chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, erythema and pain right upper extremity associated with fever, chills, weakness and fatigue. Swelling extends from shoulder to mid humerus and extend from the axilla down to the level of the breast.  Large palpable mass adjacent to right breast.  Seen in PCP's office on 6/29/21.  Started on Bactrim without responce. Currently on Clindamycin
Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with no family history of seizures or drug allergies who received all three doses of GARDASIL and then experienced seizures. All 3 doses were administered at a different facility and the patient just started coming to the nurse's office in December 2008 so the dates or lot number of the GARDASIL administered were not available. The patient was vaccinated with the third dose of vaccine in mid-January 2008. The seizures began in April 2008. In December 2008 the seizures became consistent and occurred daily. Starting 09-FEB-2009 the patient experienced blackouts. A neurologist determined the patient was having monoclonic seizures and prescribed KEPPRA and DILANTIN. The KEPPRA would be discontinued and replaced with LAMICTAL. Neurological tests indicated abnormal electroencephalogram. The nurse also mentioned that the patient has been experiencing headaches but had no further information about them. At the time of reporting the patient was getting worse. The patient was hospitalized and was seen by a neurologist. Additional information has been requested.  2/24/09 Received hospital medical records of 12/10-12/11/2008. FINAL DX: myoclonic seizures Records reveal patient experienced HA, photophobia x 2 days then had involuntary jerking/shaking/twitching episode while in class 12/9.  Neuro consult done.  Tx w/meds.  3/5/09 Received Neuro medical records of 1/15/09 FINAL DX: seizure disorder, generalized, myoclonic Records reveal meds were adjusted.
This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patient were vaccinated with improperly stored doses ROTATEQ, oral, from lot# M046000 with expiry: 27-JUN-2018, for prophylaxis. No adverse effects reported. The vaccine was stored at a temperate of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA008351: US-009507513-1707USA008350:
Pain began about 6hours after I received the shot, and lasted about 24 hours. Today when showering I noticed that there's an area 4? wide that is still bright red and bruised. It looks pretty bad.
body aches, fever, chills - all lasting 12 hours,.  vomiting, throbbing headache - lasting 24 hours,  swelling, itching  and allergic reaction at injection site - still ongoing on day 3.
Vomiting; blood in the stool / bloody bowel movements; Possible Intussusception; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 3-month-old male patient who received Rota (Rotarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, HAEMOPHILUS INFLUENZA B VACCINE (HIB VACCINE) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   Concurrent medical conditions included breast feeding.   On 7th May 2020, the patient received the 1st dose of Rotarix (oral), the 1st dose of Pediarix, HIB VACCINE and PREVNAR. On 9th May 2020, 2 days after receiving Rotarix and Pediarix, the patient experienced blood in stool (serious criteria GSK medically significant) and intussusception (serious criteria GSK medically significant). On 20th May 2020, the patient experienced vomiting. On an unknown date, the outcome of the blood in stool, intussusception and vomiting were unknown.   It was unknown if the reporter considered the blood in stool, intussusception and vomiting to be related to Rotarix and Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's mother reported that, 2 days after receiving Rotarix, Pediarix, Prevnar and Hib vaccine, she noticed blood in the stool. MD informed her to keep breast feeding.  They visited on 18th May 2020 and a hemoccult was performed, which was positive, and a stool culture was also performed to rule out Salmonella.  She stated that at that time, the patient appeared to be normal with normal stool (yellow from breast feeding).  The day before reporting, the patient fed well, but the mother called on the day of reporting stating that the patient was vomiting after each feeding.  PI information was provided regarding bloody bowel movements and vomiting, which could be a sign of intussusception.  MD stated that she would be seeing the patient again on the day of reporting and would probably refer to the ED.
Inability to function, headache, fatigue, vomiting that was ongoing for approximately 52 hours.
Pt vax w/ 3 doses Recombivax; Pt had no measurable antibody level. Vax w/ booster dose & antibody level was 34.
