chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergy.  Concomitant products included SERTRALINE for an unknown indication.    On 07-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 vaccine.  Company Comment: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, that occurred approximately 2.5 months after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with rebound COVID-19 symptoms and a positive SARS-CoV-2 test 4 days after completion of a 3-day-course of Nirmatrelvir, Ritonavir (Paxlovid) for the initial COVID-19 infection. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, that occurred approximately 2.5 months after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with rebound COVID-19 symptoms and a positive SARS-CoV-2 test 4 days after completion of a 3-day-course of Nirmatrelvir, Ritonavir (Paxlovid) for the initial COVID-19 infection. No information was provided on the previous 3 doses of COVID-19 vaccines received by the patient prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Hep B #3 administered at middle school setting- child presented 2 days later to school nurse, child states mother applied ice last PM- TC to mother- recommended OTC ibuprofen or Tylenol and Ice.
At 15:18 pt reported to observation RN that she is feeling dizzy. Pt noted to be pale, vitals takes at 15:20 are: T: 97.4 P: 75 RR: 20 BP: 138/80 O2: 99%. Pt provided water at her request and feet propped up on a chair. Pt vitals taken again at 15:30 are: T: 98.3 P: 91 RR: 16 BP: 119/74 O2: 99%. Pt reported dizzy feeling subsided. Pt discharged at 15:45 in her mother's care.
Pt is 86 yo male who received 0.5ml influenza vaccine IM inj into his left deltoid, (Sanofi-Pasteur; pre-filled; Lot# UT3640BA Exp - 06/30/2011) on 11/16/2010. Pt presented to ED 11/29/2010 with one week h/o headaches. He also stated he had approximately 3 days of generalized muscle aches, more noticeably in his hips & shoulders that was associated with some generalized weakness. Pt noticed, on awakening 11/29/2010, some worsening of his speech with swelling of his tongue & lips. He denied increased confusion. He has no prior history of CVA. CT of head demonstrated no acute intracranial abnormalities with stable chronic age-related changes per ED provider note 11/29/2010. Pt was discharged & told to f/u with PCP the following week. Pt returned to ED 12/1/2010 with increased generalized weakness, slurred speech, right sided facial droop, inability to eat, unable to void, and generalized headache. He denied any fever, chills or night-sweats, flu-like symptoms, or neck stiffness. He also c/o blurry vision & spinning sensation which changes with head position. His vertigo has been present for many years according to him. CT scan 12/1/2010 demonstrated possible chronic small vessel disease. Pt was admitted & neuro assessed pt & diagnosed him with GBS-Miller, Fisher variant R/O infection by neurology on 12/2/2010. Neuro started IV IgG for five day course at 0.4g/kg/day & completed all IV IgG therapy without adverse reaction. Pt remains in the hospital 12/6/2011, now in CLC receiving PT/OT. Pt is ambulating using GTW, & participating in "dynamic standing" activity. He is described as little unsteady ambulating w/o device during dynamic activity but no loss of balance per OT note 1/5/2011.
Pt. developed bil leg weakness within 5 days of the vaccine. Diagnosed with MS by MRI of brain on 11/23/17.
Large indurated area (6" x 3") on inside lt upper arm; Mildly warm & tender; Resolved w/in 48 hrs; tx ice 1st day, then warm compresses 2nd day;
Pt. reportedly had no chronic medical conditions prior to shot. 3 weeks after the shot she was hospitalized for a stroke, SAH, 2 ruptured aneurysms. 5 days later underwent right craniotomy w/ 2 clipped aneurysms, left brain stents, cranial angiogram. This was followed by months of extreme fatigue.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 22 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Cellulitis on left deltoid.  Site was swollen, warm and painful.  Patient received antibiotics for treatment.
Blurred vision, headache- started immediately after giving shot.  At 2pm mom called and patient had continued blurred vision, headache, and started vomiting.  Mom was told to take patient to ER.
19APR96 pt recv vax in the lt leg localized rxn included swelling greater than fifty cent piece
Cellulitis injection site - Rx doxycycline 100mg BID x 10 days.
sore throat, cramps, diarrhea, chest congestion, upper resp sx w/cough, yellow productive sputum & muscle aches;T99;
STARTED RUNNING FEVER ON 2ND DAY. RAN FEVER FOR A WEEK. I FELT LIKE I WAS GOING TO DIE. BECAME DEHYDRATED AND SPENT A DAY IN ER. THEY RAN ALL KINDS OF TESTS AND FOUND NOTHING THE MATTER OTHER THAN A SEVERE REACTION TO THE SHOT. THEY RECOMMENDED I NOT GET THE 2ND SHOT. I WAS VERY WEAK FOR THE NEXT 2 WEEKS AND MISSED 3 WEEKS FROM MY JOB. I STILL AM HAVING PERIODS OF WEAKNESS.
EPILEPSY, UNSPECIFIED 5/12/2022,  6/21/2022,  9/11/2022,  9/21/2022,  1/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Out of balance, weakness, not super dizzy, odd severe headache. There adverse reactions started several hours after vaccination.
