chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clot, stroke Narrative:  4/15/2021: Patient self-presented to community emergency facility Emergency Notification Intake Date Presenting to the Facility: Apr 15,2021 Community Care Hospital Name: Hospital: Address: City: Chief complaint: stroke Primary Diagnosis: Patient Admitted? Yes Admitting Diagnosis: unknown 4/21/2021: Writer was called by spouse and informed that patient had be admitted to Hospital on 4/15/2021 for c/o CVA. Spouse states that patient received Covid-19 vaccine by Johnson & Johnson thru medical facility on 3/6/2021. Spouse states patent was diagnosed with a 2 inch blood clot to right side of neck. Pt currently in ICU at outside medical facility.
Large, raised area of itching, swelling. redness, heat, and mild pain around injection site.  Began on 1/4, seven days after vaccination and continues now.  Self-treating at home with cold packs and topical hydrocortisone.
Lethargic; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced lethargy. On an unknown date, the outcome of the lethargy was recovered/resolved.   It was unknown if the reporter considered the lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was not reported but captured as adult as per vaccine indication. The reporter mentioned that, there were many patients who received Shingrix and reported feeling lethargic for over 48 hours. Then on the third day, the patient's felt fine like nothing had happened. No additional details were provided.
Pt lost consciousness 30 seconds after immunization. Lasted 5 seconds. No treatment needed. Pt's mother stated pt passes out when blood drawn.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored PROQUAD (Merck) (Lot # L007231 with expiration date of 03-SEP-2016), (dose and route were not reported), which were stored at -9.7 C for 12 hours and 47 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
got two shots and still got them/Suspected Vaccination Failure; still got them a few times; so painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had got two shots and still got them a few times and was so painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
On July 3rd ate hamburger for lunch.  Had terrible burning in arms and legs during night.  The following Wednesday again had hamburger for lunch and had terrible burning during night.  Saturday July 19th had hamburger for lunch and burned again during night.  Just to test had small amount of ribs Sunday and burned again.  Now it seems that nearly everything I eat with any amount of protein makes me burn 6 to 8 hours after eating.   Have lost 5 pounds since July 20th.  Getting shaky and weak.  I feel like I'm starving.
Initial report received from a pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch: 104045P1, expiry date 30 Apr 2010) 0.5 ml once, intramuscular, stored at temperatures as low as 34 F and 35 F, on an unspecified date. No adverse event was reported.
fever, nasal congestion, cough, headache, exposure, chills, shortness of breath. starting 1/10/22
FEVER 102 DEGREES. RIGHT ARM AFFECTED - INJECTION SITE WAS HOT TO THE TOUCH AND SWOLLEN WITH SEVERE REDNESS LASTING 4 DAYS.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having lots of problems since getting these shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Demerol).On 27-Aug-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Having lots of problems since getting these shot). At the time of the report, VACCINATION COMPLICATION (Having lots of problems since getting these shot) had not resolved. Not Provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.This case was linked to MOD-2021-369133 (Patient Link).
Crushing headaches, dizziness, blurred vision, confusion, anxiety.  Muscle pain and stiffness, heart palpitations, loss of coordination.  Sinus and jaw pain.
<5mm papule red, umbilicated on both hands. Small pox vaccine auto inoculation no bacterial infection at this point.
Rash near injection site.  The redness was like the outlines of an oval, but the oval wasn't filled in.
Information has been received from a physician assistant concerning a 15 year old female who on 23-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and included hepatitis A virus vaccine (manufacturer unknown). The physician assistant reported that the patient received the first vaccination with GARDASIL VACCINE on 23-MAY-2008 and passed out. The patient became pale in color and passed out while sitting on the examination table. The patient was treated with cold compresses and recovered after an unspecified time frame. The patient was asked to wait in the office after recovery, but mother needed to leave. There was no product quality complaint. Additional information has been requested.
Injection site redness; itchiness; arm soreness; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, itchiness, redness at injection site.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin, Hydrochlorothiazide for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) arm soreness. itchiness, redness at injection site.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness, itchiness,redness at injection site was unknown.
The evening of receiving the above vaccine (9/6/02)-developed fever T102-103 x 3 days. Today fever declined. To ER 9/7/02.
Patient came back to pharmacy reporting tachycardial, dizziness, and flushing. Said she felt wrong. She sat down and after 20 minutes she said she was feeling better. She said that it gave her a feeling of anxiety.
