chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 23 year old active duty male who presented to the medical center and clinic for follow up. He was previously seen in the ER on 12/28/02 for a routine bandage check and was noted to have viral lymphangitis. He received the smallpox immunization on 12/18/02. The patient has no history of previous smallpox immunization. 12/18/02 3 jabs given, slight petechiae at site, no symptoms. 12/19/02 dressing dry, no symptoms. 12/20/02 dressing change C/D/I, no symptoms. 12/21/02 dressing change C/D/I, no symptoms. 12/22/02 dressing change C/D/I, no symptoms. 12/23/02 dressing change C/D/I, no symptoms, 5mmx10mm erythema, 3mmx5mm vesicle. 12/24/02 dressing change in ER--mild exudate on dressing, approximately 20x20mm erythema, 10x9mm vesicle, no symptoms. 12/25/02 dressing change in ER, dressing dry, 5x5mm vesicle, no symptoms. 12/26/02 dressing change--mild exudates on dressing, 10x10mm erythema, 7x6mm vesicle, diffuse, global, dull, achy headache 5/10, local pruritis 5/10. 12/27/02 dressing change--dry, diffuse, dull, achy headache 5/10, local pruritis 5/10. 12/28/02 dressing change in ER--C/D/I, 200x150mm erythema, 10x10mm vesicle, erythema extended contiguously from his elbow to proximal humerus, satellite urticarial lesion 3x3cm medial to the large erythematous area near axilla, warmth, swelling, slight tenderness at site, fatigue 8/10, slept 14 hours, local pruritis 5/10, diffuse, dull, achy headache 5/10, sent home to quarters x24 hours, decreased mobility of arm secondary to swelling. 12/29/02 dressing change in ER--C/D/I, decreased erythema and swelling at site, no tenderness, FROM, area of erythema increased, fatigue 6/10, dull, diffuse, achy headache 3/10. 12/30/02 dull, diffuse headache 2/10, dressing change--C/D/I, 140x220mm mild erythema, blanching, minimal erythema near inoculation site with increased erythema distal to site, no warmth, tenderness, edema, 9x9mm ulcer with 7x7mm eschar, dry, no cervical, axillary lymphadenopathy.
Chart review indicates that HPV and Pneumovax were given in the right arm. Hep A in the Left arm. Injections were given around 9:15AM  Patient called into Triage around 1:30 indicating that her arm was in pain and thought that vaccine was given to High. After Triage talked with patient around 5:30 was instructed to go to Urgent Care or the ER. Patient presented to the ER that day 7/20/20 ER Documented, Patient is a 19 y.o. female with past medical history of anxiety who presents to the emergency department for evaluation of shoulder pain. Started today after receiving 2 immunizations. Located throughout the shoulder, not present with touch but worse with movement. No numbness or tingling. No fall or injury. She received 2 immunizations of the right shoulder and 1 in the left. She also started to have left shoulder pain but is not nearly as severe. She took ibuprofen earlier. No fevers. No skin redness or swelling? Patient had Follow up with PCP 7/29/20 which documented, ?Right shoulder pain, unspecified chronicity  Patient recently in the ED for Right shoulder pain and stiffness She had 2 vaccines in that arm (HPV and Hep A) just prior to pain and stiffness Slight swelling and bruising.  No redness She says that she now doing much better Symptoms lasted about 5 days. Towards the end of her course pain went in to left shoulder as well.  Later she was evaluated by Ortho. Both ED and Ortho evals were benign?
Patient has a lot of pain on the left arm. Cannot move the arm up without a lot of pain. Said it was so painful that she couldn't sleep. She came 1 day after the vaccination was given, and said it was still very painful.
Patient had a sore arm after she got her shot at a flu clinic at her job. Patient claimed she can't move or rotate her arm for almost 10 days which is quite unusual. Patient called her doctor and he is aware of her case.
