chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu-like symptoms (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)). On 16-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-307638 (Patient Link).
neck pain near the clavicle area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain near the clavicle area".  Additional information: Reporter stated that, patient received the second dose Pfizer COVID vaccine on his left arm on Sunday around 16:30 or 17:00. Patient was having pain kind of like in the neck area, stated in the past half hour and patient is pointed to his left clavicle area, so it's not in the vaccination site, it's kind of like up from it in the neck area, and it really hurts. Patient did not receive other products. Patient's mother was worried that the vaccination was not properly administrated to the patient, and she wants to give Tylenol to the patient and response received: There are reports of muscle pain (38.3%) and joint pain (23.6%), no specific reports of neck pain, this does not necessarily mean that the vaccination could not cause this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On an unspecified date, the vaccinee received her fifth dose of DTaP. On 04/26/00, she developed swelling at her injection site. As of 03/30/01, the outcome of the event is unknown.
I noticed the hair loss significantly got worse after the 4th dose. Hair loss/ thinning on both temples. The front hairline and crown, mostly my whole head, but a very noticeable effect on the temple, like a balding, almost. I have an appointment with my dermatologist on 10/13/2022.
Uveitis/ iritis in left eye.   Light sensitive   Eye pain / inflammation.   Watering eye.   Sore ankles / knees.
Broke out in blisters approx. 5-7 days, post vax. "Thought she had a low-grade fever".
Warm and achy, temp 101, right arm hot and red, nauseous, diarrhea. Right arm was red from the shoulder to the elbow. Went to Urgent care. Dr. diagnosis bacterial infection. Prescribed Keflex.
No other AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 25-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U015689, expiration date 18-MAY-2023, 0.5 milliliter, subcutaneous) after temperature excursion for prophylaxis (product storage error). Temperature excursion was 25.9 Fahrenheit degree for 1 hour and 30 minutes. There was no previous temperature excursion. No adverse event was reported.
the following days after I was very sick now I'm getting the same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the following days after I was very sick now I'm getting the same symptoms) 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 12-May-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 ILLNESS (the following days after I was very sick now I'm getting the same symptoms). At the time of the report, ILLNESS (the following days after I was very sick now I'm getting the same symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
By 8pm on the night of my vaccine, I experienced chills & body aches. Similar to symptoms before experiencing the flu. Was tired. The next morning those symptoms went away and I had a headache for the remainder of the day on 1/9/21.
Patient was given the vaccine and after 15 mins I check on her and her arm started to get a swollen knot area. It was itchy, there was reddness, swelling and her fingers felt tight on this arm. There was no breathing issues or heart racing. Pt was given an ice pack and Benadryl 25 mg orally once. Pt was advised to stay for a little while to make sure she wouldn't get worse. After about another 15-20 mins I checked on pt again. She started feeling "off", she felt "fuzzy", just not right. Pt was also getting sleepy (due to the Benadryl).  Pt was advised to lay down. After another 15 mins we checked on her again. The swelling and redness were going down. She was starting to feel better. After speaking with Dr. again, pt was okay to go home. Advised if breathing or heart racing issues to go to the ED. Pt was taken home by her mother.
This spontaneous report as received from a registered nurse, via company representative, refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were unspecified by reporter. On an unknown date the patient was vaccinated with GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified by reporter. On an unknown date, just after the administration of GARDASIL, the patient fainted. The patient recovered while in the office, without requiring medical treatment. The relatedness between GARDASIL and syncope was not reported. Additional information is not expected because the reporter refused additional contact.
