chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking all over /felt a little shaky; dizziness; heavy breathing; weakness; My heart rate was at 96 all day while laying in bed.; felt a little shaky; had a little upset stomach but no vomiting; chilled; fatigue; temperature up to 101F; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness) and HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease and Liver disorder. Concurrent medical conditions included Asthma and Blood pressure.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue), PYREXIA (temperature up to 101F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, TREMOR (shaking all over /felt a little shaky), RESPIRATORY RATE INCREASED (heavy breathing), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue) and PYREXIA (temperature up to 101F) had resolved. On 07-Feb-2021, DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 101 f (High) temperature up to 101F. On 06-Feb-2021, Heart rate: heart rate 96 (High) Heart rate 96. On 06-Feb-2021, Respiratory rate: high (High) heavy breathing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Caller reporting temperature excursion. Excursion occurred on 8/16/2023 which is the date the customer states the products were administered.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml (lot number X006980 and X001000 have been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with expiration dates established as 07-MAR-2025 and 09-JAN-2025, respectively); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml (lot number W038810 has been determined to be valid for  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 04-JUN-2024), both administered for prophylaxis after the vaccines had suffered a temperature excursion on that same date (product storage error) (strength, and anatomical site of administration were not provided). Temperature excursion timeframe was 5 minutes at a temperature of -10.2 degree Celsius (C).; Sender Comments: Keywords :
Mother stated while trying to have a bowel movement had a episode of heart rate dropping and turning purple. Took him to Hospital and was seen by Dr after waiting 2 hours in lobby and experiencing 2 additional episodes' of turning purple.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 21:00, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patient was vaccinated with two doses of GARDASIL 9 for prophylaxis (each dose on a separate unspecified date) (dose, route and lot# were not reported). On an unspecified date, after receiving both doses of GARDASIL 9, the patient developed an unspecified rash on her stomach. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
pt recvd vax & 3 hrs p/vax exp flu-like sx, vomiting, fever; these sx resolved in 24 hrs;
1) 5/21/04 Received primary smallpox vaccination - 3 jabs 2) 5/28/04 Restarted on Accutane for acne flare up 3) 6/6/04 developed papular extremely puritic rash on trunk->arms > thighs  4) 6/7/04 presented for health care on arrival since then has been isolated, RXN for extreme puritis. Without fever, liver, cardiac or CNS involvement. On medical hold (but not inpatient)
Rapid heart rate on day two of third vaccine dose. A couple weeks later also had and still have rib pain/discomfort
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt recieved pfizer and flu vaccines in the right arm. pt then experienced flushing and sweating and then fainting. Rph on duty had pt lie down on her back with her feet elavated. tech then called emergency. paramedics checked her vitals which was normal. A medic checked her heart beat, which was also normal. after 30 minutes, pt was ok and able to leave the pharmacy by herself.
Patient is a 17 year old male with only past medical history of anemia at 1 year of age (resolved with iron and vit C supplementation), who presented to an Hospital on 7/7/21 with 2 days of chest pain radiating to his L arm, generalized upper extremity weakness, SOB, vomiting, found to have an an elevated troponin level of 0.626 with ST segment elevation on EKG, echo reportedly normal.   Patient reportedly tested positive for COVID-19 on 6/6  and subsequently went into quarantine, was re-tested on 6/21 and tested negative.  He arrived on 6/28 and received his 1st dose of Pfizer COVID-19 vaccine on 07/03/21.  Of note, he was told he might feel dizziness and arm achiness after the vaccine but denies he was informed about possible inflammation of or around the heart after the vaccine.  On 7/5 he was awakened in the morning by chest pain 6/10 and shortness of breath that started in the right lower sternal border and progressively moved to the left lower sternal border and then to his L shoulder and arm which he describes as feeling like he had been "punched" or a constant achy feeling.  He took Tylenol x1 on Monday with minimal improvement.  He initially thought it was reflux pain and took tums but it did not improve.  He had one hour of relief but then the pain returned.  He reportedly felt dizzy Monday evening as well.  The pain was absent on Tuesday, but he woke up this morning again with the same chest pain and shortness of breath, prompting him to seek medical attention.  In the outside ED, he had one NBNB emesis that was not preceded by nausea.  En route from Hospital to Hospital he complained of chest pain 7/10 for which he was placed on 2L O2 which reduced the pain to 4/10.  During his admission his troponin levels initially up trended and peaked at 5.67 before beginning to downtrend.  He was diagnosed with myopericarditis and started on ibuprofen three times a day around the clock. He was discharged home on 7/8 with specific return precautions, follow-up appointment with cardiology, and strict instructions to avoid exercising and strenuous exercising until cleared by cardiology.
