chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial undergo temperature excursions; The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03 Oct 2022 and was administered on 11 Nov 2022.).    No concomitant medication was provided.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681321:Same reporter
Has felt drained since second vaccination and reported getting ignored by doctors and health care system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19 , Prev dose brand: Pfizer , Prev dose brand unknown: False , Is bivalent: False , Prev dose lot unknown: True , Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Has felt drained since second vaccination and reported getting ignored by doctors and health care system". The events "has felt drained since second vaccination and reported getting ignored by doctors and health care system" required physician office visit. It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed a throbbing in injected arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Developed a throbbing in injected arm.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and TRAMADOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Developed a throbbing in injected arm.). At the time of the report, PAIN (Developed a throbbing in injected arm.) had resolved.            Concomitant medications also included: high blood pressure medications and diabetes medication.  No treatment was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076448 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received: Updated event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076448:1 dose
fatigue; I had slight muscle soreness; Very slight chills; My right arm was also a bit sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm right on 15Feb2021 09:00 (at the age of 25-year-old) at dose 2, single for covid-19 immunisation. Medical history included Slight allergy to Amoxil, Covid-19 (If Covid prior vaccination: Yes). Patient did not receive other vaccine in four weeks. Patient has not tested for covid post vaccination. Concomitant medication included fluoxetine (FLUOXETINE); ethinylestradiol, levonorgestrel (KURVELO) (Other medications in two weeks) both taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm right on 25Jan2021 16:00 at dose 1, single for covid-19 immunisation. On 15Feb2021 14:00 the patient experienced I had slight muscle soreness, fatigue, and very slight chills. My right arm was also a bit sore. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of GARDASIL (intramuscular injection, dose number, route, batch and lot #, expiration date not reported, could have been administered to an unspecified amount of patients. No adverse evens reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Local reaction of tenderness, redness, and hot to the touch larger than 10 cm in diameter.  Concerns for cellulitis so a course of Keflex 500mg, tid for 7 days was initiated on 6-5-2019, on the 3rd day post vaccine and 2nd day of the reaction,by her spouse, who is a infectious disease doctor.
Local erythema and area of edema at injection site, started 24 hours after injection, gradually improved over 5 days.
This case was reported by a consumer and described the occurrence of autism in a 1-year-old male subject who was vaccinated with Engerix B for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date on or after 01 February 2003 and before 03 march 2003, the subject received the 1st dose of hepatitis B vaccine (unspecified Manufacturer). On 03 March 2003, the subject received 2nd dose of Engerix B. On 18 August 2003 the subject received 3rd dose of Engerix B. On an unspecified date in August 2004, approximately one year after vaccination with the 3rd dose of Engerix B, the subject was diagnosed with autism. The consumer reported that, on an unspecified date before 02 March 2007, at an unspecified time following the 3rd dose of Engerix B, bloodwork showed heavy metals, including lead but not mercury. The subject was seen by various doctors. At the time of initial reporting, 03 March 2007, outcome of the heavy metals and lead in the blood was not reported and the autism was ongoing. Autism was assessed as medically serious by manufacturer.
Progressive onset of "aching" left deltoid (rated 2/10) radiating up to left side of neck/shoulder on Friday evening, October 11, 2019 approximately 7:00 p.m.  States pain persisted into Saturday, October 12, 2019 rated 2-3/10.  States pain dramatically increased from 2/10 to 10/10 on Monday, October 14, 2019 at 5:00 p.m. associated with numbness/tingling/weakness radiating down left arm.  States he took Advil 600 mg p.o. at 6:00 p.m. with some relief of symptoms.  Woke at 06:00  a.m. October 15, 2019 with severe pain from left deltoid to left elbow rated 10/10.  States he took Advil 600 mg p.o. at 06:00 a.m. and pain gradually subsided to 2/10.  Employee reported to Occupational Health at 1:15 p.m. to report adverse reaction.
