chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lack of drug effect; tested positive for Covid in November of 2021; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021). At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID on November 2021.         Concomitant medication was not reported. Treatment information was not reported.  Company comment: This spontaneous case concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (28 days between doses) and, at the time of the report, the outcome is unknown.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (28 days between doses) and, at the time of the report, the outcome is unknown.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Body aches, chills, upset stomach, headache, still sick 2 days later but improving.
Approximately 20 hours after receiving the vaccine, and after having no other side effects, I became very light headed and passed out   I ended up passing out two times in a span of twenty minutes.
have been feeling like a little warm; Chills; Headache; second time she took her temperature it was 101; This is a spontaneous report. A contactable consumer reported for a female patient (daughter). A female patient of an unspecified age received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0170), via an unspecified route of administration on 06Jul2021 as single dose for COVID-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of bnt162b2 on 11Jun2021 for COVID-19 immunisation. Parent stated, her and her daughter had received second dose yesterday the Pfizer vaccine which was 06Jul and her daughter have been feeling like a little warm, she had been having chills and she also been having headache and she also had taken her temperature the first time it was 96.1 and second time she took her temperature it was 101 and they wanted to report that. Patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature: 96.1 on 06Jul2021, body temperature: 101 on 06Jul2021. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Two blotchy spots at the injection site; vaccination site warmth; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Two blotchy spots at the injection site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE WARMTH (vaccination site warmth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced RASH MACULAR (Two blotchy spots at the injection site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE WARMTH (vaccination site warmth). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, RASH MACULAR (Two blotchy spots at the injection site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE WARMTH (vaccination site warmth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.
tenderness; swollen lymph nodes; headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 08:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of the COVID-19 vaccine. On an unknown date in 2021, the patient experienced fatigue, headache, tenderness, swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, tenderness, swollen lymph nodes was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
received an expired dose of VAQTA; This spontaneous report has been received from a certified medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 25-NOV-2019, the patient was vaccinated with an unspecified expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis lot#R032910 and expiration date 18-NOV-2019 (dose, and route of administration were not reported). The outcome of expired product administered was unknown.
did not mix Shingrix adjuvant suspension into Lyophilized gE Antigen; patient received Shingrix adjuvant suspension only; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The case was reported by buyer who supplied Shingrix vaccine to the long term care facility.  As per the reporter, the registered Nurse did not mix Shingrix adjuvant suspension into Lyophilized AgE Antigen. The patient received Shingrix adjuvant suspension only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter did not have details regarding, in which arm vaccination was given, first or second dose and the patient's Heath care Professional. The reporter consented to follow up.
20 year old female experienced sycopal episode after receiving Pfeizer COVID booster. Patient collapsed after 15 minutes of observation and was helpedto the flood by RN. Patient experienced LOC but awoke less than a minute after event. She did not have any trauma. D stick from the event was reported WNL, Vitals showed BP of 70's/40's. She was laid down on a stretcher and given fluids. BP's returned to baseline without any other interventions. 911 was  activated and patient was transported to hospital with parent.
whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
Patient admitted to hospital with a platelet count = 0.  Patient presented with fatigue, mouth sores and body rash and extensive bruising. Patient also tested positive for COVID 19.
At 10:30pm on date of vaccination, she felt chest pain by her heart behind her chest plate. She went back to sleep. About 3:30 am she woke back up stating that it felt like there was weight on her heart and it was fluttering. It felt like something was compressing on her heart. She stayed home, when I got off work at 2pm she still complained of chest pain. We called the doctor and they told us to take her to urgent care. At the urgent care, they gave her an EKG and everything checked out fine. The doctor assumed it was a side effect of the vaccine but everything was fine with her. By that Saturday 8/7/21 she did not feel any of the pressure or fluttering anymore.  The night of the vaccine, she did also have a headache, fever, and chills.
Physician Reports Pt. received the 1st dose of Moderna 10/19/2021, started experiencing symptoms of dizziness, swollen lips, hives, nausea, left arm numbness and tingling, and extreme fatigue. Suspected Antifalactant Shock, visit to Clinic with recommendations to follow up with Primary.
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Pt experienced stool change to clay color consistency /p vax /w Engerix .
cough; very unwell; feeling unwell with the flu; feeling cold; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Patient takes pills to maintain blood pressure.). Concomitant products included blood pressure medicines for Blood pressure management, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold) and NASAL CONGESTION (nasal congestion). On 28-Jan-2021, the patient experienced COUGH (cough) and VACCINATION COMPLICATION (very unwell). At the time of the report, INFLUENZA LIKE ILLNESS (feeling unwell with the flu), FEELING COLD (feeling cold), NASAL CONGESTION (nasal congestion), COUGH (cough) and VACCINATION COMPLICATION (very unwell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test positive: positive rapid test for covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included use of ibuprofen and intake of cinnamon water with lemon and ginger
6/3/99 sore arm, fever, h/a & back pain-fainted @ 11:00 & was taken to ER via ambulance;blood work indicated virus;
This case was reported by a healthcare professional and described the occurrence of accidental asymptomatic overdose in a 5-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ENGERIX B, poliomyelitis vaccine and unspecified (Polio vaccine). Concurrent vaccination included MMR vaccine (Merck) given on 12 September 2008. There were no concurrent medications. On 12 September 2008 the subject received unspecified dose of PEDIARIX at 0.5 ml in the left arm, 2nd dose of ENGERIX B and 2nd dose of Polio vaccine. This was considered to be an accidental asymptomatic overdose due to the excess hepatitis B and polio vaccine. No adverse events were reported. The healthcare professional considered the event was clinically significant (or requiring intervention) as she was having to contact GSK for safety considerations. For sibling case, please refer to case number A0748848A.
