chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drippy nose; Temperature was recorded at 99.4 degrees considers a low grade fever; Soreness in the left deltoid; Fatigue; A spontaneous report was received from a consumer, concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in the left deltoid, fatigue, temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose.  The patient's medical history reported, included immune/colitis disease. Concomitant medications reported, included Humair.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(batch/lot:011L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient experienced soreness in the left deltoid and fatigue. On 12 Jan 2021, the patient experienced temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose.  Treatment medications included Dayquil and Nightquil.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events soreness in the left deltoid and fatigue were recovered on 12 Jan 2021. Outcome of the events temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Patient came into clinic for a well child check. Patient received vaccines and one of the vaccines that was administered was expired by 7 days. Patient waited 15 minutes in clinic and no adverse reaction. I have contacted patient mother and no answer. Will be following up with patient mother to check on patient.
Atypical Migraine with sensitivity to light, sound, and movement. Lasted for a week past vaccination. Called Dr's office to access treatment for migraine and was sent to ER for evaluation based on symptoms and having just received the COVID-19 vaccine.
This spontaneous report was received from a medical assistant regarding a 46 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 16-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose: 0.5 ml, lot # L019835, expiration date 23-MAR-2017, via intramuscular route in deltoid in an unspecified arm). In December 2015, the patient experienced excess swelling and redness at injection site and it was very bad. The patient sought medical attention via coming to the office and received treatment with unspecified topical cream. The patient's outcome was recovered (in December 2015). The relatedness between the events and the vaccination with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
I did get a slight headache and feeling tired immediately after the vaccine, which resolved within 24 hours. Then beginning 5/1/2021, I went to the doctor for my routine doctor's visit and did blood work. The blood work showed diabetes 128 (fasting) and my blood pressure was high. The doctor prescribed Metformin for my diabetes and added amlodipine for my blood pressure. My sugars levels and blood pressure was still not control so the doctor had to increase the dosages. Recently, the metformin had been increased and added another drug called Trajenta for my diabetes. Also my Amlodipine also increased but due to weight gain and edema, it got changed to Coreg.
red, hot rash around injection site - looks like Covid Arm I have seen described online.  I did not have any such reaction after the first shot.
Patient reports having severe swelling at injection site with redness and pain. Then stated at times throughout the day patient felt bones were on fire and hurting severely. Pt only uses ibuprofen during those times. When asked if Ice or cool products were used none were listed. Patient reports bone pain gone as of Tuesday.
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, units frequency and route not reported) (lot# and expiration date not reported) too early. Reporter stated that, patient received doses of GARDASIL 9 on unspecified dates at 0 I 2 months I 3 months. No additional clarifying information provided and no adverse effects reported. No product quality complaint was involved.
Patient reported back to the pharmacy saying having trouble breathing. Didn't show any other signs of anaphylaxis. Patient had a conversation  with me and felt better when sat down and removed mask.
inappropriate schedule of vaccine; inappropriate age at vaccine administration; arm pain/hand pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ms.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the first week of July 2018. The patient experienced pain on whole arm/hand for about 3 days. The patient's age at the time of vaccination was less than the recommended vaccination age, that led to inappropriate age at vaccine administration. The patient could not get a hold of the vaccine for the 2nd dose and expected to receive it on the date of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient reports received vaccine 1/19/2022 approximately at 3:00pm and on 1/20/2022 approximately at noon- had developed facial drooping/bell's palsy
The evening of the injection (December 3, 2021) and next day I felt lightheaded, nauseous, fatigued and my left arm hurt. On January 28th, upon taking medication for Chronic Lyme & Bartonella, the left side of my face swelled. My left leg swelled and was very painful.  This swelling lasted about 4 days.  I have never had that reaction to the Lyme medications before. It's curious that the swelling and pain occurred on the same side as all three of my COVID-19 injections,
When I got my vaccine a few days later I got an uncontrollable itching all over my body. I had gotten COVID-19 before the vaccines were available and ended up getting COVID 19 toes. I now have what feels like a halo on my head that itches and right between my shoulder blades that itches, they do itchy constantly but not to the point that I am leaving scratch marks on my body like before. Medications from both my PCP and Dermatologist have not alleviated the itching.
Increase in urinary urgency  Headache Fever Diarrhea  Pain at site Joint pain
pt recvd flu vax 28OCT94 1045AM by the time pt was ready to go off duty that evening 10P-11P pt devel chills, Saturday joint ached & vomiting & diarrhea started; states diarrhea subsided Monday noc 31OCT94; some aching in the joints noted;
Fever- as high as 102, body aches, headaches. High fever last for 2 days, body aches and headaches til 3rd day. All good by 4th day.
