chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 19-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.; No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history or conditions, allergy, concomitant diseases and risk factor.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient stated she got Moderna COVID-19 Vaccine Bivalent on 28OCT2022 and she accidentally got another bivalent recently.).    No concomitant medication were reported.  Patient stated she got Moderna COVID-19 Vaccine Bivalent and accidentally got another bivalent recently. Patient did not experience any AEs with any of the vaccines. No treatment information was provided by the reporter.
Information has been received from a physician concerning a 12-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 28-AUG-2006 was vaccinated in the right leg with her first dose of ProQuad vaccine (upgrade process) (lot#654471/0821F). Concomitant therapy that day included Prevnar vaccine (lot# B086S2K). There was no illness at the time of vaccination. There were no adverse reports following prior vaccinations for the patient or siblings. On 11-SEP-2006, the patient developed a fever which lasted for five days and vomited three times. It was reported that the patient developed a three elevated molluscum rashes on the left deltoid and shoulder. The patient turned blue with cold mouth, feet, and hands, and was rushed to the emergency room. On 16-SEP-2006, the patient was pronounced dead. An autopsy was performed and the cause of death was viral myocarditis (life threatening). Additional information has been requested. 2/20/07 Received medical records & autopsy report from provider which reveal patient experienced few molluscum lesions & viral macules on day of vax but was otherwise well.  Seen on 9/16 for fever, rash, vomiting & ear pain for approx 5 days.  Dx w/gastroenteritis & tx symptomatically.  Autopsy Report reveals COD as myocarditis, most likely viral; however, micro studies did not detect virus.  It was felt that the molluscum contagiosum rash was not related to the myocarditis. 3/20/07 Received cardiac path report which reveals lymphocytic myocarditis.  No congenital anomalies or structural damage noted.
Felt SOB, little headache. After getting home, felt more fatigued, tiredness, tingling in throat, eyelids appear darker. Biggest complaint is being tired and fatigued.
Pt has area of 9.5X4 cm on  left deltoid that is reddened and tender to the touch. Pain extends toward left subclavicular area. No numbness or radiation down affected arm reported. Symptoms started within 3 hours of vaccination.
Two days after the injection, pt had increased pain and some swelling on left arm that has continued into today 9.5.23. States when he lifts his arm it hurts. When he touches injection site, area feels firm. Pt did not take any pain medications or iced the area.
Hospitalized (10.21.21);  COVID-19 positive (10.21.21);  Fully vaccinated  Admission Date: 10/21/2021 Discharge Date: 10/24/2021  HISTORY OF PRESENT ILLNESS: 73-year-old female with past medical history hypertension, hyperlipidemia, coronary artery disease, TIA, vaccinated 8 months ago for COVID presenting with worsening shortness of breath.  Found to be COVID positive on 10/21. Patient states that she has been feeling ill since Sunday.  Symptoms have included fever (T-max 101°), chills, shortness of breath, productive cough with green sputum, body aches, vomiting, loss of taste since that time.  Patient has also been experiencing dysuria, urinary frequency and urgency.  States that she recently went to the upper Peninsula this past weekend when she began feeling ill.  Confirms that she was vaccinated with Pfizer vaccine for COVID in January and February. ED course:  Positive for COVID.  Basic labs obtained.  Chest x-ray, CT abdomen/pelvis obtained. Given decadron in ED. Started on supplemental oxygen.  HOSPITAL COURSE: Admitted with COVID and AHRF, also UTI Treated, improved. Discharged on Macrobid
his right fingers were not able to move; right arm numb from time to time; had 3 PFE-BNT shots from Mar-May2021; had 3 PFE-BNT shots from Mar-May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "had 3 PFE-BNT shots from Mar-May2021"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "his right fingers were not able to move"; HYPOAESTHESIA (non-serious) with onset Jan2022, outcome "not recovered", described as "right arm numb from time to time". The events "his right fingers were not able to move" and "right arm numb from time to time" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of musculoskeletal stiffness, hypoaesthesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The morning after the vaccine I experienced severe vertigo for approximately 1 hour. I also experienced tinnitus that started approximately one day after the vaccine and lasted for 3 1/2 weeks. I believe I have had tinnitus for several years, but it has always been extremely mild (I rarely rarely noticed it, if ever, and it never bothered me before). After the vaccine, however, it became noticeably louder and more prevalent. At times the sound would swell and become very loud and disruptive, and then it would fade back to just an annoying background ringing that lasted all day and night. It was bothersome. It was a very high pitch. It started to become faint and less noticeable after 3 1/2 weeks. Sometimes I believe it is still present, but for the most part I don't notice it anymore. I also felt like I had a pressure in my inner ear (felt like there might be liquid in there and seemed like it might be related to the tinnitus). I went to the doctor and she checked my ears and said there was no fluid.
