chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/8/99, pt received Flu vaccine and Anthrax vaccine.  Pt was hospitalized on 1/1/00 to rule out GBS. Dx is confirmed positive for GBS.  Patient is still hospitalized and undergoing treatment. A 15-day follow up report received 5/9/2001 adds: Pt,  43 year old male, received the 5th dose of Anthrax vaccine (lot #FAV024) on 12/08/1999, and on 01/01/2000 experienced Guillain Barre syndrome. No relevant medical history was reported. The pt was hospitalized for Guillain Barre syndrome. He had a lengthy disease course (specifics are unknown) and made a full recovery.
pt in SNF with neurocognitive decline; history of a positive COVID test on 9/11/21 with history of COVID pneumonia; was transferred from another SNF to this one due to aggressive behavior towards staff; very little information in medical record; pt passed away in the SNF
pain when injection was being given, red and swollen at site, red all around arm and down bicept, pain in muscle. even after 4 days still same, tired for 4 days.
Right upper arm red; arm and shoulder swollen; Dr notified and a steroid regimen (prednisone) initiated.
rash initially on trunk & then spread to all extremities; felt like mad itch; never had a rash prior to Hep vax; pt was given DPH & Atarax to control itching;
First week: Fever for 1 day. Extreme and continuing fatigue, severe headache and brain fog, and memory dysfunction. Toes and fingertips turning dark red and purple with edema, much better but still continues. The second week: Day 8, painful, large itching warm, red knot at the injection site. spread for a few days and resolved. Continuing memory/fog problems, fatigue, shortness of breath with activity, pink and red toes, and fingertips.
1. Arm sore and a bit swollen at injection site.  2. Fever over 100*.  3. Muscle aches.  4. Severe exhaustion.  5. Headache.  6. Nausea.  7. Throat clearing & minor coughing.
Became unwell over a period of months in that his mobility  was severely affected - diagnosis, finally, is Polymyalgia which he is now having to be on medication for
injection give 8-13-2009 approx. 11:00 am. by evening, pt arm too sore to lift, red, swollen, painful. came in to office 8-14-09. approx 4" swollen, raised, redness, going from L delt. to under pts arm. very painful under arm. Pt given 40 mg. Depo-medrol, IM, in r glut., also levaquin.
Patient states she woke up this morning and noticed that her left subclavicular lymph nodes were swollen. She states that they are painful to the touch and rates the pain a 3/10 on the pain scale. She reports no other adverse events at this time. Advised to take OTC pain reliever and continue to watch the area, if discomfort or swelling gets worse to seek medical care.
Presented at hospital at 12:03 with complaints of Rt side facial numbness, unable to smile on Rt side, unable to close Rt eye completely.
6/8: received SHINGRIX at Dr's office 6/10 (6PM): unable to eat any food (d/a nausea, abdominal bloating, pain, shivering, discomfort, couldn't sleep) 6/11: went to Emergency Room  -  took EKG and troponin test, which ruled out heart issues; abdominal and chest X-ray (ruled out "lung consolidation, pleural effusion, or pneumothorax... nonobstructive bowel gas pattern"); CT scan, which ruled out "obstruction, abdominal bloating with decreased activity"  - patient received Gas-X (1 tablet TID)  Within a week (clarified as "after 06/14/2023"), patient recovered
Fainting with seizure-like appearance not before experienced.; Fainting with seizure-like appearance not before experienced.; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 17-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnancy at time of vaccination.  Medical history was none.  No known allergies.   Concomitant medication included sertraline hydrochloride (ZOLOFT). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting with seizure-like appearance not before experienced on 26May2021 09:00 with outcome of unknown.  The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received.  Patient received second dose on 16Jun2021 09:00 AM in left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number has been requested.
Pfizer 5/15 and 7/31. Positive on 12/16
(On 02/14/2020, After receiving vaccine Father states patients legs became sore and patient is no longer wanting to walk , states child prefers crawling now. Father states child had fever of 102 F after vaccine w/ cough (Saturday and Sunday)  . Per: Provider on visit date 02/14/2020 child had no fever, nasal congestion, and rhinorrhea. Provider did diagnose pt with non-recurrent acute suppurative otitis media on Right Ear w/o spontaneous rupture of Tympanic membrane. Therefore, Provider prescribed child with Amoxicillin and Guaifenesin. Provider advised father to bring child in 2 weeks for follow up.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 10 months old male patient and reported that asking the side effects are and what do to regarding 4th dose, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Oct-2018, the patient received a 4th dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number for Hib: C5576AB and for Dtap-IPV: C5447AA and expiry date: 18-Oct-2019) via intramuscular route in left thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if the patient had any adverse event. 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. List of documents held by sender: none.
Patient observed a rash around chin and lip area after receiving the second Shingrix shot.  Patient had previously discussed with pharmacist that she experienced a rash with first vaccine, and had informed her doctor at that time, and had decided to get the second Shingrix shot. Patient feels fine, reports no pain, just a visible small rash.  We recommeded she call doctor to inform them of the reaction.
