chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling started immediately on the right side of my entire body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling started immediately on the right side of my entire body) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 032B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling started immediately on the right side of my entire body). At the time of the report, PARAESTHESIA (Tingling started immediately on the right side of my entire body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication information was not provided.  Treatment medication information was not provided.   This case was linked to MOD-2021-127235 (Patient Link).
little tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (little tired) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little tired). At the time of the report, FATIGUE (little tired) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant and treatment information was reported by reporter.
2 days after receiving the immunization, rash appeared on legs, arms, torso. Relieved with BENADRYL.
Red, painful to touch, induration on L upper arm at injection site. Advised to apply warm compress to site for 20 minutes at home. If swelling doe snot subside return clinic. Give children's Tylenol for pain.
Pain in my hip started to worsen. It was bilateral hip pain that I had before the shot. Saw a NP and was referred to PT. After that, was referred to orthopedist, who gave me a bilateral steroid injection into my hip bursa. Felt a little better, but only for a short time and continued to get worse. (10/19/2021) Moved and established a new PCP and did blood, urine, and took X-rays. Discovered Avascular Necrosis of Hips. Was given a referral to orthopedic surgery. Have seen two surgeons for preliminary evaluation.
Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (Pericarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (Pericarditis) to be related.    This case was for patient no.5, who experienced pericarditis after second dose of Moderna vaccine.  No concomitant or treatment medications were reported.  This study is based on a cohort evaluation of all adults administered =1 mRNA COVID-19 vaccine, including boosters, in the Agency between 14 December 2020 and 9 October 2022.  From 14 December 2020 to 9 October 2022, 2 184 449 first and 2 036 948 second doses of mRNA-1273 (Moderna) were administered. In addition, 1 156 160 mRNA-1273 booster doses were administered. Among vaccine recipients in our cohort aged 1839 (predominately male, as expected in a cohort), estimated incidence rates of confirmed myocarditis/pericarditis ranged from 0.46 cases per million (for Moderna dose 1, all ages) to 19.76 (Pfizer dose 2, ages 1839). Of the 178 potential safety events identified by the RCA, only 33 were ultimately confirmed following an mRNA vaccine. Potential cases were ruled out after chart review for various reasons. In summary, the incidence of myocarditis or pericarditis in patients was low across >10 million doses of mRNA COVID-19 vaccines (primary or booster doses) administered.   This case was linked to US-MODERNATX, INC.-MOD-2023-734758 (Linked Report).  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender, with no reported medical history, who experienced the serious (due to medically significant) expected, event of Pericarditis, which occurred after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was reported as recovered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow-up received by safety on 27-JUL-2023 has email with full text article that contains significant information: Reporter information, literature information and an updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734758:Same literature (Master case)
The pt received the first and second doses of Lymerix in June, 1999 and July, 1999 respectively.  In August, 1999, the pt experienced myalgia and pain in his buttocks.  The most recent information, received on 09/13/99, reports the condition of the pt is unknown.  No further information is available.
initial arm pain; Felt thirsty; felt like she was out of breathe; Slept for three days; Upper back back like she stood to long; Felt sick; Felt nausea; Had Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days) and BACK PAIN (Upper back back like she stood to long) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache). At the time of the report, PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug used was Bayer Aspirin
Right arm - 35mm x 40mm reddened-raised-hot to touch and itchy. Recommended she talk with her family provider to determine if she needed anything for the itch.
After my vaccine I had to sit and wait for 15 minutes. During this time my face felt tingly. I did not have any swelling or any other symptoms. Just tingling in my face around my mouth and cheeks. My; My arm was very sore for about 24 hours.; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that the 34-year-old female patient who received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer, Pfizer-BioNTech, lot: Paa156051), via an unspecified route of administration on right arm on 22Dec2020 08:00 AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in fourweeks. No other medications in two weeks. The nurse reported that "After my vaccine I had to sit and wait for 15 minutes. During this time my face felt tingly. I did not have any swelling or any other symptoms. Just tingling in my face around my mouth and cheeks. My arm was very sore for about 24 hours". The event started from 22Dec2020 08:15 AM. The patient recovered in Dec2020. No treatment received. No covid prior vaccination. No covid tested post vaccination. Known allergies: Not that I am aware of. The case was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fire (very painful 7 on the pain scale), my phantom pain is going nuts in my missing left forearm and hand (very painful too 7 on the pain scale)
Patient feels metalic taste on the right side of her tongue, along with pain behind the right eye.
