chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 07-NOV-2016. This case involves an 80-year-old male patient who was vaccinated with a dose of FLUZONE HD) (batch number, expiry date, dose, dose in series were not reported) intramuscularly, in the left deltoid on 18-OCT-2016. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergy to codeine. Concomitant medications were not reported. On 19-OCT-2016, one day following the vaccination, the patient felt very fatigued and 24 hours later he has instability in walking, severe tremors, having difficulty keeping his thought straight. On an unspecified date, following the vaccination, the patient was diagnosed with mild urinary tract infection. On an unspecified date, the patient was seen in the emergency room and by a neurologist. On an unspecified date, the patient was hospitalized for three days. Lab data reported as on an unspecified date, MRI, CT, chest X-ray all tests were negative and corrective treatment was reported as unspecified medication. The outcome of the events was reported as not recovered (symptoms have improved only slightly). List of documents held by sender: none. Sender's Comments: This case concerns an 80 year old male patient who was hospitalized with diagnosis of mild UTI (Urinary tract infection) with complaints of fatigue, unstable walking, tremors and difficulty in thinking one day after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. However details such as, previous immunization history and tolerance, concurrent conditions, patient immune status at the time of vaccination and diagnostic work-up to confirm alternative etiology/diagnosis etc. are needed for complete assessment of the case.
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 02-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U021995 which was determined to be valid with expiration date 13-JAN-2023, for prophylaxis, after a temperature excursion of 0 degrees Celsius (C) for a time frame of 168 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, no previous temperature excursion was reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA007090: US-009507513-2206USA007070: US-009507513-2206USA007059: US-009507513-2206USA007045: US-009507513-2206USA006981: US-009507513-2206USA006952: US-009507513-2206USA006852: US-009507513-2206USA006731: US-009507513-2206USA006674: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA006770: US-009507513-2206USA006432: US-009507513-2206USA006670:
Headache; body aches; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 33-year) in left arm on 16Feb2021 at 10:30 AM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. Historical vaccine includes first dose of BNT162B2 administered in left arm on 26Jan2021 at 10:30 AM for COVID-19 immunization. Reported facility type vaccine was workplace clinic. The patient received no other vaccine in four weeks, and no other medications in two weeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 17Feb2021 at 06:00 AM the patient experienced headache and body aches when waking up. The patient received no treatment for the adverse events. The clinical outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Information was received from the authors in a published literature article. The authors presented a rare case of vaccine-associated measles infection in an immunocompetent, HIV-negative patient. This case concerns to a 13 months-old male patient, the child was an immunocompetent healthy patient, he had no previous adverse reactions to immunizations. His past medical history was significant for allergic rhinitis for which he had been prescribed cetirizine. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported) for prophylaxis. The patient did not receive any medication for 10 days prior to his admission. On an unknown date, 9 days after the vaccination, the patient presented to the hospital with a diffuse maculopapular rash, fever, cough, and coryza, the patient had no known sick contacts or any known contacts with a rash. He had no history of barn yard animal contact, no ingestion of unpasteurized dairy products, and no consumption of undercooked meats. He was placed in a negative pressure room with strict droplet precautions. On an unknown date, the patient was admitted; his vital signs upon admission were stable. He was found to be positive for Respiratory Syncytial Virus (RSV) by nasopharyngeal PCR swab testing. On examination, the patient had a full-body blanchable maculopapular rash. All routine laboratory values were normal. A blood culture showed no growth after 5 days, and a urinalysis was negative for signs of infection. A nasopharyngeal PCR test for measles was obtained; testing for Human Immunodeficiency Virus (HIV), Cytomegalovirus, Ehrlichia, EpsteinBarr virus, Parvovirus B19, and Rocky Mountain spotted fever all resulted negative. The patient's rash and congestion resolved after 5 days of supportive care. P-N was 2.103 and P/N was 30.406, both of which met criteria for a positive measles IgM  indicating an acute measles infection (a positive measles IgM capture occurs if the mean optic density of the positive control serum reacted on viral antigen (P) subtracted from the mean optic density of the negative control serum reacted on viral antigen (N) is greater than or equal to 0.10). Reverse transcriptase-polymerase chain reaction (RTPCR) testing for measles RNA from nasopharyngeal swab and measles-specific IgM from serology both returned positive 2 weeks after the patient was discharged on an unknown date. The authors considered the measles infection was related to the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). As they presumed vaccine-associated measles in an immunocompetent, pediatric patient whose HIV status was confirmed to be negative at the time of presentation. Upon internal review, the measles infection was considered a medically significant event and serious due to hospitalization.