Mom states client's uncle related that after immunizations on 4/10/01, client had a seizure that lasted about 1 minute. No fever until the next day. No further seizure activity after this one episode.
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
Swelling of under eye. Right eye significantly more swollen than left eye. Puffiness and redness.  Took a Benadryl and swelling subsided.  No itching of eye.
Within the first fifteen minutes, I experienced a sore arm, headache, muscle aches, fatigue and brain fog, all of which continued throughout the day. About two hours after the shot, I had an upset stomach/ churning stomach which continued throughout the evening. About 8 hours after the shot, I began my period--about three times heavier than usual. The next morning, I woke feeling feverish with a slightly elevated heartrate, which slowed after getting up and drinking water,. My headache was gone most of the second day, but my muscle aches were worse and quite painful--especially on my left side and left lower back, my left arm, my neck and my right arm. My stomach continued to be upset and cramp and my period was very intense, still much heavier than usual. My lowgrade fever returned in the evening (around 100 degrees F). I also am weak and have some brain fog/ trouble focusing..
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in an adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional information reported as follows: The age at vaccination was not reported. The patient reported that it was not been informed, if the dose was administered subcutaneously instead of intramuscularly.
pt devel fever p/vax;T104R had 2 jerking episodes;No LOC;no tongue bitting;exam WNL;
2nd Degree Heartblock 6/20/08-records received:10/2/07-C/O mid-sternal CP with lightheadedness, palpitations, mild SOB. DX: non-cardiac chest pain.
Within 8 minutes of receiving the COVID-19 vaccine, patient developed feeling of throat feeling itchy, tongue tingling,  and progressed to throat tightness and difficulty speaking and squeaky voice within 15 minutes of receiving the COVID-19 vaccine. 911 was called with request for the  facility's Rapid Response Team (RRT) to assist. While awaiting RRT arrival, patient was administered Epinephrine 0.3 mg IM via EpiPen, first dose within 18 minutes of onset of adverse symptoms, with short-lived improvement of symptoms. The Rapid Response Team arrived on the scene and when the same symptoms started to return, about 7 minutes after the first dose of Epinephrine, a second dose of Epinephrine was administered IM. Patient's symptoms responded positively to the second dose of Epi and patient was transported to the Emergency Department by the Rapid Response Team for observation and further evaluation/treatment as needed.
Pt developed a rash with 18 - 20 small vesicles, subsequent to receiving one dose of varicella virus vaccine live. She was diagnosed with chickenpox.
The day of and the next couple days after injection, I had typical side effects like soreness in the arm and some fatigue. On the 7th day after my vaccine, I had a red blotch on my injection site about 4 inches wide by 3 inches tall. The blotch was tender and warm to touch.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 26-FEB-2013 was administered a dose of GARDASIL (lot # H011350 and expiration date 21-FEB-2015) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
I had swollen cervical lymph nodes + repeated fever for over 2 weeks. I had another course of symptoms after a month later. The second time different cervical nodes were swollen. Only took ibuprofen and Tylenol for fever. Because I had Kikuchi disease history, physicians agreed my symptoms look like a reoccurrence of Kikuchi disease.
I woke at 3:00 am; Rash on my face neck and arms/Covered in the rash everywhere; my stomach was hurting; This is a spontaneous report from a contactable other health care professional (patient). A female patient of an unspecified age (reported as 41) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 26Feb2021 14:00 as dose 1, single for COVID-19 immunisation. Medical history included known allergies to hydroxide ion. Concomitant medication included cetirizine and multivitamins taken for an unspecified indication. Patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior vaccination. After the vaccination, on 27Feb2021 04:00, patient woke up with a rash on her face, neck and arms and her stomach was hurting. She went to hospital, treated with Benadryl and sent home. The next morning on 28Feb2021, she woke up at 3:00 am. She was covered in the rash everywhere and stomach was excruciatingly. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had not been tested for COVID-19. Therapeutic measures in response to the events included, Steroids, Steroid cream, Benadryl, and Hydroxyzine. The outcome of the event middle insomnia was unknown and of other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Post covid vaccine dose #2, patient was waiting for 30 minutes in the observation area. Patient was c/o dizziness after 15 min of waiting. Patient then c/o feeling numb in his upper extremities and lethargy. It was determined to send the patient to the emergency room. Transport was called. 0835 Patient was transported to ER via agency transport. Pt's chart flagged with ADE.
