chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received full dose instead of half dose as booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose instead of half dose as booster) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M036728 , expiration date 20-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1.5 degrees Celsius, 31 degrees Fahrenheit/ -1 degrees Celsius or colder for 2 hours and 53 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003571:
1st 3 days reddened rash @ injection site, body aches & pains  9 th day;  reddened rash @ injection site, hives L neck, body aches & pains
Dose #2 given 14 days after Dose #1 (12/30/2022)
Rash; Itch; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itch) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch). On 22-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itch) 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.   No concomitant medications were provided. No treatment information provided.
Received Heplisav-B That Was Stored at 14°C for 30 hours; Initial Report Received on 18-Jul-2023  A purchasing supervisor in the reported that a 49-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was stored at approximately 14°C for 30 hours.  Medical history and medications at the time of vaccination were not reported. The patient had no allergies.  On 19-Jun-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).  On 17-Jul-2023, the patient received the second dose of HEPLISAV-B vaccine (Lot # 943241; expiration date 07-Sep-2025, NDC # 43528-003-05; route not reported) in the left deltoid. This second dose of HEPLISAV-B was stored at 14°C for 30 hours. No adverse reactions were reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This is a spontaneous report from a contactable consumer. An 82-year-old female patient received PREVNAR 13, (Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had was sick; and had soreness all over (not just on her arm). The outcome of the events, 'sick' and 'soreness all over', was unknown.
This case involves patient who experienced flu (influenza), after receiving INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, The patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. (Patient stated that: Yes you can. The only time the patient got the flu was the year he/she got the shot). No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the event influenza. There will be no information on the batch number for this case.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.  On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M035487 with expiration date of 23-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit (°F) for 30 minutes. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012703:
Adult patient got pediatric dose instead of adult; Adult patient got pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis.   On 17-MAR-2023, the patient received the 3rd dose of Engerix B pediatric. On 17-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient got pediatric dose instead of adult) and adult use of a child product (Verbatim: Adult patient got pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 A nurse informed that earlier that day, an adult patient came in to receive the 3rd dose of Engerix-B but received a pediatric dose instead. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  An adult patient received Engerix B pediatric, which led to underdose and adult use of a child product.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 13:30 as dose 1, single (Lot number: EN6201), in left arm, on 01Mar2021 at 13:00 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 at 08:30 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 19Apr2022 at 08:45 as dose 4 (booster), single (Lot number: FM0698) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2015, stop date: 05Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: had negative at-home test yesterday; (16Jul2022) Positive, notes: Today congested and retested positive after course of Paxlovid. Therapeutic measures were taken as a result of covid-19.  Additional information: COVID 19 treatment was started on 06Jul2022 and stopped on 11Jul2022. Other medication used in 2weeks was Atorvastatin from 01Jan2015 to 05Jul2022. Adverse event reported was relapse and had negative at-home test and retested positive after course of Paxlovid on 16Jul2022 and the patient was not recovered. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
pt exp redness, pain, stiffness in rt shoulder upper arm;no fevers, SOB;12x12 cm area red warm skin intact;tx ice, DPH, Motrin; f/u 26FEB96 w/o problems almost completely resolved;
My left shoulder and upper arm where the second shot was given has been and continues to be, quite painful. I am experiencing radiating nerve pain in my shoulder and down to my elbow. I cannot sleep on my left side and sleep in general has been sporadic. If I end up on my left side during sleep I'm awakened by radiating pain that changes to piercing pain when I move. My left shoulder and elbow constantly ache and massage or rubbing makes it worse. 500mg Naproxen has not helped. I now have a limited range of motion in this shoulder due to the pain.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 23-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Nausea, Headache, Fatigue, Weakness,  Fever. Took Tylenol Cold and Flu Severe to try and manage symptoms.
