chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US025136, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 72-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
A non-serious report of administration of expired FluMist has been received from a nurse in concerning four-year old female. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved.  It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006659; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
She had an itchy rash widespread on body and her knees hurt.  She took 1 diphenhydramine 25mg.  She did not have to go to the doctor and said that she is feeling fine now.
After having the vaccine, felt out of breath, decided to take a shower, heart rate 155 bpm. Yesterday it was 133 bpm. Took it now it is 134 bpm. Feeling very anxious. Having some soreness in the arm.
Myalgia, UrticariaPruritus, throat constriction, nausea, fatigue, heart racing Narrative:
painful arm, long glove distribution on upper distal extremities; some weakness, can not use hands; some leg pain w/sl amount of edema; better @ times when treated w/steroids;
I don't feel like myself; Tiredness; dizzy; wicked Headache; chills; Shaking; fever; aching all over; "could barely stand"; anemia; 'fell face down" (fainted); This case was reported by a consumer via call center representative and described the occurrence of anemia in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2021, less than a day after receiving Shingrix, the patient experienced tiredness (serious criteria hospitalization). In August 2021, the patient experienced anemia (serious criteria hospitalization), fainting (serious criteria hospitalization and GSK medically significant), dizziness (serious criteria hospitalization), headache (serious criteria hospitalization), chills (serious criteria hospitalization), tremor (serious criteria hospitalization), fever (serious criteria hospitalization), general body pain (serious criteria hospitalization) and loss of balance (serious criteria hospitalization). On an unknown date, the patient experienced feeling abnormal (serious criteria hospitalization). On an unknown date, the outcome of the anemia and feeling abnormal were unknown and the outcome of the fainting, dizziness, headache, chills, tremor, fever, general body pain and loss of balance were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the anemia, fainting, tiredness, dizziness, headache, chills, tremor, fever, general body pain, loss of balance and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's husband and the patient herself. In the afternoon, the patient received Shingrix in left arm and hours later at dinner time, she felt very tired and in night had a wicked headache, chills, shaking, fever, dizziness and achy all over that she could barely stand. The patient said she was assisted by her daughter to rest room at night and she fainted and fell face first. The patient was hospitalized, labs diagnosed her with anemia. Less than 2 months after vaccination, the patient stated that she did not feel like herself since she got Shingrix shot. The reporter consented to follow up.
pt came into the pharmacy on 4/6/2020 and stated that her left arm was still hurting from her flu vaccine.  She described the pain to be in her upper arm.  I looked up the date the vaccine was given.  She stated that her other arm did not hurt.
After vaccinating I asked the pt to sit in out waiting room for 15 min, a few min later I heard a commotion and ran to the waiting room with Epi pen in hand and instructed my team to call 911, child face was pale but she was regain consciousness. I asked if she was ok, she said yes I ask what happen and she stated she black out. I asked if I could offer her water, she agree.  I offered her water she drank it.  I ask if she had lunch, she said around 11am. Dad stated she had a seizure.  EMS took over and she was transported to the Hospital.
Over 100 degree fever, chills, achy. Achiness started in evening. Fever and chill started around midnight lasting around 24 hours. Fever, chill subsided late on 3/11.  Better but still achy on 3/12.
A temperature excursion involving PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an inappropriate storage of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, for prophylaxis (lot # T021302 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 19-DEC-2021) (strength, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -5° Celsius (C) for 20 hours respectively.  A digital data logger was involved, and there was not previous temperature excursion.
