chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports experiencing a large blood clot exiting from her nostril on 6/7/21.  She had second Pfizer COVID vaccine dose 5/19/21.  She reported to an Urgent Care facility and was instructed to go to Emergency Room if any vision changes.  Later in the day 6/7/21 the patient reported having double vision and she went to Emergency Room.  She states she had CT scan in hospital and the patient reports an aneurysm was discovered.
Patient is a 12 year old previously healthy male presenting with bilateral conjunctivitis, fever and rash. History provided by mom and dad at bedside. On Sunday 10/3, he developed nausea and a headache. The following day he started to become febrile and has had persistent fevers since then with a Tmax of 103 at home. Fevers did respond to Tylenol at home. On Tuesday/Wednesday (105-10/6) he developed SOB, chest tightness, epigastric abdominal pain, malaise, and dry cough. Over the course of the week he had 2 days of NBNB emesis and then has had several episodes of nonbloody diarrhea daily. 10/7 he developed an erythematous rash on the soles of his feet that appeared like a sun burn.  On admission he had non-purulent conjunctivitis with limbic sparing, cherry red dry lips, strawberry white tongue, red palms and soles; and non palpable discreet macules on torso. clinically consistent with MIS-C
Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelling in arms and legs and face, numbness and tingling in extremities. Slight tightness in chest.
Headache, Arthralgia, Severe fatigue, chills, severe HA Narrative:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 30Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in left arm for Covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 08Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2022; METOPROLOL SUCCINATE, start date: 01Jan2022; LOSARTAN, start date: 01Jan2022; VITAMIN D 3, start date: 01Feb2022; KIRKLAND ALLER-TEC, start date: 01Jan2022; FLORA, start date: 04May2022; FLONASE SENSIMIST ALLERGY RELIEF, start date: 01Feb2022. Past drug history included: Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough); Lisinopril (cough), reaction(s): "Known allergies: Lisinopril (cough)", notes: known allergies Lisinopril (cough). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive Covid rapid test; (unspecified date) Negative, notes: tested negative for 8 consecutive days; (May2022) Positive, notes: tested negative for 8 consecutive days and then tested positive; (May2022) Positive, notes: Positive test was 5 days after completing Paxlovid. Therapeutic measures were taken as a result of Covid-19, vaccination failure. Clinical course: The patient received anti-viral product for Covid-19 treatment, brand-Paxlovid, treatment start date 15may2022, treatment stop date 19may2022. Positive Covid rapid test and mild Covid symptoms after treatment with Paxlovid. The patient tested negative for 8 consecutive days and then tested positive and experienced mild symptoms on day 9. Positive test was 5 days after completing Paxlovid treatment. Symptoms are mild but he concerned that he may still be contagious and he getting conflicting advice from his doctor over whether he should continue to quarantine or not.
had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm; numbness; a headache for the past week; feels disoriented; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), DISORIENTATION (feels disoriented), HYPOAESTHESIA (numbness) and HEADACHE (a headache for the past week) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced DISORIENTATION (feels disoriented). On 18-Oct-2022, the patient experienced LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), HYPOAESTHESIA (numbness) and HEADACHE (a headache for the past week). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In October 2022, HEADACHE (a headache for the past week) had resolved. At the time of the report, LIMB DISCOMFORT (had great difficulty using her left arm and fingers/Her hand is limp and feels like it is someone else's/seemingly no control over that arm), DISORIENTATION (feels disoriented) and HYPOAESTHESIA (numbness) outcome was unknown.            No concomitant medication was reported. On 29-JAN-2021, the patient received first Moderna dose with lot no. 041L20A, expiration date 31-JUN-2021. On 10-MAR-2021 the patient received Second Moderna dose with lot no.003A21A, expiration date unknown. On 24-NOV-2021 the patient received Third Moderna dose with lot no. FH802H,expiration date unknown. Patient not had any reactions with previous doses. Patient had broken glasses, cups, and a vase because of numbness and seemingly no control over that arm.   This case was linked to MOD-2022-662397 (Patient Link).
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients experience flu like symptoms after receiving Shingrix. The reporter stated that this was more common in 50-59 year olds and less frequent in those over 70 years of age. No other information was provided.
patient developed rash 3 days after receiving the dose.  The rash is local and in her shoulder.  I told the patient to set up the appointment with her doctor to get a check up right away
Pain in arm from injection site down to just above the elbow. It's a constant throbbing and aching feeling that varies intensity from 2-7 on a 10-chart. Not able to sleep on that arm.
