chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.; Patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Plaintiff was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye.|1; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or around 19-AUG-2014, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (anatomical location, administration route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the patient suffered many black occasional flash dots, flashes and floaters in his left eye and went for an urgent eye exam. Later, the patient was diagnosed with posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine, mental an emotional distress due to resulting physical limitations and seriousness of his condition; the patient sustained severe and permanent personal injuries. 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. At the time of the report, the outcome of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye was not recovered. The reporter considered the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye to be related to Zoster Vaccine Live (ZOSTAVAX). The events of posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered to be disabling. Upon internal review, the posterior vitreous detachment, vitreous hemorrhage, and retinal tear of the left eye were considered as medically significant event.
sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm at injection site). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-094935 (Patient Link).
MMR vaccine was ordered to be administered if the patient had a negative rubella titer.  The dose was administered despite a positive titer.  No harm to the patient.
MMR administered at 11:40, at 11:50 approx., I noticed hives on pt's left hand and arm and 1 on face. There was a couple on the back of her legs. Spoke with MD via phone. Advised to give 1 tsp of Benadryl. Hives lessening and no wheezing. Child had a small hive on her chest before the MMR was given. She ate egg this AM and she had a previous reaction to deviled egg once before.
Patient presented on 10/11/2021 with complaints of dyspnea x1 month. Patient is healthy with no significant underlying conditions. EKG at that time in my office was abnormal, patient sent to ER for evaluation and treatment. Found to have EF of 17%, acute systolic Heart failure with no CAD on cardiac cath. Patient discharged to home on 10/13/2021 with Life Vest and cardiac follow up.
approx 3hr post vax pt felt unwell;next morning, rt arm swollen pt felt nauseous, tired, arm was pink in color & cont to swell until 48hr post vax;no MD contacted;notification was >1mo later to pub hlth dept;
PT RECEIVED 0.5ML INSTEAD OF 0.25ML, NO AE TO REPORT.
Seven days after vaccination my arm started itching and swelled up at the vaccination site and turned more red and became 2 to 3 inches in circumference.
SEVERE,INTENSE PAIN IN LEG OR GROIN AREA; SEVERE,INTENSE PAIN IN LEG OR GROIN AREA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 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 severe, intense pain in leg or groin area, and severe, intense pain in leg or groin area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe,intense pain in leg or groin area, and severe,intense pain in leg or groin area. This report was non-serious. -; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
04MAY95 pt recv vax 815 & @430PM pt woke from nap & had sudden onset of crying-crying was cont until 8:00 x/ for 2-3 mins intervals for pt to catch breath; fever peaked 103.8; mom gave APAP for pain;
This is a spontaneous report was received  from a registered nurse via a field representative concerning an 11-old-year male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 30-OCT-2018 (reported as "about one month ago"), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided). On an unspecified date in 2018, the patient experienced "inflammation, heat, and a cellulitis like appearance" in the injection site area. The outcome of the inflammation, heat, and a cellulitis like appearance at the injection site was unknown. The causality assessment between GARDASIL 9 and inflammation, heat, and a cellulitis like appearance at the injection site was not reported.
Tdap given IM RA - extreme swelling/redness approximately 4 hours after injection with low grade temp, irritability, weakness. Symptoms worsened and persisted for 2 days, 6/19-6/21. Resolved with NSAIDS, ice pack, rest. Continued to work 8-5.
Patient arrived 5 days early for 2nd vaccine.  Provider explained CDC guidelines, but patient wished to proceed with the vaccine
Information has been received from a physician concerning himself who on an unspecified dates was vaccinated with three doses of VARIVAX (Merck) subcutaneously.  It was reported that he was not still showing any immunity.  It was reported that the patient had not recovered at the time of the report.  Additional information has been requested.
