chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; Initial information received on 19-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication 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 expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that they had High Dose for senior flue shot last August when the flue shot first available. Thankfully, due to masks and shut down, they were not exposed to what ever other versions of the flue for got to put in the shot for 2020/2021. Most years is so incompetent, negligent, stupid that they fail to put the right virus in the flue virus in the shot and son and they get what ever virus they didn't put in the shot for that year and we are sick for a week or more  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the lot number for this case.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with diabetes. On 12-DEC-2012, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number and expiry date not provided). The patient stated to the pharmacist that he experienced a severe headache described as a migraine and a rash mostly on one side of his upper body on an unspecified date shortly after being administered ZOSTAVAX. The patient sought medical attention at an unspecified physician's office on an unspecified date in January 2014 and was diagnosed with shingles. Treatment reported by pharmacist were prescriptions for VICODIN and Valacyclovir filled on 03-JAN-2014. The outcome of shingles, rash mostly on one side of his upper body and severe headache described as a migraine were reported as recovered/resolved on an unspecified date. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been requested.
Information has been received from a registered nurse concerning a 13 month old premature born female at 34 weeks gestation with a history of allergic rhinitis and no other allergies, who on 30-JUL-2007 at 13:30 was vaccinated with her first SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 657654/0611U) in the left thigh. There was no illness at the time of vaccination. Concomitant vaccinations administered that day at 13:30 included her first SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck) upgrade process) (MSD) (Lot# 657782/0612U) in the left thigh and her first IM dose of hepatitis A virus vaccine inactivated (Lot# AHAVB163AB) in he left thigh. Other concomitant drug therapy included Zyrtec prn. It was noted that the patient inadvertently received the dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27-3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD) instead of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) due to human error not product confusion. The patient was not experiencing any known symptoms. No medical attention was sought. No labs or diagnostic studies were performed. There was no product quality complaint. Additional information has been requested.
pt recv vax 20FEB96 & devel optic neuritis 28FEB96;
fatigued for about 3; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced fatigue for about 3 days after receiving 1st dose of Shingrix. For tolerance with the 2nd dose of Shingrix, refer linked case US2020AMR015679.
patient received a vaccination of Pfizer bivalent on 10-7-22. Patient received a second bivalent vaccination on 1-12-23
Information has been received from a registered medical assistant concerning a  5 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004381: US-009507513-1706USA004382: US-009507513-1706USA004383:
Terrible upper arm pain. Mostly went away 2 weeks later. After 2 brain bleeds,  the pain came back in November. I had 2 mri's done in January and February. While having  both mri's, my arm filled with burning pain both times. The pain was horrible. I have had mri's many times and this has never happened. I am in physical therapy and the pain won't subside.
sinus pressure; mild headache; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021260053 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: The patient Received first dose COVID vaccine on 03MAR2021.Just wants to know if a mild headache and sort of a sinus pressure is normal for a side effect. Caller stated her friends has stated to her that the second dose gives you more side effects than the initial dose.   No follow-up attempts are possible. No further information is expected.
They injected through a little white sticky thing - like a band-aid; I had horrible itchiness at the injection site afterwards. That itchiness lasted for days. That never happened before but I've never had a sticky band-aid in place before injection.  Saturday and Sunday, I had headache, stomachache, and diarrhea; Monday - felt like a migraine - it was so bad. I couldn't function. I slept for a few hours and that is not what I do. I don't get headaches or migraines anymore - I got them a long time ago when I used to work swing shift. I don't ever get a headache three days in a row. I called into work and that was my first call-in of the year. I got the injection on a Friday so I wouldn't have to call-in.  I had stomach symptoms after the vaccine. The stomachache and diarrhea had stopped. I took Tylenol every one of the days that I had a headache. I got sick then a week later - I got cold symptoms - the following Tuesday. I went to Urgent Care on Thursday - bad sore throat and bad congestion. It was like a bad cold. They didn't do a throat culture; they listened to my lungs and looked at ears and nose. Every single time I go to a cold, it usually goes into asthmatic type symptoms and must go on to Prednisone and nebulizer treatment but this time, I didn't have to. It didn't go to asthmatic symptoms and so it was very strange. It was different than what usually happens with me with a cold. I took Mucinex. I'm still having symptoms - still sneezing and having congested but it's not the worse cold. It's not making me have trouble breathing and it's not going into a bronchitis.  I got a flu vaccine a week before this vaccine - I got it on my left arm. I was literally itching both arms after both the flu and the COVID-19 vaccine. I normally don't get any reactions after a flu vaccine; I'll never do that again getting these two vaccines so close together. Not sure which brand of the flu vaccine it was. I got it at work.
