chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm,  I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand.  Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 25-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
pt had first immunization , and within seconds pt felt dizzy,  and sweaty. was brought to observation room #1. via w/c w/ mother . Pt  given crackers and water .  vs - 5:09 pm   100/74  79-18- pulse ox 100%        5:14 pm vs 127/76-65-18  pulse ox 100%        5;222PM   VS 113/72 -76- 16 PULSE OX 99%. PT FEELING BETTER , VSS , PT REEASED TO MOTHER VIA W/C  AND TAKEN TO EXIT  .
Vaginal bleeding/spotting mid-cycle next morning/day after injection. Documented history of regular menstruation.
Mother; approximately 12 hrs after fever, chills for about 8 hours. Diarrhea 3 days. Mother is pumping breastmilk. Injection was Friday.  11 month old infant had Fridays milk on Sat, Sat milk on Sunday. Infant fatigued and fussy with loose stools Sunday. Infant had diarrhea, vomited and spiked 102.2 fever Monday evening 1/11. Fever broke Tuesday morning 7 am. Infant still fussy and loose stools. Vomiting ceased.
redness, swelling and itching beginning at shoulder and extending downward past elbow first noticed on 1/19/2021 and worsening on 1/20/21. no reaction noted at injection site.
She Got Fluzone HD on 10/12/2022 at 01 :00 pm and came back on 10/14/22 at around 2:30 pm and the site of injection is swollen, Red, hot to touch and Patient said on Thursday morning  when she woke up she felt stiffness, but it got better after 30 minutes.
Mild soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included famotidine (PEPCID), calcium carbonate (TUMS) and clindamycin phosphate (MANUFACTURER UNKNOWN) topical lotion; all for unknown indications, from unknown dates and unknown if ongoing. On 02Mar2021, the patient experienced mild soreness at injection site. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild soreness at injection site was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
It was discovered after vaccine was given that the freezer temperature was out of the correct storage range for the MMRV.  Per manufacturer doses were compromised therefore this MMRV dose is invalid.
Information has been received from a physician concerning a 77 yr old female pt who on 07Jun05 was vaccinated IM with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). On 07Jun05 in the evening, the pt developed arm, redness, pain and warmth. On 08Jun05, the pt also experienced fever and chills. The pt was treated with ice, cephalexin (Keflex), and acetaminophen (Tylenol). The pt's outcome was unk. The physician indicated that he would like an investigation into that lot #. There was no product quality complaint involved. The records of testing prior to release of the lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
had the shot. Got it 3times/suspected vaccination failure; Got it 3times/ Fighting it in my eye!!; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that it was one of the worse things that can happen to you and he/she had the shot and got them 3 times.  The patient stated that fighting them in his/her eye. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt entered observation around 1950.  Around 2010, stated that "his body felt warm and tingling, throat was sore, and he had a flush feeling".  Denies SOB or chest pain when asked.  Continued to remain in observation.  Stated that he felt somewhat better around 2015.  Still had the same symptoms but they were letting up some.  Around 2025, he stated that he felt better and the symptoms had stopped.  Pt left observation @ 2027
This spontaneous report as received from an other health professional refers to a patient of an unknown age. On 18-AUG-2017, the patient was vaccinated with GARDASIL 9 lot # L018351, intramuscular for prophylaxis. On 18-AUG-2017, the patient experienced expired product administered. No adverse effects were reported.
30 minutes post vaccination patient began to feel short of breath and had tightening of the chest. SpO2 98% HR 68bpm. After response team began assessment patient developed cough and began to visibly shake. Patient was reclined in front seat and feet were elevated. EMS was called and patient was transported to local ED.
SLE flare (mild/moderate recurrent oral ulcers); This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) to be related.    Treatment and concomitant medications were not reported.  Company Comment: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Systemic Lupus Erythematosus on an unspecified date after the second dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-476138 (Patient Link).; Sender's Comments: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Systemic Lupus Erythematosus on an unspecified date after the second dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th.  On Sunday, March 21st, 911 had to be called as his seizure did not end.  He had a grand male.  He was seizing for several hours.  At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily).  He passed 1 week later, March 28 at approx 6:45pm at the Clinic.  I am unable to get any information  on his medical report for that week.  Statement from his Nurologists is on second page. Additional information for Item 18:   Statement:  47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram.   Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident  Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM  Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles, 2 days after receiving the vaccine. It was unknown if the patient sought medical attention. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was not provided for ZOSTAVAX. Additional information has been requested.
PATIENT ARRIVED WITH A SWELLING ON THE RIGHT MIDDLE ASPECT OF THE THIGH. MOTHER STATED THERE WAS PAIN. WARMTH AND REDNESSED ASSESSED, PT WAS AFEBRILE.
Can I get mi second dosis after 3 months/Second dose after two months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months) had resolved.            No concomitant medication was provided.  No treatment medication was provided.  Patient asked can patient get second dosis after 3 months/second dose after two months.