CHILLS; FOGGINESS; MEMORY LOSS; CONFUSION; Anxiety; TEMPERATURE OF 98; Body aches, muscle aches; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches, muscle aches), FATIGUE (feeling very tired), CHILLS (CHILLS), VISION BLURRED (FOGGINESS) and AMNESIA (MEMORY LOSS) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced FATIGUE (feeling very tired). On 15-Feb-2021, the patient experienced MYALGIA (Body aches, muscle aches), CHILLS (CHILLS), VISION BLURRED (FOGGINESS), AMNESIA (MEMORY LOSS), CONFUSIONAL STATE (CONFUSION), ANXIETY (Anxiety) and BODY TEMPERATURE INCREASED (TEMPERATURE OF 98). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Myalgia, at an unspecified dose and frequency and NAPROXEN for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches, muscle aches), FATIGUE (feeling very tired), CHILLS (CHILLS), VISION BLURRED (FOGGINESS), AMNESIA (MEMORY LOSS), CONFUSIONAL STATE (CONFUSION), ANXIETY (Anxiety) and BODY TEMPERATURE INCREASED (TEMPERATURE OF 98) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received some unknown treatment medications to calm him down.
sudden onset redness with rash to face and neck, generalized itching to upper body, skin tingling
Moderna  COVID-19  Vaccine EUA  Patient called here at the health department and reported one week later that her arm had erythema at the injection site and extended from shoulder half way down the upper arm. She reported that the area has itched occasionally. The side effect started Feb. 1, shot was given on Jan. 25. She reports that redness is fading and the site does not itch like it did.
SETTLED AROUND KIDNEY; CHILLS; HEADACHE; FEVER LIKE SYMPTOMS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.   No concomitant medications were reported.  On MAR-2021, the subject experienced settled around kidney. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the settled around kidney, headache, chills and fever like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210327800.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
I woke up with a rash on my chest, arms and legs. I had a lot of pimple like bumps all over. I had to go to the dermatologist and he prescribe me a steroid cream. The were very itchy. It last about 6 weeks.
received 2nd dose 3 months after 1st dose; extreme sleepiness; leg twitching; chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose), SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and CHILLS (chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose), SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and CHILLS (chills). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 3 months after 1st dose) had resolved. On 11-Apr-2021, SOMNOLENCE (extreme sleepiness), MUSCLE TWITCHING (leg twitching) and CHILLS (chills) had resolved.            Concomitant information were not provided. Treatment information were not provided.   This case was linked to MOD-2021-114207 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information include event outcome with no new information.
Patient can smell the vaccine in nostrils; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils). At the time of the report, VACCINATION COMPLICATION (Patient can smell the vaccine in nostrils) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
knot at the site of injection.; Red knot at the site of injection; Itchy knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot at the site of injection.), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (knot at the site of injection.), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection). At the time of the report, VACCINATION SITE MASS (knot at the site of injection.), VACCINATION SITE ERYTHEMA (Red knot at the site of injection) and VACCINATION SITE PRURITUS (Itchy knot at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
MIGRAINE FOR 6 DAYS, SEVERE BODY ACHES, COUGH, CONGESTION, SEVERE NECK PAIN AND JOINT PAIN, INCREASED HEART RATE.
Patient says she received the Boostrix vaccine. She has been experiencing arm and shoulder pain for the last two weeks. She says she still has full shoulder mobility but it is painful. Recommended patient to take tylenol or ibuprofen and see if it resolves the pain. If it continues to hurt patient can contact primary care provider.
EXTREME fatigue, headache,  inability to eat, pain left and right side at the high of the waist, thirst, feeling hot had to rest.
I contracted Guillian Barre after having the Moderna Vaccine shot; I spent 12 days in the hospital receiving blood-cleansing treatments; I have severe nerve pain in my lower extremities; I could not walk  or stand-alone 1 day after entering the hospital
Patient noticed a few hours after getting vaccine that arm was very red and swollen but did hurt all around the inside of  her elbow area. Pt described the swollen arm as looking like an "egg" and being extremely red. Pt said each day the arm seems to have been getting less swollen. Pt presented to pharmacy today. Inside of elbow is still swollen, red, and almost looks a little black and blue. Pt said arm is giving her pain now when she touches it.
Lymph node in right arm pit swelled to size of golf ball after the first 18 hours. Could feel my lymph nodes across my body from right arm and down right side then to left side and down left torso get affect over the next 48 hours. My right arm mobility became less and less over the course of 3-6 months. Still dealing with a year later and now seem to have two tears in the tendons.
pt recvd vax & rt eye swollen w/exacerbation of pre existing exema; t100.0; no sz, no crying; a bit fussy;
Got the shot and two days later I had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that the shot works, it would give you shingles. The follow-up would not possible as no contact details were available.
