chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered the Moderna covid19 vaccine to a 15year old teenager; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the Moderna covid19 vaccine to a 15year old teenager) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the Moderna covid19 vaccine to a 15year old teenager). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the Moderna covid19 vaccine to a 15year old teenager) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were reported.
Information has been received from a registered nurse concerning a child patient who on approximately 30-AUG-2010 "week of 30-AUG-2010", was vaccinated with a dose of VARIVAX (Merck) (Lot# 667293/0640Z). Lab diagnostics studies were not performed. Subsequently, on an unspecified date, the patient's area was very red, swollen and painful at injection site. Skin around site was hard and the child was going to see the physician on 03-SEP-2010. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
pfizer (grey cap) was kept in freezer instead of fridge- vaccine given outside of starge requirements
Very bad side effect; Red spots on her skin (all over her body, mostly on her arms); Feeling blisters on her back\ back blisters are "tiny grape" size; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE) and ROSUVASTATIN.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size). At the time of the report, VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-250591.
SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial report received from a consumer or non-health care professional on 05 November 2010. A patient (date of birth, 30 January 1969) had an appointment with an allergist for evaluation of previous "anaphylactic reaction" after vaccination with last years influenza vaccine (trade name, manufacturer name, and lot number unknown) that was received as part of an employee health program. The reporter stated the patient have not been evaluated yet and had no further information to provide since the patient had not received the vaccination at their practice. Recovery status was not reported. The reporter declined to provide contact information for address of facility where he/she was from. Contact information for responsible physician was not identifiable. No further contact information was provided, and no further information is expected. Documents held by sender: None.
This spontaneous report as received from a consumer refers to a 77 years old female patient reporting on herself. On approximately 18-AUG-2011 (reported as "about 3 years ago") the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included prednisone. On approximately 21-JUN-2014 (reported as "2 months ago this coming Thursday") the patient developed an acute case of shingles. Patient sought medical attention. At the time of the report the outcome of developed an acute case of shingles was reported as recovering. Additional information has been requested.
rash; pain; esophagus spasm; sneezing; gas; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PAIN (pain), OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), GUAIFENESIN (MUCINEX), FAMOTIDINE, CYCLOBENZAPRINE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), TRANEXAMIC ACID (XANEXTRA), LEVOSALBUTAMOL (LEVOLIN [LEVOSALBUTAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), BUDESONIDE (PULMICORT), MOMETASONE FUROATE (NASONEX), DICLOFENAC POTASSIUM (VOLTAREN ACTI), METRONIDAZOLE (NORITATE) and MINOXIDIL (ROGAINE).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Feb-2021, the patient experienced OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing), FLATULENCE (gas) and DISCOMFORT (not feeling like herself). On 15-Feb-2021, the patient experienced RASH (rash) and PAIN (pain). On 09-Feb-2021, OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) had resolved. On 10-Feb-2021, DISCOMFORT (not feeling like herself) had resolved. On 22-Feb-2021, PAIN (pain) had resolved. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had a headache and cold symptoms, as well as loss of smell and taste. I never tested positive but my fiancé did so we are confident that I contracted the virus
The next morning body fatigue, joint pains, it felt like a film over my eyes and I was seeing white spots. The first day (9-3) the white spots were constant, the second day they became less severe, It lasted for 3 days.
Other people she knows got the second shot and felt really ill; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Other people she knows got the second shot and felt really ill) 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 at an unspecified dose. On an unknown date, the patient experienced MALAISE (Other people she knows got the second shot and felt really ill). At the time of the report, MALAISE (Other people she knows got the second shot and felt really ill) outcome was unknown. Not Provided          No concomitant medication and treatment information provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.   This case was linked to MOD21-086525, MOD-2021-104003 (E2B Linked Report).; Sender's Comments:  MOD21-086525:Cross linked case MOD-2021-104003:several people after first dose
Woke up with local redness, heat, tenderness, hardened on (R) arm over deltoid. Screened by provider and cleared as strong immune response.
