chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 29-JAN-2018 the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck) VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Extreme fatigue for over a month, had to work from bed for a month, barely left home, parents had to bring food over, increased inflammation, extreme malaise, over a month later and I am just able to work from my desk again
Spontaneous hives all over body, initially. Eyelid swelling, itching all over body. Currently still have chronic spontaneous urticaria, even 3 months after receiving the vaccine.
Directly after vaccine administered, patient experienced shaking and general allergy symptoms. Patient called 1/16 to pharmacy saying that she is now experience chronic sneezing with clear liquid pouring from her face since the vaccine was administerd. Also is experiencing dry heaves that will not stop.
light sensitivity; noises sensitivity,; her head was dazed from noises such as the air conditioner, or other machines; weakness,felt low with energy; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (light sensitivity), HYPERACUSIS (noises sensitivity,), FEELING ABNORMAL (her head was dazed from noises such as the air conditioner, or other machines), ASTHENIA (weakness,felt low with energy) and HEADACHE (headache) in a 45-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.     The patient's past medical history included Breast cancer. Concomitant products included TAMOXIFEN for Breast cancer.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HYPERACUSIS (noises sensitivity,), FEELING ABNORMAL (her head was dazed from noises such as the air conditioner, or other machines), ASTHENIA (weakness,felt low with energy), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, PHOTOPHOBIA (light sensitivity), HYPERACUSIS (noises sensitivity,), FEELING ABNORMAL (her head was dazed from noises such as the air conditioner, or other machines), ASTHENIA (weakness,felt low with energy), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Heart rate: abnormal (abnormal) heart raced a lot, for 30-40 minutes.     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.   Treatment medication information were not reported
pt had what appeared to be sz 3-5 mins p/recvd vax jerking, twitching of head & shoulders; loss of memory & very lethargic p/episode; BP 82/50 denies any previous sz activity;
4-5 hrs p/vax, began w/nausea & had 4-5 bouts of vomiting through the night; This morning is nauseious, but vomiting seems relieved; mildly sore lt arm vax site; "full head"; no fever, h/a, diarrhea knows no one w/similiar sx;
Formation of medium-sized, raised, warm, red patch at site of injection . Noticed it on  02/10, not sure how long it has been present for. I have had a headache today as well (02/10). Not sure if it has anything to do with the rxn
fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
5 days after the vaccine the patient developed left sided facial weakness, tingling, and numbness.
3 days after vaccination: sweating, low grade fever, total body aches, nausea, weakness.
Over 50 vesiculopapular rash in varying stages over face, trunk and extremities. Afebrile and no itching. Exposed to Chickenpox, 2 weeks ago, while babysitting a child who came down with Chickenpox.
Physician called condition "Covid arm". Upper arm sore and paralysis, lower arm purple and sore. Could not hold onto things. MD prescribed a steroid for patient.
12 year old Patient received 5-11 pediatric dose for the second dose. No adverse reactions noted
24 hr post vaccination felt achy, cold, freezing, erythema at ZOSTAVAX site, swelling, red rash, went to urgent care temp 103, tachycardia -> ER IV ANCEF & KEFLEX for home ER again 10/21/12 BACTRIM/ZOFRAN cellulitis diagnosed.
sensitivity in arm at the site of injection; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (sensitivity in arm at the site of injection), CHILLS (chills) and PYREXIA (low grade fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN & MINERAL and COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever). On an unknown date, the patient experienced VACCINATION SITE REACTION (sensitivity in arm at the site of injection). At the time of the report, VACCINATION SITE REACTION (sensitivity in arm at the site of injection), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Patient with COVID vaccines who admitted to hospital with a COVID detected test.  Provider d/c note below:  " Brief Summary of Hospital Stay:  Per HPI, a 95 YO female with h/o paroxysmal atrial fibrillation, CKD III, COPD, dementia presenting to the ED for evaluation of acute hypoxic respiratory failure    Patient unable to provide any history. Entire history obtained via chart review, conversation with caregiver and son. Per caregiver, patient was feeling fine when she came off of her shift yesterday however found to be in significant respiratory distress this AM, was satting in the low 80s upon EMS arrival. Caregiver also states that she had some nonproductive cough ~2 weeks ago which at that time they tested her for COVID and returned positive. Patient reports of shortness of breath but otherwise feeling fine, denies cough, chest pain, palpitation, fever, chills.    In the ED, pt initially placed on BiPAP, later transitioned to 3L O2 with adequate saturation. Lab work significant for WBC 14.7, Hgb 11.6, Cr 1.1, Na 133, BNP 6465. CT chest showing bilateral basilar infiltrates   Hospital Course:  1. Acute hypoxic respiratory failure: due to COVID-19 +/- superimposed bacterial PNA. Pt satting 8-85% on RA, placed on BiPAP with brisk improvement, weaned immediately down to 3L O2. Patient was otherwise hemodynamically stable. WBC 14.7, procal low on admission. Patient was started on empiric ceftriaxone/doxycycline as well as remdesivir, dexamethasone.    2. Paroxysmal a-fib: initially in RVR due to above, responded well to dilitiazem. Patient was restarted on Lopressor (allergic to BB due to ""bradycardia"").  - Continue Xarelto  - Consider decreasing/stopping BB if recurrent bradycardia    3. CKD III - Stable    4. Dementia: mentation appear to be baseline  - Remeron   5. Normocytic anemia - iron supplement    6. S/p TAVR   7. Urinary retention: straight cath PRN"
headache, weakness, dizziness,nausea, vomiting heart palpatations.
