chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Description: __On 4/14/2021, Patient arrived for his COVID vaccine. Moderna  lot number 047B21A.  This was his first dose of Moderna. Patient did not disclose to staff any pre-existing medical issues prior to vaccine administration at screening or to nurse prior to administration of vaccine during screening process.  Patient was deemed safe to receive vaccine based on information he provided to both screening nurses and administration nurse.  Vaccine administered by RN into left deltoid via IM injection.  Patient immediately shared he has a history of ?passing out? after injection was provided, information client did not share during original screening process.  Patient then lost consciousness for brief moment.  Onsite contracted paramedics called to assess directly as event unfolded. The RNs notified at assisted directly as well. Client regained consciousness within a few seconds of event Privacy screens were placed for patient dignity and privacy.  Patient assisted to wheelchair by onsite EMS crew.  Patient was then taken to EMS area and further evaluated by onsite EMS crew.  Sheriff Detputy outside area for additional backup if needed. RN remained with EMS crew for duration to assure Public Health RN available for assistance. EMS assisted client to cot and had client lay flat. Vitals assessed with machines. B/P 105/60 initially Patient slow to respond but answered questions appropriately. Patient shared he has been seeing a neurologist for fainting spells and other health issues.  Additionally shared asthma history and is on lisinpril, Advair and Benadryl for allergies.  Took all medications on day of event. Repeat b/b 114/62 pulse ranged from 59-66. O2 sats WNL on room air. EMS placed 12 lead. Patient noted to be in sinus to brady rhythms.  EMS then called the hospital for further evaluation due to patient continuing to remain unstable. Patient was agreeable to transfer to hospital for further eval.  At time of transfer, patient was alert, orientated, and responding.  No IV placed at time o transfer of care to transport.  RN updated team that patient was being transferred to local hospital for further eval.
seem to get fairly mild breakthrough cases of Covid; seem to get fairly mild breakthrough cases of Covid; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 05Feb2021 (Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE both for covid-19 immunization. Medical history included tendency to get a fair amount of inflammation. The patient's concomitant medications were not reported. It was reported that seem to get fairly mild breakthrough cases of covid (drug ineffective and suspected covid-19) on an unspecified date in 2021. It was reported that patient seem to get fairly mild breakthrough cases of Covid somewhat often and had a tendency to get a fair amount of inflammation. Patient isolated a lot to avoid Covid. The outcome of the event suspected covid-19 was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt recv'd flu & pneumonia vax on 11/1/99.Later that evening, pt developed T102, swollen injection site, & knotted bulging cellulitis. Seen in ER on 11/4/99.
Fever, swelling, redness at injection site, tenderness and mother states that patient "will not move his leg".
Developed periferal artey disease in late March 2022, no prior pre-exisiting condition, Popatiel artery blockage, epitomy of PAD unknown
C/o feeling dizzy, had a terrible HA, body aches and extreme nausea. More intense than previously experienced.
Patient was given a full dose Moderna vaccine as a 12 Year old.   Patient parents were notified and patient will follow up with Dr. monthly. No symptoms or adverse reactions.  Medical Assistant administered the vaccine and has been retrained and we have created a buddy system for checking ages and vaccine that are given.
This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. Medical history and current condition of the patient was not reported. On 12-JAN-2015 the patient was inadvertently administered a dose of GARDASIL (lot#, expiry date unspecified), 0.5 ml, intramuscular, that had been improperly stored. No adverse effects reported. No product quality complaint (PQC) involved. Additional information is not expected as we are not permitted to contact the reporter.
Pt describes initial redness following injection. Two days later this increased. He presented to emergency dept with a 10cm x 10cm well demarcated area of erythema (on 9/12/10). Exam revealed no fluctuance or induration. No joint symptoms. X-ray negative for foreign body. US neg (9/14) for abscess. He was tx with antibiotics empirically.
This vaccine was given just below the left shoulder but higher than the first vaccine. After 12 hours or so, I started feeling rundown and fever -102.3 - had the fever for a few hours or so; bad headache. No treatment and that went away.  About six hours total is how long I was laid up. I was rundown longer than that and by the 18th I felt 100% normal again.