Information has been received from a representative of the physician's office concerning a 19 year old female who was vaccinated twice with the varicella virus vaccine live. Subsequently the patient failed to seroconvert. Additional information has been requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
In approximately September 1998, the pt experienced a local reaction with erythema and swelling up to the elbow.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "In remission from SLL/CLL" (unspecified if ongoing), notes: In remission from SLL/CLL; "In remission from SLL/CLL" (unspecified if ongoing), notes: In remission from SLL/CLL. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; METOPROLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown Results, notes: Test: COVID-19 Antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Rebound Covid 29 antigen test three days after completing the 5 day course of Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date: 20May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client states felt warm sensation throughout body, feels faint, put head between legs - blood pressure taken 92/70 pulse 61 weak & thready pulse maker set for 60 respirations 20 regular- client states blood sugar 118 wnl for him client greyish looking.  Given fluids and sugar states feeling better and color returning able to leave clinic at 1:15 after speaking by phone to MD office.  Client states will visit MD office on the way home. Nurse accompanied client to his vehicle.
No adverse event. Administration Error--original manufacturer expiration date 9/30/22. Vaccine was given within extended manufacturer stability guidelines.
This spontaneous report was received from a physician and refers to a 11 year old immunocompetent male patient. Who had no chickenpox exposure or no history of breakthrough disease, he did not have shingles or rash. Additionally, there were not  drug reactions, allergies and concomitant therapies. On an unknown date, the patient was vaccinated with a dose of VARIVAX (route, anatomical place of vaccination, dose, dose number, lot# and expiration date were not provided), for prophylaxis. On 20-DEC-2016, the patient began having headache and vomiting and subsequently presented with aseptic meningitis. Subsequently, on 23-DEC-2016, the patient tested positive for varicella zoster virus in cerebrospinal fluid (varicella virus test positive). Additionally, a Magnetic resonance imaging (MRI) angio performed in approximately, December 2016 showed no venous fluid but, MRI of brain with contrasts showed no intracranial process. On 22-DEC-2016, the patient was hospitalized and received Acyclovir intravenous 350 mg (10mg/kg) every 8 hours for 10 days as treatment. Approximately, in January 2017 the patient recovered from the events and on 02-JAN-2017 the patient was discharged. The reporter considered the events as life threatening and serious. Nevertheless, the reporter did not provide a causality assessment between VARIVAX and the events. Additional information has been requested.
Serious* adverse events (irrespective of attribution to Covid - 19 vaccination Moderna two doses ' shots and additional dose of Bivalent - Omicron Booster) Heart failure. Thrombosis Blood Clots blocking blood flow in both legs and ankles Edema that require medical and surgical intervention to prevent one of the outcomes heart attacks. Chronic venous insufficiency. Water retention - discoloration of skin. Swollen inflammation and fluid retention in the ankles, feet, legs and stomach and eyebrows. Loss of time at work, loss of promotion transfer opportunity and productivity due to illness and medical treatments. Experienced Inpatient hospitalization and prolongation of existing hospitalization. Taking medicines - such as some blood thinner medicines, contraceptive pills, therapy  A persistent, significant incapacity and substantial disruption of the ability to conduct normal life functions weakness of legs, not able to walk by myself without a worker, fatigue-tiredness, muscle and back and leg pains and vomiting. Loss of taste and appetite. Consisting dry cough. Unable to sleep. Sex and Intimacy with my husband due to chronic illness. Weight lost of over 20 pounds. Hospitalized numerous times on vaccine side effects, immune reaction and trombosis risk as per hospital studies consequences on health and many patients are experiencing due to Covid - 19 vaccinations and bosters.
Vaccine was found to be expired as of 8-31-21. Contacted Health facility. They then followed up with Moderna. Received confirmation from Moderna that vaccine given was still considered viable. No adverse outcomes noted.
Patient came to ER with left arm weakness gradually worsening for 2 weeks.  CT head showed brain mets.
This case was reported by a physician via call center representative and described the occurrence of reactogenicity event in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reactogenicity event. On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that he administered many doses of SHINGRIX to his patients. The reporter reported that, not withstanding the reactogenicity he had observed in his use of SHINGRIX with his patients. The reporter saw the benefit risk profile of SHINGRIX as favorable. This case has been linked with US2018148543, reported by the same reporter.
Patient was supposed to have received the vaccine for up to 36 mos. Patient did not turn 36 mos until 10/17.  No additional treatment or adverse event except for the wrong vaccine was given.
Painful swollen red rash on left arm near vaccine location - rash is about 6 inches long by 3 inches wide; have also been feeling unsual fatigue for the past two days, headaches, and diarreah.
