chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 74 year old male patient regarding himself. The patient's wife currently had shingles for the last two months and the patient was symptom free. On 12-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and dose were not reported) on recommendation of his physician. Concomitant medications were none. Two days after receiving the vaccine, approximately on 14-NOV-2012 the patient developed a rash and two red blisters, the area was itchy and painful. No laboratory test was performed. The patient sought medical attention (unspecified). The patient was treated with valacyclovir 3 times daily and TYLENOL. All the reported events were not recovered at the time of this report. Additional information is not expected.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Drug allergy (unspecified drug) and Single functional kidney. Concomitant products included LISINOPRIL and CHLORTHALIDONE for an unknown indication.    On 03-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient reported had rebound headache starting on 24-May-2022, symptom were  worse toild cold. Device Date was reported as 29-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred after receiving the fourth dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that headache recurred, and cold symptoms worsened 2 days after completion of anti-viral treatment. Patient also tested positive for COVID-19 four days later. The clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred after receiving the fourth dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that headache recurred, and cold symptoms worsened 2 days after completion of anti-viral treatment. Patient also tested positive for COVID-19 four days later. The clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received regarding a case in litigation concerning a 7-week-old female who on 21-DEC-1994 was vaccinated with a dose of Recombivax HB (manufacturer unspecified). On 21-DEC-1994 the patient experienced sudden infant death syndrome (SIDS). The patient death occurred the same day as her 21-DEC-1994 vaccinated at 7 weeks old, which was reported to be too quickly to have been the result of a catastrophic auto-immune reaction called cytokine storm as pustulated by the petitioner. Cerebral Edema: "Reports of cerebral edema following infection of nervous tissue generally are acommpanied by fever and significant symptom development usually requires several days to occur," reported the petitioner. Although the patient received Recombivax HB (manufacturer unspecified) on the same day of her death, the physician opined that a cytokine-induced cerebral edema would have required days to manifest." The cause of death was ruled SIDS by a forensic pathologist in the coroner's office who noted signs associated with SIDS such as "rare epicardial petechia," pulmonary congestion and edema, the petitioner reporter. And her age was within the accepted temporal window for SIDS. Also the child's mother during her pregnancy took the antipsychotic haloperidol, which was said to have been associated with "sudden and unexpected death." The reporter felt that sudden infant death syndrome was not related to therapy with Recombivax HB (manufacturer unspecified). Additional information is not expected.
Chills. Body aches. Fever. Headache. Stomach ache. Also received this years influenza shot simultaneously in the right arm.
GOT HIVES AT INJECTION SITE (LEFT UPPER ARM) ON LEFT NECK AREA AND LEFT UNDER EYE; TOOK BENADRYL WHICH RESOLVED MOST OF HIVES; STILL HAD A TOUCH OF HIVES VISIBLE UNDER MY EYE AREA THIS MORNING
This was a booster shot following two Pfizer vaccines in April 2021.  painful itchy red raised rash on vaccine arm below the injection site.  topical treatments, over counter pain reliever, warmth helped with pain, ice for the itching
7 hours after receiving the influenza, quadrivalent (P-free) vaccine I started to get intense body aches, nausea, light headedness, and a fever (101). The fever and body aches lasted for approximately 10 hours (from 4 pm - ~2 am?). When I woke up at 6 am the fever was gone and I felt back to normal.
Injection Site Soreness - day 1-2 Narrative:  Other Relevant History:
This spontaneous report as received from a pharmacy intern refers to a unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 14-JAN-2015, the patient was vaccinated with expired dose of ZOSTAVAX (dose, frequency and route were unspecified) (lot # J003723 and expiry date: 24-JUN-2014). No symptoms were reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 10:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.03 for dose administered on 03-Mar-2021 and 67.10 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range of 34-, 35- and 51-degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A administered on 31-Mar-2021 underwent temperature excursion with temperature range of 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Huge fever blisters on mouth; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 18:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included colecalciferol (VITAMIN D), iron (MANUFACTURER UNKNOWN), ESTRO-CORT, CORT-EAZE and THYRO-BOOST for an unknown indication from an unknown date within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:00, the patient experienced huge fever blisters on her mouth and never had a fever blister in her life. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event huge fever blisters on mouth was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Muscle aches, headaches, eye soreness, chills, felt feverish and had sweats. On exam on 9/15/00, pt had otitis externa on the left. None at time of injection.
