chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 6/3/2020, second dose on 5/26/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd June 2020 via intramuscularly on an unknown arm).   On 26th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by patient herself.  The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M014937 with expiration date 18-FEB-2019; dose and route were not reported). It was reported that the vaccine was improperly stored at 31.8 Fahrenheit for 4 hours. There was no prior temperature excursion. It was unknown if data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Right shoulder swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Right shoulder swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff repair in 2013. Concomitant products included FENOFIBRIC ACID and ATORVASTATIN for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced SWELLING (Right shoulder swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Jan-2021, SWELLING (Right shoulder swollen) had resolved.
pt recv vax 5NOV96 & 6NOV96 pt exp a faintly papular, itchy rash over entire body;
Information has been received from a physician concerning a 24 year old female who on an unspecified date was vaccinated IM with the third dose of 0.5ml GARDASIL vaccine (Lot # not reported). On 20-DEC-2010, the patient experienced a "sore arm and it was hurting for about 3 weeks". No treatment was given. The patient did not seek medical attention. Follow-up information was received from the physician who stated that the patient has not had an adverse reaction to GARDASIL. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
no adverse reaction, vaccine ordered, and vaccine given have the same generic name Bexsero, education given to employee and immunization schedule reviewed.
Patient self-reported the following symptoms: "I received the Covid vaccine Feb 6 at 1115 am. When I got up for work I had a bad headache, body aches, chills, lightheaded and nauseated. Day 2 I still had body aches, lightheadedness, headache, chills nausea and started running a temp 101.4. Day 3 continue with same symptoms temp and emesis. DAY 4 still have symptoms haven't been able to eat for 3 days. Day 5 felt a little better was able to get up symptoms subsiding. Day 6 started running a temp again 101.7 chills, headache, nausea, vomiting, body aches. Day 7 all symptoms have subsided. Now feeling back to normal."
pt had vomiting, t101 & abdominal pain following an inadvertent admministration of DTP; pt also recvd MMR; No additional clinical info available @ the time or report;
Cough, diarrhea, fever, headache, loss of appetite, muscle aches, sneezing, sore throat, vomiting, body aches, chills, difficulty breathing, earache, loss of voice, shivering, tightness in chest, unusual tiredness, weakness, difficulty swallowing.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-FEB-2014, the patient received ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose the prevention of shingles. On or about 01-DEC-2015, the patient suffered from a shingles outbreak in addition to chronic pain, rash, and lesions to various parts of the body. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of the condition. The patient has sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak was determined disabling. Additional information has been requested.
On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if she had received previous injections of Engerix-B. On 4/23/02, she experienced nausea, vomiting and abdominal cramps. As of 4/23/02, the events were ongoing.
i was wiped out the next day; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 20Aug2021, outcome "unknown", described as "i was wiped out the next day".  Follow-up attempts completed. No further information is expected.
So it started around 10PM that night of the vaccine 7/20/2021, I started throwing up like 10-15 times and was throwing up blood and around 3:00AM went to the ER. They gave fluids and anti-nausea medication in an IV. I was at the ER for about three hours. I went home and slept the whole next day, then the following day I was okay other than just soreness at the injection site.
Patient Covid + on 10/18/2021. Patient received Pfizer vaccine with 1st dose on 01/16/2021, 2nd dose on 02/05/2021 and booster dose on 10/01/2021. Per ED Note:  Patient is an 82-year-old female with PMH significant for HTN who presents complaining of weakness, cough, shortness of breath.  Patient states she tested positive for Covid 1 week ago. Per H & P: The patient states that she is little bit cold when I first walked in the room but after getting her blood get she actually feels quite warm.  She states that she just feels very exhausted from her bout with COVID-19.  She is having some mild diarrhea.  She is stating that she is short of breath and having a cough as well.  The cough is dry in nature.  She denies any chest pain or pressure.  Denies any overt dizziness or palpitations but apparently had an episode of passing out at home that lasted about 2 seconds.  She has been having some dysuria as well.   Lungs?coarse breath sounds bilaterally with diminished breath sounds diffusely  Extremities?no edema bilateral lower extremities   Plan Inflammatory markers are pending  Rocephin for urinary tract infection  Urine culture is pending  Initiate IV Decadron  Trend inflammatory markers  COVID-19 isolation  ID consult is pending  Hold immunosuppressive agents  Monitor electrolytes closely  Monitor oxygen closely  Supportive care  DVT prophylaxis??Lovenox  GI prophylaxis due to steroids?pepcid 82-year-old female past medical history of hypertension, hyperlipidemia, rheumatoid arthritis on MTX and leucovorin and possibly leflunomide, recurrent UTIs, unexplained syncope s/p loop recorder in 2015 without significant results, came in with fatigue, cough and shortness of breath. Patient states that the symptoms started about 2 weeks ago and it been gradually getting worse. Patient got a COVID-19 test at a local pharmacy about a week ago which was positive. She states that she did not see a doctor nor take any medications after testing positive. She has been fully vaccinated with the Pfizer vaccine and received her Pfizer booster dose on 10/1, she denies having COVID infection in the past. Patient was also treated for a acute UTI at that time with a 5-day course of Keflex. Patient states that she has been having dysuria, and noticed a darkened color to her urine for about 3 to 4 days. Patient recalls having small amount of loose watery and dark stools with increasing urgency for about 1 week. Patient states that she started wearing adult pull-ups because of the urgency to have a bowel movement and states that she has become incontinent, she cannot recall the amount of bowel movements she has been having in the past 24 hours but states that she had to change her pull ups multiple times. This morning patient experienced a 2-second episode of loss of consciousness, while being seated, witnessed by her grandson. According to him she seemed very anxious and her eyes rolled back to the back of her head and she was unresponsive. When she regained consciousness she was not confused but seemed very anxious. Patient admits to increasing anxiety about her diagnosis of COVID and her prognosis.
