chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE ADMINISTRATION AT 16 YEARS OF AGE; This spontaneous report received from a consumer concerned a 16 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The drug was associated with Off label use. Age at time of vaccination 16 years old. No concomitant medications were reported. On OCT-2021, the patient experienced vaccine administration at 16 years of age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration at 16 years of age was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000242127.
Received the Polio vaccine less than 24 after the first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine). On 24-Feb-2021, WRONG PRODUCT ADMINISTERED (Received the Polio vaccine less than 24 after the first Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sx onset 7/22/21 with cough, runny nose, chills, fever, headache, fatigue, loss of smell & loss of taste. Tested on 7/25/21 which returned as positive. Tested on 7/25/21 which resulted as positive.
Patient complained of flu like symptoms (low grade fever, sore all over but mostly in joints, very bad headache) and rash at injection site. She states that it was worse than getting the flu and left her wiped out all day.
No reported adverse reaction yet, however patient got a third dose of Moderna Covid-19 Vaccine instead of getting a second dose of Shingrix. Patient did not specify what second dose of vaccine he needed and when he was in the room to get vaccinated he was told that he is getting second dose of Moderna Covid-19 Vaccine and he did not stop the vaccination process. He claified with the technician in th pharmacy window if got Shingrix vaccine right after the vaccination.
Itchy in area of injection. Warm to touch. Checked in mirror. Swollen hive-like, bright red area. Took 25 mg Benadryl. Almost 24 hours later redness has diminished, swelling remains and still warm to touch.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 21-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009113:
pt reports he had swelling and pain in the left arm from the shoulder to the elbow within hours of the vaccines.  he came in within a half hour of talking him on the phone after his daughter called me.  on examination he has cellulitis which is treated with oral keflex as recommended by my medical supervisor.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 37 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice parks for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reported of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse event) and reporter's comment. Amended narrative accordingly.
VAQTA which had expired was given on OCT 26, 2020; No other issues were reported or verbalized; This spontaneous report was received from a certified medical assistant (also reported as (licensed nurse practitioner (LPN)) concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.    On 26-OCT-2020 the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, lot # S024396, expiration date: 12-OCT-2020 for prophylaxis (dose, route of administration, and anatomical location were not reported). No other issues were reported or verbalized combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S024396; expirationdate: 12-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The vaccine was given on 10/04/2022 but the expiration date was 9/30/2022.  Pfizer mfg was contacted and information was received that the "current available stability data demonstrated product quality is maintained for unpunctured vials for 4 days after expiry date".
He is 4 month old boy was in office on 1/12/15 afternoon for first dose of immunization which was done 15 min after shots. Was in office no reaction. Next day parents brought him to office around 13:00 on 1/13/15 and mentioned few min before had roll eyes and mouth opened which be pertussis cause seizure on 1/13/15.
SHINGRIX vaccine - red area about size of dollar bill at injection site in upper deltoid, irregular shape, described by patient as a "scald mark" or "blotch" and is "firm" to the touch, not painful or itchy, no fever.
Redness and inflammation on same arm as vaccination below the vaccination area. Patient seen by physician, did not think it was caused by injection. Prescribed Triamcinolone cream and sulfamethoxazole for 10 days.
Soreness to left arm; a raised, red, bumpy rash all over her body; Itchy rash on Left side of body under breast.; red rash all over her body; bumpy rash all over her body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hydrocortisone and tramadol.   On 10th July 2020, the patient received the 1st dose of Shingrix. On 11th July 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, raised rash, itchy rash, red rash and generalized rash. On an unknown date, the outcome of the pain in arm, raised rash, itchy rash, red rash and generalized rash were recovering/resolving.   It was unknown if the reporter considered the pain in arm, raised rash, itchy rash, red rash and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient received dose late that night, and on next day the patient had soreness to left arm, a raised, red, bumpy rash all over her body, and a very itchy rash under her left breast. The doctor told to the patient not to get the 2nd dose, but the patient wanted to know opinion about this. The reporter conented to follow up.
4/9/21- pain in left arm 4/10/21 to 4/13/21 - body aches and sore 4/13/21 to  4/15/21 - body aches went away, started diarrhea. Eating was normal around 4/13/21 and then ate less because of the diarrhea and stomach aches/cramp increasing 4/15/21 (evening) - ate a bit of sushi, instant diarrhea and vomitting. Vomitted 4 times and 12 times of diarrhea from 18:00 to the next morning. 4/16/21 - vomitting stopped and not really nauseous but still diarrhea. Ate a half banana at night and drank water 4/17/21 - ate half a banana in the morning made me super nauseous but didn?t vomit. Ate a lipton soup for diner, drank water and apple just during the day. Night: slept good from 22:30 to 2:30 and then diarrhea every hour.
-dark bruse with swelling the size of a quarter around injection site, lighter brusing with swelling  approx 2" across, generalized area of swelling 4 inches across measured longitudinally and 6 inches across measured horizontally.  The patient complained of the cotton swab being filled with a yellowish clear liquid and significant tenderness during the night.  Symptoms of pain and tenderness had abated at the time of the report.
Patient is under 18 years old and currently is an employee at a supermarket, we did not realized his age until after we gave him the shot. Pt experience no abnormal adverse effects.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown). On 19th April 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 12 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The healthcare professional (HCP) had no expiry date for the vaccine given. The HCP was unsure if the patient saw a physician who documented the shingles.
On 1/12/2021 around 2 am I started feeling, chills, body aches, headaches, diarrhea & fatigue. They lasted 50 48-72 hours. I took Tylenol for my symptoms. I did have Covid-19 on May 2020.
