chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse events noted.  Patient should have received DTaP at age 4. Tdap was given in error
Moderna Covid-19 Vaccine EUA The first 24 hours after injection, experienced headache, arm pain, and fatigue. Developed an itchy, red rash in a large circular area around injection site after one week from injection.
Rash starting within a few minutes of injection, lasted a day or so Pain, warm to touch, numbness and hard lump at injection site started within a few hours and lasted about 4 days then eased significantly Sore throat like I was getting a cold and fatigue first day then were gone next day Itchiness and a hard lump came back at Day  7 Today is Day 8 and itchiness and hard to the touch is still there.  Have used lavender essential oil to ease itching
I had fever, body aches, diarrhea and nausea, fatigue and swollen lymph notes under armpits and neck, migraines and headaches lasted a week and right armpit still swells on and off. Chest pains and difficult breaching in Jul2021, brain fog and went to see the doctor for long Covid "Had Covid twice 11 months apart - 31March2020- no test available at that time and Feb2021 was negative but I love I had Covid".
pt got to feeling really sick w/ headache, nausea, light headed and fever of 100.9.  Pts son called ambulance.  Pt passed out when EMTs were treating her.  Pt was taken to hospital ER on 3/12/2021. They did blood work, covid test (negative) and CT.  She was given fentanyl then admitted to the 2nd floor room for observation and given an IV.  DX was reaction for Covid Vax.  She was discharged on 3/14/2021  to FU w/ PCP within 1 week.
This is a spontaneous report from a Pfizer-sponsored program, from a  contactable nurse who reported similar events for two patients, and from a contactable physician. This is the first of two reports. A 17 year-old male patient received the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Lot M004116, Expiry Date 12Oct2017) at 1 DF single in the left arm, both intramuscular on 18Jul2016 at 03:15 pm for immunisation.  The patient medical history was not reported.  There were no concomitant medications. No other vaccines were administered within the four weeks prior. The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 26Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 16Nov2009, 15Feb2000 and 24Aug2000, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000 and 18May2004, Haemophilus Influenzae B on 08Apr1999, 10Jun1999, 12Aug1999, 24Aug2000, Pneumococcal vaccine on 24Aug2000 and 16Feb2001, Polio on 08Apr1999, 10Jun1999, 15Feb2000 and 18May2004, Measles, Mumps and Rubella vaccine on 25May2000, 18May2004, Varicella vaccine on 25May2000, 30Sep2008, Hepatitis A on 14Nov2011, 19Nov2012, DTAP on 17Aug2000, Meningococcal vaccine on 17Aug2010 and 09Mar2015, Influenza on 13Oct2009, 14Nov2011 and 19Nov2012. On 19Jul2016 at 12:00 am the patient experienced chills, vomiting, fever, nausea, diarrhoea, right arm pain injection site, he was tired, fatigued, lethargic and had body aches. Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporting physician considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable physician includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines, causality assessment. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016367240 same reporter/ products/events, different patient; 2016367212 Legacy paper report number.
This case was reported by a consumer (also the subject) and described the occurrence of pneumonia in a 81-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received ADVAIR  250/50 multi dose powder inhaler over a period of 18 months for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. The subject's medical history included allergy to CEFPODOXIME, CIPRO, SEPTRA, CODEINE, ENDOCET, MEGACE, TRIMADOL and SULFA. The subject had previously received unknown number of influenza vaccinations (manufacturer unknown), with no adverse events. The subject had not experienced adverse events following other previous vaccinations. Concurrent medical conditions included chronic obstructive pulmonary disease. Concurrent vaccination included pneumonia vaccine (non-GSK) (manufacturer unspecified). Concurrent medications included LISINOPRIL, WARFARIN, and DILTIAZEM. On an unknown date in 2007 the subject started Fluticasone propionate+salmeterol xinafoate (inhaled) twice per day. In the Fall of 2008 the subject received unspecified dose of FLUARIX (details unknown). On 24 February 2009, less than one year after vaccination with FLUARIX, the subject experienced pneumonia and runny nose. The subject noted that the pneumonia started out as a runny nose which would not stop. The subject was hospitalised for 6 days. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting the events were resolved.
Incorrect booster vaccine dose  to patient. Parent and patient aware. No s/s of adverse reactions during wait time after administration of vaccine. Aware to call MD for adverse reactions.
Swollen painful lymph nodes under arm and by collar bone on the same arm as vaccine was given  Covid arm rash began on arm where injection was given
fever, headache, chills, muscle aches for 8 hours. Took 1 Advil & that reduced symptoms but still have all of same symptoms just not as bad.  Very sore right arm - hurts to lift arm; burning sensation in right arm.
1 to 1.5 hours after immunized, Mom called HD and said he had hives around his eyes, nose, mouth, and ears. Denied trouble breathing. Mom was dropping him off at day care. Urged her to just go to ER as she wouldn't be there if he needed to go later. ER said it wasn't an allergic reaction but gave Benadryl and said to continue it until itching gone.
