chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; it was the bivalent vaccine and it was administered to a patient as a first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was reported.
This NICU nurse advised she was given her annual influenza vaccine on 9/13/2016 during shot-ex. She advised she was standing when vaccine given to upper portion of her left arm about 1-2 finger breaths below shoulder. She stated the site did bleed and required a band-aid. She returned to work and noted the site was sore for then next few days and began taking MOTRIN 800 mg orally. This eased the pain, but she advised pain worsened if no NSAIDs taken over next week. She advised over the last 10-12 days she has been having increasing difficulty dressing herself, lifting arm over head or at 90 degree angle, has difficulty lifting her purse due to weight or anything over 15 lbs. She denied any fever, site redness or swelling, trauma, recent travels or insect bites. ----10/6/16: this ICU nurse advised while on oral steroids (preferred oral vs IM) and using heat and oral MOTRIN her pain was markedly improved, though still present, she could use her arm and do mild ROM exercises. She completed her 5 day short burst on Sunday and over next 48 hours pain increased to point she could not lift arm over head to remove scrubs and she C/O pain with lifting/moving items over 10-15 lbs, especially with extension of her arm. MOTRIN is not controlling the pain any longer. She denies any weakness, paresthesia, numbness, discoloration to nail beds/skin, no stiffness in shoulder/elbow, no recent trauma or travels, no bug bites or past issues with her arm. Pain, unspecified.
Redness and swelling at vaccine site, vesicular cluster of lesions. Prednisone 20 mg Q AM x one week. Valacyclovir 1 gram tab TID x 1 week.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 26-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 86 year old female patient. On 20-DEC-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml , intradermal in the right forearm. There were no concomitant medications. Approximately on an unknown date in December 2013 the patient experienced some redness and swelling at the site of administration in the right forearm. The patient sought unspecified medical attention. The physician was called up for follow up. No treatment was provided. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
2-3 hours of inconsolable crying within 1 hour after administration of Prevnar, IPV, Rotateq, DTap, Hep B vaccines without fever, loss of consciousness, or seizure.
Information has been received from a certified medical assistant concerning an 83 yr old female with cardiac failure congestive, angina pectoris, hypertension, gout, wheezing, osteoarthritis, hypercholesterolemia, gastroesophageal reflux disease, hearing loss, vision loss, penicillin allergy, sulfonamide allergy, seafood allergy, iodine allergy and allergies to epinephrine, allumiu; diphenhydramine HC1 (Benadryl), acetaminophen (Tylenol), cortisone, hydroxyzine HC1 (Atarax), prednisone and sedicane who on 21Feb05 was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). Concomitant therapy included albuterol, levothyroxine Na (Synthroid), olmesartan medoxomil (Benicar), metoprolol, folic acid, colchicine, aspirin, furosemide and calcitriol. Within 24 hrs of the injection, the pt developed hives at the injection site and up her neck and face. The pt called the office regarding her experience and received unspecified medical attention. At the time of this report, the pt's hives persisted. Additional information has been requested.
Adacel and DTAP bottles look alike, no problems experienced by patient.  Patient did have to receive 2nd injection same day, 2nd injection was DTAP. Follow-up: Tdap was given instead of DTaP. The pt did return the same day and a DTaP was given.
pt recvd vax & exp blurred vision & devel blindness following vax w/Hep B;
fatigue and tiredness for about 30 hours very low grade fever 99.5 - 100.2
Redness, swelling, knot at site and warm to touch. Patient said has headache and sweating. 1 week after injection. Applied CORTIZONE to site and warm compress.
Initial information has been received from a female consumer concerning her 9 week old daughter with no pertinent medical history and no allergies who on 03-MAY-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 665162/1633Y). There was no concomitant medication. On 03-MAY-2010 the patient was reported to be very fatigued and cranky the day and night after the vaccination. The patient vomited which seemed severe for a couple of days. She was also constipated which progressed and got worse. She was screaming and crying trying to pass stools. On 13-MAY-2010 and 14-MAY-2010 it seemed that the constipation cleared up. Last night (17-MAY-2010), the patient had a mild form of constipation. Today, on 18-MAY-2010, the patient had red streaks in normal stools. It was reported that the patient was seen at the office on 06-MAY-2010 for the constipation and received DTAP.  The mother was unsure if her daughter receiving the DTAP made the constipation worse. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Additional information was received from a medical assistant who stated that the patient only received ROTATEQ on 03-MAY-2010 (because the mother didn't believe in vaccines"). She confirmed that the patient was not seen on 06-MAY-2010 for the constipation and DTAP administration, as reported by the mother. It was not until the mother called the office on 18-MAY-2010 that the staff learned of some of these events. Upon internal review, red streak in normal stool was determined to be other important medical event. Additional information is not expected.
nausea; Body pain; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558).  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 55 years 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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "Body pain".  No follow-up attempts are possible. No further information is expected.
patient stated while in process of getting second shot. He had experienced an occasional heart flutter but he was also under quite a bit of stress the last 3 weeks also. he got his second shot today.
