chrisvoncsefalvay/vaers-outcomes huggingface dataset:
client was verbalizing anxiousness prior to vaccination and stated that client stated "feeling dizzy" while walking to the observation room post vaccination. Co Lead rn observed client to be visibly shaking and gripping boyfriend's hand with both of her hands. Client was A&Ox2 to person and situation. Co Lead RN determined client could not ambulate towards observation room and went to retrieve wheelchair. Client was safely transferred into wheelchair with two nurse assist and then taken to observation room. Secondary RN set up gravity chair in observation room for client. Client then transferred into gravity chair from wheelchair with two nurse assist. Co Lead RN recommended for client to lower her face mask and take long deep breaths. At 11:15 AM first vitals taken on client: BP LA 170/100, pulse 78, O2 SAT 98%. Client stated, "I am diagnosed with anxiety by a doctor and take anxiety medications for it. Last time I was this anxious around needles was about 3 months ago. I always begin to feel short of breath." Client was unable to remember her medication name. Client stated, "I forgot to take my anxiety medication today, I have the medication bottle in my car." Client was provided water to drink but declined snacks. Co Lead RN observed client to become more relaxed and was answering questions with smiling and giggling throughout conversation. Client stated, "I am starting to feel better" and was now observed to be A&Ox4. Co Lead RN educated client to follow up with primary care physician. Boyfriend confirmed that he would be driving both of them home. Co Lead RN stated to client to continue taking deep breaths and relax for another 15 minutes. At 11:36 second set of vitals: BP LA 132/88, Pulse 68, O2 SAT 98%. Secondary RN educated client on the importance of taking anxiety medication before any procedure she knows that would trigger an episode and to have them on her person. Client verbalized understanding and then stated, "I am ready to go home now." Co Lead RN walked as standby assist with client as she walked with a steady gait (boyfriend at her side) outside the facility at 11:42 AM.
pt recvd vax;c/o lt knee swelling;,no discoloration, no bruising but tender to touch; noted local rxn to dtp;
This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). On an unknown date, the patient received KINRIX. On an unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction and pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient had a severe local injection site reaction. This physician believed that there is a quality issue with this lot because. A related product quality complaint was being registered. The physician retained the product for return to GSK for investigation and was requested that GSK put a hold on this lot until investigation is completed. The physician was requesting investigation results. No credit was arranged. The physician refused to provide details and will fax the adverse event information to the Safety Department. She would also email photos to the Quality Department. The physician already reported the AE details to VAERS. This is 3rd of 3 cases reported by the same reporter. Follow up information received on 28th November 2017 from the QA department. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
Hives all over the body 14 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body 14 days after vaccination) in a 34-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives all over the body 14 days after vaccination). At the time of the report, URTICARIA (Hives all over the body 14 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient got Moderna COVID-19 vaccine and 14 days later he had hives. No concomitant medication were provided. No treatment information were given.
It was reported that a 45 year old female patient received a Fluzone SV '01 -02 vaccination, administered on 10/01/01. Approximately 15 minutes after injection the patient stood up complained of left jaw pain, was unable to speak without slurring and passed out. She was transferred to ER; all test results were normal. Patient was discharged to home, Patient recovered. from this experience.
fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7/30/2018  @ 8:30 am. Pain where the shot was given, red, muscle pain. Headache, fever, dizzy, throwing up.  Loose stools. Very tired, weak.
Started with sore throat, then runny nose, sneezing, high fever with flu-like aches, then coughing. Treated symptoms with Children's Tylenol Cold formula.
Approximately 10 days after receiving her first dose of Covid19 vaccine, patient began to experience swelling, redness, itching in the vaccination arm.  She treated with ice.
Had vaccination 10/21/08 in PM. Early AM 10/22 noted redness, itch and induration about injection site. Seen and Rxd BENADRYL PO. Yesterday PM. Last noc. patient's wife outlined about a 15-16 cm oval area of redness. Today it is about 8 x 10 cm with associated induration as well as central vesiculation both linear and grouped. Symptomatically also somewhat improved. No evidence infection/cellulitis. No fever/chills. Will continue BENADRYL (none so far today - 10/23/8) 25 - 50 every 6 hours PO PRN. No prior Hx reactions.
Diarrhea, vomiting, back pain, muscle weakness. Started about 3 hours after vaccine. It?s 10:51 pm  on Sunday, June 13, 2021 and still have symptoms.
Two days after my first Moderna Covid-19 vaccination, on 03/05/2021  8am when I woke up my vision was slightly bleary as the day progressed it got worse  at 4pm I had double vision. This lasted 24 hours until the next day.
When I woke up the morning after the shot, I could tell I had a temperature. I checked and it was 101.5. When I had COVID-19, it only got up to 99. I had a headache and felt very ill. I took Tylenol to help with the temperature. The symptoms were consistent throughout the day. The next day I felt a little better. This resolved within 36 hours. My cycle, which is very consistent, has become very erratic.  I noticed my flow is lighter and I have spotting in between. It was almost 5 weeks between which is almost double what it usually is before I got the vaccine. My cycle is routine and punctual, so this is a concern to me. I saw my Naturopathic doctor who suggested I see a Gynecologist. I had bloodwork done on Friday, so I do not have any results yet.
