chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse effect; Nausea; Vomiting; Could not walk; Very sick; Gargled words; Did not sleep all night; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words) and INSOMNIA (Did not sleep all night) in a 99-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 026A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse effect), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. On an unknown date, Body temperature: 97.6 (normal) No fever 97 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant therapy included blood pressure medication. No treatment medication was reported by reporter.  Patient's adverse events except fatigue were recovered by the date of reporting.
Patient received 0.3mL of the vaccine rather than the recommended 0.2mL.  Patient and family was educated.
PT IMMUNIZED AT 10:30 AM AND AT 9:00PM PRESENTED IN ER. PARENTS REPORTED 6 TO 10 SEIZURES WHICH STARTED AT 7:30 PM. PT'S EYES ROLLED BACKWARDS BECAME STIFF AND TURNED BLUE.
Right shoulder pain, right flank pain, midback pain, right knee pain. Started AM on 2/19/2021. Worsened, unable to move right arm ,pain hindered mobility for walking, unable to bend sue to back pain.
Raised, red, itchy lesion at vaccine site that began two days after vaccination. Hot and painful to touch. Feels better with cold compress. Steroid cream does not treat itch (tried betaderm)
Almost immediate fainting after GARDASIL vaccine. Still sitting on exam table so caught by me/Mom as she fell forward. Vaccination nurse helped position on back on table. Four nurses and doctor came in after.  Some stiffened muscles (straight legs) with fainting. Came back around shortly after nurse rubbed her closed eyelid. Very pale. Provided juice, water, and Nutri-Grain bar. Some nausea on drive home after waiting a bit to leave clinic.
I developed shingles in my ear that led to Ramsay Hunt syndrome with facial paralysis. As an otherwise healthy, 20 year old girl it?s very rare for my demographic and should not have happened
Pt presented with lips and face swollen w/i 2 days. Went to prescriber on day 4, prescribed diphenhydramine 25mg Q8h. Swelling went away by day 7 as reported by pt.
Cellulitis left arm at injection site. Antibiotics given - CEPHALEXIN 500 mg x 5 days.
Patients gets flu shot every year yeah get sick every year; patient was so bad they thought he had cold it but when they tested and he did not but had to be on a breathing machine a z-pack; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patients parents) via social media.  This case involves a male patient of unknown age who gets flu vaccine every year yeah get sick every year (illness) and he was so bad they thought he had cold it but when they tested and he did not but had to be on a breathing machine a z-pack and have his oxygen levels checked (dyspnoea), after patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who gets flu vaccine every year yeah get sick every year (illness) and he was so bad they thought he had cold it but when they tested and he didn't but had to be on a breathing machine a z-pack and have his oxygen levels checked (dyspnoea), (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of events was unknown.  There will be no information available on the batch number for this case.
About 5 hours after my shot, I started to have a horrible headache.  As the evening progressed, my arm was extremely sore and a little red around the injection site.  Over the next couple of days I continued to have a headache and also ended up having nausea, muscle soreness, some food started tasting not right (I did not lose taste or smell), cough, & horrible fatigue.   I went to Urgent Care on 1/17/21 due to feeling so poorly and had to miss work that evening.  While at Urgent Care, the doctor provided me with cough medication that also had something in it to help with nausea.  They also said that they would be doing a COVID test since I was having some symptoms and even though it was probably from the shot, they wanted to test anyway.  The test finally came back as negative.  A week after the shot was done, my arm turned horribly red and swollen around the injection site.  Over a few days, the spot on my arm grew a little bit but was just more so irritating that it was itching/hurting.  By week #2 after having the injection, the redness in my arm as well as all of the symptoms, minus the fatigue, went away totally.
