chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient inadvertently received a dose of MENQUADFI instead of TRUMEMBA with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient inadvertently received a dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead of trumemba with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Nov-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE  (lot U7450AA; 10-OCT-2024)  via intramuscular route in the left arm for prophylactic vaccination.  On 08-NOV-2022 the patient reported a non-serious event a patient inadvertently received a dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE instead of trumemba with no reported adverse event (wrong product administered).  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the 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.; Sender's Comments:  01358281:
Invalid dose : Vaccine administered to a patient younger than 18 years old; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021. The most recent information was received on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals and Asthma (as per her mother).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old) had resolved.        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.   Upon an internal review on 20 May 2021, the age was corrected to 16 years in the narrative. Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up Received on 06-apr-2021 Contains Added: Date of birth, Weight and height, Race, historical condition and allergy.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.
Expired dose to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) 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.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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.   Linked case(s) involving the same patient:  US2022114879   Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The nurse reported that they administered an expired dose of Bexsero to a patient. The reporter consented to follow up. Additional Supportive Information:  The administration of expired dose of Bexsero to the patient, dose was expired since 31st July 2022 which led to expired vaccine used. This case was linked with US2022114879 reported by same reporter for different suspect vaccine.; Sender's Comments:  US-GSK-US2022114879:Same reporter
Excruciating joint/bone pain; Excruciating joint/bone pain; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 05Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included allergy to Penicillin and Tamiflu. The patient was not diagnosed COVID-19 prior to vaccination. The patient was not pregnant.  Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and multivitamin. The patient experienced excruciating joint/bone pain on 06Jan2021 18:00 that resulted in a Doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The events recovered on an unknown date. The events was considered non-serious by the reporter. The patient was not tested for COVID-19 post vaccination
THROAT STARTING HURTING AT NIGHT/ LYMPH NODE ON LEFT START HURTING AND FELT INFLAMED/ HURTS WHEN SWALLOWING; JOINT PAIN; MUSCLE ACHES; FATIGUE; FEVER UP TO 100.1 DEGREE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced joint pain. On 19-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever up to 100.1 degree. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 20-MAR-2021, the subject experienced throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever up to 100.1 degree on 19-MAR-2021, was recovering from joint pain, and had not recovered from fatigue, muscle aches, and throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. This report was non-serious.
Patient received her 1st COVID-19 vaccination on 12/17/2021 at 12:00 pm. Around 10:00 pm on 12/17/2021, she began to notice body aches. Around 3:00 am on 12/18/2021, she began to notice numbness to the left-side of her face including her lip, cheek and chin as well as, on the inside of her left mouth. She then noticed twitching to her left cheek brought on by smiling.
Received Vaccine on 3/16/21 and on 3/18/21 developed nausea and muscle pain in back, hip, and legs.  Has been taking Aleeve and Tylenol with no relief.  Has appointment with PCP this afternoon. Reported PCP gave Steroids, muscle relaxer and antinausea medicine.
pt recv vax 30SEP97 around 10AM & about 3Pm returned w/urticaria;pt not on med, no new foods, no skin products;pt w/o known allergies;
This spontaneous report was received from a registered nurse concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX, 0.65 mL (route and lot # not provided). On an unknown date, the patient developed an injection site rash and just a few vesicles. At the time of the report, the event outcomes were unknown. It was unspecified if the patient sought medical attention. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
On November 22, 2021 (a month after pfizer booster) patient developed severe tinnitus in both ears.  He was seen by urgent care, and prescribed antibiotics and steroid drops.  On November 23/24, 2021 was seen in the ER for unrelenting high pitched tinnitus and had a CT scan without contrast.  He was given Decadron, Valium and Toradol and released home. On November 27th, was again seen at ER for the same condition and given the same medications, this time with lesser effect.  On November 29th, PCP, Dr, who started patient on Lexapro.  On December 1, patient was still experiencing  severe tinnitus to the point that he had not slept soundly in two weeks.  Was seen at the ER.  CT scan completed with contrast.  ENT saw patient, advised he needed an audiogram and ENT consult.  Audiogram conducted at Dr office on December 2.  December 3, patient saw Dr ENT at medical center.  Determined that he had unrelenting tinnitus, potentially? related to the vaccine. Dr ordered steroids, and a hearing aide consult.  Patient had minor improvement in tinnitus, so Dr has ordered another dose of steroids. Dr has now stopped the Lexapro and patient is starting Wellbutrin. High pitched squealing continues, and inexplicably, he has sudden hearing loss in the lower tones, now necessitating bilateral hearing aides.