LVN reported to NP that influenza vaccine was .5mL not .25mL. Mom notified immediately & no complications reported. Mom advised to call with any c/o.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild
congestion that has lasted over 2 months; Fatigue; cold chills; cold chills; headache; sever cough; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 07Sep2021 14:00 (Lot number: FE3592) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Morphea" (unspecified if ongoing); "IST" (unspecified if ongoing); "LBBB" (unspecified if ongoing). Concomitant medication(s) included: CORLANOR; NEURONTIN. Past drug history included: Gemifloxacin, reaction(s): "Known allergies: Gemifloxacin". The following information was reported: PULMONARY CONGESTION (medically significant) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "congestion that has lasted over 2 months"; FATIGUE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "Fatigue"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021) and all described as "cold chills"; HEADACHE (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "headache"; COUGH (non-serious) with onset 09Sep2021 04:00, outcome "recovered with sequelae" (2021), described as "sever cough". The events "congestion that has lasted over 2 months", "fatigue", "cold chills", "cold chills", "headache" and "sever cough" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Sep2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary congestion, fatigue, chills, feeling cold, headache, cough and included treatment with Antibiotics, Inhaler, Cough Syrup, Covid Testing (Negative).  Clinical course: Patient did not have covid prior vaccination.; Sender's Comments: Based on the close temporal relation, the association between the event of pulmonary congestion and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
COVID-19 Booster given to patient who had already completed primary 2 dose vaccine and booster. Vaccine tolerated, no symptoms while in clinic and no symptoms reported by parent since.
I was called to pick him up at daycare. He had diarrhea and was repeating everything I said in a pitiful voice. I kept asking him what was wrong and how he felt, but he could only repeat what I was saying. I cared for him that day. He was very lethargic, and would not even look at me when I spoke to him. Drs. later told his parents that he was deaf, and that he needed tubes and adenoids out. They never caught his symptoms, which were very obvious. Just a few months ago, doctors took out his tonsils, saying they were too big. They have been bullied by doctors who want to treat without looking into his obvious reactions and symptoms of encephalitis and encephalopathy. My son reported to me he'd beat his head on the crib and the floor. Doctors are ignorant and our kids feel like they have to follow doctors orders. When they first refused vaccinations, under a year old, the Dr. made them sign a refusal form, then apparently they sent letters stating they'd better get the shots, I don't know when all he might have gotten them, but the 2 year ones (I assume that included the MMR,) were incredibly devastating. Prior, he'd take his baba, lay down for a nap, no problem. He developed sleep disorders that his tonsils were blamed for. They never looked into patient's health history, even though I had myself and my son tested for MTHFR, both homozygous, resulting in about 70% mitochondrial dysfunction.
Pt brought in the office 12SEP91 as per mom pt legs were limp for a few hrs p/vax administered; Also neck & arms were limp x 1hr;
I had no adverse reactions to the first injection of the Moderna vaccine. I had only mild fatigue the day after my second injection of the Moderna vaccine. The third injection caused a strong reaction approximately 44 hours after the injection. Strong chills and shakes accompanied by stomach cramps and fatigue which lasted over 2 days.
Patient claimed no pain at the time of injection. She stated the injection was the most comfortable shot she has ever had. About a month later developed shoulder pain.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, County Health took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a county medical director and based on this information from Moderna, no re-vaccination is needed.
Lump/bump at injection site and red rash a little larger than the size of a $1 coin at injection site.
Patient is a 17 year old male who currently presents to the emergency room for chest pain after receiving COVID (Pfizer) vaccination. He received the second dose on 8/16/2021 at pharmacy. The following day he had a fever, myalgia, and headaches. That subsided the following day, but then developed epigastric burning abdominal pain. He looked up his symptoms and saw it could be due to reflux, so he took some antacids with relief. 3 days after the vaccine he developed sharp left sided chest pain that was severe in nature. The pain lasted for about 1 hour with spontaneous relief, but later that day also developed left arm pain and tightness. Again pain went away, but this morning upon waking up he again had left sided sharp chest pain and left arm/forearm pain that was worse than the day before. He denies any palpitations, near syncope, or syncope.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with a history of chickenpox as child. On unspecified date around 2006, the patient was vaccinated subcutaneously with ZOSTAVAX (lot# and dose information were unknown). The patient developed herpes zoster on 05-SEP-2012. No rash occurred at the site of injection. Lesions were located at right anterior and posterior chest wall, and lesions were too numerous to count. It took 20 days for rash to resolve. The patient's max temperature was 97.9. Pain was quantified as 8. Other systemic symptoms included fatigue, no appetite, and pain with inspiration. There was no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody done. There was no specimen collected for PCR. On an unspecified date, the patient recovered. This is one of several reports received from the same source (1209USA002361, 1210USA004891). Additional information is not expected.
