chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18 month old boy received FLUZONE -Lot U3199AA-, from multidose vial with Thimerosal, also Polio Vaccine -Lot- D0120-2-, and Hep A Vaccines -Lot VAQTA 1604X-. 2 days subsequent to the vaccine he experiences an episode of paralysis in the upper body and a gazing stare. He had opened eyes but would not respond. This episode last approximately 5 minutes. He came out of this "absence seizure" like state very slowly. It took about 20 minutes before he had his normal energy level. EMTs came to the house as the pediatrician had us call 911. We took him to hospital. He was given a neurological examination, and vitals, and EKG. No EEG was done. He was cleared with a Neurologic Consult and D/C to home.   11/09/09 Medical records received for DOS 10/20. Neurology office note. FInal DX; FIrst Seizure. Child fell to ground. limp, eyes deviated laterally(suggestive of focal onset), unresponsive. Pale, discolered around lips. Aroused at 5 min. On hour until completely conscious.  S/p 18 mos vaccines and flu vaccine. Neuro PE WNL. Recommended MRI.   12/9/09 ER recs received for date 10/1/09. DX: seizure, viral syndrome Presenting c/o: parent states pt was playing then became limp x20min, eyes were gazing. Parent states pt had rhinorrhea, cough x2-3days, 1 vomit x10 days ago.
I have a very sore arm, which I expected but I also seem to have a low grade fever and aches in my joints (hands, knees, neck).
Injection site very swollen, very bad headaches for 2 days couldn't get out of bed very bad
Swelling, redness, sore 7-10 days after no treatment at site of injection.
Report 20010077221 describes a 31 year old female who did not seroconvert following receipt of an injection of hepatitis B vaccine. Concurrent medical conditions included a positive response to tuberculin purified protein derivative, depression and environmental allergies to dust, pollen, and leaves. The vaccinee is a smoker. Concurrent medications included isoniazid and sertraline. The vaccinee received hepatitis B vaccine on 07/07/2000. On 08/07/2000 and 01/11/2001, she received Engerix B pediatric rather than Engerix-B adult. The vaccinee received Engerix-B from lot ENG3221A2 on 08/07/2000, and lot ENG3223A2 on 01/11/2001. On 02/14/2001, 34 day sfollowing receipt of the second injection of Engerix-B, antibodies against hep B surface antigen were <2 (positive, >10). Failure to seroconvert persisted as of 05/18/2001. The reporter indicated that the failure to seroconvert following receipt of the second dose of Engerix-B ped. could be associated with lack of efficacy, or could be associated with the pre-existing depression or positive response to tuberculin purified protein derivative, or to therapy with isoniazid or Zoloft.
Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Rash ) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN, AMLODIPINE and TRAMADOL for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced RASH (Rash ). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH (Rash ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient said after 20 -30 min of vaccination, headache, chill, nausea mild symptoms.
PATIENT DESCRIBES "OUTBREAK OF SHINGLES STARTED 3 TO 4 DAYS AFTER VACCINATION, OUTBREAK OCCURRED ONLY INSIDE MOUTH".
I woke up the next morning with a fever and feeling pretty shaky and wobbly. I was tired and slept a lot the first day. The next day I was dry heaving, several times. Many times. I was given a nausea prescription Ondansetron. The next day, I had a flair with my trigeminal neuralgia. Worked with my neurologist to increase my gabapentin intake and alternated with Tylenol. With my IBS, I had a lot of pain and made an appointment with my GI and that eventually went away. I also had different symptoms different days and by 8/28/2021 I was feeling much better. 2 virtual doctor visits.
1. Large indurated, erythematous area at site of vaccination.  Still expanding at time of visit. 2. Headache, dizziness.  Resolved at this time.
About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started racing, my hands started shaking, and I felt dizzy and lightheaded and my hands also felt numb.  The worst of it probaby only lasted 5 minutes.  I felt well enough to drive home but was still lighthead and shaky for about 45 minutes.   An hour later, I feel ok except for a little lightheadedness.
By evening he had trouble walking and get out of chair - little fever - got to bed and felt better in am. Fine now on 9-24-10 injection on 9-21-10.
Onset of lower extremity weakness progressing to complete paralysis of both legs within one week of HPV vaccine. Diagnosed with transverse myelitis. Treated with steroids.
Chills, dizziness in the evening after injection. At about 4:30 am leg pain, chills, pain in injection site, swelling of lymph node in left arm (apple size). 1/6/2022, left arm pain, lymph node swelling has not decreased and lymph node is painful. Also experiencing muscle pain in back, hips and legs.
Patient states she had no immediate soreness or fever.  She states week of 11/11 & 11/18 she had 3 days each week where she felt feverish with a duration of 4 hours but the thermometer didn't reflect fever.  Patient states she developed difficulty walking and extreme muscle pain that got progressively worse.  Patient visited the ER and had an overnight stay.  The patient states she was seen by neurology and rheumatology and had numerous tests.   The patient was treated with steroids.  Patient states the steroids were ineffective.  She got progressively worse and was admitted to the hospital 12/11-14.  She has had to have occupational and physical therapy.  She is improving.  Patient reported to pharmacy on 1/10/20.
