chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, was initially received from other health professional (nurse) on 05-Oct-2017, concerning a 38-year-old adult female patient. The patient's medical history was not reported. The patient's concomitant medications included: VENTOLIN, NEXPLANON and calcium for unknown indication. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195221 and expiry date: 30-Apr-2018). The patient received vaccine that underwent temperature excursion (less than 32.54 degree F for about 25 hours). It was reported that, after vaccination the patient had not experienced any adverse event. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up received from the reporter on 24-Oct-2017: The route of administration, anatomical location and additional event were added. Narrative amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (195221) was captured in the case form and narrative was amended accordingly.
Red blotch noticed by patient near the site of vaccine administration, left deltoid.  Noticed more blotches developing on 10/22/2009 AM.  Patient took Benadryl 25mg at 05:30AM on 10/22/2009.  Seen in clinic at 09:45 AM.  No itching reported. No pharyngeal edema noted. Denies difficulty breathing or swallowing.  Vital signs stable.  Benadryl 25mg po repeated at clinic and instructed to continue as directed until resolves.  Instructed to call 911 if develops difficulty swallowing or breathing.
Developed pain, swelling right shoulder evening after injection. 2 days later, could not lift right arm. Presented to PCP on 10/17/2005 with right shoulder bursitis and torticollis.
Swolen lymph node under left arm, noticed  morning of second day after shot -- that is less than 48 hours.
Fever <102F, malaise, nausea, swelling, soreness, myalgia.
Not sure if the vaccine was administer into the muscle or into the joint; Difficulty of moving it or raising it; Shooting pain down the arm when receiving the vaccine/Arm very tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint), VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint), VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included paracetamol and advil.  No concomitant medication was provided.   This case was linked to MOD-2021-031708 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate route of vaccination for mRNA-1273, lot# 024M20A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pediatric pfizer was not mixed with diluent. I contacted the child's mother to explain the situation. I told her that her child may experience stronger site reaction than usual. The mother did not seem to be too concerned. I offered to call the child's doctor and let him/her know the details of what occured.
Pt received FLUMIST, MENACTRA and GARDASIL, had syncopal event, fell & head injury, and had approx. 15-20 sec generalized seizure.
Within a few hours, pt. had back and neck pain, crying, giddiness, weakness in her limbs.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # L016429 and expiry date on 30-AUG-2017) (dose and route of administration were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt rcvd a 0.2 mL volume injection of Moderna vaccine (blue cap for 6 months-5years) when it should have been 0.25 mL. Clinic noticed error, notified parents of patients, advised of current CDC recommendation for this error, and change clinic practice to prevent future errors.
Lymphadenopathy, left axilla - severe. developed same side as injection in 24 hours - persisted >72 hours.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: needle broke off into arm-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Upon removing the needle from the arm of the patient the needle broke off and remained in the patient's arm. Staff were unable to remove the needle as it had gone below the surface of the skin. Patient was taken by ambulance to the nearest emergency room for further evaluation and treatment.
Revaccination with different COVID-19 vaccine; No adverse event; they administered a 2nd dose of Pfizer today to a pediatric patient who got the Moderna Covid-19 Vaccine as their 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (they administered a 2nd dose of Pfizer today to a pediatric patient who got the Moderna Covid-19 Vaccine as their 1st dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 08-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (they administered a 2nd dose of Pfizer today to a pediatric patient who got the Moderna Covid-19 Vaccine as their 1st dose). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (they administered a 2nd dose of Pfizer today to a pediatric patient who got the Moderna Covid-19 Vaccine as their 1st dose), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (they administered a 2nd dose of Pfizer today to a pediatric patient who got the Moderna Covid-19 Vaccine as their 1st dose) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). No treatment medication was provided.
Headache, chills, muscle and joint aches, dizziness and lightheadedness beginning 8 hours after vaccination and lasting approximately 36 hours.
afib and myocarditits over past year or two, now cabg needed, stress tests etc. before covid vaccine showed a strong heart, now multiple blockages and 1 90-95% blocked
Chills/shaking, very sore arm, flu like symptoms, malaise, headache, sore chest, tiredness
Extreme fatigue, muscle aches, fever, chills, followed by chest pain, heart palpitations, tachycardia, general feeling of something very wrong with my heart. Heart felt as if it was beating out of my chest.
Was given shot Jan 10, 2022 on Jan 27th I started with pain in left calf. Went to ER Jan 31st 2022. Was positive for blood clot.
Patient had no adverse effects, but he was given FLUZONE QUAD instead of the Meningitis vaccine that he was requesting. Patient had already received his flu shot earlier in the year.
