chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not get a second dose; She experienced significant side effects; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) and VACCINATION COMPLICATION (She experienced significant side effects) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) and VACCINATION COMPLICATION (She experienced significant side effects). In 2021, PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) had resolved. At the time of the report, VACCINATION COMPLICATION (She experienced significant side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided by the reporter She experienced significant side effects which scared her mother from getting the 2nd dose of the vaccine. She did not experience any symptoms and has not received any treatments.
felt achy; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt achy) and FATIGUE (fatigued) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (felt achy) and FATIGUE (fatigued). At the time of the report, MYALGIA (felt achy) and FATIGUE (fatigued) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.
Large, itchy red rash at sight of infection one week later. The same rash appeared 2 days after second dose.
A non-serious spontaneous report of petechial rash and fever has been received from a physician concerning a 33-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither past medical history nor concomitant medications were reported for this patient. On 03-Jan-2011, the patient received FLUMIST. On 05-Jan-2011, the patient developed a fever of 103 F and 104 F. The patient also developed a petechial rash on the arm. The outcome of the events petechial rash and fever was unknown.
feel crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked if it was normal to feel crappy 24 hours after vaccination.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a licensed practical nurse concerning a sever-year-old male. The product expired on 19-Jan-2010. On 20-Jan-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.
Swollen lymph node (right under arm), sore right arm, hypersensitive skin on right side of body and scalp, blister sores under right arm. Within five days blister sores on right side of Che's, down right arm and on right side of back. Diagnosed with shingles on 10/09/2013.
3 days after my 3rd dose vaccination I experienced consistent heart palpitations (40skips/day) and it went for about 7 days. I went to the ER on 12/28/2021 and there was no prescription given and was advised to visit a cardiologist which I did and had an ECG (Holter Monitor) and the result was. 61 PVCs and a total of 10 PSVCS. (PVC - Polyvinyl chloride) I was not prescribed with anything and my symptoms subsided around January 2, and as of today I have on and off palpitations.
This spontaneous report was received from a registered nurse and refers to a 7 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982, expiration date unspecified), intramuscular on 14Jan2021 15:30 at single dose (left arm) for Covid-19 immunization. Medical history included vitamin d deficiency (def), Beta Thalassemia, some shellfish allergy, Sulfa allergy and COVID-19, which was prior to vaccination. Concomitant medication included vitamin D3. The patient received vitamin D3 within 2 weeks of vaccination. On 15Jan2021 at 06:45, the patient experienced sore left (L) arm, body aches, chills, diarrhea, and headache. The patient did not received treatment for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for Covid-19 since the vaccination. Outcome of events was recovering.
Had shingles immediately after, lasted for 7 months; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. the patient had got the shot and had shingles immediately after, It lasted for 7 months. GSK note -  the time to onset added as less than a month considering worst case approach, as immediate TTO seems to be incorrect.
diarrhea; severe cramping/leg cramping; severe muscle aches; injection site pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "severe cramping/leg cramping"; MYALGIA (non-serious), outcome "unknown", described as "severe muscle aches"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse, for VARIVAX vaccine (MERCK), a Pregnancy Registry product concerning a 17 year old pregnant female with no medical history or allergies (The pregnancy test was performed on unspecified date, last menstrual period: 14-FEB-2009 and estimated delivery date: 21-NOV-2009) who on 04-MAR-2009 was vaccinated with VARIVAX (MERCK) (previous dose administered on 14-APR-1999). There was no concomitant therapy. The patient sought unspecified medical attention. No adverse effect was reported. Follow up information was received from another registered nurse. It was reported the patient was vaccinated with VARIVAX (MERCK) (lot # 662010/1741X). The patient's last menstrual period was 13-FEB-2009 (previously reported as 14-FEB-2009), so the estimated delivery date was changed to 20-NOV-2009. Follow up information was received from a nurse via phone call. It was reported that she received call from the patient's foster parents, and that they informed her that the patient had had a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
pt expired 11/7/99-COD accidental asphyxiation d/t lissencephaly, microcephaly;
My coughing from Allergies came worse.  Fatigue, diarrhea, headaches.  I had itchy toes on the 8th of April and developed a blister between my toes.  This happened the first time I had covid.   I  tested positive for Covid for the second time on April 11, 17 days after the vaccine, after going in for antibiotics for sinus /lung infection.    I tested positive for  Covid  October 9, 2020 in.  Pneumonia continued through December.   I have had long hauler symptoms since then.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included COVID-19 (unspecified if ongoing). The patient's concomitant medications not reported. The patient developed illness (she and her husband both sick after the vaccine) and malaise (felt lousy), with outcome of unknown. Additional information: Reporter stated her friend (patient) had COVID-19; she got the vaccine and she was fine other than feeling lousy. Patient and her husband both were sick after the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s) : US-PFIZER INC-2021421209 same reporter/product/event, different patient.
