chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; Tired; Chilly; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Asthma since December 2007, Hypogammaglobulinemia since December 2018, Hypertension since 2005, High cholesterol, Herpes simplex type I (before 2000), Anxiety depression since 1995, Hypothyroidism (Before 2000), Trigeminal neuralgia since 2005 and GERD (before 2000). Concomitant products included SERTRALINE HCL for Anxiety depression, BUDESONIDE, ALBUTEROL SULFATE, SALBUTAMOL SULFATE (VENTOLIN HFA) and MONTELUKAST for Asthma, ATORVASTATIN for Cholesterol, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Eye disorder NOS, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, ACYCLOVIR [ACICLOVIR] for Herpes simplex type I, LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE for Hypertension, LEVOTHYROXINE for Hypothyroidism, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy, MELATONIN for Sleep disorder, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and CALCIUM PHOSPHATE, TOCOPHERYL ACETATE (ENDUR VM) for Supplementation therapy, GABAPENTIN for Trigeminal neuralgia, UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly). On 12-Mar-2021, PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100.9 (High) 100.9.         Other concomitant medication include Gamma Globulin with Prednisone for Hypogammaglobulinemia, Every three Weeks Infusion.  No Treatment medication information was reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received 28-JUL-2021 contain significant information and Patient information, Medical history ,Dose details, Concomitant medication and outcome of events updated from unknown to recovered.
This spontaneous report as received from Nurse Practitioner refers to a patient who was vaccinated with the first dose of GARDASIL, intramuscular, in 2007 (sometime in 2007). On 18-OCT-2012 the patient was vaccinated with the second dose of GARDASIL, intramuscular. No adverse effect reported. The patient present status was other: no known adverse effect. Additional information has been requested.
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 21-MAY-2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided) Lot# J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338 and 1405USA013916 by the same reporter link. Additional information is not expected.
Shingles after Shingrix 1st dose; This case was reported by a physician via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The reporter stated that a patient developed shingles after the first dose of Shingrix. The reporter give consent to follow up.
pain at all at the injection site; fever of 101; severe headache; nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), PYREXIA (fever of 101), HEADACHE (severe headache), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at all at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LANSOPRAZOLE for Heartburn-like dyspepsia.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 30-Mar-2021, the patient experienced FATIGUE (tired). On 31-Mar-2021, the patient experienced PYREXIA (fever of 101), HEADACHE (severe headache) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at all at the injection site). On 02-Apr-2021, HEADACHE (severe headache) had resolved. At the time of the report, FATIGUE (tired), PYREXIA (fever of 101), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at all at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       She was scheduled for 2nd dose on 29Apr2021 and gave the consent for follow up by safety.
Back pain started 12/26 lower back pain got progressively worse, on 12/29 leg weakness started, on 12/31 AM (R) fingers got numb, on 1/2 numbness started in (L) fingers, on 1/4 the left mouth drooped. Diagnosed with Guillain Barre on 1/5/16; IVIG started 1/5/16 at approx. 6 pm 5 days Ig received.
Patient fractured his hip and 2/22, underwent hip surgery, discharged to but readmitted with R lower DVT and bilateral pulmonary emboli.. Treated with IV heparin. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
The evening of the injection the patient had arm shaking lasting 1 minute.  The next evening had full body shaking lasting 3 minutes,
red hurting itch rash on L arm of vaccination site, changed to triangle shape day and 2 weeks after, still having pain and lost range of motion in that arm, ongoing  1 week red hurting itchy rash on R butt cheek, then on both butt cheeks 2 weeks after, took Zyrtec 3 day and tar cream RX by Dermatologist, clearing up
Around 11:30 pm that night I start coughing and I felt I was in a bear hug. I went to bed woke up around 6 am. It was worse.  I had an abuterol inhaler. Started to use that. Kept walking around. Anytime I would take a deep breath I would start to cough and cough. Around 3 pm on May 5th I started to feel relief.   Then I got the usual tiredness for 2 days
4:20PM Patient was pale, complained of vertigo, blood pressure 70/50, pulse weak, diaphoretic.  Ice packs applied to back of neck and wrists.  Feet elevated.  Patient refused to lay on floor.  Blood pressure 104/70, pulse 60, patient had a juice drink and a cookie.  Advised not to drive.  Blood pressure 100/70, pulse 60, r 20 at 4:50PM.
Localized redness and swelling along with hard hot arm within 24 hours.  Fever 100-102.3 for 4-5 days along with hallucinations and mailaise which lasted several beyond the fever.  Arm itched, throbbed, and felt like was alseep for 2 weeks.  My left hand had less feeling in it for several months.
