chrisvoncsefalvay/vaers-outcomes huggingface dataset:
few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11.  Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she was seen by an internist and immunologist, and eventually diagnosed with probable serum sickness. She had completely recovered. Of note, the patient reported a past history of increased reaction to PPD testing, possibly a hypersensitivity. Her physician felt that "she may have received too many PPD tests too close together". The most recent PPD showed no increased reaction.
the onset of blurred vision in one eye and flashing colored lights in both eyes.; the onset of blurred vision in one eye and flashing colored lights in both eyes.; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular at the left arm on 21Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included Parkinson's and neuropathy. The patient has allergies to CIPRO antibiotics. Concomitant medication included unspecified multiple supplements. On 22Jan2021 at 09:00 (24 hours after vaccination), the patient had the onset of blurred vision in one eye and flashing colored lights in both eyes. This was unlike anything he has ever experienced, and it persisted for several hours. Vision gradually returned to normal and lights disappeared. This was not a retinal detachment or vitreous detachment. It was not associated with eye pain. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date in 2021.
Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this time at 2200 temp was 103.7 took Advil at this time. Temp stayed 102-103.7 with Tylenol and Advil round the clock until 2/8/21 around 1300 at this time temp had gone down to 101. Noticed once fever started to drop my left toes started to tingle. Tingling got worse over the next few days until 2/11/21 my whole leg went extremely heavy (could not lift at all). Admitted to hospital 2/12/21.
Low grade fever 06/08/2003, erythematous rash abdomen, slightly fussy, rash spread all over body 06/09/2003 until seen 06/11/2003. Diagnosis. Erythemamultiforme and old patch on abdomen.
Migraines; Severe insomnia again/Sleep difficult; Terrible side effects; Throwing up (repeatedly)/dry heaving; Nauseated, starting throwing up (repeatedly); Full-blown fever; Had the chills (no fever); No appetite since Wednesday; Began to feel achy/I was achy; Not feeling well (nauseated); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult) and DECREASED APPETITE (No appetite since Wednesday) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd dose- experienced severe insomnia) and Pfizer (1st dose- experienced severe insomnia). Past adverse reactions to the above products included Insomnia with Pfizer and Pfizer.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), DECREASED APPETITE (No appetite since Wednesday) and CHILLS (Had the chills (no fever)). On 09-Dec-2021, the patient experienced MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)) and PYREXIA (Full-blown fever). At the time of the report, PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), DECREASED APPETITE (No appetite since Wednesday), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)), PYREXIA (Full-blown fever) and CHILLS (Had the chills (no fever)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that she had to leave work because she was not feeling well (nauseated). Patient also reported that she had terrible side effects for couple of days. She also had migraines and severe insomnia again. She had only 3 hours of sleep since Wednesday. Patient stated that first 2 does were Pfizer and she had severe insomnia after both does and it lasted for 3 months, it was debilitating, and she was really ill.
This spontaneous report received from a registered nurse referred to a 11 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
12/10/09 MR received for DOS 11/04/09. Pt presented with SVT. Pt not acting normally, not playful.  On examination in ED, HR: 300s. tx: Digoxin, switched to Propranolol. Heart converted to sinus rhythm. Pt discharged in stable condition.  12/28/09 Immunization record received.
This spontaneous report as received from a physician via a company representative refers to a 71 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 09-FEB-2016, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (dose, lot # and expiry date were not reported). There were no concomitant therapies reported. On approximately 04-MAY-2016, reported as two weeks ago, the patient experienced skin irritation, skin ulceration and an eruption at the injection site. The patient sought medical attention and she was referred to a dermatologist. The reporting physician provided a photograph of the patient's reaction. The outcome of the events was not reported. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
I experienced the following: shoulder pain and soreness; fever, shivering (I could not get warm even with lots of blankets and clothes) headache and fatigue. In addition to the side effects outlined above, what I consider the real adverse event was the phantom pain. I experienced severe or what I would describe, violent phantom pain in my left amputated limb. The phantom pain was so severe, that I often cried out, my entire body tightened as i felt the jolt, and I did not sleep from 12 am until the next evening. I have had phantom pain before, but nothing this severe, or continuous. This was not normal.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-OCT-2014 the patient was inadvertently administered a expired dose of ZOSTAVAX lot # J002241, expiration date 21-MAY-2014, subcutaneous, single dose. Does was not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
Pt gently slid to floor from chair into a sitting position against the wall. Brief loss of consciousness of about 5 seconds.
Muscle pain, shivers, initially. Next day headache and need to sleep a lot.  Took naproxen for headache.
Pt recvd vax on 12MAR93; discovered was pregnant;@ 40 wks gestation, approx NOV93, delivered 7 lb 15 oz baby; baby was jaundiced & was treated w/Phototherapy for 4 days; In 1993 approx 4 wks of age baby had surgery for pyloric stenosis;
Very sore arm the day of injection into the next day, lump, red, hot to touch at injection site.  Tired
Febrile szs occurred @ 800am, today while pt was w/ sitter. Child was checked @ ER. T 102 pt has ear infection
Information has been received from a physician concerning a adolescent female who was vaccinated with a third dose of GARDASIL (date, route and Lot# not provided).  Two months post vaccination the patient experienced vomiting and stomach cramps.  Unknown medical attention was sought.  The patient's outcome was unknown.  The reporting physician was not the primary physician.  No product quality complaint was involved.  Additional information is not expected.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 06 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Chills, myalgia, headache, fatigue lasted 1 day. headache persisted to the next day
Upper arm muscle started with extreme pain.  Could not use or lift my arm. Fingers would tingle and go numb. Doctor gave me pain meds...took for 1 1/2 weeks symptoms are much better but arm is still a little sore and I have a hard time lifting it above my head. Still on pain meds.  Also got a very bad cold that I still have and can't seem to get rid of!