arm pain/somewhat sore/very sore arms; Body aches; Sweating/woke up sweating wet; fever; Chills; muscle aches; tiny cough; froze/cold all day; This is a spontaneous report received from a contactable consumer (patient) in response to Non-HCP letter sent to consumer. This 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03FEB2021 11:00 AM (24 hour clock) at single dose (lot: EL9262) at Arm Left for COVID-19 immunisation. Medical history was not reported. Concomitant medications were none. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot: EJ1685) on 30Dec2020 for COVID-19 immunisation and experienced got covid from 07Jan2021, No reaction. The patient experienced arm pain/very sore arms, 2nd shot Some what sore, Body aches, Sweating/woke up sweating wet, Tiny cough from 03FEB2021, no treatment received. The patient also experienced Chills/2nd shot froze 48 hours treated with Tylenol, Fever treated with Tylenol and Advil, Cold all day from 03FEB2021 and treatment with Tylenol and Advil. No admission to the hospital due to the events. The patient experienced some muscle aches as well. The reported issue occurred after use of Pfizer product. The patient and her husband both got covid dalp after shot as many of their friend have, husband was hospitalized. The outcomes of the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
PT DID NOT HAVE ANY ADVERSE REACTION AT THE TIME OF THE VACCINE ADMINISTRATION ON 01-22-21 AND 02-19-21.  SHE DEVELOPED COVID-19 ON 12-4-21 AND WAS ADMITTED TO A LOCAL HEALTH HOSPITAL. SHE IS STILL THERE BEING TREATED.
PATIENT DEVELOPED A REACTION AT THE SITE OF INJECTION.  WARM TO TOUCH, INFLAMMED, AND RED.  37CM X 37CM.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 30.42.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 13-Feb-2021, Excursion time was 09 AM temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report as received from certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# J014402 with expiration date 13-NOV-2015 and lot#K003412 with expiration date 06-MAR-2016, dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Covid infection after completion of Covid vaccine series 0/15/2020 COVID positive from non-Source 02/26/2021 Covid vaccine dose #1 03/18/2021 COVID vaccine dose #2 06/07/2021 pt. reported 2-week h/o cough, congestion unrelieved with OTC cold/flu medication 06/08/2021 Pt seen in ED w/c/o cough sore throat and sinus congestion for x 10 days, tested positive for Covid.
15 year old patient came into receive COVID-19 vaccine. RN gave Moderna vaccine at parent request. Patient returned for second dose with RN giving the pfizer due to the patients age.
Info has been received from a health professional concerning a 65 year old female with diabetes, dyslipidaemia and hypertension who on 11/20/2002 was revaccinated with pneumococcal vaccine 23 polyvalent (lot #640576/0923L). On 11/21/2002 the pt experienced a severe site reaction which the physician called cellulitis. The pt sought medical attention and was treated with cephalexin (Keflex). Additional info has been requested. The health professional also reported that the pt's sister received pneumococcal vaccine 23 polyvalent (MSD) (WAES #0305USA00506) and developed cellulitis.
This case was reported by a physician via a sales representative and described the occurrence of fever in a child subject of unspecified gender who was vaccinated  with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. No medical history, conditions or concurrent medications were reported. On an unspecified dates subjects received unspecified dose of Pediarix. The physician reportedly stated that he seen a higher incidence of fever with the use of Pediarix in his patients. Actual number of patients and demographics were not reported. At an unspecified time after vaccination with Pediarix, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Pt complained of itching to left deltoid where vaccination given. Upon removing band aid, redness to site Treated with Benadryl.
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 22-JUN-2017, the patient was vaccinated with an expired and improperly stored dose of ZOSTAVAX lot number: L046295, expiration date: 17-FEB-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. It was unknown the duration and the temperature at which the vaccine was maintained. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported in the patient. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a registered nurse 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 25-JAN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # L014426 with expiration date on 08-MAR-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590: US-009507513-1803USA013073: US-009507513-1803USA013074.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 14-AUG-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Patient developed large red, hot area on upper left arm down towards inner elbow. No treatment needed.
Itching, hard lump swelling, rash at injection site 8 days after 1st shot.
A little over 2 hours after receiving the shot, I experience severe pain and stiffness in my left shoulder (the arm in which I was injected).  The pain and stiffness was so severe that I was unable to lift my arm or otherwise rotate my shoulder.  I went back to my general physician on 10/21/2010 and received a steroid shot.  I was referred to an orthopedic, whom I saw on 10/22. X-rays were clear; I received a cortisone injection in my shoulder and was prescribed an anti-inflammatory for 3 weeks.  Went back to the orthopedic 3 weeks later because pain was not gone; I had regained some motion, but it was still painful to move my shoulder.  The orthopedic prescribed physical therapy, which I began one month later.  I currently go to physical therapy once a week (total treatment plan right now is 5 sessions).
