chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third 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) at an unspecified dose every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of felt fatigued afterwards Moderna covid-19 vaccinations with Humira was reported as no reasonable possibility.  No treatment medication was provided.
Participant was in observation area when they fainted. Recovered quickly and left on his own accord.
Patient reports muscle was severely painful and stiff starting later in the day of the vaccine which progressed over a few days, then chronically remained stiff and sore with periodic worsening can even limit range of motion.
SINCE SECOND DOSE IN MARCH 2021 THE SHORTNESS OF BREATH, CHEST PAIN, CONSTANT ARM PAIN, LOTS OF FATIGUE. STILL PRESENT TILL THIS DAY. THIS IS NOT LIKE ME I WAS ABLE TO MOVE AROUND AND WORKOUT, CANT DO HALF OF THOSE THINGS ANYMORE.
Client was given Pfizer for her second dose in the series but was given Moderna for the first dose. No adverse reactions noted.
14 hours after injection developed 99 degree fever, chills, muscle aches, fatigue, headache, red eyes, soreness at injection site with a one inch wide red steak half down the left arm from the deltoid. Symptoms lasted 24 hours before beginning to subside; 36 hours to end. the headache was the last to end. Treated with Tylenol, Advil and liquids.
35 y/o WM, who received AVA#2 9/21/2008; was well prior to and day of vaccinations. On 9/22 he developed malaise, fatigue, joint stiffness; on 9/23 he developed fever (no temp taken) & chills; on 9/24 he awoke with severe headache & nausea w/o vomiting; headache was worsened with movement. He did have mild sore throat. On 9/25 he presented to ER and was admitted. Spinal tap was positive for viral meningitis. He was discharged 9/27/2008. As of 9/30 he is headache-free, but continues with mild joint stiffness and intermittent mild fatigue. SM has 2 children ages 2 & 4 y/o who were both ill w/nausea & vomiting from 9/18-9/19-2008 but recovered with 24 hrs. SM received AVA#1, HepB#2, & Flu Mist on 9/7/2008 w/o reactions. Symptoms: Headache, general, Nausea w/o vomiting, Fever, Chills, Fatigue, Malaise <60 Days, Joint Pain, multiple joints. 10/7/08 Reviewed medical records of 9/25-9/30/2008. FINAL DX: viral meningitis Records reveal patient hospitalized 9/25-9/27/08, 4 days s/p anthrax #2, after experiencing malaise, fatigue, joint stiffness, fever, chills, severe HA, nausea, mild neck stiffness, mild sore throat, small injection site nodule w/minimal redness.  ID consult included.  Patient w/2 young children who were ill w/vomiting 2-3 days prior to patient's vaccination.  No reaction to previous vaccines: anthrax #1, Hep B #2 & Flumist received on 9/7/08.
This spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient  was administered with full dose (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
He presented with and was admitted May 27 due to weakness, dysphagia and unable to eat or drink much for several days.  Has pain with eating and drinking. Viscous lidocaine helps.  Found to be in atrial flutter (not new, asymptomatic) with RVR, converted with IV diltiazem bolus in ER. All problems were treated ad patient ready for discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/11/21 2nd dose02/08/21 Diagnosed covid positive:08/17/21 Symptom onset:08/13/21 Exposure: Symptoms:oss of smell/taste, runny nose,
Exactly one week, the injection site became indurated, pruritic, hot, erythematous, about 7 cm in diameter.   Lasted for 72 hours.
Developed varicella rash on 7/24/04--had six classic lesions.  Symptoms resolved in 2-3 days.  Fine now.
approx 5-10 mins p/vax pt became diaphorectic et weak; BP 110/70, P88, R24; pt vomited undigested food; VS p/15 mins; sat up w/ no ill effects;
Patient was 17 years old at time of administration of Moderna Covid-19 Vaccine which is authorized for patients 18 and older.
This spontaneous report has been received from a medical assistant referring to a 11year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
pt girlfriend recv vax pt had chickenpox as a child & 2MAY96 pt devel chickenpox concentrated on chest, thighs, buttocks, & stomach w/a few pox on back;MD & girlfriend felt that there was possible secondary transmission;
pt vax hepta B.  1/2 hr after vax pt's upper mid-back, along w/ shoulder became tight and pt ex. tension in neck.  pt remained in prone position and in approx. 5 hrs sx subsided.