PATIENT COMPLAINED OF FEELING FAINT, TINGLING TO FINGERS AND RADIAL SIDE OF HAND.  HE WAS DIAPHORETIC. PATIENT DRANK WATER. PATIENT  LAYED DOWN ON COT AND WAS OBSERVED.
under age patient received dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under age patient received dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under age patient received dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under age patient received dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Got woozy; Fever; Pain on arm of injection; Cannot lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Cannot lift her arm), DIZZINESS (Got woozy), PYREXIA (Fever) and INJECTION SITE PAIN (Pain on arm of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LIMB DISCOMFORT (Cannot lift her arm) and INJECTION SITE PAIN (Pain on arm of injection). On an unknown date, the patient experienced DIZZINESS (Got woozy) and PYREXIA (Fever). At the time of the report, LIMB DISCOMFORT (Cannot lift her arm), DIZZINESS (Got woozy), PYREXIA (Fever) and INJECTION SITE PAIN (Pain on arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ibuprofen.  Concomitant medicines include baby aspirin  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD21-075957 (Patient Link).
Large swelling in left armpit and chest that lasted over a week. Flu like symptoms for 24 hours. Typical soreness at injection site.
I started that afternoon with a lot of headache, I felt extremely tired and I ended staying at home from work for the following two days, chills and body ache. Also my left arm was in pain.
mom had though sx d/t vax as p/1st set of vax pt devel diarrhea & loose stools w/o weight loss x 3 1/2wks;tx included multiple exams, changes in formulas & observation;
Information has been received from a registered nurse concerning an 18 year old white female with an allergy to sulfa and otherwise "apparently well" who on 5/20/02 was vaccinated in the left deltoid IM with a first dose of hepatitis A virus vaccine inactivated (lot 0162-invalid lot). Concomitant vaccination and therapy on 5/20/02 included a first dose of meningococcal polysaccharide vaccine (MENOMUNE) (lot UB106AA) in the left deltoid IM and a dose of tuberculin purified protein derivative (TUBERSOL) in the left forearm. Although the patient had been treated with amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN) for sinusitis from 5/7/02 until 5/17/02, there was no illness at the time of vaccination. It was reported that the patient inadvertently received 1ml of the hepatitis A virus vaccine inactivated instead of 0.5ml. This does not comply with the dosage recommendations. Subsequently, on 5/28/02 (also reported as 24 to 48 hours post vaccination), the patient experienced lower abdominal cramps and diarrhea for 3-4 days which then subsided. On 5/31/02 the patient presented to the physician's office with bloody, mucousy diarrhea stools and abdominal pain. She had an intermittant low grade fever, no vomiting, appetite within normal limits, and not weight loss. On 6/1/02 the patient presented to the ER and was hospitalized overnight. Stool cultures were sent and the abdominal computed axial tomography was negative. On 6/4/02 the patient was diagnosed with Clostridium difficile and her therapy included metronidazole (FLAGYL), which made her quite ill, vomiting for 10 days during therapy. On 6/26/02, studies demonstrated Clostridium difficile toxin A & B and the patient received vancomycin therapy for 10 days. On 7/22/02 neither toxin was detected. On 8/26/02, it was reported that despite the negative stool culture result, the patient continues to have increased stools of 5-6 per day. She is afebrile and has lost 15 pounds but now regained 5 pounds. She is now on acidophilus and being followed by a gastroenterologist. On 9/27/02, the patient was reported as recovered by "not totally recovered yet". Follow up information received on 10/14/02 reported that the patient "still sees a gastroenterologist", with treatment of metronidazole (Flagyl)and vancomycin, for Clostridium difficile. The patient reportedly had 3-4 diarrheal stool daily when off antibiotics. a colonscopy reportedly "may be scheduled if necessary." It was reported that the patient has not recovered. Additional information has been requested.
Fever chills body aches headache tired. Sleep excedrin  migraine and cold was cloth on forehead. Fever and chills lasted 12 hours. Aches and tired lasted much longer
pt recv vax 23MAY96 & 31MAY96 pt devel hives The hives started on the face & moved down the trunk & legs;pt recovered by 3JUN96;
Ever since being vaccinated, I have suffered from chronic urticaria , brought on by temperature change  and chronic inflammation throughout entire body. I am currently being seen by a naturopathic doctor to treat my symptoms and it is believed that I am suffering from an autoimmune disorder due to my immune system being overloaded from my vaccinations.
