chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe illness; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that the he/she got the first shot and had severe illness from the shot and he/she would not get the second shot. Hope he/she never get the shingles as the shot had almost got him/her. Additional supportive information: Shingles was not coded as an event, as per the verbatim it was unclear whether the patient had got shingles or not and seems to be referring it to the illness only and was raised to confirm the same. Follow-up would not possible as no contact details were available.
missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown.            No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
lymph node swollen on left collar bone with the 2nd dose and booster shot; Off label use; Extra dose administered; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 30Aug2021 (at the age of 36-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications reported as too many. Historical vaccines included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 23Mar2021(at the age of 36-year-old) as dose 1, single and received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 30Aug2021 at 11:00AM (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient had no known allergies. On 31Aug2021 the patient experienced lymphadenopathy, off label use, extra dose administered. It was reported that lymph node swollen on left collar bone with the 2nd dose and booster shot. Since the vaccination, the patient not tested for COVID-19. Patient was not received treatment for the events. Outcome of the event lymphadenopathy was not recovered and other events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
At night she went to the bathroom and fell; could not stand holding so had to crawl; Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since; felt like she was going to pass out; very dizzy after lunch/dizzy/ she fell due to being dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 001A21A, 012F21A and 051B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy). At the time of the report, FALL (At night she went to the bathroom and fell), DYSSTASIA (could not stand holding so had to crawl), ASTHENIA (Had to hold her hand to walk her to bed so she can lie down/ was feeling very weak/ had to crawl to the room and back to the bathroom/ Has been lying down since), PRESYNCOPE (felt like she was going to pass out) and DIZZINESS (very dizzy after lunch/dizzy/ she fell due to being dizzy) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/20/2021 Is this your first or second dose- 2nd dose Date of symptom onset - ? 9/21/2021 Symptoms - ? Severe headache, body aches, body cramps, sweating, and just "doesn't feel like herself" Last day of work and shift - ? 09/20/2021 Home remedies- Tylenol for headache and aches Any improvement- employee stated it helped a little bit. Recommendation- Advised employee to continue taking Tylenol or Ibuprofen if not allergic per package instructions as needed for headache and aches. Also advised employee to monitor symptoms and it they worsen or new symptoms develop to call us to assess if treatment is needed. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
took 1st capsule, had dinner & had fast heart beats & was up all noc; took 2nd capsule had same; will take 3rd & see how it goes;
He woke up with a headache and congestion. We tested for COVID-19 on 10/06/2022. We went to the doctor, but he was not allowed to take PAXLOVID. He was given molnupiravir. He had headaches the next day but that subsided. He had congestion and coughing. He still has congestion, and we plan to retest him tomorrow. A PCR COVID-19 test was completed on the same date and it was positive as well.
I had chills and sweat the bed the first night which was a Sat.  Was exrtremly achy all over.   Next day was again extremely achy and that night i went to bed right after supper and slept 12 hours,  Again very achy and again sweat the bed all night and woke up on Monday just fine.  Aches are gone but have continued to sweat the bed each night.  Not dramatically but just slightly these past 2 nights
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown). which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 101.2, BP 131 at 7:20, BP 103 at 9 AM, BP 124 at 8:30 PM, on 09/05/2016 BP 85 at 7:20 AM, BP at 95 at 8:20 AM. ALL BP are resting systolic. On 09/04/2016 headache, body aches, fatigue, appetite loss.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 09-Feb-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 VACCINATION SITE PAIN (Soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  .   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant follow up. Another reporter contact details provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 09-Feb-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 VACCINATION SITE PAIN (Soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  .   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant follow up. Another reporter contact details provided.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient fell and bumped knee-Mild
rt arm w/marked swelling, erythema, induration 4 days post vax;
Upon administration, patient felt flushed and had trouble breathing. She described "tingling all over" and "seeing stars." She was taken to the ED where it was determined she had a vasovagal response to the injection. She was monitored and no intervention was required.