On 10/9/02 employee came to my office with flu like symptoms since vaccine was given on 10/1/02. Achy, chest hurting, fatigue.
High fever 24 hours, weakness 24 hours- couldn't sit or stand, chills, arm pain, muscle pain, tooth pain lasting days preventing eating and drinking
8/7/21 Patient had headache and was tired. 8/8/21 Patient said hives appeared everywhere Patient Felt hyped up patient went to ER - received medications antihistamine + steroids.
Mild fever and rash covering torso and neck that is still spreading to other parts of the body.
Have Congestion/Have stuffy nose; Have Cough; I think it is common cold; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Have Congestion/Have stuffy nose), COUGH (Have Cough) and NASOPHARYNGITIS (I think it is common cold) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Have Congestion/Have stuffy nose), COUGH (Have Cough) and NASOPHARYNGITIS (I think it is common cold). At the time of the report, NASAL CONGESTION (Have Congestion/Have stuffy nose), COUGH (Have Cough) and NASOPHARYNGITIS (I think it is common cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment details reported
Patient stated that she experienced dizziness and shakiness at 9 pm on 08/04/20 in which she received second dose of Shingrix vaccine. She also experienced little bit of dehydration. She experienced shakiness and dizziness the morning after the vaccination (08/05/2020) and felt unconscious/passing out. She went to the ER and there were no findings. She said she also saw PCP as well and doctor related the event to be one of adverse reaction to the Shingrix vaccine.
patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse referring to an unknown age patient. Information about concurrent condition, concomitant medication and medical history was not provided.     On 26-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # S004548, expiration date 12-AUG-2020, therapy type: digital data logger; strength and route were unknown) for prophylaxis. The temperature was 47.3 Fahrenheit and time frame 20 minutes. There was no previous temperature excursion. The call was because of a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician concerning a 21 year old female who in 2008 was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that the patient recently developed abnormal Papanicolaou smear (PAP) with high grade lesions. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Follow up information have been received from the physician who stated that she never had a patient with this adverse event. Additional information is not expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 46 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Achy, fatigue, loss of appetite, loss of weight, I've lost 20 pounds since.
A small 12-year-old male (birthday less than a month earlier), accidentally given the pediatric dose, rather than the adult dose, which he should have received based on his age.
12-29-2005 C/O PAIN LEFT UPPER ARM PER MOM, CHILD CRYING FOR 5 MINUTES. 12-30-2005 C/O INCREASED PAIN, LEFT UPPER ARM RED, SWOLLEN, SKIN TIGHT, HOT TO TOUCH, AFFECTED AREA "THE SIZE OF AN EGG", CHILD CRYING AND "SCARED", ACETAMINOPHEN GIVEN.
Fever of 103.0, large area of redness at injection site on left arm Fever resolved by 12/04/2014, redness remains at injection site on left arm.
A slughtly raised red rash that is warm to the touch appeared 2 days post vaccine, just lower then the injection site on my left arm. It went away after 2-3 days, fading a bit more each day. Then on April 6th, almost 2 weeks post vaccine, the rash appeared again. Warm to the touch, red raised rash. It does not currently itch. It is currently about 2 inches by 2 inches.
Vertigo lasting 1 and a half months.  Fever for 4 days.  Large swollen patch at vaccine site.  Menstrual period lasting  since vaccine,  4 months and counting.
This case was reported by a nurse to a sales representative and described the occurrence of welt injection site in a 4 yr old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The nurse reported that more than one 4 yr old experienced a welt at the injection site following the administration of Infanrix, however, a specific number of subjects was not provided. On an unspecified date on or before 18Jan06, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time following the administration of Infanrix, on an unspecified date on or before 18Jan06, the subject experienced welt injection site. The outcome of the event was not reported. The nurse reported to the sales rep that, this vaccine has caused this reaction (a welt at the injection site).
Patient stated she had a "sensation" in her throat. Patient requested EMS on site. EMS and clinical staff on site attended patient. EMS offered injection of Benadryl and patient refused. Patient refused medical transport. Clinical staff on site monitored patient for additional time until patient was cleared to leave.
Pounding severe headache, intractable vomiting, high blood pressure, high respiration rate, high heart rate. Needing hospitalization 2 days.
feeling foggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling foggy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling foggy). At the time of the report, FEELING ABNORMAL (feeling foggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were provided by reporter  Treatment details were not provided.   Reporter did not allow further contact
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: patient had mild flu like symptoms after 2nd dose that lasted for about 12 hours and started 20-24 hours post vaccine. after the booster, patient's symptoms started about 20 hours later and are still continuing. patient described pain as "shooting pain thru out entire body". patient fainted twice which caused an injury to her ankle. patient is still feeling "off"
THE INJECTION WAS GIVEN TO A PERSON WHO HAS NOT TURNED 18 AS OF YET.
