chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US020250 is an initial spontaneous report from the nurse received on 08 Oct 2014 with a follow up report received from the nurse on 04 Nov 2014. This report refers to a 17 year old male patient. His past medical history was not reported. His concomitant vaccinations included GARDASIL (other manufacturer, batch number: J009788) at a dose of 0.5 ml intramuscularly and FLUVIRIN (batch number: 145204) at a dose of 0.5 ml intramuscularly on 06 Oct 2014. On 06 Oct 2014, at 11:06 AM, he was inadvertently vaccinated with a dose of MENVEO (batch number: M13015) of which the Men A lyophilised component was expired, at a dose of 0.5 ml intramuscularly into his left deltoid. No adverse event reported following this medication error. Follow up report was received from the nurse on 04 Nov 2014: Updated height and weight of the patient, concomitant vaccinations, event details, dose of MENVEO and anatomical site of vaccination of MENVEO.
discomfort; pain / achiness; put her down for two days at home; This case was reported by a consumer via call center representative and described the occurrence of discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced discomfort, pain and bedridden. On an unknown date, the outcome of the discomfort, pain and bedridden were resolved with sequelae.   It was unknown if the reporter considered the discomfort, pain and bedridden to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix about 5 months ago and she did experience achiness, pain, discomfort.  The patient's husband can not remember well her symptoms but they did show up 6 to 8 hours after the vaccination and put her down for two days at home.
Quadracel was given outside of indication to an 18 mo old patient with no reported adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involves a 18 months old of non-health care professional patient who received quadracel was given outside of indication to an 18 month old patient with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site as Prophylaxis (immunization).  On an unknown date the patient developed a non-serious event quadracel was given outside of indication to an 18 month old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (product administered to patient of inappropriate age).  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.     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 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.
Fever, chills Extreme fatigue  Full body aches and pains Strong headache Swollen vaccination site Had to take two Tylenols which helped a little.  Still feeling the fatigue after one day.  But not as bad as before probably due to the Tylenol.
Immunizations listed below given in the afternoon of 8/5/09.  The next morning child reported a headache, stomach ache, was febrile (mother did not remember exact temp.), anorexic, lethargic and had poor oral fluid intake.  Mother gave child 1 dose of BENADRYL and Ibuprofen (dose was appropriate for age & weight).  Took child to Dr. on Friday AM (8/7/09) -> Rt. deltoid injection site was 10 cm X 20 cm red and hot to touch & very itchy.  BENADRYL and ice pack topically prescribed.  Pt improved by noon 8/8/09.
I was really unconscious; Unable to do anything for myself; so sick that I could not communicate with my family; had to remove my wet clothes due to the amount of sweat in my night clothes; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature). The patient was treated with PARACETAMOL (TYLENOL) for High temperature, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I was really unconscious), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.    No concomitant medications were reported.   Patient reported being sick for a couple of days but was unsure about the exact duration.  The patient had second vaccine which was horrible for patient as the patient had high temperature and had no idea what day it was so sick that the patient could not communicate with family. The patient was unable to do anything and when the temperature patient's son gave Tylenol. The patient was sick for at least 2 days and was really unconscious.  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  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.
Moderna COVID-19 Vaccine EUA  First day, Jan. 28, head felt funny and went to bed at 6:30 pm and by 9:30 pm when I work up, I felt fine.  Day 8: felt itchy on left arm where vaccine took place and pink.  Same thing this morning.
Potential lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of DRUG INEFFECTIVE (Potential lack of efficacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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 DRUG INEFFECTIVE (Potential lack of efficacy). At the time of the report, DRUG INEFFECTIVE (Potential lack of efficacy) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Company Comment- This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who reported non serious unexpected event of potential lack of efficacy (reported as I don't feel like the doses I have received have been optimal in protecting me) unspecified days after receiving the first Booster dose of mRNA vaccine. Details of first 2 doses and first booster dose are not provided. There is no information if the patient experienced any symptoms specifying lack of effect. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who reported non serious unexpected event of potential lack of efficacy (reported as I don't feel like the doses I have received have been optimal in protecting me) unspecified days after receiving the first Booster dose of mRNA vaccine. Details of first 2 doses and first booster dose are not provided. There is no information if the patient experienced any symptoms specifying lack of effect. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Low grade temp; fatigue; body aches. Next day developed hives (reported on 6/12/13). Was not aware that she had developed hives.
This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 08:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 01Feb2021 07:00 AM patient experienced rash and welts mostly on right arm. Some on other parts of body. Patient did not have COVID-19 prior vaccination, Patient did not COVID-19 tested post vaccination. Outcome of the event was not recovered. Information on the lot/batch number has been requested.
