chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. This Consumer reported that a 76-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Jan2021 as 1 ST DOSE, UNKNOWN for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that her husband experienced only shoulder pain. She stated my husband had a sore arm, he (Husband) was fine, he was good with it he just had a sore. The outcome of the events was unknown.
4 minutes post vaccine pt began to have tingling of face, tongue and throat pt states that she also felt that her throat was starting to close and felt mild SOB
The night of when I received my vaccine 03-25-2021, I experienced fever, chills. I took Tylenol for pain. I also developed soreness at the injection site and a red, rash on my left arm. I went to see my doctor, but saw a nurse practitioner who prescribed antibiotics and anti-inflammatory medication. My left arm is still sore at the moment and I have not completely healed.
Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. The evening of 08-MAY-2007, the patient experienced fever. On 09-MAY-2007, the patient experienced ear ache but was afebrile. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 23rd August 2016, the patient received PEDIARIX .5 ml. In August 2016, less than a week after receiving PEDIARIX, the patient experienced fever. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced fever. They had used PEDIARIX for many years and never experienced this type of problem so they are concerned that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation, then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with this complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by same reporter.
pt recvd vax 8FEB93 & devel blister rt hand, rash-fine like heat bumps; h/a, 11FEB93 fever 102;
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
12 hours after vaccination  a low fever emerged increasing to 102 degrees  over  next  8 hours.  Symptoms accompanying fever were extreme skin sensitivity, chills & headache.  Symptoms receded after approx  24 hours leaving only residual flushing of neck & chest skin  which is  a normal post fever response for me.
Patient reported right arm swelling at site of injection on 12/09/19.  Patient does state the swelling is improving.
This case was reported by a healthcare professional and described the occurrence of death nos in a 12-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), MMR II (strain not specified), VARIVAX and PREVNAR. On 21 January 2009 at 07:43, the subject received unspecified dose of HAVRIX (.5 ml, unknown, right thigh), unspecified dose of MMR II (unknown), unspecified dose of VARIVAX (unknown), and unspecified dose of PREVNAR (unknown). On 22 January 2009, 1 day after vaccination with HAVRIX, after vaccination with MMR II, PREVNAR, and VARIVAX, the subject experienced death nos. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject died on 22 January 2009 from death nos. It was unknown whether an autopsy was performed. It was reported the subject had "no history of illness or medical problems. Not on medications at time of death. Medical examiner stated undetermined cause of death on death certificate".  3/5/09 Autopsy report received with COD:  Undetermined.  Manner of Death:  Undetermined. Child had presented to PCP earlier on the DOD with fever and URI sx. 4 vax given taht day. Child remained cranky and put down to nap.  Approx 1 hour later found face down without pulse or respirations.  Resuscitation unsuccessful.
Pain in shoulder area following vaccination. Evaluated on 9/2/2020 and prescribed NSAID for tender to palpation, firm area measuring 1-2inches in right deltoid.  Follow up on 9/9/20 area was less firm to touch and only uncomfortable with movement. Advised additional follow up at that time if no improvement.
Low Grade Fever (100-101 degrees) for 24 hours. Fatigue for 24 Hours.
This spontaneous report was received from a physician via company representative refers to a 6month old female patient. On an unknown date, the patient was vaccinated with dose 3 of ROTATEQ. No concomitant medications were reported. On an unknown date, the patient vomited 4 or 5 times during administration of the third dose of ROTATEQ. The patient recovered and the dose was not re administered. The patient had previously received the first and second doses of ROTATEQ without complications. Additional information is not expected.
Information has been received from a 61 year old female with no pertinent medical history and allergies to medications, food and environments. The consumer reported that she had a reaction to the PNEUMOVAX 23 after receiving a small amount under her skin as a testing for PNEUMOVAX 23 allergic reaction. The reaction consisted of warm itchy red area the size of a nickel. The patient was also tested with a flu vaccine that contained a thimerosal and she had the same reaction. The reactions occurred at the office. No lab diagnostic study was performed. At the time of the report, the patient had not recovered.  Additional information has been requested.
nausea, fatigue, joint pain & redness in legs; nausea began 1 hr p/then subsided; join pain & redness began 2 days p/vax & lasted 2 days;
This case described the occurrence of itching and welts in a 47 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other health care professional.  The pt reported that she had no known drug allergies.  She stated that she had no adverse experiences following the first injection of Engerix-B.  Other medical history and concurrent conditions were not reported.  Concurrent medications included Accupril.  On an unspecified date in November 2002, the pt received the 2nd dose of Engerix-B.  She reported that, one or two days post-immunization, she began to experience itching on her legs and the insides of her arms.  When she would scratch these areas, welts would develop.  She was seen by her primary physician and a dermatologist.  She stated that she "had to soak in ice cold water".  The events were also treated with diphenhydramine and topical triamcinolone.  She stated that the events resolved after two to four weeks.  She reported that her primary physician and dermatologist considered the events to be unrelated to Engerix-B administration. She planned to consult an allergist.