24 hrs p/DTP/OPV/HIB/Hep B pt had an event of dec or absent responsiveness & generalized tonic extremities of less than 1 min following feeding;
Child was brought to clinic for high fever upon waking in middle of the night. Temperature was 104 per mother's statement. In clinic at 0255 am temp. 102.7 rectal. Infant was given immunizations late afternoon - approximately 10 hours prior to fevering. Temperature taken prior to administering shots 98.4. Child given TYLENOL 0.8 ml and alternating ibuprofen per MD's orders.
Severe/atypical frontal headache 1 day after vaccination. Resolved with treatment, unremarkable CT scan.
Information has been received from a pharmacist concerning a 73 year old female who on 16-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 06-APR-2011, the patient returned to the pharmacy reported that she was seen by her physician because she developed a rash on her back on unspecified date. The patient reported that the rash was triangular in shape and it itched and "had little bumps," but no burning or pain. She stated that her physician said, "That looks like shingles." On the same day, the patient called to clarify that she had not seen her doctor and was asking the pharmacist if she should contact her doctor. The rash was at the base of her spine, triangular shaped, itchy with little blisters, felt rough to touch. Used generic NEOSPORIN first aid ointment on area (manufacturer unknown). She had not called the doctor yet but stated she would contact him in the AM. At the time of the report, the patient's status was unknown. Follow up information has been received from a physician and the registered pharmacist respectively concerning the 73 year old female patient with hypertension, high cholesterol, osteoporosis, allergies to LEVAQUIN, MACRODANTIN, cefdinir and antihistamines and a history of chickenpox who on 16-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (expiry on 15-JAN-2012) into the left deltoid. Concomitant therapy included carvedilol, lisinopril (manufacturer unknown), LEVOXYL, and LIPITOR. On 23-MAR-2011 (onset date also reported as approximately 01-APR-2011), the patient experienced rough raised, red rash. Number of lesions were reported as 3 cm cluster. Distribution of lesions was midline. On 08-APR-2011, doctor's office evaluated the adverse experience. On an unspecified date, the patient's rash was recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 08-APR-2011, a lesion sample was collected. The sample was taken from swab of dry erythematous patch on midline lower back. No results provided. Follow-up information was received from a health professional who reported that on 13-APR-2011, the specimen arrived to the laboratory. There was no VZV DNA amplified and no B-globin DNA was amplified. The final PCR analysis result from the vesicular specimen indicated that the specimen was inadequate. Additional information has been requested.
10APR mom called @ 245PM reporting pt has been very pale,almost grayish in color since vax given yesterday;pt looks better today but still pale;t102-103;no sz activity;fussy but consolable;
Had fever of 103.5F and seizure X 5 minutes. On 5/12/01, was stable without distress and with normal neuro exam, 4 hours, later.
Intussusception 10/15/07-records received for DOS 10/1/07-DX Intussusception. Presented to ED with vomiting and bloody stools last 2 days. Onset abrupt. Exploratory laparotomy with reduction of intussusception and incidental appendectomy. Therapeutic enema with air contrast unsuccessful in reduction of intussusception beyond the level of ileocecal. Follow-up Information 02-OCT-2007: Intussusception treated with surgery
Confusion, Headache, Myalgia, Fever, HYPERtension, severe headache , elevated temperature, fatigue, brain fog, chills Narrative: Did not receive any medications in the Urgent Care. c/o severe headache/like head in vice. brain fog. fever. chills. extreme fatigue.
MMR administered to Right Deltoid SC. Around 6:00PM itching noted around site. Rubbed with Alcohol to stop itching. Noticed swelling about 1/16/11.
This spontaneous report as received from a consumer via Clinic refers to a currently 9 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 25-JUL-2017 and 18-SEP-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were received as follows: The patient was in mid of 60's. The age at vaccination was not reported. The patient received a full immunization schedule of Shingrix and still got shingles. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test was unknown. No other details provided. The reporter consented to followup.
Starting on June 27,2021 and continuing to present: severe muscle and joint pain, severe nausea/vomiting, severe fatigue, respiratory congestion, sinus congestion, SOB, racing heartbeat . Respiratory and sinus congestion, SOB, and racing heartbeat have been coming and going over the time indicate. Due to severity and prolonged symptoms I have been unable to work.