This male subject was enrolled in a study. On 24 January 2013, he received the 1st dose of either the new candidate pneumococcal protein vaccine (dPly/PhtD, 10 mcg) or vaccine placebo (ALPO4) co-administered with Pfizer's PREVENAR 13 and Merck's PEDVAXHIB. On 25 January 2013, one days after the 1st dose of Blinded vaccine, one day after the 1st dose of PREVNAR 13, one day after the 1st dose of PEDVAXHIB and one day after receiving a dose of the concomitant vaccine PEDIARIX, this one-month-old subject developed fever. The subject was hospitalised. The subject was treated with ampicillin trihydrate, cefotaxime and paracetamol. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the fever may have been caused by investigational product, PREVNAR 13 and PEDVAXHIB and that the event was possibly due to the concomitant vaccine PEDIARIX (GlaxoSmithKline) and to a viral infection. Investigator Comments: INITIAL CLINICAL SUMMARY 6 week old boy who had cough for 3 days, received vaccines at 14:15 on 24 Jan 2013. No congestion or rhinorrhea. Sick contacts include three cousins with cough, rhinorrhea, all of whom live in subject's home. At midnight on 25 Jan 2013, baby noted to feel warm and was irritable. Baby brought to ED, Temp documented at 101.2 Rectal and septic work-up initiated, including CBC, blood culture, urinalysis, urine culture, lumbar puncture, Influenza swab, and RSV swab. CBC, U/A and LP were reassuring. Influenza and RSV swabs were negative. Cultures are pending. Unfortunately, due to difficulty obtaining lab studies, baby was started on Cefotaxime prior to obtaining blood culture. Baby was to be admitted to the hospital for observation and antibiotics, but there were no more beds available. Baby was transferred to another facility where the baby was admitted for observation and antibiotics (Ampicillin and Cefotaxime). On admission, the baby was afebrile and appeared well. 29JAN2013 Addendum to Clinical Summary: The infant had temp elevation to 101.9F the first night of hospitalization. The next day the infant was noted to have some cough and RN but no further fever. At 48 hours the cultures were neg (noted antibiotics may cloud the blood culture results). UA and CSF findings did not support either as source of fever. Antibiotics were discontinued after 48 hrs. and the infant was discharged to home on 27Jan2013. Discharge DX: Fever, (Provider's narrative indicates Viral Infection as be most likely cause). Discharge Follow-Up: 29Jan2013 Discharge Meds: None.
Redness and swelling at injection site after 8 days. Started at 8am the size of a quarter and has doubled by 3:30 pm.
PENTACEL administered instead of PEDIARIX. No adverse events, mother reports child ran a low grade temperature on the morning of 3/17/18.
PT TOLD EMS ON SITE THAT SHE HAD A TINGLE IN HER TONGUE. AS EVALUATED THE PT EMS WAS IN CONTACT WITH ER AND STATING SWELLING NOT TINGLE. PT WAS AT THE 15MIN MARK BY THIS POINT AND WE DECIDED TO HAVE THE EMT DRIVE HER TO THE ER JUST TO BE SAFE. THE PATIENT DID NOT SHOW ANY SYMPTOMS ON SITE (NO PHYSICAL SWELLING). KNOWING THE ER WAS 2 MIN AWAY SENT PT WITH EMS. THEY GAVE BENADRYL THAT SEEMED TO CALM HER NERVES AND SHE FELT FINE. THEY GAVE HER PREDNISONE 20MG DAILY FOR 3 DAYS AS THW DID HAVE VERY MINOR SWELLING OF UPPER LIP IN ER OVER 20 PAST INJECTION. I HAVE FOLLOWED UP WITH HER TWICE AND SHE IS DOING WELL. SHE WAS OUT AND ABOUT YETERDAY HELPING HER HUSBAND GET HIS SECOND SHOT
Ten minutes after patient received the COVID vaccine patient informed Medical Assistant that she was not feeling well. Patient told her that she was nauseous. The patient then began to faint. Medical Assistant caught the patient and called for assistance. Medical Assistant came and assisted Jan to sit the patient in a chair. Once the patient was seated I was notified and brought the patient water, crackers and placed an ice pack on her neck. PA came in shortly after and asked for her blood sugar and blood pressure to be taken. The patient's blood sugar was 122 and her BP was 162/91. Per PA's instructions the patient was monitored an additional 20 minutes and was escorted to her vehicle once she was feeling better.
On 10/31/12 patient reporting rash on arms, neck and chest. Rash itchy and painful.
Patient age is 16.  Patient given Moderna vaccine which at the time of the vaccination is not approved for persons under the age of 18.  There were no reported side effects or untoward outcomes.
during administration of vaccine patient only received the diluent and not the ACTHIB powder/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 12 months old female patient who received only diluent and not the ACTHIB powder (product preparation issue), while administration of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccines included PROQUAD, PREVNAR 13 and HEPATITIS A.   On 26-Dec-2019, the patient received only diluent and not the ACTHIB powder of suspect HIB (PRP/T) vaccine [diluent lot: U6376AA, diluent expiration date: 08-Feb-2024, powder lot UJ099AA, powder expiration date: Jun-2020] via unknown route at an unknown administration site.  It was a case of actual medication error due to product preparation issue.  At the time of report no adverse event was reported.  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 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.
left upper lobe pneumonia with a benign parapneumonic effusion; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  On 24-JUN-2010 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered left upper lobe pneumonia with a benign parapneumonic effusion (pneumonia). The outcome of event was unknown.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (noise in my head/tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A/049C21A and 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LORAZEPAM (ATIVAN), SIMVASTATIN (ZOCOR), LOSARTAN POTASSIUM (COZAAR), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE, ALLOPURINOL (ZYLOPRIM) and MESALAZINE (APRISO) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2021, the patient experienced TINNITUS (noise in my head/tinnitus). At the time of the report, TINNITUS (noise in my head/tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-342829 (Patient Link).
