chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix was administered to a 9-weeks-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-week-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 09-AUG-2023, the patient received Kinrix. On 09-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 9-weeks-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2023 The reporter called to report that the Kinrix was administered to infant patient. The reporter did consent to follow up. The reporter reported that the infant patient administered Kinrix, which leads to inappropriate age at vaccine administration.
General mild knee stiffness in all joints began two days after second dose. Continued to worsen in left knee over the next month until diagnosed as Prepettellar Bursa Infection.
A nurse reported that a 56 year old female received an injection of Pnu-Imune 23 on 10/11/99. On 10/12/99, she developed an injection site reaction characterized by a 17cm X 18cm area of redness, swelling and warmth. She was seen by the physician and treated with ciprofloxacin.
He got his vaccine, continued on as normal that day.  At one point he got a muscle spasm in that area for about 5 minutes.  The next morning he felt fine, didn't do much activity that day but resting up for a music gig later.  He set up his musical gear, started to get dizzy and speech was affected.  He was having trouble communicating with the people at the bar, had not been drinking just setting up.  He started packing up thinking this may have been a stroke, which he informed him, who called 9-1-1.  They ambulance came and he went to a local healthcare center.  He had an MRI and a CT scan which confirmed an small vessel ischemic stroke without bleed.  He was in the hospital for 4 days.  He was treated with blood thinners and statin's and aspirin, which he is now.  They put him on Plavix for 21 days, and is now on 81 mg aspirin and on Lipitor 40 mg but now since on the aspirin and has a new PCP which has dropped it down to 20.     His dizziness did go away after his treatment in the hospital.  He has an irregular heart beat which he did not have this in the past.   He is now seeing a Dr.
Symptoms included swelling of the throat, tingling of the lips, shortness of breath within 20 minutes of receiving the vaccine. Treatment consisted of diphenhydramine 50mg and famotidine 40mg  at onset of symptoms, followed by EpiPen 5 minutes later since symptoms were still progressing. Patient was then taken to the ER.
pt recv vax;fever over 104 for 5 days;moaning, whining, crying; shaking violently 2nd day;completely listless;would not move;lying down completely in a daze;trouble sleeping;rxn to MMR per mom;pt to receive no more shots per mom;
w/in 5 mins of vax area of erythema approx 2 1/2 x3" devel @ MMR inject site LLA: area of induration approx 1/2" in diameter devel @ the inject site;
On 1/9 and 1/10 had diarrhea plus headache and nausea.  On 1/13 felt dizzy with continued headache.  Called PCP on 1/11 and 1/13 and received medication for nausea and ibuprofen for headache.  Felt better by 1/15 but was advised by PCP not to return to work until1/18.  I request name of physician several days ago but he has not communicated that information.  His PCP is strongly advising receiving second dose but wants to pre-medicate.
shoulder injury 24 hours after vaccination pain and decreased Range of motion  has persisted greater than 6 months
Slight swelling in deltoid, mild redness around injection site extending down the deltoid, happening between 16 and 20 hours after shot, there was also soreness beginning about 5 hours after shot. The soreness was gone at 48 hours. The redness continues at 72 hours. The redness patch was about 6 cm wide and 6 cm tall . After 30 hours the patch appeared to be clearing at the top and moving further down the arm. At 72 hours the redness had lightened, had mostly cleared the deltoid, had widened slightly, had a somewhat diagonal movement downward extending 8to 10 cm in the bicep area. There was also a slight headache in the first 24 hours and again at 64 hours after shot.
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 11/25 COVID swab, result: detected 11/17 pt cc: chills, cough, fever, headache, loss of taste or smell, exposure: unknown
PT STATES NUMBNESS OF ENTIRE LEFT ARM ONE DAY FOLLOWING VACCINE ADMINISTRATION, PT HAS NO FEELING IN LEFT ARM AFTER 3 WEEKS SINCE GETTING FIRST DOSE
(L) leg where vaccine was administered swell 1/3x size, skin red. Patient walking with limp. Swollen from hip to knee.
mom stated child had a seizure about 30 min. /P receiving immun. stated she took pt to "night time" Pediatrics & T was 104. Treated for T states father. Also "ears were blocked" according to father
Vomiting x 18 hours, migraine  and chills x 36 hours
15 hours of uncontrolled vomiting every 10-15 minutes followed by 3 days of nausea and vomiting - couldn't keep clear fluids down.
I have strep sore throat symptoms. It hurt to eat, talk, and swallow.; got the shot on 04/15/2021 and notice my throat pain on 04/17/2021.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced strep sore throat symptoms. It hurt to eat, talk, and swallow. He got the shot on 15Apr2021 and noticed his throat pain on 17Apr2021. It was unknown if therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event strep sore throat symptoms and throat pain were not recovered at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No ADR Patient had no history of COVID-19 vaccinations and was supposed to receive a monovalent dose for their first primary dose. They inadvertently received the Pfizer bivalent COVID-19 vaccine which is not indicated for a primary series dose.