Swelling, redness, rash, pain, tenderness in L delt. area.
pt recvd vax;seen in ofc,T 105, irritable;on Ceclor for possible ROM;leg swollen to below lt knee; some redness in calf & ankle noted;switched to ceftin & pred;adm to hosp 11mar95, inc erythema;
Temperature 100.4 - fussy.  Advised to use Tylenol for temperature.  Call if changes.
Information has been received from a registered nurse (R.N.) concerning a 14-month-old female (23 lb, 29.5 in) with no pertinent medical history or allergies, who on 27-APR-2006 was vaccinated subcutaneously in the left arm with a 0.5 ml first dose of Varivax (lot# 649998/0909R). Concomitant vaccination given on the same day included a first dose of MMR II (lot# 650105/0829R) given subcutaneously in the right arm and sodium fluoride. There was no illness at the time of vaccination. On 07-JUL-2006 the patient developed varicella. Unspecified medical attention was sought. It was reported that the patient had 50 lesions or more on various areas on her body, such as her scalp, underarms, arms, legs trunk and back. No laboratory or diagnostic tests were performed. TYLENOL and comfort measures were recommended to help with the symptoms. The patient recovered as of 20-JUL-2006. No product quality complaint was involved. The reporter considered the adverse experience to be other important medical event. Additional information has been requested.
elevated blood pressure, 160/100; This case was reported by a consumer and described the occurrence of increased blood pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included medication unknown (Blood Pressure Medication).   On 19th September 2019, the patient received the 1st dose of Shingrix. On 20th September 2019, 1 days after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient had an elevated blood pressure of 160/100.  The patient also undergoing a blood pressure medication adjustment at this time as well. The reporter does not have vaccine information for this adverse event. The reporter consented to follow up. In the XML document outcome of event was reported as recovering, but in Argus its mentioned as not recovered, so kept as reported in Argus.
This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. Since 06-OCT-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot # K025002, expiration date 20-JUL-2017; lot # L002867, expiration date 11-NOV-2017; lot# L009649, expiration date 29-NOV-2017, dose, anatomical location and route of administration were not reported). No adverse experiences were reported. This is one of several report received from the same reporter. Additional information has been requested.
Initial information received 06/10/2002: A male patient, previously treated with Tice BCG bladder irrigations, for an unspecified indication, currently has a disseminated BCG infection, and is being monitored by the reporter, an infectious disease specialist.  Follow up information received 01/16/2003: A male patient with past history of Transitional Cell Carcinoma (TCC), Grade II, of Bladder (1969) and recurrence of Grade II TCC in 1998, at which time he received 6 weeks of BCG therapy, was diagnosed with a recurrence of TCC Grade I in January 2002.  A cystoscopy in November 2002 showed another recurrent bladder tumor.  The patient, with a history of bilateral hip replacements prior to his current symptoms, had been hospitalized on 05/31/2002 for evaluation of a right hip abscess and had undergone removal of his right hip prosthesis the same day.  The hip infection was identified as "mycobacterium and bovis".  Per the evaluation of an infectious disease physician on 06/04/2002, while the patient was still hospitalized, it is noted that a left upper lobe mass had been found prior to hip surgery, and a bronchoscopy had been done, with negative findings; a subsequent culture positive for "myobacterium tuberculosis complex, resistatn to PEA."  On 03/27/2002, a bronchial brush had been "positive for an organism consistent with MTBC complex, pyrasinamide resistant."  As of 06/04/2002, while still hospitalized since 05/31/2002), the patient "denies any fevers, chills, or sweats, and admits to only a modest weight loss around the present hospitalization."  As of 06/04/2002, he had been "given twice-weekly directly-observed therapy by the health department", for the lung conditions, and as of 06/04/2002, "his chest x-ray has substantially improved and is said to have cleared."  The infectious disease physician assessed the patient as "Pulmonary bacillus Calmetta-Guerin infection, probably disseminated bacillus Calmetta-Guerin infection, with infection of the right hip."  On 07/24/2002, the right hip prosthesis was replaced.  On 10/17/2002, when reassessed by the infectious disease physician, it was noted that the patient "has been continuously on antimicrobacterial therapy," including Azithromycin while hospitalized, and continuing, since in the hosptial "INH, Ethambutal, and Rifampin."  The infectious disease physican's impression on 10/17/2002: "BCG infection with dissemination following intravesical BCG therapy of bladder cancer."  The plan of treatment was to continue the patient on Rifampin, Myambutal, and INH for 12-24 months.