Injection site pruritus; Pain during injection; Injection site urticaria; Fatigue; ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), INJECTION SITE PRURITUS (Injection site pruritus), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain during injection) and INJECTION SITE URTICARIA (Injection site urticaria) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-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) 1 dosage form. In March 2021, the patient experienced PAIN (ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE PAIN (Pain during injection) and INJECTION SITE URTICARIA (Injection site urticaria). At the time of the report, PAIN (ache) and INJECTION SITE PAIN (Pain during injection) outcome was unknown and INJECTION SITE PRURITUS (Injection site pruritus), FATIGUE (Fatigue) and INJECTION SITE URTICARIA (Injection site urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  On unknown dates, the patient experienced painful injection and itchy welt at injection site. In 2021, the patient experienced fatigue and achiness. In March 2021, the patient experienced fatigue and achiness. In March 2021, the fatigue and achiness resolved. In August 2021, the patient experienced fatigue and achiness.   In 2021, the fatigue and achiness resolved. On an unknown date, ITCHY welt at injection site resolved.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of fatigue onset in March 2021, fatigue onset in 2021, fatigue onset in August 2021, painful injection, itchy welt at injection site unknown onset, itchy welt at injection site unknown onset, achiness onset in March 2021, achiness onset in 2021 and achiness onset in August 2021 with Humira was not provided.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
I was feeling fine only I felt a bubble near my collar bone tender swelling went to emergency room went to ER at 8:30am Dr checked my neck said i had Acute Lymphadentitis Unspecified - Lymphadenopathy no blood taken  or scans made this assesment was by  Touch and visual . I was prescribed an antibiotic DoxycyclineHyclate 100 mg 1 capsule by mouth twice a Day was told to get a mammogram after so i will take one 6 weeks after injection to make sure
I had been taking care of a new baby. The family went to away and was gone for a week. His older daughter had COVID-19 and joined them, during that time the mother and father got COVID-19. When they got back home on 7/5/2022. I noticed the family was coughing but they did not mention anything. On Thursday she was still having a bad cough. On my way home from work, I went to get a COVID-19 test, I was positive. I had quarantined until 7/18/2022. I felt fine the whole time but on the 7/21/2022 I had a fever. I went to the doctor and had a positive test again and I started feeling bad, I went back into quarantined. On the 08/01/2022 I had another PCR done and that was negative. I waited for 3 days and had another PCR test done and it was negative. I?ve been feeling fine but for ¾ days I was tired coughing a lot and a headache.
Patient experienced more severe soreness in her arm starting several hours after administration. Within hours, she developed one large hive running from her upper arm to her elbow, and the area was swollen and sore.
a 4 year old girl developed a "vesicular rash" on her upper legs and groin area within 12 hours of receiving PROQUAD; he girl had urticaria and vesicles on her forehead.; This spontaneous report was received from a company representative on behalf of a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On the same day, 12 hours after receiving the aforementioned vaccine the patient developed a "vesicular rash" (rash vesicular) on her upper legs and groin area. Additionally, the patient experienced urticaria and vesicles on her forehead (urticaria vesiculosa).  It was unknown by the reporter if the patient sough medical attention, if laboratory diagnostics and if studies were performed due to the event, or if she received any treatments for the event. The outcome of the events was unknown by the reporter. On 16-AUG-2021,Identification Program packet was faxed to physician per article instructions.   The causality assessment  between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), rash vesicular and urticaria vesiculosa was not reported. As of 16-AUG-2021, all telephone attempts trying to obtain additional information has been unsuccessful. Also, program information was provided.
Patient stated that he began having tingling on his right arm the day after he received the flu vaccination, and it hasn't gone away since that date.
17YR old got the 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17YR old got the 1st shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Pt was given expired vaccine PROQUAD exp 2/24/14 and was given 2/26/13. Merck contacted.
Rash at injection site (large lumps) itchiness all over body, headaches, could not lift arms, aches.
Finger joint pain, stiffness & swollen. I used salonpas patch, wore  arthritis gloves, took ibuprofen 200mg.
Started feeling a bit dizzy Monday 22nd in the evening.  Woke up Tuesday  23rd room was spinning (patient had labyrinthitis 18 years ago symptoms lasted 2-3 weeks) dizziness lasted throughout the day (Tuesday 23rd, 2021).  Vomiting started late afternoon Tuesday.  The symptoms were lessening Wednesday and Thursday.
My symptoms started on 9/14/21. My heart rate was 125 bpm and I could not get it to come down with deep breathing. Since that day, I have experienced this frequently and to the point that it is waking me up at night and my heart is pounding out of my chest and I can't calm it down. My head is aware of what is happening, but I can't seem to calm my heart down. I have experienced heart palpitations almost every day since. It beats so hard it moves my hand when I place my hand over my heart. My normal heart rate has always been 60-70 bpm and now I check it multiple times a day and it is between 80-100 even when I am at rest. On 9/14, I almost felt like I was going to pass out because it was beating so hard. I thought it was anxiety, but after seeing my doctor about it and looking at the timeline, it was clear this all was happening due to the vaccine. I am still in the process of my treatment. I am waiting on a call from a cardiologist to get a full work up to make sure my heart is functioning properly. I have never experienced any of this before in my life until after the vaccine.
Experienced extreme spike in heart rate not related to activity. Heart rate remained over 120 for almost an hour at times spiking to 130-150. Since the first dose I have felt week and had a headache for 3 start days. I will not be taking the second dose. No ?vaccine? should make someone?s heart rate spike to 150. This has never ever happened before. I?m a runner and my heart rate never rises above 120 during vigorous activities. I have also experienced weird twitching in my left shoulder (the shoulder where I received the shot).  I had a regular PCP appointment the Monday before my first Moderna shot and all my levels were normal. No levels were out of range. The only thing that has changed is taking an experimental shot that has not been approved by the FDA called Moderna. If I had it to do over, I would not take the shot. I still just feel weird all around.
This spontaneous case reported by a consumer, describes the occurrence of fatigue and pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue and pyrexia (fever). At the time of the report, fatigue and pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.