Patient reported 30 minutes after having COVID J&J Vaccine noted shortness of breath, stomach pain, mouth and throat itchy called 911, patient was able to control shortness of breath as she has a hx of asthma with rescue her rescue inhaler . The next day patient on 09/23/2021 woke with stomach cramps, no diarrhea, no blood in stool, and hives diffuse across body. Patient on 09/24 went to hospital was started on oral steroids and benadryl. Patient was than followed up with my clinic as her PCM on 27 Sep 2021.
Thursday, Feb 17/11 - Flu vaccine administered in the afternoon, approximately 1430 or 1500 hrs by RN. Associate reports feeling pain from injection site to her elbow initially following. Thursday, Feb 17/11-Associate developed s/s hives and lip swelling after supper that evening. Associate reports she did not eat anything different than she has eaten before and the only new event was receiving the flu vaccine that afternoon. Friday, Feb 18/11- Associate reports continued hives, with lip and hand swelling. Associate states she took BENADRYL 25 mg orally at 1330hrs. Associate into Hospital-Occupational Health Services to see work comp provider, given KENALOG 40 mg IM at 1525hrs for continued lip swelling and hives. Friday, Feb 18/11-Associate reports she developed increased swelling to lips and hands at 1730 hrs and took BENADRYL 2 tabs. She also report feeling like she had a tight airway and a cough and took her Albuterol Inhaler. She described her palms of hands feeling like "they were on fire" and had painful wrists. Saturday, Feb 19/11-Associate states she woke up at 0000 hrs, feeling like she was on fire, had blotch-like hives to arms, eyes, ears, face, neck under breasts, stomach, low back and also to pubic area and knees. She continued taking BENADRYL 2 tabs every 4 hours on Saturday. She reported feeling an ear ache with swollen ear canals, however, later in the evening felt like the symptoms were starting to resolve. Sunday, Feb 20/11-Associate reports she continued BENADRYL 2 tabs every 6 hours. She states her hands started to decrease in swelling, but continued to itch. Thursday, Feb 24/11-Associate reports single, occasional hive eruption with itchy palms, is able to wear her wedding ring again and overall feels much improved. She states she notices that skin redness remains for 10 minutes after scratching itchy areas. Work Comp provider reviewed case and determined probable allergic reaction to influenza vaccine. Seen in office for follow up visit 4/15/11. All symptoms resolved.
I woke up on Saturday (4/24) and noticed a red circular spot near my injection site that was about 2 inches wide. As the day went on it it became a little hot to the touch and raised. I'm reporting this on Monday (4/26) and it is now less red, but has grown to about 4 inches in size and more oblong shaped.
got very sick from the last one; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got very sick from the last one) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In December 2021, the patient experienced ILLNESS (got very sick from the last one). At the time of the report, ILLNESS (got very sick from the last one) outcome was unknown.            No concomitant medication were reported.  Patient stated that she got very sick from the last one that patient took in December 2021. Patient received Moderna booster on 11-NOV-2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-674381 (Patient Link).
Information has been received from a woman in a physician's office and a physician concerning a 6 year old female with no past medical history or allergies who on 09/10/1996 was vaccinated with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 01/25/2002 the pt developed 20 pox lesions which were scattered all over the body, including the genital area. The pt was seen at a physician's office. Additional info has been requested.
This spontaneous report as received from a pharmacist refers to a 18 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was inadvertently vaccinated with a fourth dose of GARDASIL 9 (dose, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
I began having skipped heart beats 5 days after receiving the covid vaccine from Moderna.  I have never had these before this time and I continue to have them almost everyday.
My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization.  The patient medical history included food allergy from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.
7/4/12 Patient came in with redness & swelling & a bump at and around injection site. She said it was warm to touch. 7/5 improvement ZYRTEC HS & QDRYL topical bump smaller & redness decreased.
PER PATIENT, THE PATIENT HAD A LOCALIZED REACTION TO THE SUBQ IMMUNIZATION OF ZOSTAVAX. PAINFUL AND SWOLLEN. THE PATIENT WENT TO THE DOCTOR AND RECEIVED A MEDROL DOSE PACK.
Information has been received from a nurse practitioner concerning a 59 year old male who on 27-MAR-2007 was accidentally vaccinated with a dose of varicella virus vaccine live (Oka/Merck), instead of zoster vaccine live (Oka/Merck), (duration, dose and indication not reported). As of 27-MAR-2007, no adverse effect was reported and the wrong drug was administered by mistake. This was not a product quality complaint. This was a nursing error. Additional information has been requested.
