chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 09-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day beyond use date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 09-Jul-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. Patient received half dose. The vial did not undergo any temperature excursions. No treatment medications were reported.
Fever with wet sneezing ( may have been aggravated by 2 days of hard mountain biking). Improving after 3 days.
Felt yucky; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt yucky) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 1 wk. In 2021, the patient experienced MALAISE (Felt yucky). At the time of the report, MALAISE (Felt yucky) was resolving.            No relevant concomitant medications were reported. On an unknown date, the patient experienced humira was not lasting/ prescribed weekly dose. Therapeutic response shortened was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) in aspect for Humira of humira was not lasting/ prescribed weekly dose with  humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt yucky with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I am about 6 weeks pregnant. No known complications in this pregnancy, or any previous pregnancies.  On 4/14, 6 days after receiving the Janssen vaccine, I started to break out in an itchy rash at about 5:30pm. It started on my left calf, and over the course of the next couple hours it spread to my left arm (bicep area), right arm (bicep area), right calf and knee, and left thigh. The areas were red, hot, and itchy, with some larger raised welts scattered through the area.   It didn?t seem to respond to Benedryl, but I was able to sleep after liberally applying hydrocortisone cream. It seemed better in the morning, with a few lingering patches by the knees. However, at about 1:30pm it came back, this time mostly covering new places- lower back, shoulders, forearms, stomach.
Information has been received from a physician concerning a 14 year old female patient with no previous history of seizures who in January 2010, was vaccinated with the first dose of GARDASIL (route and lot# not reported). In February 2010, the patient experienced tonic-clonic seizure. On an unspecified date the patient fully recovered from tonic-clonic seizure. Upon internal review, tonic-clonic seizure was determined to be an other important medical event. Additional information has been requested. The patient's sibling also experienced tonic-clonic seizure after receiving the first dose of GARDASIL. (WAES # 1010USA00377).
At approximately 9:00 pm, my left arm began to ache.  I went to bed about 10:30 pm and awoke about 12:00 am with my left arm, left shoulder and left side of my neck in extreme muscle and nerve pain that throbbed with the beating of my heart.  I was unable to move my arm, the pain was so intense.  I managed to get up and take 4 ibuprofen tablets and kept wishing I had ice.  Two hours later, I took 4 more tablets and was able to fall asleep.  The next day, I was unable to use my arm, but the intensity of the pain was gone.  The following day, my arm was still very sore, but I could use my arm a little.
Information has been received from a physician concerning an 8 year old female who on 08-JAN-2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient's mother called the physician's office to report the patient had developed "chickenpox disease." Subsequently, the patient recovered. There was no product quality complaint. Additional information is not expected.
No adverse event; expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose administered).    Concomitant medication was not provided. Number of doses per vials were 35 doses, 4 vials. The vial was initially stored in the refrigerator on 07-Jun-2022. Dates of administration of vaccines were 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. Vial did not undergone any temperature excursion. Treatment information was not provided.
sharp chest pains, constant; pain in neck; tightness in neck; tightness in shoulders; lingering headache; pain on shoulders; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (sharp chest pains, constant), NECK PAIN (pain in neck), MUSCLE TIGHTNESS (tightness in neck), MUSCULOSKELETAL STIFFNESS (tightness in shoulders) and HEADACHE (lingering headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 040A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced CHEST PAIN (sharp chest pains, constant), NECK PAIN (pain in neck), MUSCLE TIGHTNESS (tightness in neck), MUSCULOSKELETAL STIFFNESS (tightness in shoulders), HEADACHE (lingering headache) and ARTHRALGIA (pain on shoulders). At the time of the report, CHEST PAIN (sharp chest pains, constant), NECK PAIN (pain in neck), MUSCLE TIGHTNESS (tightness in neck), MUSCULOSKELETAL STIFFNESS (tightness in shoulders), HEADACHE (lingering headache) and ARTHRALGIA (pain on shoulders) had not resolved.            Concomitant medications were not reported. Treatment medications were not reported.