rapid heart rate (5 days later) 11-3-07, hoarseness (2 days later) 10-31-07, fever (6 days later) 11-4-07, pneumonia (reported to Rx) 12-28-07
I received vaccine #1 on 12/21/2020, 24 hours after initial vaccination  I experienced sudden onset of severe joint swelling that lasted for 5 days.  I went to my facility Infectious Disease Nurse and reported severe symptoms and inquired if I should get the second dose.  I was told ths was a positive immune response to the vaccine and since the symptoms had resolved it was safe to proceed with the second vaccination.  I recived the second vaccination on 1/11/2021 and 12 hours after I again had sudden onset of severe joint swelling that only responded to high dose steroids and continues.  I am and have been followed by a rheumatologist and continue on steroids.  Methotrexate was added and I also continue to take this medication.  I am no longer able to function full time as an Emergency Room RN and now work part time.  I take Celebrex to assist with the pain which has some benefit, but daily I continue with swelling/discomfort.
The medical assistant who gave the patient the vaccine did not confirm what the vaccine schedule was in system before she administered the Hep A. Patient already had a dose of Havrix on 11/10/21, and was not due for the next dose yet. Therefore,  the Hep A vaccine was given too early. The parent was told what happened by doctor and it was also explained that their child would need to come back again at the appropriate time for another Havrix injection.
The pt developed hives all over the body, had a temperature, sweating, nausea, and headache. These sysmptoms occurred one day post vax. The vax has been discontinued.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 23-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19,400 plaque-forming units (PFU) (Lot # L046897 and expiration date 23-MAR-2017) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported) (expired product administered). There were no adverse effects reported. Additional information has been requested.
Dizziness, nausea, tachycardia, general hives/rash. Onset 2 hours post vaccine.
Left thigh with edema and warmth (11 1/2" measurement); slight fever and firm to touch. Tx: Ice and Motrin. Mom brought child into clinic.
Moderna COVID-19 Vaccine EUA gastrointestinal upset/diarrhea
patient felt light headed and was unable to keep eyes open. he never did completely pass out but was struggling to stay awake
1 day after vaccination patient states she developed a rash on her torso that was inflamed skin, not itchy. She took benadryl and said that did help
Recipient was given the Moderna vaccine instead of the Pfizer vaccine.  Recipient was not at the correct age for the Moderna vaccine
arm swelled; deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest; started itching; she feels hazy, a little disoriented; allergic reaction; didn't feel well; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZlA and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter. No concomitant medication reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction). 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), HYPERSENSITIVITY (allergic reaction), VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue) outcome was unknown and DISORIENTATION (she feels hazy, a little disoriented) had not resolved. Not Provided          Concomitant medications were not provided by the reporter.  The patient went to an urgent care on 13MAR2021. Details about the visit were not provided.
NauseaVomiting painful swelling under left arm. Max temp of 99.1. Narrative:  From nursing report of 1/25/21: "Here with c/o took 2nd Moderna vaccine on January 21st. States began aching on Friday [1/22], had fever and nervous stomach which states consisted of nausea and vomiting. Denies diarrhea. States Saturday night [1/23] started developing mass under left arm. Low grade temp of 99.1 and then 98.6. Rate pain under left arm at level 8. Recommended follow up with primary care provider for further evaluation of mass under arm and pain."
Shortly after getting the shot she reported feeling "off" as she was driving she started feeling short of breath and her heart was racing. When she got home around 5 PM she was still feeling short of breath and reported that her heart was racing. She was unable to speak clearly, but was stating that it was due to be being short of breath.  She also reported feeling lethargic and fell asleep until the next morning. She slept until approximately 12 pm the next day. When she woke up she reported feeling right sided cheek tingling. At that time she thought she had just slept wrong. When she attempted to walk down stairs she was limping and reported just feeling very weak on her left side. On Wednesday she slept in late again complaining of lethargy. When she awoke that Wednesday (3/10) her speech was markedly slurred. She was also saying things that didn't make sense. She was dragging her left leg when she tried to walk. We immediately took her to the ER and she was worked up for stroke. When she was triaged in the ER we mentioned that she had just had her COVID vaccine and voiced concerned that maybe she had a reaction to her COVID vaccine. She was admitted to hospital on 3/10 for a possible stroke.  Her MRI was done later on 3/11, Her MRI showed that she has strokes on both sides of her brain in the frontal, parietal and occipital lobes. The doctor referred to her stroke as being caused by a "showering of clots". The doctor said this usually only happens to someone with cardiac issues. My mom has no cardiac history. Her doctor ordered an 2D Echo of her heart and no abnormalities were found (3/12).   She is still disabled from her stroke. She was hospitalized from 3/10 - 3/16. She was the discharged to other care facility from 3/16-3/26. She is currently needing outpatient rehab in a day neuro program. She attends this at outpatient facility. She has to walk with a cane due to persistent left leg weakness. Her speech has a slight slur, and she suffers from short term memory loss. She intermittently has trouble with her equilibrium and reports feeling dizzy. She sometimes has a hard time swallowing or says that it doesn't feel right when  she swallows. She also trouble with word retrieval. She has left-sided neglect which correlates  left eye visual deficits. She currently requires care from a general physician, neurologist, physical therapist, occupational therapist, speech therapist, neuro ophthalmologist and neuo psychologist. She was started on a new medication regime 325 mg aspirin daily, plavix for 21 days (now completed), metformin, amlodipine, coreg and losartan. She is going to need outpatient rehab until at least June from the last update we received from her rehab doctor.
