chrisvoncsefalvay/vaers-outcomes huggingface dataset:
See attached chart note dated 4-15-09  Patient presents today for evaluation of reaction to VARICELLA vaccine given 2 days ago.  Red swollen and tender over last 24 hours.  Now with new blister formation.  Primarily right upper arm, but some redness and warmth of left arm as well.  Diffuse warm erythema measuring about 3.5 inches in diameter in deltoid region of right arm with a few small yellow fluid filled bulbous lesions superficially largest about 1/2 cm in size.  Left arm with some mild erythema and warmth, non tender.  Immunization reaction- Ice to affected area TID.  Wrapped with silvadene and telfa bandage.  TYLENOL #3 for pain.  F/U tomorrow if not improving or worsening.  Complete VAERS form given large degree of reaction.
report from internet article;pt recv vax & some time later, pt exp severe debilitating autoimmune neurological damage;
Information has been received from a health professional concerning a 22 year old female who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL vaccine IM (Lot# 657868/0523U). On 06-OCT-2007 the patient was vaccinated with her second dose of GARDASIL IM (Lot# 658558/1061U). Concomitant therapy included SINGULAIR, KARIVA and albuterol VENTILAN (albuterol). After the first dose of GARDASIL vaccine, the patient experienced cramping and bleeding discharge. The patient's outcome is unknown. After the second dose of GARDASIL vaccine, the patient experienced cramping and bleeding discharge only it was worse this time. The patient's cramping and bleeding persisted. The patient was not in her menstrual cycle. Physician performed vaginal screening and results were normal, sexually transmitted disease screen which was negative and a pelvic ultrasound  on 18-OCT-2007 that was within normal limits. It is also reported that the patient is experiencing pain during intercourse. The patient sought medical attention in the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Additional information has been received to indicate the patient has recovered.
Rash over body and petechia on face received in the clinic with Benadryl. More petchia after blood count.
headache, pain in joint/muscles, chills, fatigue, injection site pain and swelling Narrative: Took OTC Motrin
unconsolable crying x 5 1/2 hrs beginning @ 1700 hrs 1APR96;local swelling to inj site;refusal to eat/drink
My highest temperature was 101.8 °.  Fever lasted about 28 hours. My heart was pounding for about 6 hours until I got my fever under 100° ( not sure if the fever was the cause) I was also havIng PVCs. .  I was very tired and had to lay down in bed for 3 days. This includes the day of the shot and two other days. I had a headache for about 10 hours.
This spontaneous report as received from a female patient of unknown age refers to herself. The patient's medical history included breast cancer and removal of the lymph nodes under the arms (dates unspecified). On an unknown date the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) injection and with a dose of pneumonia vaccine (brand name and manufacturer unknown). The patient reported that the vaccines were administered in her hips. Dose number, dose, frequency and lot number were not specified for both vaccines. Concomitant medications were not specified. The patient did not seek medical attention. Additional information has been requested.
Vasovagal syncope fainting. Patient was still sitting in immunization chair. Immunization had been completed. Approximately 10 seconds following vaccination, patient fainted and his head fell back against the wall behind his chair. He was moved down to the floor, where he slowly regained consciousness. He lied on the floor approximately 10 minutes, then slowly sat up on the floor, then was moved to a chair, where he relaxed with a cool, wet towel and drink. He was observed for 20 more minutes, then allowed to leave with his mother. His mother did note that he had done this same thing (syncope) after a Rocephin injection as a young child.
joint pain headache fatigue low grade fever vertigo brain fog  starting several hours after vaccination, lasting for 36 hours.
Vaccine were given, pt tolerated well. The following morning pt found quarter sized area of redness with a whelp at area of injection site - area is red and warm to touch with minimal pain.
The patient is a 59 year old FEMALE who is being admitted to the  Hospital. This patient meets inpatient level of care because  hepatic encephalopathy and covid.         Active Inpatient Medications                           Status   ========================================================================   =   1)   ACETAMINOPHEN TAB  2 TABLETS PO Q6H PRN FOR MILD PAIN  ACTIVE          OR FEVER. ALTERNATE WITH IBUPROFEN IF USED FOR          FEVER. NTE 2G APAP DAILY FROM ALL SOURCES   2)   ASPIRIN TAB,EC  81MG PO QDAY                           ACTIVE   3)   ASPIRIN TAB,EC  325MG PO DAILY                         ACTIVE   4)   ENOXAPARIN INJ  40MG/0.4ML SQ Q24H                     ACTIVE   5)   LACTULOSE SOLN,ORAL  40GM/60ML PO BID (0700-1630)      ACTIVE          SCHEDULED   6)   MAGNESIUM OXIDE TAB  400MG PO BID                      ACTIVE   7)   ONDANSETRON TAB,ORAL DISINTEGRATING  4MG ODT BID PRN   ACTIVE          PRN FNV   8)   POTASSIUM CHLORIDE TAB,SA  20MEQ PO QDAY               ACTIVE   9)   REMDESIVIR INJ REMDESIVIR 100 MG in SODIUM CHLORIDE    ACTIVE          0.9% 100 ML  INFUSE OVER 30 Minutes IVPB Q24H  Antiviral Assessment   Remdesivir 200mg/250ml NS over 60 minutes given at 0651  Indication:  Covid   Anticipated duration:   5 days  Patient is still in the hospital
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA000782: US-009507513-1912USA000780: US-009507513-1912USA000777: US-009507513-1912USA000778: US-009507513-1912USA000779: US-009507513-1912USA000781: US-009507513-1912USA000785: US-009507513-1912USA000784: US-009507513-1912USA000783:
Acute Pulmonary Embolism, 3 clots found in the left leg, 2 clots in the right lung.  Lung capacity reduced to 1/10th of normal.  Extreme chest pain.  Condition worsened when administered Heparin blood thinner.