Pain 7-8. Not continuous but hurts when lifting, taking off shirt, if put in a certain position during sleeping will wake her up. Hurts when she puts arm up over head. Hurts in the area of the shot. Pain rate 9 on the day of the shot down to the bones. Upon administration, it hurt more than normal. Took ALEVE day of shot but has not taken since.
got the 2 dose vaccine and became quite ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the 2 dose vaccine and became quite ill with the second shot.  The patient know it was not as bad as getting shingles, so he/she was glad and had got it.  But the patient would advise scheduling the second dose on a day they were free the next day.  It lasted about 24 hours. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Client received Moderna vaccines for Covid at end of January and end of February, 2021 (client does not know exact dates but states end of Jan and Feb).  Tested positive for Covid on 9/24 with symptoms starting on 9/24/2021 - nasal congestion, fever, myalgia.  Reported as breakthrough Covid case in a client who was previously vaccinated.
Patient came to my office 13 days after receiving varicella at a clinic.  She developed a pruritic rash 3 days prior to seeing me.  Also fatigue, low grade temps at home.  Rash was vesicular in appearance - total of 5 lesions the majority on her torso. Pruritic
Patient noted her arm was very itchy within minutes after administration. Patient was given 50mg oral Benadryl and noted the syrup was difficult to swallow. An EPI Pen was administered at that time as well as 911 called. Patient's BP was 156/124 with HR 106. Patient was responsive and stable until EMS arrived.  Patient was taken to the hospital where she received treatment and is now feeling fine awaiting discharge.
polymyalgia rheumatica; Information has been received regarding a case in litigation from a lawyer and consumer, referring to the 60 year old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) by a pharmacist at a pharmacy.   The patient suffered the following injuries and was diagnosed on the following dates: as a result of the zoster vaccine live (ZOSTAVAX), patient was diagnosed with polymyalgia rheumatica on 09-SEP-2014. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, polymyalgia rheumatica was considered to be medically significant.
Headache, Myalgia, Arthralgia, arm soreness Could not lay on his left arm, couldn't sleep due to the pain. Woke up feeling sluggish, started getting a headache, chills, had to leave  work. Took Tylenol OTC.
03/16/22 presents to ED for "abdominal pain". PMHx of "PCOS, sickle cell trait and surgical history of C/S"
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 62 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Pt took 1st Vivotif capsule 01/28/2006, In am of 01/29/2006 pt noticed itchy rash on knees. Monday 01/30/2006 pt had rash on elbows and knees. Pt took capsule #2 01/30/2006 and on 01/31/2006 has itchy rash on ankles and elbows. Stated rash on ankles is very bothersome. Benadryl given 01/31/2006 in AM for rash.
Patient states that he felt weak and not able to walk without assistance. He also had hallucinations. His symptoms lasted a week. He has had both of these vaccines in the past.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 301308a), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FD3350), in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure and COVID-19 as the patient received PAXLOVID on 02Dec2022 until 07Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a literature report. The reporter reported two reports for same events for 2 patients, this is the second of the report. Recently reported cases of myocarditis and pericarditis after coronavirus disease 2019 (Covid-19) messenger RNA (mRNA) vaccination.1 In recently published reports, diagnosis of myocarditis was made with the use of noninvasive imaging and routine laboratory testing. Here, authors report two cases of histologically confirmed myocarditis after Covid-19 mRNA vaccination. Patient 2, a 42-year-old man, presented with dyspnea and chest pain 2 weeks after mRNA- 1273 vaccination (second dose). He did not report a viral prodrome, and a PCR test was negative for SARS-CoV-2 He had tachycardia and a fever, and his electrocardiogram showed diffuse ST-segment elevation. A transthoracic echocardiogram showed global biventricular dysfunction (ejection fraction, 15%), normal ventricular dimensions, and left ventricular hypertrophy. Coronary angiography revealed no coronary artery disease. Cardiogenic shock developed in the patient, and he died 3 days after presentation. An autopsy revealed biventricular myocarditis. An inflammatory infiltrate admixed with macrophages T-cells, eosinophils, and B cells was observed, a finding similar to that in Patient 1.  In these two adult cases of histologically confirmed, fulminant myocarditis that had developed within 2 weeks after Covid-19 vaccination, a direct causal relationship cannot be definitively established because we did not perform testing for viral genomes or autoantibodies in the tissue specimens. However, no other causes were identified by  essay or serologic examination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: A contributory role of BNT162B2 to the event myocarditis cannot be fully excluded based on temporal relationship and since it is part of the product safety profile. This case will be reassessed if additional information becomes available. 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. Linked Report(s): PFIZER INC-202101076911 Same reporter/drug/event, different patient; Autopsy-determined Cause(s) of Death: biventricular myocarditis.
