chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. The was no information about patient's medical history, concurrent condition and concomitant therapy. The patient was vaccinated with M-M-R II (lot # L028273, expiration date 28-JUL-2017) via unknown route of administration for prophylaxis (dose not provided). It was reported that M-M-R II was improperly stored before vaccination. The storage temperature was 50 F and time frame was 1440 hours. No adverse effect was reported. This case is linked with 1612USA004760 (same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1612USA004760.
pain started on upper stomach straight up to the heart area; soreness of lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area) and LYMPHADENOPATHY (soreness of lymph node in left arm) in a 70-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Apr-2021, the patient experienced LYMPHADENOPATHY (soreness of lymph node in left arm). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area). At the time of the report, ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area) and LYMPHADENOPATHY (soreness of lymph node in left arm) outcome was unknown.            Concomitant medications were not reported.   Lab data on an unknown date include Blood pressure measurement and Pulse rate which are normal.  Treatment was not reported.   This case was linked to MOD-2021-066529 (Patient Link).
pt recv vax;low grade T started w/in 1hr p/ vax;apap & tepid bath;pt sitting upright when head dropped to chest,started jerking(sz?)to er;exam in er;instructed apap as needed;runny nose & watery eyes;afebrile 2 days p/ vax;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really Bad Side effects) 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 VACCINATION COMPLICATION (Really Bad Side effects). At the time of the report, VACCINATION COMPLICATION (Really Bad Side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Reporter did not allow further contact
Cellulitis, antibiotics, in progress. Rash, steroids, in progress.
pt recv vax 2DEC96 & red cross on 30DEC96 indicated that was hepatitis B surface Antigen positive;all liver function tests & tests for Hep b markers performed on 22JAN97 were found to be negative;on exam pt reportedly feels great & has no s
temp to 104 noc of vax;parents gave APAP;temp @ time of exam 7MAY96 @ 9AM was 99.2;
3cm Bilat Swelling thighs, no fever, mild pain able to walk and run
Injection given on 4/18/05 pt (donor) reported it to us on 5/16/05 at time he stated his arm was very sore. Appt was scheduled with physician and (donor) did not return 5/18/05.
Arm pit became swollen; Arm pit became painful when she moved her arm; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Chills; Nausea; Headache; Body aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date 26Mar2021 12:20 (Lot number: ER8727) at the age of 43 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing); "Frequent UTIs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Anatomical Site of injection: Arm), administration date: 05Mar2021, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. The following information was reported: CHILLS (non-serious) with onset 27Mar2021, outcome "recovered", described as "Chills"; NAUSEA (non-serious) with onset 27Mar2021, outcome "recovered", described as "Nausea"; HEADACHE (non-serious) with onset 27Mar2021, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 27Mar2021, outcome "recovered", described as "Body aches". Therapeutic measures were not taken as a result of chills, nausea, headache, pain.  No follow-up attempts are possible. No further information is expected.
Within an hour I had a rash at the injection site, malaise, exhaustion, and headaches. At 6pm, 3 hours after injection, I was watching TV & suddenly couldn't see the faces on the screen & then saw a C-shaped zig-zag with an aura around it when eyes were open or closed. It went away after about 30 minutes. At 9PM, I developed teeth-chattering chills and flu-like symptoms, went to bed. All symptoms were gone in the morning with the exception of the malaise and exhaustion which lasted over a week. I let my primary care physician, optometrist, and ophthalmologist know of my symptoms. My opthalmologist asked me to come in and he gave me a dilated eye exam. My eyes were fine and he confirmed I had experienced an ocular migraine after the vaccine.
