chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Never received the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter enquired how to proceed with 2nd dose of Shingrix and asked for recommendations if any. The patient was wondering if he could get the 2nd dose. The reporter was unable to provide vaccine and some of patient details. The reporter did not consent to follow up.
Under right arm swollen lymph nodes; Itching along right side of breast tonipple; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 12:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), acyclovir (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), IBPROP and cetirizine hydrochloride (CETRIZEN) from unknown date for unknown indication. The patient was allergic to peanuts, he has taken DEPAKOTE on an unknown date and experienced drug allergy. 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 right arm on 04Mar2021 at 12:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation.  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 00:00,     the patient experienced under right arm swollen lymph nodes and itching along right side of breast to nipple. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lymphadenopathy axillary and itching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist, concerning an adult female patient who on 04-AUG-2008 was vaccinated with a booster dose of VARIVAX (Oka/Merck).  No adverse reactions were reported after the first dose of VARIVAX (Oka/Merck) was given.  The patient felt "light headed" after the booster dose was given.  The patient went to the emergency room on 12-AUG-2008 and was admitted for acute bacteremia.  At the time of reporting the patient was recovering.  There was no product quality complaint.  Additional information is expected.
I felt like a severe cold. I had head congestion, with a severe cough. I also had severe sore throat and throat congestion. Shortness of breath and fatigue.
Overnight, I had a elevated heart rate and I was not able to bring it down after several hours. In the morning, I was unable to get it down so I went to the Emergency Room. I was told that I had tachycardia and unexplained heart palpitations. I had a few occasional episodes where my heart rate was elevated at random moments. I eventually went to a cardiologist, but they discharged me and said that I was fine.
Starting around 6PM 7 days after my vaccination the injection site started to itch and became red. Put Cortizone cream on site which continued to itch throughout the night. The next day large red circle of roughly 1.5 to 2 inches in diameter was present and extremely itchy.  Cortizone  cream and Benadryl did nothing to stop the itching but ice did. Circle did not shrink in size, heat, or itch for 7 days.
I developed lump in left arm. Within a week, I had stiffness on both knees.
Product administration error; accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose). On 01-Nov-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were used no treatment information was provided
7/19/12 vomit x3. 7/23 vomiting large volumes. Stool greenish, breast fed. Mom on dairy-soy avoidance. Stools positive blood. ER 7/28 IV fluids stools positive blood.
2 months after my second vaccine shot - 17 days late period, which is unusual, maybe miscarriage, and after delay whole month heavier flows with big clots.
mom states reddened knob on thigh size of fifty cents peice; pt very irritable; rash present on back & legs-bottom; diarrhea, bright green;
Tasted the vaccine in my mouth - 2 hours smelled the vaccine in my nasal passages - 2 hours Felt odd just strange euphoric/weird - 6 hours Jitters - 2 days face felt swollen and puffy - 1 1/2 hours throat swelled  but not closed I could still swallow but it was tight - 1 1/2 hours racing heartbeat - 3 hours off balance - vertigo - 6 hours
Patient received the covid 19 Moderna booster without omicron instead of bivalent Moderna booster with omicron. No adverse reaction reported.
Patient had an allergic reaction after the vaccine . Onsite EMS was called vitals were taken BP 162/88  99% O2 room air HR 86. Patient was treated, Transported by the EMS  to the hospital.
102 fever, migraine and severe pain in shot arm, which, for a few hours was hard to move. Fever down now, but persists at 99. Migraine down to headache, which also persists.
A report was received from a health care professional on 12/10/03 concerning a 44 year old female vaccinee who experienced a sore, achy arm after receiving Fluvirin on 11/10/03 On 11/10/03, the vaccinee received Fluvirin vaccine. On 11/13/03 the vaccinee started to experience soreness in the area. On 12/10, she returned to the clinic and reported that her left arm continued to feel sore and achy. According to the reporter there was no nodules around the area but the patient had a global achiness in the area. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up received 8/18/04 from health care professional. Letter received stating no further information regarding the vaccinee could be located.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-FEB-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-SEP-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt received 1st dose of Covid vaccine (unknown brand) on Friday.  In the middle of the night on Friday she developed nausea, vomitting and right sided weakness. She spent 2 days in the hospital where stroke was ruled out. She presents back with primary care provider (myself) 6 days after event. She still has marked weakness on her right side and generalized fatigue and lethargy.