Information has been received from a physician concerning a 13 or 14 month old female child who on 9/5/00 or 9/19/00 was vaccinated with 1 dose of MMRI and 1 dose of varicella virus vaccine. Approx. 1 week, post vax, on approx. 9/12/00, the pt experienced ataxia and was hospitalized. Upon hospitalization, the child was evaluated by a neurologist and had a normal MRI. As of 10/18/00, the child was still symptomatic with ataxia. Follow-up information on 11/5/00, indicated that the pt was never hospitalized. As of 11/5/00, the child remained at home and symptomatic with ataxia. The physician "unfortunately was not able to get CSF on the child for PCR analysis, however he has sent blood work for unspecified tests. Follow-up information from the pediatrician indicated that the pt had a mild ataxia, with "very subtle" changes in her walking. He indicated that the ataxia and changes were more evident to the child's mother, than to the pediatricians and consulting pediatric neurologist. He stated that the child's mother felt that the child had a very "acute change" in her gait, manifesting in a lot of "falling down", beginning approx. 1 week, post vax, however, neither the pediatrician nor the pediatric neurologist observed any acute or significant ataxia. He also stated they have not identified any etiology for the child's symptoms and that it has taken several months for her to recover. He indicated the child's symptoms have "for the most part, resolved". A lumbar puncture was never done on the child. The pediatrician had no additional information to report. No further information is available.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown date, reported as "unspecified time in the past", the unknown number of patients were vaccinated with ZOSTAVAX (lot numbers, expiration dates were not reported). The doses of ZOSTAVAX had been possibly exposed to 41 Fahrenheit degree for 24 hours. No adverse effect was reported. Additional information has been requested.
24 hours after vaccine developed diarrhea, after 1 mo became bloody.  All stool tests neg.  CT Abd, GI consult, colonoscopy; LGI, UGI no SB series; CT pelvis showed thickening of wall of rectosigmoid colon.  Treated with Immuran->developed Bell's palsy 1/22/08.  D/c'd Immura.  Currently on Asacol & Pentasa.  Still with diarrhea +/- 10/day. 3/24/08-records received-11/23/07-presented to PCP office with 2 month history of diarrhea which began after out of state travel and a few days after her vaccintion. Weight loss. Mild abdominal cramping in lower half of abdomen, stools have unusual odor. Seen on 3/3/08-History of colitis and diarrhea continues. States she also had Bell's Palsy.
Before receiving her first dose of the one-dose series, pt stated that she always "faints or passes out" with IM injections/vaccines - in an attempt to prepare for this, another pharmacist assisted during the time of vaccination, and the patient did well. We sat with the patient for about 5 minutes and asked that she stay seated for the remainder of her "15 minute wait period." She was accompanied by her husband. Roughly 10 minutes after administration, one of our technicians alerted the pharmacists that the patient had experienced vasovagal syncope, so we rushed to the patient, called 911, and remained with her until she woke up (which was within less than 1 minute after the event) and was in the care of other healthcare personnel.
Injection site, about 4 inches down the arm from top of shoulder about 180 degrees from the body.  When injected I didn't feel the needle.  But did have a noticeable sensation of the liquid going in.  So much so I remarked to the tech giving it to me.  She remarked, "It is more than normal.  It also had to be mixed and may be thicker".  Within an hour or two the injection site was noticeably swollen.  The swelling continued throughout the day and evening.  By bedtime the swollen area was a good 3-4 inches in diameter and about 1/2 inch high.  I didn't notice any redness.  It has diminished 6 days latter but is still there though smaller.
Information has been received from a health care worker concerning a 26 year old female with no medical history or allergies reported. On 1/13/05 the patient was vaccianted with the first dose of Pneumococcal 23v polysaccharide vaccine. There were no concomitant medication reported. On 1/14/05 the patient developed redness, swelling and burning of injection site. The patient sought unspecified medical attention. The events subsided in a few days and no treatment was required. Additional information has been requested.
Patient was inadvertently given an expired vaccine that was not physically taken out from inventory. No adverse effects have been report from patient's mother as of today. Staff member that gave the vaccine has not yet contacted the mother yet but is planning to do so.  Sanofi has been contacted and recommended that vaccine be given again as soon as possible.
dizziness; rapid heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 01), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset May2021, outcome "unknown", described as "dizziness"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "rapid heartbeat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 102.0 F 10/6/11 with erythema, warmth, raised at site of injections.
Pt suffered localized reaction to injection areas bilaterally to thighs. BENADRYL injection 12.5mg IM and cold compresses applied to thighs as well. 20 mins post treatment, pt doing better, rash and swelling subsided. Pt reevaluated by Provider and dc home with mom and rx for BENADRYL. RTC PRN.
got the shot and got shingles twice/Suspected vaccination failure; shingles twice; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and got the shingles twice and it was after the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Back and head arched back. eyes Rolled back arms flexed and extended lasting 1minute. Pt recovered on her own walked her own into building. Family reported episode occurred 45 min to 1 hr after receiving  .  vaccine
On 12/12, I tested positive for COVID-19 on a rapid test, I had a fever that ranged from 101 - 103 till 12/17.  I had a cough as well, that lasted till 12/27.
Systemic: amxious and rerestlessness-Medium, Systemic: Stroke-Medium, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Medium, Additional Details: patient has autoimmune disease.
