experienced arm turned red then black then now it was green. Patient asked is it normal. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Large, painful cold blister-like lesion on lower lip one week following vaccination.  I?d have had cold sores  in that location, but the difference is that this lesion was larger, quite painful, and has persisted for about 3 weeks.
30 hours later , profound sensorineural hearing loss in right ear.  Treated by steroid, hearing returned in one week .  Black tarry stools  INR increased from 2 to 12 ER visit , admitted to hospital on March 23.  TIAs
Started my period right after (within 30 minutes of) getting the shot--2 weeks before my usual cycle.
Patient states that he has had a persistent itching in his arm since the day after he received the vaccine on06/28/2023
This case is received from a company. This case is administered for Pharmacy Family of Companies. Initial report received from a non-healthcare professional on 21 October 2013. A patient (demographical details was not reported), whose medical history and concomitant medications were not reported, had received a dose of Inactivated Influenza vaccine with Lot number: UE4781AA and Exp. date of 25 May 2016, route of administration and anatomical site of administration was not reported) on unspecified date. It was reported that the patient had adverse reaction. Complementary investigations and corrective treatment were not reported. The outcome of the adverse reaction was not reported. Documents held by sender: none. Follow-up report received from a healthcare professional on 25 November 2013. An 81-year-old male patient, had received high dose flu vaccine for seniors in shoulder on 23 September 2013 in public health clinic. The vaccine was put in wrong site above shoulder. On 26 September 2013, the patient experienced pain and inflammation. He had injury to nerve and tendons. The physician injected KENALOG into site to relief pain and advised physiotherapy on shoulder for 6 weeks. No other vaccine was administered. Documents held by sender: none.
The next day, post vax, the pt experienced redness, warmth and induration at the injection site. Warm soaks were applied. The most recent information, received on 9/30/99, reports the condition of the pt is ongoing.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Patient began to experience generalized itchiness within 15 minutes post vaccination.  Gave Benadryl 25 mg po at 7:15pm.  Patient began to improve after 15 minutes and was released with directions to return or seek medical care if condition worsened.
Similar to previous Moderna vaccines - nausea, vomiting, fatigue.  However Pfizer vaccine caused SEVERE chills and shaking for over 1 hour.  As time has passed, my tinnitus has gotten much worse!  I can hear my pulse and in the last 3 days have developed peripheral vertigo which I have never had before.
Fever, headache, neck soreness, vomiting, nausea, dizziness and fatigue