Weakness, tingling, numbness 02/13/07-records requested from receiving facility. 02/13/07-records received from transferring facility. ER services 2/7/07 DX: paralysis presented on day of vaccine with left arm weakness, profound speech problems, lower extremities feeling weak. denies shortness of breath, no chest pain, tightness, pressure, no pain. No incontinence, no seizure. No altered mental status. Symptoms have not gotten worse but not improved.  PE: speech garbled, unable to really express herself. Crainial nerves II-XII are intact. Alert and oriented times 3. Cerebellar exam intact but only evaluated in the right upper extremity. No strength in her lower extremities, flaccid paralysis. Sensation intact. Deep tendon reflexes intact. Left upper extremity exhibits similar paralysis and neurolgoic findings as well. Right arm is normal. REcords from Scottich Rite for DOS 2/8/07-DX:Immunization Reaction discharged.
rash at site of vaccination, about 4" in diameter accompanied with itching. 5 days duration
Patient received a J&J vaccine indicated for age 18 and up. Patient is 17. No adverse events reported.
Pt recvd 3 doses of Engerix-B vax 13SEP90, 12OCT90 & 12MAR91 & it was determined that pt did not respond to the vax series;
Patient given a vaccine on 11/6/2021 that expired 11/5/2021.
This spontaneous report has been received from a pharmacist and referred to an unknown number of patients of unknown ages and genders.  The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (strength, dose, frequency, and route of administration were not reported; lot number M018593 with an expiration date 28-JUN-2017) for prophylaxis. The vaccine data logger measured a temperature of 15°F for a total time frame of 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007898:
contracted Covid-19 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 3 weeks ago) in a 59-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19 3 weeks ago). At the time of the report, COVID-19 (contracted Covid-19 3 weeks ago) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported Patient got quarantined for 10 days.; Sender's Comments: This case concerns a 59-year-old female patient who experienced the non-serious  unexpected event COVID-19, after receiving mRNA-1273 Moderna vaccine. No information was provided regarding the event and date doses of the product. Further information has been requested.  No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report
I started hearing a high pitched sound in the morning. The sound continued and I started to feel dizzy. I went to the doctor and was told no treatment was needed and it would subside on its own. I did not have any problems hearing prior to the shot. I was diagnosis with Tinnitus and still currently hear the high pitch noise.
4hours after the injection got severe hive all over body.  Few weeks after the vaccination started having hives every day
Patient came in stating that she had chills right after the vaccine. Her arm was red and swollen and warm to the touch.
I was advised by a friend that I was exposed to COVID-19. I have what feels like head cold symptoms but no fever. Stuffy head, congestion, sinus issues, fatigue, sleeping a lot, no body aches and pain. I took a home COVID-19 test at 5pm and it was faint, I took second test that came back positive. I called my doctor and was prescribed Paxlovid. I started taking it for a day and have not started feeling any difference yet.
For past 4 years, patient had not had a SLE flareup, and also had not had blood clot in past 4 years.  Patient's lab work for SLE had been extremely healthy for past 4 years, with no indication of SLE or APS involvement.  Patient had been feeling healthy, with energy, and had easily went on a 3 mile run just 12 hours, the night before the shot.  So, the following symptoms, typical of a SLE flareup for the patient were abrupt and sudden, upon the flu shot injected at 9:15 AM on 9/29/2020.  Within 2 hours of flu shot, had Lupus red skin and Lupus red rash spots on cheeks.  Within 2 1/2 hours, had additional Lupus hard tissue on face in 1" to 2" section that was bright red.  From 3 hours to 3 days after shot, had bright red face on entire face.  Within 12 hours had extreme dizziness, nausea (but no stomach pain or cramping), and vomiting (food or water) that lasted for 3 days.  No fever, but clammy skin for 3 days.  Within 24 hours, had blood clot on lower right thigh, a few inches higher than a prior blood clot (about 20 years ago) when diagnosed with Antiphospholipid Syndrome, secondary to SLE.
first dose of Twinrix in Nov 2020, the second dose was given in June 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in November 2020, batch number 75C72, expiry date 13th June 2022).   In June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: A Pharmacist reported that a male adult patient received the 2nd dose of Twinrix later than recommended schedule which led to lengthening of vaccination schedule and had not received the 3rd dose yet till the time of reporting. The reporter consented to follow up.