Narrative: 63 yo male PMH significant for homelessness and schizophrenia presented to ED on 2/23/22 and admitted for suicidal ideation, found to have covid19 pneumonia w/o hypoxia. Pt had coughing paroxysms in the ED. CXR showed bilateral interstitial infiltrates. Treated with remdesivir 2/26, 2/28, pt refused on 2/27. Pt discharged to facility on 03/2/22.
So I got pretty high fever it started around 03:30AM in the morning at 7AM I still had fever so I took TYLENOL. I had muscle aches and body aches it felt like someone had been kicking me, I had chills with more severe body aches. The next day it slowly got better although fatigued.
Patient diagnosed with clinical chickenpox on 12/07/02, Received Varivax 06/30/97 i.e. chickenpox poss varivax vaccine.
vaccine came out of the sides; This case was reported by a other health professional via interactive digital media and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. It was reported that the Intern (unspecified) administered 1st dose of Shingrix vaccine to the patient and upon administering the vaccine, syringe failed and some of the vaccine came out of the sides where the needle was screwed into the syringe, which led accidental underdose. The follow-up would not possible as no contact details were available.
give the ACTHib (lypholized powder) portion of the Pentacel vaccine/no AE; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that give the ActHib (lypholized powder) portion of the Pentacel vaccine/ no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE (HEPATITIS B VACCIN); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 07-Jun-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. Liquid: U6327AA; expiry date: date 20-Sep-2019, Powder: UJ102AA; expiry date: date 20-Sep-2019, Carton: Lot: UJ102AAA; expiry date: date 20-Sep-2019  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of documents held by sender: none.
This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No pertinent concurrent conditions or medical history was reported. On multiple unspecified dates, the patients were vaccinated orally with an unspecified amount of improperly stored doses of ROTATEQ, oral liquid (lot # M004883, with expiration date of 02-OCT-2017; exact dose was not reported). There were no concomitant therapies reported. The doses of the vaccine were exposed to a temperature excursion of -0.3 degrees Celsius for a total time frame of 22 hours on an unspecified date. A Digital Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Slight fever; Aches all over; Don't feel well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, PYREXIA, PAIN, and MALAISE in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced CHILLS, PYREXIA, PAIN, and MALAISE. The patient was treated with ASPIRIN on 17-Jan-2021 for Ache, at an unspecified dose and frequency. At the time of the report, CHILLS, PYREXIA, PAIN, and MALAISE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No concomitant medication was provided.
Started getting little red circles on my hands 6mo ago. It progressed to other parts slowly up until a week ago (01/09) when it showed up on my neckline and my hands were swollen. Called the morning after and made an appt. for Wednesday (01/12). At doctors, had physical exam and blood test (all fell within normal parameters). With that she doubled my usual antihistamine medication and gave a new prescription for Pepcid. (01/14) Took Covid test of my own volition and it came back positive. Follow up to be scheduled in April. Was advised if it got worse to call and come back. Ongoing and has not recovered.
At time and the months up to March there was no local or systemic reaction to any of the Immunizations given on 12/19/08. On March 3 patient came to the office with s/sx of fatigue, abd pain,and jaundice. UA done showed 3 plus Bilirubin and 2 plus Urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG  antibody which may indicate a past infection-mono. Patient returned to the clinic with severe jaundice, Negative Hepatitis panel with abnormal Hepatic levels. Was consulted with Pediatric Infectious Disease Specialist, repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallblader wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 4/5/2009 and her hepatic functions and INR are continuing to be monitered.  This form is filled out at the request of physicians in the event the vaccines contributed to the illness. We can send copies of hospital visit and labs if needed. Dr. is calling this "seronegative hepatitis". 4/16/09-records received-for DOS 3/17-4/5/09-DC DX:DC DX: Liver failure.   Rash. Presented with sudden onset of emesis,l abdominal pain, diarrhea and jaundice 3 weeks  prior to admission. Developed erthematous pruritic papular rash.
