chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got a terrible headache for a couple of days after vaccine, stll has slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]), LORAZEPAM and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Feb-2021, the patient experienced HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to 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 4 weeks prior to the COVID vaccine.
reported irritation under the left arm and swollen lymph node that lasted about 4 days. Red circle around the injection site  for 1-2 days. Swelling gone when called today
Pt developed dizziness, nausea and weakness 10min following immunizations. Public Health staff assisted her in lying down HR=60 RR=20 no difficulty breathing, no skin rash. Color was pale and skin clammy. She reported that this may be her "period" coming. She was assisted to an exam room and observed for and additional 30 min BP 98/60 HR 64. She was alert and oriented Gave pt 4 oz of juice. She ambulated from clinic with her mother and brother.
Patient received Moderna vaccine 1/15/21, 2/12/21, and Pfizer on 11/3/21. Presented to ER on 1/27/22 and found to be COVID positive. was admitted on 1/27/2022 presented with shortness of breath, weight gain dyspnea on exertion, leg edema.             Known combined CHF, was on outpatient diuresis.Chest x-ray left pleural effusion marked cardiomegaly.  BNP 815. Echo EF 30-40%.  Cardiology consulted.   AKI on CKD, Creatinine 1.8, baseline 1.5-1.6. Found to have COVID-19 positive, clinically asymptomatic. Vital stable on room air.  No new concerns. Patient is medically stable to be discharged Home on 2/1/22
4days p/vax pt devel nodule, red and itchy rash, spreading from the nodule.
suspected vaccination failure / had the shot for shingles and got the shingles; shingles /had the shot for shingles and got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient got the shingle shot and got shingles. The reporter stated that he/she was not gonna get the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
I have felt very sick since my shingles vaccine (Shingrix). Within about five hours, I had severe flu-like symptoms including: muscle aches, extreme fatigue, nausea, dizziness, lack of appetite and chills. The left arm where I got the vaccine is very sore. Those symptoms have slightly, but not fully, subsided 24 hours after the time of the vaccine. I am still feeling muscle aches, fatigue and dizziness and soreness at the injection site. I have taken Advil a few times since the vaccine, but it has not helped very much.
Fever of 100.4, lethargy, headache, hives. My hives are not completely gone yet. The other symptoms lasted approximately 12 hours.
This spontaneous report as received from a certified medical assistant refers to a 25 year old female patient. The patient did not have any pertinent medical history, drug allergies or concomitant medications. On 03-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L028082, expiry date- 18-SEP-2017, dose 1, 0.5 ml, intramuscular in the left arm. On 03-MAR-2016, the patient experienced pain in the left shoulder and a "cold, frozen shoulder". She was not treated for the same. The patient had come back on 07-APR-2016 for the second dose in series although the physician did not givenher the second dose, instead deferred the vaccination by "one month". No laboratory tests were conducted. No product quality complaint (PQC) was involved. The outcome of events was unknown. The causality assessment was not provided. Additional information has been requested.
Had it twice! Had shots too !/Suspected vaccination failure; Had it twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them twice, it was not fun. The patient had shots too. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
That night the vaccines were administered, patient with apneic and cyanotic episodes as well as eye deviation. Inital EEG with focal seizures, MRI unchanged from NICU. EEG normalized on KEPPRA. Will repeat EEG in 1 month.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Medium, Systemic: Fever-Mild, Systemic: rash on leg, stiffness in neck, back pain, abdomnial cramping, sharp pain in stomach-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: Pt states that other vaccines gives similar stomach side effects
Pt has multiple comorbities, including CH, COPD, and obesity.  He arrived to the ER due to dyspnea and orthopnea.  He was found to be COVID positive.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/14/2021 and 2/12/2021. Presented to ED on 8/16/2021 with complaints of worsening hypoxia after a positive COVID test the previous week from an outside facility. Symptom onset was 8/11/2021. Patient has been on 5L NC at baseline for pulmonary fibrosis. Patient treated with dexamethasone, remdesivir, and highflow oxygen. Patient initially improved after 5 days of remdesivir and 10 days of dexamethasone, but hypoxia worsened starting on 8/30/2021. On 9/3/2021 patient rapidly deteriorated, and expired at 1545 on 9/3/2021.