This spontaneous report as received from a pharmacist refers to a 29 year old patient of unknown gender, who on 18-FEB-2013, was vaccinated with VARIVAX (merck) (lot # 1101z exp date: 25-AUG-2012) dose 1, 0.5 ml, subcutaneous. No concomitant medications were reported. The Pharmacist states that there was no adverse effects. Additional information has been requested.
pt vomited, became pale &  listless on evening of day recvd vax;  mom took pt to ER where pt appeared well to ER MD who dx immunization react on report;
itching in the midsection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in the midsection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itching in the midsection). At the time of the report, PRURITUS (itching in the midsection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
had vax 2NOV94 afternoon 130PM lt arm hurt immed pain & swelling went down arm 7NOV94 pain is getting worse, can't move arm very well;
Periocular edema. Medication: Hydroxyzine 10 mg/5ml 5mL q 6 hours.
N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Fever over 101 degrees, body muscle twitching, headache, nausea.  This lasted for 24 hours and he is still fatigued.  It was horrific to watch him be so sick.
neck and arm soreness; neck and arm soreness; L supraclavicular lymph nod swelling; This is a spontaneous report from a contactable other HCP (patient). A 35-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via unspecified route of administration in left arm on 27Jan2021, (at the age o f 35-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported as non-chronic (not specified). The patient had no known allergies. 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 concomitant medication was reported as none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 09Feb2021, the patient Initially had neck and arm soreness 12 days post vaccine noted L supraclavicular lymph node swelling. The patient did not receive any treatment for the events. The outcome of the events was not resolved.
No adverse reactions Reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State.)
Moderna vaccine spot do magnet metals such as keys; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Moderna vaccine spot do magnet metals such as keys) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna vaccine spot do magnet metals such as keys). At the time of the report, VACCINATION COMPLICATION (Moderna vaccine spot do magnet metals such as keys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment information was not provided
Information has been received from a registered nurse for a 23 month old male who on 03/02/99 was vaccinated with the Varicella Virus vaccine live SC. On 02/08/00 the patient experienced chickenpox with 8-10 vesicles. Another case was reported with similar symptoms after vaccination with the vaccine live. (WAES000209508) No further information is available.
Pt states she woke up Saturday, 2 days later, and her right eye hurt and was stinging, felt like something was in her eye. She called her eye doctor monday and he advised her that it was very unlikely due to the vaccination.
Following the vaccine on 3/2/2021, I had severe pain at the injection site as well as redness, itching and swelling in that specific area.  I applied an ice pack periodically.   On 3/5/2021, I did take 2-200mg Advil gel caps since the pain, redness and swelling were still present.   By 3/8/2021 the redness at the injection site had faded to a faint bruise-like appearance.    On 3/10/2021 I found what I believe to be a swollen lymph node near (actually located over) my left collarbone.  It's slightly painful to touch, but otherwise it's just a grape-size lump that hadn't been there the day before.   On 3/14/2021 I woke to find redness, heat, swelling and itching at the injection site...the same type of symptoms I experienced on Day 1, but now there is a red ring surrounding the injection site also.  The lymph node is still swollen and painful to touch.    In what I've read, this all seems to be known side effects related to the Moderna vaccine, so I haven't done anything more than wait it out.  But with the renewed appearance of the redness and new red ring effect, I thought I should report it here. My second dose is scheduled to be administer on March 31, 2021.  I'll get that vaccine in my right arm.