Seven days after receiving the shingles vaccine I developed a rash from head to ankles! Despite a Prednisone Pak the rash & severe itching lasted 3 wks, I still have small red dots on my abdomen & some scaly red patches on my back, arm & thigh.
No symptoms or reaction to vaccines; Child was given Kinrix outside the age guidelines. The child was over the age of 6 and Kinrix was given; which they fell outside the window to the get Dtap and should have received Tdap. Supervisor and parents aware. No known reaction.
Tiredness; Poor sleep; Arm Pain; Swelling; Sore throat; Dizziness; Chills; Muscle aches/pains; Nausea; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included vitamin c (NATURES BOUNTY) and HUM pre and probiotics (MANUFACTURER UNKOWN) started on an unknown date for unspecified indication.  On 29Mar2021 at 16:00, the patient experienced tiredness, poor sleep, arm pain, swelling, sore throat, dizziness, chills, muscle aches or pains, nausea and night sweats but no fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events tiredness, poor sleep, arm pain, swelling, sore throat, dizziness, chills, muscle aches or pains, nausea and night sweats was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Patient has blister like rash on tongue and chest area. Rash develop on 8/22/12 at night after the vaccine. Rash on the chest has subsided but still see rash on tongue.
I woke up on 12/18/2021 with cold symptoms. Raw throat and nasal congestion, and muscle aches.
Patient presented to ER on 03/03/2021 with right arm numbness and weakness. He was initially evaluated for stroke. On CT of neck, an aortic dissection was partially visualized. A CT of his chest was done and aortic dissection was diagnosed. He was transferred to IMC for surgery. At surgery, it was discovered that the dissection had been chronic. He struggled during recovery and was eventually discharged to a SNF. Unfortunately, he developed a stroke in the SNF and was brought back to the ER on 03/17/2021. His prognosis is poor and on 03/22/2021 he was discharged home on hospice.
1 hr. after receiving Adacel - felt like needed to clear throat - took inhaler and then better (Albuterol inhaler). Noticed red bump 8/21/07 5x4cm red area - sl. raised - sl. warm to touch. Achy started yesterday AM - no fever - took Motrin to help sl. itchy.
Took both the pfizer covid 19 vaccine and flu (fluzone) shot together on Friday, October 8, 2021. Both vaccines were given in my upper right arm. Starting from that Friday, the day one of vaccination  throughout the Saturday and Sunday (the weekend after the shot) -Low grade fever, fever, chills, body aches; extremely painful, red, itchy and swollen injection site; overall feeling of being unwell, depressed and confused; pain shooting from the upper arm (injection site) up through the neck and back. Called the pharmacy on Saturday morning (the morning after the vaccine) and took Tylenol every 6 hrs and used ice pack as directed by the pharmacy. On the Monday following the vaccine still experiencing pain and more redness around the vaccine site, however mental and physical well-being has improved somewhat. This has not been a good experience for me. And if I would need another booster in the future, I will give it very much consideration. Also I would not take the booster and flu vaccine ever together again as I feel they may have made the adverse reactions somewhat worse.
Patient was 17 when vaccine was administered (authorized for 18 and older). No known adverse events.
Expired Tenivac given to patient/nurse; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 44 years old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U5526AA, expiry date- 15-Dec-2018 via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Expired vaccine used.  It was reported that, gave a vaccine to a patient and then found that it expired 12/15/18.  It was unknown if any adverse event was occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
No symptoms. Patient received bivalent moderna booster when it should have received monovalent as it was patient's first dose.
Information has been received from a physician concerning a 14 month old male who was vaccinated once SC with a 0.5ml dose of varicella virus vaccine live. Last week, on approx 20Jul05, the pt experienced natural varicella. It was noted that he came into the office and had a mild case with a few lesions. No labs or diagnostic studies were done. No product quality complaint was involved. Additional information has been requested.
Patient also stated feeling flu-like symptoms such as chills and fatigue.; This is a spontaneous report from a contactable Other Health Care Professional. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient stopped taking Xeljanz XR approximately 2 weeks ago due to concern of immunosuppressed effect because patient recently completed 2nd dose of COVID-19 vaccine. On an unspecified date in 2021, after vaccination, Patient experienced feeling flu-like symptoms such as chills and fatigue. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available the causal association between the event flu-like symptoms and the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Administered Booster Dose 22 Days Early Due to reading a written 2nd dose date as 08/30/21 in place of 09/30/21
Leg pain in left calf for  a number of days starting almost a week after getting vaccinated. I thought it might be a blood clot (this was e any news of blood clots was known). I had an ultrasound and it showed nothing. But I thought I?d report it anyway.
received first dose in 02March2021, has not received second dose yet; Thyroid tumour; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) and THYROID NEOPLASM (Thyroid tumour) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 02-Mar-2021. Concurrent medical conditions included Breast cancer (The patient states that she has a breast cancer and is scheduled for needle biopsy of thyroid, states she has two tumors). Concomitant products included LETROZOLE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) and THYROID NEOPLASM (Thyroid tumour). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 02March2021, has not received second dose yet) had resolved and THYROID NEOPLASM (Thyroid tumour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy thyroid gland: Needle biopsy of Thyroid stated that there is presence of two tumors..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme pain in the deltoid muscle that has lasted months. Unable to raise arm without extreme pain. Pain is finally tolerable (but not fully resolved) 7 months after receiving the vaccination.