Thrombocytopenia detected through monitoring CBC. Normal platelet counts for 5+ years     Normal platelet count 2.5 weeks prior to vaccination.   Low counts (69k) detected 1 week post vaccination Count of 42k detected 1.5 weeks post vaccination.  Prednisone treatment started. Counts have partially responded to prednisone treatment.  Patient is still receiving treatment 4 weeks post vaccination
After the vaccination, I felt a little dizzy waiting in the parking lot and had a sore arm, but felt fine otherwise.  (12:00-1:00 pm)  After returning home, I felt increasingly tired and warm.  I laid down  and took my temperature after walking the dog around 3:00 pm.  My temperature read 99 degrees.   I drank a lot of pedialyte to hydrate.  Throughout the afternoon, I felt sluggish and the glands seemed to swell up on the side of my neck. I also got a headache.   My temperature dropped down to 98.7 before I went to bed, but this morning, my glands under my jawline are a bit more swollen and I still have a slight temperature; 98.9 degrees.  My eyelids are puffy and I feel a little feverish, but it is tolerable.
dose of expired diluent administerd; This spontaneous report was received from a nurse regarding to a 36-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-APR-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N013296, expiry date: 28-APR-2019) 0.5 milliliter via subcutaneous route for prophylaxis along with one dose of expired sterile diluent(MERCK STERILE DILUENT) (lot# N013296, expiry date: 28-APR-2019) (expired product administered). It was reported that Merck diluent was stored in proper storage conditions according to nurse. No adverse effect reported. The outcome of expired product administered was unknown.
tested positive to covid; tested positive to covid; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 11:30 (Lot number: EN6199) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to Penicillin" (unspecified if ongoing); "Bell's Palcy" (unspecified if ongoing), notes: Patient had Bell's palsy in late 90's. There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "allergy: Prednisone", notes: He is allergic to Penicillin and all steroid medications.; Methylprednisone, reaction(s): "Allergy: Methylprednisone"; Meclizine, reaction(s): "spider veins in eyes", notes: He is also allergic to Meclizine, an anti-inflammatory medication. It gave him spider veins in eyes, the floaty things. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021 18:30, outcome "unknown" and all described as "tested positive to covid"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovered" (2021), described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) negative; (Dec2021) negative; (22Dec2021) positive, notes: 18:30; (22Dec2021) negative. Therapeutic measures were taken as a result of headache.  Additional information: Patient did not received other Vaccinations four weeks prior to the first administration date of the suspect vaccine. He had headaches for about 8 weeks. He tested positive last Wednesday, so he was on Day 6.The only symptoms he had were headache and nausea, but was not very bad. So, on day 6, and he feels kind of normal. He had headaches for about 8 weeks, which deterred him from 2nd shot and scared him a little. After he had headaches, a couple of days later, he took Tylenol and it did not seem to do anything.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 at 12:00 as dose 3 (booster), single (Lot number: Fk9894) at the age of 30 years, in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (COVID 19, manufacturer unknown, lot number: Ew0173, administration time: 03:00 pm, dose number: 2, vaccination location: right arm), administration date: 09Jun2021, when the patient was 29-year-old, for COVID-19 immunization; COVID-19 vaccine (COVID 19, manufacturer unknown, lot number: Ew0185, administration time: 02:00 pm, dose number: 1, vaccination location: right arm), administration date: 18May2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 30Mar2022, outcome "unknown", described as "my vision was blurry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vision blurred. Additional information: Age group: Adult (18-64 Years), patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. I could not see my tv and driving became extremely difficult. I also then realized in between my 2nd dose and booster I had a spot appear in my vision that remained for 2 weeks. My vision since my booster has not returned to normal and is still constantly blurry. Follow-up attempts are completed. No further information is expected.
Information received from the review of scientific literature on 02JUL2018. This is case 3 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT,18000142LT, 18000143LT) The article notes a 25-year-old active duty male who presented to the ED with one day of achy chest pain 11 days after receiving ACAM2000. His chest pain was gradual in onset, centrally located, non-exertional, non-positional and without any radiation. The patient had no significant family history of cardiac disease. The ECG showed, ST depression in lead aVL and mild PR depression/ST elevations in lead I. These were new findings compared to a previous ECG. His troponin-I was elevated at 2.24, and his C-reactive protein was elevated at 1.49. No acute cardiopulmonary disease was seen in chest x-ray, and a bedside transthoracic echocardiogram showed no pericardial effusion. Cardiology was consulted from an outside hospital and the patient was transferred for further treatment of myocarditis. After discharge, the patient was placed on ibuprofen and instructed to follow-up with his primary care physician. At follow-up, he was placed on a 3-month medical profile and made non-deployable. He was to be followed by cardiology as an outpatient. The patient's outcome was not reported in the article. Additional information has been requested.