Mild swelling at injection site 12 hours after getting the Moderna COVID-19 vaccine (January; Chills 12 hours after getting the Moderna COVID-19 vaccine (January 22nd, 2021); Persisting and intense headache 12 hours after getting the Moderna COVID-19 vaccine (January; Tenderness 12 hours after getting the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Persisting and intense headache 12 hours after getting the Moderna COVID-19 vaccine (January), VACCINATION SITE PAIN (Tenderness 12 hours after getting the Moderna COVID-19 vaccine), VACCINATION SITE SWELLING (Mild swelling at injection site 12 hours after getting the Moderna COVID-19 vaccine (January) and CHILLS (Chills 12 hours after getting the Moderna COVID-19 vaccine (January 22nd, 2021)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Persisting and intense headache 12 hours after getting the Moderna COVID-19 vaccine (January). On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness 12 hours after getting the Moderna COVID-19 vaccine), VACCINATION SITE SWELLING (Mild swelling at injection site 12 hours after getting the Moderna COVID-19 vaccine (January) and CHILLS (Chills 12 hours after getting the Moderna COVID-19 vaccine (January 22nd, 2021)). At the time of the report, HEADACHE (Persisting and intense headache 12 hours after getting the Moderna COVID-19 vaccine (January), VACCINATION SITE PAIN (Tenderness 12 hours after getting the Moderna COVID-19 vaccine), VACCINATION SITE SWELLING (Mild swelling at injection site 12 hours after getting the Moderna COVID-19 vaccine (January) and CHILLS (Chills 12 hours after getting the Moderna COVID-19 vaccine (January 22nd, 2021)) outcome was unknown.        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 INCLUDE Tylenol
Developed abscess -MRSA at injection site 2 days later. Performed incision & drainage & antibiotics.
Per pt., she had moderate nose bleed for 4 days post 1st injection of Pfizer vaccine. Did not seek  medical attention. Returned for 2nd dose , today. Instructed to let facility know if nose bleed or other symptoms with 2nd dose. No history of nose bleeds prior to vaccine.
Exposure to COVID by family member prompted testing of family. Tested for COVID 19: 01/03/2022, sneezing running noise cough and fatigue but no fevers. Positive for COVID 19: 01/07/2022 Re-tested.
urticaria 6 hours after vaccine; This is a spontaneous report from a contactable Physician. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8735), via intramuscular route of administration on 26May2021 (at the age of 33 years) as single dose for covid-19 immunization. Medical history included hypothyroid, hyperlipidemia, allergic rhinitis from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included levothyroxine (LEVOTHYROXINE) for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8735) via intramuscular route of administration on 05May2021 for covid-19 immunization. The patient did not receive any other vaccines in four weeks. It was unknown if covid prior vaccination. Since the vaccination, the patient not been tested for covid-19. On 26May2021, 6 hours after vaccine, patient experienced urticaria. The event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received: Benadryl. The outcome of events was not recovered.
Patient's wife stated Husband 2021/03/12 muscle pain in legs, fever 2021/03/14 (100.4), chills (Treated temp down 99.8), stomach/muscle pains. Contact with Dr. 2021/03/17 (Fever 100.7) phoned. No treatments for nausea, headache, muscle pains.  Hospital visit ER with confusion/hallucinations. Temp 100.4 BP 136/110, *8:30am 2021/03/19. Home incident of falling, EMS called (vitals normal) admitted in Hospital. Transferred to another Hospital (Covid Neg.), stated bad infections. Death 2021/03/21
no adverse effect; improperly stored dose administered; This spontaneous report was received from a registered nurse referred to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot # S000623 and expiry date 06-JUL-2020 via subcutaneous route for prophylaxis (dose was not reported). The concomitant therapy included sterile diluent (STERILE DILUENT) which was stored appropriately. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature of 6 degree F (Fahrenheit) to 14 degree F for 2 hours 40 minutes and from 15 degree F to 46 degree F for 7 hours and 40 minutes. There was no previous temperature excursion reported. The digital data logger was involved. The patient did not experience any adverse effect. Product quality complaint was not involved.  This is one of the several reports received from the same reporter (link case # 1906USA009902, 1906USA009880, 1906USA009914, 1906USA010076)
When vaccine administered it appeared to leak down the arm. Unclear how much if any was administered. Per physician, patient to receive another one to ensure proper dose.
