chrisvoncsefalvay/vaers-outcomes huggingface dataset:
became "really sick"; in bed for 24 hours with a fever; shaking; chills; "the worst headache I ever had / had to "pack my head in ice; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced sickness, fever, tremor, chills, headache, muscle pain and weakness. The patient was treated with non-drug therapy (Ice Pack (No Medication)). In November 2020, the outcome of the sickness, fever, tremor, chills, headache, muscle pain and weakness were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, tremor, chills, headache, muscle pain and weakness to be related to Shingrix.  Additional details were reported as follows: The patient reported that she became really sick after getting the 1st dose of the Shingrix vaccine. She was in bed for 24 hours with a fever, shaking, chills, headache, muscle ache and weakness. She reported that the headache was so bad she had to pack her head in ice. The patient was fine at the day of reporting. She reported about not having trouble breathing nor having an anaphylactic reaction. She stated her healthcare professional was not aware of these reactions, but she has an upcoming appointment and would inform them. The reporter did not consent to follow-up. This case was linked with case US2020229498, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229498:same reporter
Interstitial Cystitis/Inflammation of the bladder is the dx. Began in July 1999, having symptoms of pain, pressure and frequent urination. Was dx'd in November, 1999 and treated for 2 months (Rimso #5) and still under treatment now.
Information has been received from a physician referring to multiple patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II (lot #K004948, expiration date 04-APR-2016, Albumin Status: rHA, dose and route unknown), which were under the temperature of 24 C with time frame reported as 838 hours. The temperature was back in range. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Noticed upon waking hives starting on upper left arm (same area as HPV injection) which spread to both arms and legs.  As of May 22nd, noticing new hives still showing up and no sign of going away. Now hives on ears, feet and hands too. They are not that itchy, however.
Vomiting, fever, lethargy - cough, fever, 103-104 for 2 1/2 more weeks - ear infection (amoxicillin) - pneumonia - (Zithromax) anorexia - lost 14 pds. Seizures, A.D.E.M - acute disseminated encephalomyelitis. 5 days pulse Prednisone, I.C.U. E.B.V. and MRA's. 4/14/08-records received for DOS 2/7-2/19/08-DC DX: Presume acute demyelinating encephalomyelitis. Treated with azithromycin and on day four developed mask-like facies, tremors, rigidity, sweating and facial flushing. On 2/7/08-change in mental status. Intensive care. Treated with high dose decadron. Decreased gag relfex, increased tremors and sweats. Autonomic storms. NG tube placement. Anxiety. 1/21/2010 Emotional, psychological diagnosis of brain injury that has resulted in ADHD, learning disabilities, special accommodations at school and home, asthma, balance problems, still received occupation therapy, is on medication related to sustained injury and continues in therapy with a psychiatrist. Also qualifies for D.D.A.  My son also suffers from P.T.S.D. Follow-up: Now diagnosed with Asthma. Also, emotional problems, ie., anxiety, depression, post traumatic stress syndrome, headaches, lightheadedness, endurance issues and generalized fatigue. Yes, patient educational is suffering with memory problems and we are in the process of Neuropsy and Neuroeducational testing to measure potential permanent damage due to encephalomyelopathy.
mom states pt had episode of becoming stiff for approx 1min;pt was w/grandma @ that time;mom wasn't present;grandma states temp 105 R;pt had APAP 4hr a/this;given more APAP;mom felt it was a sz secondary to fever;
Patient began having 10/10 chest pain for 3 hours  1 day after 2nd COVID vaccination.  He was previously healthy although overweight.   He did not have any chest pain or dyspnea prior to this episode.  The pain resolved the patient was tachycardic and troponin was found to have a max of 0.080.  patient did remarkably better and his troponins did down trend to normal levels again.  He was discharged on ibuprofen every 6 hours.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were unspecified. On an unknown date an unspecified number of patients were vaccinated with improperly stored ROTATEQ, exposed to 33 F for 6 days (144 hours), (dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I started having pain in my left leg in late June 2022. I went to see my Primary Care Physician who had a leg CT Scan and found a blood clot behind my knee going down my lower leg. He sent me to see my blood doctor who took me off Xarelto and had me start using Enoxaparin 0.4mg injections and I will be going back August 8, 2022. My blood doctor had referred me to the hospital who wants to scan my veins because I have been on Xarelto for years and have still got a clot.
