chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose of DAPTACEL with no adverse event; Initial information received on 21-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced received an expired dose of daptacel with no adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and HEPATITIS A VACCINE (HEPATITIS A).  On 21-Apr-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5706AA via intramuscular route in unknown administration site for Immunization.  On 21-APR-2022 the patient developed a non-serious received an expired dose of daptacel with no adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of DAPTACEL with no adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of daptacel with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as M040804, expiration date 20-MAY-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up. Sender's Comments: US-009507513-1612USA012870: US-009507513-1612USA009590.
The soreness in the arm was less the second time than the first.; This is a spontaneous report received from a sponsored program. This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation, estrogens conjugated (PREMARIN), via route of administration on an unspecified date (batch/lot number and dose were not reported) for an unspecified indication. Medical history included eye disorder. During the call, the patient stated I have problems with my eyes. The patient previously received first single dose of BNT162B2 on unknown date for Covid-19 immunization. The patient's concomitant medications were not reported. It was reported by patient that I had my second COVID vaccine shot and I had Pfizer and not only did it not have any after effects, the soreness in the arm was less the second time than the first. The outcome of event was unknown.  Information on the lot/batch number has been requested.
high fevers (104-105) several weeks after vaccine with negative infectious work-up. Also with anterior cervical lymphadenopathy and cracked lips. I am concerned for Kawasaki disease flare-up although did not have all typical features of this disease
This spontaneous report was received from a office manager (also reported as healthcare worker) refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever of approximately 101 degrees F lasting for 2 days. Muscle aches and fatigue lasting at least three days.
Increased general arthritic pain followed by increasing rt hip pain. Increased for 4 weeks until I could not walk. Had a rt hip steroid injection. No help. 8 Weeks physical therapy with little improvement.
I took the Shingrix vaccine around 2:00 PM. Then I had chills all throughout the night. Then I developed a 101 fever. I'm currently enduring these side effects as I write.
Vaccine given on 7/17/02, DTaP on right anterior lateral thigh. Patient awakened at 02:00 on 7/18/02 complaining of pain, by 7:00am right thigh and right knee were moderately swollen and could not bend knee as per mother. Applied cold compresses every 30 mintues, as per Dr's instructions. Dr told mother to wait one more day. Leg continued to swell with redness and warm to touch. No fever at any time. Child's behavior was normal except for pain to leg. Mother took child to pediatrician on 7/19/02. Doctor prescribed Motrin for pain. Gave mother form. On 7/20/02, swelling down, no pain to leg on a little when bends knee. No longer warm to touch and no longer redness at site of injection.
had second dose on 5/14/21, passed away during the night of 5/15/21. Found dead on 5/16/21 morning
Site: Pain at Injection Site-Medium, Additional Details: Pain at injection site the following day.  the pain then improved after a day or two but then came back and has spread to neck and lower arm.  advised patient I would make report and follow-up.
Local erythema and swelling in 4 x 6 1/2cms around injection site (right thigh).
Progressive neck soreness and inability to extend the neck/support his head, in addition to droopy eyelids and difficulty swallowing. Progressed to upper limb weakness. Patient was initially admitted to the ICU due to concern for possible botulism poisoning given his descending paralysis, and was given Botulism heptavalent antitoxin on 7/19 with minimal improvement. He was also on a course of antibiotics (Unasyn and then Zosyn) from 7/21 to 7/28. He had slow gradual recovery of neck strength, with mild residual ptosis and dysphagia requiring feeding through a nasal tube which persisted for about a month. At time of discharge 8/14, he still had some mild limb weakness. Of note, he also had multiple episodes of intermittent scattered erythematous macules  that appeared over his abdomen for a few minutes before completely resolving, which continued throughout admission.  On 8/5-8/6, he also had chest pain with an EKG consistent with pericarditis and an echo showing mild pericardial effusion.   Although the pericarditis was mild, given the clinical picture of bulbar and descending weakness/paralysis, there was the concern for his symptoms being due to a variant of Guillain Barre syndrome called "phayngeal-cervical-brachial" GBS which apparently can be descending and limited to the upper body, and might match this patient's findings. This is especially a concern since botulism testing by Public Health was negative.  Please contact the family for more details about his vaccine administration, as he is now discharged
Received Pneumovax shot believes it's his 2nd dose 1st given about 7 years ago or so. That night he developed soreness, mild erythema and swelling which extended down/distal his upper ext to wrist. Some improvement now, 3 days later, but not completely resolved.
bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug information does not provided . Treatment information does not provided.