No additional AE; HCP reporting expired ROTATEQ was administered to a patient today, 28SEP2022. ROTATEQ Lot #1742083, Expiration Date: 22SEP2022. ROTATEQ did not have any previous TEs. No additional information provided. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-SEP-2022, the patient was administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml/once, lot #1742083, expiration date: 22-SEP-2022, administered orally for prophylaxis (strength and dosing schedule were not provided) (expired product administered). Administered dose of vaccine did not have any previous temperature excursions (TE). No additional adverse event was reported (no adverse event).
infection/ flare up of diverticulitis (a reoccurring condition); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 68; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, in Feb2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history included ongoing diverticulitis. The patient's concomitant medications were not reported. The patient received the first injection of the Pfizer vaccine 2 weeks ago. The patient received amoxil/clav 875mg for an infection/ flare up of diverticulitis (a reoccurring condition). The patient would like to know if it will it interact and when should the patient get the 2nd shot. Outcome was unknown.  Information on the lot/batch number has been requested.
Got double vision on May 7, 2021, uncontroled blasser around end of May 2021,  later diagnosed with myasthenia gravis.  Have double vision, difficulty swallowing, trouble catching my breath after exercise or walking, uncontrollable bladder functions.
fatigue, body aches, chills, poor appetite Narrative: Patient is a 65 year-old-male who received the Moderna COVID-19 vaccine on 2/12/21. On 2/23/21, patient contacted his primary care nurse to inform he was having side effects from the vaccine, including headache, fever, chills, fatigue, body aches, rash on top of his feet that extends to his knees, bumps on his chest, bleeding from nose, mouth, and gums, and hyperglycemia. Patient reported took aspirin and Airborne for the symptoms. His primary care provider ordered bloodwork to be done the next day. On 2/24/21, patient had the following labs done: BMP (WNL except for glucose which was 363 mg/dL), CBC with diff (notable for very low platelets of 1 K/mm3), and PT/INR/PTT (all WNL). PCP examined patient and noted no obvious rash on chest, skin fair but not pale, no significant bruising or acute bleeding but petechial rash from the knees down. Patient had been sent home to rest while awaiting lab results. Once lab results returned, patient was contacted and instructed to go to the local ED due to his critically low platelets. Patient went to the local ED, bloodwork showed platelets of 4000 at that time. He was tested for COVID-19 on presentation and was found to be COVID-positive. Patient was diagnosed with idiopathic thrombocytopenia purpura. He was given a total of 4 platelet transfusions as well as IVIG for 2 days and prednisone for 4 days. Platelets reached 78,000 before patient was discharged on 2/26/21. At the time of this reaction, patient's active medications included: metformin, testosterone cypionate inj, allopurinol, atorvastatin, carvedilol, dulaglutide, empagliflozin, lisinopril, aspirin, calcium/vitamin D, multivitamin. He also received the TDaP vaccine 1/21/21 (22 days prior to the COVID-19 vaccine). Post-discharge follow up with primary care provider on 3/5/21 revealed patient feeling better, no bruising, bleeding, fever, or chills since discharge. Patient finished the course of oral prednisone started in the hospital. Glucose remains elevated. PMD to recheck CBC for platelets once patient is done with his mandatory quarantine for positive COVID-19 test results.
per mom pt has had a dry cough and grasping for air after the vaccine. no other symptom was reported.
about 30 minutes after taking I felt some numbness in left side of face, but went away. Went home and felt fine until about 8pm when I could feel a slight headache coming on and I heard something that wasn't there. I went to sleep and had very bad headache and heard someone say my name which I knew all of this was because of the vaccine. The next day I had chills, lethargy, and bad headache and stayed in bed most of they day. That night still headache and bad, vivid dreams. Today, some ringing in the ear, headache not as bad, more energy, some tightness in the chest, flash of light.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. The vial did not undergo any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contain Non-significant information.
After receiving the vaccine, I felt fatigue and soreness in the arm for a day. On 12/16/2022, I had symptoms of a urinary tract infection and I tested for COVID-19 which was negative. I went to an urgent care clinic and received an antibiotic for the urinary tract infection. On 12/17/2022, I tested positive for COVID-19, and I contacted my doctor's office and got the prescription PAXLOVID. I had no complications taking PAXLOVID. As of today, I have two more days of taking PAXLOVID.
