chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/20/21 11:30am - vaccine given 3/20/21 5:00pm - muscle soreness at injection site 3/21/21 4:00am - severe nausea, fever, chills 3/21/21 (entire day) - nausea, fever, chills, headache, muscle pain, fatigue  3/22/21 - mild nausea, fatigue, diarrhea
Few hours, post vax, pt developed fever, irritability and wheezing. Treated at home with antipyretics and albuterol nebs. Fever stopped, 4 days, post vax, but wheezing continued.
On-and-off tingling in shoulder, upper left arm near area of injection, extending a bit to the left neck area. Also experiencing some itchiness in those areas.
No additional AE/PQC.; to report inadvertent administration of ROTATEQ to a patient after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # X004919, oral (strength, dose number, dose, and expiration date were not provided) for prophylaxis during 32 minutes under temperature of 08.4°C (product storage error). There was no previous temperature excursion.  The nurse stated product was not expired but would call back to provide the specific expiration date. No additional  adverse event reported.
Patient was to receive her first dose of pediatric Pfizer vaccine. Instead of receiving the pediatric dose, she received the adult Pfizer dose. As of 11/12 patient only has a sore arm. Mother gave her ibuprofen on 11/11 at night.  No fever or other side effects yet. Going to see the doctor on 11/13
Patient had his first Moderna booster 0.25mL. He stated he had a red rash at the injection site and swelling 2 days later; went to the ER. They gave him an antibiotic. He never had a reaction to the first two doses.
Patient received flu vaccination at 4:00 pm. Around 6:30 pm she experienced dry cough, itchy throat and eyes; this became progressively worse; her tong and throat started swelling up. Family called "911", patient taken to hospital. Condition stabilized in the E.R., by 10 pm. Pt discharged home by 11 pm. Pt seen by private MD for follow-up on 10/18. Recovery complete.
Patient is pregnant at the time of vaccination/ Gestation period: 30 weeks; Dizziness; Tachycardia; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 02Sep2021 at 08:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included recurrent kidney stones and cluster headaches. The patient's last menstrual date was on 08Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent SARS-CoV-2 polymerase chain reaction (PCR) test via nasal swab on 16Jan2021, 09Feb2021 and 16Jun2021 respectively and the results were negative. The patient received other vaccine within four weeks prior to the COVID-19 vaccine which included first dose of tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine (MANUFACTURER UNKNOWN), Lot Number: 59TH3 in the left arm on 16Aug2021 for immunisation. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), levetiracetam (KEPPRA) and acetylsalicylic acid (ASA)/butalbital/caffeine/codeine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received sumatriptan (MANUFACTURER UNKNOWN) and experienced drug allergy. On 02Sep2021, the patient experienced dizziness and tachycardia. The gestational period was 30 weeks. The patient's estimated delivery date was 08Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. 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 dizziness and tachycardia was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fever 101F, Chills, Intense  body aches, headache, nausea. Duration was 24 hours
Gas and diarrhea, continuing with very little change from 12/09/2022 to the present (02/14/2023), being generally active for four hours in the morning, quiet for a couple of hours in late morning, active after lunch, then generally quiet for the afternoon and evening, sometimes acting up on the middle of the night.
19 h after vaccine started getting rashes on elbows, knees, ankles, butt, and neck that were very itchy / 28 hours after vaccine the rashes started getting worse and itchy ness increased significantly; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Aug2021 at 18:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included MAGNESIUM and unspecified birth control, taken for an unknown indication from an unknown date and unknown if ongoing. On 12Aug2021 at 13:30, 19 hours after the vaccine, the patient started getting rashes on elbows, knees, ankles, butt, and neck that were very itchy. 28 hours after the vaccine, the rashes started getting worse, and itchy-ness increased significantly. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 event rashes on elbows, knees, ankles, butt, and neck that were very itchy and the rashes started getting worse and itchy-ness increased significantly was not resolved 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.  This follow-up report is being submitted to amend previously reported information, Vaccination Facility was added.