Within 15 min of vaccination felt hot all over, arm pain, chest pain, nausea, face red. 1:25p RN states gave client BENADRYL 25mg PO. Pt fine at this time. No further problems.
Patient arm has knot and is red and itchly, looks like typical injection site reaction but patient did want reaction reported. No issues with movement and slight pain if touched. Reaction (redness and itching) is gradually improving.
injection in her fat; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (injection in her fat) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-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 PRODUCT ADMINISTRATION ERROR (injection in her fat). At the time of the report, PRODUCT ADMINISTRATION ERROR (injection in her fat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 15-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
PT was found to be complaining of not feeling good and feeling anxious. She was shaking and asking to call 911. PT vitals were 176/111 pulse 130, and oxygen 100. She requested to be taken to be taken to the hospital and that she feels like someone is suffocating her. Nurse offered her some drink and she drank 3 bottles of water.
After my vaccine I felt hot and cold for a few days and general fatigue that happens with every shot. Around 10/30/2021 I began to bleed vaginally and got in touch with my OBGYN and he stated that this seemed to be normal for elderly patients with vaccines being administered. The bleeding did stop after bout 4 days later and still got checked with my OBGYN. They did do an ultrasound and did not find anything out of the normal. Biopsies came back clear as well. The only other thing that came up was surrounding my thyroid. I went in for my physical on March 03rd and with blood work and my THX levels were way out of proportion and not within normal range. I was told to get it checked out as soon as possible, he ordered an ultrasound, a check in with endocrinology as well. Ultrasound did see areas that may be questionable and will be doing additional scans and found that thyroid is off. I am waiting for now a biopsy on Wednesday.
SPIKED A TEMPERATURE/TEMPERATURE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 07:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 07-APR-2021 01:00, the subject experienced spiked a temperature/temperature. Laboratory data included: Body temperature (NR: not provided) 99.3 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 49-year-old female patient who received FLUARIX QUADRIVALENT (batch number L94EX, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
Woke up shaking, temperature 99.7, pulse 104, pain and cramping in left leg which was injected with Botox 3 days before.  For the next 2 days I was too weak to stand.
Woke up with severe chills, shaking,  fever of 100.8,  generalized body aches, generalized sensitive skin, and mild headache.   All symptoms resolved after 1 day.
Patient received vaccine at 4:45pm on 8/25/19 and woke up on 8/26/2019 at 11pm with fever, chills, body aches, exhaustion and pain in and around his entire shoulder this continued until 8/30/2019. It started off slowly and progressed quickly. On 8/31/2019, he woke up feeling better, just tired and vomited a few times in the morning. He has not vomited since this morning and is now drinking Gatorade and was able to eat a piece of toast. He did visit his doctor on 8/29/19 because he has tested positive in the past for Lyme disease so he wanted to rule that out. He was given Doxycycline prophylactically while he awaits his lab results.
