chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough. Patient tested positive for COVID on 2/25/22 while admitted to the hospital for other reasons. Patient is asymptomatic for COVID.
received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe). At the time of the report, PRODUCT STORAGE ERROR (received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product details was not reported.  Treatment details was not reported .  On 01Jun2021, 14 unknown patients each received one Moderna COVID-19 vaccine dose that was stored in refrigerator beyond 30 day timeframe. No additional adverse events reported; all fields apply to all patients.
HPV vaccine admin deltoid. 1 minute or less later, pt had syncopal episode and quickly revived with ammonia capsule. 2 min later/LOC; BP not audible, pulse thready, diapharetic, gray color - IV started with normal saline O2 per mask, EMS called - revived - NO ER visit. Nausea and headache remainder of day.
the evening of the administration of vax pt awoke w/labored breathing & entire body trembling; pt appeared flushed & had a t103+; pt taken to ER, was monitored & then sent home; episode last approx 30 mins; next day pt had low grade temp;
The case was reported by a healthcare professional and described the occurrence of fever in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline), PNEUMOVAX, (Merck) and Tetanus diphtheria vaccine (Sanofi Pasteur).  On an unspecified date in September 2008, the subject received an unspecified dose of FLULAVAL (.5 unknown), an unspecified dose of PNEUMOVAX (unknown), and and unspecified dose of Tetanus diphtheria vaccine (unknown).  At and unspecified time after vaccination with FLULAVAL, PNEUMOVAX and Tetanus diphtheria vaccine, the subject experienced fevers of over 102 degrees Fahrenheit during the next five days.  The subject treated her symptoms at home, but was seen in the physician's office for a follow-up.  At the time of reporting, the event was improved.  Follow-up information received on 07 October 2008 indicated that the subject was 51 years old at the time of event.  She had never had flu or Pneumovax.  The subject's fever went up to 104 degrees F for 1 to 2 days starting on 12 September 2008 and then resolved.  In  the reporter's opinion, the event was possibly related to treatment with FLULAVAL.  All vaccines were administered intramuscularly at a dose of 0.5 ml each.  FLULAVAL and Pneumovax were administered in the same unknown arm.
patient states she had a painful injection site shortly after the injection that lasted a few days then resolved. on 11/20/23 she states she had a bruise appear at injection site and felted flushed. the bruise was still there on 11/21/23 and is sore.
Patient did not have any reactions. Still awaiting a full report from Moderna to confirm if vaccine is still viable 1 day after the beyond used date. Outcome will be determined after we hear back from Moderna.
Fatigue; very hot; slight tenderness left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight tenderness left arm at injection site), FATIGUE (Fatigue) and very hot in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0010218) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness left arm at injection site). On an unknown date, the patient experienced FATIGUE (Fatigue) and very hot. The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (slight tenderness left arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported   This case was linked to MOD-2021-083794 (Patient Link).
Shaking; Sickness; Cold; Feeling bad; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness). At the time of the report, TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness). At the time of the report, TREMOR (Shaking), ILLNESS (Sickness), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feeling bad) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter.
Starting 06/12/2022, I developed a headache, sore throat, slight sweating, no fever and lots of body aches. I did an at home test on 06/12/2022 which was positive. I went to the clinic on 06/13/2022 to get a rapid COVID test and it was positive. So, I went home to rest. I called the nursing line and she recommended MUCINEX, ROBITUSSIN and EXCEDRIN for headaches. As of today, I am feeling a little better but still feeling pretty fatigued. I did an at home test today and it was positive.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of RECOMBIVAX with lot number  N002913 and expiration date of 23-FEB-2019 (strength, dose and route of administration were unknown) for prophylaxis. The vaccine was stored from 47 Fahrenheit degrees (°F) to 77°F for 18 minutes and reconstituted with properly stored sterile diluent with lot number reported as N007550 and expiration date of 03-MAY-2018. There was no previous temperature excursion. However, the temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA010583: US-009507513-1705USA010584:
Information has been received from a registered nurse concerning a 63 year old male with no pre-existing allergies, birth defects or medical conditions, who was vaccinated in the right arm at 10:00 AM with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 658763/1341U) instead of zoster vaccine live (Oka/Merck).  Concomitant medications included: influenza virus vaccine (unspecified) and pneumococcal 14v polysaccharide vaccine (manufacturer unknown). Nurse stated this was not a product quality complaint, staff error only. There was no adverse events recorded. There was no illness at time of vaccinations. There were no adverse events following prior vaccinations. No other information. Unspecified medical attention was sought. The patient was seen in the office. The outcome was reported as recovered. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 month old male, with no pertinent medical history or allergies, who on 17-JAN-2008 at 10:30 am was vaccinated subcutaneous with his first dose of Zostavax (Oka/Merck) (lot # 658838/1412U) instead of a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  There were no illnesses at the time of vaccination.  There were no concomitant medications.  It was reported that the error occurred because both vaccine's vials and boxes were similar in appearance.  No diagnostic labs were performed.  A product quality complaint was not involved.  Additional information is not expected.  This is one of several reports received from the same source. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Further information is not expected.