This spontaneous report was received from a pharmacist and refers to a 15 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 26-OCT-2017, the patient was vaccinated with a dose of VARIVAX for regular routine vaccination (strength, dose, route, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). It was reported that the VARIVAX dose got on the patient's leg while it was being administered. On an unknown date in October 2017, the patient developed a rash on the back of both of her hands and on her face under her eyes (rash) and on the bottom of lip (cheilitis). The pharmacist reported that "the patient had no fever and felt fine."  The patient did not seek medical attention and did not received treatment for the events, the events did not cause significant disability or incapacity, the patient did not required hospitalization and the events were not life threatening events. The outcome of cheilitis and rash was reported as recovering/resolving.  The causality between cheilitis and rash with VARIVAX was not reported.
Vaccine breakthrough disease that resulted in death.  The individual died on 09/28/2021; positive COVID-19 test was from nearly about a month prior on 08/27/2021. However, COVID-19 is listed on the death certificate cause of death. The individual was interviewed prior to passing away and had symptoms of fever, loss of taste/smell, shortness of breath, chills, cough, fatigue, and runny nose.   The individual was hospitalized 08/27/2021-08/29/2021 for the COVID-19 symptoms, and then had a later hospitalization 09/14/2021 until his death on 09/28/2021. The primary reason for this later hospitalization seems to be joint issues/pain that resulted in a toe amputation.   Death certificate details: Part I Cause of Death A: Respiratory Failure B: Acute Respiratory Distress Syndrome C: COVID 19 Part II Other Significant Conditions: None Listed
Confusion, Headache, Myalgia, Arthralgia, lasted 4 days Narrative:
Extreme pain 4 hrs at site post injection with redness, 102-103 fevers next 48-72 hrs back pain, joint pains, diarrhea, severe headache not recovered yet, same rxn as 4 years ago but was forced to get flu shot against wishes.
After administration of pediatric pfizer-biontech vaccine, patient felt extreme fatigue within five minutes of the vaccination and started to close her eyes.  Mom said she was breathing fine, there was no sign of rash, redness.  We called paramedics to the scene just in case.
Within 12 hours of vaccines, temp 104F and febrile seizure. Seen in ER. Not admitted. Examined on 05/02/05 and had normal exam.
Pt received Pfizer for dose 1 of the series on 6/28/21 in the left arm. Lot EW0217. Today, my medical assistant made an error and gave Moderna instead of Pfizer for dose #2
pt recv vax & a few days p/vax felt not himself & exp insomnia;devel possible herpes zoster infect
Approximately 3-4 hours after getting his 3rd Moderna vaccine he developed headache, fatigue, muscle cramps, worsening back pain and cough x 6 days.
Client passed out. Lost consciousness for approximately 5 seconds. Nurse helped to lying position and put feet up above heart. Prepared to give Epi. No Epi given. Client came around and stated "I'm a fainter".
6 days later, developed urticarial rash entire body.  favor delayed reaction to vaccine- urticaria multiforme type reaction
An incorrect DOB was provided for the individual receiving the vaccine in the presence of an adult who claimed to be the legal guardian.
Patient was given vaccinations in clinic on 11/21/2018. On 11/22/2018 patient found red region under her BAND-AID on the back of her left arm. Over the course of yesterday (11/22/2018) and today (11/23/2018) the rash grew in size. Region is a little pruritic. Reaction size 5 cm x 3 cm. No fever. Patient reports that she does not feel sick in any way. Patient reports that she has had 5 prior Varicella Vaccinations without any reactions in the past. Our clinic only has record of 2 of those vaccinations given. She has had same problem with MMR. Patient will continue to monitor and call if symptoms worsen.
I experienced shortness of breathe and immediately went to the ER from Urgent Care (blood pressure was extremely high) and the doctor diagnosed me with  pleural effusion (fluid under the lungs). I was given aspirin and Imolamine blood pressure medication since the doctors suspected that it was related to heart issues. The Cardiologist ordered a series of tests to find out what was causing my symptoms. I still experience periods of shortness of breathe.
Information has been received from a physician referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 02-MAR-2016 the patient was vaccinated with PROQUAD (Merck) (strength, lot#, expiration date, dose and route were unknown). Other suspect therapy included VARIVAX (Merck) (strength, lot#, expiration date, dose and route were unknown) which was vaccinated on the same day. No adverse events were reported. Additional information has been requested.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 21 months old male patient who was inadvertently vaccinated with an expired dose of PENTACEL (DTaP portion lot number: C5262AA, expiry date: 18-Dec-2018, ACT-HIB portion lot number: C5456AA, expiry date: 18-Dec-2018, via intramuscular route in unknown administration site on 18-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PVC 13) for Immunisation. It is an actual medication error case due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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.
Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and oriented x4. Had pt lay done supine and observed for an extra 15 minutes. Pt felt fine and symptoms resolved. Left with father feeling better
about 10 days after 2nd dose of pfizer covid vaccine developed a headache and sore scratchy throat that persists advised evaluation .
This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date on or before 18 December 2006, the subject received the 3rd dose of Pediarix. At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Pediarix. Follow-up information was received on 13 April 2007. Concurrent conditions included otitis media with onset of 12 December 2006. Previous and/or concurrent vaccinations included pneumococcal vaccine, unspecified, intramuscular given on 11 December 2006. The subject experienced pain, fever, and crying on 11 December 2006. The events resolved on an unknown date. The reporting healthcare professional indicated that she did not consider the events as serious, but thought they jeopardized the subject or required intervention. The immunization series with Pediarix was not re-introduced, discontinued, or delayed. The subject did not experience any adverse events following previous vaccinations. The healthcare professional considered the events were possibly related to vaccination with Pediarix and believed that the DTaP components of Pediarix caused the events.
Nausea; Weakness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 86 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 (Lot number: EN5318) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IgG Kappa monoclonal protein" (unspecified if ongoing), notes: years ago; "Gastritis" (ongoing); "HTN" (ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastritis (ongoing); AMLODIPINE BENAZEPRIL taken for hypertension (ongoing); HCTZ taken for hypertension (ongoing); METOPAR taken for hypertension (ongoing). The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "recovering", described as "Nausea"; ASTHENIA (non-serious) with onset 15Mar2021, outcome "recovering", described as "Weakness"; FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", described as "Fatigue". The events "nausea", "weakness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of nausea, asthenia, fatigue.  Additional information: No Prior vaccination (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
pt recv vax 6OCT96 & 16DEC96 pt exp chills, fever, cough & h/a;pt was examined by MD who dx pt w/resp flu;pt was prescribed an ATB, an inhaler, & a cough syrup;pt med hx is remarkable for triple bypass surgery in APR93 & arthritis;
Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia). At the time of the report, INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Arm pain, nausea, vertigo, extreme fatigue, fever (8 hours post vax, lasting 5 hours). Chills at same time as fever. Metallic taste in mouth day following immunization. Abnormal menstrual cycle (heavier, cramping), and shorter ovulation (only 9 days post- period start, versus usual 12).  Swollen lymph nodes under arms. Brain fog (constant for two weeks following vaccine).
One week after my first vaccine shot I took Alavert for my allergies and developed a severe fever. I had chills and could not get warm in my apartment that was 79 degrees. I was drowsy and slept and had little energy for two days.  This happened again when I took Alavert on 8/27.  I have taken Alavert since I was a child and never experienced these symptoms before. There have been no changes in diet or lifestyle or environment. The only change is my COVID vaccine shot. I had COVID in November 2020, so I did experience 3 days of mild side effects from the vaccine, including aches, sore arm, and fatigue.
patient had hives several minutes after vaccine adminstration  Benadryl given to patient by RN
10/28/09 - rec'd Intranasal vaccine. On 10/29/09 lost sense of smell and taste, no treatment, fluid R ear. Taking decongestant. 11/11/09 - saw PCP. Taste improved, smell still decreased.
At 10 pm pt. started feeling unwell so he went to lie down. About 10 minutes later he had chills, body aches and was shaking.  After a couple of hours he started feeling hot and flushed but did not have a fever.  He had body aches and  a headache.  At 4am he went to the bathroom and started feeling faint so he tried to go back to his bed but fainted in the bathroom.  His Mom helped him back to his bedroom, he had no injuries just a headache at that time.  He stayed in bed until approx. 5pm when he felt better.  No other injuries, or doctor visits.
Two weeks post vax, the pt experienced a hot sensation on the sole of her left foot and a cold sensation on the top of her right foot.
Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient.  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included asthma.  The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 week after vaccine given, swelling, rash, and itching  occurred at injection site.
Pt. reports developed rash on 7/20/14 still present 7/23/14 when seen in clinic. (+) itchiness, no fever no h/a. Rash presents mainly on chest/abdomen few spots on back. No present extremities or lower body. Given MEDROL dose pack and instructed to get hydrocortisone 1% cream OTC to help with itchiness. Spoke with pt. on 7/24/14 after treatment. Reports rash has improved.
PATIENT COMPLAINED OF SWOLLEN LEFT ARM AND PAIN AT THE SITE OF THE INJECTION.
allergic reaction (hives, no cough, fever, or sore throat, just hives)
I had a fever. I developed what I thought was a UTI. I had pain in my left side and kidney. I went to the doctor about this. They did a urine culture, negative for a UTI. I had serve pelvic pain. They gave me antibiotics for it, which is not helping. So they are doing a CT scan tomorrow for it.