chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Fever of 102°C; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Fever of 102°C) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Fever of 102°C) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (Fever of 102°C) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 102 (High) fever of 102°C.         Concomitant medications was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273  in response to the event was not applicable.
Case number PHHY2011US44327 is an incomplete spontaneous report received from a nurse on 23 May 2011. This report refers to two patients whose age and gender were not specified. They were given only the MenA lyophilized component of MENVEO (batch number: unknown) reconstituted with another solution on an unspecified date. No other adverse reaction was reported.
Fever for 24h Weakness for 36h Nausea for 36h  Delirious while sleeping 24h Hot and cold 24h Intense hair loss after 36h
9/18/12 - 3:30pm - Flu vaccine. 6:00pm - Lt arm heavy, hand - general malaise entire body. ADVIL 400mg with relief. 9/19/12 - Every part of body: shoulders, hands, hips aching. 9/20/12 - ADVIL as directed. 9/21/12 - Symptoms resolving.
please see VARS E-report number: 277022 for additional information. Due to reaction to 1 dose, I requested he come back after 1 hour and 2 hours respectively to check vitals. He came back after 1 hour stating he feels "different and funny." Complained of a froggy throat and that he could feel a heart beat in his ears. At 3:53 PM, pulse was 98 and BP 150/103. Regular respirations=16. skin was warm and dry. no rash or redness noted. no shortness of breath or difficulty swallowing noted. At 4:10 PM, continues to deny pain. BP 165/108 with pulse of 102. 4:17 PM, 147/98, pulse in the 90s. Continued feeling of heart rate in ears.  4:20 PM, 147/94 P 94. remains alert and oriented. continued frogginess in throat and sensation of heart rate in ears. Denies shortness of breath or chest pain.  O2 sats are 99%. Refuses need for ambulance. Agreed to have family member transport to ER for further evaluation. 4:24 PM, 148/103 P 96 Respirations 18. Skin remains warm and dry. Denies pain or shortness of breath. sensation in ears continues. 4:30 PM. 139/99 pulse 84 resp 18. no shortness of breath or chest pain. skin warm and dry. oriented and alert. continued sensation of beating in the ears. 4:32 PM, picked up and taken to ER.
injection given 9/25/2023 pm and on 9/26/2023 evening  parents found upper arm red, warm to touch and area was firm. At time of visit size of redness was 11 x9 cm, was warm to touch and firm. Pt told provider area itched. Provider instructed parent to use ice, Benadryl and return if not better in 24-48 hours.
Sweating; Patient had an upset stomach; Sore left arm / muscle pain; Chills; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ABDOMINAL DISCOMFORT (Patient had an upset stomach), MYALGIA (Sore left arm / muscle pain), CHILLS (Chills) and FATIGUE (Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Decreased immune responsiveness (Patient had a compromised immune system prior to vaccine administration). Concomitant products included ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), ABDOMINAL DISCOMFORT (Patient had an upset stomach), MYALGIA (Sore left arm / muscle pain), CHILLS (Chills) and FATIGUE (Fatigue). 08-Apr-2021, the patient experienced PYREXIA (Fever). On 10-Apr-2021, HYPERHIDROSIS (Sweating), ABDOMINAL DISCOMFORT (Patient had an upset stomach), MYALGIA (Sore left arm / muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 101.2 (High) Reported as 101.2.         Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-064238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-jun-2021 contains No significant information. the patients ridged crescent has  moved approximately way up to nail in the 2 months since the second dose.
No additional adverse events reported; Expired dose of vaccine administered to patient.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-AUG-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # R030453 was confirmed to be valid, expiration date 23-JUL-2021, for prophylaxis (dose, route and site of administration were not reported). No additional adverse event was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report as received from a nurse refers to a 18 month old patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was administered 2 doses of M-M-R II, injection (dose, route of administration, lot # and expiration date were not reported) at 2 different office visits. The same patient was then administered an additional 2 doses of M-M-R II at 2 different office visits (on unspecified dates) when the patient was 3 years old. No adverse effects were reported. Additional information has been requested.
arm swollen,  painful, and  difficult to move.  headache and stiff neck.  body aches. chills. extreme fatigue. I got the shot Monday morning. the arm pain started that evening and by Tuesday morning I had all of the above.  it was very difficult to make it through the work day. several times I had to put my head down on my desk and rest.  after work I went home and went to bed and slept until Wednesday morning.  the arm was still a little tender to the touch Wednesday but that slowly faded away.
