chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible Relationship with regard to time of development of systemic Lupus erythematosis, acute renal failure, and congestive heart failure and receiving first dose of anthrax vaccine.  Service member received vaccination on 2 February 2007 and reported to 15 days later on 17 February 2007 with symptoms of "coughing up blood", nausea, vomiting, and diarrhea. Admitted to Hospital and subsequently transferred to the Intensive Care Unit of Medical Center.  Treated at this institution for approximately one month.  Patient transferred to his home of record once stable for convalescent leave. Now followed as an outpatient, but with periodic related medical problems requiring inpatient admission, including Congestive Heart Failure and Sepsis.  8/20/2007 Extensive MR received for DOS 2/18/2007-4/7/2007.  Pt initially transfered from facility for management of thrombocytopenia, anemia, nausea, vomiting, diarrhea, fever, hematochezia, hematemesis, and potential hemolytic uremic syndrome.  Pt had an extensive ID w/u which was (-).  Developed seizures during admission requiring intubation. Multiple transfusions of PRBCs for anemia. Nephrology following acute renal failure and dialysis. Pt developed heart failure and was diuresed Discharge DX:  Systemic lupus erythematosis.  Heparin induced thrombocytopenia. Depression. Anemia 2' to SLE. Hx of seizures (lupus neuritis). Acute renal failure (lupus nephritis) on hemodialysis PRN. Hyperglycemia-steroid induced.  Hypertension-steroid induced. Hx of tracheobronchitis.  Left ventricular systolic dysfunction with EF of 25-30%.  09/10/2007 Lengthy MR received for 4 admissions DOS 4/07-13/2007, 4/18-5/08/2007, 6/23-7/03/2007, and 7/7-9/2007 with the following DX: 4/7-13/07: Acute Renal Failure 2' to glomerulonephritis, Systemic Lupus Erythematosus, Heparin induced thrombocytopenia/hemolytic uremic syndrome. Steroid induced diabetes. Anemia.  HTN, steroid induced. L ventricular systolic dysfunction, Lupus neuritis with seizure disorder.  Depression.  Gastritis. 4/18-5/08/2007:  Severe CHF with L ventricular dysfunction.  Bilateral pneumonia, resolved. Staph infection of Ash catheter. Lupus nephritis with chronic renal failure.  6/23-7/03/2007: Septic shock, resolved. Pneumonia in resolution, Pancytopenia, resolved. 7/7-9/2007:  Recurrent seizure disorder.  Steroid induced gastritis. SLE relapse on prednisone, Plaquinil, and Cellcept.  Cardiomyopathy with ejection fraction of 20%, possibly from lupus myocarditis.  Nonnephrotic proteinuria, Major depression.  Mitral regurgitation.  Mild anemia.  Recent hx of septic shock with multiorgan failure.  Acute renal failure. Per 60 day follow up: 1. Systemic lups erythematosus symptoms continue 2. Diabetes mellitus Type II related to corticosteroid treatments 3. Continued Heart Failure Patient remains at this home on convalescent leave from military. He is now followed by multiple specialist at medical center.
received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D4CZ3, expiry date 10th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose of shingrix in 2018).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that a patient received full dose schedule of Shingrix in 2018 but last year in December patient received 3rd dose of Shingrix, which led to extra dose administered.  The reporter wanted to know if there was any further information regarding safety of patient. The reporter consented to follow up.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted approximately 3 minutes after vaccination, fell onto partner and partner lowered patient slowly to ground. RPh and team provided support for patient, elevated feet and provided ice packs. Patient was unconscious for less than 30 seconds, recovered in 10 minutes and left store of own accord. Partner reported pt had severe anxiety prior to vaccination but that was not made clear to vaccinator.
Pt recvd vax 1DEC92 & exp full-body itch; pt also exp dizziness, nausea, flushed face, raised temp, aching @ inject site as well as in arm & neck; later that day entire lt arm was sore & felt heavy; pain radiated into the lt side of neck;
Received yellow fever and Hep-A on 3/12/01. About 19:00, felt very tired and went to bed. Woke up with vomiting, weakness, headache and metallic taste. No specific Rx taken. Felt improved but weak on 3/13/01.
Headache and Fever (101.4) and extreme chills, shivering, lasting approximately 7 hrs, then fever reduced to 99.1, then no fever approx 3 hours after that.  Still have slight headache.
Subsequent to receiving one dose of Engerix B, the pt experienced high fever, dizziness and faintness. The most recent information received reports the condition of the pt is unknown.
I was feeling out of sorts, I would not say I had one symptom that made me think I was sick, but just felt a little off. I had COVID-19 home tests and I decided to take one and it was positive. I reached out to my healthcare provider, but he did not get back to me for about 48 hours. In that time frame I had a headache, sore throat, and fatigue, these were really my only symptoms that I had throughout my time of being positive. The sore throat was the worst and the fatigue lasted throughout as all. I finally spoke with my health care provider, and he gave me PAXLOVID and that did help and shortly after that I did test negative. However, 48 hours after that negative test I tested positive again. Then the cough started with a tightness in my chest. This cough has continued now but once I am up and around and it dies down and is not as bad. I tested negative three days consecutively starting on January 5th and then the last day on the 7th. The last day I had been positive was the day before that on January 4th.