headache; body aches; chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown".  Clinical course: patient with no additional health conditions had COVID-like symptoms within 24 hours of receiving the COVID bivalent booster dose. Symptoms included headache, body aches and chills. These AEs were not experienced after administration of either initial series doses or the first booster dose. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt out of sorts; Achy; Fatigued; Fever of 101.7F; Chills; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt out of sorts), PAIN (Achy), FATIGUE (Fatigued), PYREXIA (Fever of 101.7F) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MALAISE (Felt out of sorts), PAIN (Achy), FATIGUE (Fatigued), PYREXIA (Fever of 101.7F), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MALAISE (Felt out of sorts), PAIN (Achy), FATIGUE (Fatigued), PYREXIA (Fever of 101.7F), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
PATIENT STATES THAT HE HAS LEFT SHOULDER PAIN AFTER RECEIVING HIS 1ST MODERNA VACCINE IN THE LEFT ARM HE HAS HAD SHOULDER PAIN.  HE STATES THAT IT GOT WORSE WITH THE 2ND VACCINE AND HAS BEEN PAINFUL EVER SINCE. HE STATES THAT THE PAIN HAS INCREASED IN THE LAST 2 WEEKS. HE HAS TRIED ICING IT. HE STATES THAT HE WILL MAKE AN APPOINTMENT WITH HIS PRIMARY CARE PROVIDER TO FOLLOW UP
Round-red, swollen and itchy at site where injection was administered for past 2 days
Patient awoke on 5/11/06 and 5/12/06 with the feeling he had a fever, his sheets were wet and he was achy with a slight headache.  He reports he passed out at 1930 on 5/12/06, and was out for about one minute and witness described that the patient was shaking and convulsing in a seizure like manner.  EMT services were called.  By the time the EMT's arrived the patient reports he was stable and recovered and declined tranport. Patient states his VS were WNL.  Since that event the patient reports he feels fine - no further issues.  He is following up with his primary care physician when he returns from vacation in two weeks.
Approximately 3 weeks post vax, this pt "developed a rash that started on his buttocks, then spread to his extremities, then to his neck and back. He had tiny pimples on his forehead as well. He presented to a physician and was dxed with maculopapular rash. The physician believed it was and atypical reaciton." Follow up states additional information has been requested.
Allergic reaction; Rash; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), HYPERSENSITIVITY (Allergic reaction) and RASH (Rash) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benadryl.) and Hearing reduced.    On 12-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 PRURITUS (Itching) and RASH (Rash). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, PRURITUS (Itching) and RASH (Rash) had resolved and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Benadryl, another medication similar to Benadryl, Pepcid   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received as TCR. New event was included and outcome of rash and itching were updated. It contains significant information.
hives starting at wrists and then progressing through day to include arms, legs and neck.  No respiratory difficulty or swellingof lips or tongue.
Sore arm - five days, fever and chills - one day, leg cramping - one day, cough and congestion - four days, no appetite - two days, diarrhea - two days, dizzy and nauseous - four days, headache - nine days. Felt better - two weeks, Last three weeks - headache, feel jumpy, fast heart.  Doctor prescribed Metoprolol.
Seen in ED - mild symptoms of feeling like his throat is swelling and he has shortness of breath. Physical exam was normal. Vital signs normal. EKG with sinus tachycardia at 106. Given PO benadryl and prednisone. Observed in the ED for a couple hours without further worsening of his symptoms. Impression/plan: possible reaction to Covid vaccination. Improved. D/C home
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot numbers L026551, expiry date 16-JUL-2017 and L027591, expiry date 23-JUL-2017 (dose and route were not reported). Additionally, it was reported that improperly stored doses of PEDIARIX (reported as "PEDIRIX"), (lot number, dose, route and frequency were not reported), were also administered. Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was reported that the vaccine GARDASIL 9 was also improperly stored, however, it was not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.
Pain in the upper arm (bicep & tricep) in vaccinated arm.  Pain more severe after second dose.  Pain has been continuous for past 2 months.  Currently taking Ibuprofen to manage pain.
Information has been received from a physician concerning a 10 year old male with a history of measles post vaccine, chickenpox, possible acid reflux and no drug reactions/allergies, who on 27-OCT-2007 was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was also noted that the patient had the flu at the time of the visit.  On 25-OCT-2007 the patient was seen in the office for an injection site reaction which included, redness, swelling, and itching at injection site.  On 26-OCT-2007 the reaction had become the size of a softball but the area around the reaction was less red and not painful.  The patient had a fever of 99.5F and had vomited once.  The injection site reaction had been treated with diphenhydramine hydrochloride and ice packs.  There were no lab diagnostics studies performed.  The outcome was reported as not recovered.  The physician was interested in the VZVID program.  Unspecified medical attention was sought.  There was no product quality complaint.  This is one report of several from the same source.  Additional information has been requested.
PATIENT COMPLAINED OF A VERY SORE ARM FROM A FLU SHOT 3 WEEKS AGO.  SHE HAS HAD THE SORE ARM SINCE VACCINATION AND STILL HAS TROUBLE LIFTING IT UP.
The pt developed right upper arm cellulitis (redness, swelling, tenderness) from shot site to proximal upper arm; started one day after vaccination. Received antibiotics with clinical resolution.