Mild - Moderate tingling in throat, mild - Moderate tightness in chest, mild dizziness and feeling weak
maternal exposure during pregnanacy; 7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications; palpitations; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications), PALPITATIONS (palpitations) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Dec-2021, the patient experienced VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications) and PALPITATIONS (palpitations). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy). At the time of the report, VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications) and PALPITATIONS (palpitations) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter  Patient mother had mentioned that her daughter received  for the first and second dose the Moderna covid19 vaccine, and that she was pregnant before the first dose
Info has been received from a physician concerning a 12 month old white male who on 29-AUG-20055 was vaccinated with a 1st, 0.5 ml, SC dose in the left arm of MMRII, (lot 647562/0579R). There was no illness at the time of vaccination. On 9/17/2005, the pt experienced a swollen area in her left cheek. It was noted that an NSAID was given as treatment. Subsequently, the pt recovered. No product quality complaint was involved. No other info was provided. Follow-up info from a physician indicated that on 9/5/05, the pt experienced a fever and a rash. On 9/17/05, the pt experienced a swelling of the left pre-auricular area with no other symptoms. It was reported that the pt recovered. Additional info is not expected.
Rash at injection site developed within 24 hours of receiving vaccination. Rash oval in shape. Rash remained for three days after shot.
Pain and soreness started in the area of the shot within a few hours. I normally sleep on my left side and have been unable to do so since the injection. The pain increased to a throbbing level over the next three weeks, and is so intense as to restrict left arm motion vertically and rearward. I went to see my PCP at week five, but there was nothing she could offer. The soreness has decreased some, but returns at the end of a day of normal activity such as grocery shopping or light housekeeping. My left arm?s vertical and rearward motion are still limited so it is very difficult if not impossible to back up my car looking over my right shoulder and trying to steer with my left arm. I also am losing strength in my left arm to the point that last week it caused me to fall. I was standing one step up, reached with my right arm, became a little off balance and reached up with my left arm to steady myself on the wall, and could not do so, causing me to then fall to the floor. I am anticipating requiring physical therapy.
This case was reported by a physician via out of hour services and described the occurrence of fever in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache. On an unknown date, the outcome of the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache were unknown. It was unknown if the reporter considered the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported via after hours voicemail which contacted by staff member from doctor of medicine (MD) office. The reporter did not provide name, calling on behalf of the physician and reported above side effects in regards to one of their patient's experienced with SHINGRIX. The patient experienced tenderness on ear lobe in left side, redness on face in left side, swelling on face in left side, droopy eye lid in left side and headache in left side.
Fever of 102 chills sweats headache 48 hours of vomitting and dry heaving shakes diarhea fatigue Mental confusion
The vaccine was given on April 24th 2001.  By April 26th (am),pt had a rash at the site of injection.  She also had small bumps on her nose and legs.  By the 27th she had a full body rash including red spots on the bottom of her feet, legs, back, legs, buttocks, arms and trunk.  She has hives on her face.  I called the doctor on Monday and she returned my call on Tuesday.  I started giving her Benedryl.  The rash has not cleared up to date.  (one week).  The rash has gotten better in the last 8 hours.
Information has been received from a health professional concerning a female pt who was vaccinated on 10/06/2000 with a dose of varicella virus vaccine, live. Subsequently, on approximately 02/24/2004, the pt developed breakthrough chicken pox with less than 50 lesions. Follow up information indicated that " there was not a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other patients developed  breakthrough cases of chicken pox ( WAES # 0405USA02615, 0405USA00572,0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577,0405USA00578,0405USA00579, 0405USA00580, 0405USA00581,0405USA00582,0405USA00583,0405USA00584,0405USA00585, 0405USA00586, 0405USA00587,0405USA00588,0405USA00589,0405USA00590,0405USA00591,0405USA00592,0405USA00593,0405USA00594,0405USA00595,0405USA00596,0405USA00597,0405USA00598,0405USA00599,0405USA00600,0405USA00601,0405USA00602,0405USA00603,0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609,0405USA00610, 0405USA00611,0405USA00612,0405USA00613,0405USA00614,0405USA00615,0405USA00616,0405USA00617,0405USA00618, and, 0405USA00619).
2 vaccines were given to her on her right leg, which were the Hib (Aventis) and PCV (Wyeth). She cried for about 10-15 min. Straight. Her leg stated to get swollen and red. We gave her Benadryl and it calmed her down.