had side effects; Nodules in my chest and breast area; extreme swelling; Nodules in my chest and breast area; lymph nodes were swollen and he needed a biopsy.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to antibiotics.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.). At the time of the report, IMMUNISATION REACTION (had side effects), MASS (Nodules in my chest and breast area), SWELLING (extreme swelling), BREAST MASS (Nodules in my chest and breast area) and LYMPHADENOPATHY (lymph nodes were swollen and he needed a biopsy.) outcome was unknown.            Patient's height was reported as 5'9". Patient had his first and second Moderna COVID-19 vaccinations as well as the first booster at the facility in contact 2. He had side effects to the first doses. No concomitant medication were provided. No treatment medication were provided.   Reporter did not allow further contact
swollen lymph nodes left side of breast caused positive mammogram  blood pressure elevated for 1 month, slowly returned to normal
Sunday 8-25-19 Patient reported that she has large spread redness and swelling about 9 x 5 inches and also soreness on the left arm where she got Flu shot which was administered on 08-23-19 . She also said that she developed itchy throat and congestion the next day after she got Flu vaccine. She reported that the swelling and redness has decreased compared to the first day. She said she is taking Tylenol for pain relief. The patient confirmed that she did not have any symptoms such as difficulty breathing, hives, swelling of throat and tongue or dizziness. She was advised to follow up with her doctor and seek immediate medical attention if she developed serious allergic reactions.
PROQUAD that underwent a temperature excursion was administered; No adverse event; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 19-JAN-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) Lot # T018274, expiration date 23-NOV-2021 for prophylaxis (dosage regimen and anatomical location were not reported). The temperature was reported to had been in between 14 °Fahrenheit (F) to 46 °F, specifically at 16.8 °F for  1 hour and 55 minutes. A previous temperature excursion was reported had taken place and temperature was reported to had been in between 5 °F to 14 °F specifically at 7.5°F for 6 hours and 53 minutes; and  between 5°F to 14°F,  specifically at 10.9 °F  for 12 hours and 46 minutes  No additional adverse effect reported and there was digital data logger involved.
Fever to 102.7, body aches. Fever not responding well to antipyretics.
06/27/1997 vax administered, 7/5/1997 seizures began (febrile, photosynthesis about seizures. No prior history of seizures.
The night of my first dose I got really sick  and almost went to urgent care. I woke up in the middle of the night with a fever,  chills, sweating and migraine.   A week after my second dose (8/25/2021), I noticed my right bicep where I got the  shot felt swollen and hurt while I was at work. When I got home I noticed a large swollen rash. The next morning it had spread, and urgent care prescribed a steroid and  something for the itching. 6 days later  (8/31/2021) I was taken by ambulance to the ER. They originally thought I had a seizure but have not performed  the proper tests but a followup has determined it was  possibly convulsive syncope and not a seizure. Also got a concussion from the accident and how hard I hit my face on the floor. Was advised by a nurse and a family friend with  their doctorate to fill this out.  I am the only person in my family that had a reaction to the vaccine.
11/4/17 1:00 AM until ~11:00AM 11/5/17 Fever between 100.2-102.6. ~1:00PM on 11/5/17, measles like rash appeared and remained until 11/13/17. Rash covered head, neck torso, buttocks, all extremities, and dorsum surfaces of feet and hands. Tylenol was given on 11/4/17 at 12:00 PM, 5:00PM, and 8:00PM. Fever between 99.0-99.8 came and went from 12:00PM 11/5/17 until 9:00PM 11/6/17. Patient was examined by Dr. on 11/7/17 and as per Dr., patient had vesicles in his throat. As per Dr., patient's symptoms were possibly caused by a reaction to the MMR vaccine that patient received on 10/26/17. Pt refused to eat acidic foods such as oranges and tomatoes from 11/5/17 until 11/10/17. Patient also presented with symptoms of irritability, avoidance of firm foods (bread, meat, apples), and difficulty sleeping.
On the 16th I had a kiddo who tested positive for Covid, she is also fully vaccinated as I am, I started having symptoms late that night. I went in to to the Dr. to take a test and it showed I was negative. My symptoms were getting worse and I thought that I had to be positive. I tested on the 19th and 21st at home both also showed negative. I did feel better on the 22nd and then had no symptoms on the 23rd but took one last test to be sure that test showed I was positive. Starting the 24th I had horrible symptoms and was out for about 2 weeks with symptoms. Coughing sore throat fever no taste or smell. The Covid did cause a flare up from my existing condition, Urticarial vasculitis.
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JAN-2016, the patient was treated by a physician at a medical center for a vesicular outbreak, which was then diagnosed as herpes zoster conjunctivitis. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, herpes zoster conjunctivitis was considered to be medically significant. Additional information has been requested.
