chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recently feeling chilly; I just feel very nauseous and weaken like my body some parts are hot and some parts are cold; I just feel very nauseous and weaken like my body some parts are hot and some parts are cold; weaken like my body some parts are hot and some parts are cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (reported as COVID Vaccine, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the COVID Vaccine and had been recently feeling chilly and also just really weak and nauseous and patient guessed just never felt this way before. The patient know that they were side effects but just felt very nauseous and weaken like the patient's body some parts were hot and some parts were cold. The outcome of events was unknown. Information regarding lot/batch has been requested.
Parents report sudden onset of Rt knee pain 8 hrs after injections. Pain & weakness, mild ataxia progressed for several days involving hips, knees & feet. Sx resolved on 6-18-11. Pt saw MDx2, ERx1 & had labs.
Pt began having heavy bleeding the day after the 2nd COVID vaccines reporting soaking 6 heavy pads in  a 24 hr period that continues today at reporting on 5/25/2021. Has only had 1 episode similar to this and was in 2015. She historically is more prone to amenorrhea rather than heavy bleeding.
After administering the vaccine I was documenting in the pts chart I realized at that time the vaccine had expired. I immediately reported to the Dr. Pt was notified . He had no adverse reactions . He followed up with the provider today . He still had no adverse reaction . Pt was given second dose of Meningococcal Conjugate . He was instructed if he had any adverse effects to report to us immediately.
Pfizer Monovalent 6 Month to 4 years was diluted with 1.3 ml saline.  The correct dilution volume is 2.2 mL. The patient received the incorrect dose due to incorrect dilution.
On 1/28 developed sore throat and headache.  Saturday during the day slept throughout and has been fatigued.  On 1/29 spiked a fever of 102 and did not want to move due to head feeling heavy.  As mom was waking him up he was going back to sleep.  He had 2 episodes of watery diarrhea as well as of vomiting.  He was drinking 20 ounces of water over the course of the day but had decreased p.o. intake.  In the ED on 1/30 glucose was found to be 18 with a CRP of 7.2, CBC showed a WBC of 14.42.  CMP remarkable for glucose of 10, hyponatremia and bicarb of 14.  Normal kidney and liver function.  Covid flu RSV negative.  He was given IV bolus and was started on D5 NS after which glucose had normalized.  He was admitted to main campus for further work-up.  Due to concern for sepsis blood culture was obtained which he received IV vancomycin and ceftriaxone and given blood culture negative antibiotics were stopped.  Have not been having any fevers, vomiting or diarrhea while at the hospital. Lab work evident for CRP of 7.2 on admission, proBNP of 510.  Since then his CRP is now 1.9 but proBNP had increased to 2979. Cardiac echo obtained and normal.  Diagnosis is adrenal insufficiency/crisis that may have been precipitated by viral gastroenteritis.  Since admission, he has not had any fevers and has improved with respect to diarrhea and vomiting.  Activity is almost back to baseline.  Given initial concern for MISC upon admission with mildly elevated inflammatory markers with CRP of 7.2, and proBNP of 510.  Cardiac echo was obtained and was normal.  Currently CRP is downtrending and is now 1.7 but proBNP increased to 2 2979 and D-dimers are 2200 and IL-6 was found to be 84.3.
No adverse event; Dose from a vial with a BUD 23-Apr-2023 to adult patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient).    No concomitant medications were reported.     No treatment medications were reported.  This case contains information for the 2nd of 2adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721017 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721017:Patient 1
Convulsive chills for about 15 minutes and then changed to flushing sensation for about 15 mins.
1st dose 28Jul2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 28th July 2022 with batch number 9254S, expiry date 18th September 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The patient had not yet received second dose. The pharmacist reporting second dose was 3 weeks late. The HCP (health care practitioner) gives consent for safety team follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccines given at about 12:15 PM June 16. Headache began immediately upon leaving the clinic. At 10:00 PM her R arm began significant muscle twitching. At 11:00 PM her entire right side felt tingly. At about 12: AM she noticed a rash appearing on her inner arms. The morning of June 17 she felt quite ill, arms were weak and shaking, legs weak, no appetite, throat felt thick as with nausea. She continued to feel ill all day. Improved slightly late in the day, with better function in arms and legs, and some appetite. June 18 she began to really improve, regained appetite, and felt well by late afternoon.
Patient was given 0.3 mL of undiluted Pfizer Vaccine by pharmacist on duty.  It was suppose to be the patients second dose. Patient received 6 times the dose. Patient developed severe fatigue and body aches about 12 hours later.  Patient visited the urgent care overnight due to fever.  Patient is currently resting at home and being monitored 24 hours after the administration of the vaccine.