Patient complained of redness at injection site, and that the injection site grew from a quarter sized redness, to a half dollar sized redness over the course of a couple days.  Pharmacist on duty advised patient to ice the location, take Benadryl and contact PCP if it gets any worse.  Followed up with patients a couple days later, and reported redness had not got any worse, but was still off and on painful.
PATIENT RECEIVED COVID-19 VACCINE AND WAS TAKEN BY WHEELCHAIR TO THE OBSERVATION AREA WHERE A PROVIDER AND NURSE WERE OBSERVING FOR ANY ADVERSE REACTIONS.  THE PATIENT WAS ADVISED TO  WAIT 15 MINUTES BEFORE LEAVING THE FACILITY.  THE PROVIDER NOTICED THE PATIENT LEANING FORWARD IN HER WHEEL CHAIR.  SHE TRIED TO ENGAGE HER AND SHE WAS UNRESPONSIVE.  SHE TRIED TO ALERT HER AND SHE WAS AGAIN UNRESPONSIVE.  THE PROVIDER ADVISED NEARBY STAFF TO CALL 911 AND FOR THE NURSE TO BRING THE CRASH CART AND OXYGEN AS SHE ASSESSED THE PATIENT FOR A RADIAL PULSE.  NO PULSE WAS PALPABLE.  SHE THEN ASSESSED FOR A CAROTID PULSE AND NO PULSE WAS PALPABLE.  ANOTHER PROVIDER ARRIVED AND THEY QUICKLY PUSHED THE PATIENT TO THE CLOSEST EXAM ROOM FOR FURTHER ASSESSMENT AND POSSIBLE CPR.   VITAL SIGNS WERE BEING OTAINED WHICH REVEALED HYPOTENSIVE.  BLOOD GLUCOSE TAKEN AND WAS WITHIN NORMAL LIMITS.  AS THEY STARTED TO REMOVE HER CLOTHING TO PREPARE FOR RESUCCITATION SHE BECAME ALERT AND APPEARED ANGRY AND CONFUSED.  SHE QUICKLY BECAME ALERT AND ORIENTED.  EMT'S ARRIVED AND COLLECTED THE INFORMATION NEEDED TO TRANSPORT THE INDIVIDUAL TO THE NEAR BY EMERGNECY ROOM FOR FURHTER EVALUATION.
Pt running fever of approx 104-105 21JUN91; Did not improve w/APAP & parents took pt to ER on 23JUN; pt seizured in ER; Admitted w/dehydration (had also had diarrhea several days off & on); Seizured 2 more time in Hosp; Dx stomach flu;
The child complained of itching of the arms and body and she had a constant dry cough. No difficulty breathing. Epinephrine was given and itching and cough cleared. EMS was called. The child was taken to hospital ER. As per ER doctor, she was discharged on Prednisone.
This is a spontaneous report received from a consumer, concerning herself (68-year-old female patient), who was administered the Moderna COVID-19 vaccine (mRNA-1273) and experienced fever, headache, nausea and vomiting. The patient's medical history and concomitant history not provided. No lab data reported. On Feb 1, 2021, patient received the first of two planned doses of mRNA-1273 (lot# 007M20A), intramuscularly, in left arm, for prophylaxis of COVID-19 infection. On Feb 2, 2021, patient experienced fever, headache, nausea and vomiting; with outcome of unknown. The treatment history was not provided. The action taken with the first dose of mRNA-1273 in response to the event: not reported. Sender's comments: Based on the current available information, which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the known safety profile of mRNA-1273.
Red, swollen, hot to touch Augmentin XR one tablet p.o. BID x 7 days
rash at injection site for about 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site for about 2 weeks) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZOA) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site for about 2 weeks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. On 02-Mar-2021, VACCINATION SITE RASH (rash at injection site for about 2 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medical information were not reported. treatment includes ice.
Mild cellulitis, right upper arm (+) erythema (+) induration 3cm X 4cm with mild pain, after TD injection on 9/25/00 at 15:30.
fainting spells; Chills; Pain at site of the injection; itchiness at the site of the injection; rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting spells) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection). On 02-Apr-2021, the patient experienced SYNCOPE (fainting spells) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (fainting spells), CHILLS (Chills), VACCINATION SITE PAIN (Pain at site of the injection), VACCINATION SITE PRURITUS (itchiness at the site of the injection) and VACCINATION SITE RASH (rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment included Tylenol.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 22JUN98 & same evening pt devel hives as stated by mom;medical attention was sought;pt recovered;