32-35 minutes after the injection - started to feel sick generally - a "crashing" feeling:  dry throat (no swelling), dizzy, as if I might faint, weak, fatigued, general sick feeling.  Worsened for an hour after the vaccine and then started to level off enough to walk out of clinic.  Felt very fatigued when I arrived home and went to bed.  Next day - fever of 99 F, over all sick -achy feeling, profound fatigue, weak, dizzy, not able to sit up without leaning on pillows, headache, gastrointestinal discomfort.  Fever ended two days following administration of the vaccine, but other symptoms persisted - diminishing slowly.  Fatigue was the last symptom to dissipate. A week later all symptoms gone except minor fatigue.  I actually have slept better after both 1st and 2nd vaccine doses than I normally do.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: Patient experienced tingling in left arm and subsequent itching. She then became flushed and sweating. Emergency services were called and she was brought to hospital for further evaluation
p/vax pt exp moderate local react;inc intensity c/burning;erythema;warmth; swelling upper arm on triceps extending to elbow;tx: ice pack
patient family called for help after patient fainted. Volunteer staff called EMS. EMS arrived at 1340, left with patient at 1350. RN assessed patient at approximately 1335 - patient conscious immediately after syncopal event. Patient stated during nurse assessment that he had donated plasma that morning and had not eaten or had anything to drink that day. Also states he has needle phobia and has had syncope with previous plasma donations/etc. No difficulty breathing or other symptoms beyond syncope. EMS transported out of abundance of caution.
This spontaneous report as received from a physician via company representative refers to a 2 year old patient of unknown gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced hives at the injection site immediately while the reporting physician was still administering the patient's first dose of VARIVAX (Merck). The physician reported that the patient had similar reactions to PREVNAR 13 and DTaP vaccines as well on unspecified dates. The outcome of the event was unknown. The relatedness between the event and the vaccination with VARIVAX (Merck) was not provided. Additional information has been requested.
slight fever; chills; tiredness; achy all over; slightly dizzy; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: OW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate and cholesterol. Concomitant medications included atorvastatin calcium (ATORVASTIN), finasteride (MANUFACTURER UNKNOWN)  and dexamethasone, tobramycin sulfate (TOBRAMYCIN/DEXAMET) . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 the patient experienced slight fever, chills, tiredness, achy all over, and slightly dizzy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the event slight fever, chills, tiredness, achy all over, and slightly dizzy were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Injection at 7:30 p.m. Noticed frequent yawning. Went to bed early, tired. Awoke earlier than usual. Slight headache that continued until it got troublesome so took Advil iii plus Tylenol500 i with coffee. Relief from headache but continued tired. Mild headache returned mid afternoon.  Bed early at 9:p.m. but headache (especially in the bones behind my ears) was keeping me awake so I  took Advil iii plus Tylenol 500 with half cup coffee. (This was the pain relief regimen that my dentist had recommended and it had been effective) Woke up this morning feeling fine.
Via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unknown date the patient who was vaccinated with PNEUMOVAX 23 (manufacturer unknown). Other suspect therapy included MMR II. On an unknown date, the patient experienced erythema. The reporting investigator felt that erythema was related to PNEUMOVAX 23 and there was no relationship to MMR II. Erythema was considered to be an other important medical event. Additional information is not expected.
breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (breastfeeding) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced BREAST FEEDING (breastfeeding). At the time of the report, BREAST FEEDING (breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.
slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IRON and VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (slight sore arm). At the time of the report, PAIN IN EXTREMITY (slight sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         No treatment medications were reported.