~30 seconds of bleeding from injection site. About 10 hours after injection, severe flu-like symptoms including nausea, headache, exhaustion, body aches, high fever. Intense flu-like symptoms, including fever, lasted about 12 hours after onset (~24 hours after injection). Severe symptoms treated by OTC ibuprofen ~20 hours after injection -- moderately helpful at abating symptoms. Milder symptoms, including headache, body aches, and tiredness persisted for 36 hours after injection.
On 06/03/2000 the patient developed red bumps in her groin that were non-pruritic. It was noted that the patient was afebrile. On 06/05/2000 she sought unspecified medical attention and was diagnosed with chickenpox. Follow up information reported that the patient developed 4 crusted erythematous lesions in the groin and erythematous papules on her stomach. It was noted that the rash was "non-ill appearing". No further information is expected.
High fever, irritability, restlessness, took to the doctor who tested for flu and RSV.  He ended up wheezing over the weekend so we took him to the ER on 03/30/2014 and was diagnosed with bronchiolitis.
Moderna COVID-19 Vaccine.  Severe headache yesterday, neck pain, chest pain and back pain today, arm hurts too
Beginning of itchy rash, increased in intensity. Saw Dr. at 8:30 AM 07/23/2010. Diagnosed with shingles. Prescribed 1GM Valacyclovir and 0.1% Triamcinolone.
This spontaneous report as received from a pharmacist refers to a 71 year old male patient who was allergic to penicillin. The patient's medical history included an unspecified surgery. On 16-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX23(Lot number, expiry date were not reported), 0.5 ml, intramuscular. On 02-OCT-2013, the patient was vaccinated with a second dose of PNEUMOVAX23 (Lot number was reported as J004387, expiry date was 04-JAN-2014), 0.5 ml, intramuscular. On 02-OCT-2013, the patient also received influenza virus vaccine(manufacturer unknown)(Lot number, expiry date, route and dose were not reported). The reporter was informed by an unspecified nurse that since approximately on an unknown date in October 2013 (reported as currently), the patient had temperature. The patient sought medical attention and was being treated with TYLENOL. Lab Diagnostics Studies Performed was none. The patient was currently residing in an unspecified long term care facility due to an unspecified surgery that he had prior to receiving any doses of PNEUMOVAX23. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
No adverse reaction.  2nd injection was given at 2 wks not 3 wks.
He started vomiting and diarrhea. He has been having fever on and off. Not tolerating solids. Complaining of abdominal pain. Local reaction on injection site: bruise, redness and mild induration.
Chills, slight temperature, headache joint pain.  Chills have continued off and on.  Headache still present after9 hours, joint ache continues.
Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.
Received FLUMIST 9/16. Cough and fever 3 days later, came to our office saying "swabbed". Asked pt if wet or dry. She said "dry", showed Q-tip and she said that's what it looked like.
This spontaneous report was received from a doctor of pharmacy concerning a 62 year old male patient with no pertinent medical history. Current conditions of the patient included GARAMYCIN allergy and unspecified allergic reaction. On 15-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001698 and 08-MAY-2014 (also reported as 01-JAN-2014) respectively), subcutaneously. There were no concomitant medications. Approximately on an unknown date in September 2013, the patient developed a welt, currently 2 inch x 1 inch at the injection site and has had the welt for approximately one week. It was also reported that the welt had become larger over that time-frame but the patient had no complaints of pain or itching. The patient sought medical attention (at pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the event at the time of report. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Dizziness/woke up dizzy/feel very dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, post vaccination in morning the patient woke up dizzy. The patient reported patient is fine if walking from room to room, so Patient is fine when sitting down, walking room to room or anything felt very dizzy. The outcome of the event was reported as unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Client received moderna the first vaccine Lot 004c21a  And received pfizer second dose.