10/24/09 11:00 A Client received a H1N1 in right arm. She stated two minutes after receiving H1N1, she noticed numbness around the mouth with slight slurred speech.
PATIENT COMPLAINED THAT THE DAY AFTER THE VACCINATION, HER ARM HAD AN ITCHY, STINGING RASH AND FELT CHILLS, WHICH ALL RESOLVED THE FOLLOWING DAY.
Severe pain on right upper back, right axilla, right arm. Tingling & numbness distal 2/3 of lower right arm & hand. No loss of function, no erythema at site of injections or on back or axilla or arm, no swelling on exam except minor swelling of hand, no rash, hives, or respiratory symptoms. Breath sounds clear to auscultation. Normal sensation on right hand, normal function right hand, limited range of motion of right arm (to 90 degrees abduction laterally, to 75 degrees anteriorly).
pt states that she starts nodding  on and off due to extreme fatigue.  She doesn't feel well and has trouble walking says she thinks its because her muscles are hurting.  She says she doesnt feel right but doesnt know how to describe.  Pt states she has had these symptoms going on about a month.
About 20 hours after vaccine I had chills, aches, fatigue--felt like a mini version of COVID.  I had COVID in December of 2020.  I had a bad case but did not require hospitalization.  On Saturday night (May 22, 2021)I developed a sore near my mouth that was quite painful.  I went to the dermatologist on Tuesday May 25 and he said I had a cold sore. He gave me medication and it has healed, but it took a while.
Gastrointestinal issues, Fever, Chills, Cold sweats, Malaise, Fatigue, Body Aches
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-NOV-2012 13:51, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Starting on 4/27/2020 (12 days after vaccine was given), he started having burning type pain in left mid posteriormedial thigh.  On 4/29/2020, he started to have a rash that consisted of a cluster of red bumps later turning into vesicles in the same area as the pain..  The rash and pain combination was clinically consistent with shingles.  On 5/2/2020 there was spread of rash to left mid posteriorolateral shin.  He was started on Valtrex 1000 mg tid for 7 days on 5/2/2020.
Migrating pain, stiffness and swelling of joints. Began in bilateral toes and Left knee; 24 hours later it was gone, but appeared in Right knee. Again that was gone 24 hours later, but then affected bilateral hands and fingers, Right more than Left, lasting at least 4 weeks. Ibuprofen as needed. Intermittent numbness hands and fingers too.
Mom reported a few days p/rx resolved; apparently broke out in urticaria @ home on the day of the vax;
Patient was incorrectly given Pfizer Covid 19 12yr & up vaccine instead of Pfizer Covid 19 5-11 yr old vaccine. Patient was currently 11 years old at the time of vaccine administration. No adverse reactions were noted.
Within an hour of the vaccine, pt started having nausea and vomiting.  She later developed diarrhea that lasted for several hours.
pt recvd vax;exp episodes of high pitched crying in the 5 days since vax adm;
Pt presented to MD office on 7/31/01 with a rash but no fever. He was positively diagnosed by MD with chicken pox.
(L) Deltoid cellulitis secondary to imm administration (KINRIX). Cephalexin 250mg/5ml 6ml tid for 10d.
TORPEDOED QUALITY OF LIFE AFTER VACCINATION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced torpedoed quality of life after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from torpedoed quality of life after vaccination. This report was non-serious.
After dose #2 I had severe itching 48 hr after second dose Dr notified it lasted 17 days
8:45 injection: 2pm  Headache. Took 500 mg Tylenol  7pm: Body Aches all over, specifically in spine, joints, and anything moved, Parched 9pm: took 500 mg Naproxen.  12am (next day): Fever - not sure of temperature but warm,  Body Aches all over, specifically in spine, joints, and anything moved, Parched, took 500 mg Tylenol Body aches continue the next day, while not as sever, spine specifically still aches. A little light headed - out of it.
pain; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported through online chat that the patient experienced pain and swelling after 1st dose of Shingrix. The reporter did not consent to follow up.