Patient reported redness/swelling within 2 days of receiving shot followed by severe pain and rotator cuff issues. Went to ER for treatment.
severe pounding headache; severe nausea; severe vomiting; fever; chills; injection site pain; This is a spontaneous report from a non-contactable pharmacist. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an intramuscular route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an intramuscular route of administration in the left arm on 28Feb2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, 47 hours after the vaccination, at 10:00, the patient experienced severe pounding headache, severe nausea and vomiting. On the same day patient also had a fever, chills, and injection site pain. On 24Mar2021, the patient was treated with acetaminophen 500mg for the event fever and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe pounding headache, severe nausea, vomiting, fever, chills, and vaccination site pain was recovered on 25Mar2021.    No follow-up attempts are possible. No further information is expected.
a sensation of loss of gravity or floating feeling,  increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
recent flare ups; joint pain tends to increase; booster shot; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "booster shot"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "recent flare ups"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain tends to increase".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a 33 years male patient was accidentally vaccinated with Fluzone Quadrivalent vaccine that was expired, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA292827 (same reporter).  This case involves a 33 years old male patient who received an 0.5 ml dose expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled Syringe lot UJ049AB, expiry date: 30-Jun-2019 via Intramuscular route in the left arm on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  The patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
felt fatigued; This is a spontaneous report from a non-contactable consumer (wife of the patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 09:30 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Medical history included allergy and anxiety. Past drug history included allergy to VICODIN. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Concomitant medications included unspecified drugs for allergy and anxiety. The patient said to the consumer just at the time of report that he felt fatigued the morning after his second shot on 14Jan2021 at 06:00. The patient was not treated for the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
Pt recvd 1st vax on 22MAR91 & exp cramping,nausea,& a skin rash on face which started on 24MAR91.
palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 13:45 (Lot number: EV8732) 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: PALPITATIONS (non-serious) with onset 19Apr2021 10:00, outcome "recovering", described as "palpitations". The event "palpitations" was evaluated at the physician office visit. Therapeutic measures were taken as a result of palpitations.  Additional Information: The patient experienced similar symptoms of palpitations on 19Apr2021 at 10:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. The AE was treated with High strength Advil recommended by MD. It was reported that the patient had covid prior to vaccination but was not tested for covid post vaccination. The patient had no Allergies or other medical history  No follow-up attempts are possible. No further information is expected.
I was asleep, I suddenly woke up at 3am and my feet were moving weird and I got up to walk and I was very confused and had really bad anxiety. I was walking around the house on the verge of a panic attack. For about a week I had very vivid dreams and nightmares. It scared me to death and I thought I might die. I never wake up in the night like that, ever!
Patient recieved 1/2 the dose from NDC 80777027505 which is a booster vial but the dose is 0.5ml
Severe headache, dizziness, extreme high blood pressure, vomited 5 times, stomach pain, and unstoppable shivering. Went to Hospital. I went in to coma. I was put on ventilator and then to a Rotating Bed. Was in a coma for ~2 weeks.
I had a flare up of what I believe to be Leprosy, specifically in my left hand.; I had a flare up of what I believe to be Leprosy, specifically in my left hand.; vaccine caused my immune system to flare up, and once my immune system returned to normal I suspect that a pre-existing bacterial infection flared up.; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 12:00 (Batch/Lot Number: EW0153) as 1ST DOSE, SINGLE (at the age of 35 years old) for covid-19 immunisation.  Medical history included none. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient experienced had a flare up of what he believes to be leprosy, specifically in his left hand on 17Apr2021 with outcome of unknown, and vaccine caused his immune system to flare up, and once his immune system returned to normal he suspect that a pre-existing bacterial infection flared up on 17Apr2021 with outcome of unknown. Details were reported as follows: "I had a flare up of what I believe to be Leprosy, specifically in my left hand. What I suspect happened is that your vaccine caused my immune system to flare up, and once my immune system returned to normal I suspect that a pre-existing bacterial infection flared up. I have contacted my doctor however have yet to receive a response / treatment".  It was reported that the event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received.
Adacel is indicated for patients up to 64 years old. Patient is 67 at time of administration.
I have had joint pain in my right arm since the 2nd vaccine. I received both doses in that arm. The pain varies from my shoulder to my elbow and at times my wrist. Sometimes it radiates from my shoulder down to my fingers. I also at times feel tingling in my fingers. There's no rhythm or pattern to where the pain is. I describe the pain as burning and weakness.
Erythema and induration at injection site (LUE bicep) as well as circumferential UE edema around bicep.
Mildly sore arm, onset within an hour of injection Fatigue, onset around 4 p.m. Insomnia, first noticed when trying to sleep at 8:30 Nausea, onset around midnight which gradually worsened but has since become mild Chills, onset around midnight Mild chest tightness, onset around 2 a.m. Headache, onset around 3 a.m. which gradually worsened
Inflammatory reaction to DTaP in Rt deltoid. Redness and swelling. No pain or tenderness. Reaction started within 6 hours of vaccine per mom. Reported to us on day 3.