Chills, fatigue and body aches after the shot .  An extreme change in menstrual period and  symptoms . Nausea, lower back pain and really really bad cramps.
Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This lasted for 2 days at the same pain level. On the third day the stiffness, pain, hard to move went down to about 5% of what it was.
15 year old in clinic with limited vaccine history.  Relocated from another country.  Received Tdap in February 2019.  Given Tdap instead of TD for vaccine.  No adverse complications noted.  Pt observed 20 minutes following immunization.
Severe abdominal cramping, nausea, vomiting, inability to eat or drink, chills, fever.  The cramping lasted approximately 48 hours, vomiting lasted 24 hours, chills lasted 24 hours, fever last about one hour.
Initial report received from a physician on 09 Dec 2009: This patient was vaccinated inadvertently with FLUVIRIN on 09 Dec 2009. The patient did not experience any events. No further information was provided. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following correction was made: The event off label use was coded.
Approximately 5-10 minutes after receiving shot, patient said she felt dizzy, got up to get water.  We had her sit back down and pharmacist went to her side.  She slumped over and it was evident she passed out.  Pharmacist sat patient up,  her eyes rolled in the back of her head and she convulsed slightly.  After about 45 seconds she came to.  She was sweating and disoriented.  We called 911 at the beginning of her symptoms.  The paramedics checked vitals and did an EKG in the ambulance.  I called pt later in the day and she was fine.  States she believed it to be a vasovagal response.
Information has been received from a nurse concerning a 23 year old female who on 09-UN-2009 was vaccinated with the first dose of GARDASIL (661764/0650X). Concomitant therapy included (LODRANE). On 09-JUN-2009 the patient passed out after the first vaccination. The patient was alright to leave the office but was recommended to go up to the urgent care. Then the next day. 10-JUN-2009, the patient called the office stating that the urgent care would not see her because she did not received the vaccination there and also stated she was experiencing dizziness. Then on 15-JUN-2009 the patient called the office and stated she was experiencing dizziness, headache and tingling all over her body. The nurse reported that the patient had not called back stating she was still having any issues so they were not sure how she was doing at this point. At the report time the patient status was unknown. Additional information has been requested.
Fever of 100 began 02/20/21; has continuously taken ibprofin to reduce fever and has worked  Chills began 02/19/21 around 10 pm Extreme body sensativity began 02/19/21 around 10 pm; nauseaous to the touch of anything hitting my skin, hurt so bad to the point of tears and ibprofin did not relieve symptoms. Took melatonin to help me sleep. Symptom continued into the morning and throughout the next day  Nausea the night of the shot and into the next morning  Lack of appetite from right after the shot and the whole next day  Rash appeared about 3 hours after recieving the shot Bruise appeared the following day  Pain to the touch of whole upper arm began the night of the shot and into the next day
After vaccine patient reports that she did not feel well she advised later that is was as if she was having tunnel vision.  Patients BP checked at 10:10 and elevated 151/94 patient reports that her BP is never elevated, HR stayed WNL, 10:25 checked patients BP again 166/90. 10:35 BP 148/75 patient reports that she is starting to feel better HR remained WNL, 10:45 patients BP 130/78 Patient reports that she feels better and would like to go back to work.  I have advised her to make sure she has another health care provider check on her in a few minutes and check her blood pressure again. Patient acknowledged understand.
(L) upper arm slightly swollen and bright red, no pain or itchy. Presented 9/17/14. PNEUMOVAX administered 9/15/14.
BLOOD CLOTS; This solicited report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2023, the patient experienced blood clots, and was hospitalized on an unspecified date in APR-2023. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported as "Just last week I had my sister and another friend hospitalized for blood clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was not related.  This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230433876.; Sender's Comments: V0: 20230434716 - blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Not got a schedule for my second dose and it is going to be after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days). At the time of the report, OFF LABEL USE (Not got a schedule for my second dose and it is going to be after 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient stated that she received her first dose of Moderna Covid-19 vaccine on 06-MAR-2021. They were supposed to call her to schedule dose but they did  not call her back and it was going to be 42 days on 16-APR-2021 and she still did not have an appointment.