herpes zoster; postherpetic neuralgia; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 06-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
hospitalized; Patient had first dose on 03Mar2021 and has yet to get second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (hospitalized) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     There was no medical history provided.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient had first dose on 03Mar2021 and has yet to get second dose). On an unknown date, the patient experienced HOSPITALISATION (hospitalized) (seriousness criterion hospitalization). In April 2021, PRODUCT DOSE OMISSION ISSUE (Patient had first dose on 03Mar2021 and has yet to get second dose) had resolved. At the time of the report, HOSPITALISATION (hospitalized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided. No details for events leading to hospitalization was provided.  Company comment:Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Fever of 106.8 on 3/17/2020 and not eating or drinking. Temp in the office 103.1. Patient had chills and one loose stool (not diarrhea per mom). Reassuring exam per provider, offered cath but the parent declined. Sent home with instructions to continue to monitor, Tylenol or Motrin as directed. Call for appointment the following day if still with fever.
I had a reaction to the first shot. It is assumed to have been a vasovagal response on 03/13/2021.  However, I did not ever loose blood pressure or have disruption in my vitals. I have otherwise never had a reaction like this. It felt like a panic attack that lasted hours. If I have a similar reaction I experience:  ? Heat in my hands and feet- Please provide me a cool cloth ? Metal feeling/taste in my mouth and chest ? I cannot feel myself breathing- Please remind me I am breathing ? I cannot feel my throat ? I was extremely vertigo. I was given Zofran (ODT) and would like that option again if needed as it made a significant improvement.  ? Intense sensation of panic
The first event was an incredibly sore shoulder joint.  Could not raise my arm more than one foot.  This started within hours of the injection.  Within 48 hrs the pain and range of motion improved but two weeks later it is still slightly sore.  This is not the injection site, but the shoulder joint. The second event was heart palpitations.  This did not start for approximately one week.  It mainly occurred when I was lying down.     It was concerning enough that I went to my cardiologist and discussed it with him and told him about the relationship to the injection and that I suspected that it was related to the covid vax.  I had started taking 200 mg of magnesium and ate a potassium rich diet immediately and by the time I got to the Doc it had subsided for the most part and he was not particularly concerned as a stress test that i had a year ago was exceptionally good.  Unfortunately the problem continued but on a periodical basis.  I started taking the magnesium a few hrs. before bedtime and it has apparently stopped for the time being.
Headache.  Treated the headache with hydration and rest.  It resolved within 12 hours.   The vaccine did not affect my pregnancy at all.  I was 26 weeks at time of vaccination and baby's health was confirmed via ultrasound a day later.
Approximately 1.5 inch subcutaneous nodule developed on left thigh at site of vaccination. It is unknown exactly when nodule first appeared however it was noticed the day after the vaccination.  Day of and day after vaccination child wanted to sit and be held all day long, extremely fussy and child was constantly rubbing injection site.  Child returned to clinic 12/9/2019 for a persistent cough and to show the doctor the nodule on the left thigh. On 12/10/2019 ( 4 weeks and 1 day after injection ) a rash that looks like two interlocking rings of small red and pink bumps appeared on left thigh directly behind injection site.  Since the vaccination, child continues to rub leg several times a day and patient will not sleep on left side of body, possibly the nodule is causing leg pain or soreness.
COVID-19 symptoms began May 31 I had a sore throat and fever, highest was over 101. The next day I went to urgent care to get tested, get PAXLOVID. Within the next two days I was feeling fine. I also had laryngitis and fatigue. I was only sick for a couple of days. Then on June 13th I started coughing with a sore throat again and laryngitis. I began taking Z-PAK antibiotic and prednisone on June 16th. I have finished those prescriptions but the laryngitis has not gone away completely and I have mild sore throat. When I got sick the second time I was traveling. I have been back home for 10 days.