I experienced overactive bladder and excessive urination  starting a couple weeks after the 2nd dose of Moderna vaccine for Covid-19. I then experienced fatigue and headache along with an early and excessive menstrual cycle lasting longer than normal by 10 days so far. The bleeding is on and off heavy and I am very concerned that my menstrual cycle is interrupted and still going on for 15 days.
sore arm; mild headache; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included UTI. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Urinary tract infection, LORATADINE (CLARITIN [LORATADINE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], LEVOTHYROXINE, ZINC, COLECALCIFEROL (VITAMIN D3), AMLODIPINE, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) and PANTOPRAZOLE for an unknown indication.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg twice a day and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache) and FATIGUE (little tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a sore arm, was a little tired, mild headache for about a week.   This case was linked to MOD-2021-348139 (Patient Link).
Localized site reaction. Arm is hot to touch, swollen, and red throughout the entire Deltoid area.
The night vaccine was administered fainted twice, sweating and hot when she got up in night. Husband found twice unconscious. Hurt back due to fall.
1 week after receiving the varicella vaccine, my daughter reported that the injection site was itchy. We applied some Benadryl cream several times. By the next day, there was a 2' raised red circle around the site. I called the Dr's office and was advised to give ibuprofen and apply ice. The area continued to worsen, to the point my daughter was limping from pain in her upper leg. Her lymph nodes in the area were also swollen. By Friday of the same week, the area around the injection site had doubled in size and was spreading. It was hot to the touch, swollen and painful. We returned to the Dr and my daughter was prescribed an antibiotic and steroid. Now, 3 days after beginning the antibiotic, the swelling and redness are almost gone.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 07-JUL-2016, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
severe muscle pain (arms, legs, back); swelling and redness at the injection site; Redness at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 59-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 15May2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. 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. Concomitant medications were not reported. On 21May2021 at 08:00 (day 7 and 8 after the first dosage), the patient experienced severe muscle pain (arms, legs, back) and swelling and redness at the injection site. No therapeutic measures were taken. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle pain (arms, legs, back) and swelling and redness at the injection site was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 28OCT94 5PM started having sx 29OCT 12noon fever, chills, vomiting, couldn't hardly breath-4PM went to ER 7PM 30OCT saw MD said viral flu w/bronchial spasms, given Albuterol tx in ER;
This morning she also felt fatigued and had a stomach ache.; This morning she also felt fatigued and had a stomach ache.; Sore left arm started yesterday 6/2.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Jun2021 (Lot number: EW0185) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; CLARITINE. Vaccination history included: Bnt162b2 (Dose; 01, Lot number: EN5318, Route of administration: Intramuscular, Anatomical Location : Arm Left), administration date: 12May2021, when the patient was 12 years old, for COVID-19 immunization, reaction(s): "Sore left arm", "Tiredness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Sore left arm started yesterday 6/2."; FATIGUE (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 03Jun2021, outcome "not recovered" and all described as "This morning she also felt fatigued and had a stomach ache.". Therapeutic measures were not taken as a result of pain in extremity, fatigue, abdominal pain upper.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: Sore left arm, fatigue, stomach ache. Sore left arm started yesterday 02Jun. This morning she also felt fatigued and had a stomach ache. Date of start of reaction/event: 02Jun2021, Outcome of reaction/event at the time of last observation: Not recovered /Not resolved. Hospitalization Prolonged: No, Prior to vaccination, was the patient diagnosed with COVID-19?:No, Since the vaccination, has the patient been tested for COVID-19?:No.   Follow-up attempts are completed. No further information is expected.
PATIENT  FAINTED AND BECAME UNRESPONSIVE BUT BREATHING WITH PULSE, PARAMEDICS  ARRIVED WITHIN FEW MINUTES, PATIENT CALLED FEW HOURS LATER TO INFORM US THAT SHE IS OK AND HER ADVERSE REACTION WAS DUE TO HYPOTENSION.
Patient felt a little ill after the first Moderna covid-19 vaccine; felt tired; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache) in a 69-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache). At the time of the report, VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported.