This spontaneous report as received from a healthcare student refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, route, dose and injection site were not known) on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient received a dose of ZOSTAVAX which was expired on 18-AUG-2012, and the patient received the dose on 21-AUG-2012. No adverse effect reported. It was unspecified  if the patient had sought medical attention. Additional information has been requested.
red, swollen are around injection site. swelling spread all the way down the arm. Skin blistered and peeled off on that arm as well. Pain and discomfort lasted 3 weeks according to the patient
coughing-t102, aches, chills, runny nose, h/a;pains in chest-stuffed up-rib pain from coughing;
On 4/1, 7 days after the vaccine, the back of my head started itching. Then my neck itches. I has some swollen lymph nodes in the back of my neck. On 4/10, a rash began on my left forearm. It was extremely itchy. On 4/11, it was on my left and right forearm and my chest and legs. Since then it has spread everywhere. By spots, I mean it starts as a spot but then turns into a big rash. There was a rash with 2 weeks and 2 days past the vaccine and since then the rash has spread all over my body. It was awful, I did not ever have skin problems. On 4/19, I went to the dermatologist who prescribed a steroid cream. On 5/11, I went to an allergist/immunologist, he also agreed that it was from the vaccine. I have no idea how long this will last since it is in my body. The itching is much more tolerable now. It itches more in the mornings but it is not such a nuisance now. It has gone in some areas but new ones do keep coming.  I'd like to emphasize that this still going on. This is a rash that has been going on since it started.     Dermatologist
PATIENT DEVELOPED WIDESPREAD MACULAR RASH OVER BODY SOMETIME OVERNIGHT ON 9/19/23 AFTER ADMINISTRATION OF FLUZONE HD (RIGHT DELTOID) AND AREXVY (LEFT DELTOID).  PATIENT HAS  H/O FLUZONE HD ADMINISTRATION WITH NO PAST ISSUES.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-MAR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (also reported as 10 mg/1 ml) (lot # J001389, expiration date 07-NOV-2014; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 384, 33 and R; 248, 34 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Stronger fatigue than normal (given I have narcolepsy) around 24 hours after shot as I couldn?t focus on work even with methylphenidate and felt the need for 2 hour nap. Woke up with low grade fever (~99-100) with fatigue, haziness and mild muscle aches (similar to a cold without the respiratory symptoms).  All symptoms subsided a couple hours later (~10pm) and felt completely fine the next day.
Approximately 24 hours after receiving vaccine patient had diarrhea lasting one hour, scalp itched and tongue swelled up. Also had transitory fever type feeling-itchy scalp and diarrhea lasted about 2 hours- felt ill after 48 hours.
ARM SWOLLEN. "HURT ALL THE WAY UP TO MY NECK AND BACK TO MY SCAPULA." INJECTION SITE HARD AND RED, BUT IMPROVING.
Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved.
Case number PHEH2012US005912 is an initial spontaneous report received from consumer on 07 Mar 2012: This case refers to multiple patients (several patients). These patients may have received MENVEO (batch number: unknown), intramuscularly on an unspecified date. The MENVEO vaccine stored at temperature of about 33 Fahrenheit for up to one-month. No adverse events were reported following this administration error.
A few days after the shot I started experiencing premenstrual symptoms. I found that very strange as I have always had a very regular 28 day cycle and I had just finished a period. Day 1 of my previous cycle was April 2. On day 13 (the 15th of this month) of my cycle I started spotting pink then menstruating. This period if still ongoing now and feels very different from my regular period. I have another girlfriend who experienced the same and I have read reports about this happening on Facebook. I am extremely concerned that the vaccine disrupted my hormones and normal body functions.
Approx 48 hours after receiving Moderna booster vaccination, the area around the injection site developed a HUGE (3") rash, very itchy, and raised from the surrounding skin, as thought the vaccine didn't go in the muscle and was sitting just under the skin.  Rash is also extremely warm to the touch.
Arm/Shoulder pain; Arm/Shoulder pain; Redness at injection site; Burning at injection site; Hardness at injection site; Itchy at injection site; Breathing issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and ARTHRALGIA (Arm/Shoulder pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (Breathing issues), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm/Shoulder pain) and ARTHRALGIA (Arm/Shoulder pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Breathing issues), PAIN IN EXTREMITY (Arm/Shoulder pain), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), ARTHRALGIA (Arm/Shoulder pain), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Burning at injection site) outcome was unknown. Not Provided          Patient used Benadryl as concomitant and treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient declined further follow up.
Tilt table test - Amb EEG 2009 - hospitalized overnight 2009 - Sitting after vaccine - felt usual tunnel vision - got rigid - lowered to floor per 3 adults - 30 second to respond.
High Blood pressure, above 145, Starting  Sunday March 7, 2021.  [ 2 ] Two days after vaccination  of Pfizer Covid injection.  To at least March 14, 2021 when this written.
ANAPHYLAXIS, INIT ALLERGIC REACTION, INIT ALLERGIC REACTION, SUBSEQ
Could not move arm; Headache; arms swell; difficulty in speaking; Nauseous; This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 78-year-old female patient (a retired paralegal attorney) received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation.  Medical history included drug allergy to Suplha.  The patient's concomitant medications were not reported.   On an unspecified date, 3 to 4 days before this report the patient had a very bad reaction. On an unspecified date she experienced headache, arms swell, difficulty in speaking, she was nauseous, she could not move arm. The events outcome was unknown.  A Product Complaint was filed.