Pt had mild swelling and muscle twitching in RUE after receiving SQ Zostavax. Pt asked to sit for 10 minutes. After 10 minutes, swelling had seem to go down dramatically, but there were some muscle twitching still seen.
Friday, March 12, I woke up with the same symptoms that I had the Friday before, March 5 which included body aches, head ache and nausea.  About 10:00 am, I started to experience something like knives in my stomach area.  They subsided.  I felt like I must have the flu.  By the evening, I reported to my husband that I might go to Urgent Care the following morning. About 2:00 am on Saturday, March 13 I woke up with what felt like 'knives' around my right lung every time I breathed . My husband drove me to the ER and was later hospitalized for a Pulmonary Embolism. I was released from the hospital on Sunday, March 14.  I had a fever of at least 100 on Sunday,  Monday, Tuesday and Wednesday., with the highest being 101.4.
10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs.  Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's  1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure.  Referred for colonoscopy.  6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL.  Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat.  Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech.   Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis.  1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration.  Tx w/IVF & d/c to home.  2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily.    ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling.  S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF.  Illness lasted approx 1 mo & pt lost 25#.  Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports.  Patches of hair loss, numbness & tingling LEs, intermittent itchy rash.  Referred to Rheum & Endo in addition to further lab studies.  2/3/09 Received PCP medical records of 3/18/08-1/12/09. FINAL DX: Records reveal patient experienced depression, constipation, anal fissure, Depo-Provera contraception, weight gain, stretch marks, URI, pharyngitis, insulin resistance, dysuria, allergies, sinusitis, arthralgia, vomiting, diarrhea, dehydration, intermittent rash, chronic fatigue, pustular scalp lesions, recurrent infections, folate deficiency.  Tx w/antibiotics for RMSF & referred to ID
Muscle cramps; Pain on the back of the legs; pain on the front shins; very painful; Bad; Felt like Jumping up; Cramps on the left thumb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps on the left thumb), MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins) and PAIN (very painful) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE, ZYRTEC LIQUID GEL CAPSULES, NAPROXEN SODIUM (ALEVE) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Mar-2021, the patient experienced MUSCLE SPASMS (Cramps on the left thumb). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins), PAIN (very painful), PAIN (Bad) and PAIN (Felt like Jumping up). At the time of the report, MUSCLE SPASMS (Cramps on the left thumb), MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins), PAIN (very painful), PAIN (Bad) and PAIN (Felt like Jumping up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was  provided.
Information has been received from a physician concerning a 17 year old male who on 23-DEC-1993 was vaccinated with the first dose of MMR II (HSA) (lot number not reported) and on 21-AUG-1996 was vaccinated with the second dose of MMR II (HAS) (lot number not reported). The patient had no fever. On 16-NOV-2009 the patient experienced mumps and on the same date the patient was diagnosed as parotitis. Follow-up information was received which reported that the patient on 22-NOV-2009 developed mumps. On 23-NOV-2009, the patient was diagnosed and was afebrile, and laboratory data revealed that IgM 0.35, IgG 4.43 and serum amylase 172. The patient had parotitis on both sides. At the time of the report, the patient's status was unknown. No further information is available.
pt received vaccine on 6-2-09. on 6-5-09 patient still complains of injection site redness, warmth and itch. i advised pt to take some ibuprofen for the redness and swelling and benadryl for the itch. patient is to notify us if the symptoms stay the same or get worse within the next 24 hrs.
Inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician concerning a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given the vaccine from a vial that was punctured a day before (expired product administered).  The patients' medical history was not provided. Concomitant product use was not provided.  On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the patient was inadvertently given the vaccine from a vial that was punctured a day before.  A single dose was taken out of that vial and put back outside the six-hour window.    Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The event, was inadvertently given the vaccine from a vial that was punctured a day before, was considered resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 41-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013964:same reporter, different patient US-MODERNATX, INC.-MOD-2021-013965:same reporter, different patient
Felt faint after receiving ADACEL sat in exam room for 15- 20 minutes. Felt better, left with father to check out at front desk and passed out hitting head on floor. Taken back to exam room patient was confused and had laceration back of head caused by barrette. Ambulance called and decided to airlift to hospital according to admission notification admitted with syncope and collapse. Information from 60 day follow-up report states: diagnosed with congenital lung qt syndrome. 1/31/06 Diagnosis was listed as syncope and collapse as per VAERS report. D/C med was Nadolol. Review of medical records (hospital records) confirms syncope as reason for admission. Pt c/o HA, emesis x2. Slight head laceration required 4 sutures. Child appeared pale and anxious. .
