chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos given intradermally; Jynneos given to a patient at a dose of 0.1 mL; Case reference number US-BN-2022-002025 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1135) and concerns a patient of unknown demographics.   The patient's medical history and concomitant medication details were not reported.  On 23-Aug-2022, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), intradermally (ID) (explicitly coded as 'inappropriate route of vaccination') at a dose of 0.1 mL (explicitly coded as 'vaccine underdose'), at unknown site, for unknown indication.   It was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 23-Aug-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, intradermally (ID), which is considered as inappropriate route of vaccination at a dose of 0.1 mL, which is considered as underdose, at unknown site, for unknown indication. No associated adverse events have been reported with the reported medication error. The events of incorrect route of product administration and underdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Incorrect route of product administration and underdose have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, intradermally (ID), which is considered as inappropriate route of vaccination at a dose of 0.1 mL, which is considered as underdose, at unknown site, for unknown indication. No associated adverse events have been reported with the reported medication error. The events of incorrect route of product administration and underdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Incorrect route of product administration and underdose have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
No adverse reaction, patient was administered FLUCELVAX and he is under 18 years old.
local erythema, swelling, tenderness, high fever, sleepy on & off for 4 days;
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Looks like she is having reaction called COVID arm
Breast tenderness and vaginal bleeding. Bleeding was light and lasted about two weeks.  I didn?t think much of it until I got my second shot and I started bleeding again the same day. The breast tenderness was worse after the second shot than the first, I will file a separate report for the second shot.
Information has been received from a healthcare worker concerning a 64 year old menopausal female with hyperlipidemia, arthritis, hypertension, incontinence and diabetes who on 04-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX (651400/0618F).  Concomitant therapy included ezetimibe (ZETIA), metformin HC1 (GLUCOPHAGE XR), fexofenadine hydrochloride (ALLEGRA), pravastatin Na (PRAVACHOL), diclofenac sodium (+) misoprostol (ARTHROTEC), tolterodine tartrate (DETROL LA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), calcium (unspecified) (+) vitamin D (unspecified) and metoprolol succinate (TOPROL XL TABLETS).  On 04-OCT-2006 the patient had injection site soreness and pain.  The patient had redness at the injection site and redness also around the arm (redness was not completely around the arm).  On 08-OCT-2006 the patient also felt sick.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  Additional information has been requested.
Pt was scheduled to receive HIB vaccine and was given HPV vaccine by mistake. Mom was notified of error by Dr.
This spontaneous report was received from a nurse refers to an unspecified patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with less than a full adult dose of RECOMBIVAX HB lot # L014418, expiry date 13-APR-2017. No adverse reactions have been reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Within several hours of receiving Pediarix, HIB and Prevnar developed fever to 101 and became limp and gray on mom's shoulder.  No choking. No seizure activity.  Not apneic.  Limp episode lasted about 30 minutes.  No CPR needed.
Severe muscle pain starting in my low back, progressing down the muscles of both legs-front, sides and back to the lowest part of my calves; pain in the muscles of my abdomen began 3:31:2017 around 1:00 PM. Now I am developing muscle pain that is moderate to back of right arm. Vaccine was given in left deltoid.
Maderna COVID-19 Vaccine EUA Got injection at 10:49 am Tuesday 3/9/21. At approximately 9:30 pm same day, started having chills and low grade fever of 99.3.  Woke up around midnight with chills and body aches. Woke up at 5 am and was extremely fatigued. But fever was gone.  Could barely get out of bed. Also had a headache. Able to go to work but left after being there for 45 minutes due to being dizzy, really fatigued, bad headache, and just sore all over. Got home and basically went to bed.
This case was reported by a consumer and described the occurrence of autism in an 18-month-old female subject who was vaccinated with Engerix B (GlaxoSmithKline), Hepatitis A (Merck). A physician or other health care professional has not verified this report. Concurrent medications included Paracetamol (Tylenol). On 21 October 2005, the subject received 3rd dose of Engerix B (unknown, left thigh). On 10 October 2006, the subject received the 1st dose of Hepatitis A vaccine (unknown). On 12 October 2006, 48 hours after vaccination with Hepatitis A vaccine, and approximately one year after vaccination with Engerix B, the subject experienced regression in development, speech deterioration, screaming, and grunting. On unspecified dates in December of 2006, the subject experienced periods of immobility or paralysis, which occurred on two separate episodes. On 10 April 2007, the subject received the 2nd dose of Hepatitis A vaccine (unknown) and experienced five episodes of immobility within the next six months. The reporter was the subject's mother, who reported that her daughter was diagnosed with mild autism (date of diagnosis unspecified). The subject's mother considered the events to be disabling. The subject's mother stated that she is in the early stages of investigating vaccines that her daughter has received which may contain ingredients the child may be allergic to. Per the subject's mother, there were no signs of regression until 12 October 2006. At the time of this report, the child has been in therapy for 19 months and her condition has improved, but she remains behind her peers.