Pounding Headache, general  muscle and joint pain, chills, exhaustion , inability to concentrate, general malaise
Patient had no adverse reaction. I have contacted the mother of the patient/child already. Mother reported patient/child is doing well after receiving vaccines on 05/11/2022.    On 05/11/2022 patient who is 14 months old, came in for a well-child check. Patient was due for immunizations and lead testing. Patient was given a DAPTACEL but wasn't due for it yet. Sheet was pulled prior to giving vaccines. I had another MA with more experience with peds vaccines help me. It was also verified by MA. I have reported the error to the provide
Patient was admitted to healthcare facility on 5/23 with chest pain and elevated troponin. Normal biventricular systolic function. Cardiac MRI showed myocardial fibrosis
Within 2 minutes I had a horrific taste in my mouth followed by light headedness/dizziness.  I almost passed out & had to be caught by a nurse & put into a wheelchair.  They administered EpiPen, 50 mg of liquid benadryl & 2 puffs of a rescue inhaler.
Patient had intussusception on or before 5/24/08.  Over a month after his second dose of rotavirus vaccine, he had failed reduction in a local facility, hence sent to hospital for laparoscopic reduction.  07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX:  Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy.  F/U visit 6/9/08-doing well post-op.    Labs and Diagnostics: CT scan (+) for IS. Contrast enema (+) for IS. Abd X-ray suspicious for IS.  CBC and Chem unremarkable. 07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX:  Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy.  F/U visit 6/9/08-doing well post-op.
Pt received influenza vaccine in am. In the afternoon during a soccer game, she had a severe asthma attack that appears to have been an anaphylactic reaction. No new foods or known exposures. Can not r/o flu vaccine as precipitation factor.
pt was given vax 4FEB93 & devel hives the next day which cont for several days; pt was seen in ER on 6FEB93 & 7FEB92 for treatment of severe urticaria which was thought to becaused by the vax;
Left arm (injection given in left arm) "fell asleep" the night after injection. Arm felt heavy all day. Began to feel heaviness in left leg by the next day. Entire left side of body "feels as if it is heavy or under water". Symptoms decrease but do not go away during the day. Very bothersome at night and affect sleeping.
No adverse event. Patient given Tdap. This is only licensed for patients 11-64 yrs. Follow-up Information 22-JUL-2008: She did not have an adverse reaction. She is over the recommended age for this vaccine.
Intense headaches, back and hip pain and right arm pain.  The pain got so bad and lasted for a few months ultimately landing me in the Emergency Room for 3 visits in 2 days.  I also had Bells Palsy.  They were pumping me full of morphine and it did not take away the pain.  Treatment was pain management - vicodin and prednisone for the bells palsy.  Severe pain is gone , but now have joint pain, weird skin sensations and dealing with fatigue and some depression.  This is vaccine related - I had no issues with any of this prior to the shot.
Vertigo or dizziness. Symptoms are mild. They became evident 30 hours after inoculation. I will remain home for the day and see how I feel tomorrow.
Pain to hands; Pain to wrists; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient did not have any history of arthritis or joint pains. The patient's concomitant medications were not reported. The patient had pain to hands and wrists on an unspecified date. Patient wanted to know are these side effects caused by the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient became lightheaded and her vision was getting darker.  Vital signs within normal limits.  Symptoms resolved.