chrisvoncsefalvay/vaers-outcomes huggingface dataset:
super tired; blood pressure elevated (170/93, 160/89); feeling shaky; lightheadedness; nausea; lower back was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), NAUSEA (nausea), BACK PAIN (lower back was sore), BLOOD PRESSURE INCREASED (blood pressure elevated (170/93, 160/89)) and TREMOR (feeling shaky) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Jan-2021, the patient experienced DIZZINESS (lightheadedness), NAUSEA (nausea) and BACK PAIN (lower back was sore). On 23-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure elevated (170/93, 160/89)) and TREMOR (feeling shaky). On an unknown date, the patient experienced FATIGUE (super tired). At the time of the report, DIZZINESS (lightheadedness), NAUSEA (nausea), BACK PAIN (lower back was sore), BLOOD PRESSURE INCREASED (blood pressure elevated (170/93, 160/89)), TREMOR (feeling shaky) and FATIGUE (super tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Blood pressure measurement (93-170): mmhg 170/90, 160/89 High. On 24-Jan-2021, Blood pressure measurement (93-170): mmhg 150/79 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Tylenol.   Reporter did not allow further contact
Still battles with heat flashes and Nausea; Heat flashes all over the body; Heart Rate went up right away post vaccination; Nausea following heat flashes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Heart Rate went up right away post vaccination), HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2020, the patient experienced NAUSEA (Nausea following heat flashes). On 07-Jan-2021, the patient experienced VACCINATION COMPLICATION (Heart Rate went up right away post vaccination). On 14-Jan-2021, the patient experienced HOT FLUSH (Heat flashes all over the body). On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (Still battles with heat flashes and Nausea). On 07-Jan-2021, VACCINATION COMPLICATION (Heart Rate went up right away post vaccination) had resolved. At the time of the report, HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
No additional AE details or PQC.; an improperly stored VARIVAX was inadvertently administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W016746, expiration date: 23-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) inadvertently that experienced a temperature excursion (product storage error). No additional adverse event details.  The vaccine experienced a temperature excursion of 5.8 degrees Fahrenheit (F) for 2 minutes. There was no previous temperature excursion.  This was one of the two report due to the same reporter.; Sender's Comments:  US-009507513-2303USA005072:02352904
On 1/18/2021, at approximately 02:00 AM, I woke up with extreme pain in my right arm. The pain radiates from the shoulder/bicep down to the forearm. The pain did not subside until later in the evening. I continued to have discomfort and pain on and off throughout the week. On 1/25/2021, I again woke up with extreme pain in my right arm. I have tried ibuprofen and different arm positions to reduce the pain and discomfort without any luck. The arm is tender/sore.  I am not sure if this is a reaction to the vaccine or if the needle protruded too far when administered.  I have an MRI scheduled to rule out any type of injury.
Tingling and burning in legs and feet and numbness and tingling in hands and across back, muscle loss in legs and cause me to fall 3 times. Lost the use of my legs. Had hard time using my hands.
Macular Papular rash entire body. Blanches. Temp 101 2 days ago.
Two weeks after MMR & Varicella vaccination. Red rash on chest, legs, neck and face. Physician diagnosed as "measles" rash. Also a raised rash on face, neck and ears. Child was put on Motrin.  Resolved in two weeks.
03/20/19 Soreness at injection site a few hours after 4pm. 03/21/19 2am muscle stiffness and soreness. Woke at 5am with joint and muscles aches, headache, tiredness, not hungry but no nausea. 11am still feel the same.
She spiked a 104.5 fever. Ibuprofen only brought it down to 102. She broke out in hives starting at 1:30 PM on 04/15/2016 and has been extremely nauseous.
Patient had pneumonia related to covid, severe sepsis related to perforated bowel with peritonitis and covid pneumonia.  Patient was transitioned to inpatient hospice and passed away on 2.12.22.
Initial misuse report received from a healthcare professional on 27 September 2013. The case was received on 21 March 2014. The patient had received FLUZONE HD and FLUZONE was given to a patient at the same visit. No adverse event was reported. List of documents held by sender: none.
Intense radiating lower back and leg pain for 1 week. Increasing numbness over weeks in left foot and leg. Left with extreme numbness in left toes and foot.
Redness & swelling at localized area (left thigh). N/T able to walk.
Starting 4 hours post injection, patient developed severe chills and goosebumps. About a week later she developed hives and welps. She called 911 and was taken to the emergency room.
Pt. complained of dizziness, nausea, sweating, blurry vision. No temp. BP was normal. He had an empty stomach when he got the shot. Paramedics were called. No treatment was needed. Pt. was sent home. He recovered within 20 minutes.