This is one case out of a cumulative total of 216 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 October 2013. These 216 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 18 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot numbers not reported received on 07 June 2011, 13 September 2011 and 13 December 2011 and lot number C4194AA received on 26 July 2012 (routes and sites of administration not reported). The subject developed a cough on 23 August 2013, approximately one year after the last dose and paroxysmal cough on 23 August 2013 with a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 07 September 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 September 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 08 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Cramping in 1 finger in 8/99, progressed to cramping, muscle weakness, fasiculations and atrophy of both hands and forearms by 11/99 causing progressive disability. Treatment with Doxycycline and occupational therapy, did no improve. Extensive testing resulted in dx in 7/00 of motor neuropathy with nerve conduction block on auto-immune response. IV immunoglobulin therapy initiated on 11/27/00 with unknown results; may have to be continued indefinitely.
On October 12, 2011, I received a flu shot. On October 31, 2011 I had to leave work with a bad migraine. The next evening I began to have a pounding sensation in my head, after about 20 minutes I notified family. About 10 minutes later that pounding made me lethargic, and I had small drooping on the left side of my face. I was brought to hospital by family. I was discharged from hospital on 11/3/11. On 11/5/11 I felt cramping in both legs, the following day I had more pain up to my knees. On 11/7/11 I was awoken with throbbing pain in both legs, when I went to get out of bed my legs could barely hold be up. Again I went into hospital. After testing I was given treatment for Guillain Barre (IV/IG). Prior to the treatment the numbness has traveled up to the left side of my chest and in both arms and hands. I was given the treatment and breathing tests throughout the night. I was treated with the IV/IG for 4 more nights. On or about 11/10/11, physical therapy began to teach me to walk with a walker. On 11/13/11 hospital discharged me to rehabilitation where I continued therapy for walking and hand/eye coordination. I was discharged from there on 11/26/11 with the understanding that I needed someone with me 24 hours a day. I was using a shower chair and required assistance to go up or down any steps. I began outpatient therapy on 12/2/11 through rehabilitation with visits three times a week and at home exercises. On 12/26/11, I was back at hospital for what they believed was a relapse of Guillain Barre, I was discharged on 12/27/11. On 1/13/12 I began treatment at the clinic where I am currently still treating. I have also been treating regularly with my Primary Care Physician.
Pain on right side of rib cage and right side of right breast.  Pain for approximately 1 week prior to seeing primary care MD.
Patient received first dose of Pfizer. A couple  minutes later patient felt dizzy and fainted. EMS responded and took vital signs HR 60, BP 144/87 O2 sats were 96%. Patient was offered to be transported if he felt like he needed it. Patient declined transport.
DIZZINESS; UNUSUAL TASTE IN MOUTH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, and unusual taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and unusual taste in mouth. This report was non-serious.
After administration of the vaccine within 1 minute, the patient had a loss of consciousness.  The patient was laid supine with feet elevated.  She regained consciousness after 30 seconds.  Vitals remained stable throughout.  BP 110/72   P64 O2 99% at the time of regaining consciousness.  After 5 minutes 118/88 P 64.   After 30 min 118/78 P 64.  Left with mother and sibling.
Patient felt fatigue 24 hours after vaccine.  Patient developed rash 48 hours after vaccine.  Advised use of topical hydrocortisone cream and oral antihistamine.  Advised to follow up with physician.
C/O diarrhea and cold sweats for 2-3 hours following injection.
On 1/11 started exp chills, lost of smell/taste (lasted until Saturday) and no fever.
Started as a red spot almost immediately after receiving the injection.  It is now about 3 inches in diamiter and a darb brownish/black rash.
Information has been received from a registered nurse concerning a 43 year old female who on 9/10/03 was vaccinated with hepatitis A virus vaccine inactivated (lot # 644169/0981M). Subsequently, hepatitis A titers at 2 and 4 weeks were negative. The patient sought unspecified medical attention. Additional information has been requested.
Fever, chills, rash on neck (throat area), wheezing, fatigue lasting more than two days , post nasal drip, dry cough, sore arm going on 6 days, on and off headache going on 6 days, change in appetite. Fatigue has interfered with ability.to work
Swelling and slight itching of localized area and rash around neck and stomach areas.  Took a Benadryl at night on 4-12-22 Notified doctor through portal message
pt devel a low grade temp 103.5 R & then had a focal sz followed by a generalized sz;pt was taken to hosp & tx w/ceftriaxone;pt had another sx returned to hosp & underwent several test;dx febrile sz;pt had 3rd sz & adm to hosp;Annual follow-up dated 11/27/00 provided no additional data.
Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
Tinnitus in both ears.  A very loud, high-pitched "ringing" noise, like an "angry" violin, in both ears
Right arm Swollen and tender lymph node; Right arm Swollen and tender lymph node; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 28Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included psoriasis, psoriatic arthritis, chronic back pain and childhood asthma. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient known allergies was tramadol. On 29Dec2020, the patient experienced right arm swollen and tender lymph node. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.