chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improvement in cognitive function/ improvement in memory function; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function) in a 92-year-old male patient 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improvement in cognitive function/ improvement in memory function) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.  Patient received both the doses of Moderna vaccine and almost one week later showed improvement in cognitive function and with memory as well.
Decreased breastmilk supply in left breast the side of the vaccine occurred 3 days after each vaccine and is still on going
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well). At the time of the report, ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) had not resolved and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) outcome was unknown. Not Provided. Concomitant medication was not reported. It was reported that as per the medical history patient did check with her doctor first and the doctor felt that it was better to get the shot than not. Treatment medication was not reported. This case was linked to MOD-2022-529920, MOD-2022-529893 (Patient Link).
Received call from coroner 10/17/13 that the patient had "died in the morning".
Patient developed sudden SOB 1 week after she received #1 COVID vaccine  on 1/28/2021 w/o associated chest pain/palpitation/cough. Her SOB was significant enough for her to seek Urgent evaluation on 2/8 then ED evaluation on 2/11 then again on 2/20/2021. she continues to have SOB/DOE even now.  She also has dizziness intermittently.  she had chills initially but no fever until she had transient fever for less than 12 hours 2.5 weeks later likely associated w/ unrelated problem( UTI).  so far no causes found regarding her SOB after numerous tests( see below for tests).
Pt felt tingling in arm where shot was received which spread to bilateral hands & then to feet. Vitals were taken & were stable. IM benadryl was administered at 1034 in the pt's left arm. Vitals were repeated & continued to be stable. Pt reported feeling better after the benadryl administration - no more tingling anywhere.
pain in the arm; headache; a lot of sneezing; I think I have flu; a lot of snot; a lot of cough; body ache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and VACCINATION SITE PAIN (pain in the arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (very tired) and MYALGIA (body ache). On 03-May-2021, the patient experienced SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough), VACCINATION SITE PAIN (pain in the arm), FATIGUE (very tired), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included medication for blood pressure, cholesterol and medication used for sleep. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Patient immediately reacted with fierce crying and signs of Discolored Leg Syndrome as both LE developed a flat, blotchy, purple discoloration. Patient was able to be consoled by parents, fell asleep in parents arms and discoloration resolved within 10-15 min. Patient did not exhibit any additional adverse reactions at the time or within 48 hours of vaccination.
This spontaneous report as received from a pharmacist refers to a 33 years old female patient with no medical history and no drug allergies. On 30-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # was unknown). Concomitant therapies included VITAFOL ULTRA, SYNTHROID and folic acid. The patient was currently breastfeeding. No adverse effect reported. No lab was performed. AE did not given the treatment. The outcome of events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Adverse event: Rash on upper-left arm. Rash was itchy, red, and hot to the touch. Rash spread to right arm, then to right calf, then left calf.   Treatment: During the time it was spreading, I made an online doctor?s appointment to get it checked out. Doctor told me to take Claritin and prescribed steroids for if the rash didn?t go away with the Claritin.   Outcome: Claritin turned out to be enough, rash went completely away within 2-3 hours of taking it. Steroids were not needed.
hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hives are worse; first dose on 21Dec2021, second dose on 08Jan2021; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (Lot: EL3246), via an unspecified route of administration in right arm on 08Jan2021 08:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included meloxicam. The patient previously received the first dose of BNT162b2 (Lot: EK5730), at the age of 58-year-old, via an unspecified route of administration in right arm on 21Dec2020 at single dose for covid-19 immunization. She is not allergic to anything at all. She got the 2nd shot on Friday (08Jan2021) 8:45 and then on Sunday (10Jan2021) she had hives from head to toe. She has not tried anything new, no food, products, or detergents. She has no hives at the injection site. Her Hives are on her ears, lips, neck, going all the way down to her toes. At 4 o'clock on 10Jan2021 if when the hives began and by 6 the hives had exploded. Her Hives are worse now. She has had No Positive tests for Covid prior to the vaccine. She has had no antibody test prior to the vaccine. She has had No issues with vaccines in the past. She is using Benadryl to treat her Hives, however it puts her to sleep in 30 minutes and so she cant do that at work. The patient received the first dose on 21Dec2021, second dose on 08Jan2021. The outcome of the event hives was not recovered.
Left thigh was red, swollen, and hot to the touch. Rash on chest, back, and right side of face. Loss of consciousness and gasping for air. Fever of 99.6. Xrays were taken at the hospital of soft tissue neck to confirm swelling of throat, subsided in a few hours. Symptoms came on about 4 hours after vaccines given. Pt was observed with monitors overnight in hospital. 8/20/07-records received for DOS 7/27/07-seen in ED-per parent patient has had nasal discharge for 1 week, difficulty breathing enroute to ED with increased noise of breathing now resolved. Has had skin rash. No fever, cough, vomiting or diarrhea. PE: WNL-skin mild erythematous, tender, macular skin rash with an erythematous base located on trunk abdomen, right leg and left leg. Clinical Impression:Skin rash. Dyspnea.
