chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received PEDIARIX (batch number 7275T, expiry date unknown). On 29th December 2017, the patient received PEDIARIX. On an unknown date, less than a month after receiving PEDIARIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs to be related to PEDIARIX. Additional details were provided as follows: The patient experienced baseball size redness on the thigh. This case has been linked with case US2018005860 and US2018005859 reported by the same reporter.
COVID-LIKE ILLNESS X 11 DAYS THUS FAR. DYSPNEA, DIARRHEA,  MYALGIAS, WEAKNESS, FAINTNESS.
his sense of taste was very bad; his shoulder, his left leg and his back hurt all night very bad and he experienced a headache; his shoulder, his left leg and his back hurt all night very bad and he experienced a headache; his shoulder, his left leg and his back hurt all night very bad and he experienced a headache; his shoulder, his left leg and his back hurt all night very bad and he experienced a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache), BACK PAIN (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache), TASTE DISORDER (his sense of taste was very bad), HEADACHE (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache) and ARTHRALGIA (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     The patient's past medical history included Surgery (patient had a small surgery 3-4 years ago). Concurrent medical conditions included Diabetes mellitus, Cholesterol and Blood pressure.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache), BACK PAIN (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache) and ARTHRALGIA (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache). On 04-Mar-2021, the patient experienced TASTE DISORDER (his sense of taste was very bad) and HEADACHE (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache), BACK PAIN (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache), TASTE DISORDER (his sense of taste was very bad), HEADACHE (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache) and ARTHRALGIA (his shoulder, his left leg and his back hurt all night very bad and he experienced a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.6 (Inconclusive) 97.6 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer vaccine vial was incorrectly diluted with 1.6ml of sterile 0.9%sodium chloride instead of 1.8ml. Pt was injected with 0.3ml of diluted vaccine. Vaccine administrator was informed of vaccine dilution error as soon as error was realized (after vaccine was administered). Patient was stable after administration and left clinic after observation. Clinic manager and supervising MD were notified on same day. I was advised to report event to VAERS per manager. Patient was not contacted per manager recommendation on 4/30.
Unexpected benefit; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Reporter did not allow further contact
Blotchy rash on face and neck; Could not sleep; Excessive bloating; Gas; Abdominal pain; Diarrhea; Hard to open eyes; Dark urine; Throat congestion; Blister rash on two fingers of left hand about an inch in diameter; Body aches; Very painful arm; Felt like I was hit by a bus; Chills; Headache like a migraine, headache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy. Concurrent medical conditions included Immunocompromised.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form; SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Headache, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment for events included IV fluids that patient received at an outpatient clinic. She also stated that she will not be getting the second dose of the vaccine.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Right thigh "knot" which developed into subcutaneous firm approx. 1.5cm mass with overlying skin dimple.
Patient administered PENTACEL vaccine on 8-9-2017. Developed redness at injection site later the same day. Developed fever 101.5 on 8-10-2017, fussy, sleepy,  water chunky diarrhea and local redness at injection site (golf ball size). Comfort measures(tylenol/advil), encouraged fluids. Per patient's mother, temp is 98.8 on 8-10-2017 @ 5:50 pm. Patient still fussy and still has diarrhea.  Patient refuses liquids except her formula.
Fell down; hurt his knees; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell down) and ARTHRALGIA (hurt his knees) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FALL (Fell down) and ARTHRALGIA (hurt his knees). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of taking for past 2 days. At the time of the report, FALL (Fell down) and ARTHRALGIA (hurt his knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
patient was seated in observation chair felt light head and fell to floor.  Sweaty and disoriented  shortness of breath that resolved within a couple of minutes that  did not require any further intervention.  BP was taken 110/80.  Epipen was not used
Pfizer vaccine 1st dose, Moderna 2nd dose; Two different manufacturers given; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Followup received on 15 Jul 2021:contains no new information
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: S023475; expirationdate: 26-MAR-2022; 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; Sender's Comments:  US-009507513-2009USA006106:
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired vaccine administered beyond MFG exp. date) in a 75-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 001C21A) for COVID-19 immunization. No medical information reported. On Oct 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 13, 2021, patient administered expired product (expired vaccine  administered beyond MFG exp. date). On Oct 13, 2021, administered expired product (expired vaccine administered beyond MFG exp. date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated this was the second dose but not sure. This case linked to MOD-2021-354610 (patient link).
I had excruciating  pain in my left arm and couldn't lift it two hours after receiving the Moderna Covid-19 Vaccine. A raised red rash developed on my left arm six hours after receiving the Moderna Covid-19 Vaccine. At this point my left arm was immobile. I already needed help getting off the couch and out of the bed. 21 hours after receiving the Moderna Covid-19 vaccine I started to develop blisters on my left arm. It was excruciating and uncomfortable. 30 hours after receiving the Moderna Covid-19 Vaccine my blisters developed into 3 huge blisters the size of ping pong balls. I need help getting up and down and getting dressed at this point. 40 hours after receiving the Moderna Covid-19 Vaccine one blister started to leak and the pain became unbearable.  It is a sharp burning pain. As it slowly leaked it would immediately start to fill with more fluid with no end in sight. My left arm is in constant pain and has to be wrapped for leaking fluid and fear of infection.
