chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was administered ACTHIB that was reconstituted with expired diluent, with no reported adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves a 16-month-old and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with expired diluent, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (batch lot: UJ604AA) (expiry date: 31-Mar-2023) (strength: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of was administered ACT-HIB that was reconstituted with expired diluent, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown.    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 the guidelines. 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.
Redness, edema, sm induration at injection site. Arthralgia throughout body.
Pt developed diarrhea, nausea, vomiting, dizziness and diaphoresis, pallor
FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210843019. This report was associated with product quality complaint: 90000209879.
Woke up the next morning and I had very intense pain in what felt like my rib cage, and all the way around, and it was hard to breathe. That lasted about 3 weeks, it became less intense over time, but it was quite intense for 3 or 4 days. I had a generalized fatigue, very dramatic, the kind where you want to lay down on the side walk, which I have continued to have periodically. I used to wake up early, but now I just want to sleep most of the time. I sleep through the night, which I used to never do, and sleep in more. I have been unable to maintain a normal schedule. It took me about 3 weeks to get over the most intense of the side effects. I didn't have pain at the injection site until the 3 week and one day mark. It was so bad, I just wanted my arm OFF. It was unbearable, I couldn't concentrate on anything else. That lasted about half a day, then went away. I also, through this whole time, developed diarrhea. That didn't go away for about 4 months. I can't remember when it started but I also had a bad rash on my scalp and across my torso for about 3 weeks, I think it started about a week after the dose. I had a headache the whole time, but it got really bad about 3 months and 2 days after the vaccine. Horrific headache, and then the next day its like everything broke, and I finally felt much better. However, I have continued to have problems with headaches. It was just one thing after another. Difficulty breathing, joint pain, intense fatigue, nausea, weight loss. I previously had fatigue and migraines from a bad vaccine reaction in 2005, that I took medication for and resolved, and it felt like this vaccination retriggered it. Doctor and neurologists did do a lot of blood work, and some physical therapy with neurologist but wasn't sure if it was related. He mostly helped treat the headache and nausea.
Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 in the past. Subsequently the patient experienced a "reaction" from PNEUMOVAX 23. The nurse did not have much information and did not wish to participate in the AE reporting at this time. Additional information has been requested.
Rt arm swollen, hot and red. Mom states pt c/o of hurting and could not lift her arm very far. Went to the ER.
The nurse states PROQUAD and VARIVAX was administered to the patient instead of MMR II and VARIVAX; The nurse states PROQUAD and VARIVAX was administered to the patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse practitioner, referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-FEB-2022, the patient received therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U022726, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U020239, expiration date: 28-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). She received those medications instead of Measles and Mumps Virus Vaccine, Live (M-M-R-II) with varicella virus vaccine live (oka/merck) (VARIVAX)(accidental overdose and wrong product administered).
sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), in left arm and on 24Mar2021 as dose 2, single (Lot number: EL3248) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Celiac Disease", start date: Apr2019 (ongoing); "Factor V Leiden" (ongoing); "Anxiety" (unspecified if ongoing), notes: Concomitant Drugs: , Drug name: Fluvoxamine, Reason for use: Anxiety. Concomitant medication(s) included: FLUVOXAMINE oral taken for anxiety, start date: 2021 (ongoing). The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Patient taken 3rd dose on 16Nov2021. Patient received vaccine in workplace clinic facility. Patient had not administered vaccine at Military facility.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200793384 same patient, 3 dose case;
Patient said she had a sore throat on the second day (11 PM) after the first dose. It lasted a few hours only.
received an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX769AA, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The patient received an expired dose of Bexsero. The reporter consented to follow up.   Follow-up received from Nurse on 12th July 2021 as follows: VAERS details were captured. No further details provided.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # L038669 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. Additional information has been requested.
BREAST PAIN, LYMPH SWELLING, ASTHMA PER PATIENT.. NO OTHER INFORMATION KNOWN AT THIS TIME
NEUROLOGICAL SYMPTOMS, NUMBNESS/TINGLING IN BILATERAL ARMS & LEGS. DIZZINESS & HEADACHES
VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of VAQTA (lot # K005323 with expiry date: 10-FEB-2017, lot # J000985 with expiry date: 20-AUG-2015 and lot # J011712 with expiry date: 21-SEP-2015, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Nov 3, 2008, shot given Nov 4 & 5 sore arm, "went away".  Nov 8 & 9 am sore arm around injection site.  Reports some tingling left arm shoulder to elbow posteriorly & occasional tingling to left pinky finger.  Pain aggravated with reaching, pushing, lifting (high up).  Painful at night-wakes him up.  TYLENOL is without relief.
hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Eyes feel a little heavy; Felt warm, his temperature was 99F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F). At the time of the report, ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2016US031955, is an initial spontaneous report received from a pharmacist on 05 Dec 2016. This report refers to a 66 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 04 Dec 2016. It was reported that, reporter did not think safety needle was locked to the syringe, some of the vaccine leaked on the patient's arm. Pharmacist did not think, syringe that had a problem, it was a safety needle that we used. No product complaint with syringe. No adverse event was reported following this medication errors (underdose and wrong technique in product usage process).