Extreme soreness in vaccination site . Shoulder blade and neck Migraine Headache Painful to lift or carry
Patient called pharmacy sunday march 25th 2018. Pt stated she was experiencing redness and swelling at the injection site which continue down her arm to hand. Pt stated top of her hand had area of swelling about the size of a quarter along with redness. Pt stated redness started following day of time of injection ( tuesday march 20th 2018) but noticed the area sunday. Pt was unsure if area started at injection site and continued to spread down arm and to hand or if all redness/swelling happened simultaneously. I recommended she needed to seek medical attention from her primary doctor (which had given rx to pt).
pt recv inj of Pnu-Imune 23 on 8/11/98 & inadvertently received a second inj of vax on 10/7/98; following the 2nd vax pt exp severe pain in arm; lethargy; & myalgia
Started the next morning severe burning in nasal passages April 16 still no relief saw nurse practitioner told me my BP was elevated gave me Amoxiclav no relief made followup appt with doctor was told it would be 5 week wait before that time I  experienced another event my peripheral vision started to diminish and I started to feel weak lost consciousness was taken to Hospital was treated for stroke then 2 days later told I didnt have a stroke they could not confirm what had happened to me my blood pressure continues to be very high on 2 medications 2 times daily.  My nose continues to be inflamed and keeps flaring up with pustules drainage and bleeding. I was told that its not a sinus infect but an allergic reation to the vaccine I've had 2 rounds of Amoxiclav 2 rounds of Doxycycline valacyclovir and Bactriban I also take Metoprolo tartate 50mg 2 times a day and Lisinopril 50 mg 2 times a day and my BP is still hig with those.  Prior to the injection I was not on any medications.
Arm pain. Immobility. Range of motion. Happened almost immediately and has persisted since date of vaccine. Treatment has been NSAIDs. Received prescription for PT
Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feeling feverish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Feeling feverish). At the time of the report, PYREXIA (Feeling feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
administered Boostrix instead of Infanrix; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97MR2, expiry date 11-OCT-2025) for prophylaxis.   On 31-OCT-2023, the patient received Boostrix. On 31-OCT-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administered Boostrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The reporter reported that It was supposed to be the 4th dose of the Dtap series. The reporter consented to follow up. The patient received Boostrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administration and inappropriate age at vaccine administration.
2 weeks after the vaccine on 1/9/2022, mother started noticing something wrong with his eyes. He almost seemed kind of cross eyed. She had a virtual appt with his pediatrician and he referred her to an Ophthalmologist. His appt is on 2/1/2022, she plans on calling back and updating his case after the appt.
Diarrhea, low grade fever, chills, aches and pain in lower body. As of Aug 5 diarrhea continued now stopped. Pain and burning in legs to pelvic are continues. This is a strong neuro pain, taking Neurontin from Dr. Problem continues now for 7 days.
Patient got flu quad 0.5 ml at 0911 AM, left office. Started getting hives at 1030 AM. No respiratory distress. Mom gave BENADRYL at 11 AM vomited at 11:30. Took nap, hives went away.
sweel pretty big knot; red pretty big knot; red pretty big knot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site nodule and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site nodule and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site nodule and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient got shingles shot and it was all red and swell pretty big knot.
fully vaccinated (pfizer, 4/28/21, 5/19/21)
Became ill 10 hours after vaccination with fever and chills, neck pain, weakness, lightheaded.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/16/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/16/2021 HX OF FALL J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/16/2021 CANCER METASTATIC TO AXILLARY LN
Tired; chillness (not much ); soreness due to the shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), CHILLS (chillness (not much )) and MYALGIA (soreness due to the shot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), CHILLS (chillness (not much )) and MYALGIA (soreness due to the shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (Tired), CHILLS (chillness (not much )) and MYALGIA (soreness due to the shot) outcome was unknown.            No concomitant medication reported.   This case was linked to MOD-2021-207481 (Patient Link).
I was working on a fence about 5-5:30 pm and suddenly developed blurry vision. I continued working for another 5-10 minutes, then I went inside for dinner with my wife kids and in-laws. I complained I couldn?t see in my periphial  to my wife and mother n law.  I  ate dinner, salad and spaghetti. While eating my brother in law asked if I got a new car and that he hadn?t see the white one before. I tried to tell him what happened to my old car but got caught and couldn?t think clearly about the old car, the problems it had and the story.  After dinner I want out to help on the fence again and my son was handing  my brother in law boards and I tried to tell him the board wasn?t cut with a bevel yet. But couldn?t come up with any words to describe the board. I went to my wife explained my  that my brain wasn?t working right and I clearly had a problem. I developed some tingling in my right hand. She took me to  local ER referenced. My symptoms subsided on their own and they weren?t able to see anything on a cat scan. As I felt better I didn?t take the next step to the larger ER with and MRI.
I felt a little feverish and weak. I slept a lot. I began taking Paxlovid on the second day. I had one more day in which I had a fever. Afterwards, I felt lethargic; I had some energy, but not as much as I did before getting sick. I then developed a lot of head congestion and post-nasal drip. After that passed, I felt fine.
This spontaneous report has been received from a physician via a company representative referring to a 80 year old female patient. Information regarding medical history, drug reactions, allergies and concomitant therapies was unknown by the reporter. In August-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, strength, lot#, and expiration date were not reported)  for prevent shingles. On an unknown date in 2016, and after the vaccination, the patient developed a mild case of shingles. It was unknown by the reporter if the patient received treatment for the adverse event or if laboratory diagnostics studies were performed. Product quality complaint was not involved. On an unknown date, the patient went to saw the physician. At the time of reporting, the outcome of the a mild case of shingles was unknown.   Additional information is not expected no reporter details were provided.
injection site arm  (left arm) was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm  (left arm) was sore) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site arm  (left arm) was sore). At the time of the report, VACCINATION SITE PAIN (injection site arm  (left arm) was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; The patient receivVaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'ed vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient receivVaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'ed vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 9:29 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 9:29 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient receivVaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'ed vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient receivVaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'ed vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had received the booster dose.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and lot number was no longer possessed.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).