Cellulitis left upper arm; Treated with Levaquin 750 daily for 10 days
Heightened senses, smell, hearing, skin; Smells made the patient sick; Change in body thermostat...I'm usually cold, and I have been hot ever since 4 days later; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Still tired; Aching (mostly due to wretching so badly); This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and allergy to lithium (allergy to metal). Concomitant medications included bipolar medication (Unspecified) from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 26Mar2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 23:00, the patient experienced heightened senses, smell, hearing, skin. All smells made the patient sick. Change in body thermostat. The patient was usually cold, and had been hot for 4 days. The patient vomited (dry heaved) for a full 12 hours, about every 35-40 minutes. Still tired and aching (mostly due to retching so badly). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heightened senses, smell, hearing, skin, all smells made the patient sick, change in body thermostat and had been hot, vomited (dry heaved) for a full 12 hours, tired and aching was resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
sinus pressure started; congestion; pounding headache; fevers lasting almost  2 days; I could not get out of bed, a lot of aches as well; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 11:00 (Lot number: FA7485) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 2020 (unspecified if ongoing); "High fever", start date: 2020 (unspecified if ongoing); "lots of aches", start date: 2020 (unspecified if ongoing); "cough", start date: 2020 (unspecified if ongoing); "congestion", start date: 2020 (unspecified if ongoing). There were no concomitant medications. Past drug history included: Vitamin d supplements, notes: Verbatim:  I take vitamin D supplements, along, with other vitamins like C from time to time.; Vitamin c, notes: Verbatim:  I take vitamin D supplements, along, with other vitamins like C from time to time. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious) with onset 09Aug2021, outcome "recovering", described as "sinus pressure started"; PAIN (non-serious) with onset 07Aug2021, outcome "recovering", described as "I could not get out of bed, a lot of aches as well"; NASAL CONGESTION (non-serious) with onset 09Aug2021, outcome "recovering", described as "congestion"; HEADACHE (non-serious) with onset 07Aug2021, outcome "recovering", described as "pounding headache"; PYREXIA (non-serious) with onset 07Aug2021, outcome "recovering", described as "fevers lasting almost  2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paranasal sinus discomfort, pain, nasal congestion, headache, pyrexia.  Additional information: Patient did not received other vaccine in four weeks and Other medications in two weeks. No Covid prior vaccination. Patient was not Covid tested post vaccination. No known allergies. Patient had Covid last year, with high fevers,lots of aches, cough, congestion. well finally decided to get the vaccine and had fevers lasting almost 2 days along with pounding headache, She could not get out of bed, a lot of aches as well, it was very scary. On day three the congestion and sinus pressure started. On day 5. She have had to miss work, She felt better but she was still congested but no fevers. Her husband had the vaccine same day he only had a sore arm, nothing else. Other medical history: Her covid diagnosis was in 2020. with her annual visit she still had antibodies. She do not have any chronic conditions and not on any chronic medications. She took vitamin D supplements, along with other vitamins like C from time to time.  No follow-up attempts are possible. No further information is expected.
101 temp, chills, no energy, sore arm took Tyenol and rested
CHIEF COMPLAINT:   pt c/o fever starting approx 11am today.  It was just walkin and told to come for further workup.  -sob, cp, n/v/d.  Pt had Covid booster 4 days ago.  Pt just had an MRI with some abnormal findings.   HISTORY OF PRESENT ILLNESS:     Patient is a 75-year-old male who presents emergency department with fever.  Patient states that this morning he started to feel very weak and tired.  He states that he noticed that he had a fever of 102.  He went to the walk-in with his significant other and was advised to come to the emergency department for evaluation.  Patient states that he has recently undergone testing and there is concern that he may have cancer.  He states that he feels generally tired.  He states that he does feel short of breath with any exertion.  He has not been coughing.  He denies nausea, vomiting, diarrhea.  He did receive his Covid booster about 4 days ago.
The PAP test came back positive for HPV Type 16; she was not sure if the vaccine involved was GARD ASIL or GARD ASIL 9; This spontaneous report was received from a nurse via a vaccine representative referring to a female patient of unknown age. The patient was not pregnant. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.  On unknown dates (reported as in patient's late 20s to early 30s), the patient received the 3 dose series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, anatomical location and route of administration were unknown) for prophylaxis (reported as HPV prevention). It was reported that the patient was not sure if the vaccine involved was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product name confusion).   On an unknown date (reported as recently), the patient had a papanicolaou (PAP) smear test performed. The PAP test came back positive for HPV Type 16. A colposcopy was performed on patient, which came back negative for HPV Type 16. The reporter was not aware of any error at the lab but was going to further investigate the discrepancy of results. It was reported that the patient had never been sexually active. No treatment was given for the event. The outcome of HPV test positive was unknown. The causality assessment between the event and suspect vaccine was not reported.
tired, joint pain, headache, arm swollen, arm itching, arm pain, arm tender, overall feeling of unwell
This spontaneous report as received from a nurse refers to a 6 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Individual misrepresented vaccination status to staff in order to receive third dose of Pfizer prior to CDC recommendation for booster.