Pt reported to clinic with complaints of rash and itching to arms, legs, and back that started less than 24 hours after receiving typhoid immunization. He also reported redness to neck and face this morning that had faded by the time he reported to clinic. Pt was given Benadryl 25 mg PO x 6 capsules. Instructed to return to clinic if symptoms worsen. Typhoid vaccine added to list of allergies.
Starting 3-4 days after injection, began to have increasing pain in buttocks.  Pain became more severe, spread to hips, then to knees/quadriceps over next 3 days - during this time, pain was relieved with Tylenol for 2-3 hours, then the pain would "break through" the Tylenol.  Three days after onset pain was unbearable and consistent for 2-3 days.  The pain slowly subsided over next 3 days without intervention.  Morphine and Valium was required to manage pain in ER.
Patient described constant blurred vision and palinopsia in her left eye only. This began one day after receiving her first vaccine dose and lasted approximately 4 weeks, resolving around 10/23/2021.  Today when I saw her she reported no issues, perfect acuity in both eyes, and no clinical signs of an adverse event. She reported no additional symptoms or health concerns. I believe she also received a flu shot some time after the initial covid vaccine; her PCP advised she wait longer before receiving the second covid vaccine given the recent flu shot. As of 10/27/21 she has not had the second dose.
Immediately broke out in a sweat and was very hot.  Didn't think much about it.  The staff noticed I was in some distress and kept asking if I was okay to which I replied I thought I'd be fine once I got some fresh air.  Left the facility to drive home and didn't feel right, Within 30 minutes, developed chest pains, rash and labored breathing.  I recognize the symptoms as the same symptoms I get when I've had morphine, which I now must list as an allergy.  This lasted 4 hours, then got better.  The next day around 1:00, I became ill again with flu-like symptoms and had to leave work.  Headache and body aches mostly.  I was ill with these symptoms for a 24 hour period.  Hopefully all symptoms have passed, except my arm which is red, swollen, itchy and feverish.
Mother called and states right leg - red, swollen, hot to touch.  Temp 102 rectal.  Taken to ER .  Was given BENADRYL, AMOXICILLIN.  Was told leg looked like Cellulitis.
No additional adverse events reported; Nurse reporting a dose of improperly stored VARIVAX has been administered to a patient on 18JAN2022; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration was not reported, lot # U020244 and expiration date 28-JUN-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 6 degree fahrenheit (°f) up to 14°F (31.8°F) for 1 hour an 45 minutes, and 14°F up to 46°F (14.4°F) for 25 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Headache, Myalgia, Arthralgia, Received COVID Vaccine 12/28 and developed symptoms 1 hour post-vaccination including nasal congestion, chills,and left arm soreness with a nodule at site of injection. Employee has chronic neck and back pain which were worsened after receiving the vaccine. The medications the employee is taking are her chronic meds for her chronic eck and back pain.
a rash appeared at the injection site; Injection site sore for a couple of days; felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash appeared at the injection site), VACCINATION SITE PAIN (Injection site sore for a couple of days) and FATIGUE (felt a little tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site sore for a couple of days) and FATIGUE (felt a little tired). On 19-Mar-2021, the patient experienced VACCINATION SITE RASH (a rash appeared at the injection site). The patient was treated with LORATADINE at a dose of 1 dosage form. On 14-Mar-2021, VACCINATION SITE PAIN (Injection site sore for a couple of days) had resolved. At the time of the report, VACCINATION SITE RASH (a rash appeared at the injection site) and FATIGUE (felt a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Pt recvd series of 3 Hepta B vax.  P/3rd dose on 03May90; pt failed to produce adequate antibody titers.
Mother reports fever of 105 F to 106 F and was to hospital.  Complained of decreased level of consciousness and unable to control temperature. Mother states physician diagnosed child with allergic reaction to H1N1 nasal mist.  Mother states was sent home once temperature decreased. ON 10/15/2009 client was taken to urgent care for same complaints.  Per Mother client was given a steroid and antihistamine injection and sent home. Mother states child had complete recovery after receiving medications.
10 month old patient received dose of Quadracel vaccine/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 10-month-old male patient who received dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 11-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA expiry date 13 August 2021] via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This case is linked to cases 2020SA129677 (Same reporter).
Body aches, fever 100.8, chills, loss of appetite, lasted about 24 hrs only.  Nausea lasted about 1 hr  Sore swollen arm at injection site sore for 6 days. They side affects put me to bed for the 24 hrs...slept through it.
Patient started with shortness of breath one hour after getting vaccinated.  She called our student health line.  We told her to call 911.  She did; the EMTs came and assessed patient.  Her oxygen levels were fine and she felt better. She did not go to ER.
Passed out immediately after 1st dose at pharmacy,  slight fever that night, moderate arm pain for a couple of days after,ankle and knee pain started a couple of days after.
