chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 17-year-old non-pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-OCT-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), for prevention of cervical cancer, and with a dose of an unspecified influenza virus vaccine. On approximately 04-OCT-2014 (reported as "3 or 4 days after administration"), the patient experienced diarrhoea, that lasted for 1 day. On an unknown date, a few months after the vaccination, the patient was feeling anxious, tired and was crying more often. The symptoms lasted for 1 year. Additionally, on an unknown date, the patient experienced flu-like symptoms and she did not feel very well for a few months. Since an unknown date, she had also personality changes. The patient recovered from diarrhoea (on approximately 05-OCT-2014), personality changes, tiredness, not feeling very well, anxiety and crying on unknown dates. The outcome of flu-like symptoms was not reported. The relatedness between all adverse events and GARDASIL was not reported. Additional information has been requested.
pt reports left foot pain that started 1 to 2 hours after 1st moderna dose. It is still painful 4 weeks later.  Can walk but foot is achy.  If hit just right it zings.  Pt has had left foot water retention previously and takes spironolactone for this.  Left foot is achy all the time in arch of foot.  When she pushes off/ positional change it is painful.  She also had headache the night of 1st moderna dose.  Pt had dr appt today. Dr does want pt to get 2nd moderna vax.  Dr thinks she may have been retaining water in foot the day of 1st moderna and vaccine may have intensified symptoms.
On August the 27, 2021, I have a bad bloody nose and on August the 28, 2021, I blew a big blood clot out of my nose and ever since then my voice has been raspy and a little deeper than normal and feels like I am about to get laryngitis sometimes. I called a local HCF and asked if they were doing covid-19 test and they said yes so, I went on September 6, 2021. Once I arrived to HCF they checked my vital, did a throat culture and covid-19 test and they both came back negative. On September 28, 2021, I went to see my PCP and she referred me to an ENT doctor. My appointment with the ENT doctor was October 11, 2021. At my appointment Dr. took samples of my throat and nose and put a scope down my throat. He found irritation in my throat, and it ruled as post-nasal drip. I have follow-up scheduled for November 1, 2021, with the ENT doctor.
PATIENT PRESENTED TO PHARMACY 10/12/18 TO INFORM RPH THAT AFTER RECEIVING VACCINES ON 10/1/18 SHE STARTED TO EXPERIENCE SORENESS IN EACH ARM AS EXPECTED THROUGHOUT THE DAY. IT WAS NOT UNTIL THE NEXT MORNING THAT SHE STARTED TO EXPERIENCE FULLY BODY JOINT PAIN (STATES FULL BODY INCLUDING HER HANDS AND FEET) AS WELL AS WEAKNESS. SHE RECALLS THE JOINT PAIN AND WEAKNESS CONTINUED ON FOR SEVERAL DAYS. VACCINES WERE GIVEN ON A MONDAY. SHE STATES SHE EXPERIENCE THESE ADVERSE EVENTS FROM TUESDAY UNTIL FRIDAY AND IT WASN'T UNTIL SATURDAY MORNING (5 DAYS AFTER) THAT SHE STARTED TO FEEL BETTER. SHE STATES THERE WAS ALSO SOME MILD SWELLING AND RASH AT THE INJECTION SITE BUT IMPROVED OVERTIME.
Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  It was reported that the vials were initially stored in the refrigerator on 16-OCT-2021 and 14 patients were administered with booster doses.
Within 12 hours localized reaction with redness, swelling, lump, hot to touch and extremely painful. Symptoms lasted for 48 hours. After that the area was itchy.
SWELLING AND REDNESS AT INJECTION SITE, MUSCLE SORENESS IN BOTH LEGS AND ARMS. SORE THROAT, SLIGHT HEADACHE AND BACK PAIN. SAW DR THE FOLLOWING MORNING. WAS GIVIN BENADRYL AND TOLD TO USE A COLD ICE PACK TO REDUCE THE SWELLING AT INJECTION SITE. WAS ALSO TOLD TO GO HOME, REST AND DRINK PLENTY FLUIDS. AFTER RECEIVING THE BENADRYL TWO WELTS APPEARED IN FACIAL AREA.