This 62 year old employee works as computer specialist and sent to clinic for evaluation of reported adverse reactions to 2014 flu vaccines in relationship to ongoing health issue to include Hypokalemic Periodic paralysis (HOKPP). She advised she had no adverse events with influenza vaccines every other year from 2007 to 2011. In 2013 she received 2 flu shots, one in Feb and the other in Sept. She recalls feeling weak and foggy brained however she had just been diagnosed with HOKPP in August 2012 with these symptoms being similar to her HOKPP symptoms. On Oct 29, 2014 she again received her annual flu vaccination. She denied being ill and stated she had had no HOKPP symptoms for 9 months. Approximately 5 days later she stated she felt a throbbing sensation to left clavicle region (which is her signal of an attack) then weakness-paralysis to left arm/hand that progressed to include weakness to right arm, slurred speech and foggy brained. She advised she self treated with oral potassium (bananas, Brussels sprouts, etc) and physical symptoms typically resolving in <24 hours and mental issues resolving in 3 days. Past HOKPP symptoms would show resolution of physical symptoms in 2-7 hours with mental issues lasting up to 20 hours. She did f/u with her neurologist who researched and they determined the only new event/change in pattern was receipt of the flu vaccine. She also recalls she was instructed to increase her vitamin D the month before due to low levels. She reports experiencing up to 64 HOKPP episodes in last 21 years described as "strokes" with last event in Sept 2015 with cardiology stress test (triggered by drug induced adrenaline response). She requests consult with office to discuss how vaccines affect the use of potassium in the body and if she'll have another episode of HOKPP following the flu vaccination. She did receive a Tetanus diphtheria vaccination in May 2015 following a cut in ER in which she had no adverse reaction to. No other vaccines have been given/received in >10 years.
10/10/11 - 4mm mild redness at inj. site >15min. No induration, no swelling. 10/11/11 (L) upper arm with 4 cm firm erythematous area at vaccine inj site. T. 99 degree in office. Reported 10/10/11 PM T. increased 102 degree with nausea & vomiting. Tx cool compress, BENADRYL.
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in July 2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. On an unknown date in November 2018, the patient received her second dose of GARDASIL 9. No adverse effects were reported.
Tested positive on home; Tested positive on home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVIL 12 HOUR, start date: 27Apr2022, stop date: 28Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "Tested positive on home". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (02May2022) Negative; (06May2022) Positive; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested positive on home and PCR tests and took Paxlovid on 27Apr. Covid symptoms alleviated within a few hours. Tested negative 02May. 06May, woke with renewed symptoms, tested positive on rapid home test. Still positive with symptoms today, 08May. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out immediately after vaccine for a couple seconds and remained lightheaded for several minutes. We moved patient to the floor and called 911. Patient had her mother with her and once vitals determined to be ok the mother refused to go to hospital for further treatment.
On 11/09/2022 I had headaches for few weeks after the vaccine. At night my face was red. My blood pressure was high. On the 11/17/2022 I went to my doctor she also checked my blood pressure  which was extremely high it was 159/106. I never had blood pressure before but now I have it. My doctor prescribed me metoprolol 1 per day. I will be doing a follow- up with my doctor within 4 weeks. I haven't recovered from it yet.
25-APR-89 came in for routine physical and to receive TD Booster.  Last given 7-APR-79.  Returned to office 3 days later c/o swelling & redness at injection site, severe headache day after injection.  Treated w/warm soaks & Cefatin
Patient Received Kinrix on 06/13/2023 in the left Deltoid. Mom verbalized that pt. woke up this morning with her left arm "Swollen and Hurting". Per mom, Patient had also a slight fever. Patient Examined by provider and diagnosed with "Local Adverse Effect of Vaccine". Prescription of Diphenhydramine sent to the pharmacy. Mom instructed to observe patient and take her to ER if she experiences difficulty breathing.
Rash covering most of my right arm and significant swelling. Minor common reactions after injection. The swelling and rash occurred 8 days later and lasted 6 days. Arm continues to itch at night currently. No rash or swelling.
Discovered that child received 0.5ml instead of 0.25ml of the vaccine.
Fever 101 degrees Fahrenheit, local erythema and tenderness. No induration. Subjective report of severe pain.
Tingly arm, swollen arm where shot was done a bruise developed , severe arm pain, tightness of chest, fatigue, severe migraine, tender armpit, neck and chest area.  Nausea, Ringing of ears, muscle aches fast heartbeat. 2 weeks after shot arm still tender hurts to lay on arm all other symptoms went away within a few days.
Left leg swelling 1 week after 1st moderna vaccination Swelling decreased over time. No swelling by the time pt arrived for the second dose in the moderna vaccination series.
violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        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 medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that they were thinking this may have been a latent reaction.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.