This subject is a 16 week old male, who was admitted to the hospital due to viral syndrome while enrolled in a Immnogenicity Assessment of Daptacel Co-administered with a pneumococcal conjugate vaccine. The subject received the study vaccine on 8/1/03. The subject developed a high fever of 103.5 deg F 33 days post-immunization and was admitted to the hospital on the same day. Treatment included 500mg of Rocephin given IM. The subject was discharged from the hospital on the following day. The subject recovered and continued the trial. The event of viral syndrome was reported by the investigator as unrelated to the study vaccine.
Came to recovery area and within a period of 5 minutes or less complained of a headache. Face became flushed and was taken to lay down on stretcher. BP 142/80, HR 140, RR 20. Patient was given water, Ibuprofen 800mg and Benadryl 50 mg.  BP 135/90, HR 78, SaO2 100% room air. Patient sat up and drank juice and ate granola bar. Patient left at 0925
Pt developed upper body pain 5/17, then back and chest pain 5/18.  + Troponin.  CT showed LMCA and RCA SCAD.  Cardiac MRI showed active myocarditis.
HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 390 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included asthma, diabetes, hypertension, hypothyroid, hyperlipidemia, sleep apnea, arthritis, collapsed spinal disc, lymphedema, allergic to tobacco smoke, and non smoker, and other pre-existing medical conditions included the patient had allergies to non-steroidal anti-inflammatory drugs (nsaids), adverse drug reactions (adrs) to most statins. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Toddler very crabby after immunization for 7 days.  On day 5 developed pustule on right arm that rapidly enlarged with surrounding erythema.
The next morning after I woke up with a fever of 102 and was really cold.  I had SOB which made me go to the ER and was monitored an x-rays and EKG was done and was monitored for about 4 hours and was released
WHEN WALKING OUT OF CLINIC, HAD A SENSATION OF HEAVINESS STEMMING FROM INJECTION SITE ACROSS SCAPULA TO LEFT SHOULDER.  SENSATION DISSIPATED ALMOST IMMEDIATELY. SAME EXACT ONSET 3 DAYS LATER AND AGAIN 1 WEEK LATER.  YESTERDAY (10/14/15), SAME SYMPTOMS, BUT AFTER RADIATED ACROSS SCAPULA, RADIATED ACROSS FRONT OF CHEST AND DOWN RIGHT ARM.  CLIENT FELT A "PANIC" FEELING BUT THAT WENT AWAY AFTER A FEW MINUTES. RN DISCUSSED CONCERNS FOR HEART SYMPTOMS AND CLIENT STATED SHE HAD FULL WORK UP @ CARDIOLOGIST AS PART OF REGULARLY SCHEDULED APPT (FOR UNSTABLE ANGINA).
an expired shot of Tenivac was administered to a patient with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who had an expired shot of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was administered with an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (batch number: U6831AA; expiry date: 08-Oct-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable.  At time of reporting, the outcome was Unknown for the event an expired shot of tenivac was administered to a patient with no reported adverse event.  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.
the white cell count has returned to normal at 5400, but noted that the increase was in cancer cells/ acute on chronic leukemia; he was absolutely exhausted; he had muscular pain for three months; This case was reported by a consumer via call center representative and described the occurrence of acute leukemia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic leukemia.   On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 9 days after receiving Shingrix, the patient experienced acute leukemia (serious criteria GSK medically significant), exhaustion and myalgia. On an unknown date, the outcome of the acute leukemia was unknown and the outcome of the exhaustion and myalgia were recovered/resolved.   It was unknown if the reporter considered the acute leukemia, exhaustion and myalgia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and stated that his white cell count went from 5500 to 8100 nine days after administration of  Shingrix. The patient reported that he was absolutely exhausted and that he had muscular pain for three months. He stated that the white cell count has returned to normal at 5400, but noted that the increase was in cancer cells.  The reporter did not consent to follow up.      Lab Comments: On an unknown date White blood cell count was measured and result was reported as 5400.
Approximately 8 days after receiving the vaccine I experienced a delayed injection site reaction. The injection site became hard, hot to the touch, red, and swollen. The redness was a large solid circle, approximately 2-3 inches in diameter. The site became more painful to the touch and my upper arm was very sore. These symptoms slowly dissipated over 7-10 days but my upper arm is still aching as of today.