Coughing; feel congested; got sick with flu; fever; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer (Patient) of an unspecified age reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced coughing and feel congested, got sick with flu, fever. Patient and his wife will be having their second dose. They got sick with flu, fever and congestion on Tuesday of last week. Patient wanted to know if it was okay to take the vaccine on Wednesday. Clinical outcome of the events was reported as unknown for all the events.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)) in a 74-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) nothing over 100.         No concomitant medication information provided.  Caller stated he have had Moderna shots and both boosters. Caller were experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion. Other possible side effects included altered sense of taste.  Company Comment: This is a spontaneous case concerning  a  74-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred unknown day after the third  dose of mRNA-1273 COVID 19 Vaccine. Patient was treated with nirmatrelvir,  ritonavir tablet of unspecified dose and frequency. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  74-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred unknown day after the third  dose of mRNA-1273 COVID 19 Vaccine.Patient was treated with nirmatrelvir,  ritonavir tablet of unspecified dose and frequency. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Lower Back Spasms just a few hours after vacine was administered.  I went to bed with what I thought was just flu like syptoms like achy muscles.  But this was more then that.  Even laying in bed my back would spasm and almost take my breath away.  That night did not sleep due to the sporadic unpredictable pain when laying in bed.  Describe pain as electic shock or stabbing pain that takes your breath away it's so intense, but then goes away very quickly.  The next couple of days I was forced to stay immobile due to the pain that was sporadic in nature.  Even when laying down it spasmed.   I could barely walk for a few days.  I started taking NSAIDS to help with the pain and I became more mobile after a few days.  Work has been very difficult and spasms have not gone away even now Im still having problems and am struggling making it through the work day.  I have to lay down flat on my back as soon as I get home from work and take ibuprofen to relieve the pain.  I was absolutely fine healthy and very active person prior to the vaccine.  Just hours after getting vaccine it's almost like my joints and back were inflamed for some reason.
Pain, swelling, redness at injection site. Could not lift arm. Extreme tiredness and fatigue. Dizziness and headache. Body aches all over (most likely the shot caused a flare to my ostearthritis). Stomach ache, vomiting, chills,  runny nose and fever. Symptoms similar to the flu. Started Wednesday evening after shot received and got worse over the next few days.  Went to bed early during the week after work. Was totally exhausted. Was in bed all day Saturday, Sunday and had to take off work on Monday. Seem to be feeling a little better this evening. Fever broke; sweated on and off all day.
Sore arm at injection site (given at 230pm), headache all night, fatigue for the next 36 hours
30 min after vaccination, felt dizzy, had abnormal movements of neck and upper limbs, no loss of consciousness
Severe nausea; Vomiting; Diarrhea; Headache; Low energy; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced low energy. On 10-MAR-2021, the subject experienced severe nausea. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy, severe nausea, vomiting, and diarrhea on MAR-2021, and had not recovered from headache. This report was non-serious.
A report was received from a health professional on 05Dec03, concerning a 6 month old male vaccinee who inadvertently received Fluvirin on 28Nov03. On 28Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400084, PJP200400086.
Patient reported symptoms of cough, short of breath, vomiting over the weekend after the vaccine.  When she called in she said that the symptoms had improved with home care.
Headache, fatigue, muscle soreness, and chills started the morning after being vaccinated.
Red eyes, sore throat, cough, body aches, fever to 101.5 for 2 days on and off, ear infection requiring Azithromycin (Z-Pac) and Solumedrol IV x 1.
Light chest pain/pressure/discomfort. On 10/25 went to the ER, mulitple test run, no signs of heart attack, pulse, bp, oxygen, temp, EKG all okay. Echocardiogram showed right ventricle was mildly enlarged and its systolic function was mildly reduced. Dr. my Cardioligist confirmed this was not present on my last Echo. He prescribed low dose aspirin and a D-Dimer blood test that came back at .2. He scheduled a nuclear stress test and another Echo in a few weeks. He said not to exert myself until after he can see the results of the stress test. On 11/2 I noticed some bumps on my left side below my waist line and I was diagnosed with Shingles on 11/4 by PA-C Urgent Care. He prescribed Valacylovir for 7 days. Prior to having the Shingles the shoulder opposite of the vaccine injection experienced extreme pain and later moved to my right elbow, felt like my shoulder was dislocated and set back in place. Had great difficulty sleeping, could no longer sleep in my favorite position. I had to stop exercising with my floor routine. I use to be able to do 40+ push-ups at one time and easily throw around my dumbbells. Its been over 3 months since the vaccine and my shoulder is still not right. My cardiologist did state that my most recent Echo-cardiogram shows that my heart is back to normal size and function.
On Mar 15 in the evening, patient developed left sided numbness initially in the chest, and then woke up the morning of Mar 16 with numbness on the left side of her face, left arm, and left leg. She also complained of a frontal headache that felt like a sinus infection. She went to the ER at 10am at Hospital. CT brain and CT angio head/neck were negative. MRI  brain w/o contrast showed no stroke and MRI cervical w/o contrast showed mild cervical arthrosis. She had gradual improvement in her numbness. ECHO showed mild LVH, no shunt or PFO. She was started on lisinopril due to mildly elevated blood pressures during this admission- new diagnosis of hypertension.  After discharge she continued to have episodes of left sided numbness and blurry vision nearly every day until she presented to my clinic to establish care on 04/22. At that time she was experiencing numbness on the left side of her face in a V2 distribution. She was sent to the ER at Medical Center and was admitted 4/22- 4/24. CT head was negative. Symptoms resolved after this hospitalization. MRI/MRV was ordered outpatient and performed 05/04.  MRV showed Right transverse venous sinus filling defect probable thrombus, nonocclusive. She was started on Pradaxa 05/05 and has not had any neurologic symptoms since.
Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. 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.