Chronic Knee pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient would like to know if it was fine for him to take Aleve or aspirin. The patient had chronic Knee pain in Mar2021. The patient would also wanted to know if she could take steroid injection for knee pain. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Child, muscle pain, fever, fatigue lasting 12 hours  Occasionally Night sweats continue still today
unable to work or leave bed; Felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Peanuts).    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed). On 30-Oct-2021, MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed) had resolved. Not Provided          No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2021-372550, MOD-2021-372550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received, added relevant history, patient details and event details
reports fever 102.7,  headache, nausea, body aches, metallic taste
Left arm Zostavax administration site became warm, swollen and tender approximately 16 hours after vaccine administration.  No fever, chills, difficulty breathing, or numbness or tingling or weakness in left arm.  When seen at Take Care clinic at 3;45 p.m on 10/10/08, the a 5 cm diameter area around the vaccine site was found to be erythemic, tender, warm and swollen. No neurovascular compromise of left arm. Patient is alert, oriented, conversant, and says arm is better today.  140/100, 75, 20, temp: 97.8
starting about one week after the first shot, suddenly one evening, when i leaned over to pick up something off the floor, my head seemed  to want to explode. - a tremendous pain up and behind the right side of forehead.  this continued only in the evenings for a few weeks and gradually started happening earlier and earlier but  never immediately after getting out of bed. and after the onset and gradual shift to include earlier hours in the day, i got the pain when i coughed hard or cleared my throat hard. now, and starting probably in mid july, that pain has gradually reduced until i don't really seem to feel it when i lean over but can feel it slightly when i cough hard or clear my throat hard.
Itchy hives all over my chest and both arms. Palms of my hands and soles of my feet were itchy. Fatigue. Difficulty or weakness while walking up or down the stairs. I was prescribed Prednisone and Benadryl.
No additional AEs were reported; The patient received doses on 4/9/2018, 10/11/2018, and 4/5/2023.; This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to a currently 16-year-old patient of unknown gender. Information of the patient's medical history, concurrent condition and concomitant therapy was not reported.  On 09-APR-2018 and 11-OCT-2018, the patient was administrated hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis. On 05-APR-2023, the patient was administrated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #w011264, expiration date: 05-SEP-2024, strength and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs) were reported.
Extreme right knee pain with swelling and joint stiffness, could not stand up or walk without pain for 5 days, rash formed above knee on day 4. Normal dose of ibuprofen (200mg every 4 hours) ineffective. Increasing dose to therapeutic level (400mg every 4 hours) helped relieve some of the swelling and pain.
Can not sleep/stays awake at night until at least 4 am; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can not sleep/stays awake at night until at least 4 am) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression, Sleep disorder (Sleep), Blood pressure high, High cholesterol and Acid reflux (oesophageal) (Acid reflux).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Can not sleep/stays awake at night until at least 4 am). At the time of the report, INSOMNIA (Can not sleep/stays awake at night until at least 4 am) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Medication for anxiety, depression, sleep, high blood pressure, high cholesterol and for acid reflux.  Treatment information was not provided.
Injection site inflammation; Injection site itchy; Injection site red; Injection site sore to touch and Sore arm; migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced HEADACHE (Headache). On 16-Jan-2021, the patient experienced MIGRAINE (migraine). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine) and HEADACHE (Headache) had not resolved and VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Pt given Pfizer-BioNTech COVID-19 Vaccine 10mcg/0.2ml for 5-11 years old.  Pt is 14 years old.  Inadvertent administration of less than the recommended dose of 30mcg in individuals 12 years old or older.  Notified pharmacy/Pfizer and Pfizer e-mailed information.  Dr. reviewed the information and did not recommend a repeat of another primary vaccination and that booster should be given as recommended by manufacturer and CDC guidance. (Currently Pfizer Bi-valent after 8 weeks)
injections site became itchy, red, swollen, and hot to the touch starting on day 7 after the injection: muscle pain in legs, upper arms, and torso on day 8 and 9 after the injection muscle fatigue and mild nausea on day 8 and 9 after the injection
Local edema, inflammation, and pain around site of injection, extending down to elbow. Swelling decreased after 2 days. Patient is experiencing residual inflammation and pain.
Clinical staff person reconstituted vaccine using sterile diluent instead of correct liquid reagent that is provided in the MENVEO package. Patient was informed and came back to get revaccinated.