Fever, chills, covid arm (day 1) followed by itchy and swollen right eye on day 2. Took Tylenol on day 1 and Benadryl on day 2 upon the advice of pharmacist who administered the shot.
They got something flipped up the heart.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart.) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (They got something flipped up the heart.). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Muscle aches started around 10 pm, woke up 1am with fever of 101. 0 and bad headache. Took ibuprofen, fever resolved in approximately 6 hours. Continued to have headache, fatigue and slight dizziness  for 42 hours post vaccine.
Information has been received from a physician concerning a 15 year old female patient with ovarian cyst removed in the past who in "October or November 2010" and in December 2010 were vaccinated with the first and second doses of GARDASIL. Patient did not have any reaction after dose one. Several hours after vaccination with dose two, patient developed facial itching and swelling. Patient also developed lesions on her face and neck. The patient described the lesions as looking like "pimples" which burned and itched. The patient did not seek medical attention and treated herself wit BENADRYL. Patient recovered 5 to 7 days later. Additional information has been requested.
Feel nauseous during the night of March 5,2021. From that time until last week, could not keep anything down including water. Able to eat one meal a day but still feel nauseous every morning until early afternoon.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 04Mar2021 at 15:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure, chronic kidney disease, asthma, fibromyalgia, arthritis and known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received oxycodone (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. On 05Mar2021 at 20:00, the patient began to feel nauseous during the night. From that time until last week before this report, the patient could not keep anything down including water. The patient was then able to eat one meal a day but she still felt nauseous every morning until early afternoon at the time of this report. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event began to feel nauseous during the night and could not keep anything down including water, the patient was then able to eat one meal a day was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received both doses of Pfizer COVID 19 vaccine and presented to the hospital due to her infection. Symptoms:  severe shortness of breath breath and weakness.  Treated with dexamethasone, Mucinex, Benzonatate.
Disruption of monthly menstrual cycle.  Period was due 18-Oct-2021 but arrived 10-Oct-2021.  Patient is a fertile woman with two children ages, who were procreated without medical intervention.
the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number S004548  with expiration date 12-AUG-2020 (dose, route, anatomical location were not reported) for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was exposed at 47.3 degrees Farenthold during 20 minutes. There was no previous temperature excursion. Data digital logger was filled.  This is one of several reports from the same source.  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 ; operatorofdevice: Nurse; 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; Sender's Comments:  US-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
A week after receiving the vaccine the patient began experiencing an itchy rash on the legs. Upon going to the physician, he was diagnosed with shingles.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
pt recv vax 20JUN96 & 9JUL96 pt exp an indented area or dimpling @ inj site;the area was originally 2cm in diameter, but inc in size to approx 5cm;
Received KINRIX 3/24/09 (R) deltoid. Seen 3/26/09 with swelling, erythema, warm to touch no tenderness no induration. Negative node. Ab after vaccine. Local reaction; allergies.
Days after the vaccine, arm is hurting, it feels swollen and is very warm/hot locally
Eleven-year-old patient was inadvertently given Pfizer BioNTech for ages 12+.  Patient should have received pediatric Pfizer BioNTech.
Mom calls initially with fever of 102 at 04:18pm. 04/15/2003 fever up to 103.5 degrees at 12:56 am 04/16/2003, 104 degrees 05:30 am 04/16/2003. Motrin given seen this am 04/16/2003 by no physical findings for fever.
marked rt (from elbow to shoulder) arm edema, erythema site of inj rt;
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA290124 (same reporter). This case involves a five-years-old patient of an unknown gender who received a 0.5 mL dose of IPOL lot P1A171M, expiry date: 30-Apr-2020 via intramuscular route in the right thigh on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation; HEPATITIS A VACCINE for Immunisation; and PROQUAD for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that excursion was 51.8 degrees F for 1 Hour. 101-hours-worth of excursions since 18May - 15Oct. These excursions were not included on one vial of the Unopened and Opened IPOL. There were Two Injections given during the most recent Excursion of 51.8 degrees F. x 1 Hour of the Opened IPOL Vial. It was not reported if the patient experienced any administered or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report was received from a nurse via company representative and refers to 2 female patient at the age between 11 and 12 years old. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as several years ago), the patient were vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On unknown dates, immediately after receiving their vaccines, the patients developed syncope. The outcome of syncope was unknown. The relatedness between syncope and GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA010465.
Information has been received from a nurse practitioner concerning a 22 year old female with unspecified drug reactions/allergies and medical history who on 13-FEB-2009 was vaccinated IM with 0.5ml first dose of GARDASIL (lot number:661531/1311X) and second dose on 6-APR-2009 (Lot number 661952/1129X). Concomitant therapy included hormonal contraceptives (unspecified) and Adderall. Laboratory test were not performed. The nurse practitioner stated the patient received the second dose of the vaccine and experienced swollen glands on the left side of the neck. On 30-APR-2009, the patient went to see her primary care physician with neck pain and then a chiropractor. Subsequently on 6-MAY-2009, the patient came to see the nurse practitioner and she felt that intervention to prevent serious criteria was referring the patient to an ENT physician (Ears, nose, throat physician) to determine if a biopsy was needed. The outcome of the patient was not recovered and she sought medical attention by nurse and physician's office. Additional Information has been requested.  6/2/09 Medical records received DOS 2/13/09 to 5/27/09. FINAL DIAGNOSIS: Lymphadenopathy. Post vaccination reports feeling tired, sits with head turned to left, neck pain. Took several doses of Advil followed by nausea and vomiting. Headaches. Tenderness left lateral neck, palpable lymph node. Later several swollen glands. Chiropractic adjustments. Vaginal discharge. Vaginitis. Vaginal dryness.