I had my first Pfizer COVID-19 vaccine injection. I have had recent changes to my tinnitus. I had noticing a significant tinnitus spike with ear pressure. That spike is still ongoing after going to my ENT and get a treatment with antibiotics, Prednisolone (steroids), vitamins, the pressure has gone down, but no the spike in the tinnitus.  My second dose of Pfizer is coming in less than a week, and I don't know if I should take it.
fretful on the evening of inj;3PM 7DEC95 pt woke w/high pitched shrill cry;was calmed,then went back to sleep;5PM awoke w/high pitched crying & fever of 101 ax;resp distress;had whelps on head 8DEC95;saw MD was told had a rxn to pertussis
Within 3 minutes after the pfizer vaccine was given, my heartbeat became very accelerated for a few minutes, my blood pressure went up to 143-99. The effect of my heart passed and I went home, and another episode happened where I felt the acceleration softer, that was about 1.5 hours after having the vaccine. The blood pressure remained high all day reaching 173-104. The next day it happened but I started having a headache and today, which is the third day, I only have a little headache for now. I am blood type ab +
Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Stated she could not see clearly or hear well-
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot# K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Developed a rash on her torso which then spread to her back, bum, arms and face. But cleared up within 2 days.
Patient reported feeling itchy on her face and internally, she had severe redness and swelling in her face, the epi-pen was given, and EMS was called, redness and swelling reduced after epi-pen was given, EMS transported to local hospital for further monitoring.
listness; achiness; fever; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (listness), MYALGIA (achiness) and PYREXIA (fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced LISTLESS (listness), MYALGIA (achiness) and PYREXIA (fever). At the time of the report, LISTLESS (listness), MYALGIA (achiness) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-369476, MOD-2021-369492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Patient gender details was updated.
fever; chills; muscle soreness; swollen glands; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medications within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously 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 03Mar2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 20:30 the patient experienced fever, chills, muscle soreness, swollen glands, fatigue and headache. The patient wanted to report it because she experienced so many of the possible side effects. The adverse events had not resulted in a visit to the doctors or other healthcare professional office or clinic visit or emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, chills, muscle soreness, swollen glands, fatigue and headache were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3RD COVID VACCINE GIVEN 9/21/21, PFIZER, LOT # UNAVAILABLE; pt to ED with abdominal pain and requesting staples to be removed; found to be positive for COVID; DKN and renal failure; pt coded and ROSC was achieved; intubated; ICU; pt's condition worsened; DNR, comfort care; palliatively extubated; pt passed away in the hospital
Extreme fatigue; Sneezing; Congestion; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in left arm on 30Mar2021 at 10:00 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included depression and anxiety. The concomitant medications included welbutrin (MANUFACTURER UNKNOWN), celexa (MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 was unknown. Since vaccination, the patient had not tested for COVID-19.  On 30Mar2021 at 12:00, the patient experienced extreme fatigue and some mild cold symptoms like sneezing, congestion, and mild headache. The patient did not received any treatment for the events. The clinical outcome of the events extreme fatigue, sneezing, congestion and mild headache was recovering at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning an approximately 56 day old female with no pertinent medical history and no drug reactions/allergies, who on 07-DEC-2007 was vaccinated po with a "first dose of series" ROTATEQ (lot number: 657514/0667U). Concomitant therapy included: 'routine two month old vaccines". On 07-DEC-07 the patient had two liquid black stools. No further information was provided regarding this adverse experience. No lab diagnostic studies were performed. The outcome was reported as recovered on 08-DEC-07. There was no product quality complaint. Additional information has been requested.