This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and DDAVP. On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and her last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Ovulation cycle 1.5 weeks early, 1 week after vaccine; Unusually strong cramping; and depression during ovulation; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. On an unknown date in Apr2021, one week after vaccine the patient ovulation cycle was 1.5 weeks early, the patient experienced unusually strong cramping and depression during ovulation. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ovulation cycle 1.5 weeks early, unusually strong cramping and depression during ovulation were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Developed rash after 1st injection, rash worsened with 2nd injection. Seen in ER after 2nd injection. Treated with Solumedrol IM then Benadryl, Aveeno lotion. MD advised to Stop vaccines.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient (patient ID# 152490) of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
11/15 Mom reports that child received flu shot at approximately 3:00 PM. At 7:00 PM, she began vomiting, no dinner. Restless in the NOC, temp 104. Mom gave Gatorade in NOC. Next AM, eating little, no emesis. Questionable temp. To PCP. No problems identified (Wed). Thurs, no fever, no emesis, eating and returned to school. More quiet than usual. By Thursday evening, ate good dinner and slept well. Yesterday (11/14) temp again increased to 105, poor appetite and lethargy. Better today. Kept home from school 11/15/05.
Swollen on right side of fore head.; 4 days later, swollen left eye lid area; Sore left arm shoulder area; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO151) via an unspecified route of administration in the left arm on 06Apr2021 at 13:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sulfonamide allergy, latex allergy and iodine allergy (iodine in seafood). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 19:00 the patient experienced sore left arm shoulder area. On 10Apr2021, 4 days after the vaccination the patient experienced swollen left eye lid area. On 17Apr2021,11 days after the vaccination the patient experienced swollen on right side of fore head. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore left arm shoulder area 4 days later, swollen left eye lid area, 11 days later swollen on right side of fore head were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
prescribed Bexsero to 70 year old, never started series; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 69-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error 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 Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: Pharmacy manager called in to inquire that was any information available for the healthcare professional to make informed decision and how to proceed with Bexsero. The registered pharmacist reported that a provider prescribed Bexsero and Menactra to a 69 year old patient without a spleen. The patient never started Bexsero series. No vaccine administered. The registered pharmacist gathering information to make informed decision. The reporter did not consent to follow-up. Additional Supportive Information: The 69 year old patient received prescription for Bexsero that was identified and intercepted by the pharmacist, which led to intercepted drug prescribing error.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Severe pain in right arm where injection given- pain in shoulder, upper arm, elbow lower arm and hand with numbness and tingling periodically.  Using heat, Tylenol, ASA, Advil for some slight relief.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1 (primary series)), Pfizer vaccine (first booster) and Pfizer vaccine (Dose 2 (primary series)). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date).  No concomitant medications information was reported. The vial was initially stored in the refrigerator on 2-JUN-2022. Pharmacist is aware of any temperature excursions undergone by the vial. It was reported that there were no known adverse events. No treatment medications were provided. This case was linked to MOD-2022-629202, MOD-2022-629207, MOD-2022-629208, MOD-2022-629210 (Patient Link).
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 12-year-old female patient. The patient had no medical history or concurrent illnesses. On 11-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M018810, intramuscularly in the left arm for prophylaxis and with the first dose of FLUZONE QUADRIVALENT lot # UI678AA, intramuscularly in the left arm for prophylaxis. On 28-OCT-2017, the patient experienced weakness, tiredness after taking the GARDASIL 9 shot. No lab data were available. On an unknown date, the patient recovered from asthenia and fatigue. The causality relationship between the adverse events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
After getting the shot that afternoon  at 3:00 a.m. I woke up in a flu state of chills, fever, headache, achiness.  The headache lasted a solid 24 hours almost to the point of vomiting even while taking 4 tylenol every 4 hours then my stomach was empty so I ate a few crackers, but that next night it was hard to go to sleep.  At night I suddently realized my forehead seemed larger than normal!  It really felt bigger and swollen  so I massaged it and could feel my layers of skin/dermis moving around I beleived it was the serum from the shot from all the prone position I was in for so long laying in bed.  Thankfully the next day all syptoms went away gradually and by the third day I was back to normal....at least I THINK my forehead has returned to normal so far as I can see or feel.
Arm pain, H/A, Whoozy  Vital Signs: BP 155/90 HR 68 Resp 18  Skin Signs: Warm and dry  Circulation: Cap Refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Sat in triage, drinking water  2:20 PM  Vital Signs: BP 140/83 HR 61 Resp 12 O2Sat 99  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Observation 2:25 PM  Vital Signs: BP 130/78 HR 60 Resp 10 O2Sat 96  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Notes:  Sent home with father. Feeling better. Still arm pain. Will f/u if not continuing to improve.
Employee reports dizziness, trouble breathing, nervousness, temp 101.6, numbness right arm for approximately 1 hour all happening evening after injection given. Received injection approximately 345pm 5/31/07. He had vomiting x 1 430am of 6/1/07. He denies swelling, itching, hives or other problems at left arm injection site. He was able to eat breakfast and felt no nausea at 9am 6/1/07. Medical staff notified AM 6/1/07.