Pt received first dose of SHINGRIX vaccine 2/8/18, unclear how pt tolerated that dose. Second SHINGRIX shingles vaccine on May 2. He reports that following the administration of that vaccine, he developed joint pains that spread to all my joints. He states that the pain was mild at first, then increased over the following two days to the point where it was 10/10 at times. He reports most pain in shoulders and knees, though reports pain in hands, elbows, and ankles as well. He states that pain was so bad overnight that he could not sleep, prompting him to call 911. Pt diagnosed with gout and pseudogout flare, evidenced by warm, tender swollen knee. (L) knee was tapped and synovial fluid noted few intracellular CPPD crystals. Rare intra and extracellular monosodium urate crystals. Patient given prednisone 40mg x1, with improvement in symptoms the next morning. Acetaminophen 650 mg prn.
10-3-07 resident received pneumonia and flu vaccine. There was erythema, induration and elevated temp. 1:20 AM resident sent to ER. Pneumonia and flu vaccine combined in same injection.
Prolonged irregular menstrual cycle; Prolonged irregular menstrual cycle; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 at 15:30 (Lot number: FC3184) at the age of 33 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: known allergies: Amoxicillin; Clindamycin, reaction(s): "Drug allergy", notes: known allergies: Clindamycin and Tegretol, reaction(s): "Drug allergy", notes: known allergies: Tegretol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FC3181; Anatomical site: left arm; Route of administration: unspecified), administration date: 15Sep2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: OLIGOMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 07Oct2021, outcome "not recovered", and all described as "Prolonged irregular menstrual cycle". The event "Prolonged irregular menstrual cycle" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oligomenorrhoea and menstruation irregular.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Nov2021, the patient underwent SARS-COV-2 test (Sofia) by test type nasal swab and the result was negative.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. On unknown dates the patients were vaccinated with GARDASIL (0.5 ml, lot# and expiration date were unknown) intramuscularly which underwent a temperature excursion. No adverse events were reported. Additional information has been requested.
Blacked out, severe weakness, felt like blood clots in legs,dizziness, faint feelings, fatigue, Bad heart palpitations, Serious Arrhythmias,  Treatment took aspirin, Heart Dr increase atenolol, the Heart Rhythm specialist wants to do an ablation.
I now have a mass on my left breast that seems to have ?grown? very quickly. I will be scheduled for a biopsy soon.
Heart Rate in 130's, short of breath, pulse ox 92-93%,  low grade fever (99.9-100.5), chills, generalized body aches & cramping, frontal migraine.  Fever seemed to occur in early morning (about 01:00 am). By 04:30 am, all of the other listed symptoms were present.  Treatment was related to symptom management; 1L of water, Tylenol Cold & Sinus Severe (acetaminophen, phenylephrine, guaifenesin), and sleep.
Feeling pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Feeling pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Acetaminophen.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
A week after the first dose on March 8, 2021, I spotted..  menstrually.  I am almost 52 years old and haven't had any menstrual activity for several years.  Exactly one month to the day after my second dose on March 29, 2021, I have started menstruating.   Again.  almost 52 years old.  OLD.  This is annoying.  Oh, I also have an IUD.  Well, I think I do.  It could have jumped ship with this activity.
Inconsolable fussiness + crying immediately after vaccines. Given continued for 6 hours. Crying + fussiness subsided after given ibuprofen. Acetaminophen did not help. No fever.
Fever, Chills, severe body aches, sleepiness, arm soreness at injection site for about 40 hrs.
body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches) and PYREXIA (fever). The patient was treated with IBUPROFEN for Fever and Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches) and PYREXIA (fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-020094 (Patient Link).   Reporter did not allow further contact
Information was received from a medical assistant who stated that multiple temperature excursions involving the PNEUMOVAX23 (lot # J010396, expiration date 16-FEB-2015) took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of PNEUMOVAX23 (lot # J010396, expiration date 16-FEB-2015) were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). No adverse effects reported. Additional information has been requested.