Mom reports c/o sore throat w/in 1 hr of vaccine. Fever that evening up to 102 at ER by 11pm. ER Notes Temp 38.2, asleep, no distress,  no rash, c/o sore throat.  DC Dx: 1-Acute allergic reaction  2-Febrile Illness  3- RLL Pneumonia
This spontaneous report as received from a nurse (patient's father) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was vaccinated with GARDASIL intramuscularly, first improperly stored dose on 15-DEC-2015, second improperly stored dose on an unknown date in February 2016 and third improperly stored dose on an unknown date in June 2016. The vaccine was exposed to temperature of "below 35 Fahrenheit" several times. It was unknown if there was any previous temperature excursion. The reported nurse received a letter from a physician that revaccination series of GARDASIL need to be repeated however the reporter did not receive the complete temperature excursion details. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Minutes after first HPV vaccine:  My healthy 11 yr old son, fell to the floor, jerked for a second and was in a fog for the entire day/evening.  He had very severe nausea.  He had a CAT-scan because we thought he may have had a concussion.  It was horrific.
Friday, December 3, I felt tingling in my right shoulder and then down into my forearm.  Drank 100oz of water.  Awakened Saturday morning and my body ached all over, it hurt to make a fist, it hurt everywhere, my skin felt like it had been rubbed with coarse sand paper all over.  I checked my temp and I had a 101 temp (normal is 97.8).  I took 500mg of Tylenol every 6 hours and that lowered my temp to 99.1.  I was still uncomfortable and no sweating occurred.  I woke on Sunday and the discomfort had intensified and my temp was reading 103.  I took 1000mg of Tylenol and 2 hours later I began to sweat and the temp was dropped to 101.  My skin, muscles and tendons hurt.  I took 500mg at 1pm and alternated to Motrin (200mg) at 4pm and lastly Tylenol (500mg at 9pm with a 101 temp remaining.  On Monday, I woke to a 101 temp and the only place where muscle pain existed was on the sides of my neck and right below my rib cage on my back.  Continued 500mg of Tylenol at 7am, 1pm,  Motrin (200mg) at 5pm and Tylenol (500mg)at 11pm.  Tuesday I woke to no pain and no need to take any pain meds.  Wednesday I woke to body skin aches and started the Tylenol again.
Tingling sensation; Numbness/numbness of left hand going up to left forearm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   Reporter did not allow further contact
The patient presented with increased fever, headache, nausea, slight jaundice, and increased LFT's. The patient was hospitalized for 2 weeks.
Arrhythmia/ irregular heart beat; AFib; Arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia/ irregular heart beat) and ATRIAL FIBRILLATION (AFib) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21D and 003B21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart pounding in October 2019, Pain in October 2019, Dizziness in October 2019, Feeling hot in October 2019 and Sweaty in October 2019. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced ARRHYTHMIA (Arrhythmia/ irregular heart beat) (seriousness criteria hospitalization and medically significant) and ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is hurting). The patient was hospitalized from 10-May-2021 to 11-May-2021 due to ARRHYTHMIA and ATRIAL FIBRILLATION. At the time of the report, ARRHYTHMIA (Arrhythmia/ irregular heart beat) and ATRIAL FIBRILLATION (AFib) outcome was unknown and PAIN IN EXTREMITY (Arm is hurting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Heart rate: abnormal (abnormal) Irregular heart rate. Diagnosed with AFib..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included medications to lower heart rate at hospital.  The patient states that their physician had the Cardiac Lab values of the tests that were performed during hospitalization.  Patient described some symptoms including heart pounding at 200 beats per minute, pain, dizziness, feeling hot and sweaty before receiving the Moderna COVID-19 vaccine, on Oct 2019.  The patient had not been infected with COVID-19. The patient doesn´t have a history of Myocarditis/pericarditis.   This case was linked to MOD-2021-417305, MOD-2021-418016 (Patient Link).; Sender's Comments: This case concerns a 44-year-old, female patient with relevant medical history of palpitation, who experienced the unexpected events of Arrhythmia and Atrial Fibrillation. The events occurred approximately 25 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. This patient's underlying medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Fever, chills, body aches, headache.  Injection site is red and inflamed.   It is also swollen and a hard lump.
pain following injection; fever; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2021SA425655.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain following injection"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of pyrexia. Additional information: On an unknown date, the patient developed a non serious pain following injection (injection site pain) and fever (pyrexia) (unknown latency) following the administration of diptheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)HIB(PRP/T) vaccine and Prevnar 13. It was reported that pentacle is generally given at the same time and is likely cause of fever. The patient was treated with Tylenol (paracetamol) and Advil (Ibuprofen) for fever. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At time of reporting the outcome was unknown for all the reported events. There will be no information available on the batch number for this case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Discomfort and minor swelling  inferior  to right mandible, possibly lymph gland.