Rash spreading from injection site  down arm, chest and stomach. Where rash was present popped blood vessels appeared along the entire abdomen
High temp, achey, very limp & cried for 3 days; Seen by MD given E-mycin & Laisstuss, highest temp 103.9, pain & swelling @ site of inject;
the patient had "arm mostly sore; had dark around the eyes which felt like black eye; eyes feel like I have been up for a week with no sleep,eyes feel tired; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (the patient had "arm mostly sore), DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) from 01-May-2021 to an unknown date for Migraine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (the patient had "arm mostly sore), DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired). At the time of the report, MYALGIA (the patient had "arm mostly sore) and ASTHENOPIA (eyes feel like I have been up for a week with no sleep,eyes feel tired) outcome was unknown and DARK CIRCLES UNDER EYES (had dark around the eyes which felt like black eye) had not resolved. but took nothing for it      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-132734, US-MODERNATX, INC.-MOD-2021-132945 (E2B Linked Report). This case was linked to MOD-2021-133138 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132734: US-MODERNATX, INC.-MOD-2021-132945:
Where I got the shot started itching; Is now red; Is now swollen; 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 SITE PRURITUS (Where I got the shot started itching), VACCINATION SITE ERYTHEMA (Is now red) and VACCINATION SITE SWELLING (Is now swollen) 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, the patient experienced VACCINATION SITE PRURITUS (Where I got the shot started itching), VACCINATION SITE ERYTHEMA (Is now red) and VACCINATION SITE SWELLING (Is now swollen). At the time of the report, VACCINATION SITE PRURITUS (Where I got the shot started itching), VACCINATION SITE ERYTHEMA (Is now red) and VACCINATION SITE SWELLING (Is now swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
I received the shot and initially had a sore are and felt tired for one day after (normal things I experience after getting a shot). Then the symptoms went awayand I felt fine. One week after the vaccine I had a sudden onslaught of symptoms, my arm was swollen and red at the vaccination site, it felt warm to the touch, and I had a slight fever. Clearly there was some sort of infection from the vaccine. I spoke to a nurse on the phone, who directed me to go to urgent care immediately.  I've never had a reaction to a vaccine before, and if they are using sulfa Drugs or other drugs I'm allergic to in these shots then they should really be more transparent about this and have warned me before I got the shot -- I'm very concerned about getting the second shot now & I'm concerned about getting any other mRNA vaccine in the future given my reaction to this one. I was not given a choice of vaccine since I went to a public health clinic, but their website says they had all three vaccines. I would have  preferred to get the Johnson & Johnson vaccine that is delivered through a traditional vaccine method.
The injection site swelled up to the size of a golf ball.  The arm that was injected was tingling and numb. The numbness and tingling crossed over to my chest and and my neck. I started to become short of breath.
VASO VAGAL, NAUSEA, LOSS OF SKIN COLOR, LIGHT HEADEDNESS
sick; slight fever; left arm got real red; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on the inside of the body all 3 times its even worse).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and erythema of extremities. On an unknown date, the outcome of the sickness, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she did get the 2 Shingrix shots for shingles this was in 2019, it was the best thing the patient did for himself/herself and yes it made him/her sick with a slight fever and his/her left arm got real red but after 2 days the patient was fine and have been ever since, the patient pay dollar 300, for both out of pocket, patient said he/she on but had to do it, hope who ever gets the shots would get better. The patient also had both Covid shots (Pfizer), was only sick for 2 days with fever this was 6 months ago from the time of reporting. The patient was doing fine, he/she did this for himself/herself and the patient just went to get his/her Flu shot last week, from the time of reporting that one patient get every year. For the tolerance of the 2nd dose, refer case US2021AMR178357 , reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178357:Same reporter
Rule out Td 08/04. Flu today with 6x6cm large, warm, tender.
Initial misuse report received from a healthcare professional on 19 September 2013. A 02-month-old patient had received 0.25 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Medical history reported as tree nut allergies.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 13-Feb-2021, VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sudden and persistent tinnitus in left ear.  Also bloating and abdominal pain.
Fever to 104.8, local rxn, 3 convulsive episodes - marked alteration in LOC, eyes rolled back, & loss of muscle tone lasting 2-3 seconds.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
On 05/11/2022  around 05:00PM I started getting fever.   I tested positive for COVID-19. It was over 100 degree. My husband is a doctor so  he was COVID-19 positive.  The home Nurse came and gave my husband infusion at the same time they also signed me up for the infusion. I received it the same day.  On 05/12/2022 I was  extremely tired, no appetite and low energy. I felt like I wanted to just stay in bed. I drank a lot  of liquid.  For about a week or so I felt tired but I started  healing slowly.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the right arm on 17Mar2021 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and shingles two years ago. The patient had sulpha allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) 100mg 2 per day for unknown indication from an unknown date. On an unknown date in Mar2021 at 22:00, the patient experienced shingles, five days after the shot. The patient received valtrex 1gm and zorivax as a therapeutic measure for the event shingles. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event shingles was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced pain after shingrix vaccine. The reporter asked, could aspirin be used for shingrix pain.