chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of vaccine products; revaccination with different covid19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.   This case was linked to MOD-2022-624689 (Patient Link).
two pediatric doses were maladministered as 1 dose to an adult patient; an expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 41-year-old female patient who received HBV (Engerix B pediatric) (expiry date 24-APR-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (expiry date 24-APR-2023) for prophylaxis.   On 17-MAY-2023, the patient received Engerix B pediatric and Engerix B pediatric. On 17-MAY-2023, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: two pediatric doses were maladministered as 1 dose to an adult patient) and expired vaccine used (Verbatim: an expired dose of Engerix-B was administered to a patient). The outcome of the adult use of a child product and expired vaccine used were unknown.   Additional Information: GSK receipt date: 31-May-2023 The vaccine dose administered were two pediatric doses with same expiration date but no lot number reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. An adult patient received two pediatric dose as 1 dose on the same day to complete the volume for 1 adult dose after expiration date, which led to expired vaccine used and adult use of a child product.
This spontaneous report was received from a medical assistant referring to an adult male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JUN-2018, the patient was vaccinated with RECOMBIVAX HB lot number M023718 and expiration date of 09-AUG-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
12 hours after receiving the vaccine, I experienced cold chills, fever, high heart rate, dizziness, followed by generalized joint pain, and localized pain at the vaccination site, that lasted 18 hours
Pt received Pfizer 1st dose 08/06/2021 and on 08/10/2021 pt started feeling chest tightness that radiated up her thraot and had the feeling of being swollen. Pt started a slight cough and felt out of breath,but could still breath. The symptoms stayed with pt the rest of the day and has been on and off ever since,but on with exertion.
Per pt she called her Dr since on her arm it got red & a little swollen. On her chest region were little red dots like an allergic reaction.  Pt was suggested to take Benadryl also & she said she was fine.
One month after Moderna booster, her smart watch vibrated and reported that she was having an Atrial Fibrillation. Her PCP referred her to a Cardiologist. Cardiologist performed an echocardiogram and had her wear a monitor for 2 weeks. Echocardiogram diagnosed her with Atrial Fibrillation. Prescribed Eliquis (blood thinner). Seems to be helping.
runny nose; itchy eyes; fever; body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body pain) and PYREXIA (fever). On 19-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and EYE PRURITUS (itchy eyes). On 16-Apr-2021, PAIN (body pain) and PYREXIA (fever) had resolved. At the time of the report, RHINORRHOEA (runny nose) and EYE PRURITUS (itchy eyes) outcome was unknown.            Treatment information not reported. No concomitant medications reported.   Reporter did not allow further contact
s/sx started 8/13/21, hospitalized 8/16/21 with increased shortness of breath, home oxygen requirements increased from 1L to 3-4L.
On morning of 12/24/19, patient received an intramuscular injection of PC vaccine. On evening of day 1 (12/24/19), patient began crying and screaming at the slightest of noises. She became increasingly hyper-sensitive to sounds. Being bothered by sounds and the extreme fussiness (extreme for her) lasted until 12/28. Also occurring on evening of 12/24/19, patient developed a quarter sized welt on her left thigh, consistent with that of what was described on our pediatrician?s website as a ?common reaction ? to the PC vaccine. However, on the mornings and evenings that followed, the welt and an associated rash grew significantly larger than the 3? size where, according to the pediatrician office website a phone call should be made within 24 hours. The welt was hard as a rock, bright red, hot to the touch, and quite painful for patient. Documentation pictures were taken during this time. An email was sent on the evening of 12/25/19 followed by a phone call on morning of 12/26/19 to the pediatrician office. The receptionist stated she?s received the email and would review the concern with the pediatrician who was filling in for Dr. He informed her to tell me this reaction was still considered ?normal? despite my protest of it being MUCH larger than what was considered ?normal? on their website. I asked if I could send him the pictures to prove to him this wasn?t ?normal? and she said it wasn?t necessary, that he believed what I was describing to be ?normal?. I asked if we needed to be seen (their website suggests that with a 3? or larger reaction site, a phone call should be made within 24 hours), and they simply brushed it off saying, ?only if she begins to have trouble breathing.? They basically refused to admit this was a reaction!!  On 12/25, 12/26, 12/27, and 12/28, I applied a thick paste of bentonite clay directly to the reaction site twice per day, covered it with a cool wet washcloth and encouraged patient to allow it to stay on the site for 20 minutes each time. I never received a follow up call about if the injection site healed up. There still remains a small knot on her thigh where the injection site was, and as of 1/8/20 there is the faintest hint of a rash where the welt had been. With one more treatment of bentonite clay, the rash seems to be going away.