Information has been received from a physician concerning a female with a history of experiencing aura of blindness and prevaccination anxiety after previous vaccines (unspecified which ones) and no known drug allergies, who on an unspecified date was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 659054/0315Y). Concomitant therapy included MENACTRA. "After receiving the vaccine", the patient started experiencing an aura of blindness and proceeded to have a catatonic movement that went into a seizure. The patient recovered shortly after. No lab tests were performed. The patient did not seek medical attention. Upon internal review seizure was determined to be other important medical events. Follow up information was received from a registered nurse. It was reported that the 16 year old female patient has an allergy to Amoxicillin (hives) and a history of the aura of blindness and feeling strange after her vaccination with ADACEL, 3 summers ago (date not provided). The patient's mother reported that her daughter "last time" (3 summers ago) after she got a vaccine, she experienced the aura of blindness after they got out to the car. She did not loose consciousness, but felt really strange. The patient was administered GARDASIL (lot number 659054/0315Y, Expiration date 13-JUL-2010) on 06-JUL-2009. Concomitant medications included ibuprofen PRN and MENACTRA, also given on 06-JUL-2009. The patient was observed in the physician's office saying she was having an aura of blindness, she could not see and then proceeded to become catatonic and the went into a seizure. The registered nurse reported that she recovered shortly after, and was able to go home with no problems. The registered nurse reported that as far as she knows, the patient had not experienced any more seizure activity since 06-JUL-2009. She further noted that as far as she knows, the patient has completely recovered and that she has not called into the office and has not been in to the office since 06-JUL-2009. Additional information is not expected.
Patient received Tdap after burn injury 8/30/12. Patient returned to clinic 8/31/12 with complaints of fever of 100 degrees F, headache, and pain 4/10 at injection site. Patient does not remember having this type of reaction to tetanus vaccine in the past. Provider advised NSAID & cold compress. F/U phone call on 9/4/12 student reports symptoms resolved.
Patient broke out in bumps all over his body. They started out subtle and after a few days were bright red and all over. They looked exactly like measles and were very itchy and uncomfortable for him. When we brought him to the emergency room they freaked out and put us in a type of quarantine room thinking that he really had the measles. They were finally able to determine that it was a strong reaction to the vaccines. We treated with Benadryl and calamine lotion. He also got RSV at the same time.
Flu like symptoms and malaise and sore arm lasting for about 24 hours   Required acetaminophen to control symptoms
Had Pink eye 2 wks p/MMR; temp 104 & cough; Seen by MD rx'd w/drops for eye; About wk p/1st episode was taken to ER red spot on back, belly, arms, legs, & face; Had sl. inc temp; rx'd Pediazole;
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided)reconstituted with properly stored sterile diluent. The vaccines was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA009124: US-009507513-1812USA009242: US-009507513-1812USA009244: US-009507513 1812USA009241.
Received Dtap to left arm on 9/11/08. Noticed an area of redness 5cm x 5cm with tenderness and warmth to the touch. Reaction started one day later. No fever. Syptomatic treatment advised.
flushing and difficulty talking  Narrative:  Patient had similar reaction previously to tetanus immunization with flushing and difficulty talking/thick mouth
This spontaneous report as received from a registered pharmacist refers to a 28 year old female pharmacist with no drug reactions or allergies and who on 02-AUG-2013 was reconstituting a dose of ZOSTAVAX (lot number not reported) and the vaccine accidentally splashed in an unspecified eye of hers. The pharmacist was experiencing burning of the unspecified eye that the vaccine splashed in. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. The relatedness for experiencing burning of the unspecified eye that the vaccine splashed in the ZOSTAVAX was unknown. Additional information has been requested.
Pt had a scheduled appt at 1235 pm for her 2nd dose of pfizer covid vaccine on 6/4/21 at our store .  Pt stated that she had some "chest tightness" shortly after the first dose (~4/24/21). After reviewing VAR filled out by patient today, I consulted with pt about having a reaction to the first dose.  Pt stated that EMS observed her for 30 minutes after the 1st vaccination and patient self-reports that she recovered without the use of an epi pen (pt does carry an epipen on her at all times) within that 30 minute window and was allowed to leave.  We administered 2nd dose with the understanding that patient recovered from 1st dose with no breathing difficulties or swelling of tongue or throat (just chest tightness as reported by pt).   After administering the second dose today, Pt began to show signs of an allergic reaction ~ 5 minutes after administration  and we administered the epi-pen and  911 was called.  Observed that pt vomited and complained of chest tightness, tight throat , difficulty breathing and being hot and "sleepy" after second shot.  Pt appeared to be alert and oriented and was sitting in a chair.  EMS arrived and pt is now under their care.  We dont know the lot number of the 1st covid vaccination but the lot used today was EW0167 with an expiration of 8/31/21.
A report was received from a healthcare professional on 10/28/2003 concerning a vaccinee of unspecified demography who inadvertently received two doses of Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received two doses of Fluvirin on an unspecified date.  It was not reported if the vaccinee had experienced an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/25/2003 Follow up information received from a healthcare professional indicated that a 79 year old female vaccinee was inadvertently administered Fluvirin on 10/28/2003, having previously received Fluvirin on 10/24/2003.  No adverse events were reported at the time of report.
Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 42 days since fisrt dose of vaccine/missed second dose/Inappropriate schedule of vaccine administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.