2/28/21 10pm-10pm 3/1/21, Chills, fatigue and insomnea. Headache 2/28/21 8pm-10pm Acetaminophen 650 mg. Fatigue. 3/2/21 Diarrhea, nausea, fatigue, abdominal discomfort, gas, Gas x and Imodium. Gatorade. 3/3/21 fatigue, gas, indigestion, lack of appetite.  eating light, yogurt, soup, crackers, oatmeal, scrambled egg, toast.(3/1-3/3)
12/28/21 presents to EC ED for "shortness of breath and fatigue". PMHx of "bed-bound/wheelchair bound, Dementia, CVA,  GERD, chronic atrial fibrillation, essential HTN, PE, chronic lower back pain, and prostate CA"
Severe muscle ache, including headache, severe fatigue, lack of appetite.  Extreme fever, 104.8 at 10:30 pm.
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear.  Right ear was flushed red.  No symtoms in left ear.   No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
Extreme redness 9 x7 inches to the upper left arm,  swelling for same dimensions,  extreme itching and pitting in some areas, underarm swelling, and limitation to use of the arm.
p/vax now exp tightness in chest;no s/o chest pain;c/o T100;;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-APR-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (lot # L022261, expiry date 01-APR-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Rash to face, fatigue, arm pain to injection site. Took Advil.
He developed a headache about 2 hours after receiving the vaccine.  The headache became severe and he was taken to a nearby emergency room where he was diagnosed with a subarachnoid hemorrhage.  He was transferred to another hospital where he spent 10 days recovering.  No underlying etiology was found and he has no sequelae from the event.  He reported this to me yesterday when he came in for his daughter's well check.  I was unaware of this event until yesterday.
Itching, Redness, swelling, hot on injection site. ?Moderna Arm?
a dose of PNEUMOV AX 23 was administered after being improperly stored at an elevated temperature; No adverse effects were reported in the patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On unknown date, the patient was vaccinated with one dose of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscular, lot number S012245 with expiration date on 09-FEB-2021 (frequency was not reported) for prophylaxis.  Administered dose of vaccine experienced elevated temperature. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported in the patient.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
This case was reported by a physician via sales rep and described the occurrence of pain in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided a follows: The age at the vaccination was not reported. The physician said her older children were experiencing more pain with GlaxoSmithKline flu vaccine than with non-GSK flu. The physician felt it was related to the product.
On Day 2 after getting vaccine, fluid buildup in ears spiked and persisted, causing a range of symptoms. Symptoms include ear pressure, popping, crackling, and high-pitched tinnitus. Urgent care and PCP all saw fluid behind eardrums in two weeks prior, during week 3 saw an ENT who said fluid was not present anymore, however the audiologist confirmed that negative pressure still exists in both ear tubes. Tinnitus and symptoms persist through week 4 (at present).
Arm is sore, red, swollen and hot to the touch. I am using cold compress and rotating my arm in a circle.
Pt had high pitched screaming started 6 hours later, lasting 3 hours, slept after.
Vaccine was administered beyond expiration date by 4 days Exp date:11/24/2022 and administered on 11/28/2022.
6 minutes after receiving the vaccine I became lightheaded. I was the worst for about 1-2 hours after the vaccine but then symptoms improved some. 11 hours later I am still mildly lightheaded.
Approx 2-3 min after vaccine admin, pt experienced syncope episode with 2-3 sec loss of consciousness and fall to ground from own height. Pt had not eaten that day and had expressed anxiety re: immuniz. prior to event vs immediately after event BP-110/70; P-130/min, R-24/min, O2 sat 98%. Placed pt in recumbent position and gave her mild to drink. Fs OS-109 mg/dl. Fully recovered w/in 10 min BP-100/70; P-88/mm; R-16/mn O2 Sat 99%. Recovered at 11:55 in stable condition.
Sensory issues that started in legs, then went to arms and lower jaw.  Tightness, burning, altered sensory.  These symptoms started approximately 8 weeks post vaccination and worsened over time.  Ongoing and untreated to date.  No definitive diagnosis yet.