Reading reaction signs and symptoms sign after vaccine.  Felt short of breathe and dizzy.  Resolved as soon as she arrived at med observation at 14:52.  BP at 14:53, HR 61, Resp 16, BP 125/69, SaO2 98%.  Kept patient until 15:08.  All symptoms still resolved, vitals at 13:08, HR 61, resp 16, BP 115/57,  SaO2 99%.  Patient released at 15:08 and left via her own vehicle.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. health authority notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from health authority are to notify all of the recipients that received an incorrect dose and submit an agency report for each.
I received the immunization at 28w1d pregnant. I had an ultrasound at 28w that showed a healthy placenta. I had a repeat ultrasound at 29w1d that showed significant placenta issues. It has calcified and aged prematurely and also is heterogenous.  I am currently inpatient in the hospital until delivery due to the rapid decline in placenta.   EDD is 4/5/2021
Seen 6/13/17 at PCP office for fever (intermittent) x 2 wks (102 degrees F max) and rash x 1 day. (Pink papular to trunk, back, bi-lat cheeks, chin and under eyes. Rec'd 12 mo vacc. at local HD on 5/30/17. DX at PCP with rash - viral -vs- MMR. No TX - monitor; RTC if worsens.
Patient stated that she went to the emergency department for a high fever, nausea, vomiting, and diarrhea the day after getting the vaccination.
Approximately  9 hours after the vaccine, I developed  a fever of 101.9 with rigors, a bad headache, body aches, cough with  wheezing, mild SOB, and fatigue.
Patient fainted approximately 5 minutes after receiving vaccine. She was walking around the store and fell onto the ground. The patient sat in a chair and drank water for approximately 15 minutes until she felt better and was able to leave the store with her mom.
Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired Moderna vaccine was given as booster shot to the patient on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccine was as 006C21A (10-OCT-2021).  It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed. No concomitant medications were reported No treatment medications were reported
Received PNEUMOVAX 04/07/2016. Developed R upper arm soreness on Thursday. Developed a 2X2" blotch of redness and warmth at site on Friday. Sxs resolved in full by Monday. Pt did not experience any inflammation or fever. Wants this noted in his record, "I seemed to have reacted to it more than prescribed from what I read."
within an hour of getting the vaccine, I started with a headache. After about 2 hrs I was dizzy, tingling down my left arm, stiffness in left arm and neck. I was given the vaccine around 230 pm. By late evening I was lethargic. today is Friday I continue to have the same symptoms but also to include, nausea, vomiting, body aches, chills, congestion, and shortness of breath, I have occasionally felt a heart arrhythmia.
10 year old received vaccine for the 12 years and up, dose 0.3mL, parent informed. Informed to  monitor vaccination site. Nurse made phone call to parent next day, no issues identified.
This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age. On an unspecified date, 2 unspecified patients received doses of (Merck) VARIVAX (strength, dose, frequency, route, lot # were not provided). (Merck) VARIVAX were exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
into residents to assess respiratory status at 2pm. Noted respiration's have changed since previous assessment. Respiration's shallow at the rate of 12 per minute. Skin color dusky in color. This nurse placed call to POA to update in change of condition. Per POA he will notify family and be into facility. This nurse sat with resident during this time. Respiration's have ceased at 2:21pm. No BP noted. Heart rate assess. TOD 2:21pm.   this is the note by the nurse.   Note: This was the second booster.
