chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an approximately 73 years old female patient. On 19-JUN-2014 the patient was vaccinated with a single dose of ZOSTAVAX (lot # K000995, exp. 16-MAR-2015), subcutaneous about 1.5 inches above her left elbow. The patient developed redness at the injection site. The patient was subsequently evaluated by her unspecified physician, on an unspecified date, with an asthma exacerbation. The patient was treated with prednisone (manufacturer unknown) and an unspecified inhaler. Patient sought medical attention: visited office with unspecified physician. The outcome of redness at the injection site and asthma exacerbation was reported as recovering/resolving. Relatedness between redness at the injection site, asthma exacerbation and ZOSTAVAX was not reported. Additional information has been requested.
05/06/2022 I had a severe headache and vision changes in my left eye. The pain was significant enough I knew I was having hypertension or a stroke. I went to the emergency room and my blood pressure was 200/80. They did a CTA and a diagnostic MRI to confirm that I had a right occipital stroke. I have been in recovery since. Except for some vision loss, I have recovered.
experiencing blood clotting in my right leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EL9264) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing); "known_allergies: Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose , Batch/Lot Number: EL3247, Location of injection: Arm Left), administration date: 19Jan2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Oct2021, outcome "not recovered", described as "experiencing blood clotting in my right leg". The event "experiencing blood clotting in my right leg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombosis. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination.
Blood clots in lung; coughing up large blood clots; duration lasted approximately 5 weeks
Person exhibited systemic hives.  Oral Benadryl, Medrol dose pack ordered.
Pt fainted & was caught by an attendant in the 15 min. waiting area.  Taken to Observation area on cot. Pale & diaphoretic.  BP110/70 P56 pt states has history of fainting after shots.  Rested 20 minutes, eating sweets, alert & active.  color good.  Released without assistance.
about 7 hours after injection, the site was sore and tingling. Throughput the evening, the tingling sensation progressed up the left side of my neck and my ear.  My ear felt similar s to Novacaine wearing off after a dental visit. During the night my throat got a similar sensation and created the need to try coughing it out. By 24 hours after the injection I was tired, with sore joints and muscle aches. By 36 hours I was still sleeping it off and at 48 hours I feel pretty well back to normal.
Muscle pain all over the body, injection site sore to the point cant lift left arm, nausea, low-grade fever/chill, diarrhea, sore throat, congestion and runny nose.
slept, was not really conscience from 9am until the following morning, probably around 10am.  After that I was awake but still pretty incoherant until about 3pm, then just tired and wobbly.
Immediately after administration of GARDASIL, pt had a syncope episode which lasted about 60 sec. Pt was examined by a physician. Pt pulse was 44, BP: 122/65. Pt laid down for 15 mins and was given juice. Vital signs were: BP: 114/70 O2: 100, Pulse: 60. Pt remained seated for an additional 15 mins. Vital signs were 126/77, O2: 99% and Pulse: 65. Pt was clear to go home by PA.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 06-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose). At the time of the report, ACCIDENTAL UNDERDOSE (realized it was her second dose not booster/second Moderna dose administered on 06Jul2022 Lot#054A22A half dose) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment drugs were reported. It was reported that caller declined providing any patient information at that time. Caller's first dose was Moderna as well so they did not mix. Nurse at local health department reports there was a client yesterday that received a half dose Moderna vaccine because they were informed it was their second booster dose.
swelling & pain in inject site which extended to mid-arm, shoulder, & over collar bone; neck also swollen w/lymph node enlargement;
Eyesight did get worse/ looked in the mirror and she couldn't see her brown eyes (instead it looked gray and "wishy washy")/ television did not look clear at all/ vision was diminished; woke up with her legs feeling like they had "all things running up and down,"it felt like something was crawling on her legs; legs felt like it was tired; legs felt like it had pains; injection site was red; injection site was swollen (3inches long 2inches wide); it is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Eyesight did get worse/ looked in the mirror and she couldn't see her brown eyes (instead it looked gray and "wishy washy")/ television did not look clear at all/ vision was diminished), LIMB DISCOMFORT (woke up with her legs feeling like they had "all things running up and down,"it felt like something was crawling on her legs), FATIGUE (legs felt like it was tired), MYALGIA (legs felt like it had pains) and VACCINATION SITE ERYTHEMA (injection site was red) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included TRAMADOL for Pinched nerve, LORAZEPAM, ACETYLSALICYLIC ACID (BABY ASPIRIN), CENTRUM MINIS WOMEN 50+, COLECALCIFEROL (VITAMIN D 3) and SERTRALINE for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VISUAL IMPAIRMENT (Eyesight did get worse/ looked in the mirror and she couldn't see her brown eyes (instead it looked gray and "wishy washy")/ television did not look clear at all/ vision was diminished), LIMB DISCOMFORT (woke up with her legs feeling like they had "all things running up and down,"it felt like something was crawling on her legs), FATIGUE (legs felt like it was tired), MYALGIA (legs felt like it had pains), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (injection site was swollen (3inches long 2inches wide)) and VACCINATION SITE PRURITUS (it is itchy). On 06-May-2021, LIMB DISCOMFORT (woke up with her legs feeling like they had "all things running up and down,"it felt like something was crawling on her legs), FATIGUE (legs felt like it was tired) and MYALGIA (legs felt like it had pains) had resolved. At the time of the report, VISUAL IMPAIRMENT (Eyesight did get worse/ looked in the mirror and she couldn't see her brown eyes (instead it looked gray and "wishy washy")/ television did not look clear at all/ vision was diminished), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (injection site was swollen (3inches long 2inches wide)) and VACCINATION SITE PRURITUS (it is itchy) outcome was unknown.            No treatment drugs were reported.
shivers from approximately 9:00 PM until 1:00 AM. it did not seem like a fever as I did not sweat. I felt run down and tired the following day. Felt normal two days following vaccine
Mild symptoms, slight fever; Tired the following day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Received first dose on an unknown date, refer case US2023AMR050200).   On 28-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 29-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced fever (Verbatim: Mild symptoms, slight fever) and tiredness (Verbatim: Tired the following day). Rechallenge with Shingles vaccine was positive. The outcome of the fever and tiredness were not reported.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the fever and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR050200   Additional Information: GSK receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her second dose on Tuesday. Same mild symptoms as the first, slight fever and tired following day. The follow up would not be possible as no contact details were provided.; Sender's Comments:  US-GSK-US2023AMR050200:Same reporter.