LEFT ARM, RED, SWOLLEN AND PAINFUL. ALSO C/O BODY ACHES, FEVER, NAUSEA AND VOMITX1.  ADVERSE REACTION VS CELLULITIS.  ADMIN KEFLEX AND BENADRYL IN ER.  SENT WITH RX FOR KEFLEX TIDX10 DAYS
Patient has pain in arm around the site of injection on and off slowly diminishing after 4 months.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004186, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, Oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Additional information received 13Nov2012: MMR vaccine Date given 11/02/2012. Lot # 1571AA. Additional information has been requested.
A few days after the vaccine I had scrotal pain. There was a general pain that I did not know the cause of. It was like a dull aching pain that lasted several days. I saw my urologist on 04/28/2021. The pain was already gone at that point and he did not see anything of concern. He just thought it may have been an inflammatory response to the vaccine. I have since had my booster and did not have a reaction.
within 12 hours of vaccine develop viral arthritis symptoms ( ankle, knee, hip and cervical spine pain) subsided after 24 hours but a concertation of pain develop orally-  oral pain, feels like a tooth ache across all teeth, extreme sensitivity to temperature.  over several days decreased to dull pain along the maxilla mostly on right side. Some days are better than others ie. just sensitive to cold (liquids and food) others days full pain along the upper and lower, primarily on right side but radiates to left side. on day 8 and 13 was having extreme break though pain, Alieve and Tylenol were not helping. on 13th day almost unbearable.  Currenly on day 16th and still taking tylenol daily to help with discomfort.
Patient received immunizations about lunch time.  They live about 2 hours away.  On their way home, child threw up, had itching and hives.  Mom took him to clinic to be seen.  Hives gone after one dose of Benadryl.  This is per Mom.
Hard, swollen, fevered area at the site of the injection; diarrhea, area is sore to the touch, headache, decreased appetite, chills.
Started to get dizzy and light headed on Aug 3.  after about 15 minutes too a meclizine tablet.  That helped for a while and then woke up about 3:00 am and was dizzy again.  toke another meclizine and went back to sleep. Woke up dizzy at 9:00 am and took another meclizine and still have dizziness and feel like falling over.
Within about 7-10 hours I experienced flu symptoms. Low-grade fever, headache, chill and painful aching throughout my body. It continued until 11/05/2022, before subsiding.  I took Tylenol , 1000 mgs. for headache and fever. On Sunday, 11/06/2022, I experienced itching on both of my legs. Upon examination of my legs I have red dots from my upper thigh to my ankles on both legs. I still have the red dots and the itching has subsided. I applied Cortaid cream and have been taking Benadryl tablets in the evening.  I have had Shingles twice, before this reaction. Jan. 2012 &  Oct. 2019.
Patient called today 2/1/22 and reported extreme headache, chest heaviness, arm soreness, and pin and needles feeling after receiving  vaccination on 1/31/22. Patient stated the symptoms started around 2 pm yesterday and continued today. Patient did contact her primary care doctor who instructed her if she was not feeling better by weds 2/2/22 to go to ER or Urgent care.
Arm was moderately sore for first two days. After approximately 2 weeks, a large area around the injection site became red and intensely itchy. This continued for a full week or more. The point of the injection was clearly visible with a whitish area around it.
Pt received influenza vaccine on Fri (Jan 8) and developed fluid build up in left arm, hand, and left ankle. Also had N/V and rash on arm. Reported to ER on 01/11/05. Red rash that itched. Kenalog 40mg IM given. Instructed not to ever take the flu vaccine again. No new meds started in relation to occurrence of event.
Patient was getting light headed and fainted but did not lose conscienceness. Patient fell at around 2 feet but was conscience, we had patient lay down and called 9-1-1.  I called patient afterward to follow up, as she denied going to hospital, she reports being fine, just a little sore on the head.  She most likey had her vasosyncopy
inconsolable crying for over an hr-pain, swelling;ice pack applied & motrin given;calm w/in 15min;
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in May 2017, the patients were possibly vaccinated with improperly stored doses of VAQTA injection, lot # N005274 with expiration date 03-APR-2018 (dose, route and site of administration were not reported). VAQTA was stored between 32 and 35 degrees Fahrenheit for 4 hours and 40 minutes. There was previous temperature excursion and the digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA015617: US-009507513-1705USA007801:
Initial report received from a healthcare professional on 01 OCTOBER 2013. A female patient (date of birth and age at the time of event was not reported) had received a dose of FLUZONE (lot number, route, dose in series and site of administration was not reported) on 01 OCTOBER 2013.  The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. The patients last menstrual period date was unknown and the expected date of delivery was not reported. As of the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Post vaccine day 5, started feeling tingling in legs; 2 days later had twitching and fatigue after walking 1 mile - was admitted and dx'd with recurrent Guillain- Barre syndrome and treated with IVIG. EMG pending to verify GBS (sensory only) vs small fiber neuropathy. Incidentally found B12 deficient and Vitamin D insufficient