Approximately 6 minutes after receiving vaccine, pt laid in supine position with knees bent. RN went to check on patient who reported headache with "mild dizziness." Patient was A and O x3 and denied difficulty breathing or SOB. HR 74, SpO2 99, and RR 17.Patient reports she had a smoothie this AM. Encouraged patient to remove mask, take deep breaths, and slow sips of water. Had patient remain in supine position for 10 minutes. VS reevaluated at 1236-SPO2 97, HR 69, BP 128/75, and RR 15. Patient reports improvement in symptoms. Encouraged pt to rest for 15 more minutes. Patient reports she "is feeling better"-HR 73-SPo2 99. No difficulty ambulating-escorted to car by staff RN. Referred to PCP.
Pt. Is a 17 y/o female with NKA, no past medical history. Second dose of Pfizer was given in L deltoid at 1536. Approx. 1543 pt. Began to c/o of nausea and dizziness. Pt. Was moved for privacy, she verbalized wanting to lay on the floor for comfort due to her history of fainting after injections. Pt. Was A&O x4 during event. VS were performed before patient departed. 1546: 100/70 HR:71 o2:91% RR 19 (Laying) 1550: 110/80 HR: 93 o2: 99% RR: 19(sitting) 1552: 120/90 HR:93 o2:99% RR:20 (standing)
Information has been received from a consumer concerning a pt who was vaccinated with a dose of varicella vaccine live virus. On approximately 06/04/03, "about 2 weeks ago", the pt developed chickenpox. It was noted that the reporter had no additional information to provide. The caller also reported on another pt who had been vaccinated with varicella virus vaccine live and developed chickenpox (WAES # 0306USA02323).  Additional information has been requested.
Headaches Fatigue nauseated second dose this year around Nov 8th I had a flu shot and the military administered again because I did not have the paper work on hand never had an adverse reaction before except the first shot I ever had.
Started with cold chills around 11:00 pm April 1st with aches and pain all over the body.  Headache. Low grade fever of 99.9F.   No energy.  These symptoms lasted till April 3rd 8:00 am.  No aches or pains but energy level still low.    Tylenol every 4 hours.  Vicks rubbed on chest. Rest
Moderna COVID-19  soreness noted at the injection site for approximately 2 days. On the 14th of January, developed external earpain and a left sided neck ache ("like i slept on it wrong") used ice pack. On the 16th, Saturday morning, the left side of my face was numb, lips were numb and tingling, and inside of mouth was tingling. On the 17th, the symptoms had gotten worse and couldnt hold liquids in mouth due to lips drooping and loss of muscle control. went to ER that day and got diagnosed with bells palsy by Doctor. He prescribed a steroid and an antibiotic. on the 18th eye continues to droop, mouth drooping. on the 19th, eye not closing, mouth drooping toward left side, lips remain numb
No additional AE information.; Improperly stored vaccines administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On an unknown date, the patient received an improperly stored vaccines: measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II), lot # S014430, expiry date 09-MAY-2021 and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S030243, expiry date 26-SEP-2021, both in dose reported as 0.5 mL, both for prophylaxis (concentration, dose number, route of administration and frequency for both vaccines were not reported). Digital data logger was not involved. Between 12-AUG-2020 (reported also as August 2020) to an unknown date in September 2020, vaccines underwent a temperature excursions at 6.5 degrees of Fahrenheit (F) for 45 minutes. There was no information regarding previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008312:
Received 3rd dose in the HPV series vaccine and flu vaccine at approximately 1130 am on Oct 19, 2018. At approximately 2130 on Oct 19, 2018 he develops a fever 101-102, headache, aches, and chills that lasted until Oct 20th at 1600. Oct 22nd at 9am, he developed severe chest pain and was taken to local emergency room. ER shipped him by ambulance to hospital for elevated troponins and EKG changes. More lab work was completed. Troponins were >8, echocardiogram and MRI were completed and diagnosis of myocarditis was made.