Very sore at injection site for 3 days, severe lethargy for 36 hrs and slight fever and flu symptoms for 24 hrs.
Headache, NauseaVomiting,  Fatigue. symptoms lasted a few days, migraines occurred more severely that prior to vaccine Narrative:
Throwing up all night; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Throwing up all night) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Throwing up all night). At the time of the report, VOMITING (Throwing up all night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.          Reporter did not allow further contact
Large local swelling on thigh around site of DTaP/IPV injection. Self resolved after 5-7 days. No systemic symptoms.
This spontaneous report was received from a other health professional (healthcare worker) refers to a 74 year old female patient with hypertension, diabetes, hyperthyroidism, transient ischaemic attack and high cholesterol. On 26-JAN-2015 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot # K016294, expiration date: 28-APR-2016). Concomitant therapies included lisinopril (Manufacturer unknown), clopidogrel, levothyroxine sodium (Manufacturer unkonwn), simvastatin tablets, metoprolol, metformin, anagrelide hydrochloride and KEFLEX. On 27-JAN-2015, the patient experienced injection site rash, injection site erythema and injection site warmth since she developed a hot, red, sore, 3-4 inch rash at the site of PNEUMOVAX 23 injection. On an unknown date patient went to see the physician and was treated with penicillin. Outcome of the events was reported as recovering. Causality assessment was not provided. Additional information has been requested.
I received my Pfizer booster shot on Oct 13th and around 25th, I noticed that my armpit was sore. I felt for any lumps or swollen lymph nodes but there were not any. The side of my arm hurt and sometimes there was chest pain that seemed to radiate from the arm. Few days later, I developed foot pain and one day after the foot pain, my left leg started to tingle. Both my legs felt extremely weak as well. The weakness only lasted for one day but the tingling continued for 2 weeks. Both my arms then started to hurt; especially joints and muscles. No tingling in the arms. All the pain went away mid December but it returned again around January 6th. It again started with underarm pain and arms and legs pain. The pain in the underarm, arms and the legs continued for 1 week and a half after January 6th and now is decreasing. There was no tingling sensation this time, only pain. I started taking Vitamin D and B supplements mid December. As of 1/31/2022, the pain in my arms and legs come and go but it is decreasing and not getting worse. I have not been to the doctor as the pain is decreasing but I wanted to report it here as it is possibly related to the vaccine. Additional note: I received my flu shot on Oct 9th, which was 4 days before receiving my Covid-19 vaccine.
Low grade fever, headache, chills, tiredness, joint & muscle pain, injection arm pain. Symptoms lasted 48 hours
Information has been received from a registered nurse via a company representative, concerning a 25 year old female who on approximately 22-JAN-2007 (about three weeks ago), was vaccinated with the second dose of Gardasil, 0.5 ml. Concomitant therapy included ZELNORM. On approximately 10-FEB-2007 ("within the past day or two"), the patient developed "a bump and bruise at injection site, and nausea. It was reported that the patient had "no ill effects after the first dose" (date not provided). At the time of this report, the patient had not yet recovered. The patient sought unspecified medical attention. Additional information has been requested.
ADACEL vaccine administered 7/29/10 Occ Health. Fasiculations developed 2 weeks later. Diagnosed with ALS 11/10. Expired Sept 2011.
Rash all over body. Treated with Benadryl, Cortisone injections. Rash has changed from small red bumps to dry burning rash today, 5/22/02. It is ongoing. (Brother is a doctor). Dx'd with allergic reaction.
Light Headed, Dizzy. Nausea, Vomiting. Cold Sweats.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318) and on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Jan2022 as dose 3 (booster), single (Lot number: D68h21a) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension"; "chronic migraines"; "chronic pain"; "chronic fatigue"; "possible gerd"; "chronic sinus infections". There were no concomitant medications. Past drug history included: Thyme, reaction: "Known allergies: Thyme". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Approximately @1900 day after vaccine I started experiencing a headache, stuffy nose, and drainage accompanied  with cough.  Since then it has steadily been getting worse. My head is achy and stuffy. I am fatigued, running low grade temp, and been sleeping a lot the past 2 days.  I have been taking Benadryl liquid and ibuprofen. Symptoms still the same. I feel a bit dizzy but I associate that with Benadryl for 2 days.
sudden strong dizzy feeling while walking/ light headed feeling; felt off; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included eszopiclone (LUNESTA) 3mg and cetirizine hydrochloride (ZYRTEC) as OTC, daily night time. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:30, the patient experienced sudden strong dizzy feeling while walking. It was reported that, the patient was cleared, felt off (feeling abnormal) and slightly light headed. Light headed feeling was persisting, slightly dizzy almost like the patient could become nauseous but not. Slightly dizzy was persisting. The adverse event did not result in doctor/other healthcare professional office or clinic visit/emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of event sudden strong dizzy feeling while walking/ light headed feeling was not resolved and felt off (feeling abnormal) was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.