Headache; Sore arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore arm from shoulder to elbow) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Patient medication history was not provided by the reporter.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ARTHRALGIA (Sore arm from shoulder to elbow). On 19-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. On 19-Mar-2021, ARTHRALGIA (Sore arm from shoulder to elbow) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
This spontaneous report was received from a female patient who was also a pharmacist. On an unknown date approximately in August 2012, about 2 weeks ago, the patient inadvertently touched a drop of reconstituted ZOSTAVAX with her finger. Sh immediately washed her finger and no adverse event was reported. No concomitant medications were reported. This follow up spontaneous prospective pregnancy information as received from a pharmacist for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The pharmacist reported while mixing ZOSTAVAX to administer to a patient, she injected the diluent into the ZOSTAVAX vial and withdraw it, she noticed there was a little ZOSTAVAX left in the vial so she re-injected to diluent to get full dose. She administered the vaccine with no issue but when she picked up the used vial to discard she noticed it was wet. She feared touches the vaccine might be dangerous because she was pregnant and called manufacturer to be sure it was ok and it was. The pharmacist touched it with a naked hand, but her skin was intact. There was no issue with vaccination patient. The pharmacist reported that on 19-SEP-2012 15:00, she was administered into the left arm, with the first dose of FLUZONE. Thiel pharmacy was pregnancy before getting the vaccine. Her gestation age at initial exposure to ZOSTAVAX was unknown. The LMP and EDD were not known. The pharmacist's trimester of exposure was unknown. Additional information has been requested. 20DEC2012 This is an amended report. An event of accidental exposure was added to the case.
I received my Covid19 shot on 10/26/21 around 11am. After receiving the shot it triggered my neorathphy up to my kness which lasted about an hour. The next morning I woke up with chills, fatigue and drowsy. Around 3:15pm I got up to use the restroom and felt lightheaded. Once I stood up I had a seizure  and blacked out. I was unresponsive and a family member called EMS. Once I came too, I had a severe headache that lasted about a day.
Patient had her 3rd Pfizer booster shot on 9-27-2021. She started to develop easy bruising. I saw her on 10-29-2021 with petechiae, oral hemorrhages, tongue hematoma, and diffuse bruising. I sent her by EMS to hospital and they confirmed ITP from vaccine. She was admitted and is now being managed by hematology with platelet transfusions, IVIG, steroids, and now Rituxan.
Tachycardia x 2+ months 3 trips to the ED, 30 day heart rate monitor followed by cardiology.  Echocardiogram.  March 9th I was driving with my 7 year old in the car and had to pull over and call 911.  First month symptoms were dizzyness and shortness of breath, tachycardia and chest pain.  I went from being a healthy runner/weight training to no working out.  I cut coffee and caffeine and kept a food diary to see if anything helped, nothing did.  At month two tachycardia slowed and is now more regulated.  My current  symptoms remainining are chest pain/pressure.  Cardiology believes this is inflammation post vaccine, as my overall cardiac workup was healthy.  Cardiac MRI is an option.  No medication was given.  I have completely changed my diet to anti inflammatory, changed my workouts to yoga, and am dealing with residual symptoms that have altered my life.
Patient describes he started to get a migraine on and off behind left eye and left side of neck starting about 1 week after vaccine received, pain started on 3/23/2021 and has continued since that date, on and off.  Taking Tylenol and alternating with ibuprofen to help with the symptoms of pain.
Within a couple of weeks following the second injection, "I" started experiencing Left and right shoulder pain; Muscular discomfort; Lack of range of motion. It has been basically noticeable since February with some days more intense than others; Able to relieve some pain thru exercise such as Pickleball and find it worse when I do nothing. Such as sleeping! Cannot sleep on my stomach at all anymore.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 12Feb2021 at 09:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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. The patient received other medicines (unspecified) within two weeks prior to vaccination. The patient previously received pseudoephedrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 09:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 12:00, within a couple of weeks following the second injection the patient started experiencing left and right shoulder pain, muscular discomfort and lack of range of motion. It had been basically noticeable since an unspecified date in Feb2021, with some days more intense than others. The patient was able to relieve some pain through exercise, such as pickleball and found it was worse when patient did nothing such as sleeping. The patient could not sleep on stomach at all anymore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event shoulder pain and included exercise, such as pickleball. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left and right shoulder pain, muscular discomfort and lack of range of motion and could not sleep on stomach at all anymore were not resolved at the time of this report.