Pt received the vaccine and the following morning awoke with severe headache and fatigue.  Pain in injection site.  Headache lasted for 4-5 days.  She was seen in the office on 02.07.22 for evaluation at which time COVID test was negative.  Advised to take motrin for headache and push fluids.  Headache was improved the following day but not completely gone.
Chronic, debilitating headaches. Intermittent in nature.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 16Apr2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and known allergy to IVP dye and shellfish. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included buprenorphine (BUTRANS) 5mcg patch, tramadol (MANUFACTURER UNKNOWN) 50 mg and lisinopril (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 (at the age of 43-years-old as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced chronic, debilitating headaches which was intermittent in nature and occurred 1-2 times a day. The patient had no prolonged history of headaches of this nature. The patient reported to doctor, however no action was taken except to monitor. The event chronic, debilitating headaches which was intermittent in nature resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chronic, debilitating headaches which was intermittent in nature was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
A non-serious, spontaneous report of administration to pregnant female was received from a health professional concerning a 17-year-old female, subsequent to FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Patient stated that he had some pain at the injection site but has escalated to severe pain from his elbow to shoulder. This limits his ability to use arm.
pt recv vax in rt deltoid arm, laterally outer aspect became red & also on the lt deltoid some pattern of redness as well as rt hand back of fingers;
Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very hot and body below neck felt very chilled. After five minutes these symptoms intensified, feeling hot flushed in face and vision darkened, feeling like a black out may occur. Pharmacist provided water. Symptoms began dissipating after 20 minutes after injection. After 30 minutes, symptoms ended.
pt was bitten by cat on 10JUN96 rt index finger took augmentin x 10 days;recv vax 11JUN96 then 2-3 day later devel lt arm pain & dec ROM;now @ noc has radiating pain & spasm from lt neck, shoulder, hand-paresthesia & numbness
The two locations on the back of my neck where I had been stung by a wasp two months before swelled up again as if I had been stung again by a wasp.  The swelling lasted for 4 to 7 days.  The pain was similar to the lingering pain of a wasp sting.
Pt recvd vax & w/in a few days p/2nd inject had heavier rash appearing to scald skin waist on down;  pt seen by MD 1 month later devel allergies;
got very itchy; redness and a knot(very minimal) that spread across; headache; mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness and a knot(very minimal) that spread across), HEADACHE (headache), VACCINATION SITE PAIN (mild soreness at the injection site) and VACCINATION SITE PRURITUS (got very itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2OA) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), DESVENLAFAXINE, METOPROLOL, ATORVASTATIN, MONTELUKAST and TOPIRAMATE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (mild soreness at the injection site). On 04-Feb-2021, the patient experienced ERYTHEMA (redness and a knot(very minimal) that spread across). On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (got very itchy). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. At the time of the report, ERYTHEMA (redness and a knot(very minimal) that spread across), HEADACHE (headache), VACCINATION SITE PAIN (mild soreness at the injection site) and VACCINATION SITE PRURITUS (got very itchy) outcome was unknown.        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.
Left arm erythema edema localized x 4 days. Started next day. Improving. Pt has taken benadryl and it improved.
Upper arm broke out with vesicles and erythema rash around injection site, the evening (5-6 hours), post vax. Vesicles crusted over and were very itchy.
Woke up with flushed face - hot and red. No temperature or swelling. Resolved itself by the end of the day.
p/ pt recv vax approx 10 days later pt devel varicella w/approx 22 skin lesions, a few were vesicular plus low grade fever.
On 6/7/10 patient broke out in hives all over both of his thighs. The hives were red half circles/odd shapes according to his mother. She took him to ER on 6/7/10. On 6/8/10 mother reports that patient hives are bigger and puffier and are now on his lower legs and ankles too. No fever.