On the evening of 11-30-2021, I began to have the chills and was not able to get warm. My cheeks had started to turn red. By 0600 the morning of 12-1-2021, I had severe periorbital swelling, redness, and warmth to my skin. My eyes were practically swollen shut.
she was fully vaccinated and had five shots.; she was fully vaccinated and had five shots.; has a rare immunodeficiency disease which she does weekly high center infusions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), 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 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3), for COVID-19 immunization; Bnt162b2 (DOSE 4), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "she was fully vaccinated and had five shots."; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "has a rare immunodeficiency disease which she does weekly high center infusions". The event "has a rare immunodeficiency disease which she does weekly high center infusions" required physician office visit. Therapeutic measures were taken as a result of immunodeficiency.  Clinical course: Patient had a rare immunodeficiency disease which she did weekly high center infusions and her immunologist approved travel for her. She said she was fully vaccinated and had five shots. She was approved to travel in the Withheld and there was a shortage of Paxlovid there and they are getting it through shipment. Her doctor wrote a prescription for her and her doctor called the Pharmacy and was told that they wont let her have it unless she has a positive test for COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness.  Seen Dr today
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of ROTATEQ (oral vaccine, dosage details, lot # and expiration date were not reported) which underwent temperatures which fell outside the prescribing information and which were supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies an concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lots # M033086, Lo33707 and M020521 with expiration dates 05-MAY-2018, 18-MAY-2017 and 17-NOV-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of PNEUMOVAX 23 were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Redness, warmth lower right arm. Slight tingling right arm shoulder to wrist. "splotching" of arm noted. Benadryl 25mg by mouth given.
Patient presents to ER with cough, congestion, vomiting, diarrhea, and fever.
right arm is swollen the size of a baseball; pain in arm; tching; pain started going up her neck; can't turn her neck to the right; burned a little when she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (burned a little when she got the shot), VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching) and NECK PAIN (pain started going up her neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010aq1a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), Liothyronine, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), POTASSIUM, Methocarbin and FISH OIL.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (burned a little when she got the shot). On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching), NECK PAIN (pain started going up her neck) and NECK PAIN (can't turn her neck to the right). On 24-Mar-2021, VACCINATION SITE PAIN (burned a little when she got the shot) had resolved. At the time of the report, VACCINATION SITE SWELLING (right arm is swollen the size of a baseball), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PRURITUS (tching), NECK PAIN (pain started going up her neck) and NECK PAIN (can't turn her neck to the right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-061155 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061155:Dose 1
Patient had no adverse reaction at . She states, " I was headed home and felt numbness in lips and face. I looked in rear view mirror and she stated her lips were purple. Patient states felt like her throat was closing and had her epi-pen and administered dose. She then proceeded to go to  Hospital/ for treatment where she received Benadryl and Epi. She was instructed to tell her health provider about allergic reaction to Moderna.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination (received 2 doses of Pfizer [04/20/2021; 05/11/2021] no booster received up to date). Patient was initially positive on 12/30/2021 but was only admitted on 01/04/2022 due to worsening symptoms. Patient was re-tested on 1/17/2022 and remained COVID-19 positive.
Heart palpitations, facial numbness, headache, nausea, vomiting, muscle twitching, fever, severe pressure in head. Dizziness.
Starting the day after the vaccination she started feeling cold and having a headache. She then developed a temperature of 101.1.
Tuesday, 7/20/04:  Child given MMR #2, DTaP #5, IPV #4.    Thursday,7/22/04: Child awakened at 2AM, covered in hives, face and eyes swollen, temp 101.9F.  taken to ER and given Prednisone and Zyrtec P.O.  Mom states MD said it was an allergic reaction to MMR vaccine.  Friday, 7/23/04:  Child stays with Grandmother and because rash and swelling still present, takes child to family MD and is seen by Nurse Practitioner.  This time hands and feet are also swollen along with face and eyes and still has hives all over body with fever.  Given Prednisone but child vomits following administration and med is not repeated.  Saturday, 7/24/04:  Mom calls MD again and speaks with nurse practitioner, who is on call. She is told if child is not improved by Sunday morning, to call back and meet the nurse practitioner in the ER.  Sunday, 7/25/04:  Mom takes child to ER again and child is given Phenergan for vomiting, Benedryl for rash,and Rx for Prednisone, and is told again that this was caused by MMR vaccine.
given baricella vaccine 26JUN95 devel clinical variecella 9NOV(5
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 30-JUN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L048468, expiration date 02-DEC-2017, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Pt presented c/o feeling unwell, low BP, lethargy although A&O x3
Patient recieved 2 doses of the Pfizer BioNTech  covid 19. One dose in each arm instead of one dose of  Pfizer and one dose of Pneumovax.  No adverse efeects as of this reporting date 10/28/2021