Patient received Moderna 6-11 year old vaccine instead of Moderna 6month-5 year old vaccine. Dose administered was correct at 0.25 mL but the wrong vial was used. Parent has been consulted and is aware of the error.
swollen underarm/armpit lymph node area left sided only; swollen underarm/ armpit lymph node area left sided only; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in the arm left on 19Mar2021 at 10:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to strawberries, cats, horses, hay and intolerance to Vicodin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: Unknown), via an unspecified route of administration in the arm left on 26Feb2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  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 did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) was taken for an unknown indication from an unknown date and levonorgestrel; ethinyl estradiol (AVIANE) was taken for an unknown indication from an unknown date. The patient experienced swollen underarm/ armpit lymph node area left sided only, noticed 24 hours later but still swelling was present. On19Mar2021, headache started around 12 hours, after the vaccine and it lasted for 24 hours (reported as improved with repeated Advil use). It was reported as no longer active. It was reported that the patient did not receive any treatment for the events. The clinical outcome of headache was resolving while that of lymphadenopathy and peripheral swelling was not resolved at the time of this report. No follow-up attempts are needed. No further information was expected.
Sinus headaches chills symptoms like of regular cold feel tired no energy body feel tight when I wake up this morning.
Patient reported being unable to lift arm beginning the evening of 10/1/21 and still experiencing pain on 10/4/21 although able to lift his arm above his head.
3-4 days of high fevers reaching up to 104.5 and as low as 99.9    Rash appeared starting on head and is now working its way down to the feet.  Small red bumps.
Rash-hives, stated between 10PM and 11PM 07/22/2003.
Nausea, dizziness, and chest pain within 10 minutes of immunization.
This spontaneous prospective pregnancy report as received from a 23 years old female patient with none medical history and no drug reactions/allergies refers to herself. On 11-OCT-2013 the patient was vaccinated with the first dose of GARDASIL dose, route and lot # not provided. There were no concomitant medication. The patient was 18 weeks pregnant at the time of vaccination. The patient's doctor was aware that she was pregnant. The estimated last menstrual period (LMP) was 24-MAY-2013, the date of conception 07-JUN-2013 and estimated due date (EDD) 28-FEB-2014. The pregnancy outcome was outcome pending. On an unknown date in October 2013, after receiving GARDASIL, the patient experienced pain in stomach. The patient sought medical attention by her doctor's visit. There were no lab diagnostics performed. There was no treatment given. The outcome of pain in stomach was unknown. The relatedness between pain in stomach and GARDASIL was unknown. Additional information has been requested.
Information has been received from a registered nurse concerning a 5 year old male pt with no significant past medical history and no known allergies who on 10/09/1997 was vaccinated SC in the upper left deltoid with a 0.5 mL dose of varicella vaccine. There were no concomitant medications or concurrent diseases. On 10/13/1997, at the age of 13 months, the pt presented to a local ER for treatment of sinusitis. He was prescribed amoxicillin. On 10/14/1997, the pt's mother called the physician's office to report that the pt had been seen in the ER for sinusitis and a fever. No post vaccination rash was noted. On 09/25/2001, at the age of five year, the pt developed shingles on his left arm. There was no recent exposure to chickenpox and it was reported that the pt was not treated with acyclovir. He was see by two pediatricians and had a dermatology "consult." Vesicular fluid was collected for VZV analysis. On 10/19/2001, information was received that the specimen submitted for analysis on 10/04/2001 was found to be VZV positive. The presence of Oka vaccine strain was identified. The registered nurse reported that the pt was "much better." It was reported that photos were taken. Follow-up information has been received from a completed questionnaire which indicated that the pt's lesions were vesicles and that there had been recent exposure to shingles. The lesions were located on the pt's left arm and upper back. There was no history of chickenpox. A physician noted that the pt had been treated with acyclovir from 09/27/2001 to 10/01/2001. It was reported that no photos were taken. Follow-up info received from a physician indicated that the pt's shingles had resolved. The physician felt that the sinusitis was not an adverse event. Upon internal review, sinusitis was determined to be an incidental finding. No further info is available.
ABOUT 24HRS AFTER RECEIVING VACCINE PATIENT NOTICE THAT VACCINE SITE WAS SORE. UPON OBSERVATION IT WAS NOTED THAT IT WAS SWOLLEN, BLOTCHY RED, SHE ALSO C/O THAT IT WAS ITCHY AND WARM, SHE REPORTED THIS WHILE AT WORK TODAY 11/26/2019  NOON.
swollen under his armpit (on the same arm of the injection); Felt tired; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (Felt tired). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)). At the time of the report, FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. Concomitant medications not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No new information added
After my most recent booster vaccine I mainly had fatigue. However, recently in my chest scan we found one nodule that now must be watched. I thought it was only in one lung however there are two clusters of nodules in both lobes of my lungs and I was diagnosed with Ground Glass Nodules that may represent adenocarcinoma. Further investigation and watching will be continued. For the second nodule of clusters it has been diagnosed with ground glass opacity as well. There may also be an infection that has caused aspiration.  I would also like to note that I have been exposed to many various events of COVID-19 however have not come down with it. I may believe it is due to genetics.
