chrisvoncsefalvay/vaers-outcomes huggingface dataset:
supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately; administered Quadracel to 15 months old patient; supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old patient (unknown gender) who received separate fourth intramuscular  dose of 0.5 ml of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Quadracel] in right thigh  and HIB (PRP/T) VACCINE [Act-Hib] on 13-Jun-2019 (batch number: C5532AA, expiry date: 09-Oct-2020) instead of fourth dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (Hepatitis A) for Immunization.  It was an actual medication error as Wrong vaccine administered, inappropriate age at vaccine administration and wrong technique in product usage process. It was reported a 15 month old child was supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately   It was not reported if the patient experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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 on the batch number was requested.  List of documents held by sender- none.
Cellulitis Left arm after receiving seasonal flu vaccine via pharmajet. Shoulder to elbow red, hot, swollen. Emergency room visit. Prescribed BACTRIM. Above noted 10/8 pm.
First dose administered 1 day after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.Sender's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 040C21A with no associated AEs.
Severe pain in shoulder joint making normal daily activities difficult to perform. Pain began a couple hours after injection and got progressively worse. Ice and heat were used to reduce symptoms.
Information has been received from a certified medical assistant concerning a 16 year old black student female with no known drug allergies/reactions and no pertinent medical history reported who on 08-SEP-2006 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# 653937/0637F) in the left deltoid. On 02-NOV-2007, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (Lot # 657622/0388U) in the right deltoid. On 25-APR-2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U) in the left deltoid. On 25-AUG-2008, the patient was vaccinated with an extra dose of GAEDASIL vaccine (yeast) ((lot # 660374/0275X) - invalid) in the left deltoid. No adverse effect reported. This is one of two sibling reports received from the same source. Additional information is not expected.
allergic skin wheals noticed for first time this Am aprpox 24 hrs p/inject & administration referred to MD;
Patient was give a vaccine out of her age range, Vaccine is subject age group 6 weeks- 6 years, Patient is age 7 years at time of appointment.
Fever to 102 w/pallor & limpness; 7NOV91 exam was normal;
I went to a local eye care office, then another, then the local hospital where I was diagnosed with a childhood disease in my right eye. It is off, I can see 2 different things at the same time. It was not double vision, It is 2 separate images. I can't read. If I reach for something I have to close one eye so I don't knock stuff over. I have to drive with one eye closed. It is my dominant eye (right) that is messed up.
11:35am Patient C/O hands very shaky.  11:47am Pt reported feeling much better.  BP 159/102, 88. 11:47am Patient reported feeling much better.  Patient was advised that if symptoms return to call 911 or urgent care.  Patient verbalized understanding.
This spontaneous report as received from a pharmacist refers to a 68 years old male patient. It was reported that the patient was vaccinated with two doses of ZOSTAVAX, dose 1 on 30-APR-2012 and dose 2 on 25-SEP-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
inflammation inside the arm pit; warmth at injection site; pain at the injection site; injection site is even more red; This spontaneous case was reported by a health care professional and describes the occurrence of INFLAMMATION (inflammation inside the arm pit), VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE ERYTHEMA (injection site is even more red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE ERYTHEMA (injection site is even more red). On 05-Mar-2021, the patient experienced INFLAMMATION (inflammation inside the arm pit). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. On 05-Mar-2021, VACCINATION SITE WARMTH (warmth at injection site) and VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, INFLAMMATION (inflammation inside the arm pit) outcome was unknown and VACCINATION SITE ERYTHEMA (injection site is even more red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.
On 09/07/2000 the patient developed herpes zoster. Unspecified medical attention was sought. It was noted that it is unknown whether exposure occurred. As of 09/19/2000 the patient was afebrile. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a 54-year-old female patient who received ENGERIX B adult (batch number 4XM2T, expiry date 9th May 2018). The patient's past medical history included genital herpes. Concurrent medical conditions included mental disorder nos. Concomitant products included aspirin. On 25th March 2016, the patient received ENGERIX B adult 1 ml. On an unknown date, less than one month after receiving ENGERIX B adult, the patient experienced genital herpes, skin discoloration, bruising of arm and rash. On an unknown date, the outcome of the genital herpes, skin discoloration, bruising of arm and rash were not recovered/not resolved. It was unknown if the reporter considered the genital herpes, skin discoloration, bruising of arm and rash to be related to ENGERIX B adult. Additional details provided were as follows: The nurse reported that one of their patients returned at the time of reporting associating several side effects (reactivation of genital herpes, discoloration of inner thigh, bruise in her upper arm and rash) to the ENGERIX B vaccination that the patient received on 25th March 2016. The patient had a bruise on her upper arm, however the nurse explained that the bruise was in the opposite side where she receive the injection.