After receiving vaccine, patient sat down for the 15 minute observation. He reports about 1-2 minutes after sitting down feeling flushed, lightheaded. Patient's color pale. EMS on site and took over triage of patient. BP 83/50, P 58-60. Patient reported eating a bar before coming. His blood sugar 111. Patient was given water to drink. BP increased to 100/62, color returning, still pale. He reports feeling better. He stood and sat in a w/c to take to the stretcher for additional observation. Patient ate a pack of peanut butter crackers, drank 1 16.9 oz bottle water, color pink, BP 121/76. Patient says he drove from DIFFRENT STATE to receive his vaccine and is alone. Patient reports feeling better. He was instructed to walk around, he did so without any complications, color remained pink. He says he feels better. After additional 15 minute observation, he was checked out. I instructed if the symptoms come back to pull over and call 911, he verbalized understanding.
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. On 11-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneous, lot # N002204, exp.19-JAN-2019, for prophylaxis. Concomitant therapies included sterile diluent (lot# N015631, exp. 18-MAR-2019). No adverse effects were reported.
Vaccine administered @ 11:00a.m. @ 11:01 patient vomited x1. Reported feeling hot, skin pale in color. Systolic BP in 80's. HR 60 RR 16 02 sat 92% rm air. Patient responsive, increasingly, "feeling hot" Assisted to floor in supine position.  11:15a.m. 130/79 HR 76 RR 16 Symptoms improving. 11:20a.m. Patient able to stand and walk to observation area where he sat until 11:45a.m. Declined EMS transport to hospital. Denied further complaints. Ambulated out of clinic. VS on d/c 148/72 HR 88 RR 18 02 sat 98% rm air. A&O x3. Reported hx. of syncope during past blood draws.
Patient presents to clinic with complaint of fatigue. Pleasant demeanor and ambulates without assistance. Precordial flutters felt 3-4x/day and he is unable to lay flat or on his left/right side without having difficulty breathing. Began after administration of Covid vaccine 2nd week of August. This lasted for 2 weeks and dissipated. 2nd Covid vaccine September 8th and the flutters returned. EKG completed.    Orthopnea: Intermittent dyspnea when in the supine and lateral recumbent position. This started 2-3 days after his second Covid vaccination. Currently not in respiratory distress.  Neck stiffness started 3 days ago. Limited movement in neck without pain. Pain 5 on pain scale of 0-10. The pain is constant and relieved with standing. Aggravated with lying supine and lateral recumbent.    HA: Pain started while lying supine and increased when he changed position for supine to standing. Pain described as throbbing, squeezing, pressure pain. Pain unrelieved lasting 4 hrs. Normally pt takes Excedrin for HA relief.    Heart: EKG completed precordial flutters felt 3-4x/day. Began after administration of Covid vaccine 2nd week of August. This lasted for 2 weeks and dissipated. 2nd Covid vaccine September 8th and the flutters returned. Flutters described as light tapping in the precordial region that is not painful.    Numbness and tingling: Bilat upper ext numbness and tingling usually starts in the hands and radiates to forearm. Lower ext bilat tingling and numbess. This started days after 1 Covid vaccine.
Red spots appeared on the lower arm left, few days later redder and numerous appeared on left leg the out side knee down. two weeks later spots appeared on right leg outside lower back of calf. 19 days later spots appeared on both tops of feet. second vaccine  added more spots on inside of left leg, and  also on right leg. 4/12/21 was second shot on 4/13/21 chilled all day.
This report is being submitted by the guidance of the Agency. 1 patient was affected by storage and handling excursions.
Had a rebound in sympotoms and more severely since the night of 12-May-2022; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. N31m20a and 045A21A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Endometriosis, Chronic pain, Chronic fatigue, Inflammation (Chronic inflammation) and Acute bronchitis (acute/recurring bronchitis). Concurrent medical conditions included Polycystic ovarian syndrome, Fibromyalgia and Drug allergy (Hyocine).   On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 9:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022). At the time of the report, SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022) had not resolved.            The patient was taking any other medications/products(unspecified) within 2 weeks of starting COVID-19 treatment.  Patient had a rebound in symptoms and more severely since the night of 12-May-2022.  Patient's health was improving and the meds helped severe sickness while taking them but the rebound seemed to be worse.  No treatment medication were provided.  Patient had a negative test after finishing the course of the med on 08-May-2022 and a negative test on 09-May-2022. The patient tested positive again on 13-May-2022.
Funkiness; She had a little reaction of a fever for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   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 FEELING ABNORMAL (Funkiness) and PYREXIA (She had a little reaction of a fever for 24 hours). At the time of the report, FEELING ABNORMAL (Funkiness) outcome was unknown and PYREXIA (She had a little reaction of a fever for 24 hours) had resolved.            Its been past 7 months of her first vaccination. Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-339365 (Patient Link).
pt recv vax; warm, red, firm, golf ball size LUA; 1/10 involved area spread over greater area, receeded in depth. sore at site; swelling, redness subsided in 5 days; no fever; felt good generally;