11/15/2023 I started to get pains in the center of my chest while I was walking. I rested and it resolved. It happened again the next day and continued. I had to stop my cardiovascular exercising. I contacted my doctor and he set me up for a pulmonary function test. I also had a stress test. I have not seen the cardiologist yet to get the results. I have not started my exercise program again, so it has not happened.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 9:10am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient did not respond to attempts to contact. No adverse side effects or event as result of dose reported.
This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unkonwn date the patient was vaccinated with GARDASIL, intramuscular, (strength, dosage, frequency, lot# were not reported). Concomitant therapy was not reported. The nurse practitioner informed that on an unknown date, the patient inadvertently received four doses of GARDASIL. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Dtap/IPV was given, Can they give the ActHIB part as a seperate injection.; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old female patient who received only DTap/IPV part of the vaccine Pentacel DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , Pentacel- Lot number UI954AAA, Dtap IPV Lot number U6138AB, ActHIB- Lot number UI954AA (Expiry date 30-Jun-2020) on 12-Jun-2018.  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 inappropriate reconstitution technique. (It was reported that DTap/IPV part of the Pentacel to a patient. She does not have the corresponding IPV vial anymore)  At a time of reporting no adverse event reported.  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.  Documents held by sender: none.
Rash covering all of trunk, mouth, ears 10:30am. Spread down arms by 1pm
Information has been received from a physician concerning a 17 week old male who on 20-JUN-2008 was vaccinated PO with the first dose of ROTATEQ. It was reported that on 18-JUL-2008, the patient went back in to the physician's office with bloody diarrhea and stomach pain. The patient was sent to the emergency room for a work up, and from the results of the work-up the patient was diagnosed with intussusception. The physician at the emergency room tried to give the patient an enema but that "did not work". The patient was hospitalized and had surgery "to clear up the intussusception" (dates not reported). The physician stated the patient recovered (date not reported) and the patient has received the second dose of ROTATEQ (date not reported). The reporter considered intussusception to be an other important medical event, disabling and life-threatening. Additional information has been requested. 11/11/08-records received for DOS 7/20-7/22/08-DC DX: Intussusception. Presented to ED with bloody bowel movement 36 prior to admission. Vomiting throughout the day, became bilious 8 prior to ED visit.PE: distended abdomen with mild tenderness, mass in right lower side and hypoactive bowel sounds. Open reduction of intussusception with appendectomy.
01/05/22 presents to ED for "palpitations". PMHx of "anemia, arthritis, blood in stool, cervical spinal stenosis" "hypertension".
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Thought to be allergic reaction to something. Extreme runny nose, swollen eyes, extreme fatigue. Gave Benedryl and child went to bed (at 5:30 pm). Major restlessness, sleeplessness, verbal tics and outbursts and negative behavior ensued for the next 10 days. Extreme sensitivity to stress and stimulation continues.
Patient developed a rash/area of warmth in a streaky red pattern down his arm. Rash was warm to the touch. Painful and swollen. Patient had no fever, no nausea or vomiting. At injection site there was a raised pustule left arm.
Chills, 104 degree fever, body aches, headache, fatigue, injection site pain.
the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be; the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be; It was like a little shot or something kind of going through the muscle or within it goes from where I got my injection up to my shoulder and like over my clavicle at my neck into the earlobe; This is a spontaneous report from a contactable other hcp. A  patient received bnt162b2 (CONMINTARY, Solution for injection, Lot No# EW0172), via intramuscular, administered in Arm Left on 05May2021 as 2nd dose, single for covid-19 immunisation. Medical history included hypertension since patient was  (ongoing), sinus node dysfunction from an unknown date and unknown if ongoing. The patient stated she did have a pacemaker and had then checked the pacemaker because she wanted to make sure this wasn't anything related to pacemaker. Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On 06May2021, the patient experienced event which she described as "the muscle in my neck on the site where I got my shot was extremely tight, it was just this tight and painful as to be" and "It was like a little shot or something kind of going through the muscle or within it goes from where I got my injection up to my shoulder and like over my clavicle at my neck into the earlobe". Outcome of the events was reported as not recovered.    Follow-up attempts are possible. Further information is expected.
Client had sat for at least 10 minutes after administration of the Tdap and Gardasil4 but after leaving the room he was exiting building when he became dizzy and disoriented.  His Step-father got him seated and called for assistance.  Same nurse responded.  Client had circumoral and nasal pallor and appeared sleepy but did not lose consciousness.  He was offered sips of water and his condition and color improved in 3-5 minutes.  He then admitted that he had not eaten much lunch at school that day and step-father said he had also not had his usual after-school snack.  It was also a very hot day in the school and he had not drunk much water.  When he was steady to stand, this nurse walked to car with him with step-dad on the other side.  He was steady on his feet by that time.
something stuck in his throat but he coughed it up; coughing a little but that is really it; This is a spontaneous report from a non-contactable consumer (patient's wife).  A male patient (reporter husband) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 22Apr2021 (on Thursday) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The wife stated that, on 25Apr2021, her husband experienced that something stuck in his throat but he coughed it up and coughing was a little but that was really it. As per patient, he was alright, and it was fine and that he did not feel no type of way. She stated she was trying to see if that was covid or a side effect. She said he might not even have a cough it might had just been one time. The outcome of the events was unknown, at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
05/26/2006 (Td) left arm became swollen and bruised appearance and discoloration, swelling is now present.  Right arm (PPV) arm is constantly hurting and also following the vaccines my hands and fingers started hurting and stiffening, I have never felt this before. Constant pain and discomfort.