APPROXIMATELY ONE HOUR AFTER VACCINE GIVEN, COMPLAINED OF RIGHT ARM TINGLING, DIZZINESS, NAUSEA.
He fell asleep at 7pm very quickly, 5 minutes. It usually takes 30.  He seemed fine though.  He woke up a 8:30 pm, which is unusual and did not fall back asleep until 9:30.  While awake and in my arms he cried softly and wimpered for about 30 minutes.  Normally, he cries hard and loud.  He seemed week and my wife thought he looked pale. I kept him on my shoulder and he would fall asleep wimpering and wake up 4 or 5 minutes later.  He eventually fell asleep at 9:30.  While sleeping on my shoulder he would quiver has hands and feet slightly, not usual either.  We did not take his temperature, but my wife thought his temperature seemed normal to touch.  I thought he seemed a little warm.  We checked in on him until 11:15 and then went to bed.  We checked him at 1 AM and he was OK.  At 3 he woke up crying and nursed, then fell back asleep.  In the morning he seemed fine. Basically, it seemed as if he was not feeling well.
Patient stopped getting her menstrual cycle for months, lost weight, constant feeling bloated/full. Liver levels in blood laboratory showed 7x higher than normal.
Child complain of itching at the site. Mom reported left arm reddened, swollen, hard and hot to touch where shot was given-called pediatrician and medical doctor said normal- no treatment necessary.
Rash on palms of hands and at injection site, swollen lymph nodes, myalgia, weakness, swollen eyes, itchy throat x 3 days after PCV-13. RXN Rt deltoid S/P PCV-13 given. Rash. The patient presents for Rash. This episode began 8 days ago and has lasted 3 days. The symptom(s) are described as occurs occasionally. The patient describes the affected area(s) as itchy. Associated symptoms include dry skin, edema and pruritus. Pertinent negatives include fatigue and painful rash. Additional information: Pt was in last week and got a flu shot. Afterwards, she developed itchy rash on hands and feet, myalgia, fever, chills and swollen and red eyes. She feels better today, but she still has small rash on Right shoulder. Also C/O "bumps" on her chest on R side of chest near where she had PCV shot.
On 12/31/20 (day 7) of first injection, the injection site area became red, itchy, and inflamed (firm to touch). It was localized to upper arm area surrounding the injection site and the symptoms subsided in about 2 days. As of this reporting the inflammation has gone away, just small circle of slight redness remains with occasional itching.
Initial normal flu shot reaction. Localized pain in upper arm. No lump, not warm. Hurts more when she does any ROM or if she over uses her arm it will hurt in the resting position. Ibuprofen intermittently. Since Saturday: 800 mg Ibuprofen Q 8 hours. Forearm area. Days that she is better. Other days not. Reports tenderness to palpation in L upper forearm region, no palpable mass or lump; tender to palpation at biceps tendon, ROM intact but she reports pain with arm above head in the forearm region again, painful with infraspinatus strength testing against resistance.  Pain is still not resolved. Pt scheduled for ultrasound this week.
1) Sore arm at injection site. 2) Very swollen lymph nodes under arm.  -took ibuprofen and used an ice pack for the lymph nodes.
Localized reaction at injection site. 2 1/2 cm x 3 cm red, swollen and hot.