Redness, induration, pain, swelling at site of injection; feverishness (99.8C), malaise, headache, achiness, itching (9/13/13 onset).
Moderately severe itching. I had to take Benadryl and Allegra to get relief. I'm still itching 3 days after the injection.
Information has been received from a health professional concerning a 14 year old female who on 10-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included measles-mumps-rubella vaccine, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 13-FEB-2007 the patient experienced abdominal pain and "bronco spasms". The patient had been seen by a physician on 13-FEB-2007, 23-FEB-2007, 05-MAR-2007 and on 07-MAR-2007. The patient had some visits to the Emergency Room however their is no information as to whether the patient was admitted. Patient outcome was not reported. Additional information has been requested.
sneezing; difficulty breathing; throat started to close down which was really bothering; fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit); vomiting; stomach began to feel nauseous; feeling awful/ felt worse; hardly swallow; diarrhea; retching; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a nurse via sales representative.  This case involves an 82-years-old female patient who experienced sneezing, difficulty breathing (dyspnoea), throat started to close down which was really bothering (oropharyngeal discomfort with symptom of dysphagia), fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia), vomiting (with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication/therapy were not provided.   On 08-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number, expiry date and other dosing details not reported] for prophylactic vaccination.  On an unknown date, in Oct-2020, the patient developed a serious vomiting, sneezing, difficulty breathing (dyspnoea) few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   On the same day, at afternoon, the patient had close down of throat (oropharyngeal discomfort) and then stomach began to feel nauseous (abdominal discomfort).   It was reported that, patient had appointment at heart clinic at 01:30 pm and by the time she felt awful (feeling abnormal), throat was very bothering and hardly swallow (dysphagia) then felt worse and within an hours had diarrhea (diarrhoea), vomiting, retching and fever 99.7 Fahrenheit (normally runs 97.6 Fahrenheit) (pyrexia).  These events were assessed as life-threatening. The patient was hospitalized for these events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovered from all the reported events.  Information on the batch number was requested.; Sender's Comments: This case involves an 82-years-old female patient who had a life threatening condition of sneezing, dyspnoea, oropharyngeal discomfort with symptom of dysphagia), pyrexia and vomiting with symptoms of abdominal discomfort, diarrhoea, feeling abnormal and retching few days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible with role of vaccine. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, concomitant medication/therapy, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pt's arm was red and hot to touch - sent to urgent care facility, they ordered AUGMENTIN 875 #20 1 tab BID.
This spontaneous medically confirmed (initial receipt 23-Apr-2012) concerns an elderly male patient with a medical history of hypertension, hypercholesterolaemia, prostate cancer, osteoarthritis, arthritis and possible CHF (congestive heart failure). The patient was concomitantly taking CAPTOPRIL and  CARVEDILOL for hypertension, bicalutamide for prostate cancer, simvastatin for cholesterol and warfarin for blood thinning. He was also taking ezetimibe, diclofenac, finasteride and furosemide. On an unknown date in the fall of 2011, the patient received suspect vaccine 'flu shot' (influenza vaccine) with an unknown batch number. Co-suspect vaccine PNEUMOVAX 0.5 mL given intramuscularly on the same day. On the same day as vaccination the patient developed muscle weakness, was lethargic and confused. The reporter stated that the patient was 'out of it' and was very weak. Symptoms lasted 18-24 hours after receiving the shot then he was fine. There were no symptoms of fever or flu-like illness. Symptoms abated after stopping the drug; did not experience symptoms after reintroduction. Patient outcome was reported as recovered.
This spontaneous report was received from the patient's mother and refers to a 22-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. The patient was vaccinated with three subsequent doses of GARDASIL intramuscular injection (dose, lot number and expiration date were not reported) on November 2004, June 2014 and October 2017. No adverse effects were reported.
Information has been received from a licensed practical nurse concerning a 47 year old female patient who on 10/12/01 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 10/12/01 included an injection of phytonadione (dose not reported) in the right arm and a dose of influenza virus vaccine (manufacturer not reported) in the left arm. It was unknown if there were any other concomitant therapies. It was reported that the patient was treated for abut 17 days by her primary physician (event onset approximately 11/12/01), and that cellulitis was ruled out. The patient presented to the reporters office on 11/29/01 with a red rash on her left arm. Additional information has been requested.
received her 1st dose/then tested positive for Covid; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that Patient received her 1st dose on 18Mar2021 then tested positive for Covid on 23Mar2021. The 2nd dose is scheduled on 09APR2021 (more than 21 days). She was told to wait 90 days to take the 2nd dose because of the said situation. The patient underwent lab tests and procedures which included covid-19: positive on 23Mar2021 Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large (4 inch) swollen red and white mottled circle appeared at point of vaccination. Muscle pain on outer side of arm between shoulder and elbow. Both symptoms continued for approximately 10 days.
Swelling at injection site about the size of a quarter.  No itching or discomfort.  Patient sat and relaxed and swelling decreased slightly.  Patient took his BP at the pharmacy and it was 135/84 (he is not sure what his normal BP is).  Patient felt fine when he left the pharmacy after 15min or so but was instructed to watch for signs/symptoms and to call MD if necessary and to call us with any questions.