Joint aches and moderate overall body ache 1 day after shot, very sore tender at shot site: 2nd and 3rd days after shot- less soreness at site of shot, and joint/body ache gone but diarrhea severe, through night and most of day 3.
Sore arm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm. The outcome of the event sore arm was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Info has been received from an RN, who is the mother, concerning her 28 year old daughter, who was vaccinated with 2 doses of varicella virus vaccine live. She was 18 years old (approximately 1995). It was reported that on 7/2/05, the pt had a "mild" breakthrough case of varicella with a mild fever. At the time of the adverse event reporting, the pt was recovering. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info has been requested.
Patient developed Guillain-Barre syndrome, beginning on 10/31 with diagnosis made at UVA on 11/4/9.  11/16/09 Medical records recieved for DOS: 11/3/09. MVAx10 days prior and tetanus vaccine. Progressive ascending weakness. Sensory loss UE/LE, w/areflexia. Dizziness, dry cough, body aches. Back and shoulder pain. Tingling hands/feet. CSF protein high. EMG abn.
Pt?s mother stated pt having hx of syncope after needle injections. Pt?s mother and patient were advice to have pt lay down prior to vaccine admin. Pt and mother refused to have him lay and insisted on staying seated on chair while mom hugged him. Patient was vaccinated, in chair while hugging mom, pt stated he was feeling unwell, was provided a cup of water, able to drink without problems. Pt remained hugging mom while he lost consciousness sitting in chair. He was assisted to floor where he regained consciousness after a few seconds. Patient was assessed, legs were elevated, alert and oriented to name, place and situation, Vitals were taken at 18:14 read-BP:119/66, HR:60, RR-18, O2 Sat: 98%, after a few minutes was assisted to sit up on chair, pt stated feeling better. Vitals were rechecked at 18:25 and read BP:120/72, HR:80, RR:20, and O2 sat 99%. Patient stated we was feeling fine, was monitored for 30 mins. No reactions were noted, patient talking and drinking water without a problem. Patient stated feeling fine and ok to go home. Mom advise if sees a change or symptoms of reaction developing to contact PCP or ER.
About 6-7 days after 1st dose I started having chest pains.   It?s a constant/persistent pain that I?m still having.  There is a tightness, very sore chest discomfort similar to a strained muscle, but I have not done any physical activity.  Similar to heartburn without the indigestion.  Pain directly between my breast sore even to the touch.  Sometimes the pain is worse than others but it?s been pretty constant for about 12 days now.
7 days after receiving the shot developed a hard painful red lump at injection site . Lump and pain subsided next day but still have a large red swollen and warm to touch area around injection sight approximately    5 x5 in.  in size
Change in menstrual cycle (heavy and two week early), extreme fatigue (started the day after the shot and continued for 3 months before beginning to wane), weight gain (6 pounds in 3 weeks, a 4% gain in a person with stable weight for 3+ years), deep muscle pain in the front of legs (quads)
Left arm pain from shoulder to elbow; bone pain; worsening pain. Female patient received Td on 07/14/14 due to stepping on a nail. On 07/15/14, patient reported left arm pain from shoulder to elbow; patient stated "it feels like the pain is in the bone-bone hurts." The patient's first visit to physician's office for event was on 07/21/14 and was treated with a steroid shot, anti-inflammatories and pain medication. Patient reported a mild improvement of symptoms right after receiving the treatment on 07/21/14, but indicated that the pain returned. During her follow-up visit, on 07/24/14, the patient reported worsening pain and was prescribed prednisone 10mg/6 days; she is due back at the physician's office on 7/31/14 for an additional follow-up. Follow-up on 08/12/14: Patient did not return to the physician's office for the follow-up appointment. Patient indicated she visited her primary care physician who referred her to an orthopedic doctor; no medications were prescribed. Patient indicated her condition was improved while taking steroid, however she did not specify she was recovered. Patient indicated she will not follow up with any physician for the time being. Follow-up on 09/08/14: Patient's recovery status is unknown. All attempts to obtain additional information have been unsuccessful.
THROWING UP; 103 FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 13-SEP-2021, the patient experienced throwing up. On 13-SEP-2021, the patient experienced 103 fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the throwing up and 103 fever was not reported. This report was non-serious.