chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the next day was a little tired; 5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours; was flailing; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was flailing), FATIGUE (the next day was a little tired) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (was flailing) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours). On 05-Mar-2021, the patient experienced FATIGUE (the next day was a little tired). On 04-Mar-2021, FEELING ABNORMAL (was flailing) and PYREXIA (5 hours after receiving the second dose of the vaccine had a fever of 103, fever broke within 2.5 hours) had resolved. At the time of the report, FATIGUE (the next day was a little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 103 (High) 103 degree celsius.         No concomitant medications were reported.  Treatment information was not provided. Patient has received 3 doses of the Moderna COVID 19 vaccine by intramuscular injection. 5 hours after receiving the second dose of the vaccine, patient experienced fever of 103 and was flailing. Fever broke within 2.5 hours and the next day patient was a little tired, but otherwise patient was fine. The third dose was given on 22 December 2021.   This case was linked to MOD-2021-425601 (Patient Link).
Local swelling/induration (L) deltoid area. Tx - warm compress, Benadryl PRN.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
Large red spot below injection site. Itchy redness spread almost to elbow and under arms. Not swollen. client applied ice all day. On 10-25-01, symptoms decreased, then on 10-26-01, most symptoms resolved.
I did not consider this an adverse event, but am reporting this following phoned instructions  today from the v-safe study. I contracted Covid-19 despite being fully vaccinated and boosted, plus always wearing a mask in public. The infection seemed mild, no fever, no respiratory symptoms. However, I developed acute sentivity to touch and for two weeks plus after testing negative, experienced random, intense nerve pains along with severe exacerbation of the pain in the area (lower back, buttocks, hip) affected by nerve roots caught as they exit lymbar spine on left. Acupuncture treatments plus prescribed home physical therapy exercises and medication listed above had previously kept the pain under control. My acupuncture doctor believes the acute pain response was related to Covid-caused inflammation of my peripheral nerves. The pain is reduced as of this writing, pursuant to a targeted acupuncture treatment 10 days ago, but is still more intense than prior to Covid infection.
pt recv vax & devel an inj site rxn characterized by an 8inch area of redness, swelling warmth & pain;
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Patient had vaccines on 8/31/09. Patient returned to office on 9/2/09. Patient's right arm swollen and tender to touch. Feverish around injection site.
Report A0371311A describes an adult female (age unspecified) who did not respond to the first 3 injection immunization series with Hep B vaccine (mft'r unknown). This report was received from the subject, who is a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. Approximately 10-12 yrs ago, the subject received 3 injections of Hep B vaccine and reported that she "did not respond". Subsequently, she was given a 4th injection and titer was measured. The subject stated she "finally" responded to the 4th injection.
Pt. received influenza and tetanus vaccination on 9-14-2010 and noted a few days later some increased bruising around tetanus inj. site, gingival bleeding and diffused petechiae in lower extremities. Dx with ITP.
Severe chest pain extending into left collarbone, and shoulders began on May 2nd and 3rd.    Thought it could be muscular from heavy lifting over the weekend.  Self treated with steroids for 2 days, and the problem resolved.  I did not seek medical care.   On May 10 and May 11, the pain returned.  This time I knew it was not muscular so sought medical treatment.   After describing to my physicians office I was advised to go to the ER.
I received my 2nd shot on 02/05/21 at approx. 2pm. On 02/06/21 at approx. 3pm I started having chills, body aches, and a fever. These symptoms got much worse at approx. 8pm. On 02/07/21 I woke up to severe fatigue, headache, and a fever. From 02/08/21 to today 02/13/21 I have experienced a low grade fever. I feel dizzy, nauseas, fatigued, and over all unwell. Yesterday, 02/12/21, I vomited. I've had to miss work all week due to these symptoms. Even today, 02/13/21 I have a fever and feel unwell. My fever has ranged between 99.5-100.4.
PT c/o discomfort on left side of chest, felt panic and overwhelmed. Pt was sweating, flush in the car with no AC. Vital BP: 127/75. HR: 88. Nurse practitioner cleared patient.
