chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 1-year-old male with a history of stroke and heart problems who on 10-APR-2008 was vaccinated with a dose of MMRII (lot number not provided).  Concomitant vaccinations administered on that same day included a dose of VARIVAX, a dose of PREVENAR and a dose of ACTHIB.  The physician reported that on 10-APR-2008, the patient became mottle and developed a rash from head to toe.  On 11-APR-2008, the patient was seen in the physician's office and his rash was noted to be cleaning up.  At that time, it was noted that the patient had also developed upper respiratory problems.  At the time of this report, the patient was noted to be recovering.  Additional information has been requested.
Patient was incidentally found to have COVID infection while in hospital for other diagnosis.  Patient endorsed mild shortness of breath and cough but afebrile and did not require oxygen.  Patient required no treatment for COVID and was discharged to home.  Patient had previously received his first COVID vaccination.
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
ITCHING/SWELLING AT SITE OF INJECTION AND ABOUT 2 INCHES LOWER ON MY ARM 2 1 1/2 DIA RED WELTS.  AREA WARM & SWOLLEN.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-FEB-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (dose and route not reported, lot# L027287, expiration date: 21-JUL-2017) (incorrect product storage). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 13 year old female who on an unspecified date was vaccinated with second dose of GARDASIL (dose, route and lot number not reported). It was reported that "a few minutes after receiving the second dose", the patient experience a syncope. The patient recovered "within 30 minutes to 1 hour". The patient sought medical attention by contacting the physician. Additional information has been requested.
Peri-oral rash, tingling in throat, puffiness in eyes, palms itching.
After 4 hours, patients left arm became extremely sore and immobile. Loss of appetite due to pain. Pain persisted for two days then gradually lessened over the next two days. No swelling or bruising.
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation.  Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
447pm - pt complained dizziness. she was alert and calm. vital signs stable patients mother accompanied the patient. patient was lying down with elevation both legs. patient said she felt better later. denied any dizziness. alert and calm, vitals stable. left with her mother.
pt devel chickenpox type rash;each day worsening;blister like rash all over body;pt uncomfortable, afeb per mom;
Information has been received from a physician via a company representative referring to a female patient of unknown age.  The patient's concurrent conditions, concomitant medication and medical history were not provided. "Last Friday", on 25-AUG-2017, the patient was vaccinated with one dose of ZOSTAVAX (route, lot# and expiry date were unspecified) for shingles prevention.  Then over the weekend (in August 2017) the patient started experiencing "pain, swelling and arrhythmia." It was reported that the patient's swelling consisted of a "20 cm by 15 cm lump" that had appeared around the injection site of her arm. The patient had a follow up visit with the physician the following Monday (28-AUG-2017) as a result of the adverse events. No product quality compliant (PQC) involved. The outcome of the events was unknown. Upon internal review, arrhythmia was determined to be medically significant.
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   Most recent FOLLOW-UP information incorporated above included on 25-Jun-2021: Follow-up contains, Non-significant information.
Left arm receiving shot became very painful right after injection and continued for the following week. Within approx 10 minutes I became nauseated, dizzy and felt hot all over. Within approx two hours I had to go to bed and remained there for two days.  I had lost of appetite and retained a fever of 99.1 for several days.  I felt very weak and lethargic.  Within a few days I developed blisters on the inside of my mouth and outside which took 5 weeks to completely heal.  I did report this to Dr. and showed him pictures of my mouth.
Initial report received on 13 August 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 18-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL (lot number not reported) on 18 February 2011, 20 April 2011, and 20 June 2011, and 1 dose of DAPTACEL (lot number C4035AA) on 22 June 2012. The subject developed a cough on 12 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 12 July 2013. The subject also developed cold like symptoms on 10 July 2013. Laboratory testing included positive PCR on 23 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 23 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 206 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 August 2013. These 206 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Patient reported Fever/Nausea and hives and welts on arm, face, and eyebrows.
12/07/21 presents to ED for "Dizziness, cough, diarrhea". PMHx of "lung cancer and TCC"
- Scratchy throat - deep in Throat - Not oN toNsils - Itchy eyes - wanted to dig itching badly  - PaiN Neck behind both ears - Threw up - Chills for about 4 hours  No Fever - At approximately All symptoms disappeared  - Eyes (lids) swollen For 2 days  - Slight brusing At injection site - arm red and warm to the touch.
Immediate but "normal" soreness in the left arm at the injection site.    The site soreness went away after 2 - 3 days but left with soreness in the left lower arm that got progressively worse.  Often I was unable to lift or pick up anything more than about a pound.  Recently (2 days ago) I am unable to raise my right arm beyond a 25-degree angle from my left side.  Very sore to the touch now. I Will see MD on 9/16/21  My left arm seems to be swollen all the time since the injection and not as strong.
immediate severe arm pain, 102 fever, severe weakness, severe chills, loss of appetite, diarrhea, severe body aches, the worst of which lasted 24 to 36 hours. Symptoms were to the point I could barely take care of myself and needed help. Considered going to ER
Redness and swelling at injection site with line of cellulitis near injection site. Pain in arm and under arm. Overall feeling of malaise.
One week later I have redness, swelling at the injection site and it is warm.  I also had a small fever of 99.
