chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel like I have a cold; little itchy at the injection site; big pink area at the injection site; felt sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feel like I have a cold), VACCINATION SITE PRURITUS (little itchy at the injection site), VACCINATION SITE ERYTHEMA (big pink area at the injection site) and VACCINATION SITE PAIN (felt sore at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nasal polyp. Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (little itchy at the injection site), VACCINATION SITE ERYTHEMA (big pink area at the injection site) and VACCINATION SITE PAIN (felt sore at the injection site). On 20-Jan-2021, the patient experienced NASOPHARYNGITIS (feel like I have a cold). At the time of the report, NASOPHARYNGITIS (feel like I have a cold) outcome was unknown and VACCINATION SITE PRURITUS (little itchy at the injection site), VACCINATION SITE ERYTHEMA (big pink area at the injection site) and VACCINATION SITE PAIN (felt sore at the injection site) was resolving.        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.   The patient did not receive any treatment medications.
Shot Received 3:15pm, 5:00 PM noticed hives on midline of back and armpit area. Took 2 Benadryl. Itching subsided went to bed at 7:00pm. No hives in am. Have had flu shots before without incident.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I've tested negative using the nasal swab Antigen test; Positive, notes: I've been concerned about my positive PCR covid test for over a month after my initial positive test; Positive, notes: my PCR test is still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, I have been concerned about my positive PCR covid test for over a month after my initial positive test. I have tested negative using the nasal swab Antigen test but still after a month, my PCR test is still positive.
Possible Breakthrough-Began having signs and symptoms x 2 weeks prior to presenting to ED for cough and SOB. Tested positive for Covid on 7/24 in ED.  Vaccinated for COVID per patient fully in March 2021
Information has been received from a registered nurse concerning a 15 year old female patient who was vaccinated with the first dose of Gardasil. Subsequently, the patient passed out in her car on the way leaving the health department. She had not eaten before this dose. She was fine after being taken to a local restaurant. Additional information has been requested.
Soreness at the area of injection, two days after shot played golf and partner hit the area of injection and its been sore since. No redness or swelling any stretching movement the area of injection sore. Advised call MD patient didn't do any ice or heat to alleviate soreness.
Arm swollen, red, hot to touch. no systemic fever. Treatment ibuprofen PRN.
Patient had redness/rash outbreak and go up shoulder into neck and face. Patient has been administered corticosteroids by his physician.
This is a spontaneous report received from a contactable reporter. A 45-year-old male patient received bnt162b2 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: drug ineffective, COVID-19, outcome unknown and all described as He got the second dose he develop COVID as well after the vaccine/he develop the COVID 3 days after the vaccine. Clinical course: The patient had no prior vaccination. The nurse's husband received the third dose of the vaccine the day prior, and he had COVID/was diagnosed that day. He started developing symptoms after the vaccine the day prior and that day he was very sick, so he was tested positive. But this is not the first time, when he got the second dose, he developed COVID as well after the vaccine. But last time, he developed COVID 3 days after the vaccine. So, the nurse was calling to check if there were any reports of people getting actual COVID after the vaccine. The nurse stated, it's just confusing because he got COVID after the second shot as well and now, and that time, he was tested positive and now today, he was tested positive again. So, it's every time he gets the shot the second and the booster, he got the COVID. No lab test done, and for treatment, the patient took Vitamin C, Zinc and Tylenol, Motrin but not treatment like medicine. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Lower inner face is swelling / sagging; Lower inner face is numb; tongue swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Lower inner face is swelling / sagging), HYPOAESTHESIA (Lower inner face is numb) and SWOLLEN TONGUE (tongue swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING FACE (Lower inner face is swelling / sagging), HYPOAESTHESIA (Lower inner face is numb) and SWOLLEN TONGUE (tongue swelling). At the time of the report, SWELLING FACE (Lower inner face is swelling / sagging), HYPOAESTHESIA (Lower inner face is numb) and SWOLLEN TONGUE (tongue swelling) had not 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 relevant concomitant medication reported.   She took Benadryl in the morning and upper and middle face is better.
they have sore arms; This is spontaneous report from Pfizer Sponsored program. A non-contactable female consumer of an unspecified age reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 01Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arms on an unspecified date. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Caller stated he had problems hearing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Caller stated he had problems hearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Caller stated he had problems hearing). At the time of the report, HYPOACUSIS (Caller stated he had problems hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller called to know the information on booster dose  Patient has hearing problem and on the process of preparing for surgery.it was not clarified whether those problem started before or after the vaccine. Concomitant medications were not provided. Treatment information was not provided.