Chills, Hot Flashes, Head Ache, Body Aches, Congestion, Stomach Issues
I have been experiencing hearing loss in both  ears, starting sometime in the spring,  not really sure what the starting date is.  The right ear has  the  more profound loss.  I have been treated at  CC ENT  since 9/7.  I have been on a course of prednisone, (20 mgs)  for 1 week in September and  I  just finished a course in October for 5 days (20 mgs.)  I have had only minimal success,  because as soon as I stop the prednisone,  the hearing loss returns.  However,  I don't think it is as bad as it was when I first experienced it in the spring.                     I also have been experiencing tendinitis in both ears on and off along with the hearing loss.
Localized swelling at 2 injections sites, 1 on each thigh site of right PCV and left Dtap/Hib, about 2.5 cm area swelling, induration. No warmth no tenderness.
Patient got his HAVRIX vaccine last week with his mom and his brother cause the mom was worried about the incident that happens, after, he got the shot by nearly 15-20 minutes and while they are moving to go home, my tech noticed that he was loosing his balance, I got the epipen from the drawer and ran to him immediately , my tech and his brother lay him on the floor, trying to talk to him to keep him awake, in less than two minutes , he got the epipen shot. during this time , my other tech contact 911. they came in 5-10 minutes and went to the hospital the patient's mom called me the next day, everything went ok
It was reported that a male pt received JE-VAX, TD and Pneumovax vaccines on July 26, 1999. Reportedly the pt complained of a constant headache after the 1st dose.
Pt states fine tiny red rash Friday night on arms, legs and back - itchy, Use Benadryl cream, Also completely done by 01/31/00, Did not see MD
Swollen reddened, hot area that lasted 4 - 5 days, right after shot given. Never had this happen with any of the other flu shots I have taken.
Patient sitting on exam table, TDaP, MENACTRA administered, Patient stated felt okay, HPV given patient stated felt okay and then immediately passed out.  I caught her torso but she hit her head on the wall. I assisted her to supine position and monitored her for 15 minutes. Another RN assisted me with obtaining vitals. Supine until patient no longer felt symptomatic.
Headache, 2 hours post vaccine Soreness at injection site, fatigue, headache, and chills 24hours post vaccine. Continue to experience fatigue and headaches for 4 days. On-going headache continues.
Severe pain in right arm where vaccines administered (HPV, Tdap, Hep. A, MMR), itching, severe swelling (very hard), redness, warm to touch, numbness traveling down right arm to hand. Unable to move right hand.  14 y.o boy crying from pain, according to mother.
SATURDAY HE BEGAN WITH TIREDNESS AND LOSS OF APPETITE.,PT BEGAN HAVING HICCUPS, HEADACHE, ABDOMINAL DISTRESS, BLOOD IN HIS URINE, STOOL AND EMISIS.
5/12-inconsolable crying/screaming lasting 30-50 mins baby reached for right side of head. 5/21-EEG; negative-baby continues crying fits. 6/3-hospitalized with RSV; 104 degrees fever; pneumonia. 6/28-another 104 degrees fever. An annual follow up report received 10/20/2003 adds: At present, he (pt) has no known residual symptoms. However, it is difficult to conclude that any problems he might encounter down the road is or is not related to his reaction to the vaccine. He has not received any vaccine shots since his reaction because he seems to get sick frequently. So much so that his doctor does not want him to be vaccinated at this time. To me, a mother of 3 children, it seems as if his immune system did not fully "recover". He's constantly developing colds, coughs and fevers. In February 2003 he underwent surgery to place tubes in his ears after tests revealed he had "negative pressure" in the right ear. His problems with his ears began when he was hospitalized June 2002. Prior to receiving the vaccine DTaP, he had never been sick. 2/6/08-psychological consultation note received for DOS 9/26/07-Diagnosis Autistic Disorder.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 14-JUL-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route unspecified) lot # L001332, Expiration date 13-JAN-2017. No symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1507USA007833 via same reporter link. Additional information has been requested.