17 years old adolescent was inadvertently administered Daptacel instead of Adacel (with no reported adverse event); 17 years old adolescent was inadvertently administered Daptacel instead of Adacel (with no reported adverse event); Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2023SA264531(CLUSTER).  This case involves a 17-year-old adolescent was inadvertently administered Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), Varicella Zoster Vaccine (Varicella Vaccine); Hepatitis B Vaccine and Polio Vaccine (POLIO), all for Prophylactic vaccination.  On 24-Aug-2023, the 17-year-old adolescent patient inadvertently received a dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection of standard strength (lot: C5969AD, Expiry date: 17-Feb-2024) via intramuscular route in the left arm for Immunization instead of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Graves' disease; This is a literature report from the Thyroid, "A case of graves' disease after the sars-cov-2 vaccine".  The authors present a case of new-onset Graves disease and thyroid storm within one week of SARS-CoV-2 vaccine administration. A 38-year-old woman received the SARS-CoV-2 vaccine (Pfizer- BioNTech) and 5 days later presented to the emergency department with sudden onset left lower quadrant abdominal pain. Her presentation was diagnostic of thyroid storm given her fever, tachycardia to 150 bpm and gastrointestinal symptoms (Burch-Wartofsky score 55). Thyroid function tests revealed TSH 0.008 uIU/mL (reference range 0.55-4.78 uIU/mL) and FT4 8.4 ng/dL (reference range 0.9-1.8 ng/ dL). Additional testing showed TSHrAb 31 IU/L (reference range <1.75 IU/L), TSI >40 (reference range <0.1IU/L) and TPO 1730 IU/mL (reference range <9 IU/mL). Thyroid ultrasound revealed a diffusely enlarged thyroid gland with heterogeneous echogenicity and increased vascularity. She has no personal history or family history of thyroid or autoimmune disease. A CT angiogram performed one year prior incidentally revealed thyroid gland enlargement measuring 7.3cm in transverse diameter. Beta blocker therapy was begun along with methimazole at a total daily dose of 60mg. It was titrated to 80 mg, due to persistent elevation of (free T4 5.1 ng/dL 5 weeks after initiation), with good response 2 weeks later (free T4 2.1 ng/dL). It is difficult to confirm a causal relationship between the SARSCoV- 2 vaccine and Graves disease. However, there have been other cases published of Graves disease occurring after SARS-CoV-2 vaccination. Potential mechanisms by which SARS-CoV-2 vaccines could trigger autoimmune disease are proposed. Adjuvants incorporated in the formulation stimulate autoimmunity in genetically susceptible individuals, a syndrome known as Autoimmune Syndrome Induced by Adjuvants. Molecular mimicry between the spike protein and host antigens could trigger a cross-reaction, inducing autoimmunity. Human antibodies developed against the SARS-CoV-2 spike protein cross-react with many endogenous tissues and substances, including thyroperoxidase. This cross-reactivity could be related to sequence homology between the spike protein and thyroperoxidase.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Basedow's disease cannot be excluded. The 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.
9 hour delay then onset of severe flu like symptoms lasting approximately 24-36 hours, tapering off to no side effects 12-18 hours later.
Aches and pains, fever and headache. Excessive tiredness. It's been 2 days so far but it seems to be getting better. I had minimal reaction to the first injection only a very sore arm the first time.
This spontaneous report as received from a 61 years old female patient with no pertinent medical history and with no drug reaction or allergies. The patient was vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (Lot # not reported) on 22-JUL-2012. There were no other co-suspects and concomitant medications. On 23-JUL-2012 the patient's left arm was "infected" as per what the nurse told her after getting the vaccine. Arm at injection site was red and had a bump 2" wide and 1" long. The patient sought for unspecified medical attention. No lab diagnostics studies performed. No treatment was given. At the time of this report the patient's status was unknown. Additional information has been requested.
This spontaneous report was received from a physician (a patient's colleague) via company representative and refers to a male patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On an unspecified date in approximately 2014 (reported as "approximately 2 years ago"), the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date, dose, anatomical location and route of administration were not reported). Directly following the vaccination, in approximately 2014, the patient was diagnosed with the Lou Gehrig's Disease (ALS). On an unknown date (reported as "recently"), the patient passed away. The cause of death was not provided. The outcome of the event of ALS was not reported. The reporting physician thought there might be a correlation between the event of ALS and vaccination with ZOSTAVAX. The relatedness between the patient's death and ZOSTAVAX was not reported. Upon internal review the event of ALS was considered as medically significant. Additional information has been requested.
HOT FLUSHING OF FACE,  STOMACH PAIN, LIGHT HEADEDNESS, SHORTNESS OF BREATH
"Covid Arm" : Arm at injection site became pink, itchy & somewhat tender to touch. Area was about 3" long & 2" across; slightly raised. Time Frame: April 13-18-21 No specific treatment as it wasn't particularly bothersome. Faded away after about 6 days.
The patient received Pfizer for their first dose and Moderna for the second dose. No signs/symptoms reported yet.