Narrative: chills x1 day; resolved with the fever 99 degree fever on 1/12  Other Relevant Hx: Symptoms: Fever & Chills Treatment:
16 and received the 1st dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
9 days post Moderna Vaccine #1, I woke up with redness and itching at the injection site.  Skin is warm to touch and raised up with hard lump underneath.  Within another 24 hours the injection site is more red and painful, arm is sore at injection site.
Erythema, edema, hard painful lump. Looks like a wasp bite. Size of nickel or quarter.
noticed intense itchy 2 days p/vax; started w/nausea, lightheadedness & diaphoresis also h/a 2 days p/; 28JUL92 started w/raised red area @ vax site;
Vaccine given 4 PM 9-24-17. Myalgias on 9-25-17. Fever that evening up to 102.5. Red spot developed on L deltoid evening of 9-25-17. Large red area on L upper arm. Tender, itchy and warm area about 5 x 8 cm size.
Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulder neck and around the left side of my face. Within another few minutes the warm area became slightly numb. I could move my face and feel my skin but it felt like it had gone asleep. Over the next few hours it spread down my body, only me left side, all the way to my foot. Groin area also felt numb, like when you sit on a bike too long and my penis also felt numb. Called a teledoc service on Monday as this lingered. They told me that if it had not dissapated after 2 days to let them know. Symptoms went away on Wednesday March 31st.
No adverse event; Nurse gave a Moderna shot to a 3.5 year old child but it was from the adult vial with the red caps because they didn't have any child vaccines. The nurse mistakenly gave the child a booster-size dose (whatever the booster dose is for adults); This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Nurse gave a Moderna shot to a 3.5 year old child but it was from the adult vial with the red caps because they didn't have any child vaccines. The nurse mistakenly gave the child a booster-size dose (whatever the booster dose is for adults)) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Nurse gave a Moderna shot to a 3.5 year old child but it was from the adult vial with the red caps because they didn't have any child vaccines. The nurse mistakenly gave the child a booster-size dose (whatever the booster dose is for adults)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Nurse gave a Moderna shot to a 3.5 year old child but it was from the adult vial with the red caps because they didn't have any child vaccines. The nurse mistakenly gave the child a booster-size dose (whatever the booster dose is for adults)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Nurse gave a Moderna shot to a 3.5 year old child but it was from the adult vial with the red caps because they didn't have any child vaccines. The nurse mistakenly gave the child a booster-size dose (whatever the booster dose is for adults)).    No concomitant medications information was reported.  No adverse events were reported. No treatment medications were provided.
3.5x3 area of redness at injection site; no pain, but itches.
hypoglossal nerve palsy, paralyzed tongue; paralyzed tongue; This case was reported by a consumer via interactive digital media and described the occurrence of hypoglossal nerve paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hypoglossal nerve paralysis (serious criteria disability and GSK medically significant) and tongue paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the hypoglossal nerve paralysis and tongue paralysis were not recovered/not resolved.   It was unknown if the reporter considered the hypoglossal nerve paralysis and tongue paralysis to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got first dose and ended up with hypoglossal nerve palsy. The patient stated that it paralyzed his/her tongue permanently. The follow-up could not be possible as no contact details were available.
Pt received Varivax at 1 year of age. Now has mild varicella infection-has ~ 25 macules since last night, some with papules, some with vesicles, 1-2 are scarbed, itch.
Found pale & limp, stopped breathing; Hospitalized x 3 days; discharged; 15FEB92 had another episode & readmitted x 2 days; discharged 17FEB92;
left jaw tingling and numbness x 2 lasting 15-20 minutes each time headache stabbing/pinching pains in finger tips and toes. thigh pain muscle and joint pain fever 100.9 fatigue left arm swelling  and redness at injection site lasted 7 days
1/25 vaccination 1/26 I couldn't sleep overnight, kept waking up . Arm pain, 101.8 temp, muscle aches, severe fatigue, joint pain. *had to take 2 days off of work.  48 hours after vaccination, rash with itching at injection site. Went away after 24 hours with Benadryl and hydrocortisone cream.  Within 48 hours, fever broke.
On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020; extreme blurriness in left eye; Nauseous; intense headache at the base of neck up to eye socket; This is a spontaneous report from a contactable consumer (reporting for himself).  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot  number: EL8982), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  Medical history and concomitant medications were none.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284) on 28Dec2020 for COVID-19 immunization and experienced severe headache and was nauseous.  The patient experienced extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket in Jan2021. On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020.  Therapeutic measures were taken as a result of extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket and included: ibuprofen 1000mg.  The outcome of extreme blurriness in left eye, nauseous and on 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020 as unknown and of intense headache at the base of neck up to eye socket was recovered in Jan2021.
Shortly after vaccine administration while  administering pharmacist was filling  required documentation and explaining vaccine information, the patient stood up rapidly from the chair and suffered fainting, turned pale, felt nauseous and had a subsequent single episode of vomiting.