Patient with no significant PMHx complained of a non radiating left sided chest pain 15 min after the vaccine injection.  he rated the pain as 3/10 and "needle poking like". he had been fasting since 5:00 a.m and admitted to acid reflux some time after breaking his fast. he also complained of some nausea but no vomiting and tingling of his right arm. He denied dizziness, palpitation and shortness of breath. On physical exam he was alert and oriented X3 with normal heart s1/s2 heart sounds. his lung sounds were clear bilaterally. capillary refill was less than 2 seconds There was no sign of redness, flushing/urticaria on skin exam His vitals were BP 136/88, HR 74, SpO2 97% a few minutes later he started complaining of shortness of breath and tingling sensation in his throat. the shorteness of breath improved with the removal of his two layered masks. He was then give 50 mg of Benadry and EMS was activated. They arrived at 5: 26, gave the patient 324 mg of aspirin and he was transported to ED.
Patient had large tonic muscular contraction throughout his body immediately following administration of Tdap which lasted approximately 1 minute.  The patient was then unconscious for another minute.  Patient then regained consciousness on his own.  Transported to ER by ambulance.
This is spontaneous report from a contactable reporter. The reporter reported about her 4 month old, daughter, who received second dose of PREVNAR 13 (lot number H13995) vaccine on 16Apr2014 at 0.5 ml single for immunization in the right thigh through intramuscular route at around 9:30 am. The consumer did not have any relevant medical history. Relevant drug history or allergies: No. Illness at time of vaccination: No. Adverse event following prior vaccinations: No. Birth weight: 7lbs 8ozs. Past drug history included first dose of PREVNAR 13 vaccine on 10Feb2014, first dose of HIB vaccine on 10Feb201a4 (in left thigh) and one dose of DTAP vaccine on 06Mar2014 (dose 1) and on 14May2014 for immunization. Relevant concomitant medications included one dose of HIB (lot number UH831AA) in left thigh, on 07Apr2014, for immunization. The reporter mentioned that her daughter developed high fever for 48 hours on 16Apr2014 few hours after taking the second dose of PREVNAR 13 vaccine. The patient did not have any other illness at the time of administration and was not hospitalized. The events resulted in an office visit. Relevant laboratory data were unknown. Therapeutic measures taken in response to the event included administration of TYLENOL. The consumer recovered from the events on 18Apr2014. The reporter stated that there was a reasonable possibility that the events are related to suspect product. Hib vaccine was received also on 13Jun2014. Next dose of PREVNAR 13 vaccine was scheduled for 22Sep2014. Follow-up (31Jul2014): New information from a contactable physician includes: suspect vaccine dose, lot number, updated administration date and anatomical location, vaccine history, concomitant vaccine lot number, events updated start and stop dates, treatment received, following vaccination scheduling and reporter causality assessment. Follow-up (25Sep2014): Follow-up attempts completed. No further information expected.
On January 28, she had severe itching and redness, rash, swelling at the injection site around 6:30 PM. She put ice on it and hydrocortisone cream. The next day, the redness, swelling and itching extended to a large area on the upper arm location and she also started to have pressure under both eyes. She then started to experience a red rash on other parts of her body to include her right arm, shoulder, back. She describes these rashes at hives. She took Benadryl and applied ice. In the morning, she had a red rash on both of her thighs. On January 30, she had less swelling and no noticeable itch. Later in the afternoon, she had more itching, pain, redness occur in the left arm again along with the abdomen, chest and both sides of her neck, under her arms and on her legs. She took Benadryl and repeated later in the evening before going to bed. She also used hydrocortisone cream. On January 31, had the same experience. February 1, she had tingling on her back along with neck, head. She took Benadryl and used hydrocortisone cream. February 2, her left lower eyelid began itching but no redness or swelling. This continued on February 3 but was less. Nothing on February 4th and then on February 5, she had a slight itch rash on her left arm near her armpit that was responsive to hydrocortisone. She has not had any symptoms since then.
Fever (chills and sweating) Sharp pain in arm of injection  Nausea and vomiting  Full body aches  Low energy
Intense pain in the shoulder going down my right arm approximately 1 hr after the shot was administered. Could not raise arm above the shoulder. Emergency room doctor diagnosed as inflamed bicep tendon. Got better w/anti-inflammatories but then got really worse, had trouble lifting arm and getting dressed. MRI showed tendinitis in bicep tendon and rotator cuff and slight tear in labrum tendon from previous shoulder dislocation 12 yrs ago. Physical therapy and more anti-inflammatories were prescribed.
This case was reported by a physician and described the occurrence of incorrect storage of drug in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). There were no concurrent medications. On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). The physician stated that the PEDIARIX vaccination was stored at below recommended temperatures and was then administered to the infant. The physician had no further details of the event because she did not have the subject's chart with her at the time of reporting. The physician reported that the subject was going to be re-vaccinated. The physician considered the event was clinically significant (or requiring intervention).