Numbness. On the Neck pain right side. Body ach Chill fever 103.0. My body very hot  exiety Breathing  problem.during vaccine  went away the next day
Information has been received from a consumer who is a company representative concerning her 20 year old daughter who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). The patient's mother reported that the vaccination caused the patient to feel faint, and she experienced nausea with chills and sweating. The patient was kept in the office until she felt better. No further details were provided. Additional information has been requested.
Patient contracted COVID after being fully vaccinated. Patient was in Cardiac Arrest upon arrival to the facility.  Son reports symptoms of fatigue, vomiting, prolonged cough.  Patient woke with left sided facial droop and was cold to the touch.
Third dose given. Staff miscommunication, thought the patient only had 1 dose. Patient was unable to communicate otherwise. No adverse affect has been reported.
swelling inc rt arm, swelling rt side rt breast; patching redness, inc temp @ site of rxn; tx warm packs Ibuprofen rxn started 2 days p/vax;
arm pain; fever of 101; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 101 (High) 101.         No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Achy; Severe chills; Felt very tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous). At the time of the report, PAIN (Achy), CHILLS (Severe chills), FATIGUE (Felt very tired) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not given by the reporter.
This case was reported by a other health professional via sales rep and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and pruritus. The patient was treated with Antihistamines and BENADRYL. On an unknown date, the outcome of the rash and pruritus were unknown. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced rash and non-specific skin eruption. The patient went to urgent care due to rash from vaccine and suggested over the counter antihistamines for itching. Also suggested BENADRYL just at night.
Headache, Myalgia, Fever, CoughWheeze,  chills, soreness at injection site Narrative:  Per nursing report: "Called to report took Covid vaccine on Wednesday [10/6]. Called in yesterday [10/7] and today [10/8]. C/o headache, cough, fever, chills lower back pain yesterday [10/7] and arm soreness."
she had increased pain; This is a spontaneous report received from a contactable health care professional and a consumer. A 70-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications were unknown. The patient previously received tofacitinib citrate (XELJANZ) for rheumatoid arthritis, hydroxychloroquine (PLAQUENIL), celebrex. The patient reported skipping three days of medication when she got her covid-19 vaccine on 01Feb2021. After missing three days, she had increased pain in 2021, which was so bad that she could not function, and lasted for about 1.5 weeks before returning back to normal. MD not aware. When she stopped taking xeljanz for her covid-19 vaccine, she also stopped taking her plaquenil and celebrex. She planned on getting the second vaccine on wednesday and was only holding the medication the day before because she did not want to experience the pain again. MD not aware. The patient was advised to talk with md first. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Fever/running nose/sore throat/congested chest/pain - head - body. Lack of appetite.
Patient came back to the pharmacy on 11-3-15 and wanted to show me the red spot on her arm where the Zostavax was given. The spot was the size of a quarter and very red. She comented that it was sore and felt hot.
Patient felt  chest pain, dizziness, lightheadedness approx 15 minutes after vaccination.  She was taken to the ED on site and patient had normal ECG.  Patient also complained of arm droop (opposite arm from vaccine site) so CT performed which was negative.  Approx 1.5 hours into ED visit, patient complained of nausea, wheezing  which was treated with IM epinephrine, methylprednisolone and diphenydramine IV.
Pt received pneumonia vaccine on 02-02-10 and on 02-03-10 patients right arm from deltoid to just below elbow became red and swollen. Pt received Benadryl 25 mg po one dose.