At the end of the day on March 25th 2022 it felt like my face was swelling and puffing. A few hours later, my hands became swollen. By the morning, my joints were still and sore. Had a telephone visit with the doctor and advised me to take Aleve and Benadryl. With that, I only have mild stiffness in my fingers.
Woke up the morning after vaccines with small erythematous macules behind ears and on backs, spread over next 24 hours, itchy, not raised, not hives.
Pt was light headed, warm. She asked for a glass of water. 2-3 minutes later she asked for more water then said she felt like she was going to pass out. I had her lie down on her back with her legs up. We gave her a cold bottle of water and cold compress of her forehead. After 10 minutes she sat in a chair and then 10 more minutes she felt better and could go about her business.
12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, low grade fever 99F.
In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took Morphine and experienced drug allergy. Concomitant medications taken within two weeks prior to vaccination included vitamins nos, zinc (VITAMINS NOS;ZINC) (reported as Flinstones), cetirizine hydrochloride (ZYRTEC), magnesium (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D) and omeprazole (OME) all from unknown date for unknown indication. Prior to the 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 vaccination. From 24Mar2021 at 10:00, in the 20 days since her first dose, the patient has had her period three times. It has been very heavy and the cramps were horrible compared to her normal cycle. The patient was very regular and got her period every 28 days for years prior to the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events in the 20 days since first dose, the patient has had her period three times, it has been very heavy and the cramps were horrible compared to normal cycle was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
L. arm: localized erythema and swelling 24 hours after vaccine treated with BENADRYL, Ibuprofen, hydrocortisone cream.
unresponsive Narrative:  74yo patient with pacemaker, type 2 DM, parkinson's and history of syncopal epsisodes presented to emergency dept on Jan 24th. He was observed and discharged on Jan 26th back to the home where he continued to have cognitive decline and later passed away on 2/2/2021
The employee developed a 10mm raised area on the left deltoid. Dime size area circumference with fluid-filled area. Tender, red & sore to touch.
missing antigen, adjuvant-only used; Administration of adjuvant-only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's comments: The Healthcare Professional (HCP) had called up to report about administering adjuvant-only via intramuscular route (missing antigen) to 3 patients, for whom she had no identifying information.  The reporter had also administered it to six other patients, with identifying information. The reporter had consented to follow-up. Additional supportive information: The patient had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was one of the nine case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
This spontaneous report was received from a licensed practical nurse regarding an unspecified 18 and 1/2 year old female patient. The patient's medical history, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with a adult dose of VAQTA for prophylaxis (route, anatomical location, lot # and expiration date were not provided), instead of a pediatric dose. No adverse effects were reported.
24 hours after vaccination - inflammation to the upper left chest area and tightness in upper left arm 48 hours after vaccination - nerve pain and pulsing in left arm down to the fingers and nerve pain in upper left side of chest 3 days post vaccination - nerve irritation moves down to the left side of the body including the foot and toes, with off and on nerve pulsing in the left arm and left side of the chest 4 days post vaccination - off and on nerve pulsing moves to the right side of the body in the arm, chest, hamstring, and shin. The left side continues to have the nerve irritation as prior days. Some nerve tingles in the back right and right side of the skull. Days 5-8: nerve pain continues to come and go on both sides of the body. The most frequent pulses are in the nerves around the left side of the chest and in the left arm.
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the patient had been administered with expired FLUMIST quadrivalent on 10-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
Fever,  aches, chills, headaches, nausea, exhaustion,  sore throat, ear aches, drainage, coughing