Patient was given his booster vaccination 1/24/2022. He had a headache and chills on 1/24/2022 & 1/25/2022 which subsided. On 1/26, he began to have pain in his right shoulder and lower back. The pain in his lower back went away at approximately 5pm that evening, but the shoulder pain continued. He took 7 Advil that day with little relief. On Thursday, 1/27/2022, he woke up with increased pain. The site of injection did not hurt and there was no redness or swelling noted. The pain is located in his rotator cuff area. No recent injury to his arm. Pain is 2/10 with no movement and up to 9/10 with movement. The pain radiates to his elbow. There is no numbness or tingling the the hand/fingers and he is able to move hand/fingers as normal. He took 2 extra strength Tylenol on Thursday 1/27 with some relief.  1/28/2022, pain has not resolved and he notes some swelling to pectoral region of right chest. He will be contacting his physician this morning. He had a similar experience of pain to arm following both previous COVID-19 vaccinations, but this has been more severe than the previous ones.
Filing for formality, Polio temperature excursion, no harm to patient, patient has been informed and will return for revaccination.
Patient called approximately 9:30 AM on 10/22/14. Stated arm was still in pain after pneumonia vaccine -> stated pain and swelling from injection site up to about 12 inches away from site.
My right hand swelled up.  Not able to touch the hand or use the hand in any way without severe pain.
leg swelling; anxious; body jerking; sore arm; chills; difficulty breathing; weak; lack of appetite; red face; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (leg swelling), ANXIETY (anxious), DYSKINESIA (body jerking), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Sclerosis multiple. Concomitant products included ESTRADIOL, LATANOPROST, TIMOLOL, LATANOPROST, MONTELUKAST, ROSUVASTATIN, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE), GABAPENTIN, TEMAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), FISH OIL, UBIDECARENONE (COQ 10), CENTRUM SILVER +50, CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), PARACETAMOL (TYLENOL), PLANTAGO OVATA (METAMUCIL CITRON), IBUPROFEN (ADVIL 12 HOUR) and OCRELIZUMAB (OCREVUS) for an unknown indication.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (leg swelling), ANXIETY (anxious), DYSKINESIA (body jerking), PAIN IN EXTREMITY (sore arm), CHILLS (chills), DYSPNOEA (difficulty breathing), ASTHENIA (weak), DECREASED APPETITE (lack of appetite) and ERYTHEMA (red face). At the time of the report, PERIPHERAL SWELLING (leg swelling), ANXIETY (anxious), DYSKINESIA (body jerking), PAIN IN EXTREMITY (sore arm), CHILLS (chills), DYSPNOEA (difficulty breathing), ASTHENIA (weak), DECREASED APPETITE (lack of appetite) and ERYTHEMA (red face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication included.   Reporter did not allow further contact
redness at the right of the shingled vaccine; it's a little itchy; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had redness at the right of the shingrix vaccine for a week and it was a little itchy.
SPEEDY HEART RATE; MILD HEADACHE; LOW GRADE FEVER; FLUSHED FACE; VERY FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included anaphylactic reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced mild headache. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced flushed face. On 09-MAR-2021, the subject experienced very fatigued. On 10-MAR-2021, the subject experienced speedy heart rate. Laboratory data included: Heart rate (NR: not provided) 123 decreased to 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, low grade fever, and flushed face on 10-MAR-2021, and had not recovered from speedy heart rate, and very fatigued. 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.
Itchy palms and foot soles in the morning (for about 15 minutes). After a few days added: - intense itching/burning sensation on hands, wrists, feet (upper surface), sometimes on scalp, torso and thighs, lasting for about 15 minutes a few times a day (not occurred during the sleep) - itching and hives in the same areas for 5-30 minutes when walking outdoors or being nervous.  Doctor prescribed Benadryl 25mg 2 times a day for 4 days to see if it stops the condition. It alleviated the symptoms when taken, except for morning itchy palms and foot soles. Progress TBD after stopping the medicine.
Tested positive for COVID 8/13/21 with symptoms of cough and headache that started 8/9/21