pt recv vax & w/in 24hr period pt devel fever 102 & noted redness & swelling @ inj site;marked improvement w/in 24hr duration
September 30th when I woke up  I start experiencing headaches and shortness  of breath . Then from there on I have not been able to feel any better. Muscles are in constant pain and also caught pneumonia the third week of October . I have never had pneumonia or any symptoms.  The biggest downside right now is joint inflammation and pain . I have tried everything. My lips and knees and ankles swell up at random times
Menstrual cycle started two days prior to regularly expected start date, significantly heavier, increased blood clots. Headaches intensified
Child received immunizations 12/11/12. Received phone call at 0255am from mother & grandmother stating child had been crying for hours only sleep approximately 45 minutes before waking crying. Crying "in pain" began approximately 4 hours after shots given. TX 1 Ibuprofen as directed call clinic for any concerns. Client was afebrile per parent, no redness or swelling noted.
Dizziness, altered mental status, unable to move, twitching, unable to talk or respond; pt was admitted to ED and currently in ICU.
Flu; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).    This case involves patient [age and gender unspecified] who experienced flu (influenza), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site.    On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Throbbing pain in upper arm, from site of injection to elbow area for approx 4 hours.
Information has been received from a physician concerning a 20 year old female who on 11-JAN-2007 received the first dose of the Gardasil (lot # 655619/1427F) intramuscularly at the right hip. On 11-JAN-2007, the patient developed subcutaneous fat atrophy, a 2 cm x 1 cm atrophic "dimpled" site in the right hip. On an unspecified date, the patient returned for the second injection and wished to proceed. The patient reported redness and pain with the injection, but did not return for follow-up exam. Additional information has been requested.
Itching/Hives on neck, shoulders, upper arms, chest, back, abdomen, sides, thighs, and upper buttocks
Fatigue, sensitive to cold outside temps causing shortness of breath.  Lack of sleep, no stamina....
Swelling of the lymph node on the same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Dizziness, nausea, fatigue. Got hypothyroid Hashimoto's and POTS shortly after (diagnosed).
Moderna COVID-19 Vaccine EUA - 2 reactions, Vaccination 2-18 Thursday night at 6:15 p.m., first shot.  Diarrhea next morning, no big deal.  Second reaction Sunday night 2-21, severe dizzy speels when laying down lasting less than 30 minutes, 2-22 Monday night, dizzy spell that lasted 4.5 hours.  I called the doctor and was seen on Wednesday. The doctor has no idea what it was from, the dizzy spells have left but she gave me pills for verdigo if it comes back. I told her I had the shot on 2-18 and was due again on 3-18.  LShe asked me to report back to her if the dizziness returns or after I get the second shot hnd have a reaction.  I just wanted you to know of this. Again last dizzy reaction on 2-22.
COVID-19; COVID-19; Primary series + dose 3 booster: Moderna/ Dose 4 booster: Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster, initial Pfizer dose), single (Batch/Lot number: unknown) for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 038A21A), on 09Nov2021 as dose 2, single (Lot number: 039F21A) and on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Low thyroid functioning" (unspecified if ongoing). Concomitant medications included: LEVOXYL, start date: 11Nov2021; MELATONIN; OLMESARTAN MEDOXOMIL, start date: 09Mar2022; PRAVASTATIN, start date: 18Mar2021, stop date: 16Dec2022; VIT B12; VIT D [VITAMIN D NOS]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Primary series + dose 3 booster: Moderna/ Dose 4 booster: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) Positive; (25Dec2022) faintest of faint pink line; (26Dec2022) Positive; (31Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient tested positive for COVID on 16Dec2022 using a rapid at-home test. The patient was treated with Paxlovid from 16Dec2022 to 21Dec2022. On 25Dec2022, the COVID rapid test had the faintest of faint pink line. The patient much better than she had in days. On 26De2022, the patient woke up with harsh symptoms (congestion, sore throat, coughing, etc). She took another at-home COVID test and it turned positive almost immediately. She felt bad for about 6 days and then began to feel a little better. The patient last tested on 31Dec2022 and it was still very positive. She hadn't tested since. Additional information: The patient was taking melatonin with CBD 10 mg.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.