One week to the day after the shot my arm started itching at injection site. As day progressed I developed large red whelp.
product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (product administration error) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (product administration error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt stated that she is fully vaccinated for COVID-19. Now hospitalized after a fall at home and has tested positive for COVID upon admission.
Patient was given Immunizations on 6-22-2009 (Pentacel, Engerix-B, Prevnar, & Rotarix).  He was hospitalized on 6-25-2009 when mom reported at our facility that he had fever up to 105.0 X3 days, decreased appetite, and vomiting. Mom also reported that his eyes would roll back in his head and he would draw his head back when these high fevers occurred, with the episodes lasting approximately 5 minutes & occuring approximately every 10 minutes.  Admission was for 2 days at Hospital.  7/21/09 MR received for DOS 6/25-27/09 with D/C DX:  Fever, Possible reaction to vaccines, which was reported to VAERS. Diarrhea. Pt presented with 3 day hx of fevers, emesis, watery stools, cough, fussiness, and decreased po intake. Pt also had episodes of eyes rolling back in the head, and head drawing back during fever.  Lethargic on PE. Admitted for fever & dehydration, r/o seizure, r/o sepsis. Improved with IVF but still with some watery mucus stool. ICD9 780.60, 787.91, E9499
Arm was "really sore"; Couldn't lay on that side of body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was "really sore") and DISCOMFORT (Couldn't lay on that side of body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was "really sore") and DISCOMFORT (Couldn't lay on that side of body). At the time of the report, PAIN IN EXTREMITY (Arm was "really sore") and DISCOMFORT (Couldn't lay on that side of body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment information was unknown.   This case was linked to MOD-2021-044314 (Patient Link).
No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from an other health professional and refers to a 4 year-old female patient with drug hypersensitivity for penicillin (PCN), slow transit constipation, asthma and non-seasonal allergic rhinitis due to pollen. The patient's medical history included exercise induced bronchospasm and acute cystitis without hematuria. The patient was also a premature newborn (36 weeks, 2381 gram birth weight) and had 1 sibling.  On 18-OCT-2022 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin) (PROQUAD) (lot # W024548, expiration date: 31-JAN-2024),0.5 milliliter, subcutaneous in the right vastus lateralis for prophylaxis (product storage error). The same day the patient was also vaccinated with influenza vaccine (manufacturer GSK) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).  Administered doses of vaccines experienced the temperature excursion of 10.8 degrees Fahrenheit for 18 hours 30 minutes. There was no previous temperature excursion.  There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2211USA004005: US-009507513-2211USA004003: US-009507513-2211USA004004: US-009507513-2211USA008242:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    51 doses was received to several patient from Lot AS7140C. Concomitant medications were not reported.  No treatment information was provided
The child was administered immunizations in the clinic per protocol. She was observed in the clinic 20 minutes without any adverse effects. The child and mother went to the local library where the child experienced a seizure. She was transported by ambulance to the local hospital and then transferred to another Hospital.
PATIENT HAD NO ISSUES THE DAY OF VACCINE ADMINISTRATION, 24 HOURS AFTER THE VACCINE THE PATIENT COMPLINS OF A RASH, PRESENT ON BOTH ARMS AS WELL AS INJECT SITE PAIN/SWELLING. PATIENT DESCRIBES IT AS A "MEASLES-LIKE" RASH THAT IS ELEVATED SLIGHTLY ABOVE THE SKIN. THE PATIENT DOES NOT COMPLAIN OF ANY ITCHING OR DIFFICULTY BREATHING. RECOMMENDED PATIENT TO CONTACT PCP.