Arm a bubble of swelling. Kind of itchy. Doesn?t really hurt though unless I touch it
Fever; Body aches; headache; severe hives; This is a spontaneous report from a contactable Nurse (patient) received via HCP follow-up letter sent in cross reference case. This case is for dose 2.  A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the left deltoid on 11Jan2021 at 12:30 (at the age of 47-year-old) as a single dose for covid-19 immunization. The patient's medical history included allergy, asthma and sinusitis (started on 02Dec2020 and were ongoing), post-nasal drip, GERD. Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy started on 02Dec2020 daily increase after vaccine reaction twice a day for 4 days] and was ongoing, amoxicillin/clavulanic acid (AUGMENTIN) for sinusitis started on 02Dec2020, omeprazole (PROTONIX) for GERD started on 02Dec2020 and was ongoing, fluticasone propionate/salmeterol xinafoate (ADVAIR) for asthma started on 02Dec2020 and was ongoing, budesonide (PULMICORT) for post nasal started on 02Dec2020 and was ongoing, and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), and guaifenesin, acetaminophen started on 21Dec2020 and antihistamines. The patient did not receive any recent vaccines for any other conditions prior to the event being reported and have not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient previously took SULFA and experienced allergy. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscularly in the left arm on 20Dec2020 at 10:00 as single dose for covid-19 immunization and experienced anaphylactic reaction, headache, soreness on injection site, hives and nausea. On 11Jan2021 at 12:30 after receiving second dose of vaccination, patient experienced severe hives, soreness, headache, body aches, fever. As per reporter there was a reasonable possibility that the event was related to suspect product. Patient was not hospitalized. Patient was being treated with antihistamines. Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
ACUTE RESPIRATORY FAILURE 9/26/2021 CLAUDICATION DUE TO PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  ACUTE RESPIRATORY FAILURE 9/26/2021 ANEMIA  ACUTE RESPIRATORY FAILURE 9/26/2021 HYPONATREMIA  ACUTE RESPIRATORY FAILURE 9/26/2021 ANEMIA
Initial report was retrieved from the scientific literature on 12 September 2013. This reported involved a cluster of three patients. This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09583, 2013-09584 and 2013-09585. Three pregnant female patients (age ranges of 25-35 years) had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced injection site reactions. Outcome was not reported. Documents held by sender: None.
On day 5 I started to develop bone and muscle pain and hives all over my body, in addition to fatigue. This series of symptoms last for 6 days, often worsening in the afternoon.
103 degree fever on 10/2/2014. Went to urgent care that evening after fever didn't subside. Dr. said - most likely not linked to MMR - catching cold.  Went home, fever continued till morning.  Fever gone by morning, but rash appeared on 10/3/2014 and lasted a few days.  Did not return to Dr. after looking up info on CDC website.
Covid19 breakthrough.  1st vaccine received on 02/28/2021.  61 y/o PMHx of Liver cancer with pulmonary metastisis currently on chemo, DM, depression presents to ED with c/o worsening fevers, cough, extreme fatigue, chills, N/V and hypotention.  Per Pt Tmax 103.5.  Room air sat 98% and CXR with widespread pulmonary nodules. Pt was recently diagnosed with Covid 1/18/22 and is s/p Regeneron.   Started on IV Abx.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot # L038503, expiry date: 18-DEC-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered vaccine underwent a temperature excursion at 1.3 degrees (C) for a time frame of 12 minutes. Previous temperature excursions reported occurred on 06-JUL-2016 at a temperature of 2.2 C (low), 10.7 (high) for a time frame of 3 hours and 9 minutes and on 15-AUG-2016 at a temperature of 1.2 C for a time frame of 48 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female (age unknown) who on 19-APR-2007 was vaccinated with a first dose of Gardasil. After receiving the Gardasil, the patient "almost fainted". The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19-APR-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse practitioner concerning a 17 year old female who on 19-APR-2007 at 10:59 was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (Lot #654741/0013U). After receiving the GARDASIL (also reported as 10:30), the patient "almost fainted" and had a vasovagal response. There was no loss of consciousness. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19-APR-2007, the patient recovered as the symptoms only lasted a few minutes. No product quality complaint was involved. No additional information is expected.
Severe vertigo; nausea; Fatigue; body aches; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6204) via an unspecified route of administration in the left arm on 08Mar2021 at 13:45 as a single dose for COVID-19 immunisation. Relevant medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included acetaminophen (MANUFACTURER UNKNOWN) 30 hours after shot for unspecified indication and B-12 (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6200) via an unspecified route of administration in left arm on 15Feb2021 at 14:00 as a single dose for COVID-19 immunisation. The patient took terbinafine (MANUFACTURER UNKNOWN) in the past and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 09Mar2021 at 05:00, the patient experienced fatigue and body aches which resolved in one day. On 10Mar2021, the patient experienced severe vertigo and some nausea upon awakening. Gradually and slowly resolved during the day, but effect continues to linger even after 15 days. No therapeutic measures were taken as a result of the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe vertigo and nausea was resolving while the outcome of fatigue and body ache was resolved on 10Mar2021. No follow-up attempts are needed. No further information is expected.
Around 10:30 I began to feel tired and a little sick. I went to sleep and at around 2 or 3 am I woke up freezing cold and sweating, with my left arm (arm I got the shot in) hurting a ton. I didn?t fall asleep for a few hours and couldn?t get out of bed due to coldness, lethargy, and muscle soreness. Next day had a moderate headache throughout the day that Ibuprofen didn?t help with. By 10 pm Friday all symptoms other than arm soreness had disappeared.