The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day.  He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis.   CT negative for pulmonary embolism and showed bilateral infiltrates.  Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin.  He was initially stable in the hospital on 1-2 LPM 02.  The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia.  Resuscitation was attempted for 45 minutes but unsuccessful.  Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination.
Rash on arm where vaccine injected and knot in muscle. Slight itchiness in body.
pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced pain in her arm for 6-7 days after receiving it. The reporter did not consent to follow up. This case linked with US2019183609, reported by same reporter.
I had rusty joints in both shoulders with muscle pain and fatigued.  I was modern pain.  Seen doctor, after the second shot. They did blood test.  There was 5 out 13 abnormal results in the blood test. They believe it was due to inflammation that was from the vaccination.  They started me steroid (Methprodnazoe) for the inflammation and joint pains.  I was a one-week treatment.  That was very affective.  After the treatment stopped, the symptom came back, it was about 80% more that traveled down my body.  It was more mild pain.  I am still having these symptoms.  I am going to contact my doctor to get back on a low-level steroid treatment pain.   The more I exercise the worst it gets.
Child had many itchy, red, raised bumbs all over his right side and under his arm.  After a day they turned into small pimples.  Now, two weeks later, they are scabbed over but are still itchy.
Information was received on 20-APR-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 20-JUL-2007 by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-NOV-2012, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable viral condition, the patient has been prescribed unspecified antivirals and valacyclovir hydrochloride (VALTREX) to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report received from contactable consumer or other non-HCP (the patient). An 82-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0185), Aug 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9269), Feb 2, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 108982), on Jan 14, 2021; both single dose, for COVID-19 immunization. Medical history not reported. Concomitant medication included Actemra taken for rheumatoid arthritis. The patient experienced COVID-19/positive for COVID-19 virus (medically significant) and vaccination failure (medically significant), onset May 9, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May 9, 2022) positive; (May 11, 2022) positive; (May, 2022) positive. No follow-up attempts possible. No further information expected.
Patient was administered the vaccine approximately 1.5 hours after product expired (vial was punctured at approximately 7.5 hours prior to administration, stored in refrigerator,  manufacturer says 6 hour expiration time. Contacted manufacturer and they have no information on product safety / efficacy past expiration time. Called patient and left message regarding event as it was discovered after he'd left. No known adverse effects.
Patient came in to the office on 3/24/2021 reporting mild bruising and swelling of right arm after covid vaccine
expired dose administered; This spontaneous report as received from a physician, concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-DEC-2020, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated (VAQTA) lot # S031918 with expiration date on 05-NOV-2020 (strength, dose, route of administration and frequency were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031918; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Some diarrhea after first dose Severe diarrhea on and off since the second dose with weight loss
Initial case received from a health care professional on 07 June 2010. It involves a case of "vaccine administered at inappropriate site". A 54-year-old female patient received an intramuscular gluteal injection of DECAVAC (lot number U2972AA) on 26 May 2010. The patient had a history of a "dirty wound", and was given 1 gram of ANCEF concomitantly; she also had a history of anxiety. On 27 May 2010 the patient complained of tenderness and a knot at the site. At the time of the report, the patient was scheduled to see a physician. The events remained ongoing. Of note, the preferred administration site for DECAVAC is the deltoid muscle; it is recommended that DECAVAC not be administered in the gluteal muscle. Follow-up information was received from a health care professional on 30 July 2010. The patient was seen in the clinic on 16 June 2010 "no sequelae" was noted from the knot at the previous injection site on the buttocks. The patient's hand wound had also resolved and she was revaccinated in the left deltoid with DECAVAC (lot number U2972AA and route of administration not reported). No further information was available at time of this report. Document held by sender: none.