About 20 minutes post injection, tongue began to swell, throat felt dry, hot, and itchy, and had a hard time swallowing.
Swollen lymph nodes to neck, arm pit, breast, abdomen and groin started 7 days after vaccination  lasting for2 weeks Short duration of diarrhea and fatigue lasting for 24 hours. Varicose vein burst 13 days after vaccine. After 2nd vaccination I experienced tachycardia and chest tightness 5 minutes  after vaccine. Jaw became tight hard to eat. 9hours later pounding heart tachycardia and lateral neck tightness waiting till morning went to ED. I have an increase in varicose and spider veins. Numbness to extremities and jaw/neck tightness. Sharp pain to varicose veins.
New multiple sclerosis onset / new diagnosis on 6/4/21 that presented with gait instability and slurring of words. MRI showed enhancing and non enhancing lesions in multiple locations.  Hospitalization 6.4-6.7.21
ON- OFF FEVER SINCE EVENING OF JAN 7, 2022  UNTIL TODAY, JAN 19, 2022. FEVER RANGES FROM 99.9 -102.3 DEGREES F
Rash started on 10/28/2003. Office visit 10/29/03. No fever or ill symptoms noted. 6-10 papules with surrounding edema/erythema 1-2mm (1-1mm on back) on abdomen and back.
Patient presented to office on 11/19/07 c/o "swollen red area after receiving pneumo shot" on 11/14/07 Pt was seen by physician assistant. Left deltoid area was tender and erythema present. Keflex 500mg TID x 10 days was ordered and cold compresses. 11/19/07 following visit-condition resolved.
I was very tired and my arm was sore  - right after the vaccine. In May, I started having my menstrual cycle and I hadn't had it last since December of 2018. It was really heavy and the worry was the fact that I was on blood thinner too. I had it for about five days. I got sent to  Hospital  ER  - May 17th  - and through the process, I had to get biopsy and ultrasounds done. A month later, I haven't seen another menstrual cycle. Follow up visit will be - Oncologist - July 8th  - They want to determine of what is causing my body is producing estrogen again - discussion of ovaries removed in future. Don't know yet.
PATIENT CAME TO PHARMACY STATING THEY NEEDED THEIR FIRST DOSE OF COVID VACCINE AND WANTED TO RECEIVE JANSSEN VACCINE. PATIENT WAS GIVEN THIS VACCINE, BUT LATER IT WAS REALIZED WHEN INSURANCE WAS CONTACTED FOR A BILLING ISSUE THAT THE PATIENT HAD ALREADY RECEIVED A MODERNA VACCINE ON 2/14/22. THIS INFORMATION WAS NOT RECORDED IN THE IMMUNIZATION INFORMATION SYSTEM. PATIENT WAS THEN CONTACTED TO VERIFU\Y THAT THE PATIENT DID RECEIVE THIS VACCINE.  THE PATIENT CONFIRMED RECEIPT OF THIS VACCINE AND STATED THAT SHE WAS TRAVELLING AND WAS INFORMED BY A TRAVEL AGENT THAT IN ORDER TO BE FULLY VACCINATED IN TIME FOR TRAVEL THAT SHE SHOULD RECEIVE THE JANSSEN VACCINE SO SHE DID NOT INFORM THE PHARMACY THAT SHE ALREADY RECEIVED A DOSE OF VACCINE. I CALLED THE PHARMACY WHERE SHE RECEIVED THE VACCINE TO INFORM THEM THAT THE RECORD WAS NOT SHOWING IN THE IMMUNIZATION INFORMATION SYSTEM.
Client received vaccination after reporting she felt anxious. After vaccination she lowered herself to the ground because she felt lightheaded and lost consciousness for 20-30 seconds. Episode witnessed by nurse and she reported that client did not hit her head. Upon regaining consciousness was responding and vitals were within normal limits. She stated she had history of fainting following blood draws and other vaccinations but did not tell vaccinating nurse this.  EMS called. Client refused transport.  She was monitored another 30 minutes and left after fluids and a snack.
About two weeks after receiving the vaccine, the injection site started getting very painful. It hurts to raise my arm and my joints hurt all in my shoulder, neck and hips, only on the right side.
Initial misuse report received from a healthcare professional on 30 December 2013 and at GPV on 21 March 2014. A 06 month old patient of unknown gender had received two doses of FLUZONE 08 days apart. The patient received an extra dose of FLUZONE. No adverse event was reported. The list of documents held by sender: None.