This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 24-JUL-2018, the patient were vaccinated with improperly stored ROTATEQ (strength, dose number, anatomical location, route of administration were unknown; lot # N028258 and expiration date 30-MAY-2019) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 08-NOV-2017, 16-NOV-2017; 23-JAN-2018, 06-JUN-2018, 03-JUL-2018, was 47 degree Celsius for max 15 hours. And in 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
RED ITCHY SWOLLEN AND THROBBING PAIN FROM L EAR TO ELBOW
did not feel well; severe chills; felt feverish; achy; This is a spontaneous report received from a contactable consumer. A 56-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration In the left arm on 12Apr2021 09:30 AM at single dose for COVID-19 Immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included caffeine/paracetamol (EXCEDERIN) and zolmitriptan (ZOMIG). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Mar2021 at 56 years old for COVID-19 Immunization. Approximately 14 hours after inject to about 19 hours after inject, the patient intermittently had severe chills, felt feverish, also was achy and did not feel well from 12Apr2021 11:30 PM. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Outcome of the events was recovered. This report was reported as non-serious.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; Soreness at injection site; Limitation of arm movement; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; TYLENOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Soreness at injection site"; MOVEMENT DISORDER (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Limitation of arm movement". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain. Therapeutic measures were taken as a result of movement disorder.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to covid19 vaccine and Patient was not diagnosed with COVID 19 prior to vaccination and since the vaccination patient has not been tested for COVID 19 and no allergies to medications, food other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP developed fever 102 & hypotonic, ataxia episode day following immunization. Hospitalized for 2 days
Information has been received from a physician concerning a 13 year old female patient with no medical history or drug allergies reported, who in February and April 2008 was vaccinated with the first and second dose of GARDASIL vaccine (yeast), respectively. There was no concomitant medication. On 09-MAY-2008 the patient developed systemic joint tenderness with mild to moderate joint swelling. The patient sought unspecified medical attention. Lyme and magnetic resonance imaging tests were performed with no results reported. The symptoms have been somewhat responsive to prednisone, but return when the prednisone was not used. At the time of this report, the patient has not recovered. No product quality complaint was involved. Additional information has been requested.
After taking the vaccine she felt a tingling in her arm. After a few hours she was having shooting pains in her arm where she took the vaccine.
extreme fatigue (falling asleep in front of a meal for long periods can't arouse himself), severe frontal headache,  loss of appetite, didn't eat  for over 24 hours. Poor appetite for several days after this. The only symptom remaining was extreme fatigue that seemed sometimes to be improving and then return. Then woke up in middle of the night to go to the bathroom April 5th and couldn't coordinate his legs, they were numb.  Equal in strength when checked in bed by me, but had to crawl back from bathroom in early morning.  Since then the numbness comes and goes and balance issues come and goes, fatigue is getting worse again to the point where he is sleeping or too exhausted to move for most of the day. S
fever- 101.7, chills, headache, nausea, body aches- (more so joints- hands, ankles, knees and entire back), injection site with redness, swelling and extremely sore with difficulty moving upwards and outwards from body. nasal congestion and ear pain on left side ( same side as injection). s/s started about 140 am on 2-4-2020 (day after injection). s/s lasted all day on 2-4-2020, woke up on 2-5-2020 with arm soreness, redness and edema, but improved. all other s./s besides lower back pain resolved. temp-99.4
Vision distortion immediately after receipt.  Severe headaches on a daily basis since vaccination. Approximately 10 days after, nauseau and feelings of flu-like systems.
PT developed left upper extremity cellulitis around site of immunization. Also developed daily fevers. Oral antibiotics ineffective. Required hospitalization for IV antibiotics.
Shortness of breath; Throat swelling; rash on legs, ankles and feet; Headache; hives on legs, ankles, and feet; low grade fever; local injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet) and VACCINATION SITE PAIN (local injection site pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 17-May-2021, the patient experienced VACCINATION SITE PAIN (local injection site pain). On 18-May-2021, the patient experienced PYREXIA (low grade fever). On 19-May-2021, the patient experienced URTICARIA (hives on legs, ankles, and feet), RASH (rash on legs, ankles and feet) and HEADACHE (Headache). In 2021, the patient experienced DYSPNOEA (Shortness of breath) and PHARYNGEAL SWELLING (Throat swelling). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency. On 19-May-2021, PYREXIA (low grade fever) outcome was unknown. At the time of the report, URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet), VACCINATION SITE PAIN (local injection site pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments.   Concomitant products included a birth control for an unknown indication.  On unknown date patient was submitted to CT scan which was negative for clots. On unknown date, the patient went to the urgent care where she received a Decadron shot and Inhaler to treat the events. Treatment also included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report was received and include information two new events, lab information and treatment for the new events.