Patient reported chest pain and tingling/numbness to face. HR 60 Respirations 18. Monitored and chest pain resolved - did have evaluated n Emergency Room and was discharged home and advised to return if symptoms worsen. 12/29/2020 spoke with patient and feeling good, no symptoms at all.
Arm became swollen and red.  It had a large hard area that was approx. 4" by 4" in size.  It was hot and itchy.
10 days after the date of vaccination, the injection site to the right gluteal region became hot, itchy, and started to tingle. Petechiae noted approximately 2-2.5 inches all around injection site. Large, firm "knot" developed under the area.  On day 12 following the injection, the petechiae faded and left a large bruise over the area. The large, firm "knot" area started to decrease.
Patient RETURNED to pharmacy on 08/06/2021 (Friday) concerning reaction to MODERNA IMZ.  Patient received MODERNA IMZ on 07/30/2021 (Friday). PT indicates on Tuesday (08/03/2021), he noticed swelling starting under his right armpit. It started out small and has grown larger. At its current state, the swelling is appears to be 1.5 to 2 inches in diameter and raised approximately half an inch. Swelling appears to be sub-dermal. Skin color appears normal and matches surrounding area; does not appear red. Swelling is located under the lower right armpit where the hairline ends.  Patient states he had pain in the beginning, however, the pain has subsided. States pain is only minor to an almost unnoticeable intermittent ache.  Patient indicates no fever at any time. States no other swelling. States no other obvious signs of reaction. Indicates mild diarrhea that started today, however, states he did change his dietary routine recently and suspects that could be a contributing factor. Patient indicates no difficulty breathing.
Information has been received from a physician concerning a 60 year old female patient with atopic eczema and sulfonamide allergy who on 25-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included montelukast sodium (MSD), ALLEGRA and ADVAIR. On the night of 27-NOV-2008 the patient experienced eczema, draining of her ear, vesicles on her face, ear and neck. The patient was being treated with cephalexin, gentamicin eye drops and prednicarbate. The patient sought unspecified medical attention. At the time of the report the patient was not recovered. Worsening of eczema, draining of her ear, and vesicles on her face, ear and neck were considered to be disabling. Additional information has been requested.
Rash on face. After seeing the dermatologist and receiving shot of Kanalog it cleared up considerably.. I still break out in red blotches but not as bad as initial reaction
This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in the left arm on 26Mar2021 at the age of 49-years-old as single dose for COVID-19 immunization. The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and had no known allergies. The patient had no other vaccine in four weeks. Concomitant medication included ergocalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported (medication in 2 weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6202), administered in the left arm on 05Mar2021 at 10:00 AM at the age of 49-years-old for COVID-19 immunization. On 09Apr2021, the patient got her period 2 weeks early and she was bleeding very heavy and passing clots about 3 inches around in size. This has never happened to her in her life. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was not recovered.
Longer and intermittent menstruation Change in discharge blood color PMS intense headaches pain in breasts and pelvic area
Area of erythema and swelling injection site (L) thigh progressively lame 48 hrs. Dx vaccine reaction vs. cellulitis. Rx Orapred, Keflex, Septa.
Has/have chicken pox crusted lesions on back, stomach, chest, thighs, arms, legs, scalp.
Severe headache, could not function, by July 7th developed seizures and put in medically induced coma at medical center developed saddle blood clot. Was hospitalized until August 10, 2018. Still on seizure medication and blood thinners.
5 days post vax, the pt experienced a reash from the neck down, with pruritus.
On arm that was injected with Moderna vaccine:  red rash, itching, and swollen arm.
My son became disoriented, and disillusioned. He did not make eye contact, and would not respond to the sound of my voice. He stared off toward the right, and would gaze for long periods at the ceiling. He appeared "high" and would continuously smile while dazing off in the opposite direction. He also had a difficult time staying awake. It is two days later and he is slowly starting to get back to his typical personality. He still seems disoriented at times.
Could not lift arm more than 5 inches from side. Fever 99.8. Muscle pain. Joint Pain. Heart Palpitations. Sunburn feeling on skin. Hives on torso.