Severe arm and neck pain, chest tightness, 2 hour post vaccine. No prior history of asthma, abdominal pain. Seen in the ER and discharged with Albuterol. This is in follow-up to report(s) previously submitted on 4/13/2007.  Information has been received from a registered nurse and a licensed practical nurse concerning a 12 year old female student with no pertinent medical history who on 13-MAR-2007, at 16:45 was vaccinated, intramuscularly into the left arm, with a 0.5 mlm first dose of GARDASIL (lot #655618/0186U) concomitantly with a first dose of MENACTRA (lot #0167AA) and a fifth dose of ADACEL (lot #C2456AA) into the right arm.  On 13-MAR-2007, at 17:45 (also, reported as 2 hours after vaccination), the patient developed severe arm and neck pain, chest tightness and abdominal pain.  At bedtime, the patient had difficulty breathing and pain in her chest.  Her mother took her to the emergency room where she had a chest x-ray.  It was reported that there was no detection of wheezing, swelling or pulmonary embolism.  She was treated with albuterol which "did not seem to help." As of 14-MAR-2007, the patient was improving her arm and chest were "just sore."  No further information is available.
Friday - Nausea, headache Friday night - Muscle cramping all over body Saturday - Right sided paralysis and tingling in feet Sunday - Feet tingling and paralysis Monday - Pain in back and feet tingling, muscle weakness, numbness, and also in my right hand Tuesday - Same Wednesday - Same, but more painful Today - Same, more painful
I have been experiencing irregular periods. Starting in June my period was a day or two late and heavy on the first 2 days, no bleeding the third, and continued bleeding on the 4,5, and 6 day. In August the same thing occurred. It?s now September and my period has not came this month. There?s absolutely no chance I am pregnant.
On 11/14, pt began vomiting and passed one black, tarry stool. He presented for evaluation the following day and was found to be tired, somewhat lethargic, and mildly dehydrated. He was ultimately found to have intussusception that required surgical intervention.
Fever, body aches, headache, nausea; Fever, body aches, headache, nausea; Fever, body aches, headache, nausea; Fever, body aches, headache, nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 12:45 (Batch/Lot number was not reported) at 49-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination.  Medical history included High blood pressure, depression; both from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; lisinopril dihydrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; within 2 weeks of vaccination.  The patient previously took bnt162b2 for COVID-19 immunization 03Mar2021 at 49-years-old (administration time=17:00, vaccine location=Left arm, dose number=1), codeine (MANUFACTURER UNKNOWN) and experienced allergy on an unspecified date. On 30Mar2021 at 23:30, the patient experienced: fever, body aches, headache, nausea; all non-serious and for which no treatment was received. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.   No follow-up attempts are needed. No further information is expected.
I woke up on 1/8/20 at 2:00 am with my left arm hurting badly.  I felt feverish, chilled, with a headache and full body muscles aches.  I checked my temperature at 7am and it was 100.5 oral.  I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am.  It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.
Initial report received from a health care professional on 30 October 2007. An 18-year-old male with no known allergies received a first, right deltoid, Intramuscular injection of Adacel (lot number C2759AA) on 14 August 2007 and two weeks later (approximate date 30 August 2007), he developed a generalized rash with red pustules. During approximately the third week in September, the patient complained of problems with cloudiness in his central vision area. No problems were reported with his peripheral vision. The patient was hospitalized for three days and received treatment with steroids. Results of MRI, blood tests and spinal tap were reported to be negative. The patient was diagnosed with having an autoimmune response affecting the optic nerve secondary to vaccine. At the time of the report, the condition continued to persist without improvement. The patient felt it necessary to withdraw from school. No additional information was provided at the time of this report.
At around 1 in the morning on 01/03/2021 i woke up very cold. it took around 30mins to an hour for me to warm up and stop  shaking. i then noticed that i had pain in my shoulder where i received the vaccine. i also became nauseous, my head started hurting, and i had a temperature of 101.1.
A few minutes after the shot, I became dizzy, watery eyes, blurry vision, resolved in a few minutes and I drove home, woke up to  severe pain in my right eye, foggy brain, sharp/shooting pain in left  side of chest and left breast, headache (very rare for me to have a headache), toes began to hurt and brown spots with  excessive dry peeling skin  appeared with pain (more on right toes than left) and was unable to wear closed toe shoes, hit my thumb and a blood clot appeared (never had a blood clot in my life).  Both the toes and clot is just now beginning to get better ( and is just now starting to get better).  I continue to have blurry vision and  occssional foggy brain,
facial hives w/in 10mins of vax; also was dx w/OM @ time of visit;