Information was received on 13-MAR-2017 from a Licensed Practical Nurse who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. On 10-MAR-2017, the patient received their first dose of M-M-R II (lot L00721, expired 03-MAR-2017) (site, dose and route not reported) for prophylaxis, that was past it's expiration date. The vaccine was administered by a registered nurse. No adverse effects reported. No other information was provided. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age and demographics concerns herself. Patient's current condition and medical history was not reported. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number not reported) subcutaneous injection. No concomitant medication was reported. On 04-NOV-2014, the patient presented with fever as well as pain, redness, itching and burning at the injection site. There was no product quality complaint involved. Action taken and the outcome of the events were not reported. Causality was not reported. Additional information has been requested.
2JUN local discomfort; no fever; 3JUN low grade fever; coughing & clear runny nose; 4JUN awoke 10AM fussy, whimpering; laid down on kitchen floor; in car pt slump forward & was unresponsive; seen in ER: was awake w/minimal response to tests
Injection site soreness, unable to lift left arm very high.  Headache worsening on day 3 after shot.
Patient was given Trumenba in error. Due to age, patient is not eligible for the vaccine. Patient was not correctly identified by the administering nurse  from the older sibling, who was supposed to get the vaccine, and was instead given the vaccine. Per a conversation between the medical provider and the patient's mother, she has had a headache and some vomiting. It is unclear of whether receiving the Trumenba prematurely has caused her symptoms; however, we felt it necessary to report the incident.
Nausea, Vomiting, fever, chills, body aches, severe headache. (49) hours  Fatigue, headache , lightheaded continue
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to ED on 4/24/21 with chest pain that radiated down left arm with shortness of breath. Over hospital stay, patient experienced HF exacerbation with hypoxic respiratory failure, multi-organ failure, and lactic acidosis. Patient eventually underwent cardiogenic shock from a heart attack. Patient was transitioned to comfort care and later passed away on 4/25/21. Patient had comorbidities including CAD s/p 4 stents, HFrEF, CKD4, AFib, T2DM, HTN, IDA.
Rash behind site of injection on day of administering & fever 102 day after injection.  TX of TYLENOL.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; the vial was initially stored in the refrigerator on 23-Dec-2022, Dose administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Dec-2022, Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Dec-2022, Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Dec-2022, Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23-Dec-2022, Dose administered after 30-day Use By Date).    No concomitant medication were reported.  Vial size was 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. Dates of administration of vaccine were 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.  This case is of patient 16 out of 42 patients, as described by the reporer.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
after about 12 hours had slight chills, no fever, by next morning- was nauseous, dizzy (to point of nearly passing out when standing), weak.  After several hours of sleep following day- by about 5pm felt better.
breakthrough case of covid 19 after 2 doses of Pfizer covid 19 vaccine given over 14 days prior to illness
pt given immun 25FEB93 2 days later mom took pt to ER w/fever of 106; checked by ER MD given Antipyretics which brought fever down; mom states pt also had cold & diarrhea;
Client called reporting that she noticed her arm was having an increase in discomfort and swelling that evening (Friday November 17th). By "late" Saturday evening (November 18th) her arm was red, swollen, and itching. Client reports taking Benadryl at night for the itching and states that she "believes it is helping". Client called Monday afternoon to report adverse reaction, continues to have symptoms. States she does not believe she needs to see a medical provider for it but she will update her doctor next month during her routine scheduled appointment.
Headache, Myalgia, Fever, CHILLS, WEAKNESS Narrative:
3-day course of chills (2 x at hs on day of administration and day following), fever (max 102 deg oral on day 2.5), fatigue, muscle pain throughout upper body muscles, and moderate pain (5/10) in deltoid where vaccines administered, with heat but no obvious redness or swelling. Treatment by patient ibuprofen, fluids, bed rest.
Was acting normal all day, but had fever and runny nose and was whiny.  Three minutes before the seizure, began to stare at a spot on the ceiling and wouldn't respond.  Then, began to shake and became completely stiff.  Called 911, ambulance came within 2 minutes.  The seizure(s) lasted for more than 1 hour, even after being administered 4 different medications in the ambulance and ER.
This spontaneous report was received from a pharmacy student refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent which was used for the reconstitution of ZOSTAVAX. On 11-JUN-2018, the patient was vaccinated with ZOSTAVAX (dose, units and frequency not reported) (lot# and expiration date not reported), intramuscularly. No side effects were reported. No product quality complaint was involved.
About 24 hours after the vaccine was given, I had sweats, fatigue, dizziness, nausea and homicidal ideation. The fatigue continued for 3 days and the other symptoms resolved within 48 hours after receiving the dose.