Patient received a PNEUMOVAX-23 vaccination on 9/5/12 around 5:40 pm - injection site was sore that evening - the next morning site was painful, swollen and red, warm patient was advised to go to ER - patient got antibiotic from ER.
Mouth itching and sewlling. Inside the mouth turned black with pus. Also headache. Mouth mostly dry on the right side. Took benadryl night of 2/5/2021 for oral itching and swelling. By 2/11/2021, patient saw her MD. MD thinks gingivostomatisis a form of herpes complex type 1. Prescribed Valtrex and Duke Miracle mouthwase.
Patient developed mild symptoms on 4/15/2021 but was not diagnosed with COVID-19 until she was tested as part of response testing during an outbreak of COVID-19 in a homeless shelter, where she was PCR positive on 4/29/2021
trouble breathing; tremors/extremely shaky; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program COVAX US Support. A female patient (wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, his wife got the 1st dose today 22Feb and now she was experienced an adverse reaction after the first dose. She was having trouble breathing, tremors, extremely shaky (2021). Her heartbeat was 87bpm and oxygen 93. The patient underwent lab tests and procedures which included Heartbeat: 87 bpm, Oxygen: 93. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Blood work done on  06/21/2021 came back with Platelet level @9. Blood repeated 2-3 times on 06/22/2021 and platelet level came back being at 6 -8. Dr. advised to give IViG INFUSION with Steroid to avoid immediate risk of Internal bleeding. Patient was showing signs of Petechiae on her lower legs when at the hospital. Subsequent blood work on 06/25/2021 after IViG  showed a boost in platelet to 138. Weekly blood work has been ordered to check platelet levels and impact activities have been restricted.
swelling @ site of vax 4cm x 3cm lt thigh;swelling & tender;1cm x 1cm rt thigh;
mom called clinic & states pt eyelids swollen, nose running, sneezing, coughing could not breath good this started about 15min p/leaving clinic p/well child visit;mom advised to take child to ER immed & to call back afterward;
White oral discharge; Burning sensation to tongue; Dizziness turning head; This case was reported by a other health professional via call center representative and described the occurrence of oral discharge in a 35-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT).   On 6th October 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced oral discharge, burning tongue and dizziness. The patient was treated with nystatin, lidocaine and prednisone. On an unknown date, the outcome of the oral discharge, burning tongue and dizziness were unknown.   It was unknown if the reporter considered the oral discharge, burning tongue and dizziness to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022187385   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's Comment: The medical assistant reported that the patient received second dose of Twinrix and at an unknown date after the second dose, the patient developed white oral discharge, a burning sensation to tongue and dizziness when turning head. In November 2022, the physician prescribed Nystatin suspension, Lidocaine and Prednisone and gave instructions to return to doctor's office if symptoms persist. It was unknown if symptoms remain. Nothing else was reported. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022187385:Same reporter
Within 24 hours post vax, the child started running a fever up to 103. Seen in office on 8/21/00, exam normal except for a pea sized abscess at HIB injection site. Treated with Keflex. On 8/22/00, the pt experienced a febrile seizure for 5-7 minutes with a 20 minute postictal state. Treated in ER with Rocephin.  Follow up on 03/28/2001: "Patient date of birth, age at time of vacc., adverse event onset date/time, Lot # for vaccine 1,2,3,4 is not provided."
Renal mass; Catheter access port issue; This spontaneous case was reported by a consumer and describes the occurrence of RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue). At the time of the report, RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient received Humira (1156745).  No treatment medications were reported.  The reporter assessed the events as possibly related to Moderna vaccine and did not provide any causality assessment for the events with Humira.  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.