Pt received influenza vaccine at 9:43. Mother brought him back to the clinic around noon - pt. vomited 12 times (per mother) since receiving the vaccine. Pt was sent to ER for dehydration.
-complex febrile seizure x2 of 20-30 minute duration with temp of 103 degrees F - leukopenia  - fine pink papular dermatosis consistent with measles. Treatments; Ceftriaxone 500 mg IM x1 ibuprofen 100 mg po q6h x3, and APAP 100 mg po q4h x10 doses. Fever and seizures resolved and wbc improved on day of discharge.  Nurse follow up on 08/02/04 states: "Complete."
arm weakness; Could not turn head/neck down or sideways.; neck soreness on side of shot; injection site/arm soreness,; Fever of 100.2; chills; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and psoriasis. The patient had penicillin allergy. The concomitant medication included Nikki as birth control. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 17Mar2021 at 21:00, the patient experienced almost immediate neck soreness on side of shot. 12 hours post-shot (on 17Mar2021), the patient had injection site/arm soreness, fever of 100.2 (unit unspecified), chills and severe headache. The temperature returned to normal 24-hours post vaccine. Injection site/arm soreness gone 48 hours post-shot and headache (severe) lingered for about 96 hours post vaccine. 48 hours post shot, neck pain increased dramatically. 72 hours post-shot (on 20Mar2021), the severe neck pain was there, radiating through shoulder blade and collar bone and the patient could not turn head/neck down or sideways (spasms). 120 hours post-shot (on 22Mar2021), arm soreness returned with arm weakness. The neck pain was still present (130 hours post), but not as severe. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events fever was recovered on 18Mar2021 (24 hours post-shot), vaccination site pain was recovered on 19Mar2021 (48 hours post-shot), headache was recovered on 21Mar2021 (96 hours post-shot) and chills on an unknown date in Mar2021. At the time of this report, the patient was not recovered from the events neck pain, weakness on arm and could not turn head/neck down or sideways.   No follow-up attempts are possible. No further information is expected.
Patient states he felt very tired and light headed and dizzy about 45 minutes after receiving the vaccination.
red rash approx. 1-1/2 below injection site, and 2 1/4 inch diameter red spots on inner upper arm
Developed a serious nose bleed; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient wife) via Medical Information Team. An 87-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient after his first shot of Pfizer covid vaccine, developed a serious nose-bleed, wife stated it was a water faucet. The amount of blood was like the size of a small jelly fish in palm of her hand. She asked if he should get the second dose. She thinks her husband has a bleeding disorder. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
started screaming 1 hr p/vax-screamed x 3hrs 5cm c 3cm erythematous macular area; Motrin & cool compresses
Received Tetanus shot, and arm hurt for first few days, mild soreness near site, no redness. Minimal swelling.  After that the pain increased, and went to doctors after two weeks.  DR. said she felt mild swelling, and to wait it out, taking Advil and using warm compresses.  Called after three weeks, again told to take Advil and apply warm compresses.  Was told that there is nothing that can be done, and that it will go away.  Now on week four, and pain is getting worse, more targeted, and hard to lift arm.  Have called Doctor and waiting to hear back.
Pt recvd 3rd dose of Hep B vax & lab eval showed that pt did not seroconvert following 3rd dose;
Patient experienced a fever within 24 hours of second Moderna dose. Temperature was 103. Patient passed out and was taken the ER by ambulance on 3-16-2021. The ER kept this patient until fever subsided at about 12 midnight on 3-16-2021.
intermittent dry cough; felt really tired and fatigued; night chills; night sweats; pain at the injection; mild body aches; This is spontaneous report from a contactable Other-HCP(patient).  A male patient of an unspecified age received second dose BNT162B2 , via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He previously received first dose BNT162B2 for COVID-19 immunization. He experienced pain at the injection and mild body aches a after the shot in Jan2021. About 2 nights ago(12Jan2021), he experienced night chills and night sweats. Last night(13Jan2021) an intermittent dry cough started and he felt really tired and fatigued. Today he was feeling fairly similar to yesterday with the cough still lingering. Outcome of events was unknown.   Information on Lot/Batch has been requested.
Severe pain in bones and joints for 3 days extruciating pain the worse pain imaginable unable to even get up from bed. Extreme fatigue and weakess
Hives, after first vaccine; This is a spontaneous report received from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in left arm (left shoulder), on 12Mar2021 12:00 (at the age of 85-year-old), DOSE 1, single for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19 and since the vaccination, the patient had not been tested for COVID 19. The patient had no illness at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 30Mar2021 20:00, the patient experienced hives, after first vaccine. They (patient and his wife) had Chinese takeout food and he developed hives. When he broke out in hives, he talked to his doctor about getting the second vaccine, and his doctor told him to delay, the second dose, until the hives cleared up. Patient stated the hives cleared up overnight. The patient did go to the doctor for his hives. The relevant tests were none. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8734), via an unspecified route of administration, administered in left arm (left shoulder), on 16Apr2021 12:00 PM, as DOSE 2, single for COVID-19 immunization, at 35 days, after the first vaccine. The outcome of the event was resolved, on 31Mar2021.  Follow up needed, further information has been requested.
Symptoms onset 5-10 minutes after admin. burning in back, joint pain, burning/tingling all over body randomly. Nausea, severe headache, diarrhea injection site hot/red, numbness in left leg, symptoms worsen when laying down.
Fifteen minutes after injection, site was red and 5cm around in diameter.  On 6/6/08 pt. returned to office & site was 10cm in diameter, red & warm to touch.  Dr. prescribed BENADRYL & prednisone dosepak.
Everything smells like rotting meat,  ringing in my ears,  body pains all the time.