chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful injection site; This is a spontaneous report received from a contactable male physician (patient himself) of an unspecified age received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number/Expiry date: unknown) via an unspecified route of administration and second dose received(lot number: unknown) via an unspecified route of administration on unspecified date both as single dose for covid-19 immunisation. Patient's medical history and Concomitant medications were not reported. The patient experienced painful injection site due to administration technique used by nurse, "long needle and unusually painful injection site." Safety Concern Reported it as an adverse Event, which was non serious.The outcome of the event was unknown.  Information on the batch/lot number has been requested.
approx 3yrs p/vax pt exp a rash & low grade fever,  pt dx w/chickenpox. no further info avail
Premature ovarian failure - unable to have children. Didn't realize until off of birth control and trying to conceive. Genetics testing was done and there was nothing to attribute to how else I would have got this.
Child developed a headache prior to receiving nasal spray flu vaccine at the School Flu clinic on 10/28/10. Her headache got worse following spray vaccine. Monitored vital signs for 15 min & sent to health room for ice pack. Went to lunch. Laughing with friends; headache gone 20 min later.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000593:
Arthralgia joint pain to hip, elbows and any bony prominences: employee also mentioned she has sickle cell Narrative:
Soreness and tenderness around lymph nodes at underarm and side of breast. Difficulty to move left arm and pain when lifting.
Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting
three doses of the Moderna vaccine given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A, 047B21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Hypertension, Hyperthyroidism and Hyperlipidemia.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-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 EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given). At the time of the report, EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information provided by the reporter.
intermittent fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (intermittent fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 dosage form. On an unknown date, the patient experienced PYREXIA (intermittent fever). At the time of the report, PYREXIA (intermittent fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Patient had the Moderna booster (1/2 dose) 20 days ago
Nausea, loss of appetite, night sweats started 07/18/2003.
Started with loose stools on 2/25/21- 2 days after receiving 2nd dose, has had many blood tests done, colonoscopy, x-rays & CT scan ordered.  Continues with liquid-diarrhea stools
Severe stomach pain, any other illness has been ruled out, all her blood tests have come back normal again, and xrays as well as ultrasound showed nothing. She has gone from a healthy teenage girl to missing school, coming home from school because of her pains. She has lost weight is unable to eat at times because the pain is so bad.
9/19/01 Hep B #1 given in left deltoid. 9/20/01 Red area on left ear and left side of neck; little itchy. No raised rash. Redness subsided around 2-3 pm. Problem sleeping that night. 9/21/01 In morning, redness on left side of chest with some raised area, and itchy. Got worse, neck red and itchy about 2 pm. Nurse gave hydrocortisone cream to apply to neck and chest. Itching continued. Few red areas on legs. All cleared by 9/26/01. PCP called 9/22/01 and was told to continue hydrocortisone.
low-grade fever,  mild headache, significant joint and muscle pain, extreme fatigue, brain fog, nausea, chills.
6 hours later nauseated - had feeling up to a week later.  12 hours later - woke up from sleep - fever 101- sweating- could have been higher.  Pain all over - body stiff - like frozen muscles all over.   Swelling of mouth, throat - hard to swallow water.  Very tired - weakness, shakiness.  Blood Pressure at worst point was 89/37.   The above severe symptoms lasted up to 10 hours.  Later could walk with help for a day or more.  Aches and pains, headaches lasted a week or more.  After 3 weeks feeling better. I have received Flu Shots beginning in 1964 - every year until now.  This was #56 in your 2019.   Swine Flu Shot - 1976.   H1N1 shot -2009.     Senior Flu Shot 2018 & 2019.
Received vaccination 12/15/14 10:56 am right deltoid. On doctors rounds 12/16 pt c/o pain at injection site. Was red. MOTRIN started for pain. Vital signs 12/16/14 8 am 124/80-96.8-71-18. Remained afebrile. 12/19/14 resolved per charge nurse.
post puncture vaccine was left at room temperature for over 24 hours; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     Concomitant products included CITALOPRAM for an unknown indication.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours).    No Medical History information was reported. The patient did not report being immunocompromised. The vial was first punctured on 01-Aug-2022 at 9: 30 am. Post puncture the vial was stored at room temperature. First administration was done at 02-Aug-2022 at 10 am, then administered every 15 minutes after 10 am until 11 am. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degrees to 25 degree Celsius) was just over 24 hours about 24 hours and 30 minutes. The patient received first booster dose. Patient did not report having side effects No treatment drug was reported.
Within 24 hours of flu vaccine,began with hives.  Started antihistamine immediately and prednisone the following day.  That night, face began to swell, lips, mouth, tongue and then throat. Visited ER and was given IV with prednisone and antihistamine and Zantax.  Admitted to hospital for  the next 24 hours. Went home and continued on Prednisone for one week. Still taking the antihistamine.  11/7/07 Received vax record from provider.  VAERS database updated w/same./ss 12/7/07 Reviewed hospital medical records which reveal patient experienced new onset hives. Saw pcp & tx w/steroids & antihistamine.  Worsened & admitted 10/13-10/14/2007.  On admit had hives, facial swelling & throat constriction.  Tx w/IV steroids & antihistamine.  Had 1 further episode of hives that responded to steroids.  D/C to home on tapering steroids & antihistamine.  Also prescribed epi-pen. FINAL DX: Hives.
t106.7 on 21MAR93 playful x 3 days p/vax then lethargy & fever started-poor appetite; PE WNL;
5/25/15: Patient spoke of redness swelling pain at site of inject, advised. 5/26/15-swelling and pain increased a great deal in severity - patient also noted blistering - advised patient to seek medical follow up. Patient stated has "infection due to vaccine". Received antibiotics.