Later in the afternoon after receiving the vaccine the patient experienced pain and swelling in the left arm. This has continued from Wednesday the 18th until the 21st.  The patient states that the pain feels like its coming from her bone and is radiating from the vaccine injection site to the shoulder. The patient has used ibuprofen and ice to manage symptoms.
19 year old patient administered pediatric formulation of HAVRIX. Age of patient at time of event: 19 years.
severe sore throat; Persistent coughing/virtually with every breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent coughing/virtually with every breath) and OROPHARYNGEAL PAIN (severe sore throat) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Emphysema and Irritable bowel syndrome (IBSD). Concurrent medical conditions included Cholesterol, Hypertension, Penicillin allergy and Allergic reaction to antibiotics (Clindamycin allergy). Concomitant products included ATORVASTATIN CALCIUM from 01-Jan-2021 to 21-May-2022, FLUTICASONE PROPIONATE from 01-Jan-2022 to 21-May-2022, AREDS 2 PLUS MULTI VITAMIN from 01-Jan-2018 to 21-May-2022, PSYLLIUM FIBRE from 01-Jan-2015 to an unknown date and LOPERAMIDE HYDROCHLORIDE from 01-Jan-2021 to an unknown date for an unknown indication.   On 12-Feb-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Persistent coughing/virtually with every breath). On 21-May-2021 at 11:00 AM, the patient experienced OROPHARYNGEAL PAIN (severe sore throat). At the time of the report, COUGH (Persistent coughing/virtually with every breath) and OROPHARYNGEAL PAIN (severe sore throat) had not resolved.            Patient previously received a COVID-19 Vaccine.  Patient experienced sore throat 6 hours after dosage.  Patient had continued coughing at lesser volume, about every 10-15 minutes, all day and night. It started within one hour of initial dosage.  Treatment information was not provided.  Device date was reported as 23-May-2022.  Pfizer have permission to contact about this report and have permission to contact the patient's healthcare provider.
10 weeks post vaccine arm soreness at injection site and then ~18 hours later robust diarrhea and nausea
1 week after receiving the H1N1 FLUMIST vaccine --> had several generalized seizures --> admitted to hospital --> seizures resolved. Had MRI showed generalized inflammation which had resolved with a repeat had MRI done 4 days later. 11/12/09 Discharge Summary received for DOS 11/02/09-11/04/09. Final DX: New onset of seizures.  Pt developed seizures 1 wk after receiving H1N1 vaccine.  Upon admission on 11/02/09, seizures began on the L side as tonic-clonic and later generalized. Post-ictal, Pt was agitated and combative. Neuro assessment with EEG showed diffuse slowing, but this was poor study due to Pt being combative.  At the time of discharge Pt was in good condition with no focal neuro deficits, but had a little unsteady gait.    11/25/09 AND 11/30/09  Medical records recieved for DOS 11/2/09-11/4/09. Final DX: Cerebritis C/O HA.  5 am found head thrashing, unresponsive to verbal stim. Incontinent.  EMS activated. GTC seizure in ambulance. L eye gaze. Perioral cyanosis. Drooling. Clenched fists. Shaking. Emesis. Sleepy and agitated after.
not effective; not effective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "not effective". The doctor told the patient it was not effective against the most recent variant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given the Arexvy vaccine adjuvant without the antigen. The patient got another vaccine with the adjuvant mixed with the antigen right after the pharmacist noticed that the first was not mixed first with the antigen.
Patient developed symptoms of dryness/tightness in throat, cough, mild dizziness, and nasal congestion approximately 15-20 minutes after vaccine administration. Patients vitals remained within normal range (BP/HR), breathing non-labored, lungs clear to auscultation, denied SOB, or worsening of symptoms. Patient given 25mg Diphenhydramine by mouth and observed for 50 minutes. Symptoms did not worsen. Given symptoms and audible upper airway expiratory stridor on auscultation, I recommended she be evaluated further in ED or UC, though she declined. Worsening symptoms/precautions for seeking additional care were discussed at length.   Patient has a past  history of anaphylaxis to unknown allergen necessitation ICU admission. No reaction to 1st dose of COVID vaccine (Pfizer).