This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The patient's past medical history included Surgery on 26-May-2021. Concurrent medical conditions included Throat cancer since 30-Apr-2021. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Gone beyond the 42 day mark between doses) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Reporter stated that the patient did not receive the second dose on time because the patient was in the hospital at the time. Patient was diagnosed on 30-Apr-2021 with throat cancer and had surgery on 26-May-2021. The reporter stated the patient was hospitalized until 20-Jun-2021.
Case number PHEH2013US020099 is an initial spontaneous report from the consumer received on 23 Sep 2013. The report refers to a 63-year-old male patient. He was vaccinated with FLUVIRIN (batch number: not reported) in the upper arm via intramuscular route, on an unknown date in Oct 2012. Twelve hours after vaccination, he presented with raised red rash all over his body. The outcome of the event reported as recovered on an unknown date in Oct 2012.
The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F).  My muscles ached all over.  I could not get out of bed until 5:00 pm.  After that, I was able to do my chores (laundry and washing dishes).  I was fine the following day.
Chills, headache, muscle aches, fever, nausea  Felt cold at  3:30 pm, 4/30/2021- mild muscle aches began, by 7:00 pm began having significant chills lasting till  midnight.  Took OTC ibuprofen to reduce mitigate chills and headache.   5/1/21 - still getting  headache/migraine.  12:00 pm Chills and achiness gone.  No nausea at that time.  4/30 2021 to current 5/8/2021 still getting daily headaches and migraines primarily from back of neck and head to forehead. Taking OTC ibuprofen and Maxalt melt  for relief.
Headache followed by Tinnitus. Increased blood pressure at onset of each. Headache remains at lower pain level. Tinnitus continues with no change, in both ears and has not improved.
After injection pt. had pain in shoulder (left). Pain has not gone away since injection on 9/30/17. Gets "clicking" noise and difficult to raise arm over head.
Doesn't see well anymore; Doesn't hear well anymore; Decided not to get the second dose in the series; "Didn't feel good"; Left arm hurt; Some dizziness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and DIZZINESS (Some dizziness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), DIZZINESS (Some dizziness) and PYREXIA (Slight fever). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series). At the time of the report, FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore), DIZZINESS (Some dizziness) and PYREXIA (Slight fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient had no known drug or food allergies.  No treatment medications were reported.
The patient presents with headache.  These symptoms began today.  She is not having fever.  Other comments include: mom states that pt has a Gardasil injection yesterday. Mom states that pt feels like every time she breathes, she has had some body aches, headache with light and sound sensitive  - HA L front and R back and pulsing, no belly pain now headache and throat feels weird when breathing, + lightheaded, no fever, but some chills and felt cold yesterday and today. She drank water throughout the day and has eaten as well.
exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.
1 of 2 pts devel inject site reaction-size of a golf ball which consisted of erythema, induration, swelling & site was hot to touch; also had fever to 103; dx sterile abscess; treated w/Augmentin/APAP/compresses; recovered;
No adverse effect were reported; patient was inadvertently administered one dose of expired VAQTA; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.  On 08-MAY-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) (anatomical location and route of administration were not provided, lot # N032753, with expiration date of 23-MAR-2019, which was valid) for prophylaxis. No adverse effects were reported. The outcome of the event was unknown.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JUN-2012, the patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA, expiry date 05-DEC-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted, she regained consciousness within 5 seconds, she vomited &  she was lethargic.  Paramedics arrived at the scene within  10 minutes and treated the patient off site.
I was instructed by my PCP to report that after testing positive for Covid-19 on 7/11/21 I was admitted to the hospital on 7/18/21 and was there for 17 days 10 of which were in the ICU.  I was on a high flow cannula and mask at full and have been discharged at home on oxygen at 3 liters.  I was fully vaccinated on 4/11/21 and my first dose was on 3/17/21.  (side note: after my first dose I had hives about 2-3 hours after receiving it and when I got the 2nd dose I stayed a 1/2 longer and had no reaction at all.)
headache, achy, fatigue 3/25/21 @ 1100 hrs. Rash and hives all over body 3/26/21 @ 0700 hrs and began taking benadryl. Teladoc session on 3/28 @ 1715 hrs as condition became worse. Prescribed predniSONE 20 mg oral tablet. Began medication on 3/28 @ 1800 hrs
Received Varivax 7/10/13 - developed 10 "pox" lesions on legs and trunk (bilateral). No systemic symptoms, no fever, no cough - seen in office 7/20/13 to evaluate.
A few hours after injection, I felt some pain and soreness in my arm. My arm has a large red area that is warm and painful to the touch. It has continued to grow in size over the last two days. I also experienced fatigue, decrease then increase in body temperature, dizziness, and headache.
MD @ hosp dx w/transverse myelitis-severe back pain, went from waist down-pt lost use of both legs then control of bladder & bowels;
Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Batch number: EL9265 dose 1) on 29-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (Batch number: EN6203 dose 2) on 19-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 20-Apr-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.