01/06/2022: Event occurred after 2nd vaccine.  Patient is a 63-year-old female past medical history extensive with comorbidities presenting for shortness of breath.  Patient had a brief unresponsive episode with brief bystander CPR when EMS arrived they found her to have a pulse placed her on oxygen and she started to wake up.  Patient has wheezing and diminished air movement.  COVID swab found to be positive.  NGI: No abdominal pain, no nausea, no vomiting, no diarrhea. -Remdesivir  -S/p monoclonal antibodies (1/6) -Steroids: Solu-Medrol -Mechanical ventilation
Body rash and continued appearance of bumps, or measles scars mainly on the face and chest bagan. Cognitive skills have declined, and learning has been stunted after vaccination. Other behavioral changes have been apparent such as shortened attention spand and hyperactivity.
4 days after each vaccination, I experienced severe, painful bloating and cramping, diarrhea with  bloody stool and intestinal bleeding in conjunction with inflammation and stranding of descending colon
Mom reports that site of flu shot on right thigh was red, swollen, with knot under skin. treated with Benadryl and Motrin for 2 days.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she gave 20 doses of SHINGRIX so far and 1 patient had flu-like symptoms that came on 10 hours after administration of the vaccine. The adverse event reported to reporter by Inside Sales. The reporter did not speak with the health care professional himself.
Information provided in this adverse event note, is per web report received by Health Department from submitting facility. Covid-19 vaccination information is provided by information that is in Immunization Registry. Pfizer 02/04/2021 EL9264 / public; Pfizer 2/25/2021 EL9267 / public; Moderna 12/01/2021 013F21A / public; Moderna 5/16/2022 038A22A / public PER WEB REPORT RECEIVED: Patient brought into the ED on 10/30/2022 following a fall at home. He fell on 10/29/2022, was able to get up with assistance, but then throughout the next few hours became very weak and was unable to get out of bed. Had COVID symptoms since 10/28/2022. Patient tested positive for COVID-19. Hospital stay was complicated by worsening COVID symptoms, pneumonia, aspiration, NSTEMI, bleeding, need for CBI, and worsening restlessness. Family agreed to hospice care.  Patient to go to Hospice     when possible. Admitted Hospice In-House awaiting bed. Patient?s condition worsened and patient was admitted at 15:10 to Inpatient Hospice ---- Patient died @ 2140 on 11/4/22. Death abstracted received. Death Certificated listed Covid-19 as a contributing cause of death.
Iitching at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. About one or two days later vaccination the patient developed 4 inch diameter area of redness and itching at the injection site.  The redness and itching lasted 3 weeks.  The patient had nothing else to report. The reporter did not consent to follow up. The patient declined to provide email address or contact as their physician was not involved.
I had no  symptoms until 5 hours after recieving the shot, i began to get tired and run a fever  then i became off balance and actually almost fell out of my bed, i had trouble walking straight and was having chills along with nausea and headache. the vertigo became less severe after 3 hours but stayed for about a week afterr the first dose.
red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching; itching; rash; lower entire back was red as can be like I had a sunburn; This is a spontaneous report from a non-contactable consumer (patient).   A 72-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Feb2021 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Feb2021 (also reported as a week ago Monday that afternoon), the patient experienced a bad reaction, lower entire back was red as can be like patient had a sunburn, and bumpy when hands ran over it, and itched like crazy. 02Feb2021 (also reported as by Tuesday and still ongoing), patient had red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching. The patient reported that it goes in streaks, its itchy then it stops and 4 hours later, it was itchy again. The patient wanted to know if she can get the second dose. The patient had an appointment with her doctor and prescribed her with prednisone not related to this issue before seeing her. The patient also reported that with her skin doctor, she went to see him and showed him the rash and said that it was related to the COVID shot and prescribed a salve to apply. The patient spoke to her primary doctor and said that it was not enough salve and prescribed prednisone. The doctor also told the patient that she should go where she got her shot as there as supposed to be people available to treat with something to prepare her for the second dose. Treatment of salve and prednisone was received as treatment of the events. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weird vivid dreams now for 5 nights; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 30Apr2021 at 10:30(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications included butalbital, caffeine, paracetamol (FIORICET) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 30Apr2021, the patient experienced weird vivid dreams now for 5 nights(as reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event weird vivid dreams was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.