6cm diameter area of erythema, swelling, warmth, tenderness at injection site. Chills, fatigue, rhinorrhea.  Treatment: acetaminophen prn. Outcome: Close monitoring of local reaction to injection, patient to follow up if redness/swelling/pain worsens or if develops new symptoms
Information has been received from a pharmacist referring to a 54 year old female patient. Concurrent condition and medical history were not reported. On 01-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown, lot# L012478, expiration date 10-JUL-2016) subcutaneously. No concomitant therapy was reported. The pharmacist reported that the patient's husband called the pharmacy on 03-AUG-2015 to reprot that his wife is experiencing experienced headache and a fever of 102F. No lab was performed. The patient's husband gave the patient an unspecified dose of TYLENOL on 03-AUG-2015 to help alleviate the symptoms. The outcome of the events was reported as not recovered. Additional information has been requested.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 24-year-old male subject received the following vaccinations: On 17 October 2013 an injection of ACAM2000 (lot number not reported) and on 27 September 2013 Influenza, live, intranasal (manufacturer and lot number not reported) and FLUZONE Intradermal (lot number not reported). On 31 October 2013, the subject was diagnosed with acute pericarditis, unspecified. The subject had no significant past medical history. On 27 October 2013, the subject had a abnormal echocardiogram and on 04 November 2013, the subject had an abnormal electrocardiogram (ECG). Troponin I results were not available. MRI of the brain, spinal cord and heart as well as a lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Developed dizziness, nausea after receiving vaccine. Face, chest red. Benadryl 25 mg po x 1 given. VSS. Symptoms improved. Discharged home with son in stable condition.
Patient is an 83-year-old male with history of atrial fibrillation on Eliquis, hypertension, hyperlipidemia, GERD And dementia presenting to the emergency department from a nearby nursing facility as nursing staff noted he had significant bruising to the left side of his chest. They think he may have fallen on Saturday, however they are unsure.  Patient has significant dementia and cannot give us a good history.
Patient went to the emergency department to rule out stroke and was diagnosed with Bell's Palsy and taste changes. He has now recovered fully. Stroke was ruled out
Patient presented to EM on 4/28 in early afternoon after being found confused at home shortly after waking up. Wife of patient stated that patient was trying to use deodorant as if it was a telephone. In addition, patients boss texted patient address of job site as patient works as a contractor and the patient did not know what to do with this information. In ER patient was found to be back near baseline of cognitive health and no mental deficits were noted. Over the course of 3 days, extensive lab and imaging workup, as well as consultations to neurology, infectious disease, and psychology, were unremarkable. Patients only notable aspects of hospital stay were on day 2 where he stated he was having trouble "finding several words" during conversation and being unable to state niece's name when asked. Patient was discharged on 4/30 with a f/u appt in outpatient clinic in 2 weeks unless earlier appointment needed.
On the night of 03-26-2021, I developed a fever  and chills. My fever was 105.F. I also subsequently developed diarrhea, felt sick, had a cough an a bad headache. I spoke with my PCP who told me to take Tylenol as pain medication.  I also had to get a COvid-19 test which was negative due to how I was feeling.
Hives and Covid symptoms for 2 weeks: congestion, sneezing, coughing, sore throat and muscle pain. Benadryl topical and tylenol.
MMR #2 given 3/23/2007 patient denied pregnancy, steroids or prednisone. Had MMR #1 and TD #1 on 1/23/2007. TD #2 also given 3/23/2007.
Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 9 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before) 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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided.  patient  received a vaccine accidentally, the vial had been first punctured on 09 or 10-jul-2021, it was open 1 or 2 days already, then it was put back on the fridge, and it was administered as a 2nd dose to a patient on 13-Jul-2021.  only 1 vial affected, it was not discarded and was sent again to the refrigerator, it looked normal, clear. He doesn't remember the exact temperature   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up document is received it does not contain any new information.
Day 1 (starting about 12 hours after vaccine): chills, fever, body aches Day 2: body aches, fatigue - both all day Day 3: headache all day, vomiting (x2) within 1 hour of waking
No other side effect or issues reported; the patient was given MMR II Jan 6, 2020 and then given VARlVAX on JAN 14, 2020; This spontaneous report was received from a medical assistant referring to a 5-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 06-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (route of administration, lot number and expiration date were not provided), and on 14-JAN-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form for prophylaxis. The vaccines were given off schedule. No other side effects were reported.
Fever on 4/22 night and 4/23 pain and swelling on 4/24 slight improvement felt nauseated on 4/23.