Fever; Headache; Stomach ache; Nausea; Rash on chest, stomach and arms; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, headache, stomach pain, nausea and rash. On an unknown date, the outcome of the fever, headache, stomach pain, nausea and rash were recovered/resolved.   It was unknown if the reporter considered the fever, headache, stomach pain, nausea and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient  stated that within few hours of getting the first dose of Shingrix she experienced fever, headache, stomach ache and nausea that lasted for total of 2 days. The patient also experienced a rash that was most prominent on chest and stomach and also present on her arms. The patient did not consent to follow up.
Case number PHEH2015US017500, is an initial spontaneous report from a consumer received on 03 Sep 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with intramuscular dose of FLUVIRIN (batch number: 1514501) that had a temperature excursion of 50 Fahrenheit for 2 hours on 03 Sep 2015. Reporter stated the temperature excursion was due to a power failure at the store and further there was no issue with temperature since then. No further information was provided. No adverse event was reported following the maladministration. Follow up information received from the consumer on 02 Oct 2015: Narrative comments updated.
Woke up in morning with fatigue, muscle aches and sensation of "pins and needles" in both arms, legs, hands and feet.
Information has been received from a 69 year old female consumer with a penicillin allergy and a history of pneumonia (1993, 1995 and 1996), who in approximately 1999 or 2000 was vaccinated with the first dose, and on 02-APR-2008 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). On 02-APR-2008, following the vaccination, her arm was sore, warm to touch, and slightly red. She reported the pain and swelling started about 2 to 3 inches above her elbow and extended to the middle of her left breast. She also reported she had some bruising at the site where she had blood drawn (site not specified). At the time of this report, the patient had not recovered. She sought medical attention by telephone (treatment not specified). Additional information has been requested.
DTaP - HiB combo given before 15 months of age. No reactions reported.
symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not sleeping well treatment: resting, sleeping, acetaminophen, drinking fluids all symptoms started approximately 24 hours after the shot was administered. symptoms have not resolved as of typing this at 2117 28January 2021
Diagnosed with Varicella. Received Varivax 08/18/2000.
Pt was admitted on 2/12 for CHF and was a transfer from an outlying facility where he tested COVID negative.  Pt was tested again on 2/14 prior to a procedure and tested positive.
COVID-19; A spontaneous report was received form a physician concerning a male patient who received Modern's COVID-19 Vaccine and who developed Covid-19.   The patient's medical history was not provided nor was concomitant product us. Patient was reportedly recovering from Covid-19.  Prior to the onset of events, (date not provided) the patient received the first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of Covid-19 infection.  The patient was diagnosed with Covid-19 after receiving the first dose of mRNA-1273 on an unknown date. The patient was hospitalized (admission date not provided). Treatment for the illness included mechanical ventilation. No other treatment information nor relevant laboratory/diagnostic tests were provided.  Planned discharge date from the hospital was reported as 27-Feb-2021. The reporting physician asked whether the patient could have the second dose of vaccine which was due on 27-Feb-2021.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, Covid-19, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history, concurrent conditions or allergies. On 13-APR-2015, the patient was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not provided). Concomitant therapies included ALLEGRA. On an unknown date, 2 days after onset of therapy the patient experienced difficulty breathing, chest pain, unspecified "GI complaints", reflux and anxiety. The reporting physician stated that the patient had an abnormal pulmonary function test that showed he had restrictive pulmonary disease, however the physician mentioned the patient did not put forth a good effort with this test due to anxiety. The physician also mentioned the patient had a normal chest X-ray. The patient was seen in the physician's office and was given PREVACID and albuterol as treatment. The outcome of events was reported as not recovered. The reporter did not provide a causality assessment for the events. Additional information has been requested.
Heart palpitation; Heat Sensation; May have anxiety,Terribly frightening; it wakes me up out of my sleep every single night,I can't sleep peacefully anymore out of fear; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation), TEMPERATURE INTOLERANCE (Heat Sensation), ANXIETY (May have anxiety,Terribly frightening) and SLEEP DISORDER (it wakes me up out of my sleep every single night,I can't sleep peacefully anymore out of fear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PALPITATIONS (Heart palpitation), TEMPERATURE INTOLERANCE (Heat Sensation) and ANXIETY (May have anxiety,Terribly frightening). 12-Mar-2021, the patient experienced SLEEP DISORDER (it wakes me up out of my sleep every single night,I can't sleep peacefully anymore out of fear). At the time of the report, PALPITATIONS (Heart palpitation), TEMPERATURE INTOLERANCE (Heat Sensation), ANXIETY (May have anxiety,Terribly frightening) and SLEEP DISORDER (it wakes me up out of my sleep every single night,I can't sleep peacefully anymore out of fear) outcome was unknown.            No concomitant medications were reported.  Per report, the patient experienced heat sensations and severe palpitations following dose,  which interrupted her sleep every night, but not as severe during daytime. She stated that the experience sometimes felt like an imminent heart attack. Results of diagnostic investigations ordered by the patient's cardiologist had returned as negative, as no abnormality was detected. The patient reported difficulty sleeping peacefully for fear of a recurrences at night, and she wanted to know why she had been feeling that way.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received on 02-Aug-2021 in which Event added- (Sleep disorder)
Pt reported tingling in arm that received vaccine and a racing heart. Approximately 30 minutes after administration pt complained of flushed face and swelling in hands but no tingling in arms and her heart racing appeared better. At about 6:20 PM paramedics arrived, assessed patient. O2 stat 99% heart rate and pulse were normal. Paramedics recommended going to hospital. Patient refused.