It was reported that a 70 year old female received Fluzone SV '99-'00 on 10/6/99. On 10/8/99, the pt experienced a rash on her arm. The pt recovered completely.
11:37 am. notified the RN in the Observation area that she was feeling very dizzy. Immediate evaluation by onsite EMS and NP. VS @ 11:40:  90/60;p.55; O2 sat 99% VS @ 11:42: 91/45; p 56; O2 98% Offered patient water and cereal bar.  She stated that helped with the dizziness. VS@ 11:54: 100/70; p 65. O2 sat unchanged. Discharged home at 12:00 hours.
Swelling; redness, pain down arm, Benadryl PRN, Medrol dose pack, Augmentin 500mg/Bid x 1 week
Prolonged swelling at the injection site, continued pain at the injection site as well as the entire right shoulder, and both hips and proximal thigh muscles.  Decreased range of motion of right shoulder
COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.
malaise; fever; sweats; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 10Mar2021 for covid-19 immunisation and experienced soreness in arm. The patient's concomitant medications were not reported. After second dose of Covid vaccine, patient developed malaise, fever, and sweats on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness, tingling and weakness in left arm, left hand, left leg and left foot within an hour of injection.
A 58 year old male pt was treated with OncoTICE for bladder cancer. Reportedly he experienced dysuria during the initial treatment. Due to cancer recurrence a second treatment cycle was started. In this second round the dysuria worsened. On 3Aug04 he also experienced hematuria.
bedbound; dizziness; pain; fever; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever) and MYALGIA (aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, BEDRIDDEN (bedbound), DIZZINESS (dizziness), PAIN (pain), PYREXIA (fever), MYALGIA (aches) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-055658 (Patient Link).
POST-VACCINATION AIDP-CIDP (GUILLAIRE BARRE SYNDROME/CHRONIC INFLAMMATORY DEMYELINATING POLYRADICU\LONEUROPATHY) TYPE SYNDROME ASSOCIATED WITH ATAXIA AND DIFFUSE NEUROPATHIC SYMPTOMS. ON 4/16/2021 I WOKE TO SEVERE ABDOMINAL PAIN BLOATING.  THIS HAS CONTINUED DAILY SINCE. ONE WEEK FOLLOWINGM MY FEET AND LEGS BURNED AND SINCE HAVE NO FEELING.NANOTHER WEEK LATER SAME SYMPTOMS IN HANDS FOREARMSN JAW AND TEETH. HANDS CONTINUALLY BURN 24/7. I HAVE LOST 31 LBS IN 3 WEEKS. MY MOBILITY CONTINUES TO WORSEN DAILY AND AM NOW USING A CANE AND WHEELCHAIR.  DUE TO MY LACK OF EQUILIBRIUM I LOST MY BALANCE AND FELL BACKWARDSN INTON A HOTN FIRE NPIT RESULTING IN 3RD DEGREE BURNS ON LOWER BACK AND LEFT ARM AND HAND.
Information has been received from a 66 year old female with asthma, restless legs syndrome, and an allergy to an unspecified antibiotic who on 26-OCT-2006 was vaccinated SC with a 0.5 mL dose of ZOSTAVAX. Concomitant vaccination at the same time included a dose of influenza virus vaccine (unspecified). Other concomitant medication included montelukast sodium (MSD), clonazepam (CLONOPIN), and ropinirole hydrochloride (REQUIP). on 26-OCT-2006, nine hours after vaccination, the patient began to itch all over. She was treated with cetirizine hydrochloride (ZYRTEC), but continued to itch all over. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. 6/17/10 Additional informationi has been received from the patient's physician who reported that on 27-OCT-2006, the patient had puritis and a rash and went to the emergency room. The patient recovered on 29-OCT-2006. Medical records revealed that the patient was admitted to the emergency room on 27-OCT-2006 at 19:38 PM. The complaint was reaction to shingles vaccine, rash, itch and voic going. It was noted that the patient had a history of high cholesterol and hypothyroidism. The patient took 40 mg of prednisone and at 20:00 PM no rash was noted. She was alert and oriented, her speech was clear, and no shortness of breath was noted. The clinical impression was that she had an acute allergic reaction to varicella-zoster virus vaccine live ZOSTAVAX (Merck). The patient departed the emergency room at 21:40 PM. Additional information is not expected.
