chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Information has been received from a physician concerning an approximately 70 year old male who on approximately 14-JUL-2007 (within the last two weeks from 31-JUL-2007) was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 16-JUL-2007 (two days after vaccination) the patient developed general itching.  The physician believes this to be a "mild allergic reaction".  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion; Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unkonwn gender. On 12-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Patient received 1st dose of Pfizer Covid-19 vaccine on 11/19/21. She reports that approximately one half hour after administration developed significant headache, and small area of hives.  Patient has a history of general malaise, fatigue, headache, myalgias, and nausea to seasonal influenza vaccine and as such requested the two not be administered the same day. Patient reports she then received the seasonal influenza vaccine on 11/23/2021. She reports the rash that appears after her Covid vaccine resolved within 24 hours but her headache never resolved. She received the Seqirus seasonal influenza Flucelvax vaccine intramuscular to her  left arm with a lot number of 308446 and expiration date of 06/26/2022 . She reports since then her headache persisted,  she became dizzy, fatigued, body aches, abdominal cramping, nausea, and ultimately retching. The retching started on day 10 after influenza vaccination. Symptoms (primarily the headache unresponsive to at home acetaminophen and ibuprofen as directed on OTC labeling. Patient was unable to work on 11/29 and 11/30 due to headache worsening with computer work and overall general fatigue and malaise and ultimately presented for evaluation on 12/01/2021. She was provided IM Toradol 30mg for her headache, 4mg ODT tabs of ondansetron for the nausea, advised to increase fluid intake as able and notify office in 24 if no improvement at which time lab work will be completed.
Slight sore arm for a short duration; Administered vaccine to a 17-year-old patient; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm for a short duration) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (Slight sore arm for a short duration) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient). On 23-Dec-2020, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 17-year-old patient) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm for a short duration) 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.   Concomitant medications were not provided. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Small, itchy, pink bump at the second injection site; Small, itchy, pink bump at the second injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm right on 08May2021 at 11:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included Birth control tablets and multivitamin tablets from on an unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 17Apr2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 11:45, the patient experienced small, itchy, pink bump at the injection site that appeared seven days after. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event small, itchy, pink bump at the injection site was not resolved.   No follow-up attempts are needed. No further information is expected.
My arm was pretty sore after receiving my second dose. Two days after receiving my vaccine, I started to experience a mild case of vertigo. I have experienced this in the past. I went to see an ENT, and he arranged for me to see a Physical Therapist. While there, I wasn't experiencing the vertigo anymore, so they did not perform any tests on me.
mom states fever began (101) same day vax;took pt to MD 21APR96 where dx w/ear inject & a cold & placed on amoxicillin;rash present when awoke this AM on stomach & between legs;advised contact PMD;
Next day, patient had local swelling and redness at site of vaccination. Next day woke up feeling chills, myalgia, muscle ache and weakness, real malaise and fatigue. Patient did not have fever, did not have headache or nausea. Profound fatigue, brain fog and trouble concentrating/focusing lasting for about 5 days. By third day developed acidic stomach that has not resolved yet; patient had acidic reflux in past but has been off for many years successfully. On 4/23, started to feel earlier symptoms again that had resolved already; this time there was a low grade fever 102. It has been very debilitating. Took Motrin/Advil to help with symptoms seems to help with myalgia--taken as needed. Doctor appointment scheduled for 5/1 at Hospital Internal Medicine.
Dizziness "hard" at injection site with a lot of pain, radiates to neck. nausea, blurry vision, clammy hands & feet. Narrative:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years 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: "Hypertension" (unspecified if ongoing); "pulmonary hypertension" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (03Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received the COVID 19 Treatment from 23May2022 to 27May2022 through the oral route. Rebound COVID-19 symptoms with positive test.  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 information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Swollen armpit - left arm. Very sore and hurts.; Swollen armpit - left arm.; Arm also hurt near injection spot.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0196) via an unspecified route of administration in the arm left on 26Jun2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187) via an unspecified route of administration in the arm left on 05Jun2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Jun2021, the patient experienced swollen armpit - left arm, very sore and hurt. The patient's arm also hurt near the injection spot. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events swollen armpit - left arm, very sore and hurt and arm also hurt near injection spot were not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
nausea; vomiting; diahrea; i don't feel good like i used to; upper and lower stomach gas; she had a flu shot on 29Oct2021 same time as the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 07:20 (Lot number: FE3590) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 29Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Nerve pain" (unspecified if ongoing); "Keep arteries open" (unspecified if ongoing), notes: Verbatim: Keep arteries open; "Control herpes" (unspecified if ongoing); "Restless leg" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Anaphylactic shock syndrome" (unspecified if ongoing), notes: Onset date: 30 yrs ago, Stop date: No, details: Brought on by stress hospitalized several times; "Plastic surgery" (unspecified if ongoing), notes: Onset date: 15 yrs ago, pertinent details: accident repaired facial wounds; "Tubal ligations" (unspecified if ongoing), notes: Verbatim: Tubal ligations, Onset date: 40 yrs ago. Concomitant medication(s) included: ALENDRONATE SODIUM (ongoing); CRESTOR taken for artery dissection (ongoing); GABAPENTIN taken for neuralgia (ongoing); ACYCLOVIR taken for herpes zoster (ongoing); PRAMIPEXOLE taken for restless legs syndrome (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Location: Left arm, ROA: Intramuscular, Lot/Batch number: EL9262), administration date: 27Jan2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose no: 2, Location: Left arm, Lot/Batch number: EN6W0), administration date: 22Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 29Oct2021, outcome "Unknown", described as "she had a flu shot on 29Oct2021 same time as the booster"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; VOMITING (non-serious), outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious), outcome "not recovered", described as "diahrea"; MALAISE (non-serious), outcome "not recovered", described as "i don't feel good like i used to"; FLATULENCE (non-serious), outcome "not recovered", described as "upper and lower stomach gas". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the last booster, Patient had constant upper and lower stomach gas. She got some nausea and even vomiting at times. She had ongoing diarrhea. She was planning to try to see a doctor about this, but she know that they are not making appointments for 3-4 months out. She said that she believed the events would never go away. She didn't feel good like she used to. she had a flu shot on 29Oct2021 same time as the booster.  No follow-up attempts are possible. No further information is expected.