Fever and body aches started about 24 hours after vaccine and end after about 12 hours
A serious, spontaneous report of seizure was received from a Physician concerning a three year-old female patient subsequent to FLUMIST.  The patient's past medical history includes seizures.  Concomitant therapy includes levetiracetam.  The patient received FLUMIST on 13-Oct-2008 at 9:30 am.  On 13-Oct-2008 at 2:30 pm the patient experienced a seizure.  The child was seen at the emergency room, where she was evaluated and released.  The child was also seen by a pediatrician on 14-Oct-2008.  The patient's office stated the seizures had been well controlled with levetiracetam and the patient had not suffered a seizure for about one year.  The outcome for the adverse events was not reported. Follow-up: Numerous follow up attempts have been made, no new information has been received.
Symptoms: itchy eyes, nose, throat - the same symptoms she reports when she starts to have an allergy to Shellfish. Time course: started a couple minutes post-vaccination, lasted for only about 10 minutes. Immediately started improving upon administration of Benadryl.
really bad headache; blood pressure also got extremely high; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix and the 1st dose of Boostrix. In December 2019, 1 day after receiving Shingrix and Boostrix, the patient experienced headache and blood pressure high. On an unknown date, the outcome of the headache and blood pressure high were unknown.   It was unknown if the reporter considered the headache and blood pressure high to be related to Shingrix and Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient recently received a dose of Shingrix and Boostrix, a day or two after patient began experienced really bad headache which was a side effect. The patients' blood pressure also got extremely high and have been having a problem getting it back under control. The patient asked was the blood pressure issue a reported side effect. Further information was not reported.
Information has been received from a physician concerning an adolescent female who was vaccinated with a dose of VARIVAX (Merck) as a young child on an unspecified date. The patient was showing breakthrough chickenpox on 14-APR-2010. At the time of the report, the outcome was unknown. Additional information is not expected.
He got a covid test and has tested positive; He got a covid test and has tested positive; feeling bad; chills; fever; tired; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, it was reported that the patient was due to get his second shot tomorrow, but woke up 2 days ago feeling bad, chills, fever, and tired. He got a COVID test and has tested positive. The outcome of the event was unknown. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 62-year-old female patient who received Shingrix for prophylaxis. On 10th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2018, 1 days after receiving Shingrix, the patient experienced pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell. On an unknown date, the outcome of the pounding in head, influenza-like symptoms, fever, nausea and general body pain were recovered/resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the dizziness and unwell were unknown. It was unknown if the reporter considered the pounding in head, influenza-like symptoms, fever, injection site pain, nausea, general body pain, dizziness and unwell to be related to Shingrix. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
Fever (101*F), Chills, Headache, Sore arm, Achiness from neck radiating down spine through hips
diarrhea- not a formed stool or a mousse stool; she slept like 4 days after, she slept and slept; Pain in arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received bnt162b2 (BNT162B2, formulation; solution for injection, lot number: EL9262), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 79 years) as dose 1, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing (it is hard for his wife to walk due to this, she has a lot of it, and it was diagnosed a long time ago), diabetes from an unknown date and unknown if ongoing (this was diagnosed a long time ago), neuropathy from an unknown date and unknown if ongoing (this was diagnosed a long time ago). There were no concomitant medications. On an unspecified date, the patient experienced diarrhea- not a formed stool or a mousse stool, she slept like 4 days after, she slept and slept, pain in arm. Reporter said she had a form of diarrhea, she says not, reporter said there was no form to it, it just came out, it was not formed stool, and she has always had formed stool, now she had whatever you call it, reporter called it diarrhea. She was scheduled to take her second shot on Thursday, and they were concerned about the diarrhea since it was still going on, and she was always exhausted after the bowel movement. One other thing was his wife had pain in her arm after getting the shot that lasted about 4 days. They did no treatment for diarrhea, they were not sure if it was gonna be short time or what, also because it wasn't affecting anything. When patient first got the shot, she slept like 4 days after, she slept and slept, he had to get her up to make her eat, she slept an awful lot. There has been no treatments. Clinical outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Admitted to hospital for fall and hypoxia. Was diagnosed with COVID >14 days before presenting to hospital.
Initially (09/29/09), severe pain from base of skull down through the spinal cord to the sacrum. Muscle weakness and unable to hold head up at end of day. Weak and exhausted. Neurologist have run test and prescribed physical therapy 3x q/week. Meet with neurologist on 11/30/09 for test outcome. As of 11/27/09, patient still has a dull throbbing pain in left arm, pain in neck (between 4 & 5 on 1-10 pain scale), difficulty sitting for any length of time, fatigue at end of day, decreased energy level. 12/04/09 Neurology records received for DOS 10/26/09. Pt presented with left arm numbness, neck pain x 4 weeks.  Assessment: cervical radiculitis  12/04/09 Medical Clinic records received for DOS 10/03/09. Pt. c/o redness, swelling,pain, inflammation in left arm. Treated with Decadron IM. Neurology referral.  DX: reaction to immunization left arm, allergic to hep B. 12/04/09 Medical Clinic records received for DOS 10/15/09. Pt. complaining of left arm pain, neck pain. left arm weakness, neck stiffness. neurology referral.  DX: left arm radiculopathy.  12/07/09 Medical records received for DOS 10/26/09. CXR report. 12/08/09 Medical Records received for DOS 11/10/09 labs and diagnostics.