pt recv vax & soon p/exp a cardiac arrhythmia;the episode lasted about 24hr & resolved w/o intervention;
more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pain; more than usual vaginal bleeding; more than usual vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Facility type Vaccine: Other. Medical history included known allergies: Sulfa and Folate deficiency. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) on 15Mar2021 10:30 AM in left arm for covid-19 immunisation and experienced vaginal bleeding/blood clots at mid-cycle on 15Mar2021 08:00 PM. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced more than usual vaginal bleeding/with very dark blood with clots, menstrual cramps, sharp pelvic pain, all on Apr2021 with outcome of not recovered. Clinical course: After the first dose, the patient had vaginal bleeding/blood clots at mid-cycle. The same day after the 2nd dose, she started feeling menstrual cramps and sharp pelvic pain. After taking paracetamol (TYLENOL) and feeling a bit of relief, she stood up and started having more than usual vaginal bleeding at the level that it reached the floor as if it was a hemorrhage with very dark blood with clots. This lasted for 1 minute. This lasted for 5 days and 7 days later, she started bleeding again with dark blood clots for a period of 3 days. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for events more than usual vaginal bleeding/with very dark blood with clots.
Patient is accompanied by father and sister for vaccination, requesting four vaccines to be done at one sitting for school requirement. history of vasovagal reaction. patient was seated at the bed during vaccination with father sitting next to her. Patient was stable post vaccination. About 4-5minutes after vaccination, patient fainted and hit her face on the fall. No loss of consciousness after the fall. She had chipped her tooth from right front tooth (central incisor) with small laceration on the lower inner and outer lip. The piece of chipped tooth was intact and out of mouth. Tooth root was not exposed. Bleeding of laceration was controlled. No other injury was noted. Patient was laid flat on bed, with direct supervision and frequent vital sign check. BP96-60 HR6; BP94-60 HR72; BP96-68 HR68. Heart rate and rhythm regular. RR 16. O2sat 99-100% on room air. Bilateral radial pulses palpable. Neuro check was normal. wound was cleaned with NS and gauze. Patient was able to gargle and spit to rinse her mouth. No other oral injuries, face/head injury, joint injury noted. She was able to have a small cup of water. Father declined EMS and ED transport for further evaluation and injury. Patient was in the clinic for about 90 minutes with my direct supervision with father in the room. Patient's father connected with his friend at Fire Department and took the patient there to be evaluated.  Follow up - I attempted to call for follow up on 7/27/22 at 6:24pm and 6:45 pm, 7/28/22 at 2:23pm, and 7/30/22 at 9:15am - unable to reach father/patient, unable to leave a voicemail due to voicemail box is full.
death due to myocarditis; due to type II polio virus-due to oral sabin polio vax; also found hepatitis & disease liver, & brain lesions;
Complaints of itching at site ( left inner forearm) since 8/26/2022. Not improved after using hydrocortisone cream.  Area of redness is the size of the dime and has not increased since vaccine given.
she took the syringe out of the tray and noted the flange was broken; the broken syringe cut ther finger and she had blood; the broken syringe cut ther finger and she had blood; the broken syringe cut ther finger and she had blood; This spontaneous report was received from a health professional via a company representative and refers to a female patient of unknown age. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient worked with a box of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) where one of the syringes was broken (Syringe issue). The patient reached to grab it when she cut her finger on the syringe (Skin laceration and Accidental exposure to product). It was reported in regard to the incident that "She took the syringe out of the tray and noted the flange was broken. The broken syringe cut her finger and she had blood." and also in regard to the question whether the product was administered or exposed to patient's bodily fluids "not administered but caller did get a cut on her finger from broken flange that drew blood" (Exposure via blood). The reported lot# was U032668 and the expiration date was confirmed to be 24-APR-2023. The outcome of these event was unknown.