Information has been received from a consumer concerning her daughter a 13 year old female patient with type 1 diabetes mellitus, who at 30-JUN-2008 8:45 AM was vaccinated with the first dose of GARDASIL vaccine. Concomitant therapy included HUMALOG and LANTUS. On 30-JUN-2008, the patient experienced an elevation of blood glucose level (270mg/dl at 10 AM) (Home monitor). The patient had eaten usual breakfast prior to receiving vaccine in the morning. The patient did not seek medical attention, but would call physician. Additional information has been requested. This is in follow-up to report (s) previously on 7/15/2008.
17 year old male patient was accidently administered FLUZONE HD QIV vaccine with no reported adverse event; 17 year old male patient was accidently administered FLUZONE HD QIV vaccine with no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a other healthcare professional/consumer via the Agency (Reference number- 00850414).  This case involves a 17-year-old male patient who was accidently vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 09-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AB and expiry date: 30-Jun-2022) (Frequency: once) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose (latency on same day).  It was reported "Nurse states the FLUZONE HD QIV vaccine was accidently administered to a patient under the age of 65. Nurse is looking for information in regard to possible adverse effects as well as what they should inform the patient. Agent gathered some AE (adverse event) information. Nurse states FLUZONE HD QIV was administered to patient who was 17 years of age on 09Nov2021".   At the time of report, no adverse event was 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 the 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.
I've been diagnosed with atrial fibrillation for some time (years), but it was mostly symptomless. Shortly after I received the vaccination, I had a follow-up appointment with Dr. He suggested I check my heart rate periodically. I got a watch for that purpose. It seems to me I started having symptoms more frequently at that point. I'm willing to admit it may have had nothing to do with the vaccine. It may just me paying more attention to what was going on with my heart.  I should also note that I had a Pfizer booster on 10/23/21.
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 17-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with INFANRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with INFANRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Non at the time of administration of after.    COVID booster was given outside the 30 day expiration date.  Information was provided to Moderna Medical Inquiry Response - Case PRIVATE.    Response: The vaccine administered on January 17, 2023 from lot number 023H22A maintained the activity necessary to protect against SARS-CoV-2 (COVDI-19) virus at the time of administration
Injection site was red, tender to touch, and raised (~1cm). Site was also warm to touch, but pt reported she was otherwise afebrile. Pt stated full resolution in about 96 hours.
upset stomach, states passing out a few hours after the shot. the feeling lasted about 1 hour
Information has been received from the authors in a published literature article, title as above, regarding one (also reported as 4% of 28 patients) adolescent or young adult patient of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patient was vaccinated with a dose of MMR vaccine (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and < 0.79 IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same source. Additional information has been requested.
Severe r sided abdominal pain and headache.  Was seen in ER, labs and spiral, renal protocol, CT negative.  No evaluation for clots was done.
Pt developed swelling, erythema and itch on the left upper arm the day of hep b and IPV vaccines. The swelling gradually progressed until pt was examined on 04/12/2002 (4" x 5 1/2"). There was no sign of infection. Immediate response followed Epinephria and benadryl.
did get Covid in Dec 2022 after having the 5 shots; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (did get Covid in Dec 2022 after having the 5 shots) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In December 2022, the patient experienced COVID-19 (did get Covid in Dec 2022 after having the 5 shots). At the time of the report, COVID-19 (did get Covid in Dec 2022 after having the 5 shots) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient said that they got Covid in Dec-2022 after having the 5 shots. It was a very mild infection.  No treatment drug was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live non significant follow up
about eight hours after receiving the injection, I started to feel strong aching in my muscles and joints (most strongly felt in neck, hands, jaw, inner ear, but also including legs and feet).  I also felt chills.  My temperature was 98.8 F.  Over the course of the next three or four hours, I have felt strong sensations of aching and throbbing in my chest, back, hands, inner ears, and neck.  I also felt pins and needles all over but most strongly in chest, back, hands, inner ears, and sides of my neck.
Initial report received from a healthcare professional on 13 May 2013. This is an invalid case as individual patient identifiers are missing. This case is a cluster on 07 patients, whose age, gender, medical history and concomitant medications were not reported, had received an intramuscular dose of DAPTACEL vaccine (lot number, anatomical site of vaccination and exact dose number were not reported) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, and illness at time of vaccination were not reported. It was reported that, the 07 patients had experienced a local reaction of tenderness, redness and mild swelling at the injection site. The patients had received fourth or fifth dose of the series. Corrective treatment was not reported and no laboratory investigations were done. On an unspecified date, the patient had recovered from the events. List of documents held by sender: none.
Pt vax 3 doses; non responder.  4th dose given Apr91.