The patient was missing the second dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00667193) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 27-year-old female patient who missed the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (product dose omission issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 23-Jun-2021, the patient received 1 mL of 1st dose of suspect RABIES (HDC) VACCINE (lot T1C66 and expiry date : 17-Jun-2022) via an unknown route in an unknown administration site for unknown indication but missed to receive the second dose on 30-Jun-2021 (product dose omission issue).  It was reported that "RPh (registered pharmacist) intern is calling to see what the scheduling for the IMOVAX vaccine is."  This was a case of actual medication error due to missed dose (latency unknown).  At time of reporting, no adverse events were reported.  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 the 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.
I got my 1st dose of the Covid-19 Vaccine on Dec. 17th, 2020.  On Dec. 28th, 2020 (11 days later), I developed a terrible headache, body aches, stomach aches, and fatigue.
Pt was hospitalized the evening after the vaccination. Pt has suffered from encephalopathy with no other known source. Pt has suffered from delirium, weakness, confusion, tremors. Pt has not improved and continues to undergo assessment and require hospital level care. Pt was independent in all of his activities of daily living, able to self cath, does have mild dementia for which wife does the driving and sets up meds. Pt now requires total A to self feed, complete grooming and hygiene, max assist of 2 for transfers and is not able to walk at this time.
Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe.  The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin.    On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe.  The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
2 weeks post vaccine developed itchy red rash, approximately 3 inch diameter. Went for second dose and noticed a divit in the deltoid muscle with pain still and rash still slightly evident. The divit in the muscle appears to be tone loss or atrophy. The source is 4cm wide and 2 cm deep. Approximately 9 cm distal from deltoid insertion.
I tested positive for COVID-D on July 22 after symptoms began on July 19th.
Swollen face, headache, malaise, measles like rash covering large portions of her body including her stomach, back, face, both arms and legs and buttocks
8sep2021 I had a stuffy nose, nothing more. 9sep2021, I started having sore throat and got worst. 10 sep2021 I had fever and chills. I got tested. Positive for covid. The 4th was 101 fever and it was the worst. Shortness of breath. I checked my oxygen dropped to 95. I felt really tired. for a week. I took Tylenol every 4 hrs for the fever. Then I had really bad headache which lasted for 2 more days. Then I coughing, dry cough. I was sick for total 6 days then my fever went away and chills. That Tuesday I didn't have the fever any more. The headache was still there and everything started improving. On Thursday the sore throat went away. on Friday. On 19 sep2021 i lost a sense of taste of smell I called my doctor 16September2021 and got prescribed for a cough medication Denzonatate . Felt like a was recovering from a bad cold. I went to see the doctor 25 sep2021 -urgent care , I had pressure in my chest and lungs and was painful. was told to take ibuprofen.  I still haven't get completely my sense of taste and smell.
they described it as a nasal swab and that test came back positive; they described it as a nasal swab and that test came back positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  On 26Jan2021, the patient did a rapid test which came negative. The patient did a 2 day test, and get the results back within a 2 days that was, they described it as a nasal swab and that test came back positive. The outcome of events was unknown.  Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123778 same report/drug/AE, different patient.
I had my vaccination on 09/24/2022. On 12/12/2022 I started having fatigue headache and laid in bed for 2 days. I contacted my Pulmonologist on 12/13/2022. I took Paxlovid for 5 days but then a couple days later I tested COVID-19 Positive on 12/26/2022 and spoke to my pulmonologist again on 12/27/2022.  It is affecting my breathing symptoms as of 12/28/2022.
Muscle aches, chills, joint pain, local swelling and pain, fatigue, nausea. First symptom of nausea onset 1hr after injection. Duration of symptoms 40 hours.
This spontaneous case reported by an other healthcare professional, describes the occurrence of pyrexia (99.5 fever) in an 85-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (99.5 fever). At the time of the report, pyrexia (99.5 fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 99.5 (high). The reporter did not provide any causality assessments, concomitant medication or treatment information.
headache; had chills; freezing; body aches; got really hot; passed out; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at 13:15 at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Mar2020 to an unknown date.  The patient's concomitant medications were not reported. On 24Jan2021, the patient experienced at 4:00 she was freezing and had chills and body aches. At 7:15, she felt body aches and a bad headache. Things started spinning and she passed out. After that, she got really hot and she went back to bed and stayed in bed until 14:00. It seemed very severe. She didn't have a fever, but her body hurt like she did. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Swelling, redness and heat (cellulitis) of left upper arm. Diagnosed on 9/7/2023. Treated with Keflex 500 mg tabs 1 tab three times a day and Benadryl 25 mg tabs 1 tab three times daily as needed. Symptoms starting to resolve after 4th dose of antibiotic.
N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness N93.9 - Abnormal uterine and vaginal bleeding, unspecified
intermittent fever; chills; intermittent fatigue; overnight muscles aches; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 16Feb2021 at 11:15 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history was not reported. There were no concomitant medications. No other medications were administrated in two weeks. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 27Jan2021 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation and experienced slight ache around injection site. On 16Feb2021 at 18:00, the patient experienced intermittent fever, chills, intermittent fatigue, overnight muscles aches/ sensitivity (all body, not just at injection site). The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Severe vomiting, diarrhea, dehydration. Passed out and ambulance called.
Patient reported baseball sign knot at vaccine administration site and very painful. Remained swollen and painful >24 hours after
Developed bilateral joint pain in knees later in evening; large size of 21/2 X 2 1/2 area at injection site, red, raised warm to touch
Large local hypersensitivity reaction with onset on day 9. Resolved with Benadryl.
26-28 hours, post vax, had extreme diarrhea that lasted 5 days, off and on. 28-30 hours, post vax, had vomiting which returned after any solid food eaten, for 5 days. Then I got a 2 week head cold.