Caller also mentioned that both of him and his wife experienced this/his mind seemed to be forgetful; his wife experienced this/2 days fever; weakness and tiredness for 2-3 months; weakness and tiredness for 2-3 months; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.  The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Caller also mentioned that both of him and his wife experienced this/his mind seemed to be forgetful"; PYREXIA (non-serious), outcome "unknown", described as "his wife experienced this/2 days fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "weakness and tiredness for 2-3 months".  Additional information: Caller also stated that he had "2 days fever" and "weakness and tiredness for 2-3 months. Caller also mentioned that he "all couple times and his mind seemed to be forgetful".Caller also mentioned that both of him and his wife experienced this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THE SITUATION IS THE FOLLOWING: WE WANT TO REPORT THAT PATIENT VISITED THE PHARMACY ON 7/20/21 BECAUSE SHE WANTED TO GET VACCINATED. YOU WILL BE GUIDED ON THE AVAILABLE VACCINE WE HAD (MODERN). THE PATIENT AGREED TO BE VACCINATED AND FILLED OUT THE PRE-VACCINATION QUESTIONNAIRE AND THE VACCINATION CONSENT. AT THE TIME OF REPORTING THE VACCINE ADMINISTERED TO THAT PATIENT TO THE DEPARTMENT OF HEALTH SYSTEM, WE FOUND THAT THE PATIENT HAD BEEN PREVIOUSLY VACCINATED AT TWO OTHER VACCINATION CENTERS.  TWO FOLLOW-UP CALLS HAVE ALREADY BEEN MADE WHERE THE PATIENT INDICATES TO FEEL GOOD AND HAVE NOT EXPERIENCED ANY SYMPTOMS.
Patient tested positive for COVID 4/2/21. Completed COVID vaccine series 1/18/21.  Asymptomatic. Tested positive on long term care prevalence testing.
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: patient passed out about 5 minutes after receiving vaccine, fell on carpet and received abrasions on forehead and cheek from fall.  2 pharmacists rushed to help, bradycardia noted. Patient disoriented on arousal, legs were elevated by pharmacists to help aid recovery. 911 called and paramedics came about 10 minutes later to bring patient to emergency room. He seemed to be recovering after leaving. vitals not recorded but low pressure and heart rate noted by paramedics.
Patient receives vaccine and starts to describe blurry vision.  Patient closes eyes to rest a minute and then describes heavy feeling in her arms. Patient blood pressure is elevated (130/101) Patient continues to rest and then blood pressure recheck reads 191/141 EMT's were called and Benadryl was given. EMT's evaluated and vitals returned to normal and patient was released.
This spontaneous report as received from a pharmacy student refers to an unspecified number of patients. On unknown dates the patient were vaccinated with ZOSTAVAX, subcutaneously. All patients were vaccinated at the reporter's pharmacy. The lot number was reported as J011549 (confirmed valid) with expiry date 19-DEC-2014, dose number and anatomical location were not reported. The reporter stated that all patients that were vaccinated with lot number J011549 ZOSTAVAX at the reporter's pharmacy experienced itching immediately after injection. The itching was often accompanied by a small amount of redness. The itching resolved within a few hours, the outcome of itching immediately after injection was reported as recovered/resolved. The outcome of small amount of redness is unknown. Additional information has been requested.
PATIENT WAS DISORIENTED, CONFUSED, CRYING HYSTERICALLY, STARTED SHAKING IN A SEIZURE MANNER, WALKED INTO WALLS, DID NOT KNOW WHERE TO GO, WOULD NOT TALK.
First time seizure (R56.9)  She developed left arm stiffness and left face twitching along with eyes staring upward. Pte unresponsive during this time. Episode lasted 2-3 mins and was found to be sleepy for about 30 mins afterwards. No fever, no vomiting, no diarrhea, no cyanosis
She looked to have a rash in the area, she mentioned heat at the rash site and a headache, referred her to her MD right away.
1) Large local reaction at injection site-firm, tender, swollen. 2) Fever x2 weeks (at night only). ? reload to vaccine
Body aches; exhaustion; fever related symptoms without a known fever; This is a spontaneous report from a consumer, the patient. A 55-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 55-years-old) as a single dose for COVID- 19 immunisation. Medical history and allergic history were reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021, the patient experienced body aches, exhaustion and fever related symptoms (without a known fever). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events. The clinical outcome of the events body ache, exhaustion and fever were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning an approx. 30 year old male pt from another country, who was vaccinated with a dose of MMRII. Subsequently, the pt developed measles. The pt sought unspecified medical attention. Follow-up information from the physician indicated that approx. 10 days, post vax, the pt developed a speckled rash over his trunk with a low-grade fever and some discomfort, questionable malaise. The physician indicated that it was a mild case of measles and he recommended the causal interventions; rest, fluids, acetaminophen, no aspirin and to return promptly to the physician's office if any symptoms worsen. It was reported that the pt was not known to be previously vaccinated against measles. Additional information was requested.