Severe Headache and Nausea, some dizziness lasting approximately 17 days from time of onset.
Pt said vaccine hurt when it was administered, still hurts & has been getting physical therapy for it.
No adverse event; Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022; 1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022) 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 (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022).    No concomitant product was reported. It was reported by a pharmacy staff that 51 doses were inadvertently administered of the monovalent vaccines with lot number 004M21A, expiration date 13-Jul-2022. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Patient states that she began having nausea/vomiting and  headache after receiving vaccine but this resolved 12/30/20. She states that she did notice the day after vaccination that she would have on and off pink ting of her urine when voiding. Advised her to see her provider to rule out UTI...
severe headache, mild fever, chills - Tylenol and Motrin as needed with minimal benefit
Pain in the arm where the injection was administered, fever, chills, nausea, tiredness, pain in the body after 12 hours after the vaccine was administered and up to 36 hours after the vaccine was administered.
After 15minute observation after Moderna vaccine #1.  waited15minutes after the Covid 19 vaccine - I had shortness of breath, great difficulty breathing, and had to stop and lean on cart, as I was breathing very hard, and nearly couldn't breathe. I had confusion, reporting? Epipen?  Tell anyone.  I was not aware of my surroundings otherwise during the episode. Afterwards, I was breathing ok? and went home.  I later called Moderna, and reported this issue. I called the pharmacist, and reported the problem. I called many other pharmacies, asking for advise - ranging from NO do not take the 2nd vaccine (matter of life/death) due to serious reaction to take it & wait longer.
Tongue swelling; lip and cheek tingling; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 14:15 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included auto-immune chronic idiopathic urticaria and bowel disease. The patient had allergies to a large list of medications, foods and allergens (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included several antihistamines and thyroid medication. On 24Mar2021 at 15:45, (approximately two hours after the shot), the patient developed tongue swelling, lip and cheek tingling and shortness of breath. The events did not result in doctor 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 tongue swelling, lip and cheek tingling and shortness of breath was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
2/9 at 4:00pm: moderate headache and ear pressure, arthralgia and myalgia from hips to ankles, moderate chills, moderate injection site pain 2/10 at 8:45am: vasovagal syncope episode, consciousness retained but lost vision and balance; needed fluids and to lay down for about 15 minutes  Initial symptoms from 2/9 are still presiding except for the injection site pain (it's now 2/10 at 6:30pm)
Pt called today and reported that her arm has been sore since the day following the vaccine.  I recommended that she contact her primary care.
Per patient-atypical vaccine reaction. Shortly after administration developed sharp pain down upper arm esp with movement/raising arm. Complaints of achiness down middle of arm/elbow, throbs at times. Unable to sleep on left side. Restricted movement and tender/sore to touch. Patient stated that she thought the vaccine was administered too high on her left arm. She was sent to an Occupational Health Provider and was diagnosed with symptoms of subacromial bursitis. The medical provider was not conovinced the symptoms were related to the injection. She recieved a steroid injection with some relief initially but symptoms have worsened.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Non-Significant Follow up received on 24-Nov-2021 which contains updated contact information
POST VACCINE VARICELLA PUSTULES LOW GRADE TEMP; NO TREATMENT; LET INFECTION RUN ITS COURSE.
I had the Moderna Vaccine (round 1) on Friday 7May at 11:30pm. My arm was slightly sore about 4-6 hours after the injection. No notable reactions on the first or 2nd day.  On 9May I woke up with spasming back pain. I fainted about 6 minutes later and proceeded to have a tonic seizure.  My husband placed me on the floor after I fainted. I was still for 30 seconds then I contracted into a dramatic arch on the floor and emitted a long strange exhalation. During this arching of my back, I was supported by the top of my head and my feet with the rest of my body off the ground. This lasted for 20 seconds. Then, I was unconscious for 60 seconds after this. When I woke I couldn't move my hands and I had loud humming noise in both ears. We called an ambulance. From the time I woke in pain to the time we called the ambulance was 12 mins. I've never had a seizure of any type before this event. Nor do I suffer from fainting spells.
Left shoulder pain, supraclavicular lymphadenopathy, started two days after second dose. One fever day 3, 103 F. Lymphadenopathy remains unresolved on 2/17/2021
night of vaccine became ice cold  with  severe shivering then felt very tired, nauseous and  neck and upper back hurt. body felt warm but still shivering in the evening only. Feel rundown. Symptoms still present  3 days later which is day of report.
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 14-JUL-2014, the patient was vaccinated with a dose of GARDASIL, then on 10-OCT-2014, received other dose of GARDASIL (Lot numbers, dose and anatomical location of administration were not reported) intramuscular. On 27-OCT-2015, the patient would receive another dose. No known adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.