After getting the covid-19 vaccine on 4/6/2021 at 8:00am, by that night I got sick. Headache,nausea, vomiting.Tried to get out of bed and couldn?t because my legs wouldn?t work. Couldn?t turn over in the bed. Was a little better the next day.
A few days prior to 03/02/2021, I was feeling like I was in a trance. I could not think, I could not concentrate, I  could not remember. On 03/02/2021- I went into see my cardiologist for an annual check up.  I was not able to walk very far. It felt like I was going to collapse. The cardiologist put me on oxygen. They checked my oxygen level and my oxygen was below 85. On Saturday, I got real numb in my arm and legs and I called my husband and he took me to the hospital. We thought I was having a stroke. On Saturday,  03/06/2021- at about 2:00PM ET,  My husband took me to the  Hospital Emergency Room and they admitted me to the hospital. The hospital thought I was having a stroke, but that was  not the problem. They never did find out what the problem was. Doctor   saw me in the hospital, my pulmonary doctor had all kinds of tests done,  and exhausted all the test he needed to be done on me, but did not know what happened to me. They discharged me from the hospital on Tuesday afternoon. Treatment: oxygen, they had to increase from 2 to 4. It took about 5 or 6 months for me to stop having the memory, concentration,  and forgetfulness.  Those symptoms slowly came back, but my breathing did not get any better with the oxygen.
pt c/o diarrhea, stomach cramping, h/a, flu like sx;
Patient came in yesterday reporting her reaction to the vaccine that has last greater than one month. Her arm swelled around the injection site and wrapped around her arm. She ended up going to see the doctor and received prednisone to relieve the swelling and pain. The prednisone helped some but her arm is still red with slight swelling over a month later.
No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 19-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
I feel well for 7-10 days and then feel ill for 1-3 days. Low-grade fever, feverish, body and muscle aches, severe headache, fatigue, fainting, weak. I had my first vaccine on 1/14/2021 and my second vaccine on 2/4/2021. I felt ill after my first vaccine, however symptoms wee not severe. After my second vaccine, I became very ill. Vaccine was administered by pharmacy at my place of work.
I had my vaccine Monday. On Tuesday morning I was nauseous and had diarrhea. I had a brief time where I felt very hot, sweaty, nauseous,  my arms felt like pins and needles, and my hearing started sounding muffled or far away.   I drank water, cooled down my arms and face as soon as I could,  and laid down. I felt nauseous the rest of the day and today. I feel ok now. I've never fainted before I'm not sure if that was happening but it was completely unexpected and not listed on vaccine side effects.
Hard, red, swollen, warm to touch and painful. Told him to watch hand, take Tylenol and use cold compresses
Monday the 18th,  I noticed two round circles that looked like targets that were raised, red, hot and itchy that persisted for about 3 days until they went away. I saw my PCP in person and I was prescribed an oral medication.
Within 24hr, I was suffering with terrible tinnitus in both ears. It still has not subsided.
Received ZOSTAVAX injection 3-18-2013 Complaint of arm pain on 12-24-2013 Went to see physician. Prescribed prednisone 1o mg # 30 on 12-24-2013. Still having arm pain on 1/24/14.
Information has been received from a licensed practical nurse concerning a 15 year old female with seasonal allergies, allergy to penicillin, sulfonamide antibiotic, Ceftin, and cephalosporin antibiotics who on 31-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658490/0802U) 0.5 ml IM.  Concomitant therapy included ALLEGRA-D and RETIN-A.  On 31-JUL-2007, 1 hour after being vaccinated, the patient developed hives on her chest, abdomen and back.  Medical attention was sought.  The patient self treated at home with BENADRYL and was fully recovered on 03-AUG-2007.  Additional information has been requested.
TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND EXPIRED ON 1-25-2021.
Fatigue (daily, ongoing) Headache (daily, ongoing) Nausea (comes and goes, but worse over time) Shivers and uncontrollable shuddering (started 4 days ago, worse at night, no fever) Rash on belly (in the last few days)
Got sick with both doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick with both doses) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick with both doses). At the time of the report, ILLNESS (Got sick with both doses) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Injection site is red, hard, warm, and the size of a baseball. She reports it is spreading to her armpits and elbow.