Patient said she got sick next day after receiving the vaccination with following symptoms: High fever and  rash on her right arm
REDNESS AT SITE  BY EVENING HAD HIVES ON BOTH FOREARMS - INSIDE BETWEEN WRIST AND ELBOW AND THEN AT ELBOW -- LARGE AND RESEMBLED CELLULITIS WITH ITCHING, HOT, SWOLLEN AND SPREADING  ELEVATED HEARTRATE = 113  TOOK CLARITIN AND ASPIRIN; APPLIED COLD COMPRESSES; RESTED - MUCH REDUCED THE NEXT DAY
Nurse was notified that a pt was lightheaded & sweaty.  Pt was unconscious & be held by a bystander & a soldier.  When nurse arrived pt was moving & answering questions, diaphoretic & pale.  Pt was escorted to Observation area to lay down on cot.    Pt rested 15 minutes & left on his own with no assistance.
Patient not experiencing additional symptoms at this time; VARIVAX concomitantly and inadvertently with PROQUAD.; Information has been received from a nurse referring to a 12 months old patient of unknown gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 18-NOV-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis, concomitantly and inadvertently with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. This was related to human error. The patient did not experience additional symptoms at the reporting time. The outcome of the event was unknown.
Infection to the left arm Injection site went to the hospital on 1/11/2021 at 1030pm.  Antibiotics: cephalexin  500mg every 6 hours by mouth
Redness, swelling, pain, hot arm. Redness 55cm length, circumferential arm left arm.
Distant, cranky, and aloof. Crying a lot and very clingy to me. Sleeping a lot more than usual after the vaccinations. Rash on face at 6 days after vaccines. Bright redness at site of vaccinations and hot to the touch. Large lumps in legs at site of vaccinations. Fever spiked to 103.3 6 days after vaccines. Follow up on 06/25/04 states: "Additional symptoms/illnesses after vaccination were chronic URI, vomiting and headache. Final diagnosis are autism, GERD, ADHD, gastroparesis."  Nurse follow up on 07/06/04 states: "Per review of other correspondence from reporter, the following symptoms are added: moodiness, loss of appetite, sleeping poorly, nasal discharge, and speech loss."  Nurse follow up on 08/23/04 states: "night terrors and very hyperactive."  Nurse follow up on 09/20/04 states: "No new information."
Nausea, vomiting, diarrhea, chills, weakness, couldn't stay upright for about 2 to 3 hours  around 5 am the next day after shot. Then weak and tired the rest of the day.  Note I had already had dx of Covid in December of 2020 and wasn't near this sick.
Migraine headache, fatigue, redness and swelling at injection site, nausea, bodyaches
8 days after injection of first Moderna shot the injection site became itchy, swollen (egg size), and tender to the touch. I cannot tell if there is a rash because I have a half sleeve tattoo.
acute right flank pain and difficulty breathing a few minutes after vaccine.  Onset was quick and within 5 minutes of initial flank pain, I was unable to take a full breath in.  It felt as if someone was stabbing my right flank - bra level - and taking a breath in was very difficult.  minor relief was experienced when leaning forward and applying tension (I was leaning forward and pressing my arms against the seat of the chair to apply tension to the area.  I was unable to sit straight, stand, walk or move very well without acute stabbing pain in my flank.  I was transported by ambulance to the emergency room where I was told that I has a minor UTI and had "pulled a muscle."  This "alleged" pulled muscle happen while I was sitting perfectly still in a waiting area on a conference.  As a note, I am not nervous of injections or of the vaccine.  I was feeling great before, during and immediately after the injection until the pain began.   At onset, I felt an intense heat at the injection site that radiated throughout my upper arm around the injection site followed by uncomfortable flank pain and shortness of breath.  Within minutes, the flank pain became acute and it was difficult to catch a full breath without pain - likely due to the acute flank pain.  I was released from the emergency room at approximately 3:00pm with a prescription for antibiotics for the UTI and muscle relaxers..
Patient had completed the vaccine series (3/25/2021 and 4/22/2021).  She tested COVID positive on 7/29/2021 and was found to have COVID-19 pneumonia and was admitted to the hospital.
Initial report received from a consumer on 25 September 2013. A male patient (date of birth 02 December 1946, age at the time of vaccination was not reported), whose medical history and concomitant medications were not reported, had received intramuscular dose of FLUZONE HD (batch number: unknown, anatomical site of administration was not reported) on 24 September 2013 at 2 PM. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) where unknown. On 24 September 2013 at 10 PM, the patient experience shaking chills with teeth chattering for 1 hour, headache and myalgia in legs and abdomen. He felt hot with increased pulse of 100 and felt weak, muscle aches, mild chills. Complementary investigations and laboratory data were not reported. As of 25 September 2013, the outcome  was  not reported. As of 25 September 2013, the outcome was not recovered. Documents held by sender: none