This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored doses of GARDASIL, lot # K008931, exp. 04-MAR-2017; K010215, exp. 05-MAY-2017; K016966, exp. 10-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects are reported. This is one of two reports received from the same source. Additional information has been requested.
neuralgia; sunburn feeling; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00A2117 and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling). At the time of the report, NEURALGIA (neuralgia) and BURNING SENSATION (sunburn feeling) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Fatigue and very painful headache,  took ibuprofen and a sleep aid, headache resided after about 8 hours and no further fatigue experienced after a good night's rest (9.5 hours of sleep)
Nurse administered 0.5 ml ID instead of 0.1ml ID (gave subcutaneous dose via intradermal route)
First dose - Sore injection spot for 3 days Second dose - sore injection spot for 3 days, tremors for 2 hours, headache/migraine, chills, sweating, restlessness Had severe chest pain and shortness of breath during a jog on June 9th, 2021. Chronic dry cough started after jog. Noticed swollen legs about 1 month after first dose.
Developed maculopapular rash over extremities and abd 7 days after vaccine given TX with Zyrtec 10 mg PO daily.
Patient  received the Pfizer booster vaccine on 11-4-21, patient called on 11-5-2021 at 1030  and reported she developed a rash 1700 on her body except her face, stated rash was itchy and felt warm, patient denied any respiratory distress. Patient states went to the Urgent Care, but was taking long to be seen, she went home and took a benadryl at 1830, patient states rash, itching and and warmth  was relieved with the benadryl, patient states the itchy and  warmth returned at 0830, took benadryl at 0930 and was relieved again.  At 1330 Called patient, patient states going to the Urgent Care now to be seen, patient states does not have the rash.
A spontaneous report, was received from a health care professional  concerning a 88 year-old female patient, unknown race and ethnicity, who was administered two doses of Moderna's COVID-19 vaccine and experienced Inappropriate schedule of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. On 28 JAN 2021, the patient received their first planned dose of mRNA-1273 (batch number: 028L20A), intramuscularly for the prophylaxis of COVID-19 infection. After 13 days on the day of 10 FEB 2021, the patient receive d second dose of mRNA-1273 (batch no : 010M20A) intramuscularly for the prophylaxis of COVID-19 infection. No events or seriousness criteria is reported after the administration. The  health care professional wonders if they should administered a third dose on the right date or not. Action taken for the vaccine mRNA -1273 was not applicable. The outcome of the event, was considered as resolved on 10 FEB 2021.; Reporter's Comments: This case concerns a 88-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot 010M20A), reporting Inappropriate schedule of product administration without any associated adverse events.
Site: Pain at Injection Site-Mild, Additional Details: When I was about to give the vaccine, the vaccine would not come out of the syringe, I threw that one away and adminstered another one, 2 needle pricks occured for this 1 vaccine.
Joint pain in fingers of both hands.  Early pain began with 2nd joint.  After 2-3 weeks, the same pain was experienced in the 1st joints (nearest to finger tips).  Range of motion and strength undiminished.
Within 24 hours of dose, I had low grade fever, headache, and achiness despite being on ibuprofen around the clock.  Sore arm persisted for 5-6 days as well.
Approximately 5 months after my booster shot (Dose 3) I contracted COVID-19 and have the following symptoms:  Sore throat, Body aches, Fatigue, Fever, Coughing, Brain Fog. I called for consultation and was recommended to take Chloraseptic - for sore throat  and Tylenol  - for body aches and fever. The medications did help improve my symptoms.
Pt presented 24hrs after #3 anthrax vaccine c/o large area of redness, sore, swollen of left arm; extending from mid bicep, across elbow to proximal forearm >120cm; nearly circumfrential, but sparing ant-lat strip of bicep approx 2.5cm wide by 8 cm long. Mild axillary adenopathy.  No joint symptoms, no systemic symptoms
low grade fever of 98.6 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 98.6 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (low grade fever of 98.6 degrees). At the time of the report, PYREXIA (low grade fever of 98.6 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported. Denied consent and refused to give any more information.