Shingles shots dont work. Getting over them in my EYE/ Suspected vaccination failure; Getting over them from being in my EYE; 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.   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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that the shingle shots did not always work.  He/she was just getting over them from being in his/her eye which was not good at all. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Patient was administered with BOOSTRIX and the vaccine had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 21-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix (left deltoid). On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Patient was administered with BOOSTRIX and the vaccine had expired).  The outcome of the expired vaccine used 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: 28-SEP-2023 Reporter was a Medical Assistant. The reporter called on reporting day to seek guidance. The reporter consented to follow up. The patient was administered with Boostrix, and the vaccine had expired, which led to expired vaccine used.
severe arm pain; reoccurring sinusitis; This is a spontaneous report received from a contactable reporter (physician).  An female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, solution for injection in pre-filled syringe, lot number unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "severe arm pain"; SINUSITIS (non-serious), outcome "unknown", described as "reoccurring sinusitis".  Additional Information: The patient was under "65" (no units).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy Papular Vesicular rash scattered to back and one to supra pubic region. Spreading.
Presents to clinic on 8/4/15 for doctor ordered tetanus/dip and pneumococcal shots. Daughter calls on 9/28/15 and says that mother's Lt arm (where Td given) began to swell 1 week after injection to quarter size. Daughter says that mother never sought medical evaluation and now Lt. deltoid (arm) is 4 inches in diameter for a rash/swelling. Recommended that patient seek evaluation by personal physician as soon as possible. Note - no reported fever or other symptoms.
Patient reported to pharmacy with swollen hands and wrists with red rash on hands arms and back. Patient also reported full body itching.  Vaccine was given on 5/10/22 at 5:30 and patient reported symptoms at midnight.  Patient was informed to go to urgent care for treatment.
Information has been received from a physician concerning a 4 year old male who on 16-MAR-2007 was vaccinated, in one arm, with varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine (inactive). Concomitant therapy, that same day, included vaccination, in the other arm, with measles-mumps-rubella vaccine (M-M-R II), diphtheria toxoid (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VACCIN DTP) and poliovirus vaccine (IPV-VIRELON). Subsequently, the patient experienced warmth, redness, a knotted spot and a pin prick rash, on the arm where varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine vaccine (inactive) were given. The child did not experience a fever. The mother dosed the child with Benadryl, which seemed to help initially, but subsequent doses did not evoke any response. The patient was seen at the physician's office on 20 MAR 2007. No further information is available.
Varicella, Vomiting - Information has been received from a health care professional concerning a 25 month old Caucasian male patient who on 17 Feb 1999 was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 628243/1340K).  It was noted that there were no illnesses at the time of vaccination and no past medical history.  On 12 Apr 2000 the patient developed 10-20 varicella lesions with a 17 Apr 2000.  On 14 Apr 2000 the patient experienced vomiting with a fever.  Unspecified medial attention was sought.  The patient's fever was treated with acetaminophen (tylenol) and he was placed on a clear liquid diet.  follow up information received from a health care professional reported that on 18 Apr 2000 the patient recovered.
Patient's mom stated symptoms of redness and swelling at injection site on left upper arm developed on 4/28/09 in the evening.  Arm felt hot to the touch. Pt taken to hospital ER.  Pt started on Orapred for 10 days.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at 0.5 ml single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced joint pain and inflammation on an unspecified date with unknown outcome.
20MAR91 7AM fever 103 Tylenol given but fever stayed @ 103; 21MAR91 very hot to touch, temp not measured; seemed disoriented & couldnt find mom when got up;
No addititional AEs; CMA called to report administration of expired vaccine.; This spontaneous report was received from a medical assistant and refers to a 52-year-old female. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-OCT-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T034380 rHA, expiration date: 08-JAN-2022 (Expired product administered) administered for prophylaxis (strength, and route of administration were not provided).  No additional adverse events were reported.
Papules, grouped arms, legs,patches some on face, no true crusting. Started on legs 4 days ago. Sent to dermatologist 1/27 plus varicella.
nausea; sharp arm pain/soreness in arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), NAUSEA (nausea) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm) 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 (No Medical History reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Itching) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm).   On 01-Apr-2021, the patient experienced NAUSEA (nausea).   At the time of the report, PRURITUS (Itching), NAUSEA (nausea) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Reporter did not allow further contact
No additional AE's; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-2021, the patient was vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T020652, expiration date: 16-JUN-2022 (formulation, strength, dose, frequency, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date: 05-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported), both for prophylaxis. On an unknown dates, the doses of the vaccines were exposed to temperature excursion at -14.03 Celsius degrees (C) for 1 hour 15 minutes, at -14.9 C for 9 minutes, at -10.3C for 1 hour and at -6.3C for 2 hours. There were previous temperature excursions at -14.03 for 1 hour 15 minutes and -14,9 C for 9 minutes.. The call was due to digital data logger. No additional adverse event was reported.