chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache the same day as getting your first shot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache the same day as getting your first shot) and FATIGUE (Tired) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache the same day as getting your first shot) and FATIGUE (Tired). At the time of the report, HEADACHE (Headache the same day as getting your first shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Moderate stomach cramping the evening following my injection. Significant vomiting spells at approx 9:30 AM and approx 6:00 PM the day after receiving the flu vaccine. Significant stomach ache and indigestion between vomiting spells. Felt much better following second vomiting spell.
I started menstruating on 4/11/2021, which was about 10 days early.  I have had regular menstruation for decades until this occurrence.  This was not a side effect disclosed to me when I received the vaccine, but I have heard many other reports of this anecdotally.
Cellulitis measuring 6x6.5 around flu vaccine injection site diagnosed by Dr. on 1/2/14 at 11:30 AM.  Prescribed 250 mg capsule Cephalexin 3x day for 10 days.
still hurting; heart problem; open heart surgery; between that and 2016 received 9 stents; covid in November doesn't know if really recovered fatigue never went away; Severe chest pain; pain on the arms and legs; nausea and chills; nausea and chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Severe chest pain), PAIN (still hurting), CARDIAC DISORDER (heart problem), CARDIAC OPERATION (open heart surgery) and COMPLICATION ASSOCIATED WITH DEVICE (between that and 2016 received 9 stents) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Open heart surgery in 2007.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CHEST PAIN (Severe chest pain), MYALGIA (pain on the arms and legs), CHILLS (nausea and chills) and NAUSEA (nausea and chills). On an unknown date, the patient experienced PAIN (still hurting), CARDIAC DISORDER (heart problem), CARDIAC OPERATION (open heart surgery), COMPLICATION ASSOCIATED WITH DEVICE (between that and 2016 received 9 stents) and FATIGUE (covid in November doesn't know if really recovered fatigue never went away). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) for Heart disorder, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Severe chest pain), PAIN (still hurting), CARDIAC DISORDER (heart problem), CARDIAC OPERATION (open heart surgery), COMPLICATION ASSOCIATED WITH DEVICE (between that and 2016 received 9 stents), MYALGIA (pain on the arms and legs), CHILLS (nausea and chills), NAUSEA (nausea and chills) and FATIGUE (covid in November doesn't know if really recovered fatigue never went away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information as not reported.   Reporter did not allow further contact
tonic-clonic sz by description of mom x 2-3 min; 2-3 hrs p/immmun; no fever; no illness; no history; had vax in past;
8 days p/vax devel high fever 104 crankiness & rapid resp which persisted for 2 1/2 days;no rash;no sz activity;eval by MD;no source of infect noted;mom took pt to MD d/t inc fever;
Case number PHEH2014US022755, is an initial spontaneous report from a nurse received on 11 Nov 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 131070) intramuscularly on 20 Oct 2014. No adverse event was reported following the maladministration.
About 15 minutes after the shot my heart started racing and I became light headed. Then shortly following that I felt a warm rush through my body similar to the feeling that when you get dye injected for a medical test. It heart racing lasted for about 10 minutes. the lightheadedness lasted about an hour. I was very tired that evening falling asleep 3 hours earlier than normal.
For 1 week, fever 102, runny nose, irritability, throwing up, restless & not sleeping at night. 1 week after vax, had rash all over body. 1/17/00 dermatologist determined it was a reaction from shot. Another baby at doctors office had same reaction my sone had. Follow up provided no additional information.
This case was reported by a physician via a sales representative and described the occurrence of swollen leg in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). In 2008 the subject received 3rd dose of PEDIARIX in the right thigh. The report indicated that the subject had been experiencing swelling in the right leg after receiving three PEDIARIX injections in that leg between 6 to 12 months prior to reporting. At the time of reporting the outcome of the event was unspecified. The physician considered event was possibly related to vaccination with PEDIARIX.
Breakthrough case admission after two vaccines  Pfizer 8/10/21 Lot# FA7484;  Pfizer 9/1/21 Lot# FC3181
Awakened on 04/21/2018 with stomach pain and cramps. Pain is episodic. No vomiting. One stool was a little loose. Pain was "really bad last night". Rates it at a 4/10 today. Able to tolerate food and fluids. Did not take her second dose on 4/22/18. Non tender abdomen today on exam.
Suspected vaccination failure; Have gotten / shingles vaccine yet have had it 6 times over the past 4 years; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient received all available shingles vaccine yet have had shingles 6 times over the past 4 years. The case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not given.
fever 101.9 large red swollen area on rt leg 1" above knee to the rt of knee;swollen area was @ least 2-3 inches in diameter;began screaming about 1030PM mom took to ER-ears red;dx double ear infect;put on ATB for otitis;
My left arm was sore for many days. Last night it became more red and began to be very itchy.
61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.
This spontaneous report was received from an 80 year old female consumer who was conferenced in by the Medical Team refers to herself. On 07-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and frequency not reported) subcutaneous for preventions of shingles. Concomitant medication included unspecified generic blood pressure medicine. On Monday, 07-OCT-2013, she had been administered ZOSTAVAX, immediately she experienced a pronounced headache, "similar to an ice cream headache." The headache had continued throughout the following days, accompanied by disorientation, chills, faintness, intermittent warmth and lightheadedness. The patient note that she would like to visit her physician in response to these flu-like symptoms but "is afraid to drive," due to the lightheaded feeling and dizziness. So she did not seek medical attention. She was given treatment for adverse events, using Motrin (OTC product). The adverse events were not improved. Additional information has been requested.