Information has been received from a registered nurse concerning an 8-year-old white male with asthma who on 29-MAR-1999 was vaccinated SC in the left arm with a first 0.5 mL dose of Varivax (Lot # 629642/0114J). Concomitant therapy included a third 0.5 mL dose of Comvax (Lot # 629304/1616H) administered IM on 29-MAR-1999 and a first and second 0.5 mL dose of MMR II administered on 29-MAR-1999 (Lot # 626986/1756H - administered SC) and 17-OCT-2002 (Lot # 643501/0634M). Other therapy included a first, second, third, forth and firth 0.5 mL dose of Infanrix on 15-APR-1998, 18-JUN-1998 (Lot # DTPA847A2) administered IM, 20-AUG-1998 (Lot # DPTA852A2) administered IM, 04-JU-1999 (Lot # 909A) administered IM, and 17-OCT-2002 (LOt # 568b9); a first dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) on 17-FEB-1998; the second and third 0.5 mL dose of Hibtiter on 18-JUN-1998 (Lot # M240RK) and 20-AUG-1998 (Lot # M010RN) administered IM; a second does of HIB conj-hepatitis B vaccine (manufacturer unknown) on 15-APR-1998); a 0.5 mL dose of Fluvirin on 14-NOV-2003 (Lot # 767757) and 12-DEc-2003; a 0.5 mL dose of Fluzone (Lot # U1515AA); a 0.5 mL dose of Ipol (W0010); a first, second, and third dose of Orimune on 15-APR-1998, 18-JUN-1998 9Lot # 0774A), on d04-JUN-1999 (Lot #0801F); and a 0.1 mL dose of "PPD" (Lot # C2078AA) on 31-OCT-2005. On 17-MAR-2006 the patient experienced chickenpox. Subsequently, the patient recovered from chickenpox. Additional information has been requested.
Pt recv vax on 9/18/98; post vax pt exp flu-like syndrome of nausea, fatigue, weak, headache
1. Continuesly cold like symtoms, until now. No treatment. 2. Bell's palsy, obvious symptoms  from 5/29 to 6/15. Got steroids and anti-virus medicine. Partly recovered but still have weakened right face mucsle now.
I have hives along my legs, arms, torso. I had shingles last year and this seems different. I am a nervous/high stress person and thought is it is stress related.
2 1/2-3hrs p/vax pt screamed, cried, stiffened body, turned blue, sz; mom called rescue squad & pt taken to hosp ER; given APAP 20 mins prior to episode & denies fever; t101 in ER;
Rash, UrticariaPruritus, Rash above left deltoid and forearm, nervous, diaphoretic
Headache, Myalgia, Arthralgia & SkinRash Headache, joint and muscle aches, injection site rash and mouth ulcers, missed 1 day of work
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 12-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 12, left arm, on Sep 21, 2021, single dose, for COVID-19 immunisation. No medical history reported. The patient did not take any concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 12, left arm, on Aug 31, 2021, single dose, for COVID-19 immunisation. The patient reported palpitations/heart palpitations, and chest discomfort/pressure in chest multiple times a day starting 3 days after receiving 2nd vaccine shot, onset Sep 24, 2021, with outcome of recovered (unknown date in 2021). The events were evaluated at a physician office visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations and chest discomfort. Additional information: The patient has no known allergies. 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 COVID-19 vaccine. Since the vaccination, patient tested negative for COVID-19. It was reported that the events continued for 4 days. On the 4th day the patient saw his primary doctor who had him take Aleve for 3 days. This reduced the frequency to once a day, but  lasted for 2 months. The patient also went to a specialist, but by the time the patient could get in to see them his episodes had pretty much stopped. This costed patient's mom $1,000. The lot number for BNT162B2 not provided and will be requested during follow-up.
Developed rash day after flu shot - Went to urgent care 10/7/10 and thought scabies, was given permethrin. Went to ER on 10/09/10 for pain/swelling in elbow. Pt admitted to hospital on 10/11/10 as rash spread to upper back, arms and thighs with bullae on hands. Dermatologist suspected Stevens-Johnson and patient started on prednisone. Still recovering.
From about 5-6 hours after injection, increasing pain, and extent of pain in left arm. Involved shoulder, mid humorous, elbow, wrist. Also affected left collarbone,  into left scapula. Even Some discomfort over to right shoulder. Caused decrease  Left arm,  range of motion. Severest affects first 5 days. Slept in chair to keep arm straight, lying down caused added tension on arm, increasing discomfort, which ranged from dull throbbing ache to sharp spasm with movement .  After one week, Had  appt with  Dr  to report. Also contacted pharmacy of injection site to report. Over time, much improved . Pain much diminished. Range of motion improved. But to this day, 17 days later,  still have residual symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 2, single (Lot number: el9265), in right arm, on 09Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841), in right arm and on 20Apr2022 at 12:00 as dose 4 (booster), single (Lot number: fk9896), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.