Approximately 24 hours after the first dose of vaccine he began to complain of stiff neck and back pain. Reported he was unable to lift his head or get out of bed.
Patient received a second heart transplant on 7/19/21 admitted on 1/27/22 with cardiogenic shock considered to be secondary to acute inflammatory cardiomyopathy, possible mycocarditis, and rejection. She received 3rd Moderna COVID vaccine on 1/13/2022. She was admitted 2 weeks later on 1/27/22, presenting with chest and abdominal pain, cough, and dyspnea. Her ECHO on 1/27/22 demonstrated a cardiac index of 1.3 L/min/m2 and LVEF = 20-25%; the left ventricular systolic function was severely reduced; the right ventricular systolic function was severely reduced with   moderate to severe mitral regurgitation and severe tricuspid regurgitation. In comparison, her ECHO from 1/5/22, demonstrated a cardiac index of 3.0 L/min/m2 and LVEF = 55%; the left ventricular systolic function was borderline reduced; the right ventricle was normal in size and function with structurally normal mitral valve with mild regurgitation, and the right ventricle was normal in size and function. She also had a PEA arrest on 1/27/22 with ROSC, was transferred to the ICU and a mechanical circulatory support (Impella) was placed with continued dobutamine 5 mcg/kg/min. Biopsy from 1/27/22 demonstrated acute cellular rejection Grade 2.
Seventeen days after the second injection, I noticed a very large lump in my armpit and a smaller one in my neck. I visited my primary M.D. and she thought it might be due to the vaccine, but just to be on the safe side, she ordered ultrasounds of both areas. Results revealed prominent, enlarged lymph node in armpit >2 cm.  Radiologist agreed with doctor that it might be due to vaccine and recommended ultrasounds be repeated in 3 months. I am terrified that this vaccine may have given me LYMPHOMA because I still have these lumps.
Hepatitis B and HPV vaccine trasported to clinic in Brown portable cooler. A vaccine excursion occurred with the brown portable cooler. The temperature on the brown portable cooler went out of range based on Engerix- B and Gardasil manufacturer recommendations. The portable cooler reconditioned and Hepatitis B and HPV vaccine admistered to patient. Manufacturer conatcted by HD representative. Per the Health Department Beaura of Immunization they were advised by GlaxoSmithKline and Merck Sharp & D that the Hepatitis B and Gardsil vaccine was not viable and the patient needed to be revaccinated.
Patient received the vaccine and while waiting for her 15 minute post vaccine observation period, she stated that she felt a cool rush. Patient continued to wait and stated that the cool feeling would come and go. She appeared pale in color and stated she didn't feel well. At this point 911 was called and an ambulance service responded bringing patient to the hospital.
Initial report received on 25 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 3-year-old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3227AA received on 25 November 2008, lot number C3227AA received on 27 January 2009, lot number C3280AA received on 24 March 2009, lot number C3565AB received on 04 January 2010 (routes and sites of administration not reported). The subject developed cough on 29 June 2012, approximately 29 months after the last dose. On 02 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 July 2012 for 2 days. The subject was not hospitalized. At the time of final contact on 18 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to another laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This case was reported by a physician and described the occurrence of an injection site reaction in a 17 month old female pt who received Infanrix. On 5/10/04, the pt received a dose of Infanrix. The physician stated that the Infanrix was injected with a "5/8 inch needle". On the same date, the pt also received an injection of IPOL. One day following the administration of Infanrix, on 5/11/04, the pt experienced a "local skin reaction" at the injection site of Infanrix which was treated with acetaminophen and cool compresses. The immunization series with Infanrix was discontinued. The event resolved on an unspecified date. The physician considered the injection site reaction to possibly be related to vaccination with Infanrix.
Nausea, vomiting, chills, fatigue, body ache, arm soreness starting 1/18 at 12:00 pm
covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Dental surgery NOS on 29-Dec-2022.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting , the patient experienced COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid). At the time of the report, COVID-19 (covid symptoms, sneezing, coughing, more mucous, nausea, malaise, more respiratory problems,results confirmed that he had Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, SARS-CoV-2 test: (Positive) Covid test on10-Jan-2022, and results confirmed that he had Covid on Tuesday, 11-Jan-2022..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
PT WAS ADMINISTERED SHINGHRIX (2ND DOSE) AND PT CAME TO PHARMACY AFTER FEW DAYS STATING THAT HE HAD RASH ON HIS LIPS AND SWELLING IN THE LIPS, PT WAS ADVISED TO CONSULT HIS PRIMARY CARE MD: PT WAS CONSULTED WITH DR AND AS PER MD PT HAD A MINOR REACTION TO THE VACCINATION AND PT WAS FINE AND HIS RASH STARTED GOING AWAY AND SWELLING WAS GONE.
2nd dose was inadvertently administered on day 23.  Patient was scheduled for her second shot on 5/24/21, but came during our clinic on 5/19/21.  The pharmacist did not realize until after the dose was administered that she was 5 days early.
This spontaneous report as received from a health professional refers to a 22 month old patient. On 15-MAY-2014 the patient was vaccinated with MMR II (lot # J013315, expiration date 17-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.