I threw up within an hour of the first dose of the vaccine. Three days after the vaccine I had extremely swollen Lymph nodes I have been suffering from severe fatigue and low white blood cell counts. My RBC and WBC count was dropping within one week after the vaccine. My Platelet count was also dropping. My intestines were inflamed, and I have suspected Endometriosis. I now have Hypokalemia as well. I have never had that before. I was in the ER twice in March with low Potassium even though I was taking some Potassium. I later had severe abdominal pain and I had inflamed intestines which were confirmed during an ER visit,  I have muscle and joint aches and I have been diagnosed with Osteoporosis since getting the vaccine. I have tried multiple medications to control my hypertension and nothing has worked yet. I feel awful and extremely fatigued after five months and I am dealing with all the new conditions that have been diagnosed since receiving the first dose of the vaccine. I have not been able to work since January. My blood work is still at threshold after five months. My intestines are inflamed and sometimes distended. I have seen Neurologists, Oncologist, Endocrinologist, Sleep Disorder Neurologist, Nephrologist, Gynecologist, Cardiologist, Gastroenterologist.
very large local react; unable to move arm w/redness & swelling by mom's report;
Got both shots, still get it, Had it two times/Suspected vaccination failure; Got both shots, still get it, Had it two times; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the new vaccine both shots, he/she guessed what you still get them. The patient had them two times so it was not. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Anxiety; Gastric infection / Stomach bug; Injection site bruising; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), GASTRIC INFECTION (Gastric infection / Stomach bug) and INJECTION SITE BRUISING (Injection site bruising) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANXIETY (Anxiety), GASTRIC INFECTION (Gastric infection / Stomach bug) and INJECTION SITE BRUISING (Injection site bruising). At the time of the report, ANXIETY (Anxiety) outcome was unknown, GASTRIC INFECTION (Gastric infection / Stomach bug) was resolving and INJECTION SITE BRUISING (Injection site bruising) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  On an unknown date, the patient had event of anxiety about upcoming colonoscopy and small bruise at injection site.  On an unknown date in 2022, the patient had stomach bug.  The causality for the events of anxiety, gastric infection / stomach bug and Injection site bruising was reasonable possibility with humira.
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-670) on 18-Mar-2019. It described a 50-year-old female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took unrefrigerated doses of Vivotif. The first dose was taken on 10-Mar-2019 and the last dose on 16-Mar-2019, respectively.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
FEVER, FATIGUE, BODY ACHES, NAUSEA, HEADACHE
Aug 20- experienced chest pain and difficulty breathing, 21- went to clinic for testing and IV fluids, 22-admitted to ER for chest pain, extreme shortness of breath, rapid heart rate (in excess of 130bpm), and high blood pressure. Diagnosis: pericarditis.
extra dose of Pentacel before 9 months old instead of giving 3 doses before 6 months old; Initial information received on 09-Oct-2019 and Additional information received on 11-Oct-2019  regarding an unsolicited valid non-serious case received from a Non-HCP (Office Staff).  This case involves male patient who received 0.5 ml dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ065AA (Expiry date unknown) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that vaccination intervals for Pentacel. Caller stated they give an extra dose of Pentacel before 9 months old instead of giving 3 doses before 6 months old  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Mother says she became sick with nausea, vomiting and diarrhea over a phone call the next day. They child had recently started daycare in a setting where many kids have similar symptoms. Explained that child was likely had viral illness. Mother says she is certain that it was due to the vaccine.
Slight pain, moderate itching, red warm rash at injection site measured at 14 cm in width with central darker erythema about 4 cm across.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 28-MAY-2015, the patient was vaccinated with improperly stored of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
In the middle of my sleep, the day of my vaccination I felt horrible. Probably the sickest I have felt in my whole life. Shivering and sweating at the same time as well as a fever. Burning pains in my veins on both arms. Very bad migraine. Allergic reaction, which included hives all over my body from my legs to head. Face was swollen from the hives. Had to take claritan to get reduce the allergic reaction. The migraine and cold sweats lasted for about 3 days. I was taking acetaminophen to get rid of the headache pains. The following day I had a lot of pain in my shoulder. The burning sensation also lasted for another day. I had severe fatigue for the 5 days following my vaccination. I still have a good amount of fatigue 8 days later.  I also had hives consistently for 5 days straight. The claritan was able to make it slow down for only a couple hours at a time. The hives were pretty severe, covering my whole limbs at some points. I also had dizziness for the first 4 days and a lot of mental fog.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an 10-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 08-Feb-2012, the patient inadvertently received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 26-Mar-2012: No adverse events were reported.
Within 24 hours of all three Covid vaccines, a lymph node just above my left collarbone swelled up to the size of a nickel; The area was painful; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2020 (Lot number: EK5730) at the age of 44 years as dose 1, single and administered in arm left, administration date 18Jan2021 (Lot number: EK5730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Other medical history: Seasonal allergies; "Allergy: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Within 24 hours of all three Covid vaccines, a lymph node just above my left collarbone swelled up to the size of a nickel"; PAIN (non-serious), outcome "unknown", described as "The area was painful". Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.