Got flu like symptoms 12 hours after vaccine; Really sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "sore arm (not unbearable)". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Got flu like symptoms 12 hours after vaccine"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Really sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101018904 same patient/vaccine, different AE and dose
COVID-19 Vaccine; COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Lot number: ER8132), in left arm, on 06Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.
Excessive vomiting for 24 hours; Excessive nausea for 24 hours; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported information for mother. This is maternal report. A 30-year-old pregnant female patient receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. Medical history included had COVID prior vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient received her vaccination in a nursing home/senior living facility. The patient was pregnant at the time of the Covid-19 immunization. The patient reported experiencing excessive nausea and vomiting for 24 hours (unspecified date). The patient received treatment for the adverse events which included over the counter medications. The patient was not COVID tested post vaccination. The outcome of the events nausea and vomiting was recovering while the outcome of the other events was unknown.
10PM-4/15/2021-Dizziness began. Room was spinning could not stand. Stomach began to hurt bad. Achy and 100.4 Fever/sweats. Dry Heaves began 4/16/2021 @ 1:30AM, Dry Heaves again at 3:30AM, and at 7:15AM-4/16/2021. Also, Chills, Very tired, sore arm but tolerable. Slept 1-1/2 days. Still not well on 4/17 and 4/18. Could not eat at all on 4/16/2021. By 4/19, finally feeling more normal, but still lightheaded. Not back to 100%. Somewhat weak.
Event occurred after 2nd vaccine; breakthrough case admission 4/20/21 Moderna Lot# 043B21A 5/18/21 Moderna Lot# 041C21A
low grade fever; swelling; experienced some redness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (experienced some redness), VACCINATION SITE PAIN (pain at the injection site) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (experienced some redness) and VACCINATION SITE PAIN (pain at the injection site). On an unknown date, the patient experienced PYREXIA (low grade fever). At the time of the report, VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (experienced some redness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and PYREXIA (low grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated multiple times during the call that she and her husband have confirmed antibodies to COVID due to natural immunity.   This case was linked to MOD-2021-276552 (Patient Link).
Skin lesion; arm injury; Shortness of breath; sexual dysfunction; itching all over; open wound; sweating; skin pain; pain in extremity; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Skin lesion), LIMB INJURY (arm injury), DYSPNOEA (Shortness of breath), SEXUAL DYSFUNCTION (sexual dysfunction) and PRURITUS (itching all over) in a 40-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 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN LESION (Skin lesion), LIMB INJURY (arm injury), DYSPNOEA (Shortness of breath), SEXUAL DYSFUNCTION (sexual dysfunction), PRURITUS (itching all over), WOUND (open wound), HYPERHIDROSIS (sweating), PAIN OF SKIN (skin pain), PAIN IN EXTREMITY (pain in extremity), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with ADALIMUMAB (HUMIRA) at a dose of 80 mg. At the time of the report, SKIN LESION (Skin lesion), LIMB INJURY (arm injury) and WOUND (open wound) had not resolved, DYSPNOEA (Shortness of breath), SEXUAL DYSFUNCTION (sexual dysfunction), HYPERHIDROSIS (sweating), PAIN OF SKIN (skin pain), HEADACHE (headache) and CHILLS (chills) outcome was unknown and PRURITUS (itching all over), PAIN IN EXTREMITY (pain in extremity) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.
Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported. Treatment information was not reported.   It was noted that the patient eventually went to the emergency room where the Bell's Palsy was diagnosed.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Syncopal episode & pt pale.  Sitting BP 119/54, HR 55, RR 18; Standing BP 113/64, HR 63, RR 18. Water, saltine crackers & apple juice given.  Immediately felt better. Refused wheelchair & ambulated to recovery area. Hx of vasovagal 2 months prior. Pt stable & released with recommendation to f/u w/PCP
unable to use arm; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and was unable to use arm for 3 days. The reporter was asking if they could give Shingrix in hip instead of arm.
pt came for 2nd varicella vax states arm swelled to 3x it nl size w/first dose of varicella vax;pt did not call or come back @ that time;arm is apparently nl now;
Tested positive for COVID-19, Symptoms included fatigue, stiff neck, fever, runny nose, cough, body aches, brain fog, loss sense of smell and taste.  Out of work for 5 days Frequent cough for 6 weeks, minor cough still continues after 8 weeks. Still continuing - brain fog, trouble retrieving words, using the wrong words in sentences
We received via agency, and Norvartis Pharmaceuticals, from a healthcare professional the following information on 01 DEC 2009: A 34-year-old female patient, born on 01 SEP 1975, pregnant for the third time in 27 weeks gestation, was vaccinated i.m. with seasonal FLUVIRIN, batch no. unknown) on 18 NOV 2009. The patient was also vaccinated with pandemic FLUVIRIN (batch no. unknown) on the same day (please see MA2009-5711 for reference). The patient also had a medical history of blighted ovum. On 30 NOV 2009 the patient collapsed and died on 30 NOV 2009. Autopsy was pending at time of report. A male male infant was delivered by C-section. Agency Ref. no: NA09-008971. Norvartis Pharmaceuticals ref. no.: S2009US27919.  12/30/09 ED records summary received. Service date 11/30/09. Assessment: Collapsed, unresponsive, asystolic rhythm. EMS found patient unresponsive, collapsed on floor, in asystolic rhythm. Presented at ED unresponsive, no spontaneous respirations, asystolic rhythm. Cental cyanosis, prior intubation, oxygen, epinephrine. Fixed dilated pupils, no corneal reflex. Pale. No spontaneous cardiac sounds. Fetal heart tones noted. Emergency C-Section, premature infant delivered and resusitated.   1/6/09 ED records received. Service date 11/30/09. Assessment: Cardiac arrest, expired. Pregnant patient arrived in full cardiac arrest.  Asystole/Pulseless. Reflexes absent. Emergency low transverse cesarean. Male fetus delivered.
COVID-19 Vaccine EUA About 12 hours after injection of vaccine I started to get a head ache; and about 16 hours after injection I started to get full body aches (mostly muscle) especially at injection site.  Body aches lasted a full 24 hours after they started,
pt recv vax;devel gen macular rash;also devel pruritus on noc of vax;
I received a Flu Vaccine 2 days later (10/2/2023). (Fluzone High Dose Quadrivalent). Within 1 hour, my blood sugar started to dramatically rise.  In 2 hrs, my blood sugar was over 600. I have been an insulin dependent diabetic for 48 years and my blood sugar only rose once to this level before - when I was initially diagnosed in 1975. My endocrinologist advised that I go to the Emergency Room as I was likely in the early stages of diabetic ketoacidosis. I was placed in the ICU for 3 days on an insulin drip and IV fluids.
This is a spontaneous report from a contactable pharmacist reporting for his wife via a Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and PNEUMOVAX 23, via an unspecified route of administration, on an unspecified date, at unspecified dose (unit DF), for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized due to the event on an unspecified date, and was discharged at time of report. Outcome was recovering. Sender's Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004252: Source case US-009507513-1707USA004305: US-009507513-1707USA004307.