Fever with 1st vaccine. Fever and c/o difficulty breathing during the night vaccine had been given. No medical attention was sought.
Pfizer vaccine administered after being stored at regular freezer temps longer than recommended.  Dose determined invalid, client contacted and recommended repeat dose.
lymph node swelling in both arms not just the one that recieved the vaccine, and right leg weakness of 2 days duration and headache for which she took advil
101 degree fever, body aches, chills, severe headache, injection site pain, sore arm
Admitted 72 hours after 2nd Moderna dose with acute onset chest pain, EKG changes, positive troponin and elevated CRP. Coronary CT ruled out coronary disease.  Transthoracic echocardiogram revealed EF 55-60% with inferior wall hypokinesis.   Findings on cardiac MRI consistent with acute myopericarditis.
Gave an expired vaccine.  Unfortunately, there was one vial of Pfizer vaccine that was not disposed of following expiry.  The dose was accidentally given instead of the Pfizer bivalent vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Pt's blood pressure at time of incident was 137/99. Pt also looked paler than usual. Pt is recovering with no worsening symptoms 10 minutes later under further observation
This spontaneous report was received from a female consumer who was vaccinated SQ with a dose of 0.65 ml ZOSTAVAX (lot# not reported) on an unspecified date. It was reported that the patient developed lesions and rash on her back that continued to spread. The patient stated that it felt like she was being bitten from the inside. Patient received allergy and other unspecified treatments to treat the condition unsuccessfully. The patient received STROMECTOL (MSD) prescribed by her physician, in 2009 which treated the condition successfully for 6 months and 10 days. After this 6 month and 10 day period the rash returned at full force. Since the return of her symptoms the patient had gone through additional testing and unsuccessful treatments including having ZOSTAVAX as a possible treatment if the condition were related to a shingles outbreak, which the patient later confirmed was not the cause of her rash. The patient was also treated with permethrin cream (manufacturer unspecified), which made her condition worse. The patient was also on NEURONTIN, DOXYCLIN, and "D3" (manufacturer unspecified), and put on an unspecified bisphosphonate therapy beginning with "A". The patient's current physician had been made aware of her various treatments and symptoms. It was unspecified if the patient sought medical attention. Additional information has been requested.
Pt had vaccine and said he fainted and fell down. When asked if he hit his head he said yes. His head was assessed for laceration or bumps, none were observed at the time of assessment.  He was under observation until he felt he was okay to go home. He was a&ox4 after vital signs were locations.
got tested positive for covid; got tested positive for covid; Earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got tested positive for covid"; EAR PAIN (non-serious), outcome "unknown", described as "Earache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got tested positive for covid. Clinical course: Caller's wife had 5 doses of Pfizer covid 19 vaccine and a booster. She got tested positive for covid and experienced sore throat and an earache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185908 different patient, same product/events.;
After my vaccine shot, I only had sore arm. But when my period started a few days later it was short. I bled for about 1.5 day which normally is 3-4 days. I thought it may have been just a one off but then went on to have abnormal period in July where it was very light and not full 3 days. In August I have a lot of bleeding during my period and I thought it could have been a chemical pregnancy or miscarriage as it was at 23 days instead of normal 28-30 days. In September I became pregnant and that pregnancy ended up in fetal demise. I started having high blood pressures not present in my previous pregnancy and issues in November. In December one of my test came abnormal and the doctor asked for the anatomy scan to be done. The test that came abnormal was the spina bifida one. We had done chromosomal abnormalities test ay 12 weeks and all came low/okay. During the anatomy scan, the date of the fetus shows different than my first sonogram but they can't find any abnormalities. I went through the genetic consult which they recommended to wait 4 weeks to do another anatomy scan and then do amniocentesis at that point. However on January 10th during my regular visit to the obgyn my baby didn't have a heartbeat. That week I carried on with the D&C at 20 weeks of pregnancy. The fetus was measuring around 16-17 weeks. A sample of the fetus was sent for test which came as normal. After this, my bleeding was also short just 3-4 days when the doctor has mentioned usually 7-10 days bleeding. When my period restarted, it was very light again and not quite full 3 days. It was around 27-28 days. My first period was Feb 19th 2022 again and the next one March 18th. The periods kept coming very light bleeding 3-4 days again but with 1-2 days of almost no bleeding. I also gained weight during that period and started feeling numbing on my feet and hands. I am exercising and keeping a healthy diet but I suspect after all this my hormones are probably still stressed or not stable enough for my body to return to pre-vaccination state.