Positive for Covid-19 after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot) 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 No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approximately (Thursday) 11 to 12 hours after the vaccine my ears started burning inside and I had flushing, hot hivey rash up both sides of my face.  My face was swollen. Also had fatigue, chills, nausea, body aches, headache, injection site pain. The next morning (Friday) I still felt terrible with body aches, nausea, more intense injection site pain and now painful, sore, swollen supraclavical lymph nodes.  By Saturday my lymph nodes are still large and swollen and the injection site was hard and hot with a burning sensation similar to the reaction I had with the first vaccine dose.
inc temp onset 5/21/99 PM-to MD rx amoxil;temp inc to 104 over period of 2 days p/ rx given-adm to hosp 5/23/99 w/inc temp, vomiting, rash on buttocks & legs;dec urinary output & foul stools;
The following day I had fever and achiness which I expected and started palpitations which have not subsided. I have seen a cardiologist and have had multiple tests done which were normal.
I believe the 3rd dose triggered an autoinflammatory reaction  (pre existing). I felt a little feverish the day after the shot, with a sore arm, but that passed quickly and I was back to normal 36 hours after. 4 days after the shot I started having a high fever, severe headache at the base of my neck (10/10 pain), joint pain, weakness. This went on for 3-4 days always starting in the evening, around 4-7 pm. I would wake the next day feeling fine. I don't think the vaccine caused this cyclical reaction, but it triggered my body reaction to this process. I've had this happen before several days after a viral infection. My first two doses were fine in December/January, but the 3rd full dose triggered this.
Patient was experiencing tongue swelling and difficulty swallowing approximately 5-7 minutes after receiving second dose of Moderna Covid-19 vaccine. Patient was given some sips of water, an ice pack, and an Epi-pen 0.3mg injection in Left, outer thigh. Ambulance was called and patient was taken to the local hospital. Patient was conscious the whole time.
bad side effects from second shot; 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 VACCINATION COMPLICATION (bad side effects from second shot) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (bad side effects from second shot). At the time of the report, VACCINATION COMPLICATION (bad side effects from second shot) outcome was unknown.            Concomitant medication history not provided. Treatment information was unknown.
VACCINE DOSE GIVEN AFTER 2 HOUR OF ROOM TEMPERATURE/GIVEN OUTSIDE OF TEMPERATURE RECOMMENDATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation was not reported. This report was non-serious
Information has been received from a certified medical assistant (C.M.A.) referring to a 15 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 22-DEC-2015 the patient was vaccinated with a first dose of GARDASIL (lot # K010215, expiration date unknown; route not reported) (drug administered to patient of inappropriate age). No adverse symptoms were reported. Additional information has been requested.
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's alleged wrongful conduct, the pt 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 the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was not recovered, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and postherpetic neuralgia to be disabling events.
SWELLING OF RIGHT EYE , ITCHY RASH MULTIPLE ARES ON BODY
Fever, chills, nausea and vomiting, weakness and soreness at injection site. Acute respiratory distress.
diarrhea 2 weeks after the 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 DIARRHOEA (diarrhea 2 weeks after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea 2 weeks after the second dose). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea 2 weeks after the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: normal (normal) stool tested - no issues.         Reporter did not allow further contact
This spontaneous retrospective pregnancy report as received from a pharmacist refers to a female patients of unknown age (about 120-150 patients) with unknown demographics. The patients pertinent medical history, concurrent conditions and drug reactions and allergies were reported as unspecified by the reporter. On an unknown date the patient was vaccinated with M-M-R II, HSA therapy type 0.5 ml, subcutaneous (dose number, lot#, anatomical location not reported). No concomitant medications reported. The patient became pregnant. The LMP and EDD were not known. The patient had live birth and delivered baby (unspecified) The pharmacist reported that about 120-150 unspecified patients had titers drawn after having a baby on unspecified dates and he stated that a majority of the results of the titers are equivocal for rubella. The pharmacist also stated that he was pretty sure that all of those patients had been vaccinated with the M-M-R II previously on unspecified dates. It was unspecified whether the patient sought medical attention. The outcome of the adverse event was unknown at the time of the report. The patient was not hospitalized due to experience was not life threatening. There was no persistent or significant incapacity. No death Intervention to prevent serious criteria was not required. Product quality compliant was not involved. Additional information has been requested.
Severe headache- worst I've ever had. Lasted 6 hours Fever Aches
pt recv vax 2 doses of vax & reporter stated that titers were taken on 18JUL96 & 11JUN97 & both came up non-immune;
Patient reports hives on face the morning after vaccine administration, which resolved within 24-48 hours. Patient also reports an itching rash on neck and chest, which has still not resolved at this point (14 days after vaccine administration).