A nurse reported the occurrence of an injection site reaction in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-023).  The subject had no medical history or concurrent conditions.  The subject experienced no adverse events following previous immunizations.  Concurrent medications were unspecified.  On 07/31/2002, the subject received her fifth injection of Infanrix (lot DTPA566B2) administered with a 25-gauge, 5/8 inch needle.  On 08/01/2002, the subject developed an injection site reaction characterized by redness and swelling of her "entire leg".  The reporter stated that the injection site reaction was possibly related to Infanrix administration.  As of 09/30/2002, the outcomes of the injection site was unknown.
2020-10-08 16:30:00   Joint pain, primarily in knees and hips 2020-10-08 18:45:00   Persistent cough, pain in lt upper lung lobe. 2020-10-08 22:30:00   Severe chills and fatigue. Went to bed. Temp: unavailable. 2020-10-09 01:30:00   Fever and chills gone, evidence of diaphoresis while sleeping. Temp: 99.1 F 2020-10-09 08:45:00   Teeth pain. Temp: 99.1 Pain and swelling at injection site. 2020-10-09 11:30:00   Lower sinus and soft palate sensitivity. 2020-10-09 14:15:00   Significant headache involving upper sinus and eustachians bilat. 2020-10-09 18:00:00   All sx greatly resolved. 2020-10-10 10:13:00   No sx.
Per ED physician report, patient left Pediatric office post flu vaccine and began seizing within 30 minutes. Mother took patient to Medical Center Emergency Department. Per ED physician, patient had several seizures and was in the process of transferring to hospital.
Fever, vomiting, diarrhea, swelling of fundus (soft spot) head.
whole body hurts; aching; fever; her head is killing her; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her). At the time of the report, PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) outcome was unknown.            No concomitant medications were reported by the reporter.  The events reported occurred after the second dose.   No Treatment information was provided by the reporter.   This case was linked to MOD-2021-268418 (Patient Link).
SWELLING AND BLISTERS AT SITE OF INJECTION, TENDERNESS AND PAIN WITH ERYTHEMA TO COVER POSTERIOR RIGHT ARM ABOVE THE ELBOW.
Chronic headache, POTS, Babesiosis Lyme disease, Chronic fatigue syndrome, Joint pain.
Inj site: right arm - sore; Nausea; Headache; Felt weak; Body aches; Chills; Fever of 99.6°F; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 99.6°F). On 14-Mar-2021, the patient experienced ASTHENIA (Felt weak), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Inj site: right arm - sore). At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (Felt weak), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever of 99.6°F), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Inj site: right arm - sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.6 f High.         Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked.
hearing loss; Information has been received from a lawyer regarding a case in litigation, referring to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 17-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider due to hearing loss. It was reported that the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of hearing loss was considered to be not recovered. The reporter considered hearing loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of hearing loss was considered to be medically significant.
I had a stabbing feeling in the middle left of my back. I went to the ER to rule out blood clot and the found I had Pneumonitis in my left lung. I had a lot of coughing.
pt recv vax  2JUL95 & w/in a few days p/vax pt exp hives, swollen lips & welts;ER visit was required & pt was treated w/Seldane, Tagamet, Pred;sx cont;
100.8 fever, severe body aches, headache lasting 20 hours.  After 20 hours no fever and reduced severity of body ache and headache
Information has been received from a physician that he heard from a parent of one of his patients who also heard from elsewhere concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. "Some time passed, then she died". The cause of death was not reported. The patient received unspecified medical attention. Died was considered to be disabling and immediately life-threatening. No further information is available.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported It was reported that vaccine administered to total of 24 patients including 15 males and 9 females. HCP reports administrations were mostly for booster shots. No side effects was reported. .
5/16/01 Fever. Up all night. A lot of tossing and turning. Onset of autism.
Chills first night, fever,??.2nd day chills, arm hurt with redness, not Thristy or hungry, very weak , pain in chest area, hard to breath, exploding headache??3rd day..headache continued, pain in legs & skin, continued to get weaker, 4th day..pain in legs & weak, 5th day.. breathing a little better, but any walking breathing is labored.
Patient started to experience pain in left shoulder approximately 20 min. after vaccination. Pain continued and as well as losing ability to the arm. Sought treatment from doctor after 19 days he ordered MRI, patient started on meds. MRI "appeared" "septic" though aspiration showed no puss of bacteria. Doc feels it was possibly injected into bursa. Meds given were MEDROL and Gabapentin.