SIDE EFFECT REPORT: Started feeling sleepy, very tired, then feverish, then chills and shaking, aching muscles. Never before experienced this w/flu shot in last two years. Started drinking copious amounts of water. Shaking/fever was somewhat relieved in about an hour. Slept. Extreme fatigue lasted until next morning.
High dose influenza vaccine was administered to the upper right arm muscle.  Arm was immediately sore and has gotten progressively more painful.  Pain was treated with Tylenol Extra Strength Precise Pain Relieving Cream.
Patient states that a small pocket of fluid formed at her left elbow the evening after receiving the vaccine.  The area was not red or warm to the touch. It resolved by the next morning.
Pt recvd vax & devel a pruritic rash on arms & numbness & swelling of the upper lip which lasted 2 days;
Tuesday, 20 July 2004 Well baby visit with Measles, Mumps, and Rubella (MMR) and Hib #4 shot  Tuesday, 27 July 2004 He was out of sorts today.  I gave him Advil in the morning to bring down a fever, but mother-in-law didn't think he had a temperature.  Maybe he was just tired.    5:30 pm  Dinner.  He slept in my arms almost the entire time.  After supper we all piled into the car to head home.  As we were about to turn to get onto the Thruway, I turned around and looked at him.  He was crumpled down into a ball twitching uncontrollably in his car seat.  He was also turning blue as he lied there shaking.  I screamed he was having a seizure.  As I reached over and unbuckled him from his car seat, my husband pulled off the side of the road onto some grass.  I opened my car door and ran out of the car with my son in my arms  still twitching.  I used my pinky and swept his mouth to make sure there wasn't anything in his mouth blocking his airway.  His father ran around the back of the car with his cell phone dialing 911.  The operator asked about him and I told my husband that he had Measles, Mumps, and Rubella (MMR) shot 7 days ago.  He is only 15 months old.  As we were getting hysterical, people stopped to help us.  If I had to guess, roughly 15 to 20 people stopped to help.  One woman, a nurse, took my son in her arms and held him facing down.  She tired to calm me down by telling me he is okay.  He is having a seizure and there is nothing we can do but wait it out.  She was facing him down and noticed I was sitting on the grass in the pouring rain.  A man brought over a fleece waterproof blanket and put it over us to keep us dry.  I reached over to close the passenger side door I left open and noticed there was a young woman sitting there talking to the other passenger.  He seemed fine  he wasn't crying or looking worried.  When I looked back at my son, he had stopped twitching.  The seizure was over!  I wanted to hold my baby again.  He didn't look right.  He couldn't focus on my face or even wrap his little fingers around my finger.  I started to panic again.  His eyes would roll toward the back of his head and close.  I kept talking to him trying to keep him awake.  He just wanted to sleep, but I was afraid to let him close eyes.  That is about the time the ambulance arrived.  6:45 pm   In the 15 minutes it took to get to the hospital the EMT took down all the information.  I began thinking the heart medication I took while pregnant with him did this  the EMT said no.  They placed an ice pack on him after finding out he had 103.8 F temperature.  The EMT asked if I know what happened and how long it lasted.  I guessed 2 to 3 minutes, but I didn't even know what time it was now.  She told me 6:45 pm.  7:00 pm  We got to the hospital around 7 pm and the poking and prodding began no history of seizures in the family no unusual birth  - born 15 days early due to lack of placental fluid no cold symptomsThey performed the spinal tap, drew blood, and took a urine sample.  9:00 pm The doctor said he had a febrile seizure due to a high temperature.  He also had a low white blood cell count.  He received 500 mg of Ceftriaxone.
A female patient received an injection of MANACTRA (lot number U2409AA); date, site, and route of administration were not reported. She subsequently developed spine pain and a headache. No additional information was reported. This health professional also reported a similar event in another patient, captured in case number 2008-02209.
MD reported pt devel a sterile abscess in the rt deltoid area 10 days p/vax;
Tightness/soreness in chest around heart. Unable to exert a lot of force. At times shortness of breath.
Narrative:  Cause of death bilateral PE, however patient has other potential causes of PE: amputee Reported as a possible cause/catalyst of PE resulting in death.
24 hrs post receiving vaccines mom noticed L upper arm red and swollen-non painful, full ROM. Advised cool compresses and Benadryl.