on Jan 20th, I took my dogs to their grooming appt and stopped at store for a few things.  I woke up in store to EMS putting me in ambulance.  I asked them what was going on and they said I had a seizure.  I had no pre-warning, hit head, right shoulder, and bit lip.  EMS took me to Emergency Department.  Had labs and head CT, all normal.  MD felt seizure was due to vaccine.
p/vax w/in 10-15 minutes devel severe inj site react & anaphylaxis; wheezing; dyspnea; cyanosis & tachycardia; oxygen saturation was 87%; pt tx w/inhaled albuterol & epinephrine; recovered w/in 10 minutes;
Received IM flu vaccine at 10:00 approximately 1.5 hours later, began itching took Benadryl per mouth.  Approximately 15-20 minutes later, vision blurred, legs weak, layed down on floor.  Transported to ER, received solumedrol IV.
Pt C/O redness / itch on L mid arm upon D/C home size 4.5 cm and lump felt about a quarter size, HO notified /seen Pt. and instructed to apply warm pack if posted D/C with increased redness / itch plan to come back to ER.
Patient reported muscle and joint pain, fever and headache within 12 hours of receiving this vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-DEC-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-JAN-2016 the patient was treated at a medical center for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Mother is reporting, he is in prison, and he got his vaccine and called his mother and stated that he was bleeding out and he was crying.  He had had a hernia repair a month or so earlier and he was bleeding at that site and that they had to "laser" it three times to get it to stop.  He was also bleeding out of his ears, his mouth, throat and eyes.  They did not know what to do with him and how to treat him, and he was transferred to Medical Prison.  They started giving him Prednisone as his WBC was down to 6000.  He was having to get transfusions of blood to build up his WBC count.  It built up to 30,000 and then went back down to 6000.  Then he told her that the doctor was putting him on Prednisone and that there may be a bad sign that he might loose feeling in both of his legs, and was taking it and then he couldn't feel anything in his right leg.  He did not want to take it anymore and they stopped the prednisone.  When he went to the doctor about the prednisone and had been stabbed in the neck with an ice pick and was told that if he moved his neck in any way, shape or form.  When he was stabbed it was 2 cm away from his spine.  Then they put him in the hospital and checked his WBC and with the prednisone it was up to 500,000.  Now, he cannot feel anything in his right leg.  Now they do not know what to give him.  He is still being treated for his symptoms, she does not know what he's being treated with since they took him off of prednisone.  He has been diagnosed with thrombocytopenia, critical stage where his blood does not clot.  He was diagnosed with this after the vaccine.  He has 2 more years to serve in prison.
Cellulitis at injection site. Started aprox 60 hours post vaccination. Treated with PO antibiotics
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 17 years old patient. On 21-DEC-2012 the patient who was intended to receive VARIVAX (Merck) was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information is not expected.
suspected vaccination failure; Got a very mild case of it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got mild shingles. The patient stated that, Shingles shots were pricey. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
2/22/17 Left leg had dime size redness with a lump. 2/23/17 redness to left leg increased to baseball size c/o leg itching. She was prescribed clindamycin. 2/24/17 center of leg looked bruised and is dark red. C/O left leg itching. Dr. recommended ZYRTEC. 3/7/17 Mom reports apple size bruised area, no redness, no lump.
I had a headache, sluggish, slight sniffles, and felt uncomfortable. I tested positive for COVID-19. I talked to a doctor, but he did not prescribe me anything because my symptoms were not severe.
Date the vial was initially stored in the refrigerator: October 24, 2022; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022).    No concomitant medications were reported.   14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 08-Dec-2022 to 10-Jan-2023.  Date the vial was initially stored in the refrigerator was 24-Oct-2022.  Vial did not undergo any temperature excursions.  No treatment medication was provided.  This case pertain to 13th of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live Significant Follow up received included patient demographics and narrative updated. On 24-Jan-2023: Live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult
Pt stated she started feeling very tired and sick; a day later she started having little bumps and then the 3rd day after the bumps got a little bigger. Pt went to dr on 10/26 and dr diagnosed pt with chicken pox.
4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing in my ears that didn't go away. Not certain exactly when it started as it wasn't very loud and other sounds would mask it.  5/12/21 - 2nd CoVid shot 11:00 a.m.- arm pain, felt like my equilibrium was off that afternoon (a little dizzy, etc), constant ringing in the ears became louder. Next day after the shot had arm pain, fairly bad headache, light nausea, low fever 100.2 in the morning but was gone later in the day. (Felt like a really bad hangover) Took a few days to feel normal, however the constant ringing in the ears has not subsided as of this writing (6/3/21) and can be quite annoying.
Edema of fingers, ankle, wrist, knee with urticaria polyarthropathy knee, elbow, ankle