Patient reports he was diagnosed with "third nerve optical palsy" following his first Pfizer vaccination.
Missed so far about 6 days work, can't move with out fast heartbreak; chest tightness continuous.; pain with deep breathing; fast heart beat; dizziness; shoulder pain left side; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Sep2021 15:00 (Batch/Lot Number: FF3389) at age of 25-years-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none, patient was healthy. There were no concomitant medications. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced chest tightness continuous on 27Sep2021 05:00 with outcome of recovering, pain with deep breathing on 27Sep2021 05:00 with outcome of recovering, fast heart beat on 2021 with outcome of recovering, dizziness on 2021 with outcome of recovering, shoulder pain left side on 2021 with outcome of recovering. Clinical course reported as follow: On 27Sep2021 5am woke up chest tightness, pain with deep breathing, last all week with fast heart beat and dizziness, shoulder pain left side, went to Dr primary on 04Oct2021 blood test, EKG then seen cardiologist on 06Oct2021 for exam, echocardiogram, holster monitor, noted by both physicians as vaccine related. Will not get second dose. Missed so far about 6 days work, can't move with out fast heartbreak, pain, chest tightness continuous. Treatment received on 04Oct2021 for the events. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
Diarrhoea; Fatigue; muscular pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhoea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MYALGIA (non-serious), outcome "unknown", described as "muscular pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache started about four hours later. The next morning (24 hours later) headache, total body muscle aches and pains, swelling, tenderness, burning and itching, and 2x4 inch redness patch at injection site on gluteus maximus
SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 13:00 (Lot number: FL0007) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=FK5618,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=10Nov2021,, prev dose administration time=09:00 AM, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 10Nov2021, when the patient was 7 years old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "SARs-COV2- PCR test via saliva obtained on 10Jan2022 was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive; (22Sep2021) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had received no other vaccination within four weeks of vaccination. The patient had received no other medication within two weeks of vaccination. The patient had not diagnosed with COVID-19 prior vaccination.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax & 10 days p/does fingers got sore & exp sarcoid-type react: acute arthritis w/sarcoid inflammation of lungs;
No adverse event; patient was accidentally give a 4th dose of GARDASIL 9 in 2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 17-DEC-2019, the patient was accidentally given the 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (extra dose administered). The patient experienced no side effects. No additional adverse event was reported.
Late menstrual cycle / no menstrual cycle. Cramping but cycle is extremely late. Not pregnant
pt recv vax; had T of 104-105;apap given & T returned to 102;few hr later went back up; cont apap for 24 hr, finally T stayed down;
No AEs were reported.; Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported.) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs were reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No AEs were reported.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.).    Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.
100mg Docusate Sodium 100mg once daily; 09/10/2021 Mild headache and congestion cough and sore thought. 09/12/2021 Diagnosed with COVID 09/12/2021 infusion therapy 09/15/2021 mild case of COVID one bad day, headache and extreme fatigue and animals help her get out of bed and she had coffee. After the 10 days no issue but had slight fatigue and never ran a fever, never taste or smell during experience headache went away. Not prone to headaches and that one of factors that took see primary, headache had lasted 3 prior to Dr. visit and headache continued after the visit for a week.
I was having dizziness which still persists, it comes and goes in waves without warning. I was also nauseous, I vomited a little bit. I also had brain fog and ear ringing that turned into a clicking.
RASH ALL OVER BODY 3 DAYS AFTER VACCINATION- STARTED ON FACE AS 3 DOTS THEN INCREASED DAILY TO ALL OVER THE BODY. BENADRYL 2.5ML  EVERY 6 HOURS, GO TO ER IF CONDITION WORSENS.
It was like having shingles again for about 36 hours--chills, fever, achiness, fatigue, tenderness of head (where shingles manifested themselves last fall, despite having had the earlier shingles vaccine). Unable to do normal activities for a day. Did not have this reaction to the first dose of the new shingles vaccine.