Information has been received from a nurse referring to a currently 12 years old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 lot # 1581027, expiration date 03-JUN-2021 for prophylaxis (strength, dose, frequency and route were not provided). The outcome of improper storage of product in use was unknown. The storage temperatures of the GARDASIL 9 was reported as -11.9 degrees Celsius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No adverse effects reported. No product quality compliance provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010666: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004571: US-009507513-1904USA004572.
15Aug90 pt vax; 24Aug90 devel temp 103-104F.  Tx w/ APAP & cool baths.  Fever persisted & presented to ER.  spinal tap neg.  Fever subsided; however devel rash.
I had symptoms on the 26th and tested positive on the 27th of January. I had headache and a dry cough. When I decided to test the symptoms worsened, and tested because I had an appointment. I called my PCP and they said to use any over the counter medication for headache relief and isolate for 5 days. Basically, wait to feel better and test after 10 days. I got sicker during isolation and called a on call doctor, and we discussed taking Paxlovid and that's what I did. I was so sick that during the five days of taking it left a terrible taste. I had more symptoms during that time as well. I had mark malaise, fatigue and a productive cough that was painful in my throat and ears. The headache was quite bad. By the time I finished the Paxlovid, in terms of symptoms they did back off a little. I feel good now.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Aspirin, Calcium, Magnesium, vitamin D, ZYRTEC, MOTRIN, SYNTHROID and Turmeric. On 14th May 2018, the patient received the 2nd dose of SHINGRIX. On 14th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms, fever and tiredness. On 17th May 2018, the outcome of the injection site pain, influenza-like symptoms, fever and tiredness were recovered/resolved. The reporter considered the injection site pain, influenza-like symptoms, fever and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient was retired cardiac Catheterization Technician. The patient experienced pain at injection site immediately upon receiving dose. Less than a day after receiving vaccination, the patient experienced tiredness, flu like symptoms and low-grade fever that worsened next day. The patient was unable to provide full demographics for hospital where she received the SHINGRIX or for the prescriber. This case was linked to the case US2018GSK097130, reported by the same reporter for her husband.
Report 2010116591 described itching in a 57 year old female who received hep B vaccine (Engerix-B). This report was received from a consumer and has not been verified by a physician or other healthcare professional. The vaccinee's allergies were unspecified. Her medical histor included cervical cancer. She took estrogen. On 10/06/2000, the vaccinee received her 1st left deltoid dose of Engerix-B. Within 1-2 days post vaccination she experienced itching which did not resolve.
On 11/18/1999 pt experienced a lesion on the left shoulder. On 11/19/1999 pt experienced a single lesion on the left hand. By 11/20/1999 she had clusters of blister like, red, raised, rash from the deltoid area down over the dorsum of the arm and onto the fingers. Pt also experienced pain. A visit to a physician was required and the dx of shingles was confirmed. One week after onset, the pt recovered.
Severe dizziness, lasting 2 days from onset. Went to emergency room. Follow up visit to P.C physician on 2nd day.
LOSS OF SENSATION IN THE WHOLE LEFT ARM REACHING HAND AND FINGERS; NUMBNESS AND TINGLING; SORE ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and did not had medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced loss of sensation in the whole left arm reaching hand and fingers. On 08-APR-2021, the subject experienced numbness and tingling. On 08-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, loss of sensation in the whole left arm reaching hand and fingers, and numbness and tingling. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
On Tuesday arm (R) became painful - swollen and red. Pt took TYLENOL all day. On Wed 6/309 Pt begins with "spinal pain" body aches, headaches, hip pain, malaise. Given 125 mg SOLUMEDROL.
developed a pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (developed a pulmonary embolism) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (developed a pulmonary embolism) outcome was unknown.            Concomitant and treatment medication was not provided.  Patient was asked should take the second vaccination. Company Comment : Very limited information regarding this event and temporal association have been provided at this time. Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event and temporal association have been provided at this time. Further information is not expected.
Patient received 2nd booster today - she registered and attested to being over 50, but is only 46. System allowed her to register and question did not flag red. Vaccine was given, patient monitored for 15 minutes according to protocol. Patient discharged in stable condition.
On 02/2023 in the morning my son had sore throat, fever, stomach aches, and fatigued. I took him to the urgent care right way. At the urgent care they did a Strep Throat test which was positive. They prescribed him with amoxycillin for 10 days.