In the evening after getting my second vaccine. I got a really high fever of 102.0F to 103.0F, really bad chills, throwing up, it felt like the worse flu I ever had. Thirty six hours after the vaccine, it seemed to clear up but then I started to feel like hands and feet had the pins and needle effect that went up my arms and legs for two or three day. As this feeling started to go into my chest muscles, it gradually went away.
the patient has not experienced any adverse reactions associated with the administrations; the patient was accidently administered another dose of VAXELIS and ROTATEQ.; a patient missed her 4 month well child visit to receive her VAXELIS and ROTATEQ vaccines.; This spontaneous report was received from a medical assistant regarding an 6-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023, the patient missed her 4 month well child visit to receive her rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) doses (Product dose omission issue). On 27-APR-2023, she was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally as prophylaxis (strength, lot #, and expiry date were not provided); and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter (strength, formulation, lot #, expiry date, route of administration, and indication were not provided) at her 6 month well child check up. On 11-MAY-2023, the patient was accidentally vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, product quantity 1, 2 milliliter, lot #1932214, expiration date: 11-APR-2024, administered orally as prophylaxis; and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), product quantity 1, 0.5 milliliter, batch/lot #U7296AA, and expiration date: 26-FEB-2025 (strength, formulation, route of administration, and indication were not provided) (Extra dose administered). It was reported that the patient had not experienced any adverse reactions associated with the administrations.
Developed left sided Bell Palsy. Treated at hospital and admitted for evaluation for possible CVA. Once studies were negative, he was discharged home. Now back to normal. Took approximately 3 weeks for most of the symptoms to resolve.
Raised red itching rash, bilateral on sides of abdomen. Tx hydrocortisone cream to affected area. DEXADRON shot from Doctor, BENADRYL, back again to dr and prescribed prednisone 10 mg x2 for 7 days, then 1 tab each day for 7 days. Starting the Prednisone today, 07/17/2018.
After dose was administered on Thursday afternoon the arm was very sore ASAP.  Friday there was redness around the injection site about the size of a half dollar.  Over the course of friday and by Saturday it spread quite substantially..  I called my doctor on Sunday and was advised to take Benedryl.  Which I did on Sunday, Monday and Tuesday..  By Wednesday, the redness was gone.  The arm was clear of redness on Thursday and Friday.  Friday night  my arm started to itch again and the redness came back.  I took a benedryl on Friday and Saturday night.  I also  put on Cortisone  10 cream.  Today, Sunday as I am writing the redness is about the size of 2 inches by 2
Patient experienced brief loss of consciousness (about 30 seconds) along with cold chills, sweating, tingling of hands and feet, and muscle weakness.  Patient was taken via ambulance to hospital per patients request.
Pt reported swelling around her eyes and eye lids as well as her lips started on 1/4/13.  Pt denied any s/s of respiratory distress or swelling of her throat. These signs resolved but pt now experiences hives on her abdomen and mild swelling on fingers.  Pt is advised to take Benadryl and schedule appt to be seen today (1/8/13).
PATIENT WAS "WOOZY" AND FEINTED APPROXIMATELY 30 MINUTES AFTER ADMINISTRATION OF FLU SHOT.  PATIENT REPORTED SPOTS IN HIS VISION, TINGLY FINGERS, AND DIZZY FEELING.  PATIENT DID NOT LOSE CONSCIOUSNESS.  PATIENT WAS NOT TREATED BY US--911 WAS CALLED, PARAMEDICS GAVE OXYGEN AND TOOK HIM TO ER FOR OBSERVATION.
Feels winded and having hard time catching breath while walking, issues not normally occurring for patient. Slight rash and knot at injection sight.
received Kinrix, exposed to temperatures above recommended; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that in october 2021 patient received Kinrix which has been exposed to temperatures above the recommended range. The Kinrix reached 59 f for 80 cumulative hours, which led to incorrect storage of drug. The permission for follow up was not asked.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 15-year-male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. (loss of consciousness), pallor, he did not remember what happened, nausea, fever of 102, headache, malaise. Fever gone in 24 hours but he was diagnosed with pre septal cellulitis. No fever third day. No headache third day. The outcome of the other adverse events was unknown.
Foggy head starting 4 days after injection, low grade fever - 99.3 - one week after for one evening
Patient received an RSV and COVID-vaccine last week Wednesday (10/11/23), and on Wednesday 2 days ago a flu vaccine (10/18/23).  Wife states that on Thursday he was having difficulty walking, and essentially unable to stand by himself, bring him to the ED