Information has been received from a physician concerning a 61 year old patient who on 14-FEB-2011 was vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # not reported). On 14-MAR-2011 the patient developed Bells palsy. At the time of the report, Bells palsy was not improved and the patient's status was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Spotted rash; Muscle fatigue; Sore joints; Intense stomach pains; Nausea; Diarhea; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9262), via an unspecified route of administration in the right arm on 18Feb2021 at 15:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and steroids allergy. Concomitant medication included vitamin B complex (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), duloxetine (CYMBALTA) and VITAMIN C (MANUFACTURER UNKNOWN); all for unknown indication from unspecified date. The patient previously received cefaclor (CECLORE) and codeine (MANUFACTURER UNKNOWN); both for an unspecified indications and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6201), via an unspecified route of administration in the right arm on 27Jan2021 at 15:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Mar2021 at 20:00, the patient experienced muscle fatigue, sore joints, intense stomach pains, nausea and diarrhoea. On 12Mar2021, the patient experienced spotted rash and symptoms continued to accumulate. On 15Mar2021, the patient underwent nasal swab test and the result was negative. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events spotted rash, muscle fatigue, sore joints, intense stomach pains, nausea and diarrhoea were not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician via field representative refers to a 12 year old female patient. On an unknown date in June 2012, the patient was vaccinated with first dose of GARDASIL, dose (unknown), intramuscular injection, for prevention of HPV. In approximately August 2012 (also reported as 2 doses 2 months apart), patient was vaccinated with second dose of GARDASIL, lot number H009746, dose (unknown), intramuscular injection, for prevention of HPV. On an unknown date in July 2012, the patient develop interruption in her menstrual cycle that started a month after receiving each dose and patient had spotting during those months. The representative stated that the patient refused the 3rd dose of GARDASIL due to the interruption in her cycle. Patient did not seek medical attention. There was no intervention to prevent serious criteria. No treatment was given for adverse event. On an unknown date September 2012, therapy with GARDASIL was discontinued. On an unspecified date, outcome of events was resolved. Causality was not provided. No product quality complaint was involved. No further adverse event information was provided. Additional information has been requested.
NA, Patient was given 0.5 ml instead of 0.25 ml for a booster
Heavy menstrual period started 6 days after receiving 2nd Covid vaccination that was 15 days from previous start day of last menstrual cycle.   First COVID vaccination was received on 15May2021.  Bilateral breast soreness was also felt for approximately two weeks prior to start of heavy menstrual period.
Pt received moderna vaccine, while her first dose of the vaccine was Pfizer. Pt informed of this and educated on options going forward. Vaccinator given remedial training.
pt recv vax & lab eval by ELISA revealed pt was positive for HIV but eval by western blot showed the pt to be negative for HIV;
First night: arm soreness Second day: arm soreness, fatigue, low grade fever (99.1), nausea
At 5:30 PM: Coughing for one hour, then stopped,  Then lower face felt swollen, lots of thick saliva production, heartburn type of feeling in chest, fast heart rate, entire body hurt.  Redness of eyes.  Entire episode lasted 6 hours and then began to recover.
Extreme fatigue and discomfort throughout entire body.  Tightness in chest, that resembled pericardial pain I have had in the past.  Sinus and respiratory congestion with extreme mucous production. Shortness of breath.  Fever.  Cold sweats, restlessness.  Cough. Tender throat.
No adverse reaction. Patient received the flu vaccine twice  10/19/2020 and 11/24/2020
Shot was received at 6:15pm and symptoms started at 7:30am.  I had a soar arm at injection site.  Severe dizziness to the point I could not walk, headache and joints pains started around 10am while at work. I left work at 1:30pm  When I got home around 2:00pm, I felt tremendous amount of fatigue.  I slept from 2pm until 5:00pm.  I went back to bed at 6:30pm.  During the night I had cold chills and sweated all night until my sheets were drenched.  I slept until 9:30am.  I felt much better after taking a shower. I would not have the second dose!!
Fever, red, swollen thigh around injection site day after injection of pneumovax.  Told lukewarm compresses and Motrin as needed for pain.  Unable to walk 1 day.