2/28/2021: Event occurred after 1st Janssen  vaccine.  71-year-old female presents to the emergency department for falls.  Patient states that she has fallen 3 times this week.  Patient is in no respiratory distress.
Rt deltoid with 4x4 (cm) annular area erythema. ZYRTEC given at hm by mom. Will premedicate at 11y Tdap.
Seen on 9/21/00 with area of tenderness and induration where shots were given in upper deltoid. Increased itching, hard and swollen with redness spreading and painful when asked but had not complained of pain. Had a fever this morning but did not measure. Reaction to immunization ? MMRII.
Patient felt funny after shot. EMS was called vitals were taken BP 140/72  100% O2 room air HR 98.  General Malaise  unknown cause patient refused evaluation/care .  Released against medical advice.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-MAR-2014, the patient was inoculated with ZOSTAVAX at a doctor's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-SEP-2015, the patient was treated at a doctor's office by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was treated with famciclovir (FAMVIR) and amitriptyline hydrochloride (ELAVIL) for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Blood pressure rose 190/100; got headaches in 10 minutes and started getting heavy chest; got headaches in 10 minutes and started getting heavy chest; Throat started to get tight, voice changed; Throat started to get tight, voice changed; had heart palpitations; Fast heart beat, difficulty breathing, dizziness and weakness; Fast heart beat, difficulty breathing, dizziness and weakness; Fast heart beat, difficulty breathing, dizziness and weakness; Fast heart beat, difficulty breathing, dizziness and weakness; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK5730), intramuscular on 17Dec2020 17:00 at single dose (left arm) for Covid-19 immunisation. Medical history included diabetic, high blood pressure and allergies to fruits such as canaloo, and peaches. Concomitant medications included amlodipine, loratadine, metformin, and ascorbic acid (VITAMIN C). On 17Dec2020 17:15, the patient experienced headaches in 10 minutes and started getting heavy chest, throat started to get tight, voice changed and injection was given; blood pressure rose to 190/100 and had heart palpitations, fast heartbeat, difficulty breathing, dizziness and weakness. The patient was given Epi injection and benadryl shot as therapy for the events. The vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient visited a doctor or healthcare professional office/ clinic due to the event. The patient was not diagnosed with Covid-19 prior to vaccination and since the vaccination, the patient had not yet been tested for Covid-19. Outcome of events was recovering.; Sender's Comments: Based on the compatible time association ,the reported events are possibly related to suspect bnt162b2 injection in this patient. 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.
Felt dizzy immediately. Nausea started up about 5 minutes later. Extreme pain in injection site.  Felt better so drove home. About 3-4 hours later a red welt/rash appeared about the size of a dime. The it continued to grow to about 5? in diameter with extreme pain. Joints hurt, headache and exhaustion. Main complaint is the welt/rash on arm growing.
Syncopal Episode after shower. Patient developed new onset nausea and dizziness and woke up on the floor. She felt unsteady on her feet for a few hours after the incident. Also experienced shortness of breath about 2.5 hours after the incident.
Redness, (10cm x 5cm) raised, painful 1/2 teaspoon of Benadryl was given with some ibuprofen. Called mom the next morning will come in @ 12:30 to get re-checked.
broke out in a rash; indigestion; pain in his stomach; lost 20 lbs because he can't eat; lightheaded; his memory is shot; This is a spontaneous report from a pharmaceutical company by Pfizer from a contactable consumer or other non hcp. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced broke out in a rash, indigestion, pain in his stomach, lost 20 lbs because he can't eat, lightheaded, his memory is shot. It was reported, the 73 years old male patient reportedly experienced he broke out in a rash and all the while he was having indigestion. The dermatologist healed the rash, but the indigestion continued and about the third or fourth week of April he stared to get pain in his stomach, and it's gotten worse and worse. He has lost 20 lbs because he can't eat. He is lightheaded. and his memory is shot. The clinical outcome for the event broke out in a rash was recovered on an unknown date while event indigestion was not recovered and rest all events were unknown.   No follow-up attempts are possible. No further information expected.