Local injection site reaction: erythema, edema, pain.  4" x 3.5" Erythematous macular lesion @ L upper arm Firm/ edematous region: 3x 2.5" & superior portion of lesion
Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL.  Subsequently, she was vaccinated with her second dose of GARDASIL.  Subsequently, she developed a blister at the injection site.  Medical attention was sought.  The patient's outcome was unknown.  Follow-up information received 4-11-08 indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0608USA06941 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 09/14/06.
After 5 minutes of receiving vaccine patient stated that her lips were feeling numb, after another minute she stated her tongue was going numb, we called 911. I observed patient she stated her tongue felt dry and she was a little sweaty. The ambulance showed up and took her vitals, she appeared at that time to have no numbness and just a dry mouth. She did not leave by ambulance.
Injection site red, intense pain in shoulder, c/o headache 1 1/2 days, joint pain, sweating and general weakness.
slight fever (<100 degrees), chills, muscle pain, fatigue, sore arm took Tylenol and slept felt much better by next day
patient reports nausea sharp pain around eye, blurry vision, dizziness, night sweats, cramps in chest.
This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional (Nurse), concerns a patient of unspecified age and gender. This was 15th out of 31 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Site: Bruising at Injection Site-Mild, Additional Details: PATIENT EXPERIENCED BRUISING AT THE INJECTION SITE AND CAME IN THE PHARMACY. PT SPOKE TO STAFF MEMBER, HE SAID HE FEELS FINE, JUST BRUISING, NO PAIN AND IT'S IMPROVING, AND MOBILITY IS NORMAL.
Fever 100.1F on 12/30/20 13:20 s/p COVID-19 vaccine received on 12/28 @13:03. Acetaminophen 650mg oral liquid administered 12/30 13:30 and 18:42 with resolution of fever. Patient experienced fever 100.1F again on 12/31 @11:31 and refused Acetaminophen; fevers also may be attributed to patient's current abscess/cellulitis Fever & 100.1F ACETAMINOPHEN 650 MG ONCE X 2
as per notes of vaccinating nurse: 1:53pm 2nd vaccine, Pt mentioned she had swallowing and breathing issue at home after 1st dose. nurse asked Pt to stay f/30min post vaccine. RN educated Pt on anaphylaxis protocol care. RN reassured Pt to return to RN if breathing or swallowing issues occur. 225pm Pt returns to RN c/o tightness in neckand throat, problems swallowing and breathing. 911 called. epi administered. 3 min Pt states not better, 2nd epi administered. waited 2 min, 3rd epi administered.  245pm EMS arrived. 250pm Pt transported by EMS to hospital to higher level of care.
Chills; nausea; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2022 (Lot number: 33025bd) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Eic 1283), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Eic 5730), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 09Feb2022, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset 09Feb2022, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 09Feb2022, outcome "unknown", described as "fatigue". Therapeutic measures were taken as a result of chills, nausea, fatigue.  Additional information: The patient received Tylenol treatment for an AE. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Vomiting and diarrhea.  Resolved after less than 12 hours.
Severe migraines; nauseousness; diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient herself) via. A 65-year-old (non-pregnant) female patient received first dose of bnt162b2 (Solution for injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 10:00 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes and vascular disease. Concomitant medication included insulin for unspecified indication. Patient did not receive any vaccine in 4 weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 24Apr2021 at 01:00, patient experienced severe migraines, 6 total starting 40 hrs, nauseousness, diarrhea and body aches. The patient underwent lab tests and procedures which included computerised tomogram scan results of which was unknown. Therapeutic measures were taken as a result of the events and patient was treated with nauseous medication and Axert for migraines. Outcome of the events was not recovered.  No follow-up attempts are Possible. No further information is expected.
Fever up to 103 within 6 hrs, crying, screaming x 6-8 hrs inconsolable