Hives; Skin rash covering entire body; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0158) via an unspecified route of administration in the left arm on 22Apr2021 at 13:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desvenlafaxine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN) all for unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 24Mar2021 at 14:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 the patient experienced hives and skin rash covering entire body within 24 hours of receiving the second COVID-19 vaccine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and skin rash covering entire body were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
From initial information received on 5/25/04 from another manufacturer regarding an adverse event occurring in the USA for a case in litigation, it was reported that a male child (date of birth 12/7/99) was diagnosed with mixed receptive-expressive language disorder at the age of 25 months and autism spectrum disorder at the age of 33 months. The patient's vaccine history included the following: on 1/10/00, he received HEP-B GAMMAGEE; on 2/11/00 he received TETRAMUNE and IPOL; on 4/17/00 he received TETRAMUNE and IPOL; on 6/14/00 he received ACT-HIB, DTaP, HEPATITIS B and IPOL; and on 12/29/00 he received MMR, ACEL-IMUNE and IPOL. The dose and lot numbers were not reported. On 12/29/01, at the age of 24 months, he received a dose of ACT-HIB. The dose and lot numbers were not reported. On 2/4/02, at 25 months of age, the patient was diagnosed with delayed receptive and expressive language skills, with an auditory comprehension age of 15 months, an expressive communication age of 16 months, and a total language equivalent of 16 months. On 6/3/02, at the age of 29 months, the patient was tested on the Peabody Developmental Motor Scale and was evaluated at a gross motor age of 18 months to 25 months and a fine motor age of 20 months. On 8/22/02, at the age of 33 months, the patient was administered the Childhood Autism Rating Scale test and was diagnosed with Autism Spectrum Disorder. The patient's recovered status was reported as unknown. The patient's autism and delayed receptive and expressive language skills were considered other important medical events (OMIC).
broke out w/red raised, itchy bumps on body (not a lot, but definitely spread across the entire body, fever, aches, h/a;
Patient reports that when he had a "no take" with 15 jabs of his 1st smallpox vaccine given in Feb 2003, he was given a 2nd dose with 30 jabs approximately one month later (17 Mar 03). He states within a couple days he became severely ill with excruciating headache, high temperature, fatigue and malaise for approximately 2 days. He also had an extremely red and swollen arm where the smallpox vaccine was placed but again had no pustule formation. He believes he never totally regained his good health and high fitness level after this illness, but felt chronically weak and tired and gradually developed abdominal pain, with alternating constipation and diarrhea. This abdominal pain has continued to the present and worsened in 2006. Extensive gastrointestinal workup has been negative. However, he has not had a motility study to rule out gastroparesis or a biopsy to definitively rule out celiac disease.
COMPLAINED OF "FEELING LIKE HEART IS FLUTTERING" . STATED HE DID NOT TAKE HTN MEDICATION.  OBSERVED
DAPT given in left thigh and Comvax given in left thigh on 3/22/04. Non stop crying soon after vaccines given- marked irritability on 3/23/04, developed fever 101.7. No relief in irritability with Tylenol or Ibuprofen. Fine by 3/25/04. Seen 3/21/04 and diagnosed with O.M. Seen by me 3/25/04. TMs clear
(L) deltoid swollen and red. No fever. Resolved after 2-3 days.
The Moderna vaccine vial lot 015B22A which was expired on 12-Feb-2023, was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023; No Adverse Event; 5 patients were given expired doses. Four patients did not report adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were given expired doses. Four patients did not report adverse reaction), PRODUCT STORAGE ERROR (The Moderna vaccine vial lot 015B22A which was expired on 12-Feb-2023, was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were given expired doses. Four patients did not report adverse reaction). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The Moderna vaccine vial lot 015B22A which was expired on 12-Feb-2023, was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were given expired doses. Four patients did not report adverse reaction), PRODUCT STORAGE ERROR (The Moderna vaccine vial lot 015B22A which was expired on 12-Feb-2023, was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (5 patients were given expired doses. Four patients did not report adverse reaction) and PRODUCT STORAGE ERROR (The Moderna vaccine vial lot 015B22A which was expired on 12-Feb-2023, was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023).    No concomitant medication information was provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine The email received enquiring about the Moderna vaccine lot 015B22A which was expired on 12-Feb-2023 administered on 23-Feb-2023 if these doses need to be repeated. reporter states that 5 patients were given expired doses. Four patients did not report adverse reaction. The vial was initially stored in refrigerator on 23-Feb-2023 and administered on 23-Feb-2023  The vial size was unsure if 2.5 ml. It was reported that the vial did not undergo temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715162 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715162:Same reporter (4 patient's case)
HEAVY PERIOD BLEEDING BLOOD COTS. SHE STILL HAS A BLOOD CLOT IN HER BREAST
Chronic hives all over my skin. There are itchy, red swollen bumps that appear randomly on my skin, usually on my back, but it has appeared on legs, butt, back of hands, arms, shoulders, neck, face, pelvis area, etc.  Treatment is taking Zyrtec (orally) every 72 hours. Symptoms reappear before 72 hours.  Symptoms are still ongoing over 4 weeks later.