He got his vaccine, nothing that day, couldn't do anything for a couple of days after it.  About 1-2 weeks later his hands started feeling numb, tingling and puffy, feeling like he's walking on sand and has gotten steadily worse.  He went to his oncologist last month and told her about it and she told him to report it to us.   He was not able to work for about 3 days after the vaccine, flu-like symptoms.
?Covid arm??..very large red circular rash. Hot  to the touch and very itchy and painful. Still have it on 9/22. Size has not decreased.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # J014855, expiry date 16-APR-2016, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Diarrhea started at midnight,     followed by chills, headache, and body aches about 3:00 am.  I took Pepto Bismol  for my stomach and Tylenol for my headache and body aches. Still have stomach issues at 11:30 this morning.  Chills and body aches are gone. Feeling a little weak.
Weakness on left side. Leaning left upon rising for several hours. Walking was difficult. Too unsteady to do stairs at first, so I came down by sitting on stairs.
Patient got Moderna bivalent vaccine. She had left the pharmacy but came back 10-15 mins later to report that she had some kind of "hot flush" all of a sudden and thought to come back. RPh checked the injection site, and also visually verified there wasn't any rashes/SOB/swelling in the face or injection site. Pt declined offers of water or ice. She was advised to sit down for another 15 minutes and was feeling okay before leaving the pharmacy.
BURNING SENSATION IN NASAL PASSAGES; HEADACHE; SORE EYES; This spontaneous report received from a consumer concerned a 77 year old female. The patient's weight was 230 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, unknown, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced burning sensation in nasal passages. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced sore eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in nasal passages, headache, and sore eyes. This report was non-serious.
3 days after vaccines given pt was seen by PCP for complaints of arms hurting day after injections 6/8/16. Fever 100.5 felt very tired, pains in arms worse, could not lift (R) arm. Tender lump (L) clavicle. Red marks on arms near site of injections. Pt. c/o difficulty taking in breaths through throat. Symptoms persisted the following day, then somewhat better 3 day. Red marks persist. Area of redness not itching, not spreading. No other associated symptoms. Physician findings: tender to palpation above left clavicle with small palpable lymph nodes in supraclavicular area. Erythematous skin on bilateral upper arms that are tender to palpation, not warm or fluctuant, no hives/welts noted.
On 4/14/2021, right elbow started to hurt.  This was a site of a removed gout-caused mass over a year ago.  That subsided within a day.  On 4/15/2021, left foot started to hurt.  By 4/17/2021, the next to smallest toe and the large toe was swollen and very tender to any sort of touch.  It was not warm.  The pain was almost unbearable on 4/18/2021 and the suspicion that it might be gout was considered.  On 4/19/2021, after a visit with his doctor, gout was confirmed as the likely cause of the pain/swelling.  However, no blood tests were run to confirm.  Treatment for gout was initiated.
Phlebitis symptoms in the ventral wrist ipsalateral to the shoulder that the Tdap and HPV vaccines were administered earlier in the day.
covid vaccine breakthrough   dose 1 5/12/21 unknown lot number dose 2 6/9/21 unknown lot number
Initial unsolicited report received from an other health professional on 31-Aug-2018. This case involves an 80-year-old female patient who was vaccinated with a dose of 0.5 ml of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date instead of FLUZONE HIGH DOSE. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. It was unknown whether 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.
Mass migraine, severe body , muscle, joint aches and pains, fever, cough, nausea
received first dose 11 weeks ago and has not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose 11 weeks ago and has not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      Reporter called to ask what should a member of reporters family do if received first dose of Moderna COVID-19 Vaccine 11 weeks ago and still has not received second dose. Consent for Safety to follow up: provided   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received and contain no new information.
Body aches, chills, diarrhea, thick green/brown mucus coming out of nose and throat, cough, headache
Information has been received from a health professional concerning a 9 year old female with no pertinent medical history, drug reactions or allergies who on 29-AUG-2007 was vaccinated with a "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 658413/1025U). Concomitant therapy included human papillomavirus vaccine (GARDASIL). On 29-AUG-2007 the patient passed out immediately after receiving varicella virus vaccine live (Oka/Merck). There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
has an infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (has an infection) and COVID-19 (COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025J20A and 032L20A) for COVID-19 vaccination.     Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), LOSARTAN and AMLODIPINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (has an infection) and COVID-19 (COVID-19). At the time of the report, INFECTION (has an infection) and COVID-19 (COVID-19) outcome was unknown.            No treatment medication provided.  Company comment:This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history provided, who experienced the non serious unexpected events of Covid-19 and Infection. The event of Covid-19 occurred approximatively  6 months after the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history provided, who experienced the non serious unexpected events of Covid-19 and Infection. The event of Covid-19 occurred approximatively  6 months after the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 22:18, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Pt recv vax on 2/2/99, needle was inserted empty 1st time; on same day pt exp aching body, stiff body, rapid heartrate, headache, odd feeling in stomach w/ no appetite, weak muscles, scabbed vax site-rt arm