administered an ActHIB vaccine that was later noted to have expired on 10/15/2022 with no reported adverse event; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 15 months old female patient who was administered by an HAEMOPHILUS TYPE B (HIB) VACCINE (prp/t) vaccine [Act-Hib] vaccine that was later noted to have expired on 10/15/2022 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  Concomitant medications included influenza vaccine inact split 4v (Fluzone quadrivalent) for prophylactic vaccination (Immunisation); pneumococcal vaccine conj 7v (crm197) (Prevnar) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Dtap) for unknown indication.   On 10-Nov-2022, the patient was administered by 0.5 ml dose 4 of suspect HAEMOPHILUS TYPE B (HIB) (prp/t) vaccine (formulation: unknown, strength: standard, lot number: UJ583ABB, expiry date 15-Oct-2022) via intramuscular route in the right arm for Immunisation that was later noted to have expired (expired product administered) with no reported adverse event (latency: same day).  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccines were given on 7/25/14 in AM on 7/26/14 mom called clinic and reported child had woken up with fine non raised rash all over body,not itching. Seen in clinic and assessed by FNP on 7/26/14. No distress, temp up to 101 resolved w TYLENOL.
5cm x 3cm irregular area of erythema. Mildly tender and warm. Mild edema. No drainage from needle site. All noted at site of varicella vaccine; Recommended cool compresses and Tylenol or Motrin for discomfort.
Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022; No adverse event; Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 09-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 09-Mar-2022).    Concomitant product use was not provided by the reporter.  It was reported the vials were shipped on 13-Jan-2022 and thawed in a cooler while being transported. Vial size was 5.5 ml red cap. Vials did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow-up received reporter added, 30 days use by date and vaccine storage date were added and narrative was updated.
First day very tired slept all the time appetite decreased Dash day after not drinking not eating complaint of headache back pain which was generalized to the whole body with her alzheimers hard to tell very weak by noon could not walk from the living room to the bathroom Not eating or drinking that day had to have Neighbor come over and help move her she slept in a reclining chair for the night ? the next day she was doing better Was in touch with the doctor ? did not take her to the clinic or to the hospital but has she been any worse we would have
Patient was given 0.2 mls of undiluted covid vaccine. Administrator failed to add diluent prior to administration.
loss of consciousness Narrative:  Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.
This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling and tickling of tongue), the first episode of PERIPHERAL SWELLING (Swelling of hands and feet), SWELLING OF EYELID (Swelling of eyes), PARAESTHESIA ORAL (Swelling and tickling of tongue) and the second episode of PERIPHERAL SWELLING (Swelling of hands and feet) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Swelling and tickling of tongue), the first episode of PERIPHERAL SWELLING (Swelling of hands and feet) and SWELLING OF EYELID (Swelling of eyes). an unknown date, the patient experienced PARAESTHESIA ORAL (Swelling and tickling of tongue) and the second episode of PERIPHERAL SWELLING (Swelling of hands and feet). At the time of the report, SWOLLEN TONGUE (Swelling and tickling of tongue), SWELLING OF EYELID (Swelling of eyes), PARAESTHESIA ORAL (Swelling and tickling of tongue) and the last episode of PERIPHERAL SWELLING (Swelling of hands and feet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up received  on 09-may-2021 updated on Second dose and  no further AE
fatigue; burning pain when her clothing touched her skin; headache; swelling in the right arm and arm pit; swollen glands in the back of her neck as well.; didn't feel were normal; nerve pain in her right elbow; pain in the right side of her neck.; took "sulfa" and she was told she was allergic; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 60 years old female patient who experienced fatigue (fatigue), burning pain when her clothing touched her skin (pain),headache (headache), swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ3243AC and Expiry date 30-Jun-2020 ) via unknown route in the right deltoid.  On an unknown date, the patient developed a non-serious fatigue, burning pain when her clothing touched her skin (pain),headache, swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was fatigue, Pain burning, headache, Local swelling, Glands swollen, Feeling abnormal, Nerve pain, Neck pain and Sulfonamide allergy.  The patient was treated with ACYCLOVIR [ACICLOVIR] (ACYCLOVIR [ACICLOVIR]).  The event outcome is reported as Unknown for all the events.  Information on the batch number was requested.