Lower back pain; Leg pain; Mobility decreased; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced low back pain, leg pain and mobility decreased. On an unknown date, the outcome of the low back pain and leg pain were not recovered/not resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the low back pain, leg pain and mobility decreased to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The patient experienced low back pain and leg pain. The outcome of low back pain and leg pain reported in the system did not match with that reported in the source document. This case is 1 of the 4 linked cases, reported by the same reporter.
I had no trouble with the vaccine. On 05/29/22 I started feeling "off". I tested with a home test and it was positive for COVID-19 on 05/31/22. I had severe coughing, hard to breathe, asthma like condition and hurt due to excessive coughing. I never had a temperature. I used prescribed cough drops to help with the coughing. I had a telehealth visit with my doctor. I was prescribed (unknown name) to help with they symptoms.
Four days after receiving flu vaccine (10/23/2023), patient started feeling pins and needles in his hands and his toes and then started getting weakness. On 10/28/2023, patient presented to emergency room; he got to the point where he could not hold himself up and collapsed as his legs were so weak. Patient was admitted for further work up. Providers believe possible Guillan-Barre syndrome possibly from influenza vaccine. During this admission, patient has received 0.4 g/kg IVIG x5 days (completed 11/2), followed by 7 days of plasmapheresis (completed 11/10). Patient was intubated (11/1) during hospital admission and ultimately received trachostomy (11/7). As of 11/11, patient is still with bilater lower extremity flaccid, although patient reports sensation. Upper extremities +2 off of the bed, but very weak, equal bilateral. Can raise shoulders. Can stick out tongue.
Patient is a worker at the assisted living we was giving boosters doses in.  She was given a 2nd booster, but did not qualify in age as she is 39 years old.
Information has been received from a health professional concerning a 12 month old white female with no known medical history who on 9/13/04 in the AM, was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 647261/1134N). Concomitant vaccination the same day included a third dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 647168/1114N) given IM In the right arm. There was no illness at the time of vaccination. On 9/13/04 at 9 PM, the patient awoke with fever and crying. It was reported that the patient was crying unconsolably for several hours. On 9/14/04 her fever was greater than 103F. The patient was seen by his physician and no other source of infection or illness was found. The patient was afebrile on 9/16/04 and recovered from fever and crying. There was no product complaint involved. No further information is available.
This spontaneous report was received from a Registered Nurse (R.N.) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. The Registered Nurse reported that on 07-MAR-2016, the patient received the first dose of VAQTA (Lot #, expiration date and dose were not reported), and about 3 months after the first dose the patient was vaccinated with the second dose of VAQTA (lot # L007559, expiration date 01-JUN-2017) (dose was not reported) which was too early according to the nurse. There were no concomitant medications reported. No adverse effects reported and there was no PQC involved. Additional information is not expected as there is no consent to consent to contact the reporter.
Armpit swelling, headache, fatigue, all over body itching that began on palms of hands and feet, throwing up bile, and later the skin on my fingers and palms began peeling, as did the skin on the bottom of my right foot.
The next day after patient was administered the vaccine around 1pm, she started to itch under her right under arm bc it was itchy and burning.  Later she noticed rashes on both her underarms. She also noticed rash around buttocks/groin. She took a Benadryl and applied hydrocortisone. I advised patient to stop applying hydrocortisone in her groin area. She also contacted her MD, but MD was closed. I advised patient to call MD the next day, and if it worsens, page the MD.
On 5/17/99, post vax, he experienced injection site soreness. His arm stayed sore for approximately 60 hours then improved. On 5/20/99, he was able to